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 ... -  《-》

Privacy and confidentiality in pragmatic clinical trials.

With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

McGraw D ，Greene SM ，Miner CS ，Staman KL ，Welch MJ ，Rubel A ... -  《-》

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 《-》

Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.

Andrews JE ，Moore JB ，Weinberg RB ，Sissine M ，Gesell S ，Halladay J ，Rosamond W ，Bushnell C ，Jones S ，Means P ，King NMP ，Omoyeni D ，Duncan PW ，COMPASS investigators and stakeholders ... -  《-》

Ethics challenges in sharing data from pragmatic clinical trials.

Morain SR ，Bollinger J ，Weinfurt K ，Sugarman J ... -  《-》