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Trust as a Foundation for Research with Human Subjects

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The Ethics of Research with Human Subjects

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

Abstract

The previous two chapters have provided some historical and philosophical background to set the stage for the discussions that will take place in this chapter. In Chap. 2, I examined the history of the ethics of research with human subjects and argued that existing regulations and guidelines were adopted to restore and maintain public trust and prevent ethical abuses from occurring again. However, since ethical issues involving conflicts between the rights/welfare of human subjects and the advancement of knowledge will continue to arise when interpreting and applying existing regulations or deciding whether to revise them, we need an ethical decision-making framework to guide policy formation and help us establish priorities. In Chap. 3, I examined some influential moral theories to determine whether they could supply such a framework. I argued that the theories have strengths and weaknesses but that no single theory satisfactorily answers all objections and satisfies all critics, and that the most reasonable position is to adopt some form of moral pluralism. I proposed that four moral principles, similar to those defended by Beauchamp and Childress (2012), can guide ethical decision-making and policy formation. I noted, however, that the pluralistic approach still faces the issue of priority-setting when moral conflicts arise. I suggested that a fifth principle, the principle of trust, can help investigators, oversight committees, institutions, and funding agencies set priorities in research with human subjects when conflicts arise. In this chapter I will elaborate on and defend an approach to research with human subject based on the notion of trust.

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Notes

  1. 1.

    Chapter 5 will explore informed consent in greater depth.

  2. 2.

    There have been more recent studies of attitudes toward research participation. See Trauth et al. (2000), Sood et al. (2009), Lemke et al. (2010), Zarate et al. (2016). The point of discussing the Kass et al. (1996) article is that it focuses on attitudes as they relate to trust and suggests that trust may serve as a foundation for ethical responsibilities.

  3. 3.

    Richardson and Belsky’s view is somewhat different than mine in they do not equate trust with a psychological attitude or state. The fact that one relies on someone else does not create a trust relationship. For there to be an entrustment, one must have a good reason for relying on the entrusted party.

  4. 4.

    Richardson (2012) drops the bailment metaphor.

  5. 5.

    It is worth noting that the Nigeria ’s National Code of Health Research Ethics includes trust as a requirement for approval of research with human subjects. According to the Code: “For research to be ethical, nothing must be done to undermine the trust relationship that is at the heart of the researcher(s)-participant(s) relationships. This requires that there is transparency in all matters relating to the research enterprise including clear description of goals, risks, benefits, alternatives to participation and voluntariness. It is also necessary to determine the social value of the research and engage in creative approaches for effective representations and involvement of researchers and communities in the entire enterprise. Strategies for dynamic and reciprocal collaboration that leads to transformation of essential relationships based on reciprocity are also essential. This trust principle encourages the engagement of individual participants and communities , respects local socio-cultural values and encourages the provision of relevant and timely feedback to communities (National Health Research Ethics Committee of Nigeria 2007).”

  6. 6.

    The Institutional Review Board Researcher Assessment Tool (IRB-ART) is a widely used survey instrument obtaining data on researchers’ perceptions of the IRB (Keith-Spiegel and Koocher 2005).

  7. 7.

    Chapter 6 will explore privacy and confidentiality issues in greater depth.

  8. 8.

    In the U.S., various federal and state laws protect individuals from discrimination in employment and health insurance. Some of these include: the Americans with Disabilities Act, the Civil Rights Act, the Genetic Non-Discrimination Act, and the Health Insurance Portability and Accountability Act (HIPAA). However, these laws do not cover every type of discrimination that could occur, such as discrimination when applying for life insurance or a mortgage, and not all of them have been well-tested by the courts. Thus, discrimination may still occur in the U.S. and other countries, despite laws that prohibit it (Hudson 2007; Hodge and Gostin 2008).

  9. 9.

    There are four phases of drug trials involving human research subjects. Phase I clinical trials are small studies (typically less than 100 subjects) which enroll healthy individuals and last only a few months. The primary goals of Phase I studies are to assess drug safety and obtain information on dosing, toxicology, and pharmacokinetics. If a drug makes it past Phase I, the manufacturer can go ahead with a Phase II study. Phase II trials are larger studies (typically around 300 subjects) which enroll individuals with a disease or condition treated by the drug and may last several years. The primary goals of Phase II studies are to assess safety and efficacy. Phase III trials are similar to Phase II studies, except they are much larger (typically around 3000 subjects). Phase IV trials are also large (typically thousands of subjects) and are conducted after the drug has been approved. Phase IV trials also collect data on safety and efficacy and may include classes of subjects not included in earlier studies. For example, if people 60 years or older were excluded from earlier studies to protect them from harm, they might be included in Phase IV trials if they data indicate that it is likely to be safe to include them (Food and Drug Administration 2015).

  10. 10.

    Henry Richardson pointed out this objection.

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    David B. Resnik

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Resnik, D.B. (2018). Trust as a Foundation for Research with Human Subjects. 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_4

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