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March 23-24, 2021 - SACHRP Meeting

March 23, 2021 - March 24, 2021

Agenda

Virtual Meeting

Tuesday, March 23, 2021

Time	Agenda Item
11:00 am - 11:15 am	Welcome Remarks from the Chair Doug, Diekema, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
11:15 am - 12:15 pm	Interactions Between Sponsor/ Clinical Trial Sites/ Subjects Mark Barnes, J.D., SOH Co-chair
12:15 pm - 1:15 pm	Mandatory Exploratory Biopsies Michele Russell-Einhorn, J.D., SAS Co-cair Panel Presentations and Discussion: James Doroshow, M.D. Deputy Director, Clinical and Translational Research Director, Division of Cancer Treatment and Diagnosis National Cancer Research Percy Ivy, M.D. Associate Chief, Investigational Drug Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute
1:15 pm - 1:45 pm	BREAK
1:45 pm - 3:00 pm	Panel Presentations and Discussions: Paul Nadler, M.D., Nadler Pharma Associates, LLC. Managing General Partner Gautam Mehta, M.D. Division of Oncology 2 Scientific Liaison for Adult Neuro-Oncology U.S. Food and Drug Administration Mark Ratain, M.D. Leon O. Jacobson Professor of Medicine Director, Center for Personalized Therapeutics Associate Director for Clinical Sciences, Comprehensive Cancer Center The University of Chicago Laura Levit, J.D. Director, Research Analysis and Publications American Society for Clinical Oncology
3:00 pm - 3:30 pm	Mandatory Exploratory Biopsies Discussion Michele Russell-Einhorn, J.D., SAS Co-chair
3:30 pm - 3:45 pm	Public Comment
3:35 pm - 4:00 pm	Summary and Adjournment Doug Diekema, M.D. SACHRP Chair

Wednesday, March 24, 2021

Time	Agenda Item
11:00 am - 11:15 am	Welcome Remarks from the Chair Doug, Diekema, M.D. SACHRP Chair
11:15 am - 12:30 pm	Justice as an Ethical Concept in 45 CFR 46 Stephen Rosenfeld M.D. SOH Member
12:30 pm - 1:30 pm	IRB Authority to Restric Use of Data Collected in Research David Forster, J.D., SOH Co-chair Mark Barnes, J.D., SOH Co-chair
1:30 pm - 2:00 pm	BREAK
2:00 pm - 3:30 pm	Considerations Affecting Bystanders in Human Subjects Research David Borasky, MPD, SAS Co-chair
3:30 pm - 3:45 pm	Public Comment
3:45 pm - 4:00 pm	Summary and Adjournment Doug Diekema, M.D. SACHRP Chair

Webcast URL:

Content last reviewed March 11, 2021