Reliance Agreements and Single IRB
INFORMATION ON RELIANCE AGREEMENTS
This page provides information on how the JHSPH handles different arrangements with external IRBs. The JHSPH will assume IRB oversight responsiblities for external institutions in very few situations. It will defer its review responsibilities to external IRBs when requested by the Sponsor of a study, and in some other specific situations. The JHSPH PI must submit an abbreviated application in PHIRST as part of the process, and review the following materials prior to requesting that JHSPH enter into a reliance agreement with an external institution.
- Guidance on Reliance Agreements
- How to Request JHSPH Reliance on an External IRB
- JHSPH IRB Reliance Request and Local Context Submission Form
- Investigator's Assurance Form
Effective September 25, 2017, the NIH requires that all grant applications for U.S. based, multi-site, non-exempt human subjects research studies include a proposal for a single IRB (“sIRB”) to review the research for all participating domestic sites. International sites are not included in this mandate. When sIRB services are required by a sponsor, and a JHSPH PI wants JHU to serve as the sIRB for a study, the School of Medicine (SOM) IRB will review all sIRB requests for sIRB services, and if approved, will serve as JHU’s sIRB for all Divisions. JHSPH investigators who want JHU to rely on a sIRB at an external institution should follow procedures outlined below (FAQ #6).
What is a sIRB?
“sIRB” refers to the use of one IRB as lead reviewer for a U.S. based, multi-site study. IRBs will either serve as the lead sIRB or deferring IRBs. All participating institutions must sign a reliance agreement with the lead site deferring IRB review responsibilities to the sIRB.
What should a JHSPH Investigator do when seeking reliance on an external IRB?
JHSPH investigators who want JHSPH IRB to rely on another institution's IRB should contact the IRB office by email (firstname.lastname@example.org) and outline the reliance proposal information. The IRB needs to know what stage the proposal is in (grant proposal stage, or under review by the external IRB), what the JHPSH investigator role in the study will be, and what activities will cause JHSPH employees or agents to be “engaged" in non-exempt human subjects research. No reliance agreements will be signed for Exempt research.
What sponsors require the use of sIRBs?
NIH now mandates the use of a sIRB (starting September 25, 2017) for “the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.” Under the new Final Rule approved by the DHHS in January, 2017, all U.S. government funded non-exempt human subjects research studies (with some narrow exceptions) will require sIRB review. This requirement goes into effect January 20, 2020. Some other foundations may also require sIRB review.
To what kind of grants does the sIRB requirement apply?
The sIRB requirement applies to all competing grant applications, including new, renewal, revision or resubmission.
How is Hopkins handling requests to have JHU serve as the lead sIRB?
The School of Medicine IRB (SOM IRB) will serve as the sIRB for all JHU divisions when Hopkins agrees to serve as the lead IRB. It will review all requests to have Hopkins serve as the sIRB, and will provide letters of support for those that it approves.
How can I submit a reliance request to have Hopkins serve as the sIRB for my grant proposal or study?
The SOM IRB has created a “reliance request tool” that is available on its website. You must submit your request before making any commitment in your grant application, as the SOM IRB needs to review and approve your request before providing you with a Letter of Support.
What is required for JHSPH investigators who seek a reliance agreement deferring review to an external IRB?
JHSPH investigators who wish to have the JHSPH IRB rely on an external sIRB should check the JHSPH Guidance on Reliance Agreements and Guidance on How to Request JHSPH Reliance on an External IRB.
What are my responsibilities as PI if JHSPH agrees to rely on an external sIRB?
If the JHSPH IRB agrees to the reliance arrangement and provides a Letter of Support, you as PI will need to make sure that all the responsibilities in the Investigator Assurance Form are carried out. You must ensure that study personnel receive appropriate training and are qualified to perform their duties, and that the study is conducted in accordance with the approved protocol and JHSPH policies. You must notify the JHSPH IRB of any changes to the study that could influence site specific requirements, such as, conflict of interest, study personnel, funding stream, clinical procedures (could affect PRA analysis), modifying the study drug (affecting local Pharmacy & Therapeutics review), etc.
Does relying on an External sIRB mean there is no JHSPH IRB review?
No. The sIRB is responsible for conducting the ethical review and overseeing the study at all sites, but each relying institution’s IRB must ensure compliance with site specific state and local law, and institutional policy. That means that the JHSPH IRB will conduct a “site specific” review to ensure that it is comfortable agreeing to rely on the sIRB, and that the study meets site specific requirements. In addition, the JHSPH IRB must review any information about the study reported by the JHSPH PI. So the JHSPH PI will have to meet sIRB requirements as well as site specific requirements imposed by the JHSPH IRB.