The Needed Revision of the Belmont Report An HIV Cure Research Case Study

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Abstract

The use of human subjects in research gives rise to a myriad of ethical concerns, which are primarily addressed in the Belmont Report. This set of guidelines for researchers focuses on protecting vulnerable individuals from being taken advantaged of in medical studies. Until recently, its breadth has been adequate guidance for contemporary concerns, but these guidelines are now failing to address novel biomedical issues. The structure of the Report creates an inadequate foundation to navigate ethical concerns not explicitly addressed in the paper, exemplified through a case study of HIV cure research. While the HIV crisis is centered in sub-Saharan Africa and largely affecting women and adolescents, cure research is happening almost exclusively in high income countries using white male subjects. This introduces an ethical dilemma, as studies have shown that population and environmental differences could lead to an HIV cure developed on one demographic to be less effective on another. Low-income countries in most need of the cure have inadequate infrastructure to pursue one on their own, leaving large populations excluded from research with no ethical guidelines to protect them. I argue that the Belmont Report must make more explicit the ethical principles that are implied in their report, calling for a distributive justice that makes clear our moral obligation to include vulnerable populations in research studies.

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References

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. [Bethesda, Md.]: The Commission, 1978.

Ndung’u, Thumbi, et al. “Why and Where an HIV Cure Is Needed and How It Might Be Achieved.” Nature, vol. 576, no. 7787, 1 Dec. 2019, pp. 397–405, www.nature.com/articles/s41586-019-1841-8, 10.1038/s41586-019-1841-8.

Dubé, Karine et al. “Ethics of HIV cure research: an unfinished agenda.” BMC medical ethics vol. 22, no. 83, 30 Jun. 2021, doi:10.1186/s12910-021-00651-1

Tucker, Joseph D., and Stuart Rennie. “Social and Ethical Implications of HIV Cure Research.” AIDS, vol. 28, no. 9, June 2014, pp. 1247–1250, 10.1097/qad.0000000000000210.

Barr, Liz, and Richard Jefferys. “A landscape analysis of HIV cure-related clinical research in 2019.” Journal of virus eradication vol. 6, no. 4, 2 Sep. 2020, doi:10.1016/j.jve.2020.100010

Kant, Immanuel. The Metaphysics of Morals. 1797. New York, Cambridge University Press, 2017.

Angier, Tom, and Cambridge University Press. The Cambridge Companion to Natural Law Ethics. Cambridge New York Melbourne New Delhi Singapore Cambridge University Press, 2019.

Mill, John Stuart. On Utilitarianism. Duke Classics, 2020.

Joint United Nations Programme on HIV/AIDS. “Global report: UNAIDS global AIDS Update – Confronting Inequalities.” 2021.

Padian, Nancy S et al. “Weighing the gold in the gold standard: challenges in HIV prevention research.” AIDS (London, England) vol. 24, no. 5, March 2010, pp. 621-35, doi:10.1097/QAD.0b013e328337798a

Hayes, Richard et al. “HIV prevention research: taking stock and the way forward.” AIDS (London, England) vol. 24, October 2010, pp. 81-92, doi:10.1097/01.aids.0000390710.04255.2b

Rossouw, Theresa et al. “Barriers to HIV remission research in low- and middle-income countries.” Journal of the International AIDS Society vol. 20, no. 1, June 2017, doi:10.7448/IAS.20.1.21521

Dubé, Karine et al. “Research on HIV cure: Mapping the ethics landscape.” PLoS medicine vol. 14, no. 12, 8 Dec. 2017, doi:10.1371/journal.pmed.1002470

Menezes, P et al. “Recruitment of HIV/AIDS treatment-naïve patients to clinical trials in the highly active antiretroviral therapy era: influence of gender, sexual orientation and race.” HIV medicine vol. 12, no. 3, 2011, pp. 183-91, doi:10.1111/j.1468-1293.2010.00867.x

Schneider, Carl J., and Thomas P. Peardon. “John Locke, Second Treatise of Government.” The Western Political Quarterly, vol. 6, no. 2, June 1953, p. 390, 10.2307/442193.