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Research and Development Service - VA Portland HCS
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Research and Development Service - Technology Transfer
Research and Development Service - VA Portland HCS
Research and Development Service - Technology Transfer
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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
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.
