Research and Development Service - VA Portland HCS
Research and Development Service - Technology Transfer
|
For assistance with all PVAMC Technology Transfer matters, contact: Voss, Trina L. |
Material Transfer Agreements
A Material Transfer Agreement (MTA) is generally used when any proprietary material and/or information is exchanged between VA and non-VA investigators, when the receiving party intends to use it for his/her own research purposes and when no research collaboration between scientists is planned.
CRADA (Cooperative Research and Development Agreement)
A CRADA is a document that is used when the VA or a VA researcher wishes to collaborate with private industry, nonprofits, or private organizations on a research study.
VA Invention Disclosure
VA employees must report their inventions to the Office of the General Counsel for a determination of ownership. VA employees include: regular salaried employees, employees hired under IPA (intergovernmental personnel agreement) contracts, WOC (without compensation) employees, and employees with dual appointments with Oregon Health & Science University (OHSU).
VA/OHSU Cooperative Technology Administration Agreement (CTAA)
The VA and OHSU have established an inter-institutional agreement, called the Cooperative Technology Administration Agreement (CTAA), for existing and future "joint-inventions" made by inventors who qualify either as "Dual Appointment Personnel" or have at least one inventor from each party. The agreement authorizes OHSU to have the exclusive right to negotiate, execute, and administer any license agreement. The CTAA was effective December 15, 2001.
VA R&D Office of Technology Transfer
OHSU Office of Technology Transfer and Business Development
- MTA
- CRADA
- Invention
Disclosure
Material Transfer Agreement
Incoming MTA Outgoing MTA Visit the following web sites for more information: |
PVAMC Researchers: Research & Development Service Building 101, Room 502 503-220-8262 x52900 herman.bouwer@va.gov |
Any researcher at the Portland VA Medical Center (PVAMC) who wishes to send or receive proprietary research materials needs to contact Dr. Bouwer for creation of a Material Transfer Agreement (MTA).
A Material Transfer Agreement (MTA) is a contract that governs the transfer of research materials between two organizations. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives.
An MTA is generally used when any proprietary material and/or information is exchanged between VA and non-VA investigators, when the receiving party intends to use it for his/her own research purposes and when no research collaboration between scientists is planned. MTAs define the terms and conditions under which the recipients may use the materials.
Incoming MTA (PVAMC is Recipient)
- If the institution providing the material would like the right to license any invention that might arise from the conduct of the PVAMC research using the material, a Material Transfer CRADA must be used. Contact Dr. Bouwer for more information about MT-CRADAs.
- PVAMC is acknowledged as the recipient institution.
- The ACOS/R&D signs as institutional official for basic MTAs.
- OHSU processes incoming MTAs that are related to research performed at OHSU.
Outgoing MTA (PVAMC is Provider)
VA owned material includes any invented material that has been disclosed to the VA and has received a VA Determination of Rights claiming ownership rights for the VA. If you are a VA investigator and you plan to provide material owned by the VA to an external organization/individual, contact Dr. Bouwer before you ship the materials.
Cooperative Research and Development Agreement
What is a CRADA?
A CRADA, or Cooperative Research and Development Agreement, is the federal equivalent of a clinical trial agreement, sponsored research agreement, or material transfer agreement. CRADAs are developed when the VA or a VA researcher wishes to collaborate in research with private industry, nonprofits, or private organizations. The purpose of the CRADA is to explain the responsibilities of the parties involved. These agreements typically contain sections that outline who will do the research, where and when the research will be done, payment schedules for funding, and intellectual property rights, among other things.
If you are a Portland VA Medical Center (PVAMC) researcher planning a research collaboration, contact Archie Bouwer, PhD (herman.bouwer@va.gov, PVAMC x52900) as early as possible in the process.
A CRADA can be developed for any kind of research collaboration: for basic research, for materials transfer, for data sharing or analysis, and for clinical research, including investigator-initiated research and Phase I to Phase IV clinical trials.
CRADAs for Clinical Research
When a proposed project at the PVAMC involves human subjects, particular issues must be addressed and must be included in the CRADA for the project:
- The project must use procedures to protect research participants
- The project must comply with the protocol and applicable law
- The CRADA must specify who is responsible for providing and paying for any medical care for research participants who sustain a research-related injury
- The CRADA must specify the steps to be followed to communicate results from a research study to participants when those results directly affect their safety or medical care
- When the sponsor has the responsibility to conduct data and safety monitoring, the CRADA must address provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the PVAMC
- The sponsor must promptly report to the PVAMC any findings that could:
- Affect the safety of study participants
- Affect the willingness of participants to continue in the study
- Influence the conduct of the study
- Alter the IRB’s approval to continue the study
Publishing Rights in CRADAs and Other Research Agreements
Publications and presentations are an important aspect of the research process. Unreasonable limitations on the right of the investigator to publish study results will not be allowed in research agreements. Study sponsors may comment upon, but may not make any editorial changes to, the results and conclusions set forth in proposed papers or presentations.
Further information about VA Cooperative Research and Development agreements is available from the national VA Technology Transfer web site.
Invention Disclosure
|
Who needs to disclose to the VA? Visit the following web sites for more information: |
For assistance with your VA invention disclosure, contact Archie Bouwer, PhD Research & Development Service Building 101, Room 502 503-220-8262 x52900 herman.bouwer@va.gov |
Dr. Bouwer in the PVAMC Research Service Office will assist you with the disclosure procedure. Contact him to begin the disclosure process.
Who Needs to disclose to the VA?
VA regulations concerning the ownership of inventions apply to all research that involves government resources (VA facilities, equipment, employees, etc.). The Veterans Health Administration requires that VA employees report inventions to the VA Office of General Counsel for a determination of ownership.
For the purposes of invention disclosures, "VA employees" include:
- Regular salaried employees
- Employees hired under IPA (Intergovernmental Personnel Agreement) contracts
- WOC (Without Compensation) appointees
- Employees with dual appointments with Oregon Health & Science University (OHSU)
Any inventors with OHSU affiliations will also have to make a formal disclosure to OHSU. Dr. Bouwer can assist with that as well.
Government and Employee Rights and Responsibilities
Under Executive Order 10096 the Government has the right to obtain the entire right, title and interest in and to all inventions made by any government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor. See also 37 CFR § 501.6.
Government employees are allowed by law to receive royalties from their inventions. Royalty payments are in addition to regular pay and continue after the inventor leaves the laboratory or agency. See also 15 U.S.C. Section 3710.
Disclosing an Invention to the VA
At the beginning of The Invention Pathway (VA Web Site, PDF), a Report of Invention is prepared by the inventor and reviewed by the Portland VA Medical Center ACOS/R&D and Director. It is then sent to the VA Research and Development, Office of Technology Transfer, for evaluation and recommendations before being forwarded to the Office of General Counsel for a determination of ownership rights. An official Determination of Rights (DOR) letter is then sent to the inventor(s) and PVAMC.
VA Outline for Report of Invention (VA Web Site, MSWord)
VA Intellectual Property Handbook 1200.18 (VA Web Site)
VA/OHSU Joint Inventions
The VA and OHSU have established a Cooperative Technology Administration Agreement (135KB, PDF) or CTAA. The document outlines what occurs when at least one inventor on an invention is a "Dual Appointment Personnel" (has an appointment with both VA and OHSU). The agreement authorizes OHSU to have the exclusive right to negotiate, execute, and administer any license agreement. All joint inventions must be disclosed to both OHSU and the VA in a timely manner.
OHSU Invention Disclosure Form (OHSU Web Site)Premature Disclosure to the Public
Inventors must be extremely careful not to disclose to the public the particulars of their invention before filing the appropriate paperwork with the US Patent and Trademark Office.
Lectures, poster presentations, even abstracts at scientific meetings could be considered public disclosure. Public disclosure can also include newspaper or newsletter interviews, publications, public use, sale, or offer of sale of the invention.
Disclosure of any information prior to filing appropriate paperwork with the Patent Office voids all international patent rights. Domestic US patent rights are voided if appropriate paperwork is not filed with the PTO within one year of disclosure of pertinent invention information.
