In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes, authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials.

Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers:

• waivers and alterations of informed consent and their implications for transparency
• managing and responding to “collateral findings” in pragmatic trials
• representativeness of study populations, and the risk of reinforcing existing inequalities in healthcare delivery systems

Read the full article.

Each of the 3 challenges has taken on increasing importance for the NIH Collaboratory’s Ethics and Regulatory Core. For example, the group completed a 2-year multimethod investigation of collateral findings in pragmatic trials, identifying the core themes and proposing directions for future research.

Propes is a doctoral student in bioethics and health policy, and Morain is an associate professor of health policy and management and a core faculty member of the Berman Institute of Bioethics—both at Johns Hopkins University. O’Rourke is a retired bioethicist who served as the director of human research affairs at Partners HealthCare Systems in Boston and as an associate professor of pediatrics at Harvard Medical School.

Learn more about the Ethics and Regulatory Core.