Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

• Type of Material: Article
• Authors: Stephanie Morain, Johns Hopkins Berman Institute of Bioethics; Stephanie A Kraft, Seattle Children’s Research Institute; Benjamin S Wilfond, Seattle Children’s Research Institute; Amy Mcguire, Center for Medical Ethics & Health Policy; Neal Dickert, Emory University; Andrew Garland, Johns Hopkins Berman Institute of Bioethics; Jeremy Sugarman, Johns Hopkins Berman Institute of Bioethics
• Language: English
• Date: 2022-05-01
• Publisher: Wiley
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2022 The Hastings Center
• Final Published Version (URL): http://dx.doi.org/10.1002/hast.1391
• Title of Journal or Parent Work: Hastings Center Report
• Volume: 52
• Issue: 3
• Start Page: 9
• End Page: 17
• Keywords: Moral Obligations; Informed Consent; pragmatic clinical trials; Communication; bioethics; clinical ethics; research ethics; Humans; Prospective Studies; Privacy; PCT; consent; Pragmatic Clinical Trials as Topic; respect

Abstract

Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)—particularly those that may alter or waive informed consent—remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.