Informed consent in pragmatic trials: results from a survey of trials published 2014–2019
| Autor: | Hayden P Nix, Jamie C. Brehaut, Stuart G. Nicholls, Cory E. Goldstein, Paul C McLean, Kelly Carroll, Monica Taljaard, Dean Fergusson, Charles Weijer, Jennifer Zhe Zhang, Spencer Phillips Hey |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Research ethics Health (social science) Health Policy MEDLINE 030204 cardiovascular system & hematology Waiver 3. Good health Clinical trial 03 medical and health sciences Issues ethics and legal aspects 0302 clinical medicine Arts and Humanities (miscellaneous) Patient autonomy Informed consent Family medicine Obtaining consent medicine 030212 general & internal medicine Search filter Psychology |
| Zdroj: | Journal of Medical Ethics. 49:34-40 |
| ISSN: | 1473-4257 0306-6800 |
| DOI: | 10.1136/medethics-2021-107765 |
| Popis: | ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (pDiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. |
| Databáze: | OpenAIRE |
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