Dominic Chiarelli

by Dominic Chiarelli

NIH Boldly Shakes up the IRB Landscape, Part 2

In part 1 of this series I described the paradigm shift that the new NIH single IRB (sIRB) review policy will bring to protecting human subjects in research. Between now and the policy’s effective date of May 25, 2017, officials at research institutions face some important decisions.

Institutional Decisions Loom

Most institutional-based IRBs do not currently have the process and procedures to successfully fulfill the role of an sIRB. These institutions will have to choose between developing the necessary forms, staff, and technology or relying on an accredited external IRB who already has these capabilities.

For those choosing to develop their own sIRB capabilities, the NIH has not agreed to provide any funding opportunities specific to this development. The NIH is, however, allowing for the additional costs associated with acting as an sIRB, namely the site-specific considerations, to be included as a direct cost within the proposals it funds. It will be interesting to see how many institutions endeavor to try and develop this capacity and whether the NIH will have any preferences in regards to a proposal that chooses an sIRB based at an institution versus an independent IRB.

Where Do Human Subject Protection Programs Come In?

What happens if a human subject protection program (HSPP) is no longer obligated to facilitate IRB oversight? The sIRB model arguably frees up this institutional resource to provide new types of support to the conduct of research at the institution. This could include new and improved auditing and investigative capabilities, more time for investigator and staff training, implementation of novel programs such as random consent process observation for greater than minimal risk studies, and development of more nuanced and protective policies.

This new world will likely need to at least include creation and maintenance of an sIRB reliance process that is reliable and efficient. This process must ensure that department heads and institutional officials are aware of and support the research; that all other required institutional approvals—conflict of interest review, scientific review, pharmacy review, and radiation safety committee review to name a few—are obtained prior to initiating the research; and that the institution can track the progress of the research and any issues that may arise.

An institution’s HSPP will also likely need to be prepared to make and defend a request for an exception from the sIRB policy whenever considered necessary due to limitations from state law, regulation, or policy or due to some other compelling justification. 1

Preparing for the Future

It is certainly an interesting time in the field of human subject protection.

Kinetiq is proud to offer its experts in human subject protection, clinical research, compliance, and technology for regulatory guidance through this blog. Further, Kinetiq is uniquely positioned as advisors to institutions that need help in preparing for their new role in the soon-to-be-revised human subject protection landscape. Kinetiq will continue to monitor any new developments resulting from the now-final NIH sIRB policy, including the publication of the promised guidance materials, and we will provide additional updates and analyses as appropriate.

Contact Kinetiq if you would like to discuss the NIH’s new policy for sIRB review and how it may impact your human subject protection program moving forward.

 

References

[i] 45 CFR part 46.103.

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