Research and Development Service - VA Portland HCS

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.

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R&D Site Map

Invention Disclosure

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.

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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.

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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)

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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.