• Professor Koch on Updates to the Common Rule

    by  • January 6, 2016 • Scholarship • 0 Comments

    By Valerie Gutmann Koch


    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).

    About

    The purpose of the C-K Faculty Blog is to provide a forum that brings together all the rich intellectual contributions of the Chicago-Kent faculty and to encourage respectful and scholarly dialogue within the extended Chicago-Kent community, including faculty, students, alumni and colleagues at other law schools and universities. For questions or more information, contact the C-K Faculty Blog Editor by e-mail at facultyscholarship@kentlaw.iit.edu.

    Leave a Reply

    Your email address will not be published. Required fields are marked *