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The Ethics of Research with Human Subjects pp 165–191Cite as

Risks

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Part of the book series: International Library of Ethics, Law, and the New Medicine ((LIME,volume 74))

Abstract

In the previous two chapters, I applied the trust-based approach to ethical issues related to protecting human rights (i.e. autonomy and privacy) in research. In this chapter, I will shift the focus away from protection of rights toward the protection of welfare by examining issues related to managing risks to human research subjects.

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Notes

  1. 1.

    National Institutes of Health (2009).

  2. 2.

    These additional protections could be viewed as a form of soft paternalism . See discussion in Chap. 2.

  3. 3.

    In Chap. 9 I will discuss research with vulnerable subjects in more depth.

  4. 4.

    The National Institute of Environmental Health Sciences and the Environmental Protection Agency conduct studies that expose healthy volunteers to air pollution. The purpose of this research is to better understand how pollutants affect the human respiratory system. See Resnik (2007a, b, c, d, 2012b).

  5. 5.

    Some writers have challenged the equipoise requirement on the grounds that clinical equipoise is a poorly defined, vague concept. I will not explore that critique here. See Gifford (2000), Miller and Joffe (2011).

  6. 6.

    For example, suppose that a hypothetical drug (Drug A) used to treat depression has been shown to be 35% effective as compared to a placebo (29%), with a standard error of 5%. Since the placebo lies outside the standard error, we can say that the drug is barely more effective than the placebo. Suppose that we compare a new drug (Drug B) to Drug A and find that Drug A is 35% effective and drug B is 34% effective, with the same standard error of 5%. Since Drug B is only 5% more effective than the placebo from the earlier trial, this active-control study does not tell us whether Drug B is more effective than a placebo, because its effectiveness is within the standard error. To find out whether B is more effective than a placebo, we would need to conduct a study that includes a placebo control group or initiate a much larger active-controlled study to reduce the standard error.

  7. 7.

    Xenotransplantation is transplantation of tissues or organs across species, e.g. pig-human; a zoonosis is a disease transmitted from a vertebrate animal to a human.

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    David B. Resnik

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Resnik, D.B. (2018). Risks. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_7

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