InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.
On 3 December 2014, the National Institutes of Health (NIH) published a Draft NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html). The stated goal of this draft policy is “…to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections.” The goal is laudable, and for TIRS readers, worthy of discussion in the context of clinical trials funded by industry and conducted by most of the same institutions that are engaged in NIH-funded clinical research.
A disclosure and a disclaimer are in order. Disclosure: For the last 2.5 years, I have been (and remain) an executive in an independent IRB. Disclaimer: The views expressed here are my own.
Ethics Committees (ECs)/IRBs use ethical principles and adhere to the regulatory criteria for approval before research can begin, and determine that the rights and welfare of participants will be protected and participants will provide informed consent. Most ECs/IRBs are local committees, captive of a particular institution (hospital/Academic Medical Center), because they arose at a time when most clinical research occurred at a single site. There are approximately 2,500 local IRBs in the US today.
Today, multicenter clinical trials (MCTs) are how drugs are tested for safety and efficacy, and are the primary way drug development advances globally. Lacking their own IRBs, community-based research sites in the US, where the majority of clinical trials occur, rely on central IRB review from an independent IRB. In many cases, hundreds of sites rely on single review. Yet the same MCTs that are reviewed centrally, are re-reviewed and re- re- reviewed by local IRBs at many institutions, because people within those institutions believe that their committees alone have the appropriate knowledge of their investigators and their communities to protect local research volunteers.
As noted in the draft NIH policy and a recent editorial in Nature magazine (11 December 2014 , VOL 516; click here to read), there is no evidence that redundant IRB review adds to human research protections. In contrast, there are good reasons to believe that independent IRB review of MCTs enhances human protections not only because they have the clout (that local IRBs lack) to require revisions to the research, but also by eliminating institutional conflicts-of-interest, centralizing the collection of unanticipated problems, and allowing local IRBs to focus on single-center studies.
Independent IRB review in the US has been widely (if not universally) accepted by the pharmaceutical industry, even if not yet required. Since the emergence of central IRBs, our industry has learned that study startup can be substantially faster when a site relies on independent review that also addresses local context issues. The US National Cancer Institute (NCI) has reached the same conclusion, and recently set a mandate for academic medical centers to rely on the NCI central IRB for most NCI-funded MCTs. Nevertheless, most pharmaceutical companies do not insist on independent IRB review for industry-funded MCTs. Instead, they allow redundant and time-wasting review at institution after institution, most of which do not have Human Research Protection Programs that are independently accredited (see www.aahrpp.org for a list of accredited institutions).
Whether the draft NIH policy should be adopted for NIH-funded MCTs will be debated in the coming weeks and months. However, for industry-funded MCTs, local IRB review is an unnecessary and unhelpful vestige of the past. It should be fully displaced by compliant, ethical, accredited, and efficient independent review.
InSites is a monthly column written by TIRS Editorial Board member Stuart Horowitz, PhD, MBA. Dr. Horowitz is President, Institutions & Institutional Services at WIRB-Copernicus Group.