NIH Single IRB Review FAQs

Note: Effective June 16, 2017, NIH pushed back the implementation date of it’s Single IRB mandate from September 25, 2017 to January 25, 2018.  The NIH requires that all grant applications for domestic, multi-site, non-exempt human subject research studies include a proposal for the use of a single IRB (“sIRB”) to review the research for all participating domestic sites. International sites are not included in this mandate. See also: NIH Single IRB Policy FAQs for Extramural Community

The Homewood IRB, the School of Medicine (SOM) IRB, and the Johns Hopkins School of Public Health (JHSPH) IRB are working together to address the new NIH requirement for sIRB. When sIRB services are required by a Sponsor, and a JHU PI wants JHU to serve as the study’s sIRB, the SOM IRB will review all requests for sIRB services, and if approved, will serve as the University’s sIRB for all divisions. JHU has signed on to the SMART IRB Reliance agreement, and investigators are urged to make sure that their collaborators have either signed on to this form of reliance agreement, or are willing to sign on.

All Planning Phase and New Applications that involve Hopkins as the reviewing sIRB must submit a “Reliance Request” through an online SOM IRB query portal. Reviewers will evaluate and act on the request. SOM faculty will use the same portal for applications seeking to rely on an external sIRB. Homewood and JHSPH investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH ([email protected]) or Homewood IRB ([email protected]) for further guidance.

FAQs on Single IRBs (sIRBs) at Johns Hopkins University for Homewood IRB Investigators

1. What is a sIRB?
   “sIRB” refers to the use of one IRB as sole reviewer for a U.S. based, multi-site study. Institutions participating in multi-site studies must agree on a sIRB and then enter into a reliance agreement with the sIRB’s institution deferring IRB review responsibilities to the sIRB.
2. What sponsors require the use of sIRBs?
   NIH now mandates the use of a sIRB (starting January 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 cooperative studies that meet the criteria for non-exempt “human subjects research,” and involve more than one site, will require sIRB review. There are some narrow exceptions. This requirement goes into effect January 20, 2020. In addition, some other companies and foundations may also require sIRB review.
3. 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.
4. 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.
5. 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.
6. Is there anything special that I need to put into my grant application when asking the SOM IRB to serve as the sIRB for my study?
   Yes. The Federal Wide Assurance (FWA) number listed on your grant application should be the SOM IRB’s FWA number, FWA00005752, not the Homewood IRB’s number. The SOM IRB can assist you with any questions regarding their FWA number.
7. Can the Homewood IRB sign on to a common IRB reliance agreement model like the SMART IRB Master Reliance Agreement?
   No. The SMART IRB Master Reliance Agreement requires that the signatory institution’s IRB be accredited or have undergone a comparable quality assessment in the past five years; the Homewood IRB is not accredited at this time. We will need to use a separate agreement to defer to an external sIRB.
8. What is required for Homewood IRB investigators who seek a reliance agreement deferring review to an external IRB?
   Homewood investigators who wish to have the Homewood IRB rely on an external sIRB will need to request that reliance through the following survey , and if the reliance request is approved, the Homewood IRB will provide a Letter of Support of that request. The PI will upload information about the external sIRB into the Homewood IRB’s survey. The Homewood PI must clarify whether the reliance request is for a project that is at the grant proposal stage, or one that is ready for IRB submission. The PI must also complete an Investigator’s Assurance form (see Statement of Homewood PI Responsibilities when Relying on an External sIRB) and email it to [email protected]. If the reliance request is approved, a reliance agreement will be negotiated separately.
9. What are my responsibilities as PI if the Homewood IRB agrees to rely on an external sIRB?
   If the Homewood IRB agrees to the reliance arrangement and provides a letter of support, you as PI will need to make sure that all study personnel receive appropriate training and are qualified to perform their duties, and that the study is conducted in accordance with the sIRB approved protocol and Homewood IRB policies. You must notify the Homewood IRB of any changes to the study that could influence site specific requirements, such as, conflict of interest, study personnel, funding stream, study procedures, etc.
10. Does relying on an External sIRB mean there is no Homewood 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 Homewood 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. So the Homewood PI will follow both the sIRB requirements as well as site specific requirements.