April 16, 2024

Has the venerable Belmont Report passed its use-by date?

Art Caplan calls for a complete overhaul

The 1979 Belmont Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research laid the foundations for bioethics standards in the United States and around the world. It identified three core principles: respect for persons, beneficence, and justice and three areas where ethical analysis was particularly needed: informed consent, assessment of risks and benefits, and selection of subjects.

But this was nearly 40 years ago. Is it time for an overhaul?

Yes, according to a leading American bioethicist, Art Caplan and three colleagues writing in the American Journal of Bioethics:

Since its release, the field of research involving human subjects has developed in complex and unexpected ways, challenging the report's ethical framework to respond not only to the fears related to research abuses that it stemmed from, but also to the increasing commodification of biomedicine, the exclusion of many groups from research, the globalization of research, the desires of many to have access to experimental drugs, the lack of generalizability and reproducibility of many research findings, and the unique harms and histories that communities have experienced as a result of research. While these challenges are likely to continue to shift and expand in the coming years, there are several areas where the report comes up short today.

The Belmont Report was issued at a time when Americans were scandalised by the exploitation of research subjects in incidents like the Tuskegee Syphilis Experiment in which poor black farmers were denied treatment for their infections long after a cure became available. But times have changed; today bioethicists place greater emphasis on patient autonomy.   

The authors identify five areas which are poorly served by the Belmont Report’s standards:

the line between research and practice is insufficient; unique harms to communities remain unacknowledged; failure to address transparency; the report’s focus on protectionism is incompatible with today's emphasis on participation; and how the ethical principles are applied.

The authors conclude: “Considering the important role the Belmont Report has played and continues to play in research ethics today it is time for a tune-up, if not a complete overhaul.”

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