Kayte Spector-Bagdady

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.

November 9, 2022: Ethics and Regulatory Grand Rounds Series Continues This Friday

Posted on by Damon Seils

Headshots of Stephanie Morain and Kayte Spector-BagdadyThis Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Stephanie Morain and Kayte Spector-Bagdady will present “Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape.”

The Grand Rounds session will be held on Friday, November 11, 2022, at 1:00 pm eastern.

Morain is a core faculty member in the Berman Institute of Bioethics and an assistant professor of health policy and management in the Bloomberg School of Public Health, both at Johns Hopkins University. Spector-Bagdady is interim codirector of the Center for Bioethics and Social Sciences in Medicine and an assistant professor of obstetrics and gynecology at the University of Michigan Medical School. Both Morain and Spector-Bagdady are members of the NIH Collaboratory’s Ethics and Regulatory Core.

Join the online meeting.

This special Grand Rounds series features moderated webinar discussions with panels of experts. The sessions focus on a range of topics, including the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent.

Read the full program.

May 4, 2022: Ethics Core Members Pen Guest Editorial for AJOB Focus on Machine Learning in Healthcare

Posted on by Damon Seils
In a guest editorial in the American Journal of Bioethics, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core introduced the issue’s target article and peer commentaries on artificial intelligence and machine learning in healthcare. Prof. Kayte Spector-Bagdady and Drs. Vasiliki Rahimzadeh and Kaitlyn Jaffe, who are Core members, were joined by coauthor Dr. Jonathan Moreno in writing the editorial.

The target article of the themed collection proposes a research ethics framework for the clinical translation of healthcare machine learning. In several peer commentaries accompanying the article, experts offer their perspectives on the proposed framework, including critiques of “the insufficiency of current ethics and regulatory solutions to adequately protect communities at higher risk for [machine learning] bias.”

Read the full editorial, “Promoting Ethical Deployment of Artificial Intelligence and Machine Learning in Healthcare.” Learn more about our Ethics and Regulatory Core.