Office for Human Research Protections (OHRP)

8:30 am – 8:45 am

Welcome: Opening Remarks

Barbara Bierer, M.D.
SACHRP Chair

8:45 am – 9:00 am

Report of Issues/Remarks

Jerry Menikoff, M.D., J.D., 
Director, OHRP

9:00 am – 10:00 am

Summary of Public Comment:
Office for Civil Rights Notice of Proposed Rulemaking
Christina Heide, J.D., Senior Health Information Privacy Policy Specialist, OCR

10:00 am – 10:15 am                     

BREAK

10:15 am – 12:30 pm

Report of Subcommittee on Harmonization (SOH)
David Forster, J.D., SOH Co-chair
Mark Barnes, J.D., SOH Co-chair
Susan Stayn, J.D., SOH member

12:30 pm – 1:30 pm

LUNCH

1:30 pm – 3:00 pm

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP, SAS Co-chair
Elizabeth A. Bankert, M.A., SAS Co-chair
David Borasky, M.P.H., CIP, SAS member

3:00 pm – 3:15 pm

BREAK

3:15 pm – 3:45 pm

Update on Federated IRB Model
Speakers TBA

3:45 pm – 4:45 pm

CTSA Consortium Report
Speakers TBA

4:45 pm – 5:00 pm

Public Comment

5:00 pm – 5:15 pm

Wrap-up Discussion and Adjourn

8:30 am – 8:45 am

Remarks

Barbara Bierer, M.D.
SACHRP Chair

8:45 am – 9:15 am

OHRP update:
Withdrawal of Subjects from Research
Request for Comment on FWA Revision
Mike Carome, M.D., OHRP

9:15 am – 11:15 am

The Use of Deception in Human Subjects Research
Frank Miller, Ph.D.
Faculty, NIH Clinical Center Department of Bioethics

Joan E. Sieber, Ph.D., Founder and Editor-in-Chief of Journal of Empirical Research on Human Research Ethics

11:15 am – 11:30 am

BREAK

11:30 am – 1:00 pm

Focus on Data “Identifiability”
Sara C. Hull, Ph.D.
Director, NHGRI Bioethics Core
Faculty, NIH Clinical Center Department of Bioethics
Bradley Malin, Ph.D.
David W. Craig, Ph.D., 
Associate Director & Investigator 
Neurogenomics Division 
The Translational Genomics Research Institute

Bradley Malin, Ph.D. Assistant Professor
Dept of Biomedical Informatics
School of Medicine
Vanderbilt University
Health Information Privacy Lab

Jane Kaye, D. Phil.
Director, HeLEX, Centre for Health, Law and Emerging Technologies
Department of Public Health, University of Oxford

1:00 pm- 2:00 pm

LUNCH

2:00 pm – 3:30 pm

Identifiability panel, continued

3:30 pm –3:45 pm

Public Comment

3:45 pm – 4:00 pm

Wrap-up Discussion and Adjourn