July 30-31, 2019 - SACHRP Meeting

Agenda

Time	Agenda Item	Speaker(s)
9:00 a.m. - 9:10 a.m.	Welcome	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
9:10 a.m. - 9:40 a.m.	Introduction of New Members: Mary Ellen Allen, J.D. Jyoti Angal, B.H.M.S., MPH Linda Coleman, J.D. Janet Freeman-Daily, MSc, ENG Robert Nelson, M.D., M.Div., Ph.D. Walter Straus, M.D. Consuelo H. Wilkins, M.D., MSCI	Stephen Rosenfeld, M.D. SACHRP Chair
9:40 a.m. - 11:00 a.m	Payment to Research Subjects	David Forster, J.D., SOH Co-Chair Nancy King, J.D., SACHRP Member
11:00 a.m. - 11:15 a.m.	BREAK
11:15 a.m. - 12:30 p.m.	End User Licensing Agreements & Terms of Service; Considerations for IRB Review Presentation: The Intersection of EULAs and ToS with Informed Consent	David Forster, J.D., SOH Co-chair Susan Stayn, J.D., SOH member David Peloquin, J.D. Ropes & Gray
12:30 p.m. - 1:30 p.m.	LUNCH
1:30 p.m. - 2:30 p.m.	Charging Subjects to Participate in Clinical Trials (Pay-to-Play)	David Forster, J.D. SOH Co-chair
2:30 p.m. - 3:15 p.m.	Site Monitoring under Single IRB Review	Stephen Rosenfeld, M.D. SACHRP Chair
3:15 p.m. - 4:15 p.m.	Standards for Unregulated Research	Stephen Rosenfeld, M.D. SACHRP Chair
4:15 p.m - 4:30 p.m.	Public Comment
4:30 p.m. - 4:45 p.m.	Summary and Adjournment	Stephen Rosenfeld, M.D. SACHRP Chair

Time	Agenda Item	Speaker(s)
9:00 a.m. - 9:15 a.m.	Re-cap of Previous Day's Work/Goal Setting for Day 2	Stephen Rosenfeld, M.D. SACHRP Chair
9:15 a.m. - 11:15 a.m.	Deceased Donor Intervention Research (DDIR)	Deceased Donor Intervention Research (DDIR) Michele Russell-Einhorn, J.D., SAS Co-chair Guest speakers: Brief Remarks Marilyn Levy, Physician, Division of Transplantation, HRSA James Bowman, Physician, Division of Transplantation, HRSA Issues for Donor Services Alexandra Glazier, J.D., M.P.H. President & CEO of New England Donor Services Transplant Perspectives for Donor Intervention Research; Evaluation and Waitlisting Sandy Feng, M.D., Ph.D. Director, Abdominal Transplant Fellowship University of California San Francisco Transplant Perspectives for Donor Intervention Research; Peri- and Post-transplant Peter L. Abt, M.D. Surgical Director of Kidney Transplantation Hospital of the University of Pennsylvania Staged Research Consent: Regulatory Challenges and Solutions Kate Gallin Heffernan, J.D. Verrill Dana, LLP
11:15 a.m. - 12:30 a.m.	Reserved
12:30 p.m. - 1:30 p.m.	LUNCH
1:30 a.m. - 2:15 p.m.	Re-consent: Ethical Issues, Regulatory Considerations	David Forster, J.D. SOH Co-chair
2:15 p.m. - 3:15 p.m.	Reserved
3:15 p.m. - 3:30 p.m.	Public Comment
3:30 p.m. - 3:45 p.m.	Summary and Adjournment	Stephen Rosenfeld, M.D. SACHRP Chair