Pharma/Biotech Perspectives Track

2019 AER Conference

Basic

D10 - Returning Research Results to Participants—Whose Job Is It?

Speaker(s)

• 

  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:

Learning Objectives:

• Discuss the ethical imperative behind the return of research results
• Identify strategies to integrate the return of results into the research workflow
• Provide resources and tools that support investigators and study teams in returning research results to study participants