A new proposal by the Obama administration would require scientists who work with human biospecimens to obtain consent from patients prior to using them in research, even when all personal information is removed. The proposed change is part of the revision of the Common Rule, the federal law used to govern research with human participants, which is currently under review. In effect, the new policy would broaden the definition of "human subject" to include tissues, blood, and urine. Some scientists, medical device manufacturers, and advocacy groups are concerned about the chilling effect this could have on research, including the Precision Medicine Initiative. Bioethicists have raised issues about plans to offer new forms of consent, with Consortium collaborator Ellen Wright Clayton, MD, JD, of Vanderbilt University questioning whether those could be effective: “The idea that this informed consent will be in any way meaningful I think is illusory.” Read an article about the debate from STAT here.
Monday, May 16, 2016