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Informed Consent in Health Research

A Practical Guide for the Global Setting

  • Review Article
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Abstract

Informed consent is a cornerstone of contemporary healthcare as well as of contemporary healthcare research. However, what counts as informed consent differs significantly from one setting to the other. This review begins with a brief discussion of the notion of informed consent itself and then applies it to the research setting. It gives a brief sketch of how the requirement for informed consent in research evolved from the Prussian Directive of 1900 to the current national and international guidelines and regulations, and outlines the various requirements that must be met for such consent to be valid. In research, the complete standard of disclosure is mandatory whereas in therapy an ‘objective reasonable person standard of disclosure’ is generally considered sufficient. In therapy, the discussion of expectations for a positive outcome and of hope for a cure form part of the consent process; in research, this must be handled differently so as to avoid unduly enticing potential research participants. For similar reasons, rewards for participating in the research must be kept to a minimum. Venue-shopping is also considered unethical. Since potential research participants who lack decision-making capacity cannot give consent, substitute decision-makers must take over the decision-making role. In considering whether to enrol incompetent persons in research, substitute decision-makers must follow either the previous competently expressed wishes of the now-incompetent persons or use what is known as the objective reasonable person standard. However, an incompetent person’s refusal to give assent is considered binding in nontherapeutic research and overrules even the duly empowered substitute decision-maker’s decision, and the wishes that have previously been expressed by the now-incompetent person in an advance directive are considered binding even if that may exclude the individual from participating in potentially life-saving trials. The article also distinguishes between deferred consent, presumed consent, prospective consent and substituted consent, and evaluates their acceptability in light of current ethical and legal considerations. The right of research participants to withdraw from any project is explained and the current standards for data management in the case of such a withdrawal are discussed. A separate section deals with consent to research in the emergency setting. It is shown why a signature on a consent form does not in itself mean that consent has been obtained, and why the concept of minimal risk that is used by some ethics committees is seriously flawed. Since legal standards of informed consent differ from jurisdiction to jurisdiction, the discussion highlights some of these differences and suggests ways to minimise any difficulties that might arise for multicentred trials involving distinct jurisdictions.

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Notes

  1. 1 It may also be of interest to note that the Canadian scene differs fundamentally in this regard since the Tri-Council Guidelines for Research on Human Subjects only stipulate that such consultation should be performed ‘when feasible or appropriate’.[21]

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Acknowledgements

No sources of funding were used to assist in the preparation of this review. The author has no conflicts of interest that are directly relevant to the content of this review.

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  1. Department of Philosophy, University of Victoria, Victoria, British Columbia, V8W 3P4, Canada

    Eike-Henner W. Kluge

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Kluge, EH.W. Informed Consent in Health Research. Int J Pharm Med 21, 405–414 (2007). https://doi.org/10.2165/00124363-200721060-00005

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