Benjamin Wilfond

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Posted on by Damon Seils

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

The article was published online ahead of print in Clinical Trials.

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

July 6, 2022: Article Offers Framework for Meeting Ethical Obligation of Respect for Persons in Pragmatic Trials

Posted on by Damon Seils

Cover the the Hastings Center ReportRespect for persons is a central obligation for the ethical conduct of research with human subjects. Traditionally, clinical trials have primarily relied on informed consent practices to fulfill this ethical obligation.

A new article in the Hastings Center Report proposes 8 dimensions for how researchers can meet the ethical obligation of respect for persons in pragmatic clinical trials. The authors, including members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, developed the framework in recognition of the challenge many pragmatic trials face with traditional informed consent practices when embedding research into clinical care.

“What respect requires in the context of [pragmatic trials] will vary based on the nature of the [pragmatic trial] in question. In some circumstances, alterations of consent may be more ethically appropriate than traditional regulatory consent practices,” the authors wrote.

The dimensions of demonstrating respect for persons—including promoting transparency, minimizing burden, and protecting privacy and confidentiality, among others—serve as context-dependent goals that researchers and oversight committees can use in considering the ethical design, conduct, and oversight of pragmatic trials.

Lead author Stephanie Morain and coauthors Benjamin Wilfond, Andrew Garland, and Jeremy Sugarman are members of the NIH Collaboratory’s Ethics and Regulatory Core.

Read the full article.