On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed. In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of the IRB review process.
BIO shares the Agency’s strong commitment to protecting the rights and welfare of human subjects involved in biomedical research and recognizes the critical role of IRBs. Further, BIO believes that the use of a single, central IRB for a clinical study represents a significant advance in public health and research and also enhances a Sponsor’s ability to more efficiently conduct studies. A centralized IRB process maintains important ethical oversight and protections for human research subjects, while being less burdensome and more efficient, with fewer delays, duplication of effort, and inconsistencies in initiating and conducting clinical research.
In a comment letter on the draft version of the guidance submitted to FDA in January, BIO requested that FDA clearly link the draft guidance on IRB responsibilities with previous guidance on the use of a centralized IRB review process in multicenter trials.
In the final guidance published Tuesday, the Agency inserted a paragraph to make clear that the guidance applies to any IRB and that the recommendations are general in order to provide IRBs with flexibility to develop agreements for cooperative research and use a centralized review process. FDA elaborated that IRBs and institutions that use a centralized review process should have a written agreement on how tasks and responsibilities will be carried out.
Promoting the use of centralized IRBs is a key priority of BIO’s Clinical Trials Modernization Initiative, which was created to help bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety.