Research Ethics and Policy Series: Seema K. Shah, JD

Examining the Dynamic and Implicit Ethical Challenges Facing Data Monitoring Committees

Seema K. Shah, JD
Associate Professor in Pediatrics at Northwestern University Medical School
Founder’s Board Professor of Medical Ethics
Associate Director of Research Ethics at Lurie Children’s Hospital

In-person! Livestreaming also available.
Boxed lunches will be provided for in-person attendees.

Abstract: The COVID-19 pandemic has exposed numerous unresolved research ethics challenges, particularly for Data Monitoring Committees (DMCs). DMCs have long faced high stakes decisions in clinical trials including whether to continue, modify, or terminate a trial based on emerging trial data. In the COVID pandemic, DMCs have been called “unsung heroes” for their work to ensure the ongoing value of research amid rapidly-changing circumstances and great pressure to release early findings to the public. Yet unlike other research oversight bodies, such as Institutional Review Boards, DMCs have limited formal ethical guidance. For example, should DMCs ensure the accuracy of press releases detailing study findings? Do DMCs consider when to unblind participants after a study is over if it is relevant for their future medical decision-making? In this presentation, I will examine ethical challenges that are often implicitly addressed in DMC decision-making. I will report preliminary results of a qualitative study of DMC members (i.e., statisticians, clinicians, and ethicists) and highlight persistent controversies about the roles that DMCs should play. Finally, I will explore whether and how bioethicists can help address the complex ethical challenges that arise for DMCs.

Seema K. Shah, JD, Associate Professor in Pediatrics at Northwestern University Medical School and an Associate Director of the Bioethics Program at Lurie Children’s Hospital, is an expert in the fields of pediatrics and global health research ethics, as well as on ethical issues in the determination of death. After attending Stanford University, Shah completed a fellowship in bioethics at the National Institutes of Health (NIH) Clinical Center. She then received legal training at Stanford and in a federal district court clerkship. Shah was previously on faculty at the University of Washington/Seattle Children’s Hospital and at the NIH Clinical Center Department of Bioethics. Shah has chaired an NIH committee on ethical considerations in conducting Zika virus human challenge trials, and lectured on the ethics of clinical research at conferences run by PRIM&R, ASBH, IAB, ASTMH, and internationally in such locations as Botswana, South Africa, the Netherlands, Vietnam, Japan, Indonesia, Brazil, and Zimbabwe.

For more information, contact Mary Pham, Mary.Pham@pennmedicine.upenn.edu.