A new NIH policy goes into effect on January 25, 2018, which mandates that research is to be reviewed by a single IRB of record (sIRB) when multiple U.S. sites will carry out the same non-exempt human research protocol that receives NIH funding. Fred Hutch investigators must include a plan for which IRB will be the sIRB in all applicable competing NIH grant applications (new, renewal, revision, or resubmission) with a receipt date on or after January 25, 2018.
Traditionally each institution’s IRB reviews the research being performed at that institution. In a multi-site study, that can lead to a number of IRBs performing duplicative review of the same research protocol. Single-IRB review means one IRB performs the review for research being conducted at all sites in a multi-site study.
Please visit the Multi-Site Study Submissions page for information about what needs to be submitted for review of multi-site studies.
Any IRB with a Federalwide Assurance (FWA) and active registration with the Office for Human Research Protections can be a sIRB. Fred Hutch researchers should communicate with the IRO Director when preparing funding applications to decide who will serve as the sIRB. The sIRB must agree to be the IRB of record and all participating sites must agree to rely on the sIRB for the review of that research.
Fred Hutch IRB will serve as the sIRB for multi-site studies, and will likewise rely on other IRBs, when appropriate and agreed to in advance. In general, Fred Hutch IRB will be the sIRB for research where the Fred Hutch investigator is the primary awardee.
Refer to Reliance Agreements for more information.
The costs associated with sIRB review may be charged to grants or contracts as direct costs, provided that such costs are well-justified. The lead site is responsible for costs. NIH has provided guidance that illustrates which IRB review activities should generally be charged as Facilities and Administrative (F&A) costs (also called indirect costs) and which may be charged as direct costs.
Refer to the IRB Fees page for information about when Fred Hutch IRB fees are applicable. If you need assistance or have questions about IRB fees, please contact the IRO. You may also contact the Office of Sponsored Research for help on details that need to be included in grant applications regarding sIRB fees.
When preparing NIH funding applications/proposals to adhere to this NIH policy, begin communication with the Fred Hutch IRO and other site investigators as early as possible. The Fred Hutch principal investigator should communicate with investigators at the planned participating sites to make sure all agree on who will serve as the sIRB. The participating institutions' IRB offices (or person of authority in absence of an IRB) will need to provide written confirmation of the planned reliance arrangement. (Signed reliance agreements are not required at the time of funding application.)
The Fred Hutch PI should also contact the IRO Director to discuss who will serve as the sIRB. The IRO Director will contact the other institutions' IRB offices and begin reliance agreement negotiations.
Have other questions? Please ask! Email iro@fredhutch.org.
When one IRB relies on the review of another IRB, this arrangement is documented through an IRB Reliance Agreement in accordance with 45 CFR §46.103 and §46.114. The reliance agreement outlines the responsibilities of each party and delegates review authority to the IRB of record. In order for one IRB to serve as the sIRB, reliance agreements must be executed between the sIRB and each other site relying on the sIRB.
The IRB reliance agreement must be signed and executed before participating site submissions will be processed if Fred Hutch is the sIRB, and before the Fred Hutch PI may send a research application to an external IRB if Fred Hutch is relying on another IRB. To prevent the reliance agreement from holding up your research submission, please plan ahead and contact the IRO as early as you can.
There are several types of reliance agreements that Fred Hutch enters in to:
Fred Hutch uses IRB authorization agreements to engage in research with other institutions that have approved Federalwide Assurances who would like to rely on Fred Hutch IRB's review, or when Fred Hutch will rely on another institution's IRB for the review of a Fred Hutch investigator's research.
If an IRB authorization agreement is appropriate for your research study, please contact the IRO to determine which institution (Fred Hutch or the participating site) will be the IRB of record.
When a Fred Hutch PI collaborates with an individual investigator at a performance site that does not have an approved FWA (e.g., a clinic or a small community hospital), an individual investigator agreement is used to assure human subjects review. In this agreement the individual investigator is covered under the Fred Hutch FWA and must agree to follow the Fred Hutch Human Research Protection Program requirements.
IRB services contracts establish reliance arrangements between the Fred Hutch IRB and independent IRBs. Fred Hutch enters into these agreements to rely on independent IRBs for the review of certain kinds of research, such as industry-sponsored studies.
Fred Hutch investigators must contact the IRO Director before using an independent IRB to see if a reliance agreement exists, and whether it is appropriate to rely on an independent IRB for the research.
Fred Hutch has cooperative review agreements with a number of institutions in the Puget Sound area. Cooperative agreements allow institutions to rely on each other's IRB review for multiple projects without a protocol-specific authorization agreement. In most cases this eliminates the need for duplicate review when research is conducted at multiple locations.
The following institutions have cooperative agreements with Fred Hutch and generally will rely on Fred Hutch IRB as the IRB of record or Fred Hutch will rely on these institution's IRB as the IRB of record.
Typically, these institutions will accept Fred Hutch IRB review and vice versa.
Seattle Children's (SCH) relies on Fred Hutch as the IRB of record when the Principal Investigator’s primary appointment is Fred Hutch but SCH as an institution is also engaged in the research. Fred Hutch relies on SCH as the IRB of record when the Principal Investigator’s primary appointment is SCH but Fred Hutch as an institution is also engaged in the research.
If you are uncertain which institution's IRB should be the IRB of record, contact iro@fredhutch.org.
