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

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 riskbenefit 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 1) whether they accord with the consent substitute model's five conditions and 2) 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 Harmonization'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.

Protocol for Deferral of Consent in Acute Stroke Trials

“…Whereas American guidelines also require community consultation prior to launching a trial using an exception from informed consent, Canadian guidelines only recommend doing so. (22) Canadian and American guidelines specify that there be a documented and diligent effort to obtain surrogate consent, while European guidelines do not make this stipulation. (23) It is important to note that American guidelines of "Exceptions from Informed Consent" allow either informed consent, surrogate consent or waiver of consent, in which no consent is sought; deferral of consent is not a recognized option.…”

The Declaration of Helsinki in bioethics literature since the last revision in 2013

“…Langlois et al demand that the DoH and the International Councilfor Harmonisation's Guideline for Good Clinical Practice should be "revised to include more specific provisions on emergency medical research." They also cite the CIOMS guidelines as an example of a guideline which contains such a provision 52. So far, the DoH refers in § 30 to the situation when informed consent cannot be given by the patient, no "representative is available and[…] the research cannot be delayed."…”

Ethical Justification for Deferral of Consent in the AcT Trial for Acute Ischemic Stroke

“…Therefore, we think it is important to justify the use of deferral of consent, by which we mean explicitly establishing whether its use is both ethically permissible and methodologically necessary. Although national and regional policies exist to frame this conversation, 10 these documents can be imprecise, are interpreted variably within jurisdictions, and are not acknowledged across jurisdictions. 2,11,12…”

“…[7][8][9] Therefore, we think it is important to justify the use of deferral of consent, by which we mean explicitly establishing whether its use is both ethically permissible and methodologically necessary. Although national and regional policies exist to frame this conversation, 10 these documents can be imprecise, are interpreted variably within jurisdictions, and are not acknowledged across jurisdictions. 2,11,12 The AcT trial (Alteplase Compared to Tenecteplase) for acute ischemic stroke 13 is a Canadian, pragmatic, prospective, randomized, open-label, blinded-end point (PROBE) trial that seeks to enroll patients with acute ischemic stroke under 4.5 hours from symptom onset to receive either alteplase or tenecteplase.…”