sIRB Mandate | Engagement | sIRB Proposals | Reliance Agreements

What is meant by Collaborative Research?

Collaborative research (cooperative research) means that the research is being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. Each site will be operating on the same overall study aims and hypothesis under a single protocol but do not need to be conducting the same specific research activities at each site. This typically involves a lead site that receives the grant or contract directly from a sponsor and then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.

Single IRB (sIRB) Mandate

The single IRB mandate of the revised Common Rule, effective ​January 20, 2020* is a set of federal policies that require non-Exempt, federally-funded, cooperative research to rely on one IRB for study review and approval. The regulation applies to all sites in the United States participating in a federally funded cooperative research study (involves more than one site) approved on or after the effective date of January 20, 2020 with the exception of: 

  • Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or Research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

  • Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

  • Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020. 

  • Cooperative research conducted or supported by NIH if either:

    • the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or  

    • NIH excepted the research from its single IRB policy before January 20, 2020.


Engagement 

In accordance with 45 CFR 46.114, any institution covered by this policy that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. There are three basic components for considering whether an institution is engaged:

  • Participant Interaction
  • Access to identifiable data
  • Prime Awardee

There are certain situations where it may seem that an institution or organization is engaged but they actually are not. The following information is based on OHRP's detailed guidance.

  • Commercial
  • Routine clinical services
  • One-time service
  • Site use / Recruitment
  • Secondary Data
  • Individuals on-site covered under overseeing IRB

Please visit our Engagement in Human Subjects Research webpage for more detailed information regarding engagement and specific information for Student Researchers and Clinical Faculty.


sIRB Proposals

If Brown is the lead site you will need to contact the HRPP at least three (3) weeks before the internal OSP grant submission deadline, to discuss the use of an sIRB. Consider the following:

  • The costs for IRB review are the responsibility of the lead site. 
  • Brown is only able to be the IRB of record for up to 3 sites total, including Brown.
  • Include relevant information about the sIRB plan in the grant application including the budget and letters of support

Please view our sIRB Proposals webpage for detailed guidance and submission instructions.


Reliance Agreements

Once it has been determined that you are conducting non-Exempt, cooperative research and that your research partners are engaged, you will need to enact a reliance agreement. A reliance agreement is a written contract between two or more research partners used to document the delegation of IRB review responsibilities. Brown is only able to be the IRB of record for up to 3 sites total, including Brown. Studies that involve more than 3 sites must either a) rely on one of the other sites or b) contract an independent IRB.

A reliance agreement can be established as: 

  • IRB Authorization Agreement (IAA)
    • An established research institution or organization with their own IRB responsible for the ethical oversight of research activities
    •  Brown can act as the IRB of Record or cede review to another institution
  • Organizational Authorization Agreement (OAA)
    • A community organization that does not typically conduct human subjects research with a PI whose qualifications meet the criteria to serve as an Investigator.
    • Brown can act as the IRB of Record provided certain approval criteria are met
  • Individual Investigator Agreement (IIA)
    • An individual investigator 1) not affiliated with Brown University or any other institution with respect to this project or 2) acting as an employee or agent of a non-assured institution that is not engaged in the research.
    • Brown can act as the IRB of Record provided certain approval criteria are met

 

Please view our Reliance Agreements webpage for detailed guidance and submission instructions.

For questions regarding sIRB and Reliance Agreements, please contact our IRB Collaborative Research Manager, Sheila Vandal, at (401) 863-9206 or [email protected].