Year: 2025
Type: article
Abstract: Introduction: Pragmatic clinical trials conducted in the context of routine care frequently satisfy the regulatory criteria for a waiver of research consent. When they do, investigators and Institutional Review Boards might assume that there is no reason to communicate any information regarding the study to participants. Yet, this approach ignores the possibility that there may be value in providing information to participants, even when the study does not pose significant risks and researchers are not obtaining their consent. Methods: Members of the NIH Collaboratory Ethics and Regulatory Core working group used ethical analysis to determine whether there are reasons to provide information to research participants, other than notifying them of significant risks or obtaining their consent. Study team members then provided examples of trials which illustrate the feasibility and different options for providing information to participants in the context of trials conducted with a waiver of research consent. Results: Communicating information to participants can promote one or more of six goals: respect for persons, participant understanding of the research, participant understanding of their contributions, participant ability to voice any concerns, participant engagement, and trust and trustworthiness. Providing information can also raise potential concerns about feasibility and cost, which need to be balanced against these reasons to inform participants. Depending on the study, a variety of methods can be used to communicate information; for example, letters, email, flyers, posters, as well as brief conversations with clinicians. Conclusion: Even when researchers are not obtaining participants' consent, communicating information can promote one or more of six important goals. Providing information to participants should thus be the default for trials conducted under a waiver of research consent.
Source: Learning Health Systems
DOI: 10.1002/lrh2.70014
Institutions: Harvard University, Johns Hopkins University, Johns Hopkins Berman Institute of Bioethics, Stanford Medicine, Stanford University, Seattle Children's Hospital, University of Washington, Seattle Children's Research Institute, Treuman Katz Center for Pediatric Bioethics and Palliative Care, Colorado School of Public Health, Hospital of the University of Pennsylvania, University of Pennsylvania, Yale University, Dana-Farber Cancer Institute, VA Eastern Colorado Health Care System, University of Colorado Anschutz, Duke University, Brigham and Women's Hospital, Dana-Farber/Harvard Cancer Center, The University of Texas Southwestern Medical Center, Massachusetts General Hospital, National Institutes of Health
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,500
Awards: G1015218882, G1634256296, G1975199611, G2359886319, G3111920434, G3600554253, Pragmatic Trials in Maintenance Hemodialysis, HEAL Collaboratory Resource Coordinating Center (PRISM) (U24), G4730475229, Personalized Patient data and behavioral nudges to improve adherence to chronic cardiovascular medications, Improving Chronic Disease Management with Pieces (ICD-Pieces), G690087974, G7189733186
OpenAlex ID: W4409647333