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NIH sIRB policy in effect January 25, 2018 for:
- NIH grant applications (new, renewal, revision, resubmission) received on or after 1/25/18
- NIH contract solicitations issued on or after 1/25/18
Common Rule sIRB in effect January 2020
As of January 2020, all non-exempt, collaborative human subjects research (i.e., studies in addition to clinical trials) will be required to use a single IRB for research sponsored by other federal agencies following the Common Rule.
Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research will be required to utilize a single IRB-of-Record (sIRB) for the review of human subject protections. Use of an sIRB avoids duplicative review by multiple institutional review boards. The NIH policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
- Domestic research only
Only the IRB review functions will be handled centrally. Related local functions (e.g., ancillary committee review, training fulfillment verification) remain with the individual participating institutions. The conduct and reporting of the research remain the study team's responsibility (see Study Team Process below).
External IRB Review
For an NIH-funded multi-site project, investigators must designate the single IRB-of-Record (sIRB) as part of the grant or contract application. The IRB-of-Record may be an external IRB (either an accredited commercial or other academic IRB). To comply with the NIH sIRB policy, when a U-M Principal Investigator (PI) is the awardee of a multi-site grant, U-M will evaluate on a case-by-case basis whether to serve as the sIRB or to cede oversight to an external IRB.
Before you begin an application for funding for a multi-site study contact the applicable U-M IRB to discuss the sIRB options.
As a result of the NIH sIRB policy and the NIH's 2014 expanded definition of a clinical trial, multi-site behavioral interventions conducted by U-M researchers will be required to designate an sIRB. This may include the use of an accredited commercial IRB, which previously has not been an option for studies under the jurisdiction of IRB-HSBS, IRB-Dearborn, or IRB-Flint.
Will U-M act as the sIRB?
The U-M IRBs will evaluate on a case-by-case basis whether they can effectively serve as the sIRB for a proposed multi-site project. The main evaluation criteria are:
- The risk level to the human subjects
- The number of sites
- The experience level of the U-M PI/study team
- The level of administrative resources available to the PI/study team to manage/coordinate the project
- Whether the U-M PI holds the funding grant
When ceding to an external IRB (whether commercial or other institutional partner), the U-M study team:
- Indicates the selected external IRB in the PAF/CTRF in the eResearch Proposal Management (eRPM) system.
- Contacts the external IRB to determine the IRB review fees for incorporation into the proposal budget. Commercial IRBs post their rates on their websites. Some academic IRBs may also charge a fee.
- Works with the external IRB and the applicable U-M IRB to request an IRB Authorization Agreement (a.k.a. "reliance agreement"). This is the legal contract negotiated and signed by U-M's HRPP Director that cedes IRB oversight authority to the external IRB.
- If utilizing a commercial IRB with which U-M has negotiated a master service agreement, an individual IRB Authorization Agreement may not be necessary.
- No one on the study team (or at the U-M IRB) has the authority to negotiate or sign the IRB Authorization Agreement.
- Completes a Requesting Review by a Non-UM IRB (a.k.a. "ceding") application in the eResearch Regulatory Management (eRRM) system. The external IRB usually will have an application process which the study team also must follow.
The Requesting Review by a Non-UM IRB (a.k.a. "ceding") application provides the project information necessary for related local (i.e., U-M) review functions not handled by an external IRB and for the administration of the research at the U-M performance site, such as:
- Ancillary Committee review (e.g., conflicts of interest, radiation safety, research pharmacy, and clinical billing.)
- Human subjects protections training fulfillment for U-M personnel via PEERRS or other training equivalent
- Amendments (e.g., changes impacting ancillary review or decision to cede oversight, project holds/suspensions)
- AE/ORIOs for related serious adverse events that occur in U-M subjects, unanticipated problems that occur in U-M subjects, and serious and/or continuing non-compliance determinations regarding U-M participation
- Annual continuing review to track study status
An external (i.e., commercial or other academic) IRB may charge for services when designated as the single IRB-of-Record (sIRB) for a multi-site, non-exempt human subjects research project. Estimated expenses are negotiated on a case-by-case basis in the service agreement between U-M and the external IRB, and budgeted for as direct costs in the sponsor's (e.g., NIH) funding proposal and award.
Common IRB services include, but are not limited to:
- IRB Reviews
- Initial review of the research protocol, investigator/site qualifications, informed consent plan and documentation, and subject recruitment materials
- Continuing/annual protocol review (regulatory requirement) for subsequent years of the project
- "Periodic" review of any incident reports (e.g., Adverse Events or ORIOs), as they are filed
- Amendments/modifications - changes to the study that require IRB review
- Administrative Services - letters, study changes not requiring IRB review, etc.
- Site/Project Closeout - review of the final status report, resolution of outstanding issues
- Other - services as applicable to the project, e.g., foreign language translation, etc.
Factors that impact the budget for sIRB services include the number of performance sites, level of risk to the subjects and/or institution, duration of the study, and more. See the External sIRB fee schedule -sample for an example.
The principal investigator is not authorized to sign the negotiated service agreement with the external IRB. As a financial transaction, the agreement must be signed by an authorized official from U-M Procurement Services and may require approval from the U-M Regents.
Always contact your U-M IRB to determine sIRB requirements prior to submitting funding proposals for multi-site, non-exempt human subjects research.