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

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e054213
Author(s):  
Hayden P Nix ◽  
Charles Weijer ◽  
Jamie C Brehaut ◽  
David Forster ◽  
Cory E Goldstein ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Randomised Trial ◽  
Ethics Committees ◽  
Cluster Randomised Trial ◽  
Research Ethics Committees ◽  
Randomised Trials ◽  
Research Participants ◽  
Inappropriate Use ◽  
Cluster Randomised

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.

scholarly journals Knowledge, awareness, and attitudes about research ethics committees and informed consent among resident doctors

2019 ◽  
Vol Volume 12 ◽  
pp. 141-145 ◽  
Author(s):  
Saddam Al Demour ◽  
Karem H Alzoubi ◽  
Anas Alabsi ◽  
Sadam Al Abdallat ◽  
Ashraf Alzayed
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees

scholarly journals Group sequential designs for stepped-wedge cluster randomised trials

2017 ◽  
Vol 14 (5) ◽  
pp. 507-517 ◽  
Author(s):  
Michael J Grayling ◽  
James MS Wason ◽  
Adrian P Mander
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Type I ◽  
Randomised Trials ◽  
Early Stopping ◽  
Stepped Wedge ◽  
Group Sequential ◽  
Interim Analyses ◽  
Cluster Randomised Trials ◽  
Cluster Randomised

Background/Aims: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Methods: Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. Results: We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial’s type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. Conclusion: The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into stepped-wedge cluster randomised trials according to the needs of the particular trial.

Protecting vulnerable research participants: A Foucault-inspired analysis of ethics committees

2011 ◽  
Vol 18 (5) ◽  
pp. 640-650 ◽  
Author(s):  
Truls I Juritzen ◽  
Harald Grimen ◽  
Kristin Heggen
Keyword(s):  
Research Ethics ◽  
Academic Freedom ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Practices ◽  
Research Participants

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault’s ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed — not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

Alzheimer Disease Ethics—Informed Consent and Related Issues in Clinical Trials: Results of a Survey Among the Members of the Research Ethics Committees in Sweden

2003 ◽  
Vol 15 (2) ◽  
pp. 157-170 ◽  
Author(s):  
Gunbrith Peterson ◽  
Anders Wallin
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Research Ethics Committees ◽  
Biomedical Sciences ◽  
Men And Women ◽  
Decision Making Capacity ◽  
Participation In Research

The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity. We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.

Payment of research participants: current practice and policies of Irish research ethics committees

2012 ◽  
Vol 39 (9) ◽  
pp. 591-593 ◽  
Author(s):  
Eric Roche ◽  
Romaine King ◽  
Helen M Mohan ◽  
Blanaid Gavin ◽  
Fiona McNicholas
Keyword(s):  
Research Ethics ◽  
Current Practice ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Participants

scholarly journals Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials

BMJ ◽  
2011 ◽  
Vol 342 (may11 1) ◽  
pp. d2496-d2496 ◽  
Author(s):  
M. Taljaard ◽  
A. D. McRae ◽  
C. Weijer ◽  
C. Bennett ◽  
S. Dixon ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Random Sample ◽  
Randomised Trials ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Cluster Randomised Trials ◽  
Cluster Randomised

scholarly journals Protecting Patients—Managing Persons

1970 ◽  
Vol 7 (1) ◽  
Author(s):  
Susanne Langer
Keyword(s):  
Multiple Sclerosis ◽  
Informed Consent ◽  
Research Ethics ◽  
Decision Process ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Individual Choice ◽  
Culturally Specific ◽  
Local Research

This paper is based on my experience of applying for ethics approval from two different Local Research Ethics Committees (LRECs) in the context of fieldwork with people suffering from multiple sclerosis (MS) in the Manchester area. I argue that LRECs are a form of audit intended to remove relationships from the decision process and to change practice. By focusing on the category of ‘informed consent’ and how it is conceptually and bureaucratically constructed, I analyse the ways in which ethics committees are able to preserve the notion of individual choice while at the same time defining its parameters. In so doing, ethics committees interfere with the efforts of people, such as the ones I worked with, to become productive in culturally-specific ways, for instance by being involved in research. I conclude by reflecting on how the removal of the relational dimension of research through bureaucratic technologies, such as ethics committees, affects anthropologists.

Sign in / Sign up

Export Citation Format

Share Document