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Pharma/Biotech Perspectives Track
2019 AER Conference
Basic
Gianna McMillan, DBe
Program Administrator, Bioethics Institute, Loyola Marymount University
Carol Juliet Weil, JD
Program Director, Ethical and Regulatory Affairs, Division of Cancer Treatment and Diagnosis, National Cancer Institute
Karla Childers, MSJ
Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson
Returning both the summary results of a clinical trial and individual research results to participants honors the essential contributions and voluntarism of study participants in clinical trials, while improving the transparency of those trials. Return of results also involves communicating in plain language understandable to the trial participants. HRPPs often struggle with what results "should" or could be returned, whose responsibility it is to return results, and whether IRB oversight is needed. The complexity of whether and how to return results differ by the type and nature of the research, the study population, and the medical significance, analytical validity, and personal utility (value) of the result. Strategies to support sponsors, investigators and their study teams, and IRBs to communicate results will be discussed, a framework for decision-making will be presented, and resources to assist in the process will be offered. During this session, speakers and attendees will: