FASEB Supports Draft NIH Policy to Streamline Multi-Site Clinical Trials

By | January 15, 2015

A draft policy released by the National Institutes of Health (NIH) on December 3, 2014 signifies a positive step towards streamlining the clinical trial process. The Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research promotes the use of a single IRB of record for domestic sites of multi-site clinical trials funded by NIH. The agency’s Office of Clinical Research and Bioethics Policy is collecting public comments on the draft policy through January 29, 2015.

In its comments on the proposed policy, the Federation of American Societies for Experimental Biology (FASEB) commended NIH for taking steps to increase the efficiency of clinical research activities. Prior FASEB statements to the Department of Health and Human Services (2011) and the National Science Board (2013) emphasized key benefits of policies that facilitate use of a single IRB of record for multi-site clinical trials. These include minimization of delays in recruiting patients and the reduction of administrative reporting requirements for research staff.