{"text_format":"1","workbook":"xlsx","n_sheets":9,"sheets":["PartA","PartB","Director Attestation","FDC Instructions","Common Findings","Definitions","ExportA","ExportB","Drop-down"],"not_rendered":{"charts":0,"images":0,"macros":1,"external_links":0,"defined_names":2,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"PartA","index":0,"n_rows":906,"n_cols":4,"rows_kept":906,"cut":false,"hidden":false,"merged":[[847,3,848,3],[849,3,854,3],[855,3,857,3],[859,3,864,3],[865,3,867,3],[822,3,823,3],[824,3,831,3],[903,3,904,3],[884,3,887,3],[888,3,889,3],[894,1,894,3],[895,3,898,3],[899,3,900,3],[901,3,902,3],[868,3,870,3],[871,3,876,3],[877,3,879,3],[880,3,883,3],[890,1,891,3],[833,3,839,3],[840,3,841,3],[842,3,846,3],[799,3,800,3],[801,3,807,3],[808,3,810,3],[812,3,814,3],[815,3,816,3],[817,3,821,3],[792,1,793,3],[796,1,796,3],[797,1,798,3],[779,3,780,3],[782,3,785,3],[787,3,788,3],[765,3,766,3],[767,3,768,3],[752,3,753,3],[754,3,757,3],[744,2,745,3],[735,3,736,3],[737,3,738,3],[729,3,731,3],[739,3,741,3],[689,2,689,3],[691,3,692,3],[694,2,694,3],[681,3,682,3],[684,2,684,3],[686,3,687,3],[673,3,674,3],[718,3,719,3],[722,3,723,3],[724,3,727,3],[709,3,710,3],[714,3,715,3],[695,3,696,3],[697,3,698,3],[700,3,701,3],[703,3,707,3],[658,3,659,3],[668,3,670,3],[678,3,679,3],[654,3,655,3],[662,3,663,3],[647,3,648,3],[636,3,638,3],[619,3,620,3],[623,3,624,3],[626,3,627,3],[608,3,610,3],[612,1,613,3],[616,1,616,3],[617,3,618,3],[630,3,634,3],[640,3,641,3],[643,3,645,3],[651,3,652,3],[601,3,603,3],[605,3,606,3],[592,3,593,3],[595,2,596,3],[584,3,586,3],[588,3,590,3],[575,3,576,3],[578,2,579,3],[564,2,565,3],[570,3,573,3],[500,2,500,3],[506,3,510,3],[487,3,488,3],[477,3,478,3],[558,3,560,3],[561,3,563,3],[539,3,542,3],[544,3,546,3],[527,3,529,3],[531,3,533,3],[535,3,536,3],[547,3,549,3],[550,3,553,3],[555,3,556,3],[501,3,503,3],[513,3,516,3],[519,3,522,3],[523,3,524,3],[467,3,468,3],[437,3,438,3],[440,2,441,3],[443,3,444,3],[445,3,446,3],[431,3,432,3],[434,2,435,3],[448,3,451,3],[454,3,456,3],[420,2,420,3],[421,3,422,3],[423,3,424,3],[427,2,427,3],[407,3,408,3],[409,3,410,3],[417,3,418,3],[399,2,399,3],[400,3,402,3],[404,3,406,3],[411,3,415,3],[425,3,426,3],[313,3,317,3],[353,3,354,3],[389,3,390,3],[395,3,396,3],[380,2,380,3],[383,3,384,3],[374,2,374,3],[376,3,378,3],[361,3,364,3],[366,2,366,3],[368,2,368,3],[350,3,351,3],[356,1,357,3],[360,1,360,3],[348,3,349,3],[372,3,373,3],[392,3,394,3],[386,3,387,3],[319,3,325,3],[328,3,330,3],[333,3,334,3],[337,3,340,3],[343,3,346,3],[304,3,306,3],[287,3,290,3],[298,3,299,3],[278,2,279,3],[280,3,281,3],[283,3,285,3],[273,3,276,3],[292,3,296,3],[308,3,311,3],[271,3,272,3],[245,3,248,3],[249,3,250,3],[233,3,236,3],[237,3,238,3],[226,3,232,3],[239,3,243,3],[252,3,257,3],[264,3,267,3],[259,3,263,3],[218,2,218,3],[219,2,220,3],[192,3,193,3],[196,3,197,3],[199,3,203,3],[181,3,183,3],[171,2,171,3],[172,3,173,3],[174,3,175,3],[204,3,207,3],[209,3,215,3],[164,3,165,3],[152,3,153,3],[158,1,158,3],[159,3,161,3],[139,3,141,3],[143,3,145,3],[147,3,148,3],[136,3,137,3],[131,3,133,3],[155,1,156,3],[65,1,65,3],[66,3,67,3],[51,3,52,3],[62,1,63,3],[54,3,56,3],[58,3,59,3],[73,3,76,3],[81,3,83,3],[905,1,906,3],[91,3,93,3],[72,2,72,3],[78,3,79,3],[221,3,223,3],[85,3,89,3],[117,3,121,3],[123,3,125,3],[127,2,127,3],[128,3,129,3],[106,3,109,3],[111,2,111,3],[112,3,115,3],[95,3,96,3],[98,3,99,3],[101,3,104,3],[6,1,7,3],[9,1,9,3],[11,1,11,3],[12,1,12,3],[1,1,1,2],[2,1,2,2],[3,1,3,2],[4,1,4,2],[48,3,49,3],[30,3,32,3],[23,3,24,3],[26,2,26,3],[27,3,28,3],[13,1,13,3],[14,3,17,3],[20,2,20,3],[36,3,38,3],[41,3,42,3],[33,3,34,3]]}
[]
[null,"Date:"]
[null,"Facility:",null,"Select Facility…"]
[null,"Facility Contact for Questions:"]
[null,"Facility Contact Email:"]
[]
[null,"Submission of this form should occur no later than August 16, 2024.  If updated information becomes available after August 16, 2024, please contact ORO at VHACOOROEDA@va.gov. "]
[]
[]
[null,"PART A - CHECKLIST OF RESEARCH - RELATED REQUIREMENTS"]
[]
[null,"Medical Facility Director - Institutional Responsibilities"]
[null,"Questions shaded in yellow are new questions from previous FDC versions."]
[null,"Questions related to Common Findings on ORO Combined Program Reviews will include an \"ORO Common Finding\" button. Clicking on the button for these items will navigate to the relevant section on ORO's Common Findings List."]
[null,"1.","Select…","Are there adequate resources and administrative support, including personnel, space, equipment, and training for the Research and Development Committee (R&DC) and its subcommittees to fulfill their responsibilities? \nVHA Directive 1200.01(1) §5.f(6); VHA Directive 1200.02(1) §11.e(2)-(3)"]
[]
[]
[]
[null,null,null,"If “No,” please provide comments in the space below."]
[]
[null,"2.","Has the Medical Facility Director:"]
[null,null,"Select…","a.  Appointed members of the R&DC and its subcommittees in writing? "]
[null,null,null,"VHA Directive 1200.01(1) §5.f(3)"]
[null,null,"Select…","b.  Delegated authority in writing for the roles and responsibilities within the facility’s Human Research Protection Program (HRPP)?"]
[]
[null,null,null,"VHA Directive 1200.05(3) §5.f(2)(c) "]
[null,"3.","Has the Research Compliance Officer (RCO):"]
[null,null,"Select…","a.  Maintained auditing plans and/or standard operation procedures (SOPs) for accomplishing required RCO informed consent audits and regulatory audits?"]
[]
[null,null,null,"VHA Directive 1058.01 §5.i(1)"]
[null,null,"Select…","b.  Completed all required annual informed consent and triennial regulatory audits for this reporting period?\nVHA Directive 1058.01 §5.i(1) "]
[]
[]
[null,null,null,"If “No,” please provide details in the space below. Include audit type(s) and number of audits to be completed. "]
[]
[]
[null,"4.","Select…","Are any of the following positions currently unfilled or held by acting or interim personnel? \nIf \"Yes,\" please select all that apply.  "]
[]
[]
[null,null,null,"If you responded “No,” click here to skip to Question 5."]
[null,null,"Select…","Medical Facility Director"]
[null,null,"Select…","Associate Chief of Staff/Research and Development (ACOS/R&D) or Coordinator/R&D"]
[]
[null,null,"Select…","Administrative Officer/Research and Development"]
[null,null,"Select…","RCO"]
[null,null,"Select…","Research Committee Coordinator(s)"]
[null,null,null,"Specify committee(s):"]
[]
[null,null,null,"For each position selected above, specify the effective date of the vacancy and any acting/interim assignments (including effective dates of assignments):  "]
[]
[]
[null,null,"Select…","a.  If the ACOS/R&D has been acting/vacant for longer than 6 months, has Chief Research and Development Officer (CRADO) approval been obtained? "]
[]
[null,null,null,"VHA Directive 1200.02(1) §11.b(4)"]
[null,"5.","Select…","Was any aspect of the research program subject to a research-focused investigation or review by a state, federal, or accreditation entity during this reporting period?  "]
[]
[]
[null,null,null,"If \"No,\" skip to Question 6."]
[null,null,"Select…","a.  Did the investigation or review result in issuance of a research-related citation or determination of noncompliance?"]
[]
[null,null,"Select…","b.  If \"Yes,\" was ORO notified as required by VHA Directive 1058.01?"]
[null,null,null,"VHA Directive 1058.01 §5.g(5)"]
[null,"NOTES: Use the space box below to provide any additional information about items in the Medical Facility Director-Institutional Responsibilities section: "]
[]
[]
[null,"R&DC and ACOS/R&D Program Oversight Responsibilities"]
[null,"6.","Select…","Does your facility use the R&DC of another VA facility?  \nIf \"Yes,” please specify facility:"]
[]
[]
[null,null,null,"If “No,” skip to Question 7."]
[null,null,"Select…","a.  If \"Yes,\" is an MOU/agreement in place that establishes this relationship?"]
[null,null,null,"VHA Directive 1200.01(1) §5.f(7) "]
[null,"7.","Has the R&DC:"]
[null,null,"Select…","a.  Reviewed all research review committees and subcommittees, including external committees relied upon by the facility, at least annually and provided the Medical Facility Director with written summary reports of each review?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §6.f; VHA Directive 1200.01(1) §8.a"]
[null,null,"Select…","b.  Reviewed subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes?"]
[]
[null,null,null,"VHA Directive 1200.01(1) §8.a(3"]
[null,null,"Select…","c.  Implemented a mechanism(s) to ensure documentation of all applicable subcommittee review and non-contingent approval has been received by the R&DC before a study is given final approval?"]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §9.b"]
[null,null,"Select…","d.  Implemented a mechanism(s) to ensure the R&DC documents its determination as to whether proposed research, which has been approved by an external Institutional Review Board (IRB), supports the VA mission and is relevant to the care of Veterans, is scientifically meritorious, and is compliant with security of VA data and specimen storage requirements?\t"]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §9.c  (1)"]
[null,null,"Select…","e.  Served as the review and approving committee of record or appointed another committee to be the committee of record, for research not meeting criteria for assignment to any subcommittee?"]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §9.d"]
[null,null,"Select…","f.  Ensured that the R&DC only approves those aspects of collaborative studies involving VA research?"]
[]
[null,null,null,"VHA Directive 1200.01(1) §10.a"]
[null,null,"Select…","g.  Reviewed justification and provided specific approval for recruitment of non-Veterans?"]
[]
[null,null,null,"VHA Directive 1200.01(1) §13.a"]
[null,null,"Select…","h.  Implemented a mechanism(s) to ensure the Information System Security Officer (ISSO) review of studies involving the collection, processing, storage, and transmission of research data and Privacy Officer (PO) review of studies using human data are complete before a study is given final approval?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §5.h(6); §5.i; §5.k"]
[null,"8.","Select…","Does the Research Program have a process to ensure investigators submit a VHA Research Protocol Privacy Review Checklist (VA Form 10-250) (if required) and an Enterprise Research Data Security Plan (ERDSP) to the PO and ISSO for all new   protocol submissions?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §5.l(3)"]
[null,"9.","Does the ACOS/R&D or Coordinator/R&D have a process to ensure:"]
[null,null,"Select…","a.  Written notification is provided to investigators when a research project can be initiated, and the period for which the project is approved, once the research project has been approved by all applicable subcommittees and the R&D Committee?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.01(1) §5.g(2)  "]
[null,null,"Select…","b.  All research personnel hold an official VA appointment from Human Resources Management Service (HRMS) as a compensated full-time or part-time employee, a Without Compensation (WOC), or under the Intergovernmental Personnel Act (IPA) prior to conducting or being involved in any way in VA research activities?"]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.02(1) §12.a(4)(a)"]
[null,null,"Select…","c.  All requests for WOC appointments for research have been appropriately justified and the appointments are in compliance with all applicable research, HRMS, and other VA policies?"]
[]
[]
[null,null,null,"VHA Directive 1200.02(1) §12.a(4)(b)"]
[null,"10.","Does the Research Office have an established system to track:"]
[null,null,"Select…","a.  Research studies, including study status, type of study, sponsor, funding source, PI, and required committee approvals?"]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(a)"]
[null,null,null,"If \"Yes,\" specify all tracking system(s) currently used for research committee management (e.g., VAIRRS, iMedris, affiliate research management systems, etc."]
[]
[]
[]
[null,null,"Select…","Is VAIRRS the primary protocol tracking system utilized at your facility?"]
[null,null,"Select…","b.  Research review committee actions, including all initial and continuing review approvals?"]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(b)"]
[null,null,"Select…","c.  Agreements, including all local Cooperative Research and Development Agreements (CRADA), research contracts, research Memoranda of Understanding (MOUs), and other written research agreements?"]
[]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(c) "]
[null,null,"Select…","d.  Personnel, including all investigators, research coordinators, research assistants, research technicians, and others conducting any aspect of research at the VA medical facility?"]
[]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(d)"]
[null,null,"Select…","e.  Completion of all ORD-required training and Annual Government Ethics training (for investigators) for all research personnel?"]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(e)"]
[null,null,null,"f.  An inventory of all research data:"]
[null,null,"Select…"," i.  that are placed in a research data repository for future use?"]
[null,null,"Select…","ii.  that are being stored until the retention requirement has been met per Record Control Schedule 10-1?"]
[]
[null,null,null,"VHA Directive 1200.02(1) §5.b(1)(f)"]
[null,"NOTES: Use the text box below to provide any additional information about items in the R&DC and ACOS/R&D Program Oversight Responsibilities section:"]
[]
[]
[null,"HRPP and IRB Responsibilities"]
[null,"11.","Select…","Is your facility's Federalwide Assurance (FWA) through the Office for Human Research Protection (OHRP) current and in good standing for your facility’s HRPP? "]
[]
[]
[null,null,null,"a.  Please provide the expiration date of the FWA:"]
[]
[null,"12.","Select…","Does your facility’s HRPP currently hold an accreditation through an external accrediting body?  "]
[]
[null,null,null,"If “No,” skip to Question 13. "]
[null,null,null,"a.  Specify the external accrediting body:"]
[]
[null,null,null,"b.  Specify the date of last accreditation visit:"]
[]
[null,"13.","Institutional Review Board(s):"]
[null,null,"Select…","a.  Does your facility operate its own internal IRB to perform review and oversight of human subjects research?"]
[]
[null,null,"Select…","b.  Does your facility use an IRB operated by your facility's academic affiliate institution(s)? "]
[]
[null,null,null,"If \"Yes,\" specify the affiliate:"]
[]
[null,null,"Select…","c.  Does your facility use an IRB operated by another VA facility?"]
[null,null,null,"If \"Yes,\" specify the VA facility:"]
[]
[null,null,null,"d.  Does your facility use any of the following IRBs?  \nSelect \"Yes\" if your facility currently relies on the IRB or is approved to rely on, if research has not yet been reviewed by the IRB:  "]
[]
[]
[null,null,"Select…","―Advarra, Inc. IRB"]
[null,null,"Select…","―National Cancer Institute (NCI) IRB"]
[null,null,"Select…","―National Institutes of Health (NIH) All of Us IRB"]
[null,null,"Select…","―Oak Ridge Associated Universities IRB"]
[null,null,"Select…","―Sterling IRB "]
[null,null,"Select…","―VA Central IRB Panels 1 and/or 2 "]
[null,null,"Select…","―VA Central IRB Panel 3"]
[null,null,"Select…","―WCG"]
[null,null,"Select…","e.  Does your facility use any other IRB not already identified in questions #13a through #13d above? "]
[]
[null,null,null,"If \"Yes,\" specify IRB(s):"]
[]
[null,null,"Select…","f.  If “Yes” to any IRBs in #13a through #13e, has your facility received approval from ORD to use the IRB(s)? "]
[]
[null,null,null,"VHA Directive 1200.05(3) §5.f(9)"]
[null,"14.","Select…","For IRBs other than an internal IRB operated by your facility, is there a current (i.e., not expired) reliance agreement or MOU in place documenting the facility's reliance on that IRB and the responsibilities that each entity will undertake to ensure compliance with the Common Rule and applicable VHA policies (e.g., VHA Directive 1200.05(3), VHA Directive 1058.01)?"]
[]
[]
[]
[]
[null,"15.","Select…","For cooperative research subject to the single IRB requirement, is there a mechanism(s) in place to ensure the research is reviewed by a single IRB unless an exception has been granted by ORD or another Common Rule agency?"]
[]
[]
[]
[null,null,null,"If cooperative research is not conducted, choose “N/A.\""]
[null,null,null,"NOTE: Effective July 19, 2018, single IRB review is required for all VA non-exempt Human Subjects Research with more than one institution engaged and the other Institution(s) is a federal institution (including another VA Facility) or the other non-Federal institution(s) is a recipient of Federal government funding or support for that research activity, unless the research was granted an exception from the requirement by ORD or other Common Rule agency."]
[]
[]
[]
[]
[]
[]
[null,null,null,"38 CFR 16.114; See also Single IRB Implementation in VAs at: "]
[null,null,null,"https://www.research.va.gov/programs/epros/education/webinars/orppe-030320.cfm"]
[null,"16.","Does the IRB have a mechanism(s) (e.g., written policies, procedures, checklists) to ensure:"]
[null,null,"NOTE:  Questions #16-18 should be answered from the perspective of the primary IRB (facility-operated IRB or academic affiliate IRB, or VA Central Panel serving as primary IRB)."]
[]
[null,null,"Select…","a.  For protocols reviewed by the convened IRB, the IRB minutes document that the IRB determined that all of the criteria for approval of the research were satisfied?"]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §8.c(1); VHA Directive 1200.05(3) §12.a(1)-(8)"]
[null,null,"Select…","b.  Informed consent documents contain all required elements?"]
[null,null,null,"NOTE: This includes VA-specific elements, including a statement that the VA will provide payment treatment for any research-related injury.  For research subject to the 2018 Common Rule, this requirements includes a concise and focused presentation of the key information at the beginning, and a statement about future use of identifiable private information or identifiable biospecimens for research that involves the collection of identifiable private information or biospecimens."]
[]
[]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §17; VHA Directive 1200.05(3) §17.b; VHA Directive 1200.05(3) §17.d(9)(a)&(b) as applicable; VHA Directive 1200.05(3) §17.e(7)-(9) as applicable; VHA Directive 1200.05(3) §17.g-h [waivers]; VHA Directive 1200.05(3) §18.b(2) as applicable      "]
[]
[]
[]
[null,null,"Select…","c.  Requests to waive informed consent are appropriately reviewed and determinations to grant waivers are fully and appropriately documented? "]
[]
[null,null,null,"NOTE:  For research subject to the 2018 Common Rule Requirements, if the research involves identifiable private information or identifiable biospecimens, approved waivers must document that the research could not practicably be carried out without using such information or biospecimens in an identifiable format."]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §17.h "]
[null,null,"Select…","d.  Requests to waive HIPAA authorization are appropriately reviewed and determinations to grant waivers are fully and appropriately documented and include the signature of the Chair of the IRB, or a qualified voting member of the IRB designated by the Chair?"]
[]
[]
[]
[null,null,null,"NOTE: Valid waiver authorizations must include a wet signature or a VA compliant electronic signature. "]
[]
[null,null,null,"VHA Directive 1200.05(3) §23.b "]
[null,null,"Select…","e.  For research subject to the 2018 Common Rule requirements, documenting the rationale for conducting continuing review of research that otherwise would not require continuing review (i.e., research eligible for expedited review, research receiving a limited IRB review, and research that has progressed to only data analysis and/or only accessing follow-up clinical data as part of clinical care)?"]
[]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §9.e(2)-(3) "]
[null,null,"Select…","f.  For research subject the 2018 Common Rule requirements, that one approved informed consent form is posted for clinical trials no later than 60 days after the last study visit by any subject to https://clinicaltrials.gov or http://Regulations.gov (Docket ID: HHS-OPHS-2018-0021)? \nIf clinical trials are not conducted, choose \"N/A.\""]
[]
[]
[]
[]
[null,null,null,"NOTE: For multi-site studies and/or sponsored studies, the responsibility for  posting the ICD may not be the local investigator’s or site’s responsibility, however, the facility should have a process in place to verify that the ICD is posted."]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §17.j "]
[null,"17.","Select…","Is broad consent allowed by local policy? "]
[null,null,null,"If “No,” skip to Question 18."]
[null,null,"Select…","a.  If “Yes” to #17, has broad consent been approved in conjunction with any active human subject protocols at your facility?"]
[]
[null,null,"Select…","b.  If “Yes” to #17a, has the IRB ensured broad consent is only approved for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens that are collected solely for research purposes?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §17.f "]
[null,"18.","Has the HRPP established written SOPs that are up-to-date and compliant with current Federal and VHA requirements including:"]
[]
[null,null,"Select…","a.  SOP(s) for review of research and reporting actions and determinations, including for expedited reviews?"]
[]
[null,null,null,"VHA Directive 1200.05(3) §8a; VHA Directive 1200.01(1) §6.e  "]
[null,null,"Select…","b.  A documented procedure for determining when research approved by the IRB prior to January 21, 2019 can transition to the 2018 Common Rule Requirements, if applicable?"]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §5.f(5)"]
[null,null,"Select…","c.  Any SOP(s) for review and reporting of unanticipated problems involving risks to subjects or others and serious or continuing noncompliance (if developed) have been updated to align with reporting timelines and requirements in VHA Directive 1058.01, dated October 22, 2020?"]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §8.a(4); VHA Directive 1058.01 §7.(b)-(c)  "]
[null,"19.","Select…","Is there a mechanism(s) in place to ensure the PO consistently reviews written HIPAA authorizations and waivers of HIPAA authorization approvals to ensure they contain all required elements and are consistent with all privacy requirements before investigators begin to use or collect individuals’ information? "]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.05(3) §23.a(3); VHA Directive 1605.03(1) Appendix D §1.k(7) "]
[null,"20.","Select…","Does your facility conduct clinical trials with FDA-regulated drugs, biologics, or devices?  "]
[]
[null,null,null,"If you responded “No,” click here to skip to Question 21."]
[null,null,null,"If “Yes,”  is there a process in place to ensure that:  "]
[null,null,"Select…","a.  Applicable clinical trials are registered to ClinicalTrials.gov?  "]
[null,null,null,"42 CFR §11.22"]
[null,null,"Select…","b.  Summary results of applicable clinical trials are submitted to ClinicalTrials.gov within 12 months after the trial’s primary completion date?"]
[]
[]
[null,null,null,"42 CFR §11.44"]
[null,null,"Select…","c.  ICDs contain a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records?"]
[]
[]
[]
[null,null,null,"21 CFR 50.25(a)(5)"]
[null,null,"Select…","d.  ICDs contain the required statement “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time?”"]
[]
[]
[]
[]
[null,null,null,"21 CFR 50.25(c)   "]
[null,null,"Select…","e.  For research involving human gene transfer therapy (e.g., treatments or vaccine trials involving administration of viral vectors or synthetic RNA/DNA) to human subjects, is there a process in place for such research to be reviewed by a properly constituted Institutional Biosafety Committee (IBC) (in addition to an IRB) as required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - April 2019, Section III-C-1? \n"]
[]
[]
[]
[]
[]
[]
[null,null,null,"If such research is not conducted, choose \"N/A.\""]
[null,null,null,"https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf"]
[null,null,"Select…","f.  For investigational drugs stored outside of the research pharmacy, is a delegation of custody in place? \n"]
[]
[]
[null,null,null,"If investigational drugs are not stored outside of the pharmacy, choose \"N/A.\""]
[null,null,null,"VHA Handbook 1108.04 §10.c "]
[null,null,"Select…","g.  For research involving the use of controlled substances, are the controlled substances stored in accordance with VHA Directive 1108.01(1)? \n"]
[]
[null,null,null,"If controlled substances are not used, choose \"N/A.\""]
[null,null,null,"VHA Directive 1108.01(1) §4.g(9) "]
[null,null,"Select…","h.  For research involving the use of controlled substances, do the controlled substances receive monthly unannounced controlled substance inspections as required by VHA Handbook 1108.04 and VHA Directive 1108.02?  \n"]
[]
[]
[]
[null,null,null,"If controlled substances are not used, choose \"N/A.\""]
[null,null,null,"VHA Handbook 1108.04 §10.b(5)(b); VHA Directive 1108.02(2) §7   "]
[null,null,"Select…","i.  For research involving investigational devices, the IRB reviews sponsor device risk determinations (or makes its own determination when the sponsor has not) for every investigational device study, unless the FDA has already made a determination or the study is exempt from the Investigational Device Exemption (IDE) regulations)?\n\n"]
[]
[]
[]
[null,null,null,"If investigational devices are not used, choose \"N/A.\""]
[null,null,"Select…","j.  For research involving significant risk device studies, an IDE application is approved by the FDA before initiation of study activities?\n\nIf significant investigational devices are not used, choose \"N/A.\""]
[]
[null,"21.","Select…","Has your facility approved any research involving: women who are known to be pregnant, human fetuses in utero, or neonates as subjects? "]
[]
[null,null,null,"If \"No,\" skip to Question 22."]
[null,null,"Select…","a.  If “Yes” to #21, were the appropriate certifications and/or approvals in place? "]
[]
[null,null,null,"VHA Directive 1200.05(3) §19"]
[null,"NOTES: Use the text box below to provide any additional information about items in the HRPP and IRB Responsibilities section:"]
[]
[null," "]
[]
[null,"Animal Care and Use Program (ACUP) and \nInstitutional Animal Care and Use Committee (IACUC) Responsibilities"]
[null,"22.","Select…","Does your facility have an Animal Care and Use Program (i.e., does any research, testing or training conducted by your facility staff, either in VA space or with VA funds or on VA time regardless of location, involving the use of laboratory animals)?"]
[]
[]
[]
[null,null," ","If you responded \"No,\" click here to skip to Question 40."]
[null,"23.","Describe the arrangement for IACUC oversight for the VA ACUP: "]
[null,null,null,"Select…"]
[null,"24.","Describe where animals used for VA research are housed: "]
[null,null,null,"Select…"]
[null,null,null,"Please specify the affiliate(s):"]
[null,null,null," "]
[null,null,"Select…","a.  If housing at an affiliate, is oversight provided according to an established written agreement?"]
[]
[null,"25.","Describe the arrangement for PHS Assurance for the VA ACUP: "]
[null,null,null,"Select…"]
[null,null,"Select…","a.  Does the affiliate PHS assurance list the VA facility as a branch/major component included under the Assurance (applicable only for VA ACUPs covered by the affiliate PHS Assurance with a VA VMU)? "]
[]
[]
[null,null,null,"PHS Policy §IV.A.1.a"]
[null,"26.","For internal VA-appointed IACUCs-of-record: "]
[null,null,"Select…","a.  Has the MFD appointed IACUC members in writing (paper or electronic)?"]
[null,null,null,"VHA Directive 1200.07 10.a(1)"]
[null,null,"Select…","b.  Do IACUC appointments identify members by name and indicate the AWR and PHS Policy role(s), as applicable, if any?"]
[]
[null,null,null,"VHA Directive 1200.07 10.a(1)"]
[null,null,"Select…","c.  Do IACUC appointments specify regular or alternate voting member status?"]
[]
[null,null,null,"VHA Directive 1200.07 10.a(1)"]
[null,null,"Select…","d.  Do IACUC alternate member appointment specify the category(ies) of individuals the alternate is authorized to serve in lieu of?"]
[]
[null,null,null,"VHA Directive 1200.07 10.a(1)"]
[null,null,"Select…","e.  For animal research conducted in collaboration with affiliate(s), is shared oversight provided according to the established written agreement for oversight?"]
[]
[]
[null,null,null,"VHA Directive 1200.07 §7.d, §10.l The Guide for the Care and Use of Laboratory Animals, 8th Edition, pg. 15."]
[]
[null,null,null,"Specify affiliate(s):"]
[]
[null,"27. ","For external affiliate-appointed IACUCs-of-record: "]
[null,null,"Select…","a.  Is at least one scientist with a VA appointment who has animal research experience appointed to the affiliate IACUC as a voting member by the affiliate Institutional Official?"]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11.c(1),(3)&(4)"]
[null,null,"Select…","b.  Is the attending veterinarian (AV) who oversees the VA research with animals is appointed to the affiliate IACUC as a voting member by the affiliate Institutional Official?"]
[]
[]
[null,null,"Select…","c.  Is oversight of the VA ACUP by an external VA IACUC established by a formal written understanding that defines the responsibilities of each party?"]
[]
[null,null,null,"VHA Directive 1200.07 §11.a \nGuide for the Care and Use of Laboratory Animals, 8th Edition, pg. 15."]
[]
[null,null,"Select…","d.  Do authorized personnel of the VA animal research program (e.g., each individual on a protocol, all personnel responsible for oversight of the protocol, etc.) have ready access to a dated copy of each version of the protocol, and any separate protocol modifications or amendments, that have been approved by the external VA IACUC? "]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11d(f)(4)(b)(2)."]
[null,null,"Select…","e.  Were annual reports required by OLAW and AAALAC International shared within 30 days of submission? "]
[]
[null,null,null,"VHA Directive 1200.07 §11d(f)(4)(b)(2)."]
[null,"28.","For external jointly-appointed IACUCs-of-record: "]
[null,null,"Select…","a.  Has the MFD appointed each member (including not only the VA representatives, but also all of the other members) to the external VA IACUC? "]
[]
[null,null,"Select…","b.  Is at least one scientist with a VA appointment who has animal research experience appointed to the IACUC? "]
[]
[null,null,"Select…","c.  Is the AV who oversees the VA research with animals appointed to the IACUC? "]
[]
[null,"29.","For the VA ACUP, describe your Institution’s arrangements for AAALAC accreditation: "]
[null,null,null,"Select…"]
[null,null,null,"Specify affiliate Institution that holds AAALAC accreditation:"]
[null,null,null," "]
[null,null,"Select…","a.  For affiliate maintained AAALAC Accreditations, does the affiliate provide a copy of the final, signed annual report to the VA facility Research Service? "]
[]
[null,null,null,"VHA Directive 1200.07 Section 11.k(3).  "]
[null,"30.","What is the status of the AAALAC accreditation for your institution (or the institution whose accreditation that covers the VA ACUP) as of the date this form is submitted?  "]
[]
[null,null,null,"Select…"]
[null,null,null,"a.  Please provide the date of the most recent AAALAC accreditation determination letter:  "]
[]
[]
[null,"31.","Is your institution (or the institution whose registration that covers the VA ACUP) registered with the United States Department of Agriculture (USDA)? "]
[]
[null,null,null,"Select…"]
[null,null,"Select…","a.  For affiliate-maintained registrations, has the affiliate provided a copy of the final, signed annual report to the VA facility Research Service? "]
[]
[null,null,null,"b.  Please provide the date of the most recent USDA APHIS Annual Report Submission: "]
[]
[]
[null,"32. ","Select…","Does your facility have any approved protocols involving non-USDA-regulated species (e.g., purpose-bred rats of the genus Rattus and mice of the genus Mus, birds bred for use in research, amphibians, invertebrates, reptiles, fish, amphibians) used for VA research? \n"]
[]
[]
[]
[null,null,null,"If “Yes,” please specify species AND locations (VA or affiliate) housed:  "]
[]
[null,"33.","Select…","Does your facility have any approved protocols that involve the following USDA-regulated (mammals, other than those listed above as non-USDA species, and wild species of birds, rats, and mice) species used for VA research?  "]
[]
[]
[null,null,null,"If you responded \"No,\" click here to skip to Question 34. "]
[null,null,null,"If you responded \"No,\" click here to skip to Question 39. "]
[null,null,"Select…","a.  Canines"]
[null,null,null,"If \"No,\" skip to Question 33b."]
[null,null,null,"If “Yes,” specify if housed at VA or affiliate:  "]
[]
[null,null,"Select…","i.  Is the canine research funded by the VA? "]
[null,null,"Select…","ii.  Has the canine research been approved by the VA Secretary?"]
[null,null,null,"If “Yes,” specify date(s) approval(s) were granted: "]
[]
[null,null,null,"Consolidated Appropriations Act, 2023 (Public Law 117-328), dated 12/29/2022, Section 247(a)-(e)   "]
[]
[null,null,"Select…","b.  Felines"]
[null,null,null,"If \"No,\" skip to Question 33c."]
[null,null,null,"If “Yes,” specify if housed at VA or affiliate: "]
[]
[null,null,"Select…","i.  Is the feline research funded by the VA? "]
[null,null,"Select…","ii.  Has the feline research been approved the VA Secretary?"]
[null,null,null," If “Yes,” specify date(s) approval(s) were granted: "]
[null,null,null," "]
[null,null,null,"Consolidated Appropriations Act, 2023 (Public Law 117-328), dated 12/29/2022, Section 247(a)-(e) "]
[]
[null,null,"Select…","c.  Non-human primates (NHP)"]
[null,null,null,"If \"No,\" skip to Question 33d."]
[null,null,null,"If “Yes,” specify if housed at VA or affiliate:  "]
[]
[null,null,"Select…","i.  Is the NHP research funded by the VA? "]
[null,null,"Select…","ii.  Has the NHP research been approved by the VA Secretary?"]
[null,null,null," If “Yes,” specify date(s) approval(s) were granted: "]
[]
[null,null,null,"Consolidated Appropriations Act, 2023 (Public Law 117-328), dated 12/29/2022, Section 247(a)-(e) "]
[]
[null,null,"Select…","d.  Swine"]
[null,null,null,"If \"No,\" skip to Question 33e."]
[null,null,null,"If “Yes,” specify if housed at VA or affiliate:  "]
[]
[null,null,"Select…","e.  Rabbits"]
[null,null,null,"If \"No,\" skip to Question 33f."]
[null,null,null,"If “Yes,” specify if housed at VA or affiliate:  "]
[]
[null,null,"Select…","f.  Other USDA-regulated Species"]
[null,null,null,"If “Yes,” please specify species AND if housed at VA or affiliate: "]
[]
[null,"34.","For VA animal facilities (owned or leased), has your facility ensured: "]
[null,null,"Select…","a.  Heating, Ventilation, and Air Conditioning (HVAC) system(s) reliably maintain temperature and humidity within required ranges in the VMU?\nThe Guide for the Care and Use of Laboratory Animals, 8th Edition, pg. 44.  \n"]
[]
[]
[null,null,null,"If \"No,\" explain: "]
[]
[null,null,"Select…","b.  HVAC systems are designed to prevent such that failure does not result in uncontrolled heating in animal rooms?  NOTE:  This includes VA owned or leased areas outside of the VMU where animals are housed for 24 hours or more.  \nVHA Directive 1200.07 §8.b(1)(a) "]
[]
[]
[]
[]
[null,null,null,"If \"No,\" explain:"]
[]
[null,null,"Select…","c.  Facilities management personnel provide continuous central monitoring of temperatures of the VMU (VA owned or leased) AND areas (VA owned or leased) outside of the VMU where animals are housed for 24 hours or more? \n"]
[]
[]
[]
[null,null,null,"If \"No,\" explain: "]
[]
[null,null,"Select…","d.  Overheat response tests of the animal facility are conducted at least once every year, the results are provided to the IACUC for review at the next convened IACUC meeting, and the IACUC’s evaluation of the adequacy of the response is documented in the IACUC meeting minutes? "]
[]
[]
[]
[null,null,null,"NOTE: This includes areas outside of the VMU (VA owned or leased) where animals are housed 24 hours or more.  "]
[]
[null,null,null,"If \"No,\" explain:\" "]
[]
[null,null,null," i.  Provide the date of the IACUC meeting where the IACUC’s assessment of the most recent overheat response test was conducted and documented: "]
[]
[]
[]
[null,"35.","Select…","For VA animal facilities, is a written Program of Veterinary Care (PVC) is in place, regardless of the species of animals involved or whether the Attending Veterinarian is appointed full-time or part-time?  "]
[]
[]
[null,null," ","VHA Directive 1200.07 §9.b "]
[null,null,"Select…","a.  Is the PVC is a separate document, approved by the IACUC and signed by the Attending Veterinarian?  "]
[]
[null,null,null,"VHA Directive 1200.07 §9.b "]
[null,null,null,"b.  Does the PVC include the following:  "]
[null,null,"Select…","i.  The minimum frequency of in-person rounds of all animals in the VMU by the AV, or another VMO or VMC who reports to the AV, as appropriate to the local programmatic needs, but not less than quarterly visits in any calendar quarter in which animals are present in the VMU). "]
[]
[]
[]
[null,null,"Select…","ii.  Visits are documented in writing.  "]
[null,null,"Select…","iii.  Communication (documented in writing) at least monthly between the AV (or another VMO or VMC who reports to the AV) and VMU personnel who can provide updates on VMU operations. "]
[]
[]
[null,null,"Select…","iv.  Communications (documented in writing) as needed between the AV and VMU personnel regarding observations of the condition of individual animals or groups of animals in the VMU and what veterinary attention is needed."]
[]
[]
[null,"36.","Select…","For VA animal facilities, does the VA VMU emergency/disaster plan documented in writing, readily accessible to VMU personnel, reviewed periodically (at least every 3 years or less, as specified by the AWAR for programs with USDA-regulated species)?"]
[]
[]
[]
[null,null,null,"a.  Does the VA VMU emergency/disaster plan(s) cover:"]
[null,null,"Select…","i.  After hours, weekends and holiday coverage, as well as normal business hours?"]
[]
[null,null,"Select…","ii.  Protection of both personnel and research animals?"]
[null,null,"Select…","iii.  Coordination with the local facility Police Chief and Emergency Preparedness Manager to ensure that both the AV and the VMU manager have access to the VMU at any time?"]
[]
[]
[null,null,"Select…","b.  Has training been provided on the VMU emergency/disaster plan to essential personnel in advance of its implementation (or as described in AWAR, if VA ACUP includes USDA regulated species)?"]
[]
[]
[null,"37.","For VA animal facilities, has the internal VA-appointed IACUC fulfilled requirements for ongoing assessment of the VA ACUP? "]
[]
[null,null,"Select…","a.  Were semi-annual program evaluations conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §10.g"]
[null,null,"Select…","b.  Were semi-annual facility inspections conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §10.g "]
[null,null,"Select…","c.  Was the Medical Facility Director briefed on the results of the semi-annual program evaluation and facility inspections during a real-time meeting (in person or by tele-conference) with the IACUC Chair (or a voting member delegated in writing by the Chair to represent the internal VA IACUC)?  "]
[]
[]
[]
[null,null,null,"VHA Directive 1200.07 §10.g(4) "]
[null,null,"Select…","d.  Did semi-annual program review reports contain a plan and schedule for correction of each identified deficiency? "]
[]
[null,null,null,"PHS Policy §IV.B.3.d  "]
[null,"38.","For VA animal facilities, has the external (affiliate-appointed or jointly appointed) IACUC-of-record fulfilled requirements for ongoing assessment of the VA ACUP? "]
[]
[null,null,"Select…","a.  Were semi-annual program evaluations conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §10.g"]
[null,null,"Select…","b.  Were semi-annual facility inspections conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §10.g "]
[null,null,"Select…","c.  Was the MFD briefed on the results of the semi-annual program- evaluation and facility inspections during a meeting in real time (in person or by tele-conference) with the at least one voting IACUC member?  "]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11.i.(4)(a) "]
[null,null,"Select…","d.  Did the VA Research Service submit a final copy of the semi-annual report, signed by the MFD or ACOS, to the VHA Office of the CVMO within 90 days of the external VA IACUC’s approval of it? "]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11.i.(5) "]
[null,null,"Select…","e.  Did semi-annual program review reports contain a plan and schedule for correction of each identified deficiency? "]
[]
[null,null,null,"PHS Policy §IV.B.3.d  "]
[null,"39.","For affiliate animal facilities, has the IACUC-of-record fulfilled requirements for semi-annual assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research? "]
[]
[null,null,"Select…","a.  Were semi-annual program evaluations conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §11.i. "]
[null,null,"Select…","b.  Were semi-annual facility inspections conducted at six-month intervals? "]
[null,null,null,"VHA Directive 1200.07 §11.i. "]
[null,null,"Select…","c.  Did the VA ACOS/R&D receive a report, signed by the affiliate IACUC Chair, that summarizes important concerns (or lack thereof) noted in the semiannual evaluation related to the local VA animal research program? "]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11.i.(4)(b) "]
[null,null,"Select…","d.  Did the ACOS/R&D sign the summary report and communicate to the MFD any information requiring the Director’s attention?"]
[]
[null,null,null,"VHA Directive 1200.07 §11.i.(4)(b) "]
[null,null,"Select…","e.  Did the VA Research Service submit a final copy of the semi-annual report, signed by the MFD or ACOS, to the VHA Office of the CVMO within 90 days of the external VA IACUC’s approval of it? "]
[]
[]
[null,null,null,"VHA Directive 1200.07 §11.i.(5) "]
[null,"NOTES:  Use the text box below to provide any additional information about items in the ACUP and IACUC Responsibilities section:"]
[]
[null," ",null," "]
[]
[null,"Research Safety and Security Program (RSSP) and Subcommittee on Research Safety (SRS) Responsibilities"]
[null,"40.","Select…","Does any research conducted by your facility staff involve biological, chemical, physical (including animal contact), or radiation hazards?"]
[]
[null,null,"Select…","a.  Has your facility obtained a waiver from the requirement for an SRS by the CRADO?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.c(2)"]
[null,null,null,"If you responded \"Yes,\" click here to skip to Question 50."]
[null,"41.","Select…","Does your facility have an internal SRS administered within the VA facility that carries out duties described in VHA Directive 1200.08(1)? "]
[]
[null,null,null,"If you responded \"No,\" click here to skip to Question 42."]
[null,null,null,"If \"Yes\" to #41, are SRS members appointed in writing by the Medical Facility Director for terms up to 3 years (renewable), including:"]
[]
[null,null,"Select…","a.  SRS Chair?"]
[null,null,null,"VHA Directive 1200.08(1) §5.f(7) "]
[null,null,"Select…","b.  At least 5 voting members exclusive of ex-officio members, including members with expertise regarding occupational safety and health, environmental protection, Department of Transportation (DOT) International Air Transport Association (IATA) requirements, knowledge of the space and facilities assigned to each PI?\t"]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.b(1) "]
[null,null,"Select…","c.  A member from the facility Safety Committee (facility Safety Officer or a member of the facility Infection Control Committee) and an individual with radiation safety expertise?"]
[]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.b(1)(e) "]
[null,null,"Select…","d.  A liaison between the SRS and IACUC (if applicable; can be voting or non-voting)?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.b(1)(f) "]
[null,null,"Select…","e.  Required ex-officio members [R&DC liaison (non-voting), employee union safety representative, or other union designee (voting status determined by local contract)]?"]
[]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.b(2) "]
[null,"42.","Select…","Does your facility use an external SRS/safety committee (not IBC) administered by another VA or an affiliated university?"]
[]
[null,null,null,"If “Yes,” specify VA facility or affiliated university:"]
[]
[null,null,"Select…","a.  If \"Yes,\" is there an MOU for the use of an external SRS / safety committee?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.a(2) "]
[null,"43.","Select…","Does your program conduct non-exempt recombinant DNA or synthetic nucleic acid molecules research in VA owned or leased space?  "]
[]
[null,null,null,"VHA Directive 1200.08(1) §6.d(4) "]
[null,null,null,"If you responded \"No,\" click here to skip to Question 44."]
[null,null,"Select…","a.  Does your facility have an internal IBC to review rDNA research in accordance with NIH guidelines?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §7.a "]
[null,null,null,"b.  If “Yes” to #43a, please indicate below how your IBC is set up:"]
[null,null,null,"Select…"]
[]
[null,null,"Select…","c.  Is the VA IBC registered with NIH-OSP? "]
[null,null,null,"VHA Directive 1200.08(1) §7.b "]
[null,null,null,"Enter date of most recent registration/update for the VA IBC:"]
[null,null,null," "]
[null,null,"Select…","d.  Does your facility use the services of an external IBC from another VA facility or an affiliated university to review rDNA research in accordance with NIH guidelines?"]
[]
[]
[null,null,null,"If “Yes,” specify VA facility or affiliated university: "]
[]
[null,null,"Select…","e.  If \"Yes\" to #43d, is the institution's IBC registered with NIH-OSP as the IBC-of-Record for the VA facility?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §7.e(5); VHA Directive 1200.08(1) §7.f(2)  "]
[null,null,null,"Enter date of most recent registration for the external IBC: "]
[null,null,null," "]
[null,null,"Select…","f.  If using an affiliated university IBC, is there an MOU for use of the external IBC?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §5.m(2) "]
[null,"44.","Select…","Does your facility conduct any laboratory/bench research (excluding BSL-3)?  "]
[]
[null,null,null,"If you responded \"No,\" click here to skip to Question 45."]
[null,null,"On-site VA laboratories:\t"]
[null,null,"Select…","Approximate number of active laboratories at on-site VA locations."]
[null,null,null,"Specify the locations (building name or number) of all on-site VA research laboratories:"]
[]
[]
[null,null,"Off-site VA-leased:"]
[null,null,"Select…","Approximate number of active laboratories at off-site VA-leased locations."]
[null,null,null,"Specify the locations (building name or number) of all off-site VA research laboratories:"]
[]
[]
[null,null,"Off-site Non-VA (i.e., non-leased):"]
[null,null,"Select…","Approximate number of active laboratories at off-site non-VA (non-leased) locations."]
[]
[null,null,null,"Specify the locations (building name or number) of all off-site VA research laboratories:"]
[]
[]
[null,null,"Select…","a.  For off-site non-VA (i.e., non-leased) laboratories, are the appropriate off-site waivers in place?"]
[]
[null,null,null,"VHA Program Guide 1200.16 §4.a-d (August 2, 2018) "]
[null,null,"Select…","b.  For VA research conducted in laboratories located in approved off-site facilities, has the ACOS/R&D (or equivalent) ensured there is a process in place for VA research to be reviewed with regard to research safety and security, and if necessary, provide feedback to the responsible party for the off-site facility on any deficiencies in such processes?\t"]
[]
[]
[]
[]
[null,null,null,"VHA Directive 1200.08(1) §5.g(2)"]
[null,"45.","Select…","Does your facility conduct any research that requires a BSL-3 laboratory?  "]
[]
[null,null,null,"If you responded \"No,\" skip to Question 46."]
[null,null,null,"If “Yes,” specify infectious agent(s):"]
[null,null,null," "]
[null,null,"Select…","a.  Does your facility have its own BSL-3 laboratory located in the facility or in VA-leased space?\t"]
[]
[null,null,null,"If “Yes,” specify location(s):"]
[null,null,null," "]
[null,null,"Select…","b.  Does your facility conduct VA-funded research at any off-site non-VA (i.e., non-leased) BSL-3 laboratories?"]
[]
[null,null,null,"If “Yes,” specify location(s):"]
[null,null,null," "]
[null,"46.","Select…","Does your facility maintain long-term storage (>6 months) of any SARS-CoV-2 positive samples or viral isolates?"]
[]
[null,"47.","Select…","Does your facility conduct any research that involves chemical hazards, as defined by the Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT) and Environmental Protection Agency (EPA)?  "]
[]
[]
[]
[null,null,null,"If \"No,\" skip to Question 48."]
[null,null,"Select…","a.  Does your facility have a research-specific Chemical Hygiene Plan (CHP) (which may be included in the Research Safety Plan) that is reviewed annually?"]
[]
[]
[null,null,null,"29 CFR §1910.1450 (e)(3) "]
[null,null,null,"Provide the date of last review:"]
[]
[null,null,"Select…","b.  Does your facility conduct semi-annual comprehensive inventory reviews of hazardous chemicals/agents used in research?"]
[]
[null,null,null,"VHA Directive 1200.08(1) §5.h(1); VHA Directive 1200.08(1) §5.k; VHA Directive 1200.08(1) §5.n(5)   "]
[]
[null,"48.","Select…","Does your facility conduct any research that involves the use of regulated and/or exempt quantities of Select Agents and Toxins (SATs), as defined by the Federal Select Agent Program (FSAP)?  \n"]
[]
[]
[null,null,null,"If “Yes,” specify toxin(s) and category (exempt/nonexempt): "]
[]
[null,"49.","Are the following items related to VA research laboratories and the RSSP current, in place, and/or conducted as specified:\t"]
[]
[null,null,"Select…","a.  Research Safety Plan?"]
[null,null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,null,"Select…","b.  Research Security Plan?"]
[null,null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,null,"Select…","c.  Emergency Management Plan?"]
[null,null,null,"VHA Directive 1200.08(1) §5.n(9)"]
[null,null,"Select…","d.  Bloodborne pathogen exposure control plan? (Select “Yes” if Research Service follows the hospital-wide plan.)\t"]
[]
[null,null,"Select…","e.  Bloodborne pathogen training (which should include an explanation of the OSHA standard and how to access the standard, an explanation of the facility Exposure Control Plan and how to access the plan, and an opportunity for questions and answers in real time during the training)?"]
[]
[]
[]
[null,null,null,"29 CFR §1910.1030(g)(2)(vii) "]
[null,null,"Select…","f.  A process to activate, decommission, or transfer PI laboratories?"]
[null,null,null,"VHA Directive 1200.08(1) §5.g(8); VHA Directive 1200.08(1) §5.n(1)  "]
[null,null,"Select…","g.  SRS annual review of each PI’s VA laboratory program?"]
[null,null,null,"VHA Directive 1200.08(1) §6.f "]
[null,null,"Select…","h.  Annual safety inspections of all research laboratories?"]
[null,null,null,"VHA Directive 1200.08(1) §5.n(6) "]
[null,null,"Select…","i.  Annual drills to test the effectiveness of each research-specific plan:  safety/biosafety, security, chemical hygiene, and emergency management?"]
[]
[null,null,null,"NOTE:  A fire drill may test provisions in the emergency preparedness plan but is unlikely to test the provisions In the safety/biosafety or security plan."]
[]
[null,null,null,"VHA Directive 1200.08(1) §5.n(9); 21 CFR 1910.1450 (e)(4)  "]
[null,null,null,"Provide the date of most recent SRS review of the following drills"]
[null,null,null,"Safety/biosafety:"]
[]
[null,null,null,"Security:"]
[]
[null,null,null,"Chemical Hygiene:"]
[]
[null,null,null,"Emergency Management:"]
[]
[null,null,"Select…","j.  Eye wash stations/emergency showers located, installed, maintained, and tested in research areas in accordance with VHA Directive 7704?"]
[]
[null,null,null,"21 CFR §1910.151 (c); VHA Directive 7704 (including Appendices A-F)  "]
[null,null,"Select…","k.  Opportunity for enrollment in the animal-user specific component of the Occupational Safety and Health Program (OSHP) for personnel with potential contact with animals and annual medical follow-up of enrolled individuals is conducted?"]
[]
[]
[]
[null,null,null,"VHA Handbook 1200.07 APP.C.§4.a "]
[null,null,"Select…","l.  Personal protective equipment (PPE) hazard assessments certified for hazards in VA research laboratories/animal facilities?"]
[]
[null,null,null,"29 CFR 1910.132 (d); VHA Directive 1200.08(1) §5.p(8)   "]
[null,null,"Select…","m.  Controlled access to all laboratories at all times? "]
[null,null,null,"VHA Handbook 1200.07 §7.i and VA Handbook 0730 Appendix B "]
[null,"NOTES: Use the text box below to provide any additional information about items in the RSSP and SRS  Responsibilities section:"]
[]
[]
[]
[null,"Research Information Security Practices (RISP)"]
[null,"Please consult with your ISSO and/or VA Office of Information and Technology (OIT) Area Manager when answering the following questions."]
[]
[null,"50.","Select…","Do researchers use any system interconnections (e.g., EDUROAM) between the VA facility network and a non-VA network for VA research purposes?"]
[]
[null,null,null,"This question pertains to direct connections between the VAMC network and a non-VA network. These system interconnections involve configuration and approvals by OIT and sometimes exist for biomedical equipment. Current VA OIT policy requires that an approved Memorandum of Understanding/Interconnection Security Agreement for each interconnection. If any interconnections are used for research purposes, the MOU must include that business purpose of the interconnection. Reference: VA Office of Information Security (OIS) Knowledge Service (KS), Control Number CA-3, Control Correlation Identifier (CCI) CCI-000257."]
[]
[]
[]
[]
[]
[]
[" ","51.","Select…","Do researchers use any non-VA networks (e.g., air-gapped networks) and associated devices (e.g., affiliate computers) at the facility for VA research purposes? "]
[]
[]
[null,null,null,"If \"No,\" skip to Question 52."]
[null,null,null,"This question pertains to non-VA networks physically located at the VAMC but are not directly connected to the VA network. These are typically affiliate networks or networks associated with external internet service providers. "]
[]
[]
[null,null,"Select…","a.  If \"Yes\" to #51, do researchers use the non-VA network(s) to process, store, or transmit VA information? "]
[]
[null,null,null,"If a non-VA information system, such as an affiliate network, is used to transmit, process, or store VA data (data obtained or generated under an R&DC approved protocol, whether bench, animal, or human research), current VA OIT policy requires the establishment and documentation of terms and conditions, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing for such uses of VA data on the external information system(s).  "]
[]
[]
[]
[]
[null,null,"Select…","b.  If \"Yes\" to #51a, are there instances where the VA information is considered VA sensitive information (VASI)?  "]
[]
[null,null,null,"If the information includes VA sensitive information (VASI), current VA OIT policy requires documenting the security controls/requirements of the non-VA information systems used to transmit, process, and/or store VASI in a contract or agreement (e.g., data use agreement) as specified in the procedures or templates provided for those types of agreements. This question does not apply to instances where a VA researcher properly discloses data to a non-VA entity and does not retain ownership (e.g., for future use in VA research), such as when VA provides data to a study coordinating site in a case report form and retains a copy for VA records. Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336; Control Number AC-19, CCI-002329, CCI-002330 "]
[]
[]
[]
[]
[]
[]
[]
[null,"52.","Select…","Do researchers transport VASI off-site/outside the VA?"]
[null,null,null,"This question pertains to the transportation, transmission, or storage of VA sensitive information (e.g., identifiable subject data, completed informed consent forms) in any format outside of VA managed facilities. Current VA policy requires that all employees must have documented approval from their supervisor before sensitive information can be removed from a VA facility that VASI is appropriately encrypted when transmitted, and that security controls are documented when VASI is stored outside (physically and/or electronically) of VA. References:  VHA Dir 1605.01 §2.g(6); VA Handbook 7002, Part 13 §5; VA OIS KS, Control Number  §MP-5, CCI-001024, and §AC-20, CCI-002338."]
[]
[]
[]
[]
[]
[]
[null,"53.","Select…","Are non-VA external information systems (IT equipment) used on-site for VA research?"]
[]
[null,null,null,"If so, current Logistics Management policy requires that equipment owned by an affiliated institution, or purchased by such institution from grant funds, and used by a VA investigator in a research project at the VA facility must be accounted for on an equipment inventory list (EIL) contained in the facility property management system. Reference: VA Handbook 7002 §11.3.a, Appendix I §10.c "]
[]
[]
[]
[]
[null,"54.","Select…","Are VA mobile devices (e.g., laptops, tablets) and VA portable devices (e.g., USB storage drives, removable media) used for VA research?"]
[]
[null,null,null,"This question pertains to VA devices that are used for sensitive and non-sensitive VA data. When the information is VASI, VA OIT policy requires documented permission must be obtained from their supervisor. In addition, the ISSO, IT Area Manager, or designee must approve and document that the mobile or portable storage device to be used meets VA’s security requirements, including that the device employs VA-approved encryption, when required. Reference: VA OIS KS, Control Number AC-19, CCI-000082, CCI-000083, CCI-000084, CCI-002326, CCI-002329, CCI-002330, CCI-002331; Control Number AC-20, CCI-000097; Control Number SC-13, CCI-002449, CCI-002450 "]
[]
[]
[]
[]
[]
[null,null,null,"Additionally, all VA mobile devices must be inventoried in the property accountability system, and the VA portable devices must be appropriately tracked/inventoried. References: VHA Handbook 7002 Part 8.5.b and VA Handbook 7002, Part 13, §10 "]
[]
[]
[null,"55.","Select…","Are non-VA mobile or portable devices used for VA research?"]
[null,null,null,"This question pertains to non-VA devices that are used for sensitive and non-sensitive VA data. If so, current VA OIT current VA OIT policy requires the establishment and documentation of terms and conditions for the use of those devices, consistent with any trust relationships established with other organizations owning, operating, and/or maintaining external information systems, allowing authorized individuals to process, store, and transmit VA-owned information using the external information system(s). Reference: VA OIS KS, Control Number AC-20, CCI-002332, CCI-002334, CCI-002335, CCI-002336"]
[]
[]
[]
[]
[]
[null,null,null,"If a non-VA mobile or portable device is used to transmit or store VASI, it must also employ VA approved encryption. References: VA Handbook 6500, §2.c and VA OIS KS, Control Number SC-13, CCI-002449, CCI-002450   "]
[]
[]
[null,"56.","Select…","Is there a mechanism(s) in place to ensure access controls are applied to VA information on the VA network to ensure only appropriate staff have access to study-related data?  "]
[]
[]
[null,null,null,"This would include VA data stored on shared drives on VA servers in the VA cloud, VA SharePoint, VA REDCap, VA Box, or OneDrive based storage.  Managements of permissions is often accomplished by restricting users’ access (either in security control groups or individually listed) to folders that contain the VA data.  Permissions management can be controlled by OIT or delegated to specific individuals (e.g., Research Service staff). In addition, the facility may have migrated to the use of the Shared Folder and File Exchange (SFFX) system to facilitate the management of folder permissions. Reference: VA OIS KS, Control Number AC-3, CCI-000213, CCI-002165 "]
[]
[]
[]
[]
[]
[null,"57.","Select…","Is there a mechanism in place to ensure PIs and study staff follow the approved conditions contained within the VINCI Data Access Request Tracker (DART) when VHA enterprise datasets are provisioned for research?"]
[]
[]
[null,null,null,"This question pertains to applications for VHA enterprise datasets provisioned by VINCI which require submissions through the on-line DART system.  The process and approval conditions are tantamount to a “DUA” between the requesting PI and the data owner or administrator in accordance with VHA Handbook 1200.12, or successor policy and VINCI Workspace User Guide."]
[]
[]
[]
[null,"58.","Select…","Is there a mechanism in place to ensure Privacy Officers (POs) confirm Centers for Medicare and Medicaid Services (CMS) research data is used, managed, accessed, stored, and protected in accordance with the terms of approved VA Information Resource Center (VIReC) DUAs?\t"]
[]
[]
[]
[null,null,null,"This question pertains to applications for CMS datasets provisioned by VIReC which require a DUA. Reference: VHA Directive 1605.03(3), Appendix D §1.k."]
[]
[null,"NOTES: Use the text box below to provide any additional information about items in the RISP section:"]
[]
[]
[]
[null,"Research Misconduct"]
[null,"59.","Select…","Has the VA facility Director appointed, in writing, an individual to serve as the Research Integrity Officer (RIO)? (NOTE: Research Integrity Officers are responsible for receiving allegations of research misconduct and providing facility-level oversight of the handling of such allegations.)"]
[]
[]
[]
[null,null,"Select…","a.  Are the name and contact information of the appointed RIO accurately recorded on this list of VHA RIOs posted on ORO’s website?"]
[]
[null,null,null,"If “No,” please email VHACOOROResearchMisconductProgram@va.gov with current RIO name, contact information, and appointment letter."]
[]
[null,"60.","Select…","Has the facility received any formal allegations of research misconduct (fabrication, falsification, or plagiarism) during this reporting period?"]
[]
[null,"NOTES: Use the text box below to provide any additional information about items in the Research Misconduct section:"]

{"sheet":"PartB","index":1,"n_rows":614,"n_cols":4,"rows_kept":614,"cut":false,"hidden":false,"merged":[[7,2,9,2],[8,3,11,3],[10,2,11,2],[12,2,13,2],[13,3,17,3],[14,2,16,2],[0,1,0,3],[1,1,1,3],[2,1,2,2],[3,1,3,3],[4,1,4,3],[5,1,6,3],[37,2,39,2],[37,3,39,3],[40,2,41,2],[42,2,43,2],[42,3,43,3],[44,2,45,2],[18,1,18,3],[21,1,21,3],[22,1,23,3],[24,2,25,2],[26,2,28,2],[26,3,31,3],[69,2,70,2],[71,2,73,2],[74,2,75,2],[78,1,78,3],[79,1,79,3],[80,1,84,3],[50,2,53,2],[51,3,59,3],[54,2,55,2],[56,2,58,2],[60,2,61,2],[61,3,68,3],[62,2,65,2],[66,2,67,2],[104,2,105,2],[106,2,107,2],[108,2,109,2],[110,2,111,2],[113,2,114,2],[115,2,116,2],[87,2,88,2],[87,3,88,3],[91,2,92,2],[97,2,98,2],[99,2,100,2],[101,2,102,2],[130,2,132,2],[130,3,136,3],[133,2,135,2],[142,3,146,3],[143,2,145,2],[147,2,148,2],[117,2,118,2],[119,2,120,2],[123,2,124,2],[123,3,124,3],[126,2,128,2],[126,3,128,3],[169,2,171,2],[171,3,176,3],[173,2,175,2],[177,2,178,2],[178,3,182,3],[179,2,182,2],[149,3,153,3],[150,2,152,2],[161,2,162,2],[164,2,165,2],[165,3,167,3],[166,2,167,2],[198,1,198,3],[199,2,200,2],[202,2,203,2],[203,3,206,3],[204,2,205,2],[207,2,208,2],[183,2,184,2],[185,2,186,2],[185,3,186,3],[190,2,193,2],[194,1,194,3],[197,1,197,3],[236,2,237,2],[237,3,241,3],[238,2,240,2],[243,2,244,2],[245,2,247,2],[245,3,248,3],[217,2,218,2],[220,2,221,2],[223,2,225,2],[223,3,226,3],[227,2,228,2],[229,2,230,2],[230,3,234,3],[231,2,233,2],[261,2,262,2],[267,2,268,2],[267,3,272,3],[269,2,271,2],[276,3,280,3],[277,2,279,2],[249,2,250,2],[251,2,252,2],[253,2,254,2],[255,2,256,2],[257,2,258,2],[259,2,260,2],[295,2,296,2],[297,2,299,2],[302,2,303,2],[304,2,305,2],[306,2,308,2],[306,3,309,3],[281,2,282,2],[282,3,288,3],[283,2,284,2],[285,2,287,2],[289,2,290,2],[290,3,292,3],[291,2,292,2],[321,2,322,2],[321,3,326,3],[323,2,325,2],[327,2,328,2],[328,3,333,3],[329,2,330,2],[331,2,332,2],[310,2,311,2],[311,3,312,3],[313,2,314,2],[315,2,316,2],[318,2,319,2],[318,3,319,3],[347,2,348,2],[348,3,354,3],[349,2,350,2],[351,2,353,2],[355,2,356,2],[357,2,358,2],[358,3,359,3],[334,2,337,2],[335,3,337,3],[338,2,340,2],[339,3,342,3],[341,2,342,2],[343,2,344,2],[344,3,346,3],[345,2,346,2],[376,2,377,2],[377,3,380,3],[378,2,380,2],[381,2,382,2],[382,3,388,3],[383,2,384,2],[385,2,387,2],[361,3,365,3],[362,2,364,2],[366,2,367,2],[367,3,368,3],[370,2,371,2],[370,3,375,3],[372,2,374,2],[397,1,397,3],[398,1,398,3],[399,1,400,3],[401,2,402,2],[403,2,405,2],[404,3,409,3],[406,2,408,2],[389,2,390,2],[390,3,392,3],[391,2,392,2],[393,1,393,3],[395,1,395,2],[396,1,396,3],[421,2,422,2],[423,2,424,2],[425,2,426,2],[427,2,428,2],[431,2,432,2],[435,2,436,2],[410,2,411,2],[411,3,417,3],[412,2,414,2],[415,2,416,2],[419,1,419,3],[420,1,420,3],[450,2,451,2],[450,3,451,3],[460,2,463,2],[460,3,464,3],[467,2,469,2],[470,2,471,2],[471,3,477,3],[473,2,476,2],[436,3,441,3],[437,2,438,2],[439,2,440,2],[443,2,445,2],[443,3,449,3],[446,2,448,2],[491,1,491,3],[493,1,493,2],[494,1,494,3],[495,1,496,3],[497,1,498,3],[499,2,500,2],[478,2,479,2],[480,2,481,2],[481,3,482,3],[483,2,484,2],[485,2,486,2],[486,3,490,3],[487,2,489,2],[521,1,521,3],[523,2,524,2],[525,2,526,2],[527,2,528,2],[532,2,534,2],[535,2,536,2],[501,2,502,2],[503,2,506,2],[504,3,510,3],[507,2,509,2],[511,2,512,2],[512,3,519,3],[513,2,515,2],[516,2,518,2],[552,3,554,3],[553,2,554,2],[555,2,557,2],[560,2,561,2],[561,3,563,3],[562,2,563,2],[537,2,538,2],[539,2,540,2],[542,2,543,2],[544,2,545,2],[546,2,548,2],[551,2,552,2],[583,2,584,2],[585,2,586,2],[587,2,588,2],[592,2,593,2],[592,3,598,3],[594,2,597,2],[564,1,566,1],[564,2,565,2],[569,2,570,2],[570,3,571,3],[571,2,572,2],[578,2,581,2],[578,3,582,3],[613,1,613,3],[599,2,600,2],[601,2,602,2],[602,3,603,3],[603,2,604,2],[605,2,606,2],[607,2,608,2],[608,3,612,3],[609,2,611,2]]}
[]
[null,"PART B – RESEARCH PROGRAM QUANTITATIVE DATA"]
[]
[null,"RESEARCH AND DEVELOPMENT PROGRAM AND R&DC"]
[null,"Note: Questions shaded in yellow are new questions from previous FDC versions."]
[null,"Note: Questions #1 to 1a are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
[null,"1. ","Number of protocols followed only by the R&DC at any time during this reporting period (e.g., IRB-exempt human subjects protocols; protocols without human, animal, or safety hazards not followed by any research subcommittee):"]
[]
[]
[null,null,"Only include protocols that are solely followed by the R&DC and not followed by any other oversight committee (including any external committees)."]
[]
[null,null,"a.  Number in #1 that were NOT initially approved by the R&DC before research was initiated:"]
[]
[null,null,"Note: For answers greater than zero for item #1a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"Notes for Research and Development Program Section:"]
[]
[]
[null,"HUMAN RESEARCH PROTECTION PROGRAM"]
[null,"Note: Questions #2 to #9 are not based on RCO audits and pertain to research conducted and events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
[null,"2.","Number of human subject protocols active (open) at any time during this reporting period:"]
[]
[null,null,"Include all human subjects protocols, including IRB-exempt human subjects protocols and human subjects protocols followed by external IRBs. Do not include research activities that are not subject to the Common Rule, such as expanded access protocols."]
[]
[]
[null,null,"MVP is approved at site."]
[null,null,"All-of-Us is approved at site."]
[null,"3. ","Number of protocols in #2:"]
[null,null,"a.  That were exempt from IRB oversight:"]
[null,null,"b.  That were nonexempt from IRB oversight:"]
[null,null,"Note: Items 3a + 3b should equal item #2."]
[null,"4. ","Number of protocols in #2:"]
[null,null,"a.  With informed consent waived per 38 CFR 16.116 for the entire study:"]
[null,null,"This is the number of protocols for which the IRB has granted a waiver of informed consent for the entire study. (Do not include protocols with waivers of informed consent for recruitment in this number.)"]
[]
[]
[null,null,"b.  With documentation of informed consent waived per 38 CFR 16.117(c) for the entire study:"]
[]
[null,null,"(This is the number of protocols for which the IRB has granted a waiver of documentation of informed consent for the entire study.)"]
[]
[null,"5. ","Number of non-exempt protocols (#3b) for which the risk level was greater than minimal risk:"]
[]
[null,"6.","Number of protocols in #2:"]
[null,null,"a.  Subject to the 2018 Common Rule:"]
[null,null,"b.  Subject to the Pre-2018 Common Rule:"]
[null,null,"Note: Items 6a + 6b should equal item #2."]
[null,"7.","Number of protocols suspended or terminated early (for local reasons) due to the protocol not being conducted in accordance with applicable regulations, policies, agreements, or IRB requirements or due to concerns about the safety, rights, or welfare of human subjects or others:"]
[]
[]
[]
[null,null,"Do not include suspensions/terminations due to approval lapses or other administrative issues. \nDo not include suspensions due to the COVID-19 administrative hold."]
[]
[null,null,"Note: For answers greater than zero in item #7, use the text box below to provide specific details about the protocol suspension / termination or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"8.","Number of events determined by the IRB to constitute serious and/or continuing noncompliance:"]
[]
[null,null,"Do not include unanticipated problems involving risks to subjects or others (UPIRTSOs) or serious adverse events (SAEs) that are unrelated to noncompliance. VHA Directive 1058.01 §7.c(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IRB."]
[]
[]
[]
[null,null,"Note: For answers greater than zero in item #8, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,"9.","Number of events determined by the IRB to constitute actual unanticipated problems involving risks to subjects or others (UPIRTSOs):"]
[]
[null,null,"A UPIRTSO in human subjects research is an incident, experience or outcome that is: unexpected; related or possibly related to participation in the research; and indicative of the research placing subjects or others at substantively greater risk of harm."]
[]
[]
[null,null,"Note: For answers greater than zero in item #9, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"Informed Consent Audits"]
[null,"Note: Questions #10 to #18 are based on RCO Informed Consent (IC) Audits for this reporting period. "]
[null,"RCOs are required to conduct an IC audit on all active human subject protocols with the exception of protocols that have previously received at least one IC audit where 1) the research is permanently closed to the enrollment of new subjects, 2) all subjects have completed all research-related interactions and interventions, and 3) the research has progressed to the point that it involves only accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care; or where the remaining research activities are limited to data analysis. Include all deficiencies found and confirmed at the time of the audit, even if deficiencies were eventually remediated."]
[]
[]
[]
[]
[null,"10.","Number of protocols in #2 requiring an informed consent audit:"]
[null,null,"a.  Number of protocols in #10 receiving a required informed consent audit:"]
[null,null,"Note: If all required audits were not completed, use the text box below to provide additional information."]
[]
[]
[null,null,"b. Number of additional protocols receiving an informed consent audit: "]
[null,null,"(This is the number of protocols that DID NOT REQUIRE an informed consent audit, yet received an informed consent audit.)"]
[]
[null,null,"c. Total number of protocols receiving an informed consent audit:",{"$f":"D87+D91","v":0}]
[null,null,"Note: This number is auto-calculated from #10a + #10b."]
[null,"11.","Total number of protocols in #10c allowing the use of broad consent:"]
[null,"12.","Number of protocols in #10c with informed consent waived per 38 CFR 16.116:"]
[null,null,"a.  Number of protocols in #12 without an appropriate waiver of informed consent:"]
[]
[null,null,"(This is the number of protocols with \"N\" in \"Waiver appropriate\" under \"Informed consent waived per 38 CFR 16.116.\")"]
[]
[null,null,"Note: Use the text box below to provide additional information about any waivers that were not appropriate. "]
[]
[]
[null,"13.","Number of protocols in #10c with documentation of informed consent waived per 38 CFR 16.117:"]
[]
[null,null,"a.  Number of protocols in #13 without an appropriate waiver of documentation of informed consent:"]
[]
[null,null,"[This is the number of protocols with \"N\" in \"Waiver appropriate\" under \"Documentation of informed consent waived per 38 CFR 16.117(c).\"]"]
[]
[null,null,"Note: Use the text box below to provide additional information about any waivers that were not appropriate."]
[]
[]
[null,"14.","Number of protocols in #10c with HIPAA authorization waived per the HIPAA Privacy Rule 45 CFR 156.512(i):"]
[]
[null,null,"a.  Number of protocols in #14 without an appropriate waiver of HIPAA authorization:"]
[]
[null,null,"[This is the number of protocols with \"N\" in \"Wavier appropriate\" under \"HIPAA authorization waived per HIPAA Privacy Rule (45 CFR sec. 164.512Ii).\"]"]
[]
[null,null,"Note: Use the text box below to provide additional information about any waivers that were not appropriate."]
[]
[]
[null,"15.","Total number of informed consent documents (ICDs) audited in all protocols:"]
[null,null,"(This is the total number of entries in the \"Subject ID\" column in the tool. MVP ICDs audited should be included in this count.)"]
[]
[null,null,"a.  Number of individual ICDs audited found to have no audit deficiencies:"]
[null,null,"(This is the number of ICDs with \"Y\" or \"N/A\" in all  ICD columns of the IC audit tool related to the ICD, except for \"ID'fiable Info/Biospecs.\" Do not include deficiencies related to CPRS progress notes, HIPAA authorization deficiencies, or other deficiencies in local policy in this count.)"]
[]
[]
[null,null,"b.  Number of missing ICDs: "]
[null,null,"(This is the number of entries with \"N\" under \"ICD or copy found.\" Missing ICDs SHOULD be included in the count of total number of ICDs in item #15, but SHOULD NOT be included in counts for other deficiencies below. Do not count ICDs thought to be missing at the time of audit, but that were eventually located.)"]
[]
[]
[null,null,"Note: For answers greater than zero in item #15b, use the text box below to provide specific details about the missing consent forms (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO. "]
[]
[]
[]
[null,null,"c.  Number of ICDs with wrong version used:"]
[null,null,"(This is the number of entries with “N\" under \"Correct version.\")"]
[null,null,"d.  Number of ICDs from another study used:"]
[null,null,"(This is the number of entries with “N” under “ICD from Correct study.”)"]
[null,null,"e.  Number of unapproved ICDs used:  "]
[null,null,"(This is the number of entries with “N” under “IRB-approved.”)"]
[null,null,"Note: For answers greater than zero in items #15d and/or #15e, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"f.  Number of ICDs without a subject (or Legally Authorized Representative) signature:"]
[]
[null,null,"(This is the number of entries with “N” under “Subject signature present.”)"]
[null,null,"Note: For answers greater than zero in item #15f, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"g.  Number of ICDs without a subject date:"]
[null,null,"(This is the number of entries with “N” under “Date of subject signature present.”)"]
[null,null,"h. Number of ICDs without research-related injury language:"]
[null,null,"(This is the number of entries with \"N\" under \"Research-related injury language present.\")"]
[null,"16.","Number of ICDs audited subject to the 2018 Common Rule Requirements:"]
[null,null,"a.  Number of ICDs in #16 without the required key information up front:"]
[null,null,"(This is the number entries with “N” under “Key info provided up front.”)"]
[null,null,"b.  Number of ICDs in #16 from protocols involving identifiable information or biospecimens:"]
[]
[null,null,"(This is the number of entries with “Y” under “Identifiable info/biospecimens collected.”)"]
[null,null,"c.  Number of ICDs in #16b without the required statement on future use of identifiable information or biospecimens:"]
[]
[null,null,"(This is the number of entries with “N” under “Information or biospecimen statement on future use.”)"]
[]
[null,"17.","Number of HIPAA authorizations required:"]
[null,null,"a.  Number of valid HIPAA authorizations not obtained (i.e., no HIPAA authorization or copy that could be located or HIPAA authorization missing signature or date):  "]
[]
[]
[null,null,"(This is the number of HIPAA authorizations with “N” under \"Valid HIPAA authorization obtained.\")"]
[null,null,"Note: For answers greater than zero in item #17a, use the text box below to provide specific details  (e.g., whether reported to a review board or Privacy Office, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"b.  Number of HIPAA authorizations obtained that required use of VA Form 10-0493 (i.e., HIPAA authorizations not combined with the ICD):  "]
[]
[null,null,"[This is the number of entries with \"Y\" under \"VA Form 10-0493 required (HIPAA separate from ICD).” VA Form 10-0493 is required for all protocols approved between March 12, 2015 and January 20, 2019, and for protocols approved on or after January 21, 2019 utilizing a separate HIPAA authorization document.]"]
[]
[]
[]
[null,null,"c.  Number of HIPAA authorizations in #17b not using VA Form 10-0493, when required:"]
[]
[null,null,"(This is the number of entries with \"N\" under \"VA Form 10-0493 used if separate HIPAA authorizations.\")"]
[]
[null,"18. ","Number of Veterans enrolled in the MVP during the reporting period:"]
[null,null,"(Only include enrollments from the main MVP; do not include enrollments in any MVP sub-studies.)"]
[null,null,"a.  Number of Veterans whose MVP ICD and HIPAA authorization were audited:  "]
[null,null,"(Items #18 and #18a are asked to ensure the requirement for auditing at least 10% of MVP ICDs has been met. The number of MVP ICDs audited should also be included in the count of ICDs audited in item #15 and the number of MVP HIPAA authorizations audited should be included in the count of HIPAA authorizations audited in item #17 above.)",{"$f":"D190/D188","v":{"$error":"#DIV/0!"}}]
[]
[]
[]
[null,"Notes for ICD Section:"]
[]
[]
[null,"HRPP Regulatory Audits"]
[null,"Note: Questions #19 to #32 are based on RCO Regulatory Audits conducted for the current reporting period."]
[null,"19. ","Total number of human subjects protocols receiving an HRPP regulatory audit for this period:"]
[]
[null,null,"a.  Number of audited protocols in #19 that were greater than minimal risk:"]
[null,null,"b.  Number of protocols in #19a (greater than minimal risk protocols) that received initial approval by expedited review:"]
[]
[null,null,"Note:  For answers greater than zero for item #19b, use the text box below to provide specific details or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,"20.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,null,"a.  Number of protocols audited in #19 initiated prior to required IRB approval:"]
[null,null,"(This is the number of protocols with \"N\" under \"IRB approval prior to research.\")"]
[null,null,"b.  Number of protocols in #20a completed without required IRB approval:"]
[null,null,"c.  Number of protocols audited in #19 initiated prior to required R&DC approval:"]
[null,null,"(This is the number of protocols with \"N\" under \"R&DC approval prior to research.\")"]
[null,null,"d.  Number of protocols in #20c completed without required R&DC approval:"]
[null,null,"e.  Number of protocols in #19 initiated prior to receiving the ACOS/R letter:"]
[null,null,"(This is the number of protocols with \"N\" under \"ACOS/R letter prior to research.\")"]
[null,null,"f. Number of protocols in #19 without final Privacy Officer (PO) review prior to final R&DC approval:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"Final PO review prior to final R&DC approval.\")"]
[null,null,"g. Number of protocols in #19 without Information System Security Officer (ISSO) review prior to final R&DC approval:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"ISSO review prior to final R&DC approval.\")"]
[null,null,"Note: For answers greater than zero in any item #20a to #20g, use the text box below to provide specific details (whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"21. ","Number of human subject protocols audited in #19 involving international research:"]
[]
[null,null,"a.  Number of protocols in #21 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,null,"Note: For answers greater than zero in item #21a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"22.","Number of human subject protocols audited in #19 involving children:"]
[null,null,"a.  Number of protocols in #22 that did not have documentation of Medical Facility Director approval (or CRADO approval as applicable):"]
[]
[null,null,"Note: For answers greater than zero in item #22a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"23.","Number of human subject protocols audited in #19 involving prisoners:"]
[null,null,"a.  Number of protocols in #23 that did not have documentation of CRADO approval:"]
[]
[null,null,"Note: For answers greater than zero in item #23a, use the text box below to provide specific details (e.g., corrective actions) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"24.","Number of human subject protocols audited involving the use of investigational drugs:"]
[]
[null,null,"(This is the number of protocols with \"Y\" under \"Does this protocol involve the use of investigational drugs.\")"]
[]
[null,null,"a.  Number of protocols in #24 with investigational drug log / accountability record not containing all required elements:"]
[]
[null,null,"(This is the number of protocols with “N” under “Does the investigational drug log or accountability record contain the required elements.”)"]
[]
[null,null,"b.  Number of protocols in #24 with investigational drugs not stored separately from regular pharmacy stock:"]
[]
[null,null,"(This is the number of protocols with “N” under “Are investigational drugs stored separately from regular pharmacy stock.”)"]
[]
[null,"25.","Number of protocols audited in #19 subject to the 2018 Common Rule requirements:"]
[]
[null,null,"a.  Number of protocols in #25 that were IRB-exempt:"]
[null,null,"b.  Number of protocols in #25a with exempt category not documented:"]
[null,null,"(This is the number of protocols with “N” under “Was the exempt category documented.”)"]
[null,null,"c.  Number of protocols in #25a with incorrect exempt category:"]
[null,null,"(This is the number of protocols with “N” under “Does the exempt category determination appear to match the regulatory description of the category.”)"]
[]
[null,null,"Note: For answers greater than zero in items #25b or #25c, use the text box below to provide specific details  (e.g., corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"d.  Number of protocols in #25a requiring limited IRB review:"]
[null,null,"(This is the number of protocols with “Y” under “Did the protocol require a limited IRB review.”)"]
[null,null,"e.  Number of protocols in #25d not receiving required limited IRB review:"]
[null,null,"(This is the number of protocols with “N” under “Did the protocol receive a limited IRB review.”)"]
[null,null,"Note: For answers greater than zero in item #25e, use the text box below to provide specific details (e.g., corrective actions, etc.) or to provide the ORO case number if previously reported to ORO."]
[]
[]
[]
[null,null,"f.  Number of protocols in #25a involving direct interaction with human subjects without provision for providing subjects required information:"]
[]
[null,null,"(This is the number of protocols with “N” under “…did the study documents include provisions for giving the subjects the information outlined in VHA Directive 1200.05(3) § 10.c.”)"]
[]
[null,null,"Note: For answers greater than zero in item #25f, use the text box below to provide specific details (e.g., corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO. "]
[]
[]
[]
[null,"26.","Number of 2018 Common Rule protocols audited (#25) subject to the single IRB requirement:"]
[]
[null,null,"(This is the number of protocols with “Y” under “Is this protocol subject to the single IRB review requirement.”)"]
[]
[null,null,"a.  Number of protocols in #26 that were reviewed by a single IRB:"]
[null,null,"(This is the number of protocols with “Y” under “Was the study reviewed by a single IRB.”)"]
[null,null,"b.  Number of protocols in #26a without a valid reliance agreement in place between the single IRB and the facility:"]
[]
[null,null,"(This is the number of protocols with “N” under “If the study was reviewed by a single IRB that was external to the VA medical facility, was a valid reliance agreement in place for the VA medical facility to rely on that external IRB.”)"]
[]
[]
[null,null,"c.  Number of protocols in #26 not reviewed by a single IRB:"]
[null,null,"(This is the number of protocols with “N” under “Was the study reviewed by a single IRB.”)"]
[null,null,"d.  Number of protocols in #26c without a valid exception granted by the VHA ORD or another Federal entity supporting or conducting the research, as appropriate:"]
[]
[null,null,"(This is the number of protocols with “N” under “If that study was not reviewed by a single IRB, was a valid exception granted by ORD or another Federal entity supporting the research.”)"]
[]
[null,null,"Note: For answers greater than zero in item #26b or #26d, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"27.","Number of protocols audited in #19 that required IRB continuing review per 1200.05(3):"]
[]
[null,null,"(This is the number of protocols with “Y” under “Is IRB CR required by VHA Directive 1200.05(3).”)"]
[null,"28.","Number of protocols audited in #19 not requiring IRB continuing review per 1200.05(3) but continuing review was required by the IRB:"]
[]
[null,null,"(This is the number of protocols with “Y” under “If CR was NOT required by 1200.05(3), did the IRB require CR.”)"]
[]
[null,"29.","a.  Number of protocols in #27 or #28 with a lapse of IRB continuing review:"]
[null,null,"(This is the number of protocols with \"N\" under \"If CR was required by either 1200.05(3) or the IRB, did CR occur as scheduled.\")"]
[]
[null,null,"b.  Number in #29a for which research activities occurred during lapse:"]
[null,null,"Do not count research activities occurring during the approval lapse period that were authorized by the IRB to continue in the best interests of already-enrolled subjects."]
[]
[null,null,"Note: For answers greater than zero in item #29b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"c.  Number in #28 with rationale for IRB-required continuing review not documented:"]
[]
[null,null,"(This is the number of protocols with \"Y\" under \"If the IRB did required CR, was the rationale for requiring CR documented.\")"]
[]
[null,null,"Note: For answers greater than zero in item #28c, use the text box below to provide specific details about why the rationale for IRB-required continuing review was not documented. "]
[]
[]
[null,"30.","For those protocols receiving an HRPP regulatory audit (#19), what was the total number of apparent unanticipated problems involving risks to subjects or others (UPIRTSOs) (including serious adverse events) reported to the reviewing IRB (local or external):"]
[]
[]
[]
[null,null,"a.  Number of events in #30 that were determined by the reviewing IRB to constitute actual UPIRTSOs (unexpected, related or possibly related to the research, and placing subjects or others at substantively greater risk):"]
[]
[]
[null,null,"(This is the number of apparent UPIRTSOs with \"Y\" under \"Unanticipated (U), related or possibly related to study participation(R), AND increased risk (↑risk).\""]
[]
[null,null,"b.  Number of UPIRTSOs in #30a not reported to the IRB within the required time period:"]
[]
[null,null,"(This is the number of apparent UPIRTSOs with \"Y\" under \"Unanticipated (U), related or possibly related to study participation(R), AND increased risk (↑risk).\""]
[]
[null,null,"c.  Number of UPIRTSOs in #30a not reviewed and categorized by the IRB within the required time period:"]
[]
[null,null,"(This is the number of apparent UPIRTSOs with \"N\" under \"Reviewed and categorized within the required time period.\")"]
[]
[null,null,"Note: For answers greater than zero in item #30b or #30c, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"31.","Total number of research personnel records audited as part of the HRPP regulatory audits in #19:"]
[]
[null,null,"a.  Number of research personnel records in #31 with lapse in required human research training:"]
[]
[null,null,"(This is the number of records with “N” under “All human research training current.”)"]
[null,null,"b.  Number of research personnel records in #31 without initial training:"]
[null,null,"(This is the number of records with “N” under “If training not current, training ever completed.”)"]
[null,null,"Note: For answers greater than zero in item #31b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"32.","Total number of subject records reviewed as part of the HRPP regulatory audits in #19 for this period:"]
[]
[null,null,"(Subject records review can be found on page 6 of the HRPP audit tool.)"]
[null,null,"a.  Number of subjects in #32 with research initiated prior to consent:   "]
[null,null,"(This is the number of subject records with “N” under “Documentation that consent obtained prior to initiation of study procedures.”)"]
[]
[null,null,"Note: For answers greater than zero in item #32a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"b.  Number of subject records in #32 for which application of inclusion/exclusion criteria were audited:"]
[]
[null,null,"(This is the number of subject records with either \"Y\" or \"N\" under \"Subject included in research not meeting inclusion or meeting exclusion criteria.\" Auditing inclusion/exclusion criteria is only required for research involving intervention or interaction with subjects determined to be more than minimal risk by the IRB.) "]
[]
[]
[null,null,"c.  Number of subjects in #32b included in research without satisfying inclusion/exclusion criteria:"]
[]
[null,null,"(This is the number of subject records with “Y” under \"Subject included in research not meeting inclusion or meeting exclusion criteria.\")"]
[]
[null,null,"Note: For answers greater than zero in item #32c, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,null,"d.  Number of subjects in #32 without a progress note present in the health record when required:"]
[]
[null,null,"(This is the number of subject records with “N\" under \"If progress note was required in VHA health record, was it present.\")"]
[]
[null,"Notes for HRPP/IRB Section: "]
[]
[]
[null,"ANIMAL CARE AND USE PROGRAM AND IACUC"]
[null,"If your program does not have an ACUP, skip questions #33 to #41."]
[null,"Click here to skip to question #42."]
[null,"Note: Questions #33 to #35 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
[null,"33.","Total number of animal protocols active (open) at any time during this reporting period:"]
[]
[null,"34.","Number of protocols suspended or terminated early by the IACUC due to the study not being conducted in accordance with applicable regulatory, policy, or IACUC requirements or due to animal or research personnel welfare concerns:"]
[]
[]
[null,null,"Note: If not yet reported to ORO, use the text box below to provide specific details, including species and associated corrective actions (if applicable). If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[null,"35.","Number of events determined by the IACUC to constitute serious and/or continuing noncompliance:"]
[]
[null,null,"(VHA Directive 1058.01 §9.d(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the IACUC.)"]
[]
[]
[null,null,"Note: For answers greater than zero in item #35, use the text box below to provide specific details about these events or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"Animal Welfare Audits"]
[null,"Note: Questions #36 to #41 are based on RCO Regulatory Audits conducted for this reporting period."]
[null,"36.","Total number of protocols receiving animal welfare regulatory audits during the reporting year:"]
[]
[null,"37.","Number of protocols audited in #36 involving cats, dogs, or NHP without the required approval from the VA Secretary?"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"If the protocol involves cats, dogs, or non-human primates, does it have the approval of the VA Secretary.\")"]
[]
[null,null,"Note: For answers greater than zero in item #37, use the text box below to provide specific details or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,"38.","Number of protocols audited in #36 involving DEA controlled substances:"]
[null,null,"[This is the number of protocols with \"Y\" under \"Does this protocol involve drug enforcement administration (DEA) controlled substances.\"]"]
[]
[null,null,"a.  Number of protocols in #38 conducted at the VA:"]
[null,null,"(This is the number of protocols with \"Y\" under \"Is this protocol conducted at the VA.\")"]
[null,null,"b.  Number of protocols in #38a with DEA controlled substances not obtained through the VA pharmacy:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"Are controlled substances used in research conducted on VA property obtained through the VA Pharmacy.\")"]
[]
[null,null,"Note: For answers greater than zero in item #38b, use the text box below to provide specific details or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[null,null,"c.  Number of protocols in #38a with controlled substances not properly stored:"]
[null,null,"[This is the number of protocols with “N” under “Are controlled substances stored securely (e.g., in a secured locked cabinet or automated dispensing machine such as a Pyxis or Omnicell) and only accessible to authorized personnel.”]"]
[]
[]
[null,null,"Note: For answers greater than zero in item #38c, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"39.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,null,"a.  Number of protocols audited in #36 initiated prior to IACUC approval:"]
[null,null,"(This is the number of protocols with \"N\" under \"Initial IACUC approval obtained prior to research.\")"]
[null,null,"b.  Number of protocols in #39a completed prior to IACUC approval:"]
[null,null,"c.  Number of protocols audited in #36 initiated prior to R&DC approval:"]
[null,null,"(This is the number of protocols with \"N\" under \"Initial R&DC approval obtained prior to research.\")"]
[null,null,"d.  Number of protocols in #39c completed prior to R&DC approval:"]
[null,null,"e.  Number of protocols in #36 initiated prior to receiving the ACOS/R letter:"]
[null,null,"(This is the number of protocols with \"N\" under \"ACOS/R letter obtained prior to research.\")"]
[null,null,"Note: If not yet reported to ORO, use the text box below to specific provide details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to committee approval. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[]
[null,"40.","Number of protocols audited in #36 that required a complete review:"]
[null,null,"a.  Number of protocols in #40 with a lapse(s) in complete review:"]
[null,null,"(This is the number of protocols with \"N\" under \"Has the IACUC performed a complete review of the protocol and granted renewed approval for work to continue prior to expiration of the initial approval.\")"]
[]
[]
[null,null,"b.  Number of protocols in #40a in which research activities continued during the lapse in complete review:"]
[]
[null,null,"(This is the number of protocols with \"Y\" under \"If NO, did any research occur during the lapse.\")"]
[null,null,"Note: If not yet reported to ORO, use the text box below to provide specific details for lapses in complete reviews, including species and associated corrective actions (if applicable). If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[]
[null,"41.","Total number of research personnel records audited as part of the animal welfare audits in #36:"]
[]
[null,null,"a.  Total number of research personnel records in #41 with lapse in required continuing animal welfare training:"]
[]
[null,null,"(This is the number of records with “N” under “All animal welfare training current.”)"]
[null,null,"b.  Number of research personnel records in #41 without initial animal welfare training:"]
[]
[null,null,"(This is the number of records with “N” under “If training not current, initial animal welfare training ever completed.”)"]
[]
[null,null,"Note: For answers greater than zero in item #41b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"Notes for ACUP/IACUC Section: "]
[]
[]
[null,"RESEARCH SAFETY AND SECURITY PROGRAM AND SRS"]
[null,"If your program does not have research involving biological, chemical, physical, \nor radiation hazards, skip questions #42 to #53."]
[]
[null,"Note: Questions #42 to #44 are not based on RCO audits and pertain only to events occurring during the current reporting period. These questions may be best addressed by the Research Service."]
[]
[null,"42.","Total number of safety protocols active (open) at any time during this reporting period:     "]
[]
[null,null,"a.  Number of protocols in #42 with no IRB or IACUC approval components (i.e., only basic science, bench, or wet lab protocols):"]
[]
[null,"43.","Number of protocols in #42 suspended or terminated early by the SRS due to research laboratory safety or security concerns, including concerns about the safety of individuals conducting VA laboratory research, or environmental concerns attributed to VA laboratory research:"]
[]
[]
[]
[null,null,"Note: If not yet reported to ORO, use the text box below to provide specific details for suspensions. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[null,"44.","Number of events determined by the SRS to constitute serious and/or continuing noncompliance:"]
[]
[null,null,"(VHA Directive 1058.01 §10.c(2) requires written notification to the VA Medical Facility Director, the RCO, and the ACOS/R&D of any determinations of serious and/or continuing noncompliance by the SRS.)"]
[]
[]
[null,null,"Note: For answers greater than zero in item #44 use the text box below to provide specific details about the SRS determinations of serious and/or continuing noncompliance or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[]
[null,"Research Safety Audits"]
[null,"Note: Questions #45 to #53 are based on RCO Regulatory Audits conducted for this reporting period. "]
[null,"45.","Number of protocols receiving a Research Safety regulatory audit during the reporting period:"]
[]
[null,"46.","Number of protocols audited in #45 conducted completely or partially at an off-site location:"]
[]
[null,null,"a.  Number of protocols in #46 without an ORD approved waiver for off-site research:"]
[]
[null,null,"(This is the number of protocols audited with \"N\" in \"ORD approved waiver for off-site research.\")"]
[null,"47.","Number of protocols audited in #45 involving biological hazards:"]
[null,null,"a. Number of protocols in #47 without precautions taken for hazards:"]
[null,null,"[This is the number of protocols audited with \"N\" in \"Has the investigator specified precautions to be taken for the specific hazards (e.g., personal protective equipment to be used, work in a biological safety cabinet).\"]"]
[]
[]
[null,"48.","Number of protocols audited in #45 involving human or non-human cell or tissue samples:"]
[]
[null,null,"a. Number of protocols audited in #48 with potential biohazard for laboratory personnel:"]
[]
[null,null,"(This is the number of protocols audited with \"Y\" in \"Will this use represent a potential biohazard for lab personnel.\")"]
[]
[null,null,"b. Number of protocols in #48a without precautions taken for specified hazards:"]
[null,null,"(This is the number of protocols audited with \"N\" in \"Has the investigator specified the hazard and precautions to be taken.\")"]
[]
[null,null,"c. Number of protocols in #48 involving handling of human blood or other infectious materials without bloodborne pathogen training:"]
[]
[null,null,"(This is the number of protocols audited with \"N\" in \"If protocol involves handling human blood or other potential infectious materials, did all personnel take annual bloodborne pathogens training.\")"]
[]
[]
[null,"49.","Number of protocols audited in #45 involving chemical hazards:"]
[null,null,"(This is the number of protocols with \"Y\" under \"Does this protocol involve chemical hazards.”)"]
[null,null,"a.  Number of protocols in #49 without required semi-annual laboratory chemical inventory review:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"Was the laboratory chemical inventory reviewed semi-annually as required by VHA policy.”)"]
[]
[null,null,"Note: For answers greater than zero in item #49a, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"50.","Number of protocols audited in #45 involving radioisotopes or radiation sources:"]
[null,null,"a.  Number of protocols in #50 without required review by the Radiation Safety Officer or Research Safety Coordinator:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"Has the protocol been reviewed by the Radiation Safety Officer.\")"]
[]
[null,"51.","Number of protocols initiated or completed prior to approval by appropriate oversight committees:"]
[]
[null,null,"a.  Number of protocols in #45 initiated prior to SRS approval:"]
[null,null,"(This is the number of protocols with \"N\" under \"Initial SRS approval prior to research.”)"]
[null,null,"b.  Number of protocols in #51a completed prior to SRS approval:"]
[null,null,"c.  Number of protocols in #45 without appropriate written notification of outcome of SRS review:"]
[]
[null,null,"(This is the number of protocols with “N” under “Investigator notified in writing of the outcome of SRS review.”)"]
[]
[null,null,"d.  Number of protocols in #45 initiated without required R&DC approval:"]
[null,null,"(This is the number of protocols with “N” under “Initial R&DC approval prior to research.”)"]
[null,null,"e.  Number of protocols in #51d completed without required R&DC approval:"]
[null,null,"f.  Number of protocols in #45 initiated prior to receiving the ACOS/R letter:"]
[null,null,"(This is the number of protocols with “N” under “ACOS/R letter prior to research.”)"]
[null,null,"Note: If not yet reported to ORO, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to committee approval. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[]
[null,null,"g. Number of protocols audited in #45 without required annual review of the PI's Laboratory program:"]
[]
[null,null,"(This is the number of protocols with \"N\" under \"Did review of the PI's laboratory program occur annually.\")"]
[]
[null,"52.","Number of protocols audited in #45 involving use of non-exempt rDNA requiring IBC approval:"]
[]
[null,null,"a.  Number of protocols in #52 initiated prior to IBC approval:"]
[null,null,"b.  Number of protocols in #52a completed prior to IBC approval:"]
[null,null,"c.  Number of protocols in #52 without appropriate notification of IBC review:"]
[null,null,"(This is the number of protocols with “N” under “Was the investigator appropriately notified in writing or electronically of the outcome of the IBC’s review.”)"]
[]
[null,null,"Note: If not yet reported to ORO, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, corrective actions, etc.) for research initiated or completed prior to IBC approval or without appropriate notification of IBC review. If previously reported to ORO, provide the ORO case number(s). If an ORO case number is provided, no additional information is necessary."]
[]
[]
[]
[]
[null,"53.","Total number of research personnel records audited as part of the research safety audits in #45:"]
[]
[null,null,"a.  Total number of research personnel records in #53 with lapse in required continuing research safety training:"]
[]
[null,null,"(This is the number of research personnel records with an “N” under “All research safety training current.”)"]
[]
[null,null,"b.  Number of research personnel records in #53 without initial research safety training:"]
[]
[null,null,"(This is the number of personnel records with a “N” under “If training not current, research safety training ever completed.”)"]
[]
[null,null,"Note: For answers greater than zero in item #53b, use the text box below to provide specific details (e.g., whether reported to a review board, board's determination, etc.) or to provide the ORO case number(s) if previously reported to ORO."]
[]
[]
[]
[null,"Notes for RSSP/SRS Section:"]

{"sheet":"Director Attestation","index":2,"n_rows":18,"n_cols":1,"rows_kept":18,"cut":false,"hidden":false,"merged":[[0,0,0,9],[2,0,2,2],[3,0,4,9],[6,0,7,9],[17,0,17,3],[17,4,17,9],[13,0,14,9],[9,0,9,9],[10,0,10,9],[11,0,11,9],[12,0,12,9],[1,0,1,9]]}
[{"$f":"PartA!D3","v":"Select Facility…"}]
["Facility Director Attestation"]
[]
["I acknowledge that I am the Director of this VHA Facility and the Institutional Official responsible for this Facility’s compliance with all federal, VA, and VHA research requirements.  "]
[]
[]
["By submitting this document, I certify that the information contained in this document is accurate to the best of my knowledge."]
[]
[]
["Complete the following steps to submit this Certification:"]
["1. Type your name in the \"Name of the Medical Facility Director\" text box highlighted below."]
["2. Save the file by clicking the \"Save File\" button below."]
["3. Click the \"Email File\" button to attach this file to an email."]
["4. In the subject line or body of the email, please include your facility's station number and/or facility name and send the email."]
[]
[]
[]
["Name of the Medical Facility Director:"]

{"sheet":"FDC Instructions","index":3,"n_rows":119,"n_cols":1,"rows_kept":119,"cut":false,"hidden":false,"merged":[[15,0,16,9],[2,0,3,9],[5,0,5,9],[7,0,8,9],[10,0,10,9],[12,0,13,9],[67,0,70,9],[18,0,18,9],[24,0,24,9],[26,0,27,9],[29,0,29,9],[36,0,44,9],[46,0,50,9],[52,0,55,9],[57,0,61,9],[63,0,65,9],[20,0,22,9],[33,0,34,9],[118,0,118,9],[72,0,73,9],[83,0,87,9],[89,0,92,9],[94,0,95,9],[97,0,98,9],[100,0,102,9],[106,0,106,9],[108,0,109,9],[111,0,112,9],[114,0,114,9],[77,0,81,9]]}
["GENERAL INSTRUCTIONS"]
[]
["1. Complete and submit the 2024 Facility Director’s Certification of Research Oversight (FDC) in MS Excel format.  "]
[]
[]
["2. Open the Excel tool in the MS Excel application. Do not open the tool through MS Teams or OneDrive."]
[]
["3. Save the tool as a macro-enabled workbook (.xlsm) so all functions work as intended. The tool has built-in logic to gray out certain questions and rows depending on the answers to other questions. "]
[]
[]
["4. Include your facility's name in the file name of the saved document."]
[]
["5. Adjust how zoomed in or out you are on the screen as needed if an item appears to be truncated. All items are formatted to be fully visible, but appearances may differ by screen. "]
[]
[]
["6. Do not separate individual Worksheets from the overall Workbook for completion. The tool must remain as a single Workbook so that all functions work as intended. "]
[]
[]
["7. Use the tab key to navigate through the items requiring a response on each Worksheet. "]
[]
["8. Double click to type your response directly into the text box. Text boxes will expand as you type in text. Please note: Long responses may not show properly if you do not double click to type into the text box (e.g., copy and paste text into the box)."]
[]
[]
[]
["9. Do not include any identifiable information (e.g., subject or investigator names) in the tool."]
[]
["10. To print a copy of the tool: Highlight the Worksheets that you would like to print by pressing Ctrl and click on the Worksheet tabs. Ensure \"Print Active Sheets\" is selected under print options."]
[]
[]
["11. Direct any questions related to the 2024 FDC to: vhacooroeda@va.gov."]
[]
["PART A"]
[]
["1. Use only the designated dropdowns and text boxes to respond. Do not copy and paste information into bright blue dropdown response boxes."]
[]
[]
["2. For dropdowns: Click in the bright blue box and the dropdown arrow will become visible. Select the appropriate response from the options shown. NOTE: If a drop-down arrow appears but the list itself will not appear, press Alt and the down arrow to expand the list or change the resolution to zoom in or out. That often will fix this issue. Most dropdown selections are in the column immediately to the right of the question number; however, a few dropdown selections are in the column with the question text, when a wider column is needed to view all options. After you select an option from one of the wider dropdown menus, all other dropdown menus may appear too wide for your screen. If this happens, make a selection from one of the dropdown menus in the column immediately to the right of the question number (the narrower column) and click save to restore all dropdown menus to the appropriate width. "]
[]
[]
[]
[]
[]
[]
[]
[]
[]
["3. To enter information into a tan text box: Double click to type your response directly into the text box. Text boxes will expand as you type in text. Please note: Long responses may not show properly if you do not double click to type into the text box (e.g., copy and paste text into the box). Text boxes will appear bright yellow when a response is required based on the selection in the dropdown menu. Text boxes will turn white once the required response has been entered."]
[]
[]
[]
[]
[]
["4. Use instructions with color-coded font to identify specific actions to take. Red font instructions provide clarification or indicate when additional information is needed. Blue font instructions provide direction to the next applicable question when certain items are not applicable to your site (based on prior responses). "]
[]
[]
[]
[]
["5. Use designated text boxes at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers that indicate outstanding noncompliance. Double click to type your response directly into the text box. Text boxes will expand as you type in text. Please note: Long responses may not show properly if you do not double click to type into the text box (e.g., copy and paste text into the box)."]
[]
[]
[]
[]
[]
["6. Scan through the tool once all responses are entered to ensure there are no remaining colored cells that need to be completed. Response boxes will turn white once completed so you can easily identify which cells require a response. "]
[]
[]
[]
["7. To navigate to additional information about the Common Findings: Questions related to Common Findings on ORO Combined Program Reviews will include an \"ORO Common Finding\" button. Click on the blue \"ORO Common Finding\" button to navigate to more information about the Common Findings applicable to that FDC item. Click on the blue \"Return\" link to go back to the FDC Part A. "]
[]
[]
[]
[]
["8. To navigate to IACUC Definitions: Click on the blue \"Go to IACUC Definitions\" button to navigate to specific definitions in Part A. Click on the blue \"Back to Part A\" button to return to the FDC Part A. "]
[]
[]
["PART B"]
[]
["1. Enter whole number responses directly into the bright blue response boxes. Do not copy and paste responses into the bright blue responses boxes. Response boxes will turn bright yellow with red font text if a response is entered that is inconsistent with other information that you previously entered into the tool. Data validation prompts will also help you to identify potential data entry errors. Response boxes will turn red if there is a potential data validation error."]
[]
[]
[]
[]
[]
["2. To enter information into a text box: Click in the box and begin typing a response. Double click to type your response directly into the text box. Text boxes will expand as you type in text. Please note: Long responses may not show properly if you do not double click to type into the text box (e.g., copy and paste text into the box). Tan boxes for text responses will turn bright yellow when more information is required based on a prior response. Text boxes will turn white once the required response has been entered. "]
[]
[]
[]
[]
[]
["3. Use designated text boxes at the end of each section for any additional notes you would like to provide to ORO or to further explain any answers indicating outstanding noncompliance. Text boxes will expand as you type in text. Please note: Long responses may not show properly if you do not double click to type into the text box (e.g., copy and paste text into the box)."]
[]
[]
[]
[]
["4. Look for additional instructions in red font throughout Part B of the tool that provide guidance on what information to include for certain responses. "]
[]
[]
["5.  Items will turn gray and responses boxes will disappear if you do not need to respond to that item based on your prior responses. "]
[]
[]
["6. Scan through the tool once all responses are entered to ensure there are no remaining colored cells that need to be completed. Response boxes will turn white once completed so you can easily identify which cells require a response. "]
[]
[]
[]
["SUBMISSION (All submissions steps should be completed by the Medical Facility Director.)"]
[]
["1. Sign (print name) on the Director Attestation tab. An electronic signature is not required."]
[]
["2. Save a copy of the completed tool by clicking on the “Save File” button on the Director Attestation tab. Make sure the facility's name is in the file name of the saved document. "]
[]
[]
["3.  Click on the “Email File” button after saving the file. An Outlook message with the file attached will appear."]
[]
[]
["4. Enter the Station Number and/or Facility Name either in the subject line or in the Outlook message."]
[]
["5. Click \"send\" on the Outlook message with the file attached. "]
[]
["6. The FDC must be signed and submitted by the Medical Facility Director. "]

{"sheet":"Common Findings","index":4,"n_rows":330,"n_cols":3,"rows_kept":330,"cut":false,"hidden":false,"merged":[]}
[]
[null,"The Common Findings Tab lists recurring findings of programmatic noncompliance captured in ORO combined program review (CPR) reports issued in calendar years 2021 through 2023. \"Common Findings\" are those findings identified at 20% or more of the programs reviewed across the combined 3-year period (2021-2023). The numbered items (shaded in orange) list the Common Findings. The bulleted points below each listed Common Finding provide representative examples of that finding from the CPR reports. Red font denotes that the description of the finding aligns with a specific question on the FDC. \n\nIn the Part A Tab, FDC items related to a Common Findings are shaded in pink to provide information about which FDC questions correspond with the Common Findings. Information about the Common Findings from CPRs has been added to the FDC to bring awareness to the nature of the noncompliance ORO regularly finds during site visits. By raising awareness of these Common Findings, ORO hopes to try to reduce the occurrence of that noncompliance.\n","←RETURN"]
[]
[null,"Common Findings Related to General Research Administration"]
[null,"1. Deficient or No Tracking of Research Activities"]
[null,"• The Research Office did not have a system for tracking research studies and committee actions.","←RETURN"]
[null,"• The Research Office did not meet the requirement to establish tracking systems that allowed for easy retrieval of information to assist in assessing compliance with applicable requirements and the status of each program activity or element. "]
[null,"• The Research Office tracking systems did not include initial and continuing review approvals given by the SRS and the inventory of research data did not contain all required information, such as where the data are stored.","←RETURN"]
[null,"• The Research Office tracking systems contained inaccuracies and thus did not allow for the easy retrieval of information. "]
[null,"• The Research Office’s inventory of all research data being stored until the retention requirement has been met was incomplete. ","←RETURN"]
[null,"• The Research Office tracking system for the training of research personnel contained inaccuracies and deficiencies.  "]
[null,"• The Research Office did not consistently use its tracking systems to assess compliance with the completion of all ORD-required training for research personnel and Annual Government Ethics training for investigators. ","←RETURN"]
[null,"• The RCO maintained responsibility for tracking the completion of an educational requirement for research personnel and investigators, although VHA policy requires that the Research Office maintain responsibility for this tracking function. "]
[null,"2. Deficient R&DC Meeting Minutes"]
[null,"• The R&DC meeting minutes did not include a list of all voting members."]
[null,"• The R&DC meeting minutes did not document the names of voting members who were absent."]
[null,"• The R&DC meeting minutes did not indicate when an alternate was present in place of a voting member and the name of the voting member being replaced."]
[null,"• The R&DC meeting minutes did not document whether recused voting members were present during discussions of the item from which they were recused."]
[null,"• The R&DC meeting minutes did not document whether members identified to have a conflict of interest were recused from voting on those items. "]
[null,"• The R&DC meeting minutes did not accurately document the number voting for, against, and abstaining from actions. "]
[null,"• The R&DC meeting minutes did not document when final approval was granted for a protocol that was previously contingently approved."]
[null,"3. Deficient R&DC Review / Approval of Research "]
[null,"• All applicable committee reviews and approvals did not occur prior to R&DC approval and notification of permission to initiate the research, to include:","←RETURN"]
[null,"     ◦ Final IRB approval was not secured prior to final R&DC approval."]
[null,"     ◦ VA-approved laboratory studies were reviewed and approved by the R&DC prior to the SRS and IBC approvals required by the proposed research."]
[null,"     ◦ Privacy Officer (PO) reviews were not completed prior to final R&DC approval."]
[null,"     ◦ Information System Security Officer (ISSO) reviews were not completed prior to final R&DC approval. ","←RETURN"]
[null,"• The R&DC reviewed and approved VA research at convened meetings without a quorum present."]
[null,"• An alternate member voted at R&DC meetings at which the primary voting member for whom the alternate substituted also voted. "]
[null,"• Final approvals by Designated Member Review (DMR) were not reported to the full R&DC at the next convened meeting, as required by VHA policy. "]
[null,"• The R&DC did not approve amendments to approved research for which it was the only oversight committee.","←RETURN"]
[null,"• The R&DC did not document all required determinations for studies overseen by an external IRB.","←RETURN"]
[null,"• The R&DC reviewed and approved non-VA research that did not qualify as VA research based on the misunderstanding that such “approval” was required for purposes of Research and Development Information System (RDIS) reporting."]
[null,"•\tThe R&DC’s written procedures for designated review allowed a DMR process to be used for the review and approval of activities that did not qualify for R&DC designated review under VHA policy, including initial review and approval of non-exempt human subjects research that was ineligible for expedited IRB review and animal research involving USDA Category E procedures. "]
[null,"• Final approval contingent upon completion of the ISSO review or the PO review was at times granted administratively by the R&DC coordinator rather than by the convened R&DC, R&DC Chair, or by DMR. "]
[null,"• A protocol that received contingent approval from the R&DC at a convened meeting did not subsequently receive final approval by either the convened R&DC or through a designated review process after the contingencies were met. "]
[null,"• The R&DC did not grant and document specific approval for the recruitment of non-Veterans into protocols. ","←RETURN"]
[null,"• The facility did not ensure an Enterprise Research Data Security Plan (ERDSP) was submitted in conjunction with new protocols submissions so that data safeguards could be reviewed and evaluated. ","←RETURN"]
[null,"• The facility ISSO did not consistently make protocol determinations regarding research data usage within the ERDSP. ","←RETURN"]
[null,"3. Inadequate R&DC Oversight of Subcommittees"]
[null,"• The R&DC did not conduct annual reviews of all research-related committees and subcommittees. ","←RETURN"]
[null,"• The R&DC did not provide a summary of its review of committees to the Medical Facility Director. "]
[null,"• The R&DC did not comprehensively review on an annual basis the facility-specific aspects of the facility’s relationships with research oversight committees that it relied upon aside from its own subcommittees, to include the VA Central IRB."]
[null,"• The R&DC did not ensure the adequacy of  subcommittee review and approval of its SOPs."]
[null,"• The R&DC did not consistently review subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes. ","←RETURN"]
[null,"4. Lack of or Deficient R&DC SOPs"]
[null,"• R&DC policies were not updated to reflect all applicable VHA policy requirements related to recurring R&DC processes."]
[null,"• The R&DC did not maintain SOPs or other written procedures for all recurring local processes."]
[null,"• The R&DC SOP was not updated to reflect all recurring R&DC processes."]
[null,"• The R&DC SOPs contained language in conflict with VHA requirements."]
[null,"• The Research Service policies were not updated to reflect all VHA Directive 1200.01(1) requirements. "]
[null,"• The R&DC SOPs did not include a description of all recurring R&DC processes, to include:"]
[null,"     ◦ Ensuring ISSO review of studies that involve the collection, processing, storage, and transmission of research data and PO review of studies using human data are complete before a study is given final R&DC approval."]
[null,"     ◦ Review and approval of amendments to protocols under the sole oversight of the R&DC. "]
[null,"     ◦ Procedures for the initial and continuing review of research and designated review."]
[null,"• The facility did not consistently follow its written SOPs regarding R&DC operations and processes. "]
[null,"• Many of the R&DC SOPs local requirements that were more specific than VHA requirements were not consistently followed. "]
[null,"Common Findings Related to Human Research Protection Programs"]
[null,"1.  Deficient IRB Meeting Minutes"]
[null,"• The IRB meeting minutes did not consistently reflect the accurate number of members voting on actions taken by the IRB."]
[null,"• The IRB meeting minutes did not consistently document all actions taken by the IRB. "]
[null,"• The IRB meeting minutes did not consistently and accurately document the votes on actions taken by the IRB. "]
[null,"• The IRB meeting minutes did not consistently document that all criteria for approval of the research had been satisfied. ","←RETURN"]
[null,"2. Deficient IRB Review / Approval of Research"]
[null,"• The IRB made an exempt determination for a study that did not qualify for exemption, resulting in the conduct of non-exempt human subjects research without IRB approval. "]
[null,"• The IRB approved minimal risk studies via expedited review without ensuring that applicable requirements pertaining to informed consent were met."]
[null,"• The IRB did not ensure that all approval conditions (e.g., Privacy Officer review of proposed changes) were met prior to granting final approval of a protocol amendment. "]
[null,"• The IRB did not document its rationale for requiring continuing review (CR) for some protocols that were both subject to the 2018 Common Rule and eligible for expedited review.","←RETURN"]
[null,"• The IRB required CR for some protocols that transitioned to the 2018 Common Rule and were eligible for expedited review; however, the IRB assigned an approval period of 3 years instead of 1 year, as required by VHA policy."]
[null,"• The convened IRB conducted initial and continuing review of protocols despite the absence of a non-scientist member, whose presence is required by federal regulation and VHA policy when a convened IRB is reviewing research. "]
[null,"• Exemption determinations were made by an administrative staff member without expertise in applying human research exemption regulations. "]
[null,"• The IRB inappropriately used expedited review procedures to approve an amendment that did not qualify for expedited review.  "]
[null,"• The IRB approved some greater than minimal risk studies without determining that all IRB approval requirements were satisfied. "]
[null,"• The IRB approved a research study on an investigational drug without following its SOPs for the review and approval of investigational drug research. "]
[null,"• The IRB did not determine if a device was either exempt from the Investigational Device Exemption (IDE) regulations or make and document a device risk determination before granting expedited approval. "]
[null,"3. IRB-Approved ICD Did Not Contain All Required Elements or was Otherwise Deficient"]
[null,"• The IRB did not consistently ensure that the approved ICD, information sheet (in lieu of a signed ICD), or IC script contained all applicable required elements of informed consent. Deficiencies included:","←RETURN"]
[null,"     ◦ No description of foreseeable risks. "]
[null,"     ◦ No statement that participation was voluntary."]
[null,"     ◦ Noncompliant language on billing for research-related medical care, services, and injury."]
[null,"     ◦ No or misleading statements about treatment alternatives to study participation. "]
[null,"     ◦ No statement that information about study participation would be included in the medical record for a study protected by a Certificate of Confidentiality. "]
[null,"     ◦ No statement on future use of identifiable private information or biospecimens for items approved under the 2018 Common Rule."]
[null,"• The Principal Investigator (PI) and the IRB did not consistently ensure that ICDs were updated to reflect changes in key personnel. "]
[null,"• The IRB approved an ICD with information about storage of biospecimens for future research that contradicted the HIPAA authorization document and the protocol."]
[null,"• The IRB approved an ICD with information about re-contact for potential participation in future research that contradicted the HIPAA authorization document and the protocol. "]
[null,"• Data sharing provisions contained in ICDs for some studies were not consistent with their corresponding HIPAA authorizations. "]
[null,"• Prospective human research subjects were not provided with required information during the informed consent process pertaining to a Certificate of Confidentiality issued to protect information for a research study."]
[null,"• Electronic signatures on combined informed consent and HIPAA authorization documents did not meet VA requirements, resulting in invalid documentation of consent and the use of protected health information (PHI) for research without legal authority (i.e., a valid HIPAA authorization)."]
[null,"• The ICD was printed in such a way that the signature date field was pre-populated rather than dated by the subject contemporaneously with the subject’s signature. "]
[null,"• The IRB approved an ICD for a clinical investigation regulated by the Food and Drug Administration (FDA) that did not include: "]
[null,"     ◦ Required statements providing awareness of the extent to which confidentiality of records identifying subjects would be maintained."]
[null,"     ◦ Information on the possibility that the FDA may inspect records. "]
[null,"     ◦ Information on the posting of a description on clinicaltrials.gov. "]
[null,"• The ICD for one protocol included a misleading statement regarding the test article being studied that implied that the test article being studied had an FDA approval that it did not actually have. "]
[null,"• The IRB approved ICDs for investigational device protocols that did not adequately identify which procedures were experimental. "]
[null,"4. Lack of or Deficient HRPP / IRB SOPs"]
[null,"• The IRB did not establish written SOPs to reflect all applicable VHA policy requirements, to include: "]
[null,"     ◦ Determining when a study subject to the 2018 Common Rule required limited IRB review. "]
[null,"     ◦ Determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review."]
[null,"     ◦ Documenting the IRB’s rationale for requiring CR for studies that do not otherwise require CR under the 2018 Common Rule."]
[null,"     ◦ Observing (or having a third party observe) research activities, include in the informed consent process, when the IRB determines this to be appropriate. "]
[null,"     ◦ Determining which protocols require review more often than annually. "]
[null,"• The written SOPs included noncompliant language, including that pertaining to:"]
[null,"◦ VHA Records Control Schedule (RCS) 10-1 requirements for investigator records."]
[null,"◦ Conducting research on human fetal tissue while on official VA duty, ta VA facilities, or at VA-approved off-site facilities. "]
[null,"• The written SOPs included outdated references to the rescinded VHA Handbook 1058.01, which resulted in outdated and deficient reporting procedures. ","←RETURN"]
[null,"• The IRB did not have a written procedure in place to inform investigators and the Research and Development Committee (R&DC) of its approval decisions and the expedited review actions.","←RETURN"]
[null,"• The facility did not have a documented procedure for when research can transition to the 2018 Requirements.","←RETURN"]
[null,"• The facility did not ensure that SOPs were developed to reflect its reliance on the VA Central IRB, Panel 3 (Community IRB). "]
[null,"• The written SOPs included deficient procedures for reporting and reviewing adverse events, unanticipated problems involving risks to subjects and others and deaths of human subjects that are unexpected and related or possibly related to the research. "]
[null,"5. Nonadherence to Local SOP"]
[null,"• The IRB did not consistently follow its written procedures related to membership:"]
[null,"     ◦ The Investigational Drug Service pharmacist was not appointed as a voting member of the IRB, as required by local policy. "]
[null,"     ◦ A primary voting member did not complete a conflict-of-interest form, as required annually."]
[null,"     ◦ The IRB did not ensure that primary voting members attended at least 75% of the scheduled IRB meetings annually, as required by local policy. "]
[null,"     ◦ The IRB did not ensure that alternate IRB voting members attended at least one IRB meeting annually , as required by local policy. "]
[null,"     ◦ No primary or alternate voting members had completed annual self-evaluation surveys. "]
[null,"• The IRB did not consistently follow its written procedures related to reviews:"]
[null,"     ◦ The IRB provided conditional approval for two protocols, although some IRB stipulations constituted significant changes that should have been tabled."]
[null,"     ◦ The convened IRB voted to approve a protocol pending substantive changes; however, the IRB SOP did not establish the category “approve pending substantive changes” as an allowable IRB action. "]
[null,"     ◦ IRB approval was at times provided prior to other required subcommittee reviews. "]
[null,"     ◦ The Research Compliance Officer (RCO) regulatory and ICD audit reports did not receive convened board review, as required by local policy.   "]
[null,"• The IRB did not consistently follow its written procedures related to meeting minutes and documentation:"]
[null,"     ◦ Minutes from the HRPP Working Group of the IRB were not reported at the following month’s IRB meeting, as required by local policy."]
[null,"     ◦ The IRB did not consistently list research that was approved via expedited review procedures in the IRB minutes of the next convened meeting. "]
[null,"     ◦ The expedited review eligibility category was not documented in the IRB meeting minutes or in the letter conveying the IRB’s decision to the investigator. "]
[null,"     ◦ IRB meeting minutes were not prepared in a timely manner in accordance with local policy. Consequently, review of meeting minutes by the IRB was frequently delayed, as was finalization and submission of IRB meeting minutes to the R&DC. "]
[null,"     ◦ The IRB transitioned studies to the 2018 Common Rule but was unable to provide documentation that the study team was notified of this transition in writing, as required by the IRB SOP."]
[null,"• The IRB did not consistently review and approve FDA-regulated clinical investigations in accordance with local policies:"]
[null,"     ◦ The IRB did not determine whether a protocol met any of the Investigational New Drug application exemption criteria. "]
[null,"     ◦ The IRB did not make the required risk determinations at a convened meeting. "]
[null,"     ◦ The IRB did not document a device risk determination and rationale in the meeting minutes."]
[null,"     ◦ The IRB did not provide written notification of a device risk determination to the study PI. "]
[null,"4. Noncompliant HIPAA Authorization Waiver(s)"]
[null,"• The IRB did not consistently ensure that approved waivers of HIPAA authorization were signed in accordance with VHA policy, which resulted in protected health information (PHI) being used for research without valid waiver of HIPAA authorization.","←RETURN"]
[null,"• The IRB did not consistently document a brief description of the PHI for which the IRB determined use and disclosure to be necessary when approving waivers of HIPAA authorization."]
[null,"• The IRB did not consistently ensure that the approved requests for waiver of HIPAA authorization included sufficient information to allow the IRB to make a fully informed decision. "]
[null,"• The IRB-approved waiver of HIPAA authorization indicated that only de-identified information would be transcribed into an electronic data capture system; however, PHI was entered into the non-VA system without valid authority provided by either the waiver of HIPAA authorization or by a signed HIPAA authorization. "]
[null,"• A waiver of HIPAA authorization was requested for recruitment purposes, but there was no documentation of waiver approval, resulting in the use of PHI without legal authority.  "]
[null,"• Approved waivers of HIPAA authorization did not document the IRB review procedure used to approve the waiver (e.g., expedited or full board / convened review). "]
[null,"• Electronic signatures that did not meet VHA requirements for digital signatures were created by simply typing in the name of the IRB Chair and the date of approval, rather than by using digital signatures with electronic credentials. As such, approved waivers of HIPAA authorization did not meet all documentation requirements, resulting in the use of PHI without legal authority (i.e., a valid waiver). "]
[null,"Common Findings Related to Animal Care and Use Programs"]
[null,"1. Animal Welfare Training Not Completed as Required"]
[null,"• The Research Service did not consistently ensure that individuals involved in the animal research program completed required training."]
[null,"• The Research Service did not consistently ensure all IACUC members completed required training and remained current with their training."]
[null,"2. Deficient IACUC Research Review / Approval of Protocol(s)"]
[null,"• The IACUC did not consistently ensure that approved protocols included:"]
[null,"     ◦ Complete, clear, congruent, and/or accurate information."]
[null,"     ◦ Sufficient information to weigh potential concerns about animal welfare against the benefits to be gained from the work."]
[null,"     ◦ Adequate descriptions and scientific justifications for the proposed use of non-pharmaceutical grade compounds."]
[null,"     ◦ Adequate scientific justifications for the use of single housing. "]
[null,"     ◦ Consistent information between the VA Animal Component of Research Protocol (ACORP) and the affiliate-reviewed protocol describing the same VHA research project. "]
[null,"• The IACUC did not consistently ensure that approved protocols included all required scientific justifications for category E activities."]
[null,"• The IACUC consistently used designated member review (DMR) subsequent to full committee review (FCR) without specifically voting unanimously to use this method in each instance. "]
[null,"• The IACUC did not consistently assign compliant approval dates when using the DMR process for protocols contingently approved by the full committee. "]
[null,"• Voting via email outside of a convened meeting, rather than FCR or DMR, was used to grant initial approval for one protocol and to approve amendments related to the same protocol on three occasions."]
[null,"• Continuing reviews of ongoing animal research activities were conducted via the DMR, and only the designated reviewer(s), rather than all IACUC members, were notified and provided a copy of the materials for review. As such, all committee members did not have an opportunity to request FCR. "]
[null,"• The IACUC did not consistently use compliant approval practices when reviewing modifications to approved protocols, to include:"]
[null,"     ◦ Administrative review rather than FCR or DMR was used to approve changes in PI in animal protocols. "]
[null,"     ◦ Changes that should only be approved using FCR or DMR were reviewed and approved by two or three committee members between IACUC meetings without first giving all committee members an opportunity to request FCR. "]
[null,"     ◦ A protocol amendment was approved administratively by the Attending Veterinarian (AV) rather than by FCR or DMR and the IACUC had not developed and approved local policies to allow the AV to administratively approve this type of significant change. "]
[null,"     ◦ Revised documents for amendments conducted by DMR that required modifications for approval were only provided back to one designated reviewer instead of to both designated reviewers for final review. "]
[null,"3. Environmental Systems Failure in Animal Facility"]
[null,"• Relative humidity in the animal housing rooms and feed storage area was not consistently maintained within appropriate ranges, and these departures from the Guide for the Care and Use of Laboratory Animals (“the Guide”) was not reviewed and approved by the IACUC.","←RETURN"]
[null,"• Temperatures in the animal housing rooms were not consistently maintained within appropriate ranges, and these departures from the Guide was not reviewed and approved by the IACUC. "]
[null,"• The VMU heating, ventilation, and air-conditioning (HVAC) system was chronically unreliable and did not provide appropriate environmental conditions for the animals housed there.  "]
[null,"4. IACUC Not Properly Constituted or Appointed"]
[null,"• Required committee members participated in official IACUC business as voting members without valid appointments.","←RETURN"]
[null,"• The Veterinary Medical Consultant (VMC) served as the attending veterinarian and attended IACUC meetings as a voting member without an appointment from the Medical Facility Director."]
[null,"• One individual participated in official IACUC business as a non-required voting member prior to being officially appointed to the committee."]
[null,"• The AV was not officially appointed in writing to serve on the IACUC."]
[null,"• The appointments ended for the sole non-affiliated member and the sole non-scientific member of the IACUC; however, these members continued to participate as required voting members for at least two IACUC meetings prior to being reappointed. "]
[null,"• The VHA scientist representative on the affiliate IACUC of record did not hold a VA-compensated appointment. ","←RETURN"]
[null,"5. Inadequate Oversight of Off-Site VA Animal Research"]
[null,"• The IACUC did not consistently receive and review affiliate semiannual reports as required.","←RETURN"]
[null,"• The facility did not receive copies of affiliate-approved protocol documents as required by the MOU. "]
[null,"• The IACUC did not participate in the affiliate semiannual self-assessments as described in the existing memorandum of agreement. "]
[null,"• Oversight of VHA animal research conducted at the affiliate was not being provided as described in local policy or in the facility’s MOU with the affiliate to use its IACUC.  "]
[null,"6. Noncompliant Semiannual Program Review / IACUC Facility Inspections"]
[null,"• The IACUC did not conduct semiannual evaluations at compliant intervals.","←VA IACUC"]
[null,"• Meetings to discuss the semiannual evaluation report with the Medical Facility Director did not include all required participants.","←External IACUC"]
[null,"• The semiannual evaluation was not documented in a compliant manner. The IACUC did not:","←Affiliate Facility"]
[null,"     ◦ Include a plan and schedule for correcting each deficiency identified.  "]
[null,"     ◦ Prepare and endorse an official committee report submission to the Medical Facility Director."]
[null,"     ◦ Assess compliance of the VA ACUP."]
[null,"     ◦ Include the nature and extent of the institution’s adherence to the Guide. "]
[null,"     ◦ Classify any identified deficiencies as minor or significant."]
[null,"• Semiannual program review reports to the Medical Facility Director did not specify departures from the approved protocol, the Guide for the Care and Use of Laboratory Animals, or the PHS Policy on Humane Care and Use of Laboratory Animals."]
[null,"• The final, signed IACUC semiannual reports were not provided to the R&DC or the VHA Office of Research & Development (ORD) as required."]
[null,"• The semiannual evaluation was only signed by two IACUC members rather than by a majority of IACUC members. "]
[null,"• The semiannual evaluation report was routed to the Medical Facility Director for signature in lieu of a meeting to discuss the outcome. "]
[null,"7. Overheat Tests in Animal Research Facility Not Conducted, Documented, or Reviewed in Compliance with VHA Policy"]
[null,"• Overheat tests were not conducted at the required intervals. ","←RETURN"]
[null,"• The IACUC did not review overheat test results to determine if the response was adequate."]
[null,"• Overheat response tests were conducted but were not reported to the IACUC."]
[null,"• The IACUC did not document the review of overheat test results in the IACUC meeting minutes.","←RETURN"]
[null,"8. Unapproved Deviation from Approved Animal Research Protocol"]
[null,"• Some animal procedures performed significantly deviated from the approved protocol and had the potential to impact animal welfare."]
[null,"• Animals were not monitored following surgery at the intervals approved in the protocol."]
[null,"• Animals were not weighed at the intervals approved in the protocol."]
[null,"• Antibiotics were not administered pre- and post-surgery as approved in the protocol."]
[null,"• Anesthetic medications were administered at doses not approved in the protocol."]
[null,"• Mice were not euthanized when the IACUC-approved humane endpoints in the VA ACORP had been reached. "]
[null,"Common Findings Related to Research Safety and Security Programs"]
[null,"1. Chemical Hygiene Plan Not Established / Not Available or Lacking Required Elements"]
[null,"• The CHP was missing required elements of the Occupational Safety and Health Administration (OSHA) standard, to include:  ","←RETURN"]
[null,"     ◦ Designation of personnel responsible for implementing the CHP, including assignment of a Chemical Hygiene Officer. "]
[null,"     ◦ Provisions for additional worker protection for work with reproductive toxins and substances with high degree of acute toxicity."]
[null,"     ◦ Provisions for medical consultation and medical examinations in the event of a chemical exposure incident."]
[null,"2. Deficient Communication / Notification of IBC Review / Approval"]
[null,"• The IBC did not notify the PI in writing or electronically of the assigned biosafety level for rDNA protocols. "]
[null,"• The IBC did not notify the PI in writing or electronically of the protocol approval date."]
[null,"• The affiliate IBC’s meeting minutes pertaining to the IBC’s review of VA rDNA research and copies of the IBC approval letters for VA rDNA research were not forwarded to the VA facility, as required by the memorandum of agreement. "]
[null,"3. Deficient Documentation of Safety Training"]
[null,"• The Research Office did not maintain all required safety training records, including: "]
[null,"     ◦ Annual safety training,"]
[null,"     ◦ Bloodborne pathogen (BBP) training,"]
[null,"     ◦ CHP training,"]
[null,"     ◦ Chemical-specific (e.g., formaldehyde) training,"]
[null,"     ◦ Lab-specific SOPs,"]
[null,"     ◦ Training on NIH Guidelines, and"]
[null,"     ◦ Radiation training. "]
[null,"4. Deficient Documentation of SRS Reviews and Committee Operations"]
[null,"• The SRS did not ensure the outcome of DMRs were documented in the SRS meeting minutes. "]
[null,"• The SRS did not ensure the Chair’s administrative reviews of clinical research protocols determined to be exempt from SRS review were reported at the next convened SRS meeting and documented in the SRS meeting minutes. "]
[null,"• The SRS did not document in writing the assignment of the Associate Chief of Staff / Research & Development (ACOS/R&D) to determine whether protocols were exempt from SRS review. "]
[null,"• The SRS did not document in writing the assignment of the SRS Coordinator to determine whether protocols were exempt from SRS review. "]
[null,"5. Deficient SRS Review / Approval of Protocol(s) / Hazards"]
[null,"• The SRS did not consistently evaluate all research-related hazards associated with the protocols it reviewed (i.e., adequate risk assessment not performed)."]
[null,"• The SRS did not consistently ensure that a description of all risks of chemical, physical, and biological hazards to personnel, the facility, and the environment were provided to the SRS for its review and assessment."]
[null,"• The SRS did not review IBC findings prior to its final approval for VA research involving recombinant DNA (rDNA)."]
[null,"• Amendments were approved using designated member review (DMR); however, the SRS had not established the criteria for amendments to be considered minor and therefore eligible for DMR."]
[null,"6. Inadequate Oversite of Off-Site Research "]
[null,"• No process was in place to review research safety or to provide feedback to the responsible party for VA research conducted in off‐site facilities.","←RETURN"]
[null,"7. Lapsed or Noncompliant Annual Review of PI’s VA Laboratory Program"]
[null,"• Required elements were not assessed during the SRS annual review of the PI laboratory program, to include: ","←RETURN"]
[null,"     ◦ Changes in space allocation."]
[null,"     ◦ A review of personnel safety training."]
[null,"     ◦ A review of inspection reports for the PI’s laboratory."]
[null,"     ◦ A review of amendments to the safety components of protocols."]
[null,"     ◦ A review of any reports of employee-related safety and security issues. "]
[null,"8. Noncompliant Eyewash Stations and / or Emergency Showers"]
[null,"• Emergency shower equipment was not installed in research locations where personnel may be exposed to corrosive chemicals.","←RETURN"]
[null,"• Emergency showers / eyewashes in research areas were not tested and inspected annually (i.e., measurements of water flow and water temperature)."]
[null,"• Emergency shower equipment in research laboratory areas was not flushed at required monthly intervals."]
[null,"• Emergency eyewashes in research laboratories did not deliver tepid water."]
[null,"• The actuator (control) handles on multiple emergency showers were not readily accessible to the user. "]
[null,"9. OHSP Services Not Offered to All Research Personnel"]
[null,"• Some IACUC members had not been offered enrollment in the institutional OHSP.","←RETURN"]
[null,"• Some Veterinary Medical Unit (VMU) staff had not been offered enrollment in the institutional OHSP. "]
[null,"• Some researchers working with animals had not been offered enrollment in the institutional OHSP. "]
[null,"• Some personnel who had intermittent contact with the animal facility (e.g., Police and Engineering Services) had not been offered enrollment in the OHSP and were not risk assessed with regards to the unique hazards potentially associated with indirect animal exposure. "]
[null,"10. PPE Hazard Assessments Not Performed and / or Certified"]
[null,"• PPE hazard assessments were not performed and certified for biological, chemical, and/or physical hazards in research laboratories.","←RETURN"]
[null,"• PPE hazard assessments did not include all required elements to include:"]
[null,"     ◦ The name of the person certifying the evaluation."]
[null,"     ◦ The date of the hazard assessment. "]
[null,"11. Process to Activate, Decommission, or Transfer Laboratories Deficient / Not Established"]
[null,"• The SRS did not have a process in place to activate, decommission, or transfer laboratories.","←RETURN"]
[null,"• The SRS did not have a process in place to ensure that hazardous chemicals were appropriately disposed of in decommissioned laboratories."]
[null,"12. Required Initial and / or Annual Medical Evaluations Not Offered or Conducted"]
[null,"• Annual medical follow-up was not completed for all personnel with animal contact or exposure enrolled in the OHSP."]
[null,"13. Required Safety Training Not Completed"]
[null,"• Required BBP training was not completed annually.","←RETURN"]
[null,"• Required formaldehyde awareness training was not completed."]
[null,"• Laboratory personnel were not provided with CHP information and training. "]
[null,"• Required hazard communication training (e.g., Safety Data Sheets, pictograms, chemical labeling) was not completed."]
[null,"• IBC members were not trained on the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules."]
[null,"14. Research-Specific Safety, Security, and / or Emergency Preparedness Drills Not Conducted at Required Intervals"]
[null,"• Drills or exercises to test the effectiveness of the research‐specific safety, security, and/or emergency preparedness plans were not conducted on an annual basis.","←RETURN"]
[null,"15. Safety Training Curriculum Did Not Include All Required Elements"]
[null,"• BBP training did not include an opportunity for real-time interactive questions and answers.","←RETURN"]
[null,"• BBP training did not cover all required content, to include: "]
[null,"     ◦ Description of symptoms of bloodborne diseases."]
[null,"     ◦ Explanation of modes of transmission of bloodborne pathogens. "]
[null,"     ◦ Explanation of the contents of the regulatory text and the BBP standard, and how employees can obtain a copy. "]
[null,"     ◦ Explanation of facility exposure control plan, and how employees can obtain a copy."]
[null,"     ◦ Explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials."]
[null,"     ◦ Explanation of limitations of methods that will prevent or reduce exposure."]
[null,"     ◦ Information on the types, proper use, location, removal, handling, decontamination, and disposal of PPE."]
[null,"     ◦ Explanation of basis for selection of PPE. "]
[null,"     ◦ Information on efficacy, safety, and administration of the Hepatitis B vaccine."]
[null,"     ◦ Explanation of the procedures following exposure."]
[null,"     ◦ Explanation of signs and labels and/or color coding required by OSHA’s BBP standard."]
[null,"• Chemical safety-related information provided to relevant research staff did not include all required elements as specified by OSHA, to include: "]
[null,"◦ The contents of the OSHA standard."]
[null,"◦ The location and availability of the Research Service’s CHP. "]
[null,"16. SRS Not Properly Constituted or Appointed"]
[null,"• Individuals voted on SRS business and were counted toward quorum in absence of having current, written appointments to serve as members of the SRS.  ","←RETURN"]
[null,"• Members of the SRS had standing appointment memos that did not specify a term of up to 3 years, as required. ","←RETURN"]
[null,"• The SRS temporarily had fewer than the number of required members due to lapses in appointment memos. ","←RETURN"]
[null,"• The SRS did not include a radiation safety officer (RSO) or an appropriate individual with radiation safety expertise. ","←RETURN"]
[null,"• The SRS did not include a member from the facility safety committee or a member of the facility infection control committee. "]
[null,"• The required non-voting, ex-officio union representative was not formally appointed to the SRS by the Medical Facility Director. ","←RETURN"]
[null,"• The SRS did not include the required non-voting, ex-officio liaison member from the R&DC."]
[null,"• The SRS ex-officio liaison member from the R&DC was appointed as a voting member rather than as a non-voting member, as required. "]
[null,"• The current appointment letters for ex-officio members did not specify a term of up to 3 years. "]
[null,"• Ex-officio non-voting members did not have written appointment letters. "]
[null,"Common Findings Related to Research Information Security Practices"]
[null,"1. Inadequate Restrictions on Access to VA Information"]
[null,"• Research-related electronic storage folders containing VASI were not appropriately restricted.","←RETURN"]
[null,"• Hard copy research information containing VASI was not securely stored when not in use."]
[null,"2. No or Inappropriate Agreement for Research VASI on Non-VA Information Systems"]
[null,"• VASI was stored on non-VA (external) information systems without documenting the security controls / requirements in an agreement. ","←RETURN"]
[null,"3. No or Inappropriate Terms and Conditions for VA Research Information on Non-VA Information Systems"]
[null,"• VA research data was used on non-VA (external) information systems (e.g., non-VA computers, portable storage devices, air-gapped networks, wireless access points) without first establishing appropriate terms and conditions for such use by authorized individuals.","←RETURN"]
[null,"4. No or Incomplete Inventory of IT Equipment Used for VA Research"]
[null,"• Affiliate-owned IT equipment was not contained in the appropriate equipment inventory list.","←RETURN"]
[null,"• VA-owned IT equipment was not contained in the appropriate inventory list."]
[null,"• IT equipment of undetermined ownership (i.e., lacking identification tags) was not contained in the appropriate inventory list."]
[null,"5. Research Data Used / Shared without Proper Approvals / Agreements (e.g., DUA, CRADA)"]
[null,"• Neither the protocol documents nor the actual data storage arrangements conformed to the stipulations in the data access request agreements in the DUAs for data obtained from VHA national databases."]
[null,"• A DUA required for the release of de-identified VA research data to a non-VA entity did not include all required details."]
[null,"• Identifiable information gathered during a research study was shared in contradiction to the terms allowed by the ICD under which it was collected. "]
[null,"• DUAs were not signed by the appropriate signing official. "]
[null,"• Although the DUAs were reviewed and signed by the PI, Information System Security Officer (ISSO), and Privacy Officer (PO), key omissions were not identified and revised to ensure that the DUAs included the appropriate security controls and required elements. "]
[null,"• Data obtained from VHA national databases, in some cases including personally identifiable information,  were downloaded to facility servers without required permissions. "]
[null,"• A dataset containing Personal Identifiable Information (PII) that originally had been downloaded from VHA national databases for a different VHA study led by the same PI was then repurposed without approval from the appropriate data steward. "]
[null,"6. VASI Transferred / Transmitted / Stored without Proper Security or Approvals"]
[null,"• Paper printouts of VASI were transported outside the VA facility without appropriate approvals.","←RETURN"]
[null,"• Hard copy research documents containing PHI were transported from the affiliate to the VA facility without proper approval. "]
[null,"• Hard copy research documents containing PHI were transported from the VA research facility to the academic affiliate without prior written approval to transport Individually Identifiable Information outside of the VA facility. "]
[null,"• Electronic research documents containing VASI were transported to the PI’s personal residence on a VA encrypted Universal Serial Bus (USB) flash drive without proper approval."]
[null,"• VASI was stored in the VA Research Electronic Data Capture application without authorization. "]
[null,"• VASI was processed and stored on a non-VA device without documenting any applicable restrictions for such use. "]
[null,"• A VA researcher transferred data collected during the VA portion of a collaborative research study to a non-VA collaborator without a required DUA."]
[null,"• PHI was entered into a non-VA web-based electronic data capture system in a manner that did not conform with the approved study documents, which specified that the information entered into the system would be de-identified. "]
[null,"• PII was transmitted to the affiliate using the Microsoft Teams application, which did not conform with the data transmission plan specified in the approved study documents. "]
[null,"• VASI was transmitted by VA email without required encryption and stored on a personally owned (non-VA) device without proper documentation. "]

{"sheet":"Definitions","index":5,"n_rows":7,"n_cols":1,"rows_kept":7,"cut":false,"hidden":false,"merged":[]}
["DEFINITIONS"]
["TYPES OF INSTITUTIONAL ANIMAL CARE AND USE COMMITTEES "]
["Internal VA-Appointed Institutional Animal Care and Use Committee. Such an IACUC oversees research for a VA program that has a VMU and its own PHS Assurance, and is described in that Assurance. This type of IACUC is a subcommittee of the R&D Committee."]
[]
["External Jointly-Appointed Institutional Animal Care and Use Committee. Such an IACUC oversees research with animals for a VA program that has a VMU and its own PHS Assurance, but for which the VA medical facility and the affiliate agree to share a single set of IACUC members, administered by the affiliate. The written agreement establishing this arrangement identifies the specific procedures that each party requires to meet its regulatory responsibilities, and commits both parties reciprocally to accommodating those procedures. The members are each appointed to two IACUCs, with each IACUC described in its own PHS Assurance: the affiliate’s IACUC (described in the affiliate’s PHS Assurance, with members appointed by the affiliate’s CEO) and the VA’s external jointly-appointed IACUC (described in the VA’s PHS Assurance, with members appointed by the VA medical facility Director). "]
[]
["External Affiliate-Appointed Institutional Animal Care and Use Committee. Such an IACUC oversees research for a VA program that does not have its own PHS Assurance, either by choice or because it does not have a VMU and is therefore not eligible to have an Assurance. The IACUC is the one described in the affiliate’s PHS Assurance. The written agreement establishing this arrangement identifies the specifics of what VA requires for the VA animal research program to meet its regulatory responsibilities, and the specifics of what the VA is required to provide for the affiliate’s IACUC to be able to oversee the VA program. Both parties commit to those specifics."]

{"sheet":"ExportA","index":6,"n_rows":261,"n_cols":8,"rows_kept":261,"cut":false,"hidden":true,"merged":[]}
["Question#","QuestionText","id-facility","id-question","FDCdate","FDCresult",null,"Cells formatted as dates are highlighted in bright blue"]
["1","Adequate Resources",{"$f":"IF(PartA!D3=\"\",\"\",PartA!D3)","v":"Select Facility…"},"FD2","2024-07-31",{"$f":"IF(PartA!C15=\"\",\"\",PartA!C15)","v":"Select…"}]
["1_detail","DETAILS Adequate Resources",{"$f":"C2","v":"Select Facility…"},"FD20","2024-07-31",{"$f":"IF(PartA!D20=\"\",\"\",PartA!D20)","v":""}]
["2a","R&DC Appointed in Writing",{"$f":"C3","v":"Select Facility…"},"FD9","2024-07-31",{"$f":"IF(PartA!C22=\"\",\"\",PartA!C22)","v":"Select…"}]
["2b","Delegated Roles","Select Facility…","FD1","2024-07-31",{"$f":"IF(PartA!C24=\"\",\"\",PartA!C24)","v":"Select…"}]
["3a","RCO Audit Plan","Select Facility…","FD6","2024-07-31",{"$f":"IF(PartA!C28=\"\",\"\",PartA!C28)","v":"Select…"}]
["3b","Audits Completed","Select Facility…","FD7","2024-07-31",{"$f":"IF(PartA!C31=\"\",\"\",PartA!C31)","v":"Select…"}]
["3b_detail","DETAILS Audits Not Completed","Select Facility…","FD11","2024-07-31",{"$f":"IF(PartA!D36=\"\",\"\",PartA!D36)","v":""}]
["4","Any Acting Position(s)","Select Facility…","FD3","2024-07-31",{"$f":"IF(PartA!C37=\"\",\"\",PartA!C37)","v":"Select…"}]
["4_FD","Acting Facility Director","Select Facility…","FD12","2024-07-31",{"$f":"IF(PartA!C41=\"\",\"\",PartA!C41)","v":"Select…"}]
["4_ACOS","Acting ACOS/Research or Coordinator","Select Facility…","FD14","2024-07-31",{"$f":"IF(PartA!C42=\"\",\"\",PartA!C42)","v":"Select…"}]
["4_AO","Acting Administrative Officer/Research","Select Facility…","FD15","2024-07-31",{"$f":"IF(PartA!C44=\"\",\"\",PartA!C44)","v":"Select…"}]
["4_RCO","Acting Research Compliance Officer","Select Facility…","FD16","2024-07-31",{"$f":"IF(PartA!C45=\"\",\"\",PartA!C45)","v":"Select…"}]
["4_CC","Acting Research Committee Coordinator(s)","Select Facility…","FD17","2024-07-31",{"$f":"IF(PartA!C46=\"\",\"\",PartA!C46)","v":"Select…"}]
["4_CC_detail","Acting Committee Coordinator details","Select Facility…","FD18","2024-07-31",{"$f":"IF(PartA!D48=\"\",\"\",PartA!D48)","v":""}]
["4_acting_detail","DETAILS Acting Positions","Select Facility…","FD21","2024-07-31",{"$f":"IF(PartA!D51=\"\",\"\",PartA!D51)","v":""}]
["4a","CRADO Approval for Acting ACOS/R","Select Facility…","FD22","2024-07-31",{"$f":"IF(PartA!C52=\"\",\"\",PartA!C52)","v":"Select…"}]
["5","Research-Focused Investigation","Select Facility…","FD23","2024-07-31",{"$f":"IF(PartA!C55=\"\",\"\",PartA!C55)","v":"Select…"}]
["5a","Research-Related Citation or Noncompliance","Select Facility…","FD24","2024-07-31",{"$f":"IF(PartA!C59=\"\",\"\",PartA!C59)","v":"Select…"}]
["5b","ORO Notification of Research-Related Citation or Noncompliance","Select Facility…","FD25","2024-07-31",{"$f":"IF(PartA!C61=\"\",\"\",PartA!C61)","v":"Select…"}]
["FDNotes","Facility Director Section Notes","Select Facility…","FD8","2024-07-31",{"$f":"IF(PartA!D65=\"\",\"\",PartA!D65)","v":""}]
["6","Another VA R&DC","Select Facility…","RD29","2024-07-31",{"$f":"IF(PartA!C67=\"\",\"\",PartA!C67)","v":"Select…"}]
["6_detail","DETAILS Another VA R&DC","Select Facility…","RD30","2024-07-31",{"$f":"IF(PartA!D69=\"\",\"\",PartA!D69)","v":""}]
["6a","MOU for Another R&DC","Select Facility…","RD39","2024-07-31",{"$f":"IF(PartA!C71=\"\",\"\",PartA!C71)","v":"Select…"},null,"NEEDS ROC ID; THIS ONE WAS MISSING FROM EXPORT TAB; ADDED ROC ID"]
["7a","Committees Reviewed Annually, Reported to FD","Select Facility…","RD18","2024-07-31",{"$f":"IF(PartA!C74=\"\",\"\",PartA!C74)","v":"Select…"}]
["7b","Subcommittee Minutes Review within 60 Days","Select Facility…","RD19","2024-07-31",{"$f":"IF(PartA!C79=\"\",\"\",PartA!C79)","v":"Select…"}]
["7c","Subcommittee Approval before R&DC Approval","Select Facility…","RD20","2024-07-31",{"$f":"IF(PartA!C82=\"\",\"\",PartA!C82)","v":"Select…"}]
["7d","External IRB Meets Requirements","Select Facility…","RD21","2024-07-31",{"$f":"IF(PartA!C86=\"\",\"\",PartA!C86)","v":"Select…"}]
["7e","Approval of Research Not Assigned to Committees","Select Facility…","RD22","2024-07-31",{"$f":"IF(PartA!C92=\"\",\"\",PartA!C92)","v":"Select…"}]
["7f","Only VA Research for Collaborative Studies","Select Facility…","RD23","2024-07-31",{"$f":"IF(PartA!C96=\"\",\"\",PartA!C96)","v":"Select…"}]
["7g","Approval for Recruitment of Non-Veterans","Select Facility…","RD24","2024-07-31",{"$f":"IF(PartA!C99=\"\",\"\",PartA!C99)","v":"Select…"}]
["7h","ISSO and PO review","Select Facility…","RD36","2024-07-31",{"$f":"IF(PartA!C102=\"\",\"\",PartA!C102)","v":"Select…"}]
["8","Privacy Review Checklist and ERDSP","Select Facility…","RD31","2024-07-31",{"$f":"IF(PartA!C107=\"\",\"\",PartA!C107)","v":"Select…"}]
["9a","ACOS Notification to PI","Select Facility…","RD16","2024-07-31",{"$f":"IF(PartA!C113=\"\",\"\",PartA!C113)","v":"Select…"}]
["9b","Research Personnel Hold VA Appointment","Select Facility…","RD25","2024-07-31",{"$f":"IF(PartA!C118=\"\",\"\",PartA!C118)","v":"Select…"}]
["9c","WOC Appointments in Place","Select Facility…","RD26","2024-07-31",{"$f":"IF(PartA!C124=\"\",\"\",PartA!C124)","v":"Select…"}]
["10a","Protocol Tracking Systems","Select Facility…","RD8","2024-07-31",{"$f":"IF(PartA!C129=\"\",\"\",PartA!C129)","v":"Select…"}]
["10a_detail1","Protocol Tracking Name","Select Facility…","RD9","2024-07-31",{"$f":"IF(PartA!D135=\"\",\"\",PartA!D135)","v":""}]
["10a_detail2","VAIRRS Primary System","Select Facility…","RD38","2024-07-31",{"$f":"IF(PartA!C136=\"\",\"\",PartA!C136)","v":"Select…"}]
["10b","Tracking of Committee Actions","Select Facility…","RD32","2024-07-31",{"$f":"IF(PartA!C137=\"\",\"\",PartA!C137)","v":"Select…"}]
["10c","Tracking of Written Agreements","Select Facility…","RD33","2024-07-31",{"$f":"IF(PartA!C140=\"\",\"\",PartA!C140)","v":"Select…"}]
["10d","Tracking of Research Personnel","Select Facility…","RD34","2024-07-31",{"$f":"IF(PartA!C144=\"\",\"\",PartA!C144)","v":"Select…"}]
["10e_ORD","Tracking of Training","Select Facility…","RD27","2024-07-31",{"$f":"IF(PartA!C148=\"\",\"\",PartA!C148)","v":"Select…"}]
["10f(1)","Tracking of Research Data (Repository)","Select Facility…","RD35","2024-07-31",{"$f":"IF(PartA!C152=\"\",\"\",PartA!C152)","v":"Select…"}]
["10f(2)","Tracking of Research Data (RCS)","Select Facility…","RD37","2024-07-31",{"$f":"IF(PartA!C153=\"\",\"\",PartA!C153)","v":"Select…"}]
["RDCNotes","FD/RDC Section Notes","Select Facility…","RD17","2024-07-31",{"$f":"IF(PartA!D158=\"\",\"\",PartA!D158)","v":""}]
["11","OHRP FWA","Select Facility…","IR13","2024-07-31",{"$f":"IF(PartA!C160=\"\",\"\",PartA!C160)","v":"Select…"},null,"CONFIRM EXISTING ROC ID; Added existing ROC IC"]
["11a","FWA exp date","Select Facility…","IR64","2024-07-31",{"$f":"IF(PartA!D164=\"\",\"\",PartA!D164)","v":""},null,"CONFIRM EXISTING ROC ID; Added existing ROC IC"]
["12","HRPP Accreditation","Select Facility…","IR100","2024-07-31",{"$f":"IF(PartA!C165=\"\",\"\",PartA!C165)","v":"Select…"},null,"ANY ISSUES WITH NEW 5 DIGIT ROC ID?"]
["12a","External Accrediting Body Name","Select Facility…","IR101","2024-07-31",{"$f":"IF(PartA!D169=\"\",\"\",PartA!D169)","v":""}]
["12b","Date of Last Accreditation Visit","Select Facility…","IR102","2024-07-31",{"$f":"IF(PartA!D171=\"\",\"\",PartA!D171)","v":""}]
["13a","Internal (Local) IRB","Select Facility…","IR1","2024-07-31",{"$f":"IF(PartA!C173=\"\",\"\",PartA!C173)","v":"Select…"}]
["13b","External (Academic Affiliate) IRB","Select Facility…","IR2","2024-07-31",{"$f":"IF(PartA!C175=\"\",\"\",PartA!C175)","v":"Select…"}]
["13b_detail","Academic Affiliate Detail","Select Facility…","IR3","2024-07-31",{"$f":"IF(PartA!D178=\"\",\"\",PartA!D178)","v":""}]
["13c","Other VA IRB","Select Facility…","IR4","2024-07-31",{"$f":"IF(PartA!C179=\"\",\"\",PartA!C179)","v":"Select…"}]
["13c_detail","Other VA IRB Detail","Select Facility…","IR5","2024-07-31",{"$f":"IF(PartA!D181=\"\",\"\",PartA!D181)","v":""}]
["13d_Advarra","Advarra, Inc. IRB","Select Facility…","IR83","2024-07-31",{"$f":"IF(PartA!C185=\"\",\"\",PartA!C185)","v":"Select…"}]
["13d_NCI","National Cancer Institute (NCI) IRB","Select Facility…","IR68","2024-07-31",{"$f":"IF(PartA!C186=\"\",\"\",PartA!C186)","v":"Select…"}]
["13d_AOU","NIH All of Us IRB","Select Facility…","IR60","2024-07-31",{"$f":"IF(PartA!C187=\"\",\"\",PartA!C187)","v":"Select…"}]
["13d_OakRidge","Oak Ridge Associated Universities IRB","Select Facility…","IR85","2024-07-31",{"$f":"IF(PartA!C188=\"\",\"\",PartA!C188)","v":"Select…"}]
["13d_Sterling","Sterling IRB","Select Facility…","IR84","2024-07-31",{"$f":"IF(PartA!C189=\"\",\"\",PartA!C189)","v":"Select…"}]
["13d_CIRB_1_2","VA Central IRB Panels 1 and/or 2","Select Facility…","IR67","2024-07-31",{"$f":"IF(PartA!C190=\"\",\"\",PartA!C190)","v":"Select…"}]
["13d_CIRB_3","VA Central IRB Panel 3","Select Facility…","IR103","2024-07-31",{"$f":"IF(PartA!C191=\"\",\"\",PartA!C191)","v":"Select…"}]
["13d_WCG","WCG IRB","Select Facility…","IR82","2024-07-31",{"$f":"IF(PartA!C192=\"\",\"\",PartA!C192)","v":"Select…"},null,"CONFIRM EXISTING ROC ID; Added existing ROC ID"]
["13e_Other","Other IRB(s)","Select Facility…","IR76","2024-07-31",{"$f":"IF(PartA!C193=\"\",\"\",PartA!C193)","v":"Select…"}]
["13e_detail","DETAILS Other IRB","Select Facility…","IR77","2024-07-31",{"$f":"IF(PartA!D196=\"\",\"\",PartA!D196)","v":""}]
["13f_ORD","DETAILS Other IRB ORD Approval","Select Facility…","IR78","2024-07-31",{"$f":"IF(PartA!C197=\"\",\"\",PartA!C197)","v":"Select…"},null,"CONFIRM WHICH ROC ID TO USE; 2 in last year's export tab (Also IR97); MOVED UP THE QUESTION ON OTHER IRBS NOT LISTED SO ONLY HAVE TO ASK ORD APPROVAL ONE TIME; WILL RETIRE IR97"]
["14","IRB Reliance Agreement",{"$f":"C67","v":"Select Facility…"},"IR80","2024-07-31",{"$f":"IF(PartA!C200=\"\",\"\",PartA!C200)","v":"Select…"}]
["15","Single IRB Review of Cooperative Research","Select Facility…","IR81","2024-07-31",{"$f":"IF(PartA!C205=\"\",\"\",PartA!C205)","v":"Select…"}]
["16a","IRB Minutes Document Approval Criteria","Select Facility…","IR86","2024-07-31",{"$f":"IF(PartA!C222=\"\",\"\",PartA!C222)","v":"Select…"}]
["16b","ICDs with All Required Elements","Select Facility…","IR87","2024-07-31",{"$f":"IF(PartA!C226=\"\",\"\",PartA!C226)","v":"Select…"}]
["16c","IC Waivers Reviewed and Documented","Select Facility…","IR88","2024-07-31",{"$f":"IF(PartA!C238=\"\",\"\",PartA!C238)","v":"Select…"}]
["16d","HIPAA Authorizations Waivers Reviewed and Documented","Select Facility…","IR89","2024-07-31",{"$f":"IF(PartA!C246=\"\",\"\",PartA!C246)","v":"Select…"}]
["16e","2018 CR Continuing Review and Documentation of Rationale","Select Facility…","IR91","2024-07-31",{"$f":"IF(PartA!C253=\"\",\"\",PartA!C253)","v":"Select…"}]
["16f","ICD Posted","Select Facility…","IR48","2024-07-31",{"$f":"IF(PartA!C260=\"\",\"\",PartA!C260)","v":"Select…"}]
["17","2018 CR Broad Consent Allowed","Select Facility…","IR92","2024-07-31",{"$f":"IF(PartA!C270=\"\",\"\",PartA!C270)","v":"Select…"}]
["17a","2018 CR Broad Consent Approved","Select Facility…","IR96","2024-07-31",{"$f":"IF(PartA!C272=\"\",\"\",PartA!C272)","v":"Select…"}]
["17b","2018 CR Broad Consent on Specimens Collected for Research","Select Facility…","IR47","2024-07-31",{"$f":"IF(PartA!C274=\"\",\"\",PartA!C274)","v":"Select…"}]
["18a","IRB/HRPP SOPs (Review of Research)","Select Facility…","IR17","2024-07-31",{"$f":"IF(PartA!C281=\"\",\"\",PartA!C281)","v":"Select…"}]
["18b","Transition to 2018 CR SOP","Select Facility…","IR40","2024-07-31",{"$f":"IF(PartA!C284=\"\",\"\",PartA!C284)","v":"Select…"}]
["18c","HRPP SOP for Review and Reporting UPIRTSOs and Serious Noncompliance","Select Facility…","IR93","2024-07-31",{"$f":"IF(PartA!C288=\"\",\"\",PartA!C288)","v":"Select…"}]
["19","PO Review of HIPAA Authorizations","Select Facility…","IR49","2024-07-31",{"$f":"IF(PartA!C293=\"\",\"\",PartA!C293)","v":"Select…"}]
["20","FDA-Regulated Drugs, Biologics, or Devices","Select Facility…","IR104","2024-07-31",{"$f":"IF(PartA!C299=\"\",\"\",PartA!C299)","v":"Select…"},null,"CONFIRM THIS NEEDS NEW ROC ID; this is not highlighted as new on the FDC"]
["20a","Clinicaltrials.gov Registration","Select Facility…","IR105","2024-07-31",{"$f":"IF(PartA!C303=\"\",\"\",PartA!C303)","v":"Select…"},null,"CONFIRM THIS NEEDS NEW ROC ID; this is not highlighted as new on the FDC"]
["20b","Clinicaltrials.gov Reporting","Select Facility…","IR106","2024-07-31",{"$f":"IF(PartA!C305=\"\",\"\",PartA!C305)","v":"Select…"},null,"CONFIRM THIS NEEDS NEW ROC ID; this is not highlighted as new on the FDC"]
["20c","ICD Confidentiality Statement","Select Facility…","IR107","2024-07-31",{"$f":"IF(PartA!C309=\"\",\"\",PartA!C309)","v":"Select…"},null,"CONFIRM THIS NEEDS NEW ROC ID; this is not highlighted as new on the FDC"]
["20d","ICD Clinicaltrials.gov Statement","Select Facility…","IR108","2024-07-31",{"$f":"IF(PartA!C314=\"\",\"\",PartA!C314)","v":"Select…"},null,"CONFIRM THIS NEEDS NEW ROC ID; this is not highlighted as new on the FDC"]
["20e","Process for IBC Review","Select Facility…","IR94","2024-07-31",{"$f":"IF(PartA!C320=\"\",\"\",PartA!C320)","v":"Select…"},null,"CONFIRM THIS IS THE CORRECT ROC ID; CONFIRMED"]
["20f","Delegation of Custody","Select Facility…","IR54","2024-07-31",{"$f":"IF(PartA!C329=\"\",\"\",PartA!C329)","v":"Select…"}]
["20g","Controlled Substance Storage","Select Facility…","IR27","2024-07-31",{"$f":"IF(PartA!C334=\"\",\"\",PartA!C334)","v":"Select…"}]
["20h","Controlled Substance Inspections","Select Facility…","IR28","2024-07-31",{"$f":"IF(PartA!C338=\"\",\"\",PartA!C338)","v":"Select…"}]
["20i","IRB Review of Sponsor Device Risk Determination","Select Facility…","IR99","2024-07-31",{"$f":"IF(PartA!C344=\"\",\"\",PartA!C344)","v":"Select…"}]
["20j","IDE Approval from FDA","Select Facility…","IR95","2024-07-31",{"$f":"IF(PartA!C349=\"\",\"\",PartA!C349)","v":"Select…"}]
["21","Pregnant Women, Fetuses, Neonates","Select Facility…","IR58","2024-07-31",{"$f":"IF(PartA!C351=\"\",\"\",PartA!C351)","v":"Select…"}]
["21a","Pregnant Women Research Certifications/Approvals","Select Facility…","IR59","2024-07-31",{"$f":"IF(PartA!C354=\"\",\"\",PartA!C354)","v":"Select…"}]
["HRPPNotes","HRPP Section Notes","Select Facility…","IR34","2024-07-31",{"$f":"IF(PartA!D359=\"\",\"\",PartA!D359)","v":""}]
["22","Animal Program","Select Facility…","IA1","2024-07-31",{"$f":"IF(PartA!C362=\"\",\"\",PartA!C362)","v":"Select…"}]
["23","IACUC Type","Select Facility…","IA89","2024-07-31",{"$f":"IF(PartA!D368=\"\",\"\",PartA!D368)","v":"Select…"},null,"Is this the appropriate ROC ID? Should this be changed? Created new ID for \"IACUC type\""]
["24","Animals Housed","Select Facility…","IA7","2024-07-31",{"$f":"IF(PartA!D370=\"\",\"\",PartA!D370)","v":"Select…"}]
["24_detail","DETAIL Affiliate Animal Housing","Select Facility…","IA90","2024-07-31",{"$f":"IF(PartA!D372=\"\",\"\",PartA!D372)","v":" "},null,"CHECK WHETHER THIS IS REALLY NEW? SHOULD BE YELLOW? Updated from Specify Affiliate (animals housed) to \"DETAIL Affiliate Housing\""]
["24a","Affiliate Housing Oversight Agreement","Select Facility…","IA130","2024-07-31",{"$f":"IF(PartA!C373=\"\",\"\",PartA!C373)","v":"Select…"},null,"CHECK WHETHER THIS IS REALLY NEW? SHOULD BE YELLOW? Used existing ROC ID for \"MOU for Shared Oversight\""]
["25","PHS Assurance for VA ACUP","Select Facility…","IA11","2024-07-31",{"$f":"IF(PartA!D376=\"\",\"\",PartA!D376)","v":"Select…"},null,"Added existing ROC ID for \"PHS Assurance held by\""]
["25a","VA Listed on Affiliate PHS Assurance","Select Facility…","IA129","2024-07-31",{"$f":"IF(PartA!C377=\"\",\"\",PartA!C377)","v":"Select…"},null,"Created new ROC ID for \"A Listed on Affiliate PHS Assurance\""]
["26a","Internal IACUC - Members Appointed","Select Facility…","IA83","2024-07-31",{"$f":"IF(PartA!C382=\"\",\"\",PartA!C382)","v":"Select…"}]
["26b","Internal IACUC - Member names and roles",{"$f":"C104","v":"Select Facility…"},"IA137","2024-07-31",{"$f":"IF(PartA!C384=\"\",\"\",PartA!C384)","v":"Select…"}]
["26c","Internal IACUC - Appointments Specify Regular or Alternate","Select Facility…","IA91","2024-07-31",{"$f":"IF(PartA!C387=\"\",\"\",PartA!C387)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW? Added new ROC ID for \"IACUC Appointments Specify Regular or Alternate\""]
["26d","Internal IACUC - Alternate Specified","Select Facility…","IA92","2024-07-31",{"$f":"IF(PartA!C390=\"\",\"\",PartA!C390)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW?"]
["26e","Affiliate Shared Oversight","Select Facility…","IA9","2024-07-31",{"$f":"IF(PartA!C393=\"\",\"\",PartA!C393)","v":"Select…"},null,"CHECK WHETHER THIS IS REALLY NEW? SHOULD BE YELLOW? Is this IA9 (24a last year)? This question appears to be redundant to 24a. Per RSAW, the 2 questions differ slightly so will keep."]
["26e_detail","Specify Affiliate (oversight)","Select Facility…","IA131","2024-07-31",{"$f":"IF(PartA!D399=\"\",\"\",PartA!D399)","v":""},null,"SIMILAR TO ITEM 24 Detail? This question appears to be redundant to 24 Detail. Per RSAW, the 2 questions differ slightly so will keep."]
["27a","VMO/VMC and Scientist Appointed to Affiliate","Select Facility…","IA84","2024-07-31",{"$f":"IF(PartA!C401=\"\",\"\",PartA!C401)","v":"Select…"}]
["27b","Attending Vet Appointed to Affiliate","Select Facility…","IA93","2024-07-31",{"$f":"IF(PartA!C405=\"\",\"\",PartA!C405)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW?"]
["27c","Academic Affiliate IACUC (in lieu of VA IACUC) MOU","Select Facility…","IA53","2024-07-31",{"$f":"IF(PartA!C408=\"\",\"\",PartA!C408)","v":"Select…"},null,"CONFIRM THIS IS CORRECT ROC ID; Confirmed."]
["27d","Access to Versions of Protocol","Select Facility…","IA94","2024-07-31",{"$f":"IF(PartA!C412=\"\",\"\",PartA!C412)","v":"Select…"}]
["27e","OLAW / AAALAC Annual Reports","Select Facility…","IA95","2024-07-31",{"$f":"IF(PartA!C418=\"\",\"\",PartA!C418)","v":"Select…"}]
["28a","Jointly Appointed - MFD Appointed Each Member","Select Facility…","IA96","2024-07-31",{"$f":"IF(PartA!C422=\"\",\"\",PartA!C422)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW?"]
["28b","Jointly Appointed - VA Scientist","Select Facility…","IA97","2024-07-31",{"$f":"IF(PartA!C424=\"\",\"\",PartA!C424)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW?"]
["28c","Jointly Appointed - Attending Vet Appointed","Select Facility…","IA98","2024-07-31",{"$f":"IF(PartA!C426=\"\",\"\",PartA!C426)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW?"]
["29","AAALAC Accreditation Arrangements","Select Facility…","IA13","2024-07-31",{"$f":"IF(PartA!D429=\"\",\"\",PartA!D429)","v":"Select…"},null,"CONFIRM NEW? SHOULD THIS BE YELLOW? Added existing ROC ID for \"AAALAC Accreditation held by\""]
["29_detail","Specify Affiliate AAALAC","Select Facility…","IA132","2024-07-31",{"$f":"IF(PartA!D431=\"\",\"\",PartA!D431)","v":" "},null,"NEEDS ROC ID, NEW ROC ID ASSIGNED: IA132"]
["29a","Affiliate Annual Reports Provided to VA","Select Facility…","IA99","2024-07-31",{"$f":"IF(PartA!C432=\"\",\"\",PartA!C432)","v":"Select…"}]
["30","AAALAC Accreditation Status","Select Facility…","IA14","2024-07-31",{"$f":"IF(PartA!D437=\"\",\"\",PartA!D437)","v":"Select…"}]
["30a","Date of Accreditation Determination Letter","Select Facility…","IA15","2024-07-31",{"$f":"IF(PartA!D440=\"\",\"\",PartA!D440)","v":""}]
["31","USDA Registration","Select Facility…","IA16","2024-07-31",{"$f":"IF(PartA!D443=\"\",\"\",PartA!D443)","v":"Select…"}]
["31a","Affiliate USDA Annual Reports Provided to VA","Select Facility…","IA100","2024-07-31",{"$f":"IF(PartA!C444=\"\",\"\",PartA!C444)","v":"Select…"}]
["31b","Date of Affiliate USDA Annual Report","Select Facility…","IA101","2024-07-31",{"$f":"IF(PartA!D448=\"\",\"\",PartA!D448)","v":""}]
["32","Non USDA-Regulated Species","Select Facility…","IA72","2024-07-31",{"$f":"IF(PartA!C449=\"\",\"\",PartA!C449)","v":"Select…"}]
["32_detail","DETAILS Non USDA-regulated species","Select Facility…","IA73","2024-07-31",{"$f":"IF(PartA!D454=\"\",\"\",PartA!D454)","v":""}]
["33","Use of USDA Regulated Species","Select Facility…","IA17","2024-07-31",{"$f":"IF(PartA!C455=\"\",\"\",PartA!C455)","v":"Select…"}]
["33a","Dogs","Select Facility…","IA18","2024-07-31",{"$f":"IF(PartA!C460=\"\",\"\",PartA!C460)","v":"Select…"}]
["33a_detail","Dogs Housed","Select Facility…","IA19","2024-07-31",{"$f":"IF(PartA!D463=\"\",\"\",PartA!D463)","v":""}]
["33a1","Dog Research Funded by VA","Select Facility…","IA56","2024-07-31",{"$f":"IF(PartA!C464=\"\",\"\",PartA!C464)","v":"Select…"}]
["33a2","Dog Research Approved by VA Secretary",{"$f":"C131","v":"Select Facility…"},"IA70","2024-07-31",{"$f":"IF(PartA!C465=\"\",\"\",PartA!C465)","v":"Select…"}]
["33a2_detail","DETAILS Date Dog Research Approved by VA Secretary","Select Facility…","IA133","2024-07-31",{"$f":"IF(PartA!D467=\"\",\"\",PartA!D467)","v":""},null,"NEEDS ROC ID; ADDED"]
["33b","Cats","Select Facility…","IA20","2024-07-31",{"$f":"IF(PartA!C470=\"\",\"\",PartA!C470)","v":"Select…"}]
["33b_detail","Cats Housed","Select Facility…","IA21","2024-07-31",{"$f":"IF(PartA!D473=\"\",\"\",PartA!D473)","v":""}]
["33b1","Cat Research Funded by VA","Select Facility…","IA79","2024-07-31",{"$f":"IF(PartA!C474=\"\",\"\",PartA!C474)","v":"Select…"}]
["33b2","Cat Research Approved by VA Secretary","Select Facility…","IA74","2024-07-31",{"$f":"IF(PartA!C475=\"\",\"\",PartA!C475)","v":"Select…"}]
["33b2_detail","DETAILS Date Cat Research Approved by VA Secretary","Select Facility…","IA134","2024-07-31",{"$f":"IF(PartA!D477=\"\",\"\",PartA!D477)","v":" "},null,"NEEDS ROC ID; ADDED"]
["33c","Non-Human Primates","Select Facility…","IA22","2024-07-31",{"$f":"IF(PartA!C480=\"\",\"\",PartA!C480)","v":"Select…"}]
["33c_detail","Non-Human Primates Housed","Select Facility…","IA23","2024-07-31",{"$f":"IF(PartA!D483=\"\",\"\",PartA!D483)","v":""}]
["33c1","NHP Research Funded by VA","Select Facility…","IA80","2024-07-31",{"$f":"IF(PartA!C484=\"\",\"\",PartA!C484)","v":"Select…"}]
["33c2","NHP Research Approved by VA Secretary","Select Facility…","IA75","2024-07-31",{"$f":"IF(PartA!C485=\"\",\"\",PartA!C485)","v":"Select…"}]
["33c2_detail","DETAILS Date NHP Research Approved by VA Secretary","Select Facility…","IA135","2024-07-31",{"$f":"IF(PartA!D487=\"\",\"\",PartA!D487)","v":""},null,"NEEDS ROC ID; ADDED"]
["33d","Swine","Select Facility…","IA57","2024-07-31",{"$f":"IF(PartA!C490=\"\",\"\",PartA!C490)","v":"Select…"}]
["33d_detail","Swine Housed","Select Facility…","IA58","2024-07-31",{"$f":"IF(PartA!D493=\"\",\"\",PartA!D493)","v":""}]
["33e","Rabbit","Select Facility…","IA59","2024-07-31",{"$f":"IF(PartA!C494=\"\",\"\",PartA!C494)","v":"Select…"}]
["33e_detail","Rabbit Housed","Select Facility…","IA60","2024-07-31",{"$f":"IF(PartA!D497=\"\",\"\",PartA!D497)","v":""}]
["33f","Other USDA","Select Facility…","IA24","2024-07-31",{"$f":"IF(PartA!C498=\"\",\"\",PartA!C498)","v":"Select…"}]
["33f_detail","Other USDA Housed","Select Facility…","IA25","2024-07-31",{"$f":"IF(PartA!D500=\"\",\"\",PartA!D500)","v":""}]
["34a","VA Animal Facility HVAC","Select Facility…","IA61","2024-07-31",{"$f":"IF(PartA!C502=\"\",\"\",PartA!C502)","v":"Select…"}]
["34a_detail","DETAIL VA Animal Facility HVAC","Select Facility…","IA86","2024-07-31",{"$f":"IF(PartA!D506=\"\",\"\",PartA!D506)","v":""}]
["34b","HVAC Failure","Select Facility…","IA62","2024-07-31",{"$f":"IF(PartA!C507=\"\",\"\",PartA!C507)","v":"Select…"},null,"NEW ITEMS? SHOULD THIS BE YELLOW; Are these the reheat coil questions (IA62); Yes, these are the reheat coil questions, Added existing ROC IDs"]
["34b_detail","DETAIL HVAC Failure","Select Facility…","IA87","2024-07-31",{"$f":"IF(PartA!D513=\"\",\"\",PartA!D513)","v":""},null,"NEW ITEMS? SHOULD THIS BE YELLOW; Are these the reheat coil questions (IA87); Yes, these are the reheat coil questions; Added existing ROC IDs"]
["34c","Facilities Management Central Monitoring","Select Facility…","IA102","2024-07-31",{"$f":"IF(PartA!C514=\"\",\"\",PartA!C514)","v":"Select…"}]
["34c_detail","DETAIL Facilities Management Central Monitoring","Select Facility…","IA103","2024-07-31",{"$f":"IF(PartA!D519=\"\",\"\",PartA!D519)","v":""}]
["34d","Overheat Tests Conducted and Reviewed","Select Facility…","IA76","2024-07-31",{"$f":"IF(PartA!C520=\"\",\"\",PartA!C520)","v":"Select…"}]
["34d_detail1","DETAIL Overheat Test Not Conducted","Select Facility…","IA104","2024-07-31",{"$f":"IF(PartA!D527=\"\",\"\",PartA!D527)","v":""}]
["34d_detail2","DETAIL Overheat Test Date","Select Facility…","IA88","2024-07-31",{"$f":"IF(PartA!D531=\"\",\"\",PartA!D531)","v":""}]
["35","VA Animal Facilities - Written PVC in Place","Select Facility…","IA105","2024-07-31",{"$f":"IF(PartA!C532=\"\",\"\",PartA!C532)","v":"Select…"}]
["35a","PVC Approved by IACUC and Signed by AV","Select Facility…","IA106","2024-07-31",{"$f":"IF(PartA!C536=\"\",\"\",PartA!C536)","v":"Select…"}]
["35bi","PVC Include Minimum Frequency In-Person Rounds","Select Facility…","IA107","2024-07-31",{"$f":"IF(PartA!C540=\"\",\"\",PartA!C540)","v":"Select…"}]
["35bii","PVC Include Visits Documented in Writing","Select Facility…","IA108","2024-07-31",{"$f":"IF(PartA!C544=\"\",\"\",PartA!C544)","v":"Select…"}]
["35biii","PVC Include Communication Monthly AV and VMU Personnel","Select Facility…","IA109","2024-07-31",{"$f":"IF(PartA!C545=\"\",\"\",PartA!C545)","v":"Select…"}]
["35biv","PVC Communications As Needed","Select Facility…","IA136","2024-07-31",{"$f":"IF(PartA!C548=\"\",\"\",PartA!C548)","v":"Select…"},null,"NEEDS NEW ROC ID; New ID assigned"]
["36","VA Animal Facilities - VMU Emergency/Disaster Plan","Select Facility…","IA110","2024-07-31",{"$f":"IF(PartA!C551=\"\",\"\",PartA!C551)","v":"Select…"}]
["36ai","Emergency/Disaster Plan Cover After Hours","Select Facility…","IA111","2024-07-31",{"$f":"IF(PartA!C556=\"\",\"\",PartA!C556)","v":"Select…"}]
["36aii","Emergency/Disaster Plan Cover Personnel and Animals","Select Facility…","IA112","2024-07-31",{"$f":"IF(PartA!C558=\"\",\"\",PartA!C558)","v":"Select…"}]
["36aiii","Emergency/Disaster Plan Cover Coordination","Select Facility…","IA113","2024-07-31",{"$f":"IF(PartA!C559=\"\",\"\",PartA!C559)","v":"Select…"}]
["36b","Emergency/Disaster Plan Training","Select Facility…","IA114","2024-07-31",{"$f":"IF(PartA!C562=\"\",\"\",PartA!C562)","v":"Select…"}]
["37a","VA IACUC - VA ACUP Semi-Annual Program Evaluations","Select Facility…","IA115","2024-07-31",{"$f":"IF(PartA!C567=\"\",\"\",PartA!C567)","v":"Select…"},null,"New IDs to distinguish VA IACUC, not marked as new on FDC"]
["37b","VA IACUC - VA ACUP Semi-Annual Facility Inspections","Select Facility…","IA116","2024-07-31",{"$f":"IF(PartA!C569=\"\",\"\",PartA!C569)","v":"Select…"},null,"New IDs to distinguish VA IACUC, not marked as new on FDC"]
["37c","VA IACUC - VA ACUP  Director Briefed","Select Facility…","IA117","2024-07-31",{"$f":"IF(PartA!C571=\"\",\"\",PartA!C571)","v":"Select…"},null,"New IDs to distinguish VA IACUC, not marked as new on FDC"]
["37d","VA IACUC - VA ACUP Semi-Annual Reports Contain Plan and Schedule for correction","Select Facility…","IA118","2024-07-31",{"$f":"IF(PartA!C576=\"\",\"\",PartA!C576)","v":"Select…"},null,"New IDs to distinguish VA IACUC, not marked as new on FDC"]
["38a","Affiliate IACUC - VA ACUP Semi-Annual Program Evaluations","Select Facility…","IA119","2024-07-31",{"$f":"IF(PartA!C581=\"\",\"\",PartA!C581)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37?  Marked as new"]
["38b","Affiliate IACUC - VA ACUP Semi-Annual Facility Inspections","Select Facility…","IA120","2024-07-31",{"$f":"IF(PartA!C583=\"\",\"\",PartA!C583)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? Marked as new"]
["38c","Affiliate IACUC - VA ACUP  Director Briefed","Select Facility…","IA121","2024-07-31",{"$f":"IF(PartA!C585=\"\",\"\",PartA!C585)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? Marked as new"]
["38d","Affiliate IACUC - VA ACUP Semi-annual Report Submitted to ORD","Select Facility…","IA122","2024-07-31",{"$f":"IF(PartA!C589=\"\",\"\",PartA!C589)","v":"Select…"}]
["38e","Affiliate IACUC - VA ACUP Semi-Annual Reports Contain Plan and Schedule for correction","Select Facility…","IA123","2024-07-31",{"$f":"IF(PartA!C593=\"\",\"\",PartA!C593)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? Marked as new"]
["39a","Affiliate Facilities - ACUP Semi-Annual Program Evaluations","Select Facility…","IA124","2024-07-31",{"$f":"IF(PartA!C598=\"\",\"\",PartA!C598)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? Marked as new"]
["39b","Affiliate Facilities - ACUP Semi-Annual Facility Inspections","Select Facility…","IA125","2024-07-31",{"$f":"IF(PartA!C600=\"\",\"\",PartA!C600)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? Marked as new"]
["39c","Affiliate Facilities - VA ACOS/R&D Receive Report","Select Facility…","IA126","2024-07-31",{"$f":"IF(PartA!C602=\"\",\"\",PartA!C602)","v":"Select…"}]
["39d","Affiliate Facilities - VA ACUP  Director Briefed","Select Facility…","IA127","2024-07-31",{"$f":"IF(PartA!C606=\"\",\"\",PartA!C606)","v":"Select…"},null,"SHOULD THESE BE MARKED AS NEW? OR ITEM 37? "]
["39e","Affiliate Facilities - Research Service Submit Copy of Report","Select Facility…","IA128","2024-07-31",{"$f":"IF(PartA!C609=\"\",\"\",PartA!C609)","v":"Select…"}]
["ACUPNotes","ACUP Section Notes","Select Facility…","IA50","2024-07-31",{"$f":"IF(PartA!D615=\"\",\"\",PartA!D615)","v":" "},null,"CONFIRMING REMOVED AND SHOULD BE USED INSTEAD OF A NEW ONE"]
["40","RSSP","Select Facility…","RS1","2024-07-31",{"$f":"IF(PartA!C618=\"\",\"\",PartA!C618)","v":"Select…"}]
["40a","SRS Waiver","Select Facility…","RS56","2024-07-31",{"$f":"IF(PartA!C620=\"\",\"\",PartA!C620)","v":"Select…"}]
["41","Internal (Local) SRS","Select Facility…","RS5","2024-07-31",{"$f":"IF(PartA!C624=\"\",\"\",PartA!C624)","v":"Select…"}]
["41a","SRS Chair","Select Facility…","RS62","2024-07-31",{"$f":"IF(PartA!C629=\"\",\"\",PartA!C629)","v":"Select…"}]
["41b","Voting Members on SRS","Select Facility…","RS63","2024-07-31",{"$f":"IF(PartA!C631=\"\",\"\",PartA!C631)","v":"Select…"}]
["41c","Safety and Radiation Safety Members on SRS","Select Facility…","RS64","2024-07-31",{"$f":"IF(PartA!C637=\"\",\"\",PartA!C637)","v":"Select…"}]
["41d","IACUC Liaison to SRS","Select Facility…","RS65","2024-07-31",{"$f":"IF(PartA!C641=\"\",\"\",PartA!C641)","v":"Select…"}]
["41e","Required SRS Ex-Officio Members","Select Facility…","RS66","2024-07-31",{"$f":"IF(PartA!C644=\"\",\"\",PartA!C644)","v":"Select…"}]
["42","External (Another VAMC) SRS","Select Facility…","RS8","2024-07-31",{"$f":"IF(PartA!C648=\"\",\"\",PartA!C648)","v":"Select…"}]
["42_detail","External SRS Name","Select Facility…","RS9","2024-07-31",{"$f":"IF(PartA!D651=\"\",\"\",PartA!D651)","v":""}]
["42a","External SRS MOU","Select Facility…","RS13","2024-07-31",{"$f":"IF(PartA!C652=\"\",\"\",PartA!C652)","v":"Select…"}]
["43","rDNA Research",{"$f":"C195","v":"Select Facility…"},"RS18","2024-07-31",{"$f":"IF(PartA!C655=\"\",\"\",PartA!C655)","v":"Select…"}]
["43a","Internal (Local) IBC","Select Facility…","RS19","2024-07-31",{"$f":"IF(PartA!C659=\"\",\"\",PartA!C659)","v":"Select…"}]
["43b","Internal IBC Separate from SRS","Select Facility…","RS50","2024-07-31",{"$f":"IF(PartA!D663=\"\",\"\",PartA!D663)","v":"Select…"},null,"CONFIRM THIS IS THE CORRECT ROC ID; Confirmed"]
["43c","Internal IBC Registered with NIH-OSP","Select Facility…","RS51","2024-07-31",{"$f":"IF(PartA!C665=\"\",\"\",PartA!C665)","v":"Select…"}]
["43c_detail","Date of IBC Registration","Select Facility…","RS60","2024-07-31",{"$f":"IF(PartA!D668=\"\",\"\",PartA!D668)","v":" "}]
["43d","External (Affiliate) IBC","Select Facility…","RS20","2024-07-31",{"$f":"IF(PartA!C669=\"\",\"\",PartA!C669)","v":"Select…"}]
["43d_detail","External (Affiliate) name","Select Facility…","RS21","2024-07-31",{"$f":"IF(PartA!D673=\"\",\"\",PartA!D673)","v":""}]
["43e","External (Affiliate) IBC Registered with NIH-OSP","Select Facility…","RS23","2024-07-31",{"$f":"IF(PartA!C674=\"\",\"\",PartA!C674)","v":"Select…"}]
["43e_detail","Date of External (Affiliate) IBC Registration","Select Facility…","RS67","2024-07-31",{"$f":"IF(PartA!D678=\"\",\"\",PartA!D678)","v":" "}]
["43f","External (Affiliate) IBC MOU","Select Facility…","RS22","2024-07-31",{"$f":"IF(PartA!C679=\"\",\"\",PartA!C679)","v":"Select…"}]
["44","Laboratory Research","Select Facility…","RS24","2024-07-31",{"$f":"IF(PartA!C682=\"\",\"\",PartA!C682)","v":"Select…"}]
["44_detail_#VALabs","Number of VA Labs","Select Facility…","RS69","2024-07-31",{"$f":"IF(PartA!C686=\"\",\"\",PartA!C686)","v":"Select…"}]
["44_detail_VALab","VA Lab Locations","Select Facility…","RS68","2024-07-31",{"$f":"IF(PartA!D689=\"\",\"\",PartA!D689)","v":""}]
["44_detail_#VALeasedLabs","Number of Off-Site VA-Leased Labs","Select Facility…","RS70","2024-07-31",{"$f":"IF(PartA!C691=\"\",\"\",PartA!C691)","v":"Select…"}]
["44_detail_OffsiteVALeasedLab","Offsite VA Leased Lab Location","Select Facility…","RS57","2024-07-31",{"$f":"IF(PartA!D694=\"\",\"\",PartA!D694)","v":""}]
["44_detail_#NonVALabs","Number of Off-Site Non-VA Labs","Select Facility…","RS71","2024-07-31",{"$f":"IF(PartA!C696=\"\",\"\",PartA!C696)","v":"Select…"}]
["44_detail_OffsiteNonVALab","Offsite Non-VA Lab Location","Select Facility…","RS26","2024-07-31",{"$f":"IF(PartA!D700=\"\",\"\",PartA!D700)","v":""}]
["44a","Offsite Waivers","Select Facility…","RS27","2024-07-31",{"$f":"IF(PartA!C701=\"\",\"\",PartA!C701)","v":"Select…"}]
["44b","Review of Offsite Laboratories","Select Facility…","RS58","2024-07-31",{"$f":"IF(PartA!C704=\"\",\"\",PartA!C704)","v":"Select…"}]
["45","BSL-3","Select Facility…","RS28","2024-07-31",{"$f":"IF(PartA!C710=\"\",\"\",PartA!C710)","v":"Select…"}]
["45_detail","BSL-3 Infectious Agents","Select Facility…","RS55","2024-07-31",{"$f":"IF(PartA!D714=\"\",\"\",PartA!D714)","v":" "}]
["45a","VA BSL-3","Select Facility…","RS30","2024-07-31",{"$f":"IF(PartA!C715=\"\",\"\",PartA!C715)","v":"Select…"}]
["45a_detail","VA BSL-3 Location","Select Facility…","RS59","2024-07-31",{"$f":"IF(PartA!D718=\"\",\"\",PartA!D718)","v":" "}]
["45b","Offsite BSL-3","Select Facility…","RS31","2024-07-31",{"$f":"IF(PartA!C719=\"\",\"\",PartA!C719)","v":"Select…"}]
["45b_detail","Offsite BSL-3 Location","Select Facility…","RS32","2024-07-31",{"$f":"IF(PartA!D722=\"\",\"\",PartA!D722)","v":" "}]
["46","SARS-Co-V-2 Positive Sample Storage","Select Facility…","RS72","2024-07-31",{"$f":"IF(PartA!C723=\"\",\"\",PartA!C723)","v":"Select…"}]
["47","Chemical Hazards","Select Facility…","RS34","2024-07-31",{"$f":"IF(PartA!C725=\"\",\"\",PartA!C725)","v":"Select…"}]
["47a","Chemical Hygiene Plan","Select Facility…","RS36","2024-07-31",{"$f":"IF(PartA!C730=\"\",\"\",PartA!C730)","v":"Select…"}]
["47a_detail","Chemical Hygiene Plan Date of Last Review","Select Facility…","RS77","2024-07-31",{"$f":"IF(PartA!D735=\"\",\"\",PartA!D735)","v":""}]
["47b","Chemical Inventories","Select Facility…","RS37","2024-07-31",{"$f":"IF(PartA!C736=\"\",\"\",PartA!C736)","v":"Select…"}]
["48","Select Agents/Toxins","Select Facility…","RS38","2024-07-31",{"$f":"IF(PartA!C740=\"\",\"\",PartA!C740)","v":"Select…"}]
["48_detail","Select Agents/Toxins Detail","Select Facility…","RS39","2024-07-31",{"$f":"IF(PartA!D744=\"\",\"\",PartA!D744)","v":""}]
["49a","Research Safety Plan","Select Facility…","RS42","2024-07-31",{"$f":"IF(PartA!C747=\"\",\"\",PartA!C747)","v":"Select…"}]
["49b","Research Security Plan","Select Facility…","RS43","2024-07-31",{"$f":"IF(PartA!C749=\"\",\"\",PartA!C749)","v":"Select…"}]
["49c","Emergency Management Plan","Select Facility…","RS44","2024-07-31",{"$f":"IF(PartA!C751=\"\",\"\",PartA!C751)","v":"Select…"}]
["49d","Bloodborne Pathogen Plan","Select Facility…","RS48","2024-07-31",{"$f":"IF(PartA!C753=\"\",\"\",PartA!C753)","v":"Select…"}]
["49e","Bloodborne Pathogen Training","Select Facility…","RS73","2024-07-31",{"$f":"IF(PartA!C755=\"\",\"\",PartA!C755)","v":"Select…"}]
["49f","Activate, Decommission, Transfer Labs","Select Facility…","RS74","2024-07-31",{"$f":"IF(PartA!C760=\"\",\"\",PartA!C760)","v":"Select…"}]
["49g","SRS Annual Review of PI Lab Program","Select Facility…","RS75","2024-07-31",{"$f":"IF(PartA!C762=\"\",\"\",PartA!C762)","v":"Select…"}]
["49h","Annual Lab Safety Inspections","Select Facility…","RS45","2024-07-31",{"$f":"IF(PartA!C764=\"\",\"\",PartA!C764)","v":"Select…"}]
["49i","Annual Drills","Select Facility…","RS46","2024-07-31",{"$f":"IF(PartA!C766=\"\",\"\",PartA!C766)","v":"Select…"}]
["49i_detail1","Date of SRS Review of Biosafety Drill","Select Facility…","RS78","2024-07-31",{"$f":"IF(PartA!D773=\"\",\"\",PartA!D773)","v":""}]
["49i_detail2","Date of SRS Review of Security Drill","Select Facility…","RS79","2024-07-31",{"$f":"IF(PartA!D775=\"\",\"\",PartA!D775)","v":""}]
["49i_detail3","Date of SRS Review of Chemical Hygiene Drill","Select Facility…","RS80","2024-07-31",{"$f":"IF(PartA!D777=\"\",\"\",PartA!D777)","v":""}]
["49i_detail4","Date of SRS Review of Emergency Management Drill","Select Facility…","RS81","2024-07-31",{"$f":"IF(PartA!D779=\"\",\"\",PartA!D779)","v":""}]
["49j","Eyewash Stations/Emergency Showers","Select Facility…","RS76","2024-07-31",{"$f":"IF(PartA!C780=\"\",\"\",PartA!C780)","v":"Select…"}]
["49k","Occupational Health & Safety Plan","Select Facility…","RS53","2024-07-31",{"$f":"IF(PartA!C783=\"\",\"\",PartA!C783)","v":"Select…"}]
["49l","PPE Hazard Assessments","Select Facility…","RS61","2024-07-31",{"$f":"IF(PartA!C788=\"\",\"\",PartA!C788)","v":"Select…"}]
["49m","Laboratory Access","Select Facility…","RS54","2024-07-31",{"$f":"IF(PartA!C791=\"\",\"\",PartA!C791)","v":"Select…"}]
["RSSPNotes","RSSP Section Notes","Select Facility…","RS49","2024-07-31",{"$f":"IF(PartA!D795=\"\",\"\",PartA!D795)","v":""}]
["50","System Interconnections","Select Facility…","IS1","2024-07-31",{"$f":"IF(PartA!C800=\"\",\"\",PartA!C800)","v":"Select…"}]
["51","Air-Gapped Networks","Select Facility…","IS3","2024-07-31",{"$f":"IF(PartA!C809=\"\",\"\",PartA!C809)","v":"Select…"}]
["51a","VA Information on Non-VA Network","Select Facility…","IS21","2024-07-31",{"$f":"IF(PartA!C816=\"\",\"\",PartA!C816)","v":"Select…"}]
["51b","VASI on Non-VA Systems","Select Facility…","IS20","2024-07-31",{"$f":"IF(PartA!C823=\"\",\"\",PartA!C823)","v":"Select…"}]
["52","VASI Transported Offsite/Outside VA","Select Facility…","IS6","2024-07-31",{"$f":"IF(PartA!C833=\"\",\"\",PartA!C833)","v":"Select…"}]
["53","Non-VA External Info Systems (IT Equipment)","Select Facility…","IS8","2024-07-31",{"$f":"IF(PartA!C841=\"\",\"\",PartA!C841)","v":"Select…"}]
["54","Use of VA Mobile and Portable Devices","Select Facility…","IS10","2024-07-31",{"$f":"IF(PartA!C848=\"\",\"\",PartA!C848)","v":"Select…"}]
["55","Use of Non-VA Mobile or Portable Devices","Select Facility…","IS14","2024-07-31",{"$f":"IF(PartA!C859=\"\",\"\",PartA!C859)","v":"Select…"}]
["56","Access Controls","Select Facility…","IS22","2024-07-31",{"$f":"IF(PartA!C869=\"\",\"\",PartA!C869)","v":"Select…"}]
["57","Mechanism for DART","Select Facility…","IS24","2024-07-31",{"$f":"IF(PartA!C878=\"\",\"\",PartA!C878)","v":"Select…"}]
["58","Mechanism for PO to Confirm CMS DUAs","Select Facility…","IS25","2024-07-31",{"$f":"IF(PartA!C885=\"\",\"\",PartA!C885)","v":"Select…"}]
["RISPNotes","RISP Section Notes","Select Facility…","IS17","2024-07-31",{"$f":"IF(PartA!D893=\"\",\"\",PartA!D893)","v":""}]
["59","RIO Appointed","Select Facility…","RM1","2024-07-31",{"$f":"IF(PartA!C896=\"\",\"\",PartA!C896)","v":"Select…"}]
["59a","RIO Contact Info","Select Facility…","RM2","2024-07-31",{"$f":"IF(PartA!C900=\"\",\"\",PartA!C900)","v":"Select…"}]
["60","Misconduct Allegations",{"$f":"C259","v":"Select Facility…"},"RM4","2024-07-31",{"$f":"IF(PartA!C904=\"\",\"\",PartA!C904)","v":"Select…"}]
["RMNotes","Research Misconduct Section Notes","Select Facility…","RM5","2024-07-31",{"$f":"IF(PartA!D908=\"\",\"\",PartA!D908)","v":""}]

{"sheet":"ExportB","index":7,"n_rows":191,"n_cols":10,"rows_kept":191,"cut":false,"hidden":true,"merged":[]}
["Question#","QuestionText","id-facility","id-question","ROC_QuestionKey","FDCdate","FDCresult","FDCdetail"]
["1","Total number of protocols followed by the R&DC only",{"$f":"IF(PartA!D3=\"\",\"\",PartA!D3)","v":"Select Facility…"},1,"R1","2024-07-31",{"$f":"IF(PartB!D8=\"\",\"\",PartB!D8)","v":""}]
["1a","Protocols initiated prior to R&DC approval",{"$f":"C2","v":"Select Facility…"},2,"R2","2024-07-31",{"$f":"IF(PartB!D13=\"\",\"\",PartB!D13)","v":""}]
["1aDetails","DETAILS Protocols initiated prior to R&DC approval","Select Facility…",147,"R5","2024-07-31",null,{"$f":"IF(PartB!C18=\"\",\"\",PartB!C18)","v":""}]
["R&DCSectionNotes","DETAILS R&DC Section Notes","Select Facility…",295,"R7","2024-07-31",null,{"$f":"IF(PartB!C20=\"\",\"\",PartB!C20)","v":""}]
["2","Active human protocols","Select Facility…",5,"H1","2024-07-31",{"$f":"IF(PartB!D25=\"\",\"\",PartB!D25)","v":""}]
["MVP","DETAILS MVP active at site","Select Facility…",155,"H82","2024-07-31",null,false]
["AllOfUs","DETAILS All of Us active at site","Select Facility…",187,"H123","2024-07-31",null,false]
["3a","IRB-exempt human subjects protocols","Select Facility…",6,"H2","2024-07-31",{"$f":"IF(PartB!D33=\"\",\"\",PartB!D33)","v":""}]
["3b","Non-exempt human subjects protocols","Select Facility…",7,"H3","2024-07-31",{"$f":"IF(PartB!D34=\"\",\"\",PartB!D34)","v":""}]
["4a","Protocols with waivers of informed consent per 38CFR16.116","Select Facility…",9,"H5","2024-07-31",{"$f":"IF(PartB!D37=\"\",\"\",PartB!D37)","v":""}]
["4b","Protocols with waiver of documentation of informed consent per 38CFR16.117(c)","Select Facility…",8,"H4","2024-07-31",{"$f":"IF(PartB!D41=\"\",\"\",PartB!D41)","v":""}]
[5,"Greater than minimal risk protocols","Select Facility…",129,"H72","2024-07-31",{"$f":"IF(PartB!D45=\"\",\"\",PartB!D45)","v":""}]
["6a","Protocols subject to 2018 Common Rule","Select Facility…",249,"H146","2024-07-31",{"$f":"IF(PartB!D48=\"\",\"\",PartB!D48)","v":""}]
["6b","Protocols subject to Pre-2018 Common Rule","Select Facility…",250,"H147","2024-07-31",{"$f":"IF(PartB!D49=\"\",\"\",PartB!D49)","v":""}]
["7","Protocols suspended/terminated early by IRB","Select Facility…",212,"H124","2024-07-31",{"$f":"IF(PartB!D51=\"\",\"\",PartB!D51)","v":""}]
["7Details","DETAILS Protocols suspended or terminated (Human)","Select Facility…",150,"H78","2024-07-31",null,{"$f":"IF(PartB!C60=\"\",\"\",PartB!C60)","v":""}]
["8","Number of serious or continuing noncompliance events (Human)","Select Facility…",110,"H64","2024-07-31",{"$f":"IF(PartB!D61=\"\",\"\",PartB!D61)","v":""}]
["8Details","DETAILS Serious/continuing noncompliance events (Human)","Select Facility…",151,"H79","2024-07-31",null,{"$f":"IF(PartB!C69=\"\",\"\",PartB!C69)","v":""}]
[9,"Number of events determined to be UPIRTSO","Select Facility…",263,"H158","2024-07-31",{"$f":"IF(PartB!D70=\"\",\"\",PartB!D70)","v":""}]
["9Details","DETAILS Number of events determined to be UPIRTSO","Select Facility…",264,"H159","2024-07-31",null,{"$f":"IF(PartB!C77=\"\",\"\",PartB!C77)","v":""}]
[10,"Number of protocols REQUIRING IC audit","Select Facility…",265,"H160","2024-07-31",{"$f":"IF(PartB!D86=\"\",\"\",PartB!D86)","v":""}]
["10a","Number of protocols that received REQUIRED IC audit","Select Facility…",266,"H161","2024-07-31",{"$f":"IF(PartB!D87=\"\",\"\",PartB!D87)","v":""}]
["10aDetails","DETAILS Required audits not completed","Select Facility…",267,"H162","2024-07-31",null,{"$f":"IF(PartB!C90=\"\",\"\",PartB!C90)","v":""}]
["10b","Number of ADDITIONAL protocols with IC audit","Select Facility…",268,"H163","2024-07-31",{"$f":"IF(PartB!D91=\"\",\"\",PartB!D91)","v":""}]
["10c","Total number of protocols RECEIVING IC audit","Select Facility…",12,"H8","2024-07-31",{"$f":"IF(PartB!D94=\"\",\"\",PartB!D94)","v":0}]
[11,"Number of IC audit protocols allowing broad consent","Select Facility…",285,"H179","2024-07-31",{"$f":"IF(PartB!D96=\"\",\"\",PartB!D96)","v":""}]
["12","Number of IC audit protocols with consent waived","Select Facility…",269,"H164","2024-07-31",{"$f":"IF(PartB!D97=\"\",\"\",PartB!D97)","v":""}]
["12a","Number of IC audit protocols without APPROPRIATE waiver of informed consent","Select Facility…",270,"H165","2024-07-31",{"$f":"IF(PartB!D98=\"\",\"\",PartB!D98)","v":""}]
["12aDetails","DETAILS Inappropriate ICD waiver","Select Facility…",271,"H166","2024-07-31",null,{"$f":"IF(PartB!C104=\"\",\"\",PartB!C104)","v":""}]
["13","Number of IC audit protocols with documentation of consent waived","Select Facility…",272,"H167","2024-07-31",{"$f":"IF(PartB!D105=\"\",\"\",PartB!D105)","v":""}]
["13a","Number of IC audit protocols without APPROPRIATE waiver of documentation of consent","Select Facility…",273,"H168","2024-07-31",{"$f":"IF(PartB!D107=\"\",\"\",PartB!D107)","v":""}]
["13aDetails","DETAILS Inappropriate ICD waiver of documentation","Select Facility…",274,"H169","2024-07-31",null,{"$f":"IF(PartB!C113=\"\",\"\",PartB!C113)","v":""}]
["14","Number of IC audit protocols with HIPAA authorization waived","Select Facility…",275,"H170","2024-07-31",{"$f":"IF(PartB!D114=\"\",\"\",PartB!D114)","v":""}]
["14a","Number of IC audit protocols without APPROPRIATE waiver of HIPAA authorization",{"$f":"C34","v":"Select Facility…"},276,"H171","2024-07-31",{"$f":"IF(PartB!D116=\"\",\"\",PartB!D116)","v":""}]
["14aDetails","DETAILS Inappropriate HIPAA authorization","Select Facility…",277,"H172","2024-07-31",null,{"$f":"IF(PartB!C122=\"\",\"\",PartB!C122)","v":""}]
[15,"Total number of ICDs audited","Select Facility…",16,"H12","2024-07-31",{"$f":"IF(PartB!D123=\"\",\"\",PartB!D123)","v":""}]
["15a","ICDs with zero deficiency","Select Facility…",17,"H13","2024-07-31",{"$f":"IF(PartB!D126=\"\",\"\",PartB!D126)","v":""}]
["15b","Missing informed consent documents","Select Facility…",18,"H14","2024-07-31",{"$f":"IF(PartB!D130=\"\",\"\",PartB!D130)","v":""}]
["15bDetails","DETAILS Missing informed consent documents","Select Facility…",156,"H83","2024-07-31",null,{"$f":"IF(PartB!C137=\"\",\"\",PartB!C137)","v":""}]
["15c","Incorrect version of ICD used","Select Facility…",188,"H121","2024-07-31",{"$f":"IF(PartB!D138=\"\",\"\",PartB!D138)","v":""}]
["15d","Incorrect ICDs used (from another study)","Select Facility…",116,"H67","2024-07-31",{"$f":"IF(PartB!D140=\"\",\"\",PartB!D140)","v":""}]
["15e","Incorrect ICDs used (unapproved)","Select Facility…",117,"H68","2024-07-31",{"$f":"IF(PartB!D142=\"\",\"\",PartB!D142)","v":""}]
["15eDetails","DETAILS ICDs unapproved or ICD from another study used","Select Facility…",216,"H128","2024-07-31",null,{"$f":"IF(PartB!C147=\"\",\"\",PartB!C147)","v":""}]
["15f","ICDs without subject signature","Select Facility…",20,"H16","2024-07-31",{"$f":"IF(PartB!D148=\"\",\"\",PartB!D148)","v":""}]
["15fDetails","DETAILS ICDs without subject signature","Select Facility…",157,"H84","2024-07-31",null,{"$f":"IF(PartB!C154=\"\",\"\",PartB!C154)","v":""}]
["15g","ICDs without subject date","Select Facility…",21,"H17","2024-07-31",{"$f":"IF(PartB!D155=\"\",\"\",PartB!D155)","v":""}]
["15h","ICDs without research injury language","Select Facility…",30,"H26","2024-07-31",{"$f":"IF(PartB!D157=\"\",\"\",PartB!D157)","v":""}]
["16","ICDs subject to 2018 CR","Select Facility…",190,"H101","2024-07-31",{"$f":"IF(PartB!D159=\"\",\"\",PartB!D159)","v":""}]
["16a","ICDs without key information up front","Select Facility…",191,"H102","2024-07-31",{"$f":"IF(PartB!D160=\"\",\"\",PartB!D160)","v":""}]
["16b","ICDs with identifiable info/biospecimens collected","Select Facility…",192,"H103","2024-07-31",{"$f":"IF(PartB!D162=\"\",\"\",PartB!D162)","v":""}]
["16c","ICDs without information/biospecimen statement on future use","Select Facility…",193,"H104","2024-07-31",{"$f":"IF(PartB!D165=\"\",\"\",PartB!D165)","v":""}]
[17,"Number of HIPAA authorizations required","Select Facility…",26,"H22","2024-07-31",{"$f":"IF(PartB!D169=\"\",\"\",PartB!D169)","v":""}]
["17a","Valid HIPAA authorizations not obtained","Select Facility…",27,"H23","2024-07-31",{"$f":"IF(PartB!D170=\"\",\"\",PartB!D170)","v":""}]
["17aDetails","DETAILS HIPAA authorizations not obtained or missing subject signature","Select Facility…",159,"H86","2024-07-31",null,{"$f":"IF(PartB!C177=\"\",\"\",PartB!C177)","v":""}]
["17b","HIPAA template VA-Form 10-0493 required","Select Facility…",132,"H75","2024-07-31",{"$f":"IF(PartB!D178=\"\",\"\",PartB!D178)","v":""}]
["17c","HIPAA template VA-Form 10-0493 not used","Select Facility…",133,"H76","2024-07-31",{"$f":"IF(PartB!D184=\"\",\"\",PartB!D184)","v":""}]
[18,"Number of Veterans enrolled in MVP","Select Facility…",197,"H108","2024-07-31",{"$f":"IF(PartB!D188=\"\",\"\",PartB!D188)","v":""}]
["18a","MVP ICDs and HIPAA authorization audited","Select Facility…",198,"H109","2024-07-31",{"$f":"IF(PartB!D190=\"\",\"\",PartB!D190)","v":""}]
["ICDSectionNotes","DETAILS ICD Section Notes","Select Facility…",160,"H98","2024-07-31",null,{"$f":"IF(PartB!C196=\"\",\"\",PartB!C196)","v":""}]
[19,"Total number of human protocols receiving a regulatory audit","Select Facility…",33,"H29","2024-07-31",{"$f":"IF(PartB!D200=\"\",\"\",PartB!D200)","v":""}]
["19a","Protocols audited greater than minimal risk","Select Facility…",203,"H114","2024-07-31",{"$f":"IF(PartB!D202=\"\",\"\",PartB!D202)","v":""}]
["19b","Min risk protocols approved by expedited review","Select Facility…",204,"H115","2024-07-31",{"$f":"IF(PartB!D203=\"\",\"\",PartB!D203)","v":""}]
["19bDetails","DETAILS GMR receiving expedited review","Select Facility…",218,"H130","2024-07-31",null,{"$f":"IF(PartB!C207=\"\",\"\",PartB!C207)","v":""}]
["20a","Protocols intiated without IRB approval","Select Facility…",38,"H34","2024-07-31",{"$f":"IF(PartB!D210=\"\",\"\",PartB!D210)","v":""}]
["20b","Protocols completed without IRB approval","Select Facility…",39,"H35","2024-07-31",{"$f":"IF(PartB!D212=\"\",\"\",PartB!D212)","v":""}]
["20c","Protocols intiated without R&DC approval (Human)",{"$f":"C66","v":"Select Facility…"},40,"H36","2024-07-31",{"$f":"IF(PartB!D213=\"\",\"\",PartB!D213)","v":""}]
["20d","Protocols completed without R&DC Approval (Human)","Select Facility…",41,"H37","2024-07-31",{"$f":"IF(PartB!D215=\"\",\"\",PartB!D215)","v":""}]
["20e","Protocols initiated prior to ACOS/R letter (Human)","Select Facility…",254,"H151","2024-07-31",{"$f":"IF(PartB!D216=\"\",\"\",PartB!D216)","v":""}]
["20f","Protocols without final PO review","Select Facility…",278,"H173","2024-07-31",{"$f":"IF(PartB!D218=\"\",\"\",PartB!D218)","v":""}]
["20g","Protocols without final ISSO review","Select Facility…",279,"H174","2024-07-31",{"$f":"IF(PartB!D221=\"\",\"\",PartB!D221)","v":""}]
["20gDetails","DETAILS Protocols without approval","Select Facility…",182,"H99","2024-07-31",null,{"$f":"IF(PartB!C227=\"\",\"\",PartB!C227)","v":""}]
["21","Number of international research protocols","Select Facility…",60,"H56","2024-07-31",{"$f":"IF(PartB!D228=\"\",\"\",PartB!D228)","v":""}]
["21a","International protocols without FD/CRADO approval","Select Facility…",61,"H57","2024-07-31",{"$f":"IF(PartB!D230=\"\",\"\",PartB!D230)","v":""}]
["21aDetails","DETAILS No approval for international protocol","Select Facility…",178,"H93","2024-07-31",null,{"$f":"IF(PartB!C235=\"\",\"\",PartB!C235)","v":""}]
["22","Number of protocols involving children","Select Facility…",62,"H58","2024-07-31",{"$f":"IF(PartB!D236=\"\",\"\",PartB!D236)","v":""}]
["22a","Protocols involving children without FD/CRADO approval","Select Facility…",63,"H59","2024-07-31",{"$f":"IF(PartB!D237=\"\",\"\",PartB!D237)","v":""}]
["22aDetails","DETAILS No approval for protocol with children","Select Facility…",179,"H94","2024-07-31",null,{"$f":"IF(PartB!C242=\"\",\"\",PartB!C242)","v":""}]
[23,"Number of protocols involving prisoners","Select Facility…",64,"H60","2024-07-31",{"$f":"IF(PartB!D243=\"\",\"\",PartB!D243)","v":""}]
["23a","Protocols without CRADO approval","Select Facility…",65,"H61","2024-07-31",{"$f":"IF(PartB!D244=\"\",\"\",PartB!D244)","v":""}]
["23aDetails","DETAILS no approval for protocol with prisoners","Select Facility…",180,"H95","2024-07-31",null,{"$f":"IF(PartB!C249=\"\",\"\",PartB!C249)","v":""}]
[24,"Number of protocols using investigational drugs","Select Facility…",280,"H175","2024-07-31",{"$f":"IF(PartB!D250=\"\",\"\",PartB!D250)","v":""}]
["24a","Investigational drug log not containing required elements","Select Facility…",281,"H176","2024-07-31",{"$f":"IF(PartB!D254=\"\",\"\",PartB!D254)","v":""}]
["24b","Investigational drugs not stored separately","Select Facility…",282,"H177","2024-07-31",{"$f":"IF(PartB!D258=\"\",\"\",PartB!D258)","v":""}]
[25,"Protocols audited subject to 2018 Common Rule","Select Facility…",202,"H113","2024-07-31",{"$f":"IF(PartB!D262=\"\",\"\",PartB!D262)","v":""}]
["25a","Protocols audited that were IRB-exempt","Select Facility…",205,"H116","2024-07-31",{"$f":"IF(PartB!D264=\"\",\"\",PartB!D264)","v":""}]
["25b","Exempt category not documented","Select Facility…",206,"H117","2024-07-31",{"$f":"IF(PartB!D265=\"\",\"\",PartB!D265)","v":""}]
["25c","Exempt category does not match regulatory description","Select Facility…",207,"H118","2024-07-31",{"$f":"IF(PartB!D267=\"\",\"\",PartB!D267)","v":""}]
["25cDetails","DETAILS Incorrect exempt category","Select Facility…",219,"H131","2024-07-31",null,{"$f":"IF(PartB!C273=\"\",\"\",PartB!C273)","v":""}]
["25d","IRB-exempt protocols requiring limited IRB review","Select Facility…",208,"H119","2024-07-31",{"$f":"IF(PartB!D274=\"\",\"\",PartB!D274)","v":""}]
["25e","Protocols not receiving required limited IRB review","Select Facility…",209,"H120","2024-07-31",{"$f":"IF(PartB!D276=\"\",\"\",PartB!D276)","v":""}]
["25eDetails","DETAILS No limited IRB review","Select Facility…",220,"H132","2024-07-31",null,{"$f":"IF(PartB!C281=\"\",\"\",PartB!C281)","v":""}]
["25f","Exempt protocols without required information provided to subjects","Select Facility…",221,"H133","2024-07-31",{"$f":"IF(PartB!D282=\"\",\"\",PartB!D282)","v":""}]
["25fDetails","DETAILS Exempt protocols without required information provided to subjects","Select Facility…",222,"H134","2024-07-31",null,{"$f":"IF(PartB!C289=\"\",\"\",PartB!C289)","v":""}]
["26","Protocols subject to single IRB requirement","Select Facility…",225,"H137","2024-07-31",{"$f":"IF(PartB!D290=\"\",\"\",PartB!D290)","v":""}]
["26a","Single IRB protocols","Select Facility…",255,"H152","2024-07-31",{"$f":"IF(PartB!D294=\"\",\"\",PartB!D294)","v":""}]
["26b","Single IRB protocols without valid reliance agreement","Select Facility…",256,"H153","2024-07-31",{"$f":"IF(PartB!D296=\"\",\"\",PartB!D296)","v":""}]
["26c","Single IRB protocols NOT reviewed by single IRB","Select Facility…",257,"H154","2024-07-31",{"$f":"IF(PartB!D301=\"\",\"\",PartB!D301)","v":""}]
["26d","Single IRB protocols without valid exception",{"$f":"C98","v":"Select Facility…"},258,"H155","2024-07-31",{"$f":"IF(PartB!D303=\"\",\"\",PartB!D303)","v":""}]
["26dDetails","DETAILS No reliance agreement or exception","Select Facility…",240,"H142","2024-07-31",null,{"$f":"IF(PartB!C310=\"\",\"\",PartB!C310)","v":""}]
["27","Protocols requiring IRB continuing review per 1200.05","Select Facility…",262,"H157","2024-07-31",{"$f":"IF(PartB!D311=\"\",\"\",PartB!D311)","v":""}]
[28,"Protocols with CR required by IRB (not required by 1200.05)","Select Facility…",223,"H135","2024-07-31",{"$f":"IF(PartB!D314=\"\",\"\",PartB!D314)","v":""}]
["29a","Protocols with lapse in IRB continuing review (HRPP audit)","Select Facility…",46,"H42","2024-07-31",{"$f":"IF(PartB!D318=\"\",\"\",PartB!D318)","v":""}]
["29b","Protocols with activity during lapse (HRPP audit)","Select Facility…",47,"H43","2024-07-31",{"$f":"IF(PartB!D321=\"\",\"\",PartB!D321)","v":""}]
["29bDetails","DETAILS Protocols with activity during lapse (HRPP audit)","Select Facility…",175,"H90","2024-07-31",null,{"$f":"IF(PartB!C327=\"\",\"\",PartB!C327)","v":""}]
["29c","Protocols with rationale for IRB-required CR documented","Select Facility…",224,"H136","2024-07-31",{"$f":"IF(PartB!D328=\"\",\"\",PartB!D328)","v":""}]
["29cDetails","DETAILS No continuing review documentation","Select Facility…",239,"H141","2024-07-31",null,{"$f":"IF(PartB!C334=\"\",\"\",PartB!C334)","v":""}]
[30,"Local adverse events and apparent UPIRTSOs","Select Facility…",259,"H156","2024-07-31",{"$f":"IF(PartB!D335=\"\",\"\",PartB!D335)","v":""}]
["30a","Local AEs determined to be serious, unanticipated and related","Select Facility…",42,"H38","2024-07-31",{"$f":"IF(PartB!D339=\"\",\"\",PartB!D339)","v":""}]
["30b","SAEs not reported to IRB in a timely manner","Select Facility…",119,"H70","2024-07-31",{"$f":"IF(PartB!D344=\"\",\"\",PartB!D344)","v":""}]
["30c","SAEs not reviewed and categorized by the IRB in a timely manner","Select Facility…",120,"H71","2024-07-31",{"$f":"IF(PartB!D348=\"\",\"\",PartB!D348)","v":""}]
["30cDetails","DETAILS SAEs not reported or reviewed within required timeframe","Select Facility…",227,"H139","2024-07-31",null,{"$f":"IF(PartB!C355=\"\",\"\",PartB!C355)","v":""}]
[31,"Total number of research personnel in human protocols audited","Select Facility…",55,"H51","2024-07-31",{"$f":"IF(PartB!D356=\"\",\"\",PartB!D356)","v":""}]
["31a","Personnel with lapse in required training (Human)","Select Facility…",58,"H54","2024-07-31",{"$f":"IF(PartB!D358=\"\",\"\",PartB!D358)","v":""}]
["31b","Personnel without initial training (Human)","Select Facility…",59,"H55","2024-07-31",{"$f":"IF(PartB!D361=\"\",\"\",PartB!D361)","v":""}]
["31bDetails","DETAILS No initial human subjects training","Select Facility…",228,"H140","2024-07-31",null,{"$f":"IF(PartB!C366=\"\",\"\",PartB!C366)","v":""}]
[32,"Total number of subject records reviewed","Select Facility…",48,"H44","2024-07-31",{"$f":"IF(PartB!D367=\"\",\"\",PartB!D367)","v":""}]
["32a","Number of records without documentation of IC prior to research","Select Facility…",49,"H45","2024-07-31",{"$f":"IF(PartB!D370=\"\",\"\",PartB!D370)","v":""}]
["32aDetails","DETAILS Research prior to IC","Select Facility…",176,"H91","2024-07-31",null,{"$f":"IF(PartB!C376=\"\",\"\",PartB!C376)","v":""}]
["32b","Number of records with Inclusion/Exclusion criteria","Select Facility…",50,"H46","2024-07-31",{"$f":"IF(PartB!D377=\"\",\"\",PartB!D377)","v":""}]
["32c","Number of subjects included in research not meeting incl/excl","Select Facility…",54,"H50","2024-07-31",{"$f":"IF(PartB!D382=\"\",\"\",PartB!D382)","v":""}]
["32cDetails","DETAILS Subjects included not meeting Incl/Excl criteria","Select Facility…",177,"H92","2024-07-31",null,{"$f":"IF(PartB!C389=\"\",\"\",PartB!C389)","v":""}]
["32d","Number of subjects without progress note","Select Facility…",283,"H178","2024-07-31",{"$f":"IF(PartB!D390=\"\",\"\",PartB!D390)","v":""}]
["HRPPNotes","DETAILS HRPP/IRB section notes","Select Facility…",184,"H97","2024-07-31",null,{"$f":"IF(PartB!C395=\"\",\"\",PartB!C395)","v":""}]
["33","Active animal protocols","Select Facility…",66,"A1","2024-07-31",{"$f":"IF(PartB!D402=\"\",\"\",PartB!D402)","v":""}]
["34","Protocols suspended/terminated early by IACUC","Select Facility…",229,"A42","2024-07-31",{"$f":"IF(PartB!D404=\"\",\"\",PartB!D404)","v":""}]
["34Details","DETAILS Suspensions or terminations","Select Facility…",173,"A38","2024-07-31",null,{"$f":"IF(PartB!C410=\"\",\"\",PartB!C410)","v":""}]
["35","Number of serious or continuing noncompliance events (Animal)","Select Facility…",243,"A46","2024-07-31",{"$f":"IF(PartB!D411=\"\",\"\",PartB!D411)","v":""}]
["35Details","DETAILS serious/continuing noncompliance events (Animal)","Select Facility…",244,"A47","2024-07-31",null,{"$f":"IF(PartB!C418=\"\",\"\",PartB!C418)","v":""}]
["36","Total number of animal research protocols audited","Select Facility…",72,"A7","2024-07-31",{"$f":"IF(PartB!D422=\"\",\"\",PartB!D422)","v":""}]
["37","Cats, dogs, NHP without VA Sec Approval",{"$f":"C130","v":"Select Facility…"},297,"A50","2024-07-31",{"$f":"IF(PartB!D424=\"\",\"\",PartB!D424)","v":""}]
["37Details","DETAILS Cats, dogs, NHP without VA Sec Approval","Select Facility…",298,"A51","2024-07-31",null,{"$f":"IF(PartB!C430=\"\",\"\",PartB!C430)","v":""}]
["38","Protocols with controlled substances (Animal)","Select Facility…",122,"A31","2024-07-31",{"$f":"IF(PartB!D431=\"\",\"\",PartB!D431)","v":""}]
["38a","Protocols  with controlled substances conducted at the VA","Select Facility…",135,"A34","2024-07-31",{"$f":"IF(PartB!D434=\"\",\"\",PartB!D434)","v":""}]
["38b","Protocols with CS not obtained through VA pharmacy","Select Facility…",136,"A35","2024-07-31",{"$f":"IF(PartB!D436=\"\",\"\",PartB!D436)","v":""}]
["38bDetails","DETAILS CS not obtained through VA pharmacy","Select Facility…",230,"A43","2024-07-31",null,{"$f":"IF(PartB!C442=\"\",\"\",PartB!C442)","v":""}]
["38c","Controlled substance not properly stored","Select Facility…",210,"A41","2024-07-31",{"$f":"IF(PartB!D443=\"\",\"\",PartB!D443)","v":""}]
["38cDetails","DETAILS CS not properly stored","Select Facility…",231,"A44","2024-07-31",null,{"$f":"IF(PartB!C450=\"\",\"\",PartB!C450)","v":""}]
["39a","Protocols initiated prior to IACUC approval","Select Facility…",78,"A13","2024-07-31",{"$f":"IF(PartB!D453=\"\",\"\",PartB!D453)","v":""}]
["39b","Protocols completed without IACUC approval","Select Facility…",79,"A14","2024-07-31",{"$f":"IF(PartB!D455=\"\",\"\",PartB!D455)","v":""}]
["39c","Protocols initated prior to R&DC approval (Animal)","Select Facility…",80,"A15","2024-07-31",{"$f":"IF(PartB!D456=\"\",\"\",PartB!D456)","v":""}]
["39d","Protocols completed without R&DC approval (Animal)","Select Facility…",81,"A16","2024-07-31",{"$f":"IF(PartB!D458=\"\",\"\",PartB!D458)","v":""}]
["39e","Protocols initiated prior to ACOS/R letter (animal)","Select Facility…",260,"A49","2024-07-31",{"$f":"IF(PartB!D459=\"\",\"\",PartB!D459)","v":""}]
["39eDetails","DETAILS research initiated prior to approval","Select Facility…",183,"A39","2024-07-31",null,{"$f":"IF(PartB!C465=\"\",\"\",PartB!C465)","v":""}]
["40","Protocols requiring IACUC complete review","Select Facility…",124,"A33","2024-07-31",{"$f":"IF(PartB!D466=\"\",\"\",PartB!D466)","v":""},null,null,"change to complete review; new ROC ID? Using existing ROC ID and added comment on when it was updated"]
["40a","Protocols with lapse in IACUC complete review","Select Facility…",114,"A28","2024-07-31",{"$f":"IF(PartB!D467=\"\",\"\",PartB!D467)","v":""},null,null,"change to complete review; new ROC ID? Using existing ROC ID and added comment on when it was updated"]
["40b","Protocols with activity during  complete review lapse","Select Facility…",115,"A29","2024-07-31",{"$f":"IF(PartB!D471=\"\",\"\",PartB!D471)","v":""},null,null,"change to complete review; new ROC ID? Using existing ROC ID and added comment on when it was updated"]
["40bDetails","DETAILS Protocols with activity during complete review lapse","Select Facility…",172,"A37","2024-07-31",null,{"$f":"IF(PartB!C478=\"\",\"\",PartB!C478)","v":""},null,"change to complete review; new ROC ID? Using existing ROC ID and added comment on when it was updated"]
["41","Total number of research personnel in animal protocols audited","Select Facility…",87,"A22","2024-07-31",{"$f":"IF(PartB!D479=\"\",\"\",PartB!D479)","v":""}]
["41a","Personnel with lapse in required training (Animal)","Select Facility…",90,"A25","2024-07-31",{"$f":"IF(PartB!D481=\"\",\"\",PartB!D481)","v":""}]
["41b","Personnel without initial training (Animal)","Select Facility…",91,"A26","2024-07-31",{"$f":"IF(PartB!D484=\"\",\"\",PartB!D484)","v":""}]
["41bDetails","DETAILS No initial animal welfare training","Select Facility…",232,"A45","2024-07-31",null,{"$f":"IF(PartB!C491=\"\",\"\",PartB!C491)","v":""}]
["ACUPSectionNotes","DETAILS ACUP/IACUC section notes","Select Facility…",171,"A36","2024-07-31",null,{"$f":"IF(PartB!C493=\"\",\"\",PartB!C493)","v":""}]
["42","Active safety protocols","Select Facility…",92,"S1","2024-07-31",{"$f":"IF(PartB!D500=\"\",\"\",PartB!D500)","v":""}]
["42a","Active basic science protocols","Select Facility…",137,"S21","2024-07-31",{"$f":"IF(PartB!D502=\"\",\"\",PartB!D502)","v":""}]
["43","Protocols suspended/terminated early by SRS","Select Facility…",233,"S38","2024-07-31",{"$f":"IF(PartB!D504=\"\",\"\",PartB!D504)","v":""}]
["43Details","DETAILS Suspensions or terminations","Select Facility…",170,"S35","2024-07-31",null,{"$f":"IF(PartB!C511=\"\",\"\",PartB!C511)","v":""}]
["44","Number of serious or continuing noncompliance events (Safety)","Select Facility…",245,"S44","2024-07-31",{"$f":"IF(PartB!D512=\"\",\"\",PartB!D512)","v":""}]
["44Details","DETAILS serious/continuing noncompliance events (Safety)","Select Facility…",246,"S45","2024-07-31",null,{"$f":"IF(PartB!C520=\"\",\"\",PartB!C520)","v":""}]
["45","Total number of safety protocols audited","Select Facility…",97,"S6","2024-07-31",{"$f":"IF(PartB!D524=\"\",\"\",PartB!D524)","v":""}]
["46","Protocols conducted completely or partially off-site","Select Facility…",125,"S17","2024-07-31",{"$f":"IF(PartB!D526=\"\",\"\",PartB!D526)","v":""}]
["46a","Protocols without required off-site waiver","Select Facility…",139,"S27","2024-07-31",{"$f":"IF(PartB!D528=\"\",\"\",PartB!D528)","v":""}]
["47","Protocols with biological hazards",{"$f":"C162","v":"Select Facility…"},288,"S48","2024-07-31",{"$f":"IF(PartB!D531=\"\",\"\",PartB!D531)","v":""}]
["47a","Protocols without precautions for hazards","Select Facility…",289,"S49","2024-07-31",{"$f":"IF(PartB!D532=\"\",\"\",PartB!D532)","v":""}]
["48","Protocols with human or non-human cell or tissue samples","Select Facility…",290,"S50","2024-07-31",{"$f":"IF(PartB!D536=\"\",\"\",PartB!D536)","v":""}]
["48a","Protocols with potential biohazard for lab personnel","Select Facility…",291,"S51","2024-07-31",{"$f":"IF(PartB!D538=\"\",\"\",PartB!D538)","v":""}]
["48b","Protocols without precautions for biohazards","Select Facility…",292,"S52","2024-07-31",{"$f":"IF(PartB!D542=\"\",\"\",PartB!D542)","v":""}]
["48c","Protocols without bloodborne pathogen training","Select Facility…",293,"S53","2024-07-31",{"$f":"IF(PartB!D545=\"\",\"\",PartB!D545)","v":""}]
["49","Protocols with chemical hazards","Select Facility…",127,"S19","2024-07-31",{"$f":"IF(PartB!D550=\"\",\"\",PartB!D550)","v":""}]
["49a","Protocols without required semi-annual chemical inventory review","Select Facility…",234,"S39","2024-07-31",{"$f":"IF(PartB!D552=\"\",\"\",PartB!D552)","v":""}]
["49aDetails","DETAILS Protocols without required semi-annual chemical inventory review","Select Facility…",284,"S47","2024-07-31",null,{"$f":"IF(PartB!C559=\"\",\"\",PartB!C559)","v":""}]
["50","Protocols with radiation hazards","Select Facility…",128,"S20","2024-07-31",{"$f":"IF(PartB!D560=\"\",\"\",PartB!D560)","v":""}]
["50a","Protocol not reviewed by radiation/safety officer","Select Facility…",144,"S28","2024-07-31",{"$f":"IF(PartB!D561=\"\",\"\",PartB!D561)","v":""}]
["51a","Protocols initiated prior to SRS approval","Select Facility…",98,"S7","2024-07-31",{"$f":"IF(PartB!D567=\"\",\"\",PartB!D567)","v":""}]
["51b","Protocols completed without SRS approval","Select Facility…",99,"S8","2024-07-31",{"$f":"IF(PartB!D569=\"\",\"\",PartB!D569)","v":""}]
["51c","Protocols without written notification of SRS review","Select Facility…",235,"S40","2024-07-31",{"$f":"IF(PartB!D570=\"\",\"\",PartB!D570)","v":""}]
["51d","Protocols intiated prior to R&DC approval (Safety)","Select Facility…",103,"S12","2024-07-31",{"$f":"IF(PartB!D574=\"\",\"\",PartB!D574)","v":""}]
["51e","Protocols completed without R&DC approval (Safety)","Select Facility…",104,"S13","2024-07-31",{"$f":"IF(PartB!D576=\"\",\"\",PartB!D576)","v":""}]
["51f","Protocols initiated prior to ACOS/R letter (safety)","Select Facility…",261,"S46","2024-07-31",{"$f":"IF(PartB!D577=\"\",\"\",PartB!D577)","v":""}]
["51fDetails","DETAILS Protocols without SRS approval","Select Facility…",167,"S32","2024-07-31",null,{"$f":"IF(PartB!C583=\"\",\"\",PartB!C583)","v":""}]
["51g","Protocols without required annual review of PI's lab program","Select Facility…",294,"S54","2024-07-31",{"$f":"IF(PartB!D584=\"\",\"\",PartB!D584)","v":""}]
["52","Protocols requiring IBC approval","Select Facility…",100,"S9","2024-07-31",{"$f":"IF(PartB!D588=\"\",\"\",PartB!D588)","v":""}]
["52a","Protocols initiated prior to IBC approval","Select Facility…",101,"S10","2024-07-31",{"$f":"IF(PartB!D590=\"\",\"\",PartB!D590)","v":""}]
["52b","Protocols completed without IBC approval","Select Facility…",102,"S11","2024-07-31",{"$f":"IF(PartB!D591=\"\",\"\",PartB!D591)","v":""}]
["52c","Protocols without written notification of IBC review","Select Facility…",236,"S41","2024-07-31",{"$f":"IF(PartB!D592=\"\",\"\",PartB!D592)","v":""}]
["52cDetails","DETAILS Protocols without IBC approval","Select Facility…",237,"S42","2024-07-31",null,{"$f":"IF(PartB!C599=\"\",\"\",PartB!C599)","v":""}]
["53","Total number of research personnel in safety protocols audited","Select Facility…",164,"S29","2024-07-31",{"$f":"IF(PartB!D600=\"\",\"\",PartB!D600)","v":""}]
["53a","Personnel with lapse in required training (Safety)","Select Facility…",165,"S30","2024-07-31",{"$f":"IF(PartB!D602=\"\",\"\",PartB!D602)","v":""}]
["53b","Personnel without initial training (Safety)","Select Facility…",166,"S31","2024-07-31",{"$f":"IF(PartB!D606=\"\",\"\",PartB!D606)","v":""}]
["53bDetails","DETAILS No initial safety training","Select Facility…",238,"S43","2024-07-31",null,{"$f":"IF(PartB!C613=\"\",\"\",PartB!C613)","v":""}]
["RSSSectionNotes","RSSP/SRS Section Notes","Select Facility…",186,"S36","2024-07-31",null,{"$f":"IF(PartB!C615=\"\",\"\",PartB!C615)","v":""}]

{"sheet":"Drop-down","index":8,"n_rows":110,"n_cols":34,"rows_kept":110,"cut":false,"hidden":true,"merged":[[23,32,23,33],[24,32,25,33]]}
["VISN","Facility #","Facility","Select Facility…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…",null,"Select…"]
[1,402,"VA Maine Healthcare System - Togus","402 VA Maine Healthcare System - Togus",null,"Yes",null,"Yes",null,"Continued full accreditation",null,"VA registration",null,"Only at the VA VMU (owned or leased)",null,"The VA ACUP is covered by a VA PHS Assurance",null,"VA-maintained accreditation",null,"The VA IACUC performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC performs its own program review and facility inspection of the affiliate(s) animal program.",null,0,null,"The IBC is a separate committee from the SRS. ",null,"Internal VA-appointed IACUC-of record"]
[1,405,"White River Junction VA Medical Center","405 White River Junction VA Medical Center",null,"No",null,"No",null,"Conditional accreditation",null,"Affiliate registration",null,"Both VA VMU (owned or leased) and affiliate",null,"The VA ACUP is covered by the affiliate's PHS Assurance",null,"Affiliate-maintained accreditation",null,"The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program.",null,"The VA IACUC accepts the semi-annual reports of the affiliate IACUC (in lieu of performing its own facility inspection and program review) as a business item during a convened meeting.",null,"1-10",null,"The SRS is constituted as an IBC, and convenes as an IBC/SRS (a single set of minutes are produced).",null,"External affiliate-appointed IACUC-of-record"]
[23,437,"Fargo VA Health Care System","437 Fargo VA Health Care System",null,"N/A",null,null,null,"Deferred accreditation",null,"No registration",null,"Only at the affiliate",null,null,null,null,null,null,null,"The affiliate IACUC-of-record (i.e., no VA IACUC) performs the program review and facility inspection of the VA animal program.",null,"11-20",null,"The SRS is constituted as an IBC, but separate IBC and SRS meetings are convened (two sets of minutes are produced).",null,"External jointly-appointed IACUC-of-record"]
[23,438,"Sioux Falls VA Health Care System","438 Sioux Falls VA Health Care System",null,null,null,null,null,"Probation",null,null,null,null,null,null,null,null,null,null,null,null,null,"21-30"]
[21,459,"VA Pacific Islands Health Care System","459 VA Pacific Islands Health Care System",null,null,null,null,null,"Revoked accreditation",null,null,null,null,null,null,null,null,null,null,null,null,null,"31-40"]
[4,460,"Wilmington VA Medical Center","460 Wilmington VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,">40"]
[22,501,"New Mexico VA Health Care System","501 New Mexico VA Health Care System"]
[10,506,"VA Ann Arbor Healthcare System","506 VA Ann Arbor Healthcare System"]
[7,508,"Atlanta VA Medical Center","508 Atlanta VA Medical Center"]
[7,509,"Charlie Norwood VA Medical Center","509 Charlie Norwood VA Medical Center"]
[5,512,"VA Maryland Health Care System","512 VA Maryland Health Care System"]
[10,515,"Battle Creek VA Medical Center","515 Battle Creek VA Medical Center"]
[8,516,"Bay Pines VA Healthcare System","516 Bay Pines VA Healthcare System"]
[1,518,"Edith Nourse Rogers Memorial VA Hospital","518 Edith Nourse Rogers Memorial VA Hospital"]
[16,520,"Gulf Coast Veterans Health Care System","520 Gulf Coast Veterans Health Care System"]
[7,521,"Birmingham VA Medical Center","521 Birmingham VA Medical Center"]
[1,523,"VA Boston Healthcare System","523 VA Boston Healthcare System"]
[2,526,"James J. Peters VA Medical Center","526 James J. Peters VA Medical Center"]
[2,528,"VA Western New York Healthcare System","528 VA Western New York Healthcare System"]
[2,"528A6","VA Finger Lakes Healthcare System","528A6 VA Finger Lakes Healthcare System"]
[2,"528A7","Syracuse VA Medical Center","528A7 Syracuse VA Medical Center"]
[2,"528A8","Albany VA Medical Center: Samuel S. Stratton","528A8 Albany VA Medical Center: Samuel S. Stratton"]
[20,531,"Boise VA Medical Center","531 Boise VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"33.","For affiliate animal facilities:"]
[7,534,"Ralph H. Johnson VA Medical Center","534 Ralph H. Johnson VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"How has the IACUC fulfilled requirements for semi-annual assessment of the affiliate(s) ACUP as it relates to oversight of VA animal research?"]
[12,537,"Jesse Brown VA Medical Center","537 Jesse Brown VA Medical Center"]
[10,538,"Chillicothe VA Medical Center","538 Chillicothe VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Select…"]
[10,539,"Cincinnati VA Medical Center","539 Cincinnati VA Medical Center",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"VHA Handbook 1200.07§8.f(1)(a) "]
[5,540,"Louis A. Johnson VA Medical Center","540 Louis A. Johnson VA Medical Center"]
[10,541,"VA Northeast Ohio Healthcare System","541 VA Northeast Ohio Healthcare System"]
[4,542,"Coatesville VA Medical Center","542 Coatesville VA Medical Center"]
[7,544,"Wm. Jennings Bryan Dorn VA Medical Center","544 Wm. Jennings Bryan Dorn VA Medical Center"]
[8,546,"Miami VA Healthcare System","546 Miami VA Healthcare System"]
[8,548,"West Palm Beach VA Medical Center","548 West Palm Beach VA Medical Center"]
[17,549,"VA North Texas Health Care System","549 VA North Texas Health Care System"]
[10,552,"Dayton VA Medical Center","552 Dayton VA Medical Center"]
[10,553,"John D. Dingell VA Medical Center","553 John D. Dingell VA Medical Center"]
[19,554,"VA Eastern Colorado Health Care System","554 VA Eastern Colorado Health Care System"]
[12,556,"Captain James A. Lovell Federal Health Care Center","556 Captain James A. Lovell Federal Health Care Center"]
[6,558,"Durham VA Health Care System","558 Durham VA Health Care System"]
[2,561,"VA New Jersey Health Care System","561 VA New Jersey Health Care System"]
[16,564,"Veterans Health Care System of the Ozarks","564 Veterans Health Care System of the Ozarks"]
[21,570,"VA Central California Health Care System","570 VA Central California Health Care System"]
[8,573,"North Florida/South Georgia Veterans Health System","573 North Florida/South Georgia Veterans Health System"]
[12,578,"Edward Hines Jr. VA Hospital","578 Edward Hines Jr. VA Hospital"]
[16,580,"Michael E. DeBakey VA Medical Center","580 Michael E. DeBakey VA Medical Center"]
[5,581,"Hershel Woody Williams VA Medical Center","581 Hershel Woody Williams VA Medical Center"]
[10,583,"Richard L. Roudebush VA Medical Center","583 Richard L. Roudebush VA Medical Center"]
[16,586,"G.V. (Sonny) Montgomery VA Medical Center","586 G.V. (Sonny) Montgomery VA Medical Center"]
[15,589,"Kansas City VA Medical Center","589 Kansas City VA Medical Center"]
[15,"589A4","Harry S. Truman Memorial Veterans' Hospital","589A4 Harry S. Truman Memorial Veterans' Hospital"]
[15,"589A6","VA Eastern Kansas Health Care System","589A6 VA Eastern Kansas Health Care System"]
[15,"589A7","Robert J. Dole VA Medical Center","589A7 Robert J. Dole VA Medical Center"]
[6,590,"Hampton VA Medical Center","590 Hampton VA Medical Center"]
[21,593,"VA Southern Nevada Healthcare System","593 VA Southern Nevada Healthcare System"]
[9,596,"Lexington VA Healthcare System","596 Lexington VA Healthcare System"]
[16,598,"Central Arkansas Veterans Healthcare System","598 Central Arkansas Veterans Healthcare System"]
[22,600,"VA Long Beach Healthcare System","600 VA Long Beach Healthcare System"]
[9,603,"Robley Rex VA Medical Center","603 Robley Rex VA Medical Center"]
[22,605,"VA Loma Linda Healthcare System","605 VA Loma Linda Healthcare System"]
[12,607,"William S. Middleton Memorial Veterans Hospital","607 William S. Middleton Memorial Veterans Hospital"]
[1,608,"Manchester VA Medical Center","608 Manchester VA Medical Center"]
[21,612,"VA Northern California Health Care System","612 VA Northern California Health Care System"]
[5,613,"Martinsburg VA Medical Center","613 Martinsburg VA Medical Center"]
[9,614,"Memphis VA Medical Center","614 Memphis VA Medical Center"]
[23,618,"Minneapolis VA Health Care System","618 Minneapolis VA Health Care System"]
[2,620,"VA Hudson Valley Health Care System","620 VA Hudson Valley Health Care System"]
[9,621,"James H. Quillen VA Medical Center","621 James H. Quillen VA Medical Center"]
[19,623,"Eastern Oklahoma VA Health Care System","623 Eastern Oklahoma VA Health Care System"]
[9,626,"Tennessee Valley Healthcare System","626 Tennessee Valley Healthcare System"]
[16,629,"Southeast Louisiana Veterans Health Care System","629 Southeast Louisiana Veterans Health Care System"]
[2,630,"VA NY Harbor Healthcare System","630 VA NY Harbor Healthcare System"]
[1,631,"VA Central Western Massachusetts Healthcare System","631 VA Central Western Massachusetts Healthcare System"]
[2,632,"Northport VA Medical Center","632 Northport VA Medical Center"]
[19,635,"Oklahoma City VA Health Care System","635 Oklahoma City VA Health Care System"]
[23,636,"VA Nebraska-Western Iowa Health Care System","636 VA Nebraska-Western Iowa Health Care System"]
[23,"636A8","Iowa City VA Health Care System","636A8 Iowa City VA Health Care System"]
[6,637,"Charles George VA Medical Center","637 Western North Carolina VA Health Care System"]
[21,640,"VA Palo Alto Health Care System","640 VA Palo Alto Health Care System"]
[4,642,"Corporal Michael J. Crescenz VA Medical Center","642 Corporal Michael J. Crescenz VA Medical Center"]
[22,644,"Phoenix VA Health Care System","644 Phoenix VA Health Care System"]
[4,646,"VA Pittsburgh Healthcare System","646 VA Pittsburgh Healthcare System"]
[20,648,"VA Portland Healthcare System","648 VA Portland Healthcare System"]
[22,649,"Northern Arizona VA Health Care System","649 Northern Arizona VA Health Care System"]
[1,650,"VA Providence Healthcare System","650 VA Providence Healthcare System"]
[6,652,"Central Virginia VA Health Care System","652 Central Virginia VA Health Care System"]
[21,654,"VA Sierra Nevada Health Care System","654 VA Sierra Nevada Health Care System"]
[23,656,"St. Cloud VA Health Care System","656 St. Cloud VA Health Care System"]
[15,657,"VA St. Louis Health Care System","657 VA St. Louis Health Care System"]
[6,658,"Salem VA Medical Center","658 Salem VA Medical Center"]
[6,659,"W.G. (Bill) Hefner VA Medical Center","659 W.G. (Bill) Hefner VA Medical Center"]
[19,660,"VA Salt Lake City Health Care System","660 VA Salt Lake City Health Care System"]
[21,662,"San Francisco VA Health Care System","662 San Francisco VA Health Care System"]
[20,663,"VA Puget Sound Health Care System","663 VA Puget Sound Health Care System"]
[22,664,"VA San Diego Healthcare System","664 VA San Diego Healthcare System"]
[16,667,"Overton Brooks VA Medical Center","667 Overton Brooks VA Medical Center"]
[20,668,"Mann-Grandstaff VA Medical Center","668 Mann-Grandstaff VA Medical Center"]
[17,671,"South Texas Veterans Health Care System","671 South Texas Veterans Health Care System"]
[8,672,"VA Caribbean Healthcare System","672 VA Caribbean Healthcare System"]
[8,673,"James A. Haley Veterans' Hospital","673 James A. Haley Veterans' Hospital"]
[17,674,"Central Texas Veterans Health Care System","674 Central Texas Veterans Health Care System"]
[8,675,"Orlando VA Medical Center","675 Orlando VA Medical Center"]
[22,678,"Southern Arizona VA Health Care System","678 Southern Arizona VA Health Care System"]
[7,679,"Tuscaloosa VA Medical Center","679 Tuscaloosa VA Medical Center"]
[5,688,"Washington DC VA Medical Center","688 Washington DC VA Medical Center"]
[1,689,"VA Connecticut Healthcare System","689 VA Connecticut Healthcare System"]
[22,691,"VA Greater Los Angeles Healthcare System","691 VA Greater Los Angeles Healthcare System"]
[4,693,"Wilkes-Barre VA Medical Center","693 Wilkes-Barre VA Medical Center"]
[12,695,"Clement J. Zablocki VA Medical Center","695 Clement J. Zablocki VA Medical Center"]
[10,757,"Chalmers P. Wylie VA Ambulatory Care Center","757 Chalmers P. Wylie VA Ambulatory Care Center"]