Webcasts:
Meeting Materials
Agenda
Day 1 - Tuesday, July 30, 2019
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: |
Stephen Rosenfeld, M.D. |
9:40 a.m. - 11:00 a.m | Payment to Research Subjects |
David Forster, J.D., SOH Co-Chair |
11:00 a.m. - 11:15 a.m. | BREAK |
|
11:15 a.m. - 12:30 p.m. |
End User Licensing Agreements & Terms of Service; Presentation: |
David Forster, J.D., SOH Co-chair David Peloquin, J.D. |
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 |
Day 2 - Wednesday, July 31, 2019
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. |
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 |