October 25-26, 2016 - SACHRP Meeting

October 25, 2016 - October 26, 2016

Agenda

Day 1 - Tuesday, October 25, 2016

TimeAgenda ItemSpeaker(s)
8:30 a.m. - 8:45 a.m.Welcome: Opening RemarksJeffrey R. Botkin, M.D.
SACHRP Chair
Jerry Menikoff, M.D., J.D.
Director, OHRP
8:45 a.m. - 10:15 a.m.Subpart A Subcommittee Report:
Considerations of Single IRB Review		Michele Russell-Einhorn, J.D.
SAS Co-chair
10:15 a.m. - 10:30 a.m.Break 
10:30 a.m. - 11:30 a.m.Subpart A Subcommittee Report:
Considerations for Single IRB Review		Michele Russell-Einhorn, J.D.
SAS Co-chair
11:30 a.m. - 12:30 p.m.Subpart A Subcommitte Report:
IRB Written Procedures Draft Guidance		David Borasky, M.P.H.
SAS Co-chair
12:30 p.m. - 1:30 p.m.Lunch 
1:30 p.m. - 3:15 p.m.Subcommittee on Harmonization Report:
"Benchmarking" in Human Subjects Research		David Forster, J.D.
SOH Co-chair
3:15 p.m. - 4:30 p.m.Subcommittee on Harmonization Report:
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Appendix M		David Forster, J.D.
SOH Co-chair
 
4:30 p.m. - 4:45 p.m.Public Comment 
4:45 p.m. - 5:00 p.m.Summary and Adjournment 

Day 2 - Wednesday, October 26, 2016

TimeAgenda ItemSpeaker(s)
8:30 a.m. - 8:45 a.m.Opening RemarksJeffrey Botkin, M.D.
SACHRP Chair
Jerry Menikoff, M.D., J.D.
Director, OHRP
8:45 a.m. - 10:30 a.m.Subcommittee on Harmonization Report:
FDA Draft Guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices"		David Forster, J.D.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 Report:
Regulatory Considerations in Cluster Randomized Trials		David Forster, J.D.
SOH Co-chair
12:15 p.m. - 1:00 p.m.Lunch 
1:00 p.m. - 2:15 p.m.Reserved for Discussion of Revised Recommendations 
2:15 p.m. - 2:30 p.m.Public Comment 
2:30 p.m. - 2:45 p.m.Wrap and Adjournment 

Webcast URL:

http://videocast.nih.gov

October 25, 20116

October 26, 2016 

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