Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual‐Level Intervention

London, Alex John; Taljaard, Monica; Weijer, Charles

doi:10.1002/eahr.500071

Cited by 9 publications

(10 citation statements)

References 20 publications

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“…In cluster randomized trials, obtaining conventional informed consent becomes impractical since the intervention is implemented on a population level; participants are not able to provide meaningful consent since they would be unable to escape the intervention. 21,33,34,42–44…”

Section: Resultsmentioning

confidence: 99%

When is it impractical to ask informed consent? A systematic review

et al. 2022

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Background Informed consent is one of the cornerstones of biomedical research with human subjects. Research ethics committees may allow for a modification or a waiver of consent when the research has social value, involves minimal risk, and if consent is impractical to obtain. While the conditions of social value and minimal risk have received ample attention in research ethics literature, the impractical condition remains unclear. There seem to be different interpretations of the meaning of impractical within academic literature. To address this lack of clarity, we performed a systematic review on the interpretation of impractical. Methods First, we examined international research ethics guidelines on their usage and interpretation of impractical. Next, we used international ethical guidelines to identify synonyms of the term “impractical.” Accordingly, PubMed, Embase, and Web of Science were searched for articles that included “informed consent” and “impractical” or one of its synonyms. Results We found that there were only a few international ethics guidelines that described what could be considered impractical. Out of 2329 identified academic articles, 42 were included. Impractical was used to describe four different conditions: (1) obtaining informed consent becomes too demanding for researchers, (2) obtaining informed consent leads to invalid study outcomes, (3) obtaining informed consent harms the participant, and (4) obtaining informed consent is meaningless for the participant. Conclusion There are conditions that render conventional informed consent truly impractical, such as untraceable participants or harm for participants. At the same time, researchers have a moral responsibility to design an infrastructure in which consent can be obtained, even if they face hardship in obtaining consent. In addition, researchers should seek to minimize harm inflicted upon participants when harm may occur as a result of the consent procedure. Invalidity of research due to consent issues should not be regarded as impractical but as a condition that limits the social value of research. Further research is essential for when a waiver of informed consent based on impractical is also reasonable.

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Section: Resultsmentioning

confidence: 99%

When is it impractical to ask informed consent? A systematic review

et al. 2022

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“…While clearly informed by hindsight, we believe there are several lessons to learn from this review. First, investigators should clearly establish why their studies would be impracticable if they were required to enroll only subjects capable of consenting (or having LARs available to do so on their behalf), and ethics review boards should ensure those reasons are legitimate (Capron, 2018, at 23; London et al, 2020). We believe it is incumbent on clinical researchers and ethics reviewers to provide explicit justification for withholding information that would typically be disclosed to trial participants and for their decisions to “waive” usual consent requirements.…”

Section: Discussionmentioning

confidence: 99%

Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials

Dhamanaskar

Feldman

Merz

2022

Journal of Empirical Research on Human Research Ethics

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Impracticability is an ethical standard for waiver of informed consent in research. We examine how well the criterion of impracticability appears to have been fulfilled in a set of 36 completed randomized controlled trials (RCTs) that secured consent from some subjects or LARs and employed waivers to enroll others. These trials were identified among 155 RCTs using waivers of consent in a convenience sample drawn from 7 systematic reviews. Recruitment data were available for 19 of the 36 trials, revealing an average of 41.6% of subjects (range 0.2–98.7%, 95% CI: 24.8–58.4%) were enrolled without consent. Six trials enrolled less than 10% of subjects without consent and an overlapping set of 9 trials sought consent from all subjects or LARs at some sites while waiving consent at other sites. We question whether these trials were practicable without waivers and identify issues for consideration by investigators and ethics review boards.

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“…27 The acceptance of these extraneous justifications creates a loophole in the ethical oversight of research. 26 Further, the illegitimate use of waivers of consent undermines the autonomy rights of participants and potentially exposes research ethics committees and their institutions to legal liability and sanction by government authorities.…”

Section: Open Accessmentioning

confidence: 99%

“…As with individually randomised trials, waivers of consent in CRTs of individual-level interventions are rarely justifiable. A useful heuristic is: a waiver of consent for a CRT of an individual-level intervention should only be granted if an individually randomised trial testing the same intervention would also qualify for a waiver of consent 26. In spite of their similarity to individually randomised trials, determining the appropriateness of waivers of consent for CRTs of individual-level interventions has been particularly challenging for research ethics committees.…”

Section: Introductionmentioning

confidence: 99%

“…Illegitimately accepted justifications for waivers of consent included: the use of ‘usual care’ study interventions; the pragmatic nature of the trial and cluster randomisation 27. The acceptance of these extraneous justifications creates a loophole in the ethical oversight of research 26. Further, the illegitimate use of waivers of consent undermines the autonomy rights of participants and potentially exposes research ethics committees and their institutions to legal liability and sanction by government authorities.…”

Section: Introductionmentioning

confidence: 99%

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Informed consent in cluster randomised trials: a guide for the perplexed

et al. 2021

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In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

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Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual‐Level Intervention

Cited by 9 publications

References 20 publications

When is it impractical to ask informed consent? A systematic review

When is it impractical to ask informed consent? A systematic review

Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials

Informed consent in cluster randomised trials: a guide for the perplexed

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