July 21, 2014 - July 22, 2014
Webcasts:
Meeting Materials
Agenda
DAY 1 – July 21, 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. Charles W. Lidz, Ph.D. Deborah Schrag, MD, MPH |
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. Neil Buckholtz, Ph.D. Jan Johannessen, Ph.D. Joe Selby, M.D., MPH
|
3:45pm - 4:00pm | Public Comment | Public |
4:00pm - 4:15pm | Summary and Adjournment | Dr. Jeffrey Botkin, M.D., SACHRP Chair |
DAY 2 – July 22, 2014
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. Zachary Hallinan, B.A. Benjamin T. Rotz, R.Ph. |
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 |