Elsevier

The Lancet

Volume 377, Issue 9771, 26 March–1 April 2011, Pages 1071-1072
The Lancet

Correspondence
Effect of consent rituals on mortality in emergency care research

https://doi.org/10.1016/S0140-6736(11)60317-6Get rights and content

References (8)

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  • Medicines for human use (clinical trials) regulations 2004

  • Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research. Final rules 21CFR50.24

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  • Effect of intravenous corticosteroids on death within 14 days in 10,008 adults with clinically significant head injury (MRC CRASH Trial): a randomised placebo-controlled trial

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There are more references available in the full text version of this article.

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    Others have argued that a requirement for informed consent in emergency situations may itself be life-threatening by potentially delaying immediately required interventions.21 A demand for prior informed consent may also limit improvements in outcomes and adoption of effective treatments for patients with time-sensitive emergency conditions16,21–23 Although the current regulations related to EFIC in the United States and Canada may be imperfect, we believe that changing these regulations to require patient or LAR consent before an intervention is not desirable. Changing these regulations to allow deferred consent afterwards, as is the case in Europe, could bias estimates of treatment effects.

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    This is considered as an ethically acceptable alternative for low-risk research, ensuring both the possibility of research benefit and respect for patient/family autonomy.325,326 In contrast, a strict requirement for pre-enrolment consent may delay the initiation of an experimental intervention, thereby hampering its potential benefit to the patient.327 Another ethically acceptable and legally supported consent model comprises exception to informed consent (EIC) with prior community consultation (and a possibility of prospective opt out for community members).328–335

  • Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review

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    The consent requirements also impacted on the numbers recruited as only 17% of all US eligible patients were enrolled, largely because of the delayed arrival of LARs with 63% arriving at the hospital >12 h after the patient and so missing the inclusion criteria [16]. The requirement for these ‘consent rituals’ may also lead to harm through delaying potentially life-saving treatment when such delays would not be encountered in clinical practice, and potentially reduce or obscure any treatment effect [76]. In emergency situations, when prior consent of the patient is not possible, and the subject's legally acceptable representative is not available, enrolment of the patient should follow alternative procedures described in the protocol that has been reviewed and approved by the IRB/REC.

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