March 15-16, 2017 - SACHRP Meeting

March 15, 2017 - March 16, 2017

Webcasts:

Meeting Materials

Agenda

NOTICE! Due to inclement weather, the March 15-16 meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) has been cancelled.

Day 1 - Wednesday, March 15, 2017

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

Welcome and Introduction of New Members:
Sandra H. Berry, M.A.
James J. Giordano, Ph.D.
Aviva L. Katz, M.D., M.A.
Leslie E. Wolf, J.D., M.P.H.

Stephen Rosenfeld, M.D.,
SACHRP Chair
Jerry Menikoff, M.D., J.D.,
Director, OHRP
8:45 a.m. - 9:15 a.m. Overview of New Final Rule Sections, §§__.101(l),  __.104(d)(3), and  __.116(d) Jerry Menikoff, M.D., J.D., 
Director, OHRP
9:15 a.m. - 10:45 a.m. Subcommittee on Harmonization Topic:
Compliance and Transition Provisions, §__.101(l)		 David Forster, J.D.
SOH Co-chair
10:45 a.m. - 11:00 a.m. Break  
11:00 a.m. - 11:30 a.m. Subcommittee on Harmonization Topic:
Compliance and Transition Provisions, §__.101(l)		 David Forster, J.D.
SOH Co-chair
11:30 a.m. - 12:30 p.m. Subpart A Subcommittee Topic:
Benign Behavioral Interventions, §__ .104(d)(3)

Michele Russell-Einhorn, J.D., SAS Co-chair
David Borasky, M.P.H., SAS Co-chair
12:30 p.m. - 1:15 p.m. Lunch  
1:15 p.m. - 2:15 p.m. Subpart A Subcommittee Topic:
Benign Behavioral Interventions, §__ .104(d)(3)		 Michele Russell-Einhorn, J.D., SAS Co-chair
David Borasky, M.P.H., SAS Co-chair
 
2:15 p.m. - 4:15 p.m. Subcommittee on Harmonization Topic:
Broad Consent, §__ .106(d)		 Mark Barnes, J.D.
SOH Co-chair
4:15 p.m. - 4:30 p.m. Public Comment  
4:30 p.m. - 4:45 p.m. Summary and Adjournment  

Day 2 - Thursday, March 16, 2017

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. - 9:00 a.m. Overview of New Final Rule Section, §__.110 Jerry Menikoff, M.D., J.D.
Director, OHRP
9:00 a.m. - 10:30 a.m. Subpart A Subcommittee Topic:
Expedited Review List, §__.110		 Michele Russell-Einhorn, J.D., SAS Co-chair
David Borasky, M.P.H., SAS Co-chair
10:30 a.m. - 10:45 a.m. Break  
10:45 p.m. - 11:30 p.m. Subpart A Subcommittee Topic:
Expedited Review List, §__.110		 Michele Russell-Einhorn, J.D., SAS Co-chair
David Borasky, M.P.H., SAS Co-chair
11:30 a.m. - 12:15 p.m. Subcommittee on Harmonization Topic:
Report of Incidental Findings

David Forster, J.D.
SOH Co-chair
12:15 p.m. - 1:00 p.m. Lunch  
1:00 p.m. - 2:00 p.m. Subcommittee on Harmonization Topic:
FDA Draft Guidance "Use of Real-World Evidence to Support
Regulatory Decision-Making for Medical Devices"		 David Forster, J.D.
SOH Co-chair
2:00 p.m. - 3:30 p.m. Reserved for Discussion of Revised Recommendations  
3.30 p.m. - 3:45 p.m. Public Comment  
3:45 p.m. - 4:00 p.m. Wrap-Up and Adjourn  

 

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