March 24-25, 2015 SACHRP Meeting

March 24, 2015 - March 25, 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.- 9:00 a.m.	Subpart A Subcommittee (SAS) Overview	David Borasky, M.P.H. Michele Russell-Einhorn, J.D.
9:00 a.m.- 10:15 a.m.	Introduction to Newborn Bloodspot Issues and Discussion of H.R. 1281	Jeffrey R. Botkin, M.D. Associate Vice President for Research Integrity Professor of Medical Ethics and Pediatrics University of Utah Michelle Huckaby Lewis, M.D., J.D. Research Scholar Berman Institute of Bioethics Johns Hopkins University
10:15 a.m. - 10:30 a.m.	Break
10:30 a.m. - 12:00 p.m.	SAS Recommendation: Newborn Bloodspot Issues and H.R. 1281	David Borasky, M.P.H. Michele Russell-Einhorn, J.D.
12:00 p.m.- 1:00 p.m.	Lunch
1:00 p.m.- 3:00 p.m.	SAS Recommendation: Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research	David Borasky, M.P.H. Michele Russell-Einhorn, J.D.
3:00 p.m. – 4:30 p.m.	Subcommittee on Harmonization (SOH) Overview; SOH Recommendation: Big Data and the Impact on Human Subjects Research	David Forster, J.D. Mark Barnes, J.D.
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.- 10:45 a.m.	SOH Recommendation: Return of Research Results and Emergent CLIA and HIPAA Issues	Mark Barnes, J.D. David Forster, J.D. CMS, FDA and OCR Representatives
10:45 a.m.- 11:00 a.m.	Break
11:00 a.m.- 12:30 a.m.	SOH Recommendation: FDA draft guidance, "General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products"	David Forster, J.D.
12:30 p.m.- 1:30 p.m.	LUNCH
1:30 p.m.- 3:15 p.m.	SOH Recommendation: Return of Individual Research Results	David Forster, J.D.
3:00 p.m.- 4:00 p.m. 3:00 p.m - 3:15 p.m Remarks 3:15 p.m.- 4:00 p.m. Discussion	Draft FDA Guidance, “Use of Electronic Informed Consent in Clinical Investigations”	Cheryl A. Grandinetti, Pharm.D. Health Scientist Policy Analyst Office of Medical Policy/CDER/FDA
4:00 p.m.- 4:15 p.m.	Public Comment
4:15 p.m.- 4:30 p.m.	Wrap-up Discussion and Adjourn	Jeffrey R. Botkin, M.D.