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October 16-17, 2018 - SACHRP Meeting

October 16, 2018 - October 17, 2018

6700B Rockledge Drive, Suite 1102

Bethesda, MD 20892

Agenda

Day 1 - Tuesday, October 16, 2018

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Welcome	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:15 a.m.	Draft Recommendations Focus on Transition to the Revised Common Rule: Issues Surrounding Informed Consent under HHS or FDA Jurisdiction	Mark Barnes, J.D. SOH Co-chair
9:15 a.m. - 10:30 a.m	Panel Discussion 1. Albert J. Allen, M.D., Ph.D. Senior Medical Fellow, Medicines Development Unit Eli Lilly and Company 2. Parthena G. Psyllos, J.D. Senior Corporate Counsel, Clinical Development Legal, Pfizer Inc. 3. Megan Kasimatis Singleton, J.D., MBE Assistant Dean, Office of Human Subjects Research John Hopkins University School of Medicine 4. Barbara E. Bierer, M.D. Professor of Medicine, Harvard Medical School Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard 5. Tim Chulindra, PharmD, CIPM, CIPP E/US, FIP Vice President Chief Privacy Officer PRA Health Sciences 6. Heather H. Pierce, J.D., M.P.H. Senior Director for Science Policy and Regulatory Counsel Association of American Medical Colleges 7. Philip Desjardins, J.D. Vice President, Global Regulatory Affairs Policy & Intelligence, Johnson & Johnson	Mark Barnes, J.D., Moderator
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 11:45 p.m.	Panel Discussion	Mark Barnes, J.D. Moderator
11:45 p.m. - 12:30 p.m.	SACHRP Discussion	Stephen Rosenfeld, M.D. SACHRP Chair
12:30 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 2:30 p.m.	"Key Information" in Informed Consent Interpretation and Application of Section 116 (a)(5)	David Borasky, M.P.H. SAS Co-chair
2:30 p.m. - 3:45 p.m.	When is a Parent or Guardian "Reasonably Available" for Purposes of §46.408 (b)	Michele Russell-Einhorn, J.D. SOH Co-chair
3:45 p.m - 4:30 p.m.	Draft Recommendations, Revised Focus on Transition to the Revised Common Rule: Issues Surrounding Informed Consent under HHS or FDA Jurisdiction	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 and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair

Day 2 - Wednesday, October 17, 2018

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Opening Remarks	Stephen Rosenfeld, M.D. SACHRP Chair
8:45 a.m. - 10:300 a.m.	Discussion and Recommendation: Office of Inspector General Report, July 7, 2017: "OHRP Generally Conducted Its Compliance Activities Independtly, But Changes Would Strengthen Its Independence"	Stephen Rosenfeld, M.D. SACHRP Chair
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 12:15 p.m.	Ethical Concerns Regarding Offer of Payment to Research Participants	David Borasky, M.P.H. SAS Co-chair
12:15 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 2:15 p.m.	Interpreation of Revised Common Rule Exemptions §46.101 (b)(1) and (2)	David Borasky, M.P.H. SAS Co-chair
2:15 p.m. - 2:30 p.m.	Public Comment
2:30 p.m. - 2:45 p.m.	Wrap-up and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair

Webcast URL:

https://videocast.nih.gov/

October 16, 2018

October 17, 2018

Content last reviewed August 23, 2017