SCCM Resource Library-Waiver of Informed Consent in Emergency Situations

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The document discusses the ethical and legal considerations of waiving informed consent for research involving human subjects, particularly in emergency situations. Informed consent is a cornerstone of ethical research, rooted in principles such as autonomy and respect for persons, as established by the Belmont Report and Common Rule. These require that subjects be fully informed and voluntarily consent to participate in research.<br /><br />However, in emergency situations where patients might be incapacitated or cannot provide consent due to their critical condition, exceptions can be made. In 1996, the U.S. Department of Health and Human Services (HHS) provided guidelines for waiving informed consent in a narrowly defined set of research circumstances where patients require immediate emergency intervention, and legally effective consent from them or their representatives is not feasible.<br /><br />Under these guidelines and the Final Rule introduced in 2017, certain criteria must be met for Institutional Review Boards (IRBs) to grant a waiver of informed consent in emergency research. These include the presence of a life-threatening condition, impaired decisional capacity, the inability to obtain surrogate consent in a timely fashion, and potential benefits to the patient from the research intervention versus available treatments.<br /><br />Furthermore, measures such as community consultation and post-research communication are essential to uphold ethical standards. Research protocols must define therapeutic windows and involve monitored safety boards. IRBs are tasked with ensuring compliance with these requirements and safeguarding participant rights.<br /><br />Judith A. Tate and Philippe R. Bauer, noted medical professionals, underscore that even in emergencies, patient welfare remains paramount, and the process for waiving consent is stringent to maintain ethical integrity in research.

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Research, Administration, 2018, 00:04:15

Asset Caption

"Waiver of Informed Consent in Emergency Situations" was published in the June/July 2018 issue of Critical Connections.

The Belmont Report, published in 1979, outlines the basic ethical principles for research with human subjects, which include respect for persons, beneficence, and justice.1 Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them.1 This opportunity is provided when adequate standards for informed consent are satisfied.1 The consent process contains three elements: information, comprehension, and voluntariness.1 Obtaining informed consent for participation in research reinforces the ethical principle of autonomy by providing the opportunity for individuals to make a voluntary choice to participate. Informed consent is also a legal doctrine based on the Common Rule. The Common Rule, published in 1991, is a set of federal regulations for ethical conduct of research with human subjects. 2 Title 45 CFR part 46 of the U.S. Department of Health and Human Services (HHS) regulations outlines the basic provisions for institutional review boards (IRBs), informed consent, and assurances of compliance.3

Critical Connections, the critical care industry's only newsmagazine, provides information on cutting-edge topics in critical care useful to the entire multiprofessional team.Philippe R. Bauer, Judith A. Tate

Meta Tag

Content Type Article

Knowledge Area Research

Knowledge Area Administration

Knowledge Level Foundational

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Membership Level Professional

Membership Level Associate

Tag Clinical Research Design

Tag Medical Legal Issues

Year 2018

Keywords

informed consent

ethical considerations

legal considerations

emergency research

Belmont Report

Common Rule

Institutional Review Boards

waiver criteria

patient welfare

community consultation

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