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October 17-18, 2017 - SACHRP Meeting

October 17-18, 2017 - SACHRP Meeting

Day 1 - Tuesday, October 17, 2017

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. - 9:15 a.m.

Introducing OHRP's Public Outreach Website About Research Participation

Yvonne Lau, M.D.
OHRP
9:15 a.m. - 10:30 a.m Subcommittee on Harmonization Topic:
HIPAA and Exemption §104 (d) (4) (iii)
Mark Barnes, J.D.
SOH Co-chair
10:30 a.m. - 10:45 a.m. BREAK

 

10:45 a.m. - 12:15 p.m.

Subcommittee on Harmonization Topic:
HIPAA and Exemption §104 (d) (4) (iii)

Mark Barnes, J.D.
SOH Co-chair

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

LUNCH

 

1:15 p.m. - 3:00 p.m. Subpart A Subcommittee Topic:
"Context" in Single IRB Review
Michele Russell-Einhorn, J.D.
SAS Co-chair
David Borasky, M.P.H.
SAS Co-chair
3:00 p.m. - 4:30 p.m.

Subpart A Subcommitte Topic:
Expedited Review List, 
§__ .110

Michele Russell-Einhorn, J.D.
SAS Co-chair
David Borasky, M.P.H.
SAS Co-chair
4:30 p.m - 4:45 p.m.

Public Comment

 
4:45 p.m. - 5:00 p.m. Wrap-up and Adjourn  

Day 2 - Wednesday, October 18, 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. - 10:15 a.m. Recent FDA Experience with Review under 21 CFR 50.54; Lessons Learned Robert "Skip" Nelson, M.D., Ph.D.
Deputy Director and Senior Pediatric Ethicist
Donna Snyder, M.D.
Pediatric Ethicist / Team Lead
Office of Pediatric Therapeutics, FDA
10:15 a.m. - 10:30 a.m. BREAK  
10:30 a.m. - 11:45 a.m. Changes to NIH Certificate of Confidentiality

Taunton Paine, M.A.
Science Policy Analyst
Clinical and Healthcare Research Policy Division
Office of Science Policy
National Institutes of Health

11:45 a.m. - 12:45 p.m. LUNCH  
12:45 p.m. - 1:30 p.m. Reserved. HIPAA and Exemption §104 (d)(4)(iii)  
1:30 p.m. - 2:30 p.m. Reserved, other  
2:30 p.m. - 2:45 p.m. Public Comment  
2:45 p.m. - 3:00 p.m. Wrap-up and Adjourn  

 

Webcast URL: 

The SACHRP webcast can be accessed at https://videocast.nih.gov/ or the link below:

Tuesday, October 17, 2017 - Day 1

Wednesday, October 18, 2017 - Day 2


Content created by Office for Human Research Protections (OHRP)
Content last reviewed on August 31, 2016