Quorum Forum, June 2012
On April 23, 2012, Quorum Review’s CEO Cami Gearhart participated in a public hearing hosted by the FDA. Ms. Gearhart presented on behalf of the Consortium of Independent Review Boards (CIRB), of which she is Chairperson. Her presentation, Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice, focused on how the FDA could consider mitigating some of the challenges resulting from increased clinical trial and complexity.
The presentation suggested the following categories of improvement: relieve the burden of IND Safety Letter reporting, harmonizing regulatory requirements with OHRP and other US agencies, and streamline IRB review of multi-site studies. The hearing was an opportunity for the Administration to solicit public input on the FDA’s efforts to modernize the regulatory framework that governs clinical trials and approaches toward good clinical practice (GCP).
Founded in 1993, CIRB is a non-profit organization of independent institutional review boards committed to the ethical review of clinical research and the protection of human research participants. Members include 10 IRBs within the United States, including Quorum Review IRB. Since 2005, CIRB has participated in numerous discussions, presented at FDA sponsored hearings, and contributed to roundtable with the National Institute of Health (NIH) regarding adverse events. Cami Gearhart has led CIRB since 2006 as Chairperson.