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by Cami Gearhart

Letter from the CEO

Institution Bulletin vol 5, issue 1

The pressure to require centralized IRB review in multi-site studies continues to increase. A variety of industry groups and agency officials have promoted the benefits of having a single IRB oversee a multi-site study. Some pharmaceutical companies are beginning to require institutional sites to agree to use a designated central IRB as a condition of participation in multi-site studies. This past December, the NIH published a guidance draft policy to promote the use of a single IRB of record for domestic sites of multi-site studies funded by the NIH.

To many in the field this focus on centralized IRB review seems a simplistic approach to the issues of managing multi-site studies. Study start-up at institutions is complex and involves multiple layers of scientific, administrative, and legal review. It is not easy to outsource IRB review when an institution has processes and procedures that rely on the IRB as the gatekeeper for these reviews.

At Quorum Review we respect that institutions have unique procedural requirements for study start-up and oversight. If and when it makes sense for your institution to outsource IRB review, we are committed to supporting you with a high quality review, a strong regulatory team and multiple quality control and compliance processes.

In the meantime, to help support you and your ethics board, today’s newsletter has three articles. One provides suggestions for IRB review of social media campaigns, another discusses the use of social media from a practical perspective, and the final article provides guidance as to how IRBs can determine whether dietary supplement studies require an Investigational New Drug (IND) exemption. We look forward to an opportunity to work with you further.

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