To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

Use of a Single IRB in multisite research NIH Policy Developed by: U-MIC University of Michigan IRB Collaborative

NIH sIRB Policy National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multisite Research single IRB of record ethical review of nonexempt NIH-funded human subjects research more than one US site issued June 21, 2016 effective May 25, 2017 Objectives enhance/streamline IRB review process in multisite research eliminate duplicative IRB review reduce administrative burdens/inefficiencies maintain human subjects protections allow IRBs to concentrate on single-site protocols Developed by: U-MIC

NIH sIRB Policy Scope US sites of NIH-funded multisite studies all sites following one protocol nonexempt human subjects research supported through grants cooperative agreements contracts NIH Intramural Research Program Policy does not apply to career development research training fellowship awards foreign sites participating in NIH-funded multisite studies Developed by: U-MIC

NIH sIRB Policy Definitions authorization agreement (or reliance agreement) documents respective authorities roles responsibilities communication between sIRB and participating site multisite study single protocol nonexempt human subjects research more than one site Developed by: U-MIC

NIH sIRB Policy Responsibilities applicant/offeror submits plan in funding application/proposal use of sIRB as IRB of record for all sites all participating sites will adhere to NIH policy how sites and sIRB will communicate delayed-onset research (sIRB not yet identified) awardees will follow NIH policy inform funding IC before initiating multisite study plan to use registered IRB of record may request direct-cost funding costs of establishment/review of multisite study by sIRB requires appropriate justification Costs must be reasonable and consistent with cost principles. NIH Grants Policy Statement Federal Acquisition Regulation Developed by: U-MIC

NIH sIRB Policy Responsibilities awardee ensures authorization agreements are in place maintains copies of authorization agreements and other documentation to document compliance with policy ensures mechanism for communication between sIRB and participating sites may delegate tasks Developed by: U-MIC

NIH sIRB Policy Responsibilities Funding NIH Institute/Center (IC) manages/oversees award communication with awardee regarding plan for complying with policy Developed by: U-MIC

NIH sIRB Policy Responsibilities sIRB conducts ethical review of NIH-funded multisite studies for all participating sites must meet Common Rule requirements (45 CFR 46 Subpart A) may also serve as Privacy Board HIPAA Privacy Rule use/disclosure of PHI for research Developed by: U-MIC

NIH sIRB Policy Responsibilities participating sites rely on sIRB to carry out review functions meet other regulatory obligations, such as informed consent overseeing the implementation of approved protocol reporting to sIRB unanticipated problems study progress information regarding local context issues state or local regulatory requirements Developed by: U-MIC

NIH sIRB Policy Exceptions permitted where sIRB review would be prohibited by a federal, tribal, or state law regulation policy NIH will consider other requests for exceptions requires justification Developed by: U-MIC

NIH sIRB Policy Effective date all competing grant applications new renewal revision resubmission received on or after May 25, 2017 Ongoing, noncompeting awards not subject to policy until grantee submits competing renewal application Developed by: U-MIC

NIH sIRB Policy Note Although NIH does not require use of an sIRB for NIH-sponsored collaborative research when the site’s involvement does not include subject interaction or intervention under a single protocol, an sIRB may still be utilized. Developed by: U-MIC

NIH Policy on the Use of a Single IRB for Multisite Research NIH sIRB Policy NIH Policy on the Use of a Single IRB for Multisite Research Developed by: U-MIC

Thank you. Brian Seabolt IRBMED Developed by: U-MIC