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by Cami Gearhart

Letter From the CEO

Institution Bulletin vol. 5, issue 4

The IRB community is abuzz over the recently published Notice of Proposed Rulemaking (NPRM). The NPRM proposes the first significant revisions to the Common Rule in the 30 years of its existence. In conjunction with proposing changes to dozens of sections and subsections of the Common Rule, HHS solicits comment on over 80 questions—an indication of a continuing lack of consensus as to how to resolve the complex issues raised by the Common Rule.

Today’s newsletter contains two articles to help untangle the NPRM’s web of proposals. One attempts to make sense of the proposed new category of excluded research; another summarizes the proposed changes to continuing review requirements.

And, of course, let us know if we can be of assistance as you contemplate the NPRM proposal to require a single IRB of record in multi-site studies. Quorum knows both worlds: we act as a local IRB in close to one-third of our studies, and we have 25 years of experience acting as a central IRB in multi-site studies. We can help, whether you want to build functionality as a central IRB or need to revise your processes to support outsourcing to other institutions or IRBs.

If and when it makes sense for your institution to outsource IRB review, we are committed to supporting you with a high-quality review and a strong regulatory team.  I hope you find these articles useful, and we look forward to an opportunity to work with you further!

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