Legal Considerations for HRPPs Track
2019 AER Conference
A11 - Legal and Regulatory Changes: A Year in Review
Holly Fernandez Lynch, JD, MA-Bioethics
John Russell Dickson, MD Presidential Assistant Professor; Assistant Faculty Director of Online Education, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania
Michele Russell-Einhorn, JD
Chief Compliance Officer and Institutional Official, Advarra
Laura Odwazny, JD, MA
Senior Attorney, Office of the General Counsel, US DHHS
Speaker(s)
A lot has happened this year! Get up to speed with this session designed to bring you the highlights and breaking news since last year's AER Conference. How are recent legal and regulatory changes fundamentally affecting research? What should institutions be ready for in the coming months and years? Get answers to these questions and more through this session's issue-spotting exploration and analysis of changes in laws, regulations, and guidance issued by FDA, HHS, and NIH. During this session, speakers and attendees will:
Learning Objectives:
- Identify recently proposed and adopted legislative and regulatory initiatives affecting research
- Illustrate the likely impact on current practices and evaluate the importance of change
- Evaluate whether further change is necessary and/or likely forthcoming
- Note: this is an overview session; speakers will not review each change in detail, but will endeavor to point attendees to other conference offerings relevant to each topic covered.