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July 30-31, 2019 - SACHRP Meeting

July 30-31, 2019 - SACHRP Meeting

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:
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

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.
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
 

 

Webcast URL: 

The SACHRP webcast can be accessed at: https://videocast.nih.gov/

 

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 15, 2019