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July 21-22, 2014 SACHRP Meeting

Meeting Agenda

SACHRP will be web cast live at http://videocast.nih.gov

Members of the public wishing to submit written comments must have comments submitted to Julia Gorey,JD no later than 5:00 p.m. ET July 15, 2014. For any additional questions, contact the SACHRP Executive Director at Julia.gorey@hhs.gov, or phone 240-453-8141.

 

 

 

Time

Agenda Item

Speaker

8:30am -  8:45amWelcome: Opening Remarks

Dr. Jeffrey Botkin, M.D.,SACHRP Chair

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

8:45am -  9:30amSubpart A Subcommittee (SAS)

David Borasky, M.P.H., CIP, SAS Co-chair

Michele Russell-Einhorn, J.D., SAS Co-chair

9:30am -11:30amInforming Informed Consent: Defining and Validating Comprehension

Christine Grady, R.N., Ph.D.
Chief, Department of Bioethics
NIH Clinical Center

Charles W. Lidz, Ph.D.
Research Professor of Psychiatry
University of Massachusetts Medical School

Deborah Schrag, MD, MPH
Attending Physician
Center for Gastrointestinal Oncology
Chief, Division of Population Sciences
Dana-Farber Cancer Institute

11:30am - 12:45pmLunchAll
12:45pm- 1:30pmSubcommittee on Harmonization (SOH)

Mark Barnes, J.D., SOH Co-chair

David Forster, J.D., M.A., C.I.P., SOH Co-chair

1:30pm -  3:45pmRegulatory Issues Concerning Big Data

Anthony L. Asher, M.D.
Co-Medical Director, Carolinas Healthcare System Neuroscience Institute

Neil Buckholtz, Ph.D.
Director, Division of Neuroscience,
National Institute on Aging, NIH

Jan Johannessen, Ph.D.
Deputy Director for Science
Office of Translational Sciences,
Center for Drug Evaluation and Research, FDA

Joe Selby, M.D., MPH
Executive Director
Patient Centered Outcomes Research Institute

 

3:45pm -  4:00pmPublic CommentPublic
4:00pm -  4:15pmSummary and AdjournmentDr. Jeffrey Botkin, M.D., SACHRP Chair

 

DAY 2 – July 22, 2014

Time

Agenda Item

Speaker

8:30am -  8:45amOpening Remarks

Dr. Jeffrey Botkin, M.D., SACHRP Chair

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

8:45am -  9:30amSubcommittee on Harmonization (SOH)

Mark Barnes, J.D., SOH Co-chair

David Forster, J.D., M.A., C.I.P., SOH Co-chair

9:30am- 11:15amPanel Discussion: Returning Research Results

Barbara E. Bierer, M.D.
Professor of Medicine
Harvard Medical School

Zachary Hallinan, B.A.
Director
Patient Communication and Engagement Programs
Center for Information and Study on Clinical Research Participation

Benjamin T. Rotz, R.Ph.
Advisor, Office of Medical Transparency
Eli Lilly and Company

11:15am - 12:00pmUpdate on Regulatory Reform in IndiaMark Barnes, J.D., SOH Co-chair
12:00pm- 1:00pmLunchAll
1:00pm - 2:30pmExploring Ethical and Regulatory Issues in Interventional Social Media Research
 
SACHRP members
2:30pm-  3:00pmWrap-up Discussion and AdjournDr. Jeffrey Botkin, M.D., SACHRP Chair