March 12-13, 2014 SACHRP Meeting

March 12, 2014 - March 13, 2014

Meeting Materials

Assurances and Engagement

Certificates of Confidentiality

Clustered Randomized Trials and Informed Consent

Agenda

DAY 1 - March 12, 2014

Time Agenda Item Speaker
8:30 - 8:45 Welcome: Opening Remarks

Dr. Jeffrey Botkin, SACHRP Chair

Dr. Jerry Menikoff, Director, OHRP

8:45 - 9:15 Welcome and Remarks Dr. Howard Koh, Assistant Secretary for Health (HHS)
9:15 - 10:15 A discussion of Cluster Randomization, Risk Assessment and Consent Requirements Mark Barnes, SOH Co-chair
10:15 - 10:30 Break None
10:30 - 11:45 NIH Collaboratory Trials Dr. Jerry Menikoff, Director, OHRP
11:45 - 1:00 Lunch All
1:00 - 2:15 Clustered Randomized Trials and Informed Consent David Forster, SOH Co-chair
2:15 - 4:15 SACHRP Future Topics Discussion SACHRP members
4:15 - 4:30 Public Comment Public
4:30 - 4:45 Summary and Adjournment Dr. Jeffrey Botkin, SACHRP Chair

 

DAY 2 - March 13, 2014

Time Agenda Item Speaker
8:30 - 8:45 Opening Remarks

Dr. Jeffrey Botkin, SACHRP Chair

Dr. Jerry Menikoff, Director, OHRP

8:45 - 10:30 Subpart A Subcommittee (SAS) - Re-envisioning Engagement Daniel K. Nelson, SAS Co-chair
David Borasky, SAS Co-chair
10:30 - 11:00 Break None
11:00 - 12:15 Subpart A Subcommittee (SAS) - Re-envisioning Engagement Daniel Nelson, SAS Co-chair
David Borasky, SAS Co-chair
12:15- 1:15 Lunch All
1:15 – 3:00 Office of Inspector General Report: Biospecimen Research and Presidential Commission for the Study of Bioethical Issues Report: Anticipate and Communicate Dr. Jeffrey Botkin, SACHRP Chair
3:15 - 4:00 Certificates of Confidentiality David Forster, SOH Co-chair
4:00 - 4:15 Public Comment Public
4:15 – 4:30 Wrap-up Discussion and Adjourn Dr. Jeffrey Botkin, SACHRP Chair
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