Learning Health Systems, Informed Consent, and Respect for Persons.

Several pieces in the Hastings Center Report's May-June 2022 issue concern research ethics issues that arise in learning health care systems. In the lead article, Stephanie Morain and colleagues propose a new ethical framework for pragmatic clinical trials (PCTs), which are trials embedded in clinical care. Their framework consists of eight dimensions of demonstrating respect for patients enrolled in PCTs. In the second article, Robert Steel argues that patients being treated in a learning health care system can be required to participate in a clinical trial even if the risk to them is more than minimal. If they wish to refuse, they must either forgo treatment in the system or seek it elsewhere. Three commentaries explore various dimensions of Steel's argument. A third article in the issue turns in a different direction, to assumptions in bioethics about the quality of lives lived with disability. The authors, Debjani Mukherjee, Preya Tarsney, and Kristi Kirschner, find much that needs to change and offer recommendations for improvements at multiple levels.

Kaebnick GE 《-》

Disability, Bioethics, and the Problem of Prejudice.

This letter responds to the essay "If Not Now, Then When? Taking Disability Seriously in Bioethics," by Debjani Mukherjee, Preya S. Tarsney, and Kristi L. Kirschner, in the May-June 2022 issue of the Hastings Center Report.

Scofield GR 《-》

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

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.

Morain SR ，Kraft SA ，Wilfond BS ，Mcguire A ，Dickert NW ，Garland A ，Sugarman J ... -  《-》

Variations on Consent.

Two articles in the March-April 2021 issue of the Hastings Center Report consider alterations to traditional informed consent. In "The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care," Marc Tunzi and colleagues argue that, in primary care settings, patient consent should be understood as taking a range of forms depending on the procedure, the patient, and the patient-care context. Traditional informed consent is at the ceremonious end; for many things done in these settings, the authors assert, assent or even nondissent is fine. In the lead article, health policy scholars Stephanie Morain and Emily Largent consider another continuum for informed consent, this one occurring with pragmatic research, at the intersection of clinical care with research.

Kaebnick GE 《-》

Necessity, Rights, and Rationing in Compulsory Research.

In "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," Robert Steel offers an argument in favor of compelling individuals to participate in some research that poses more than minimal risk. In his view, the ethics of compulsory research turns on questions of fair distribution of benefits and burdens, within a paradigm analogous to health care resource rationing. We do not dispute that it may theoretically be permissible to compel participation in certain circumstances, including those that rise above minimal risk. Nevertheless, Steel's argument for this conclusion faces several challenges that ultimately render it unconvincing in its present form. First, compulsion should be subject to a "necessity" criterion, which substantially limits its applicable scope. Second, compulsion is a prima facie rights violation that requires stronger ethical justification than Steel offers. And third, substantial structural and motivational differences between rationing and compulsion render the analogy inapt.

Schaefer GO ，Muralidharan A 《-》