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Paper Presentation

Research Ethics and Social Sciences

Session: Ethics, IRBs, and Research Design

Ethics and Data Monitoring Committees: A Systematic Review of Ethical Decision-Making in Monitoring Clinical Trial

Friday, October 24, 2025
3:45 PM - 4:45 PM Pacific Time
Location: B119
Seema Shah – Lurie Children's Hospital; Annette Rid – NIH; Corinne Miller – Northwestern University
Abstract: With increasing polarization and distrust in science, robust interdisciplinary collaboration in research is sorely needed. A key component of interdisciplinary collaboration in research that is not widely understood is the Data Monitoring Committee (DMC). DMCs are independent groups of experts in medicine, statistics, and ethics that are appointed by sponsors to protect participants and maintain scientific integrity. DMCs work together to review accumulating, blinded data from randomized control trials, and make recommendations to stop or modify ongoing trials when their value or risk for participants or society changes substantially. Yet ethical challenges for DMCs have received limited attention. This systematic review therefore sought to examine the ethical challenges DMCs face and identify gaps in existing ethical guidance for the critical research oversight they provide.

A comprehensive literature search using terms such as “Clinical Trial Data Monitoring Committee” and “Data and Safety Monitor” yielded 6,984 unique articles. Two independent reviewers screened each article for quality of ethical analysis, with discrepancies resolved through discussion and third-party adjudication. After final screening, 182 articles met inclusion criteria, and thematic analysis was used to identify key ethical concerns.

Three primary challenges emerged: (1) stopping trials early, particularly for interventions with greater than anticipated efficacy; (2) when to share interim trial data with stakeholders; and (3) the special challenges of monitoring certain types of trials (e.g., industry sponsored and adaptive trials). Our results suggest the need for ethical attention and training focused on DMCs so they are well-equipped to support the ethical conduct of research.

Keywords: Data Monitoring Committees, Ethics in Clinical Trials, Deregulation

Learning Objectives:

After participating in this conference, attendees should be able to:
  • 1. Identify ethical responsibilities of DMCs.
  • 2. Describe how external pressures can influence ethical decision-making in clinical trials.
  • 3. Understand the need for enhanced ethical training for DMC members.