1 research outputs found
Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?
In 2010 Largent, Wendler and Emanuel proposed the āconsent substitute modelā 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 patientsā urgent medical needs (2) the riskābenefit ratio is favorable (3) there are no known conflicts with patientsā 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 modelās 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 Harmonisationās Guideline for Good Clinical Practice and the World Medical Associationās Declaration of Helsinki, are revised to include more specific provisions on emergency medical research