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Editor's Correspondence |

Is Emergency Research Without Initial Consent Justified? The Consent Substitute Model

Gérald Kierzek, MD, MPH, PhD; Valeria Rac, MD, PhD; Jean-Louis Pourriat, MD, MSc
Arch Intern Med. 2010;170(16):1508-1509. doi:10.1001/archinternmed.2010.295.
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We read with interest the article by Largent et al1 justifying the consent substitute model for emergency research. Emergency research and especially advancing resuscitation science raise some important ethical and regulatory issues because of the patient's incapacity to consent. We strongly agree that emergency research considered as a “public good” is feasible most of the time, thanks to the waiver of consent. However, we think that the pivotal role of the community and citizens is underestimated by the authors. Indeed, the waiver of consent requires a balanced relationship and full confidence between health care providers and society (patients, families, and citizens); one way to reinforce them is by public disclosure and community consultation prior to study initiation required by US regulations. These requirements are remarkably unique in the United States, but little evidence is known about their effectiveness; furthermore, the opportunity for individuals to prospectively opt out is not required by federal regulation but depends on the decision by individual local institutional review boards.2 From an international perspective, the Directive 2001/20/EC of the European Parliament and Council3 has not taken into account the possibility of waiver of consent; nevertheless, many countries have adapted their regulations to allow emergency research. In France, for example, where there is a provision for incapacity to consent, deferred consent by patient or surrogate is possible,4 allowing enrollment without initial informed consent. In Canada, the waiver of consent approval in accordance with the Tri-Council Policy Agreement5 does not require the additional measures mandated by US authorities (community consultation and public disclosure).

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