by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens. In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with [...] Read more

by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager

On December 3, the National Institutes of Health (NIH) issued a request for comments on its "Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research," which "proposes that all NIH-funded multi-site studies carried out in the [United States], whether supported through grants, contracts, or the NIH intramural program, should use a single IRB."

Citing a changed research landscape, the background section of the policy suggests [...] Read more