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Standards of Care

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Abstract

Established treatment and/or prevention interventions exist for most medical disorders. These may be single interventions or they may comprise a constellation of health interventions and are widely regarded as “standards of care.” These standards range from no treatment (especially in resource-poor settings) to a gold standard that is international, expensive, and complex. In the context of international multisite research conducted by resource-rich countries in resource-poor countries, standards of care used in the control arm of the study are often controversial especially when placebo is used in this group of participants. Such controversy resulted in global debate in the 1990s when antiretroviral treatment for pregnant women was tested against placebo in several resource-poor countries despite the establishment of a gold standard of care in resource-rich countries. Charges of ethical imperialism, ethical relativity, and exploitation of vulnerable populations were expressed in global debates.

Similar arguments emerged in the context of surfactant trials in premature infants in Bolivia. Guidance regarding standards of care in control groups enshrined in the Declaration of Helsinki became extremely controversial in the context of these global debates and increased the sensitivity of research ethics committees to the standard of care being used in clinical trials generally.

This chapter discusses the evolution of the debate on standards of care in clinical trials and adds to the controversy that abounds in research ethics.

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Acknowledgement

Material within this entry was originally part of the author’s DPhil dissertation published in 2004.

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Authors and Affiliations

  1. Department of Medicine, Centre for Medical Ethics and Law, Stellenbosch University, Cape Town, South africa

    Keymanthri Moodley

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  1. Keymanthri Moodley
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Correspondence to Keymanthri Moodley .

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  1. Duquesne University Center for Healthcare Ethics, Pittsburgh, Pennsylvania, USA

    Henk ten Have

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Moodley, K. (2016). Standards of Care. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-05544-2_400-2

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  • DOI: https://doi.org/10.1007/978-3-319-05544-2_400-2

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  • Publisher Name: Springer, Cham

  • Online ISBN: 978-3-319-05544-2

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Chapter history

  1. Latest

    Standards of Care
    Published:
    27 February 2016

    DOI: https://doi.org/10.1007/978-3-319-05544-2_400-2

  2. Original

    Standards of Care
    Published:
    16 June 2015

    DOI: https://doi.org/10.1007/978-3-319-05544-2_400-1

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