Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs

被引:3
作者
Seeger, Rena [1 ]
Udoh, Ubong [2 ]
Dewar, Brian [2 ]
Nicholls, Stuart [2 ]
Fedyk, Mark [3 ]
Fahed, Robert [2 ,4 ]
Perry, Jeff [2 ,5 ]
Hill, Michael D. [6 ,7 ]
Menon, Bijoy [6 ,7 ]
Swartz, Richard H. [8 ,9 ]
Poppe, Alexandre Y. [10 ]
Gocan, Sophia [4 ]
Brehaut, Jamie [2 ]
Dainty, Katie [11 ,12 ]
Shepherd, Victoria [13 ]
Dowlatshahi, Dar [2 ,4 ]
Shamy, Michel [2 ,4 ]
机构
[1] Univ Ottawa, Fac Med, Ottawa, ON, Canada
[2] Ottawa Hosp, Ottawa Hosp Res Inst, Ottawa, ON, Canada
[3] Univ Calif Davis, Sch Med, Davis, CA USA
[4] Ottawa Hosp, Dept Med, Div Neurol, Ottawa, ON, Canada
[5] Ottawa Hosp, Dept Emergency Med, Ottawa, ON, Canada
[6] Univ Calgary, Dept Clin Neurosci, Calgary, AB, Canada
[7] Calgary Stroke Program, Calgary, AB, Canada
[8] Univ Toronto, Dept Med, Toronto, ON, Canada
[9] Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada
[10] Ctr Hosp Univ Montreal, Dept Neurosci, Montreal, PQ, Canada
[11] North York Gen Hosp, Dept Res & Innovat, Toronto, ON, Canada
[12] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada
[13] Cardiff Univ, Ctr Trials Res, Cardiff, Wales
关键词
Consent; advance directives; research ethics;
D O I
10.1017/cjn.2023.247
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators. Le consentement prealable dans le cas d'essais cliniques portant sur les AVC aigus : une enquete aupres des presidents des Comites d'ethique de la recherche au Canada. Le consentement prealable pourrait permettre aux personnes presentant un risque eleve d'AVC de donner leur accord pour participer a des essais cliniques portant sur les AVC aigus, et ce, avant meme d'etre estimees admissibles. Cette enquete entend explorer l'acceptabilite de cette nouvelle modalite aupres des presidents des Comites d'ethique de la recherche (CER) canadiens qui evaluent les essais cliniques portant sur les AVC aigus. A cet egard, les reponses de 15 presidents de CER ont montre que la majorite d'entre eux se sentaient a l'aise d'approuver des etudes ayant adopte le consentement prealable. Aucune preference nette pour le consentement prealable par rapport au report du consentement n'a emerge meme si les repondants ont exprime des preoccupations importantes a l'egard du consentement prealable general plutot que specifique a un essai clinique. Ces resultats mettent donc en lumiere l'acceptabilite du consentement prealable au sein des organismes canadiens de reglementation de l'ethique.
引用
收藏
页码:285 / 288
页数:4
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