Do National and International Ethics Documents Accord with the Consent Substitute Model for Emergency Research?

Langlois, Adèle, Armstrong, Stephanie and Siriwardena, A. Niroshan (2021) Do National and International Ethics Documents Accord with the Consent Substitute Model for Emergency Research? Academic Emergency Medicine . ISSN 1069-6563

Full content URL: https://doi.org/10.1111/acem.14179

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Do National and International Ethics Documents Accord with the Consent Substitute Model for Emergency Research?
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Item Type:Article
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Abstract

In 2010 Largent, Wendler and Emanuel proposed the ‘consent substitute model’ for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: (1) the research addresses the patients’ urgent medical needs (2) the risk‐benefit ratio is favorable (3) there are no known conflicts with patients’ values or interests (4) cumulative net risk is minimal and (5) consent is given as soon as possible. We review national and international ethics laws, regulations and guidelines to determine (a) whether they accord with the consent substitute model’s five conditions and (b) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonisation’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

Keywords:Emergency medicine, Informed consent, Ethics, International
Subjects:L Social studies > L250 International Relations
B Subjects allied to Medicine > B990 Subjects Allied to Medicine not elsewhere classified
L Social studies > L431 Health Policy
A Medicine and Dentistry > A300 Clinical Medicine
Divisions:College of Social Science > School of Health & Social Care
College of Social Science > School of Social & Political Sciences
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ID Code:43311
Deposited On:16 Dec 2020 10:43

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