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Unequal treatment of human research subjects

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Abstract

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized.

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Notes

  1. This article focuses on the Department of Health and Human Services’ regulations, otherwise known as the Common Rule because they have been adopted by 17 federal agencies. Although the Food and Drug Administration has not adopted the Common Rule, it has regulations that are very similar to the Common Rule (Food and Drug Administration 2013a,b).

  2. There is not sufficient space in this article to describe theories of justice in detail. For review, see Barnes 1996, Rhodes et al. 2002, Rhodes 2005, Sandel 2007, Sen 2011.

  3. Egalitarians take different perspectives on equality, ranging from equality of socioeconomic goods (Nielsen 1979), to equality of opportunity (Rawls 1971), to equality of basic capabilities (Sen 2011).

  4. Of course, some may not think that consistency is inherently valuable. As Ralph Waldo Emerson (1841) once said: “A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines.”

  5. Under the Common Rule, certain kinds of studies, such as some types of research involving surveys or the analysis of existing de-identified samples or data, are deemed to be exempt from IRB review (45 CFR 46.101). The Common Rule allows IRBs to forego full board review and use an expedited procedure to review new studies deemed to be minimal risk (45 CFR 46.110, Department of Health and Human Services 2009).

  6. This article focuses on US federal regulations. Other countries have similar rules (Office of Human Research Protections 2013b).

  7. Though I mention efforts in the US toward centralization, European nations have taken similar steps (Klitzman 2011).

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Acknowledgments

I would like to thank Bruce Androphy for helpful comments. This research supported by the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). It does not represent the views of the NIEHS or NIH.

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  1. National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU 03, Research Triangle Park, NC, 27709, USA

    David B. Resnik

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Resnik, D.B. Unequal treatment of human research subjects. Med Health Care and Philos 18, 23–32 (2015). https://doi.org/10.1007/s11019-014-9569-6

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