July 21-22, 2014 SACHRP Meeting

July 21, 2014 - July 22, 2014

Time	Agenda Item	Speaker
8:30am - 8:45am	Welcome: Opening Remarks	Dr. Jeffrey Botkin, M.D.,SACHRP Chair Dr. Jerry Menikoff, M.D., J.D., Director, OHRP
8:45am - 9:30am	Subpart A Subcommittee (SAS)	David Borasky, M.P.H., CIP, SAS Co-chair Michele Russell-Einhorn, J.D., SAS Co-chair
9:30am -11:30am	Informing Informed Consent: Defining and Validating Comprehension	Christine Grady, R.N., Ph.D. Chief, Department of Bioethics NIH Clinical Center Charles W. Lidz, Ph.D. Research Professor of Psychiatry University of Massachusetts Medical School Deborah Schrag, MD, MPH Attending Physician Center for Gastrointestinal Oncology Chief, Division of Population Sciences Dana-Farber Cancer Institute
11:30am - 12:45pm	Lunch	All
12:45pm- 1:30pm	Subcommittee on Harmonization (SOH)	Mark Barnes, J.D., SOH Co-chair David Forster, J.D., M.A., C.I.P., SOH Co-chair
1:30pm - 3:45pm	Regulatory Issues Concerning Big Data	Anthony L. Asher, M.D. Co-Medical Director, Carolinas Healthcare System Neuroscience Institute Neil Buckholtz, Ph.D. Director, Division of Neuroscience, National Institute on Aging, NIH Jan Johannessen, Ph.D. Deputy Director for Science Office of Translational Sciences, Center for Drug Evaluation and Research, FDA Joe Selby, M.D., MPH Executive Director Patient Centered Outcomes Research Institute
3:45pm - 4:00pm	Public Comment	Public
4:00pm - 4:15pm	Summary and Adjournment	Dr. Jeffrey Botkin, M.D., SACHRP Chair

Time	Agenda Item	Speaker
8:30am - 8:45am	Opening Remarks	Dr. Jeffrey Botkin, M.D., SACHRP Chair Dr. Jerry Menikoff, M.D., J.D., Director, OHRP
8:45am - 9:30am	Subcommittee on Harmonization (SOH)	Mark Barnes, J.D., SOH Co-chair David Forster, J.D., M.A., C.I.P., SOH Co-chair
9:30am- 11:15am	Panel Discussion: Returning Research Results	Barbara E. Bierer, M.D. Professor of Medicine Harvard Medical School Zachary Hallinan, B.A. Director Patient Communication and Engagement Programs Center for Information and Study on Clinical Research Participation Benjamin T. Rotz, R.Ph. Advisor, Office of Medical Transparency Eli Lilly and Company
11:15am - 12:00pm	Update on Regulatory Reform in India	Mark Barnes, J.D., SOH Co-chair
12:00pm- 1:00pm	Lunch	All
1:00pm - 2:30pm	Exploring Ethical and Regulatory Issues in Interventional Social Media Research	SACHRP members
2:30pm- 3:00pm	Wrap-up Discussion and Adjourn	Dr. Jeffrey Botkin, M.D., SACHRP Chair