Conferences & Symposia

Second Annual Health Law and Bioethics Roundtable

Co-sponsored by University of Maryland Carey Law School’s Law & Health Care Program and the Johns Hopkins Berman Institute of Bioethics.

Friday, April 27, 2012

By Invitation Only

The Roundtable is intended to provide scholars with an opportunity for informal dialogue on current topics at the intersection of health policy, law, and ethics.  This year the discussion will focus on Human Subjects Research Regulations: Proposals for Reform.

For the first time since the Common Rule was published in 1991, the U.S. Department of Health and Human Services (DHHS) has proposed changes to the current regulatory framework. Given this development, and the opportunity it presents to reexamine the scope and effect of the Common Rule, Roundtable organizers believe now is an important time for leading scholars to share their thoughts about how research regulations should evolve. Topics that will be touched on during the meeting include issues that DHHS identified as focal points in its announced proposal to amend the rules, including:

• Refining the existing risk-based protections;
• Utilizing single institutional review boards for multi-site studies;
• Improving informed consent forms and the informed consent process;
• Establishing mandatory data security and information protection standards, including for biospecimens;
• Creating a more systematic approach to collecting and analyzing data on adverse events
• Extending federal research protections to all research conducted at U.S. institutions that receive some funding from a Common Rule agency; and
• Harmonizing research regulations across Common Rule agencies.

Supported by the Dr. Richard H. Heller Fund

• Roundtable Agenda