March 23-24, 2021 - SACHRP Meeting

March 23, 2021 - March 24, 2021

Webcasts:

Meeting Materials

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
 
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