NIH Releases Final Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Madeleine Williams, Rick Rohrbach, Thomas Bechert
On June 21, 2016, the National Institutes of Health (NIH) released a final policy stating that all domestic sites of multi-site NIH-funded studies must use a single Institutional Review Board (sIRB) of record for non-exempt human subject research. The purpose of this policy is to streamline the IRB review process and reduce inefficiencies and redundancies while enhancing protections for research participants. The policy is a result of consideration of public comments on the draft policy issued on December 3, 2014. This policy will take effect on January 25, 2018.
Key Points of the NIH’s Final Policy:
- The NIH will require all domestic sites of multi-site NIH-funded studies, where each site will conduct the same protocol, to use a sIRB unless there is justification for an exception.
- Exceptions will be allowed where local IRB review is required by federal, tribal or state laws or regulations. The NIH will consider additional exceptions to the policy where there is compelling justification.
- The award applicant will indicate in the funding proposal the sIRB to be used for all participating sites. The applicant may also request direct cost funding to cover additional costs related to the requirements of this policy, provided that NIH cost principles are followed.
- The funding NIH Institute or Center has final decisional authority for approving the selected sIRB, and use of that sIRB will be a term and condition of award.
- The sIRB will be accountable for compliance with regulatory requirements for IRBs specified under the HHS regulations at 45 CFR Part 46, such as providing initial and continuing review of the research. The sIRB may also serve as a Privacy Board to fulfill the requirements of the HIPAA Privacy Rule.
- Participating sites will continue to be responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of approved protocols and reporting unanticipated problems to the sIRB.
- Authorization agreements will need to be executed between the sIRB and all participating sites. The awardee institution for an NIH-funded, multi-site study will be responsible for maintaining all authorization agreements and for ensuring that communication channels are established between the sIRB and participating sites.
With the release of NIH’s final policy, it is important for organizations to begin preparing for the impact this policy will have on the conduct of NIH-funded research and the IRB review process. The full policy can be found here.
- The process for executing authorization agreements with all participating sites could be time consuming if a template agreement is not accepted or used by all sites.
- If a site will serve as the sIRB, that site will need to have the infrastructure to support sIRB activities. Factors to consider include administrative IRB or regulatory staff, policies, procedures, workflows and technology.
- The sIRB will need mechanisms in place to consider local context issues during its deliberations.
- The final policy states that while not ideal, it will not prohibit a duplicate IRB review at a participating site. If sites choose to also conduct their own review, it would defeat the purpose of this policy. Also, funding will not be provided to cover the costs associated with duplicative review.
- Participating sites (pSites) will still continue to be responsible for institution specific ancillary reviews such as conflict of interest, radiation safety, etc. The identification and timing of, and process for, these reviews in relation to the IRB review will need to be accounted.
- The sIRB can be a fee-based IRB, and that cost will need to be included as a direct cost.
Over the past two years, Huron has worked closely with many of the nation’s leading research institutions as they build the processes and infrastructure needed to facilitate and operationalize these new requirements. In anticipation of the issuance of this final policy, Huron has already begun designing changes to its industry-leading HRPP Toolkit and Huron Research Suite IRB solution to facilitate the sIRB review process.
More information will follow in the coming months with specific details on those changes and release dates. If you would like additional insight into NIH’s final policy or assistance identifying the most effective ways to help prepare your organization, please contact us.Contact Us