Research Submission Process

Regulatory

Birmingham VA Health Care System (BVAHCS)

The Birmingham VA Health Care Services (BVAHCS) Research and Development Office supports four regulatory Institutional Review Boards (IRBs). The local IRB, the VA Central IRB, the National Cancer Institute (NCI) CIRB, and two Commercial IRBs.

Local IRB: The Birmingham VA Health Care Services (BVAHCS) Research Institutional Review Board is the local IRB of record. The Birmingham VAHCS works to ensure the protection of the rights and welfare of human subjects involved in Birmingham VAHCS research. The BVAHCS adheres to the IRB responsibilities and requirements outlined in 38 CFR 16 and the VHA Directives when reviewing and making determinations for research conducted at the Birmingham VA. Research protocols must be either approved or granted an exemption by the IRB before human subjects can begin participation.

VA Central IRB: The purpose of the VA Central IRB is two-fold. First and foremost its purpose is to enhance the quality of human research protection in multi-site human research projects by performing appropriate ethical and scientific review while ensuring local issues are addressed. The second is to enhance the efficiency of these reviews across participating sites.

Investigators whose studies are being funded by VA ORD should consult the applicable ORD funding service to determine whether their study should be submitted to the VA Central IRB or to each site's local IRB.

Investigators whose studies will be reviewed by the VA Central IRB should contact the VA Central IRB Administrator, whose contact information is available below, as far in advance of the planned submission as possible to obtain the most current information about submission procedures. Application forms and other information concerning the operations of the VA Central IRB can also be found on this website under the Important Links box on the right-hand side of this page.

National Cancer Institute Central IRB: The NCI CIRB is dedicated to protecting the rights and welfare of participants in cancer clinical trials. More information can be found here: https://www.ncicirb.org/.

Commercial IRB’s: The Birmingham VA IRB has reliance agreements with two commercial IRB’s: Advarra and Western Institutional Review Board (WIRB)-Copernicus Group (WCG).

To set up an account with Advarra to use CIRBI, please follow the CIRBI Quick Steps instructions. For additional assistance contact the Advarra CIRBI helpdesk between 8am - 8am ET send an email to CIRBI@advarra.com or call 1-866-99CIRBI (1-).

To set up an account with WIRB, please follow the instructions located on the VAIRRS Share Point site (VA network access only). Review the IRBNet GovCloud Training Energizer - Submitting to WIRB as WIRB uses IRBNet. If the VA facility is live on VAIRRS (IRBNet), the VA Facility Privacy Officer and ISSO may already have an account. The VA investigator or study team member with full access to the project should be able to "share" the project with the VA Facility Privacy Officer and ISSO. For additional assistance contact WIRB at VAreliance@wirb.com.

Birmingham VA Health Care System (BVAHCS) Institutional Review Board (IRB)

The Birmingham VA Health Care System IRB is the internal IRB of Record for all research involving human subjects in any area owned or leased by the Birmingham VA Health Care System. The goal of the Birmingham VA Health Care System IRB is to assure the rights and welfare of the human subjects are adequately protected. The IRB reviews new protocols and then monitors them by performing annual reviews and considering all requests for modifications, adverse events, protocol violations and safety concerns. Research Protocols involving human subjects require review and approval by an Institutional Review Board and the Research and Development Committee (R&DC) before any work is initiated.

BVAHCS IRB Forms:

All BVAHCS IRB Forms can be found at www.gov.irbnet.org under Forms and Templates. Be sure to select the Birmingham VA Health Care System Institutional Review Board Library.

BVAHCS Full Board Meeting Dates:

The BVAHCS IRB usually meets every second and fourth Wednesday of every month, occasionally dates are subject to change. All submissions should be received by the IRB at least one week prior to the scheduled meeting date.

**IRB meeting dates are based on the availability of the IRB membership to maintain quorum. Dates are subject to change or cancellation without prior notice. For any questions or concerns, contact the IRB Administrator at or by email at Latanya.Higginbottom@va.gov.

Birmingham VAHCS IRB Contacts:

• IRB Chair – Joshua Richman, MD/PhD

       Email: Joshua.Richman2@va.gov

• IRB Administrator – LaTanya Higginbottom, MS

       Email: Latanya.Higginbottom@va.gov

• Privacy Officer – Kim Moses

       Email: Kim.Moses@va.gov

• Privacy Officer – Donna Rood

       Email: Donna.Rood@va.gov

• Information Systems Security Officer – John Wiggins

       Email: John.Wiggins2@va.gov

• Information Systems Security Officer – Alicia Catney

       Email: Alicia.Catney@va.gov

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Human Subject Regulations Decision Charts

The purpose of these charts is to assist those who need to decide if an activity is research or not, if continuing review is required or not, what exemption category applies to your intended research, and whether informed consent or documentation of informed consent is required.

Human Subject Regulations Decision Charts: 2018 Requirements (hhs.gov)

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Process for Submitting Research for Review

The process for submitting research for review depends on the type of research being conducted. If you are planning a research project, you can follow the chart below to determine what initial contacts and committees will be required to review your project.