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Session 2: Exploring the Role of IRBs and IECs in Assuring Appropriate Representation in Research and Development
Session Chair(s)
Barbara E Bierer, MD
Faculty Director, MRCT Center; Professor of Medicine
Harvard Medical School, United States
Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) arose from the recognition that laws were needed to protect human rights in clinical research studies and these bodies now play an important role in assuring these protections are in place a priori and maintained throughout clinical studies. In this session we will explore questions around whether IRBs and IECs may be able to contribute to improving inclusion of representative populations in clinical research and trials. Some questions to be asked include: Can IRBs and IECs play a part in identifying issues surrounding diversity? Can IRBs and IECs aid in ensuring accurate representation of the target patient population that is representative of the explored disease? These ideas will be explored in this session as it applies to the pre-clinical phase, and beyond, of the drug development lifecycle.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain social science and justice perspectives in the clinical research ecosystem
- Apply how to engage IRBs and IECs on diversity, equity, and inclusion efforts within clinical trials and throughout the drug development lifecycle
- Illustrate the importance of engaging and building relationships with communities prior to writing protocols
Speaker(s)
Speaker
Monica L Baskin, PHD
O’Neal Comprehensive Cancer Center, School of Medicine, United States
Associate Director for Community Outreach and Engagement
Speaker
Michele Russell-Einhorn, JD
Advarra, United States
Chief Compliance Officer and Institutional Official