July 21, 2015 - July 22, 2015
Webcasts:
Agenda
Day 1 - Tuesday, July 21, 2015
| Time | Agenda Item | Speaker(s) |
|---|---|---|
|
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.- 10:45 a.m. | Subpart A Subcommittee (SAS) Report: Informed Consent for Minimal Risk Research |
David Borasky, M.P.H. SAS Co-chair |
| 10:45 a.m.- 11:00 a.m. | BREAK | |
| 11:00 a.m.- 11:30 p.m. | Centers for Medicare and Medicaid Services (CMS) Perspective on Qualified Clinical Data Registries | Kate Goodrich, M.D., M.H.S., CMS Daniel Green, M.D., CMS |
| 11:30 a.m.- 12:30 p.m. | SAS Recommendation: H.R.2, Medicare Access and CHIP Reauthorization ACT of 2015, Sec 511, Guidance on Application of Common Rule to Clinical Data Registries |
David Borasky, M.P.H. |
| 12:30 p.m. - 1:30 p.m. | LUNCH | |
| 1:30 p.m.- 3:00 p.m. | Subcommittee on Harmonization Report Waiver of Consent in Cluster Randomized Trials |
David Forster, J.D. Mark Barnes, J.D., L.L.M. |
| 3:00 p.m.- 3:15 p.m. | BREAK | |
3:15 p.m.- 4:30 p.m. |
Subcommittee on Harmonization (SOH) Report: “Benchmarking” in Human Subjects Research, Return of Individual Research Results |
David Forster, J.D. Mark Barnes, J.D., L.L.M. |
| 4:30 p.m.- 4:45 p.m. | Public Comment | |
| 4:45 p.m.- 5:00 p.m. | Summary and Adjournment | Jeffrey R. Botkin, M.D. |
Day 2 - Wednesday, July 22, 2015
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. – 8:45 a.m. | Opening Remarks |
Jeffrey Botkin, M.D. Jerry Menikoff, M.D., J.D., |
| 8:45 a.m.- 10:30 a.m. | SOH Recommendation: Return of Research Results and Emergent CLIA and HIPAA Issues |
Mark Barnes, J.D., L.L.M. David Forster, J.D. CMS, FDA and OCR Representatives |
| 10:30 a.m.- 10:45 a.m. | BREAK | |
| 10:45 a.m.- 11:00 a.m. | American Society for Investigative Pathology | Mark Sobel, M.D., Ph.D. Executive Officer, ASIP |
| 11:00 a.m.- 11:15 a.m. | National Organization for Rare Diseases | Marshall L. Summar, MD Chief Genetics and Metabolism Children’s National Medical Center Washington, DC |
| 11:15 a.m.- 11:30 a.m. | SOH Recommendation: Return of Research Results and Emergent CLIA and HIPAA Issues, cont’d |
Mark Barnes, J.D., L.L.M. David Forster, J.D. CMS, FDA and OCR Representatives |
| 11:30 a.m.- 12:00 p.m. | SACHRP Future Planning | Jeffrey Botkin, M.D.> SACHRP Chair |
| 12:00 p.m.- 1:00 p.m. | LUNCH | |
| 1:00 p.m.- 2:30 p.m. | The Ethics Police?: A Commentary on Human Subject Research Protections | Dr. Robert L. Klitzman Professor of Psychiatry Director, Bioethics Masters and Online Certificate and Course Programs Columbia University |
| 2:30 p.m. - 3:00 p.m. | Reserved | |
| 3:00 p.m.- 3:15 p.m. | Public Comment | |
| 3:15 p.m. – 3:30 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. SACHRP Chair |
