Participant informed consent in cluster randomized trials: review.

<h4>Background</h4>The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of...

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Autores principales:	Bruno Giraudeau, Agnès Caille, Amélie Le Gouge, Philippe Ravaud
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2012
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/4fb9ea9bcc9a4c118d5d1d9ec3c0d586
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spelling	oai:doaj.org-article:4fb9ea9bcc9a4c118d5d1d9ec3c0d5862021-11-18T07:13:11ZParticipant informed consent in cluster randomized trials: review.1932-620310.1371/journal.pone.0040436https://doaj.org/article/4fb9ea9bcc9a4c118d5d1d9ec3c0d5862012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22792319/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information.<h4>Methods and findings</h4>We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias.<h4>Conclusions</h4>For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely, whether participants were informed of the allocation group before being recruited) for a better appraisal of the risk of selection bias.Bruno GiraudeauAgnès CailleAmélie Le GougePhilippe RavaudPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 7, p e40436 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Bruno Giraudeau Agnès Caille Amélie Le Gouge Philippe Ravaud Participant informed consent in cluster randomized trials: review.
description	<h4>Background</h4>The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT), obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information.<h4>Methods and findings</h4>We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%). In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization) was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias.<h4>Conclusions</h4>For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully described (namely, whether participants were informed of the allocation group before being recruited) for a better appraisal of the risk of selection bias.
format	article
author	Bruno Giraudeau Agnès Caille Amélie Le Gouge Philippe Ravaud
author_facet	Bruno Giraudeau Agnès Caille Amélie Le Gouge Philippe Ravaud
author_sort	Bruno Giraudeau
title	Participant informed consent in cluster randomized trials: review.
title_short	Participant informed consent in cluster randomized trials: review.
title_full	Participant informed consent in cluster randomized trials: review.
title_fullStr	Participant informed consent in cluster randomized trials: review.
title_full_unstemmed	Participant informed consent in cluster randomized trials: review.
title_sort	participant informed consent in cluster randomized trials: review.
publisher	Public Library of Science (PLoS)
publishDate	2012
url	https://doaj.org/article/4fb9ea9bcc9a4c118d5d1d9ec3c0d586
work_keys_str_mv	AT brunogiraudeau participantinformedconsentinclusterrandomizedtrialsreview AT agnescaille participantinformedconsentinclusterrandomizedtrialsreview AT amelielegouge participantinformedconsentinclusterrandomizedtrialsreview AT philipperavaud participantinformedconsentinclusterrandomizedtrialsreview
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Participant informed consent in cluster randomized trials: review.

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