July 21-22, 2015 SACHRP Meeting

July 21, 2015 - July 22, 2015

Time	Agenda Item	Speaker(s)
8:30 a.m. – 8:45 a.m.	Welcome: Opening Remarks	Jeffrey R. Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
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.

Time	Agenda Item	Speaker(s)
8:30 a.m. – 8:45 a.m.	Opening Remarks	Jeffrey Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D., Director, OHRP
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