By Nicolas Terry and Frank Pasquale
Subscribe to TWIHL here!
Seton Hall Law Professor Carl Coleman leads our deep dive into human subjects research, the revised common rule, and the future of data and biospecimen use. We discuss the reasons for the continued delays of the revised common rule, and debate some of its merits. We also add some comparative perspective as we explore researchers’ objections to aspects of both the original and revised rules. Carl has previously written on “rationalizing risk assessment” in research, and brings a wealth of experience to the discussion.
Carl has served as Bioethics and Law Adviser at the World Health Organization (WHO) in Geneva, Switzerland, where he was one of the primary authors of the report, Ethical Considerations in Developing a Public Health Response to Pandemic Influenza. He has contributed to WHO reports on capacity building for research ethics committees, ethical issues in tuberculosis prevention, care, and control, research ethics in epidemic response efforts, standards and operational guidance for research ethics committees, and key issues in global health ethics. From 2010-2013, Carl was a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.