Pharma/Biotech Perspectives Track

2019 AER Conference

A10 - Management of Incidental Findings (IFs) in Pragmatic Clinical Trials (PCTs)

Speaker(s)

• 

  Juli Bollinger, M.S.
  

  Faculty Research Associate, Johns Hopkins University
  Faculty Research Associate, Johns Hopkins University
• 

  Debra JH Mathews, PhD, MA
  

  Assistant Director for Science Programs, Johns Hopkins University Berman Institute of Bioethics
  Associate Professor, Pediatrics, Johns Hopkins University
• 

  Stephanie Morain, PhD, MPH
  

  Assistant Professor of Medical Ethics and Health Policy, Baylor College of Medicine
  
• 

  Jeremy Sugarman, MD, MPH, MA
  

  Harvey M. Meyerhoff Professor of Bioethics and Medicine, Johns Hopkins University
  

Incidental and secondary findings pose numerous practical, ethical, and legal challenges for researchers, clinicians, institutions, and patients/research participants. While considerable attention has focused on IFs in genetics and imaging research studies, these issues have not been broadly considered in the context of PCTs. However, managing IFs in the context of PCTs poses challenges due to both the large scale of many PCTs, and the fact that many PCTs are done without patient consent or even their awareness of being involved in the research activity. In this session, speakers will present a conceptual overview of the issue, as well as results from new empirical research to inform deliberations about the ethical management of IFs in PCTs. During this session, speakers and attendees will:

Learning Objectives:

• Discuss the ethical challenges for management of IFs in the context of PCTs
• Review original qualitative interview data with key PCT stakeholders on the ethical management of IFs in PCTs
• Go over original focus group data regarding patients' views on the ethical management of IFs in PCTs