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May 25-26, 2017 - SACHRP Meeting

May 25-26, 2017 - SACHRP Meeting

Day 1 - Thursday, May 25, 2017

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

Welcome and Introducton 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(I), __,104(d)(3), and __.110

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(I)

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 
Compliance andTransition Provisions,§ __.101(I)

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. Subpart A Subcommittee Topic:
Expedited Review List, §__ .110
Michele Russell-Einhorn, J.D.
SAS Co-chair
David Borasky, M.P.H.
SAS 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 - Friday, May 26, 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, §__ .116 (d) Jerry Menikoff, M.D., J.D.
Director, OHRP
9:00 a.m. - 10:30 a.m. Subcommittee on Harmonization Topic:
Broad Consent, §__ .116 (d)
 
Mark Barnes, J.D.
SOH Co-chair
10:30 a.m. - 10:45 a.m. BREAK  
10:45 a.m. - 11:30 a.m. Subcommittee on Harmonization Topic:
Broad Consent§__  .116 (d)
Mark Barnes, J.D.
SOH 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FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices"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  
3:35 p.m. - 4:00 p.m. Wrap and Adjournment  

 

Webcast URL: 

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

May 25, 2017

May 26, 2017

 

 


Meeting Minutes: 

Meeting minutes, public comment and presentation materials are available upon request to SACHRP@hhs.gov

 

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 22, 2017