March 12, 2013 - March 13, 2013
Meeting Materials
Agenda
Day 1 - Tuesday, March 12, 2013
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| CLOSED SESSION | ||
| 8:30 a.m. – 8:45 a.m. | Welcome: Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 8:45 a.m.- 9:15 a.m. | Ethics Training | HHS Staff |
| 9:15 a.m.- 10:15 a.m. | FACA Training | HHS Staff |
| 10:15 a.m. - 10:30 a.m. | Break | All |
| OPEN SESSION | ||
| 10:30 a.m. - 10:45 p.m. | Welcome and Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 10:45 a.m. - 11:15 a.m. | Welcome and Remarks | Howard Koh, M.D., M.P.H. Assistant Secretary for Health U.S. Department of Health and Human Services |
| 11:15 a.m. - 12:30 p.m. | SACHRP Background and teh Rulemaking Process | HHS Staff |
| 12:30 p.m.- 1:30 p.m. | Lunch | All |
| 1:30 p.m.- 2:30 p.m. | Discussion of SACHRP Members' Priorities | Jeffrey R. Botkin, M.D. SACHRP Chair |
| 2:30 p.m. – 3:15 p.m. | HIPAA/HITECH Rulemaking Changes | Christina Heide, J.D. Senior Health Information Privacy Policy Specialist Office for Civil Rights |
| 3:15 p.m. - 4:30 p.m. | Subcommittee on Harmonization (SOH) | David Forster, J.D., SOH Co-chair Mark Barnes, J.D., SOH Co-chair |
| 4:30 p.m. – 4:45 p.m. | Public Comment | |
| 4:45 p.m.- 5:00 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. |
Day 2 - Wednesday, March 12, 2013
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. – 8:45 a.m. | Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 8:45 a.m.- 11:00 a.m. | Focus: Improving the Informed Consent Process | Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Johns Hopkins Berman Institute of Bioethics Heather H. Pierce, JD, MPH Senior Director Science Policy and Regulatory Counsel Association of American Medical Colleges Jeanne M. Adler, RN, MPH, CCRP Clinical Investigations Branch Cancer Therapy Evaluation Program National Cancer Institute Jeffrey S. Abrams, M.D. Associate Director, Cancer Therapy Evaluation Program Acting Director for Clinical Research Associate Director of the Cancer Therapy Evaluation Program, National Cancer Institute |
| 11:00 a.m. - 11:15 a.m. | Break | All |
| 11:15 a.m.- 12:30 p.m. | Subpart A Subcommittee (SAS) | Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
| 12:30 p.m.- 1:30 p.m. | Lunch | All |
| 1:30 p.m.- 2:15 p.m. | Subpart A Subcommittee (SAS) - continued | Daniel K. Nelson, M.S., CIP, SAS Co-chair David Borasky, M.P.H., CIP, SAS Co-chair |
| 2:15 p.m. – 3:30 p.m. | Human Subjects Research and the Internet | Elizabeth Buchanan, Ph.D. Endowed Chair in Ethics Director of the Center for Applied Ethics University of Wisconsin-Stout Dean R. Gallant, A.B. Assistant Dean for Research Policy and Administration Harvard University |
| 3:30 p.m. – 3:45 p.m. | Public Comment | Public |
| 3:45 p.m.- 4:00 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. |
