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July 10-11, 2018 - SACHRP Meeting

July 10-11, 2018 - SACHRP Meeting

Day 1 - Tuesday, July 10, 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. - 10:30 a.m.

"Key Information" in Informed Consent:  Interpretation and Application of Section 116 (a)(5)

David Forster, J.D.
SOH Co-chair
10:30 a.m. - 10:45 a.m BREAK  
10:45 a.m. - 12:15 p.m. When is a Parent or Guardian "Reasonably Available" for Purposes of 46.408 (b)

Michele Russell-Einhorn, J.D.
SAS Co-chair

12:15 p.m. - 1:00 p.m.

LUNCH 

 

1:00 p.m. - 2:15 p.m.

Appropriate Compensation for Subject Participation

David Borasky, M.P.H.
SAS Co-chair

2:15 p.m. - 2:30 p.m. Office of Inspector General Report Jerry Menikoff, M.D., J.D.
Director OHRP
2:30 p.m. - 3:30 p.m.

Discussion and Recommendation, Office of Inspector General Report

Stephen Rosenfeld, M.D.
SACHRP Chair
3:30 p.m. - 3:45 p.m.

Public Comment

 
3:45 p.m - 4:00 p.m.

Wrap-up and Adjourn

Stephen Rosenfeld, M.D.
SACHRP Chair

Day 2 - Wednesday, July 11, 2018

Time Agenda Item Speaker(s)
8:30 a.m. - 8:45 a.m. Opening Remarks

Stephen Rosenfeld, M.D.
SACHRP Chair
Jerry Menikoff, M.D., J.D.
Director, OHRP

8:45 a.m. - 10:15 a.m. Implementaton of Transition Provision to the Revised Common Rule

Lauren Hartsmith, J..D.
OHRP

10:15 a.m. - 10:30 a.m.

BREAK

 
10:30 a.m. - 10:45 a.m. Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule

Irene Stith-Coleman, Ph.D.
Director, Division of Policy and Assurances, OHRP

10:45 a.m. - 12:30 p.m. Discussion of Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule

David Forster, J.D. and Mark Barnes, J.D.
SOH Co-chairs

Michele Russell-Einhorn, J.D. and David Borasky, M.P.H.
SAS Co-chairs

12:30 p.m. - 1:15 p.m. LUNCH  
1:15 p.m. - 2:15 p.m. Discussion of Possible Modification to SACHRP Recommendations for Revised Expedited Review List

David Borasky, M.P.H.
SAS Co-chair

2:15 p.m. - 2:30 p.m. Public Comment  
2:30 p.m. - 3:45 p.m. Reserved  
3:45 p.m. - 4:00 p.m. Wrap-up and Adjourn Stephen Rosenfeld, M.D.
SACHRP Chair
 

 

Webcast URL: 

https://videocast.nih.gov/


Content created by Office for Human Research Protections (OHRP)
Content last reviewed on August 23, 2017