More than meets the IRB: On human subjects research and regulation: perspectives on the future
In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen (JD, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics) and Holly Fernandez Lynch (JD, Executive Director of the Petrie-Flom Center or Health Law Policy, Biotechnology, and Bioethics).
Lynch and Cohen are co-editors of Human Subjects Research and Regulation: Perspectives on the Future, published by MIT Press in 2014. In this conversation we talk about the contribution this volume has made to discussions about potential upcoming changes to human subjects research regulations in the US. As the much-anticipated revisions to the basic regulations guiding human subjects research are becoming a reality, ethicists, regulators, and administrators are full of questions. Many of the essays in this volume address different perspectives on these basic questions, such as biobanking or the use of research data. In the latter part of our conversation, we turn specifically toward use of research data and tissue in light of shifting notions of research participation. (29:28).bioethics biotechnology health law policy human subjects research pharmaceuticals