Informed Consent and Cluster-Randomized Trials

Autor:	Julius Sim, Angus Dawson
Rok vydání:	2012
Předmět:	Protocol (science) medicine.medical_specialty Informed Consent Public health Public Health Environmental and Occupational Health MEDLINE Disease cluster Institutional review board Task (project management) law.invention Professional Role Randomized controlled trial Nursing Informed consent law medicine Cluster Analysis Humans Public Health Psychology Social psychology Health Policy and Ethics Ethics Committees Research Randomized Controlled Trials as Topic
Zdroj:	American Journal of Public Health. 102:480-485
ISSN:	1541-0048 0090-0036
DOI:	10.2105/ajph.2011.300389
Popis:	We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions. However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission. We further argue that it should be the institutional review board’s task to evaluate whether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::acbf4d5923952b7ab4d700bf4e6fc0a4 https://doi.org/10.2105/ajph.2011.300389 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.