In January 2018, the new single IRB (sIRB) requirement for National Institutes of Health (NIH)-funded multi-site studies will go into effect. NIH’s goal for this mandate is to reduce administrative burden that does not actively contribute to protection of human subjects. The NIH posits that this policy will also result in opportunities for enhanced oversight by the reviewing IRB. Read more
TAG ARCHIVES FOR multi-site research
Research Ethics Roundup: China’s Role in Research, NIH’s Single IRB Policy, and MoreTags:
This week’s Research Ethics Roundup reflects on the past by exploring revelations that the US government conducted race-based experiments on American troops and considers emerging issues such as China’s growing presence in biomedical research and the move toward single IRB review.
A Scientific Ethical Divide Between China and West: In this article for The New York Times, Didi Kirsten Tatlow explores some ethical concerns that have come to the fore amidst China’s efforts to “become a leader biomedical research.”
Please, Corporations, Experiment on Us: [...] Read more
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
NIH Releases Draft Policy on Use of Single IRB for Multi-Site ResearchTags:
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