Reliance Agreements for Multisite Studies
What is a reliance agreement?
To avoid duplication of effort, and to comply with Federal policies for single IRB review of multi-site and cooperative research, the CRC IRB will either accept review responsibilities on behalf of another institution or rely on the review of an external IRB; this process is called an IRB reliance, or ceded IRB review. Reviewing and relying IRBs are required under federal policy to enter into a reliance agreement, or an IRB Authorization Agreement, which are the documents used to execute single IRB review, or IRB reliance with other institutions engaged in the research.
How do I request a reliance agreement?
Requests to review or rely should be made by the CRC investigator using the Single IRB Request Form. Additionally, if the site with which you are collaborating is a participating institution in SMART IRB (a national reliance agreement and reliance request system) you may be required to create an account and submit your request through this system. Please speak with the CRC Reliance Specialist to be sure you are completing the necessary documentation for your research and cooperative/multisite institutions.
Which institution should serve as the reviewing or relying IRB?
The reviewing and relying IRBs ordinarily take the following factors into consideration when deciding whether to serve as the reviewing IRB or to rely on an external IRB:
- When research is greater than minimal risk, the reviewing IRB is accredited.
- Requirements under federal policy
- Reviewing Institution selected by study sponsor
- IRB expertise
- Local context issues
- Institutional conflict of interest
- The IRB is registered and in good standing with OHRP
- Local and state laws
- Institutional policies
- Investigator and institutional resources
- Investigator qualifications
Note: The CRC IRB will not ordinarily provide oversight for large, multi-site studies. CRC investigators are encouraged to discuss their plan for oversight of the research with the CRC IRB before submitting grant and SMART IRB applications that may obligate such review.