Updating Regulations for Human Subjects Research

In early 2017, just prior to the change in administration, the 18 federal agencies that share the “Common Rule” that governs human subjects research issued new regulations. This seminar will offer a behind-the-scenes look at the 6-year rulemaking process, and review the major changes that are coming for IRBs and investigators.

Daniel Nelson, JD,  is Director of the Human Research Protocol Office for the National Health and Environmental Effects Research Lab (NHEERL), U.S. Environmental Protection Agency (EPA). He is also Adjunct Professor of Social Medicine and Pediatrics, and Faculty Associate in the Center for Bioethics at the University of North Carolina-Chapel Hill. Trained in medical physiology, Nelson previously held faculty appointments at the Mayo Clinic, the University of Rochester and UNC-Chapel Hill, where he directed the Institutional Review Boards for 16 years. A national leader in the field of human research protections, Nelson has served as past-president of the Applied Research Ethics National Association (ARENA); charter member of the Council for Accreditation and Site Visitor, Association for the Accreditation of Human Research Protection Programs (AAHRPP); charter member of the Council for Certification of IRB Professionals (CCIP); and consultant to the federal Office for Human Research Protections (OHRP). From 2004-2014, he chaired a subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which advises DHHS on the regulations that govern this area. In 2013 Nelson was honored by Public Responsibility in Medicine and Research (PRIMR) with the ARENA Legacy Award, for leadership and contributions to the field of research ethics.