On January 5, I submitted, along with Jessica Roberts, Associate Professor of Law and Director, Health Law & Policy Institute at the University of Houston Law Center, comments on the Notice of Proposed Rule Making (NPRM) for revisions to the Common Rule (45 CFR 46), the regulations that govern the majority of human subjects research in the United States. These revisions will be the first since the Common Rule was promulgated in 1991. Our letter to Jerry Menikoff, the Director of the Office for Human Research Protections (OHRP), focused on three primary deficiencies in the proposed revisions. We therefore encouraged the Department of Health and Human Services (HHS) to: (1) encourage Congress to provide a statutory private right of action for the Common Rule; (2) clarify whether research subjects have a potential commercial interest in the research done on their biospecimens; and (3) eliminate the distinction between biospecimens and personal information and data. The letter is available here.
Our letter was also featured on the blog for the Yale Journal of Law and Technology (YJOLT).