In the years since implementation of federal regulations governing human subjects protections in research, the number of clinical studies has grown substantially, trials have become more complex, and multicenter trials have also become more common. As a result, many IRBs are overburdened by their workloads and under-resourced to effectively achieve their mission. Furthermore, the conduct of trials at multiple institutions leads to much duplicative work, conflicting modifications that need to be resolved, and delays as investigators seek IRB approval at each participating institution.
In addition, the increase in biobanking and genomic analysis of patient samples has changed the landscape of clinical research, raising ethical questions about such things as consent for future research and the protection of patient information. Recognizing these and other challenges, the U.S. Department of Health and Human Services recently developed an Advance Notice of Proposed Rulemaking for human subjects research protections, which could ultimately lead to changes in federal regulations.
This workshop examined these contemporary issues in human subjects protections as they pertain to cancer research. Workshop sessions fostered dialogue among patient advocates and experts in the conduct and oversight of clinical cancer research, with the goal of identifying potential policy actions to address current challenges.
Workshop Planning Committee
Angela R. Bradbury (co-chair), University of Pennsylvania
Steven Piantadosi (co-chair), Samuel Oschin Comprehensive Cancer Institute
Edward J. Benz, Jr., Dana-Farber Cancer Institute
Laura Cleveland, Patient Advocate
Patricia A. Ganz, University of California, Los Angeles
Roy Herbst, Yale Cancer Center
Steven Joffe, University of Pennsylvania
Thomas J. Kean, C-Change
Daniel R. Masys, University of Washington
John Mendelsohn, MD Anderson Cancer Center
Holly Taylor, Johns Hopkins
Confirmed Speakers
Terrence Albrecht, Wayne State University
Melissa Bianci, Hogan Lovells
Barbara Bierer, Brigham and Women’s Hospital
Jeffrey Botkin, University of Utah
Angela Bradbury, University of Pennsylvania
Ellen Wright Clayton, Vanderbilt Center for Biomedical Ethics and Society
Laura Cleveland, Patient Advocate
Deborah Collyar, Patient Advocates In Research
Christopher Daugherty, University of Chicago
Susan S. Ellenberg, University of Pennsylvania School of Medicine
Ruth Faden, Johns Hopkins Berman Institute of Bioethics
Gail Jarvik, University of Washington School of Medicine
Alice Leiter, Center for Democracy & Technology
Brad Malin, Vanderbilt University
Mary McCabe, Memorial-Sloan Kettering Cancer Center
Jerry Menikoff, Department of Health and Human Services
Michael Paasche-Orlow, Boston University
David Parda, West Penn Allegheny Health System
Jeffrey Peppercorn, Duke University Medicine
Richard Schilsky, American Society of Clinical Oncology
Holly Taylor, Johns Hopkins University
Sharon Terry, Genetic Alliance
To view recordings of this workshop, visit:
https://www.youtube.com/watch?v=UmyRom0RdmE&list=PLGTMA6QkejfilL5ngJOVqK3CiEvRo6qo7