Abstract
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.
Highlights
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research
How can a study proceed if informed consent is not possible? Second, is consent to randomization always required? Third, what information must be disclosed to potential subjects if their cluster has already been randomized? Fourth, is passive consent a valid substitute for informed consent? Fifth, do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?
This paper addresses the question: from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects
Summary
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. The practical impossibility of obtaining informed consent in such cases presents a serious ethical challenge to CRTs. Above we concluded that the function of informed consent is to allow prospective research subjects to adopt the ends of the study as their own, thereby (partially) justifying exposing subjects to risk for the benefit of others. Long as prospective research subjects are approached for informed consent at the earliest opportunity, and prior to study or data collection interventions, we believe the ethical principle of respect for persons is satisfied. In cases in which the intervention is administered to groups of health care providers or if their numbers are large, it may not always be possible to obtain informed consent In these circumstances, researchers may apply to the research ethics committee for a waiver of consent. Recognizing this general obligation does not diminish – in any way– the need to obtain the informed consent of health care professionals [37]
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