GESTIÓN EN SALUD PÚBLICA: BioEdge: Has the venerable Belmont Report passed its use-by date?

domingo, 13 de agosto de 2017

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

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

Bioedge

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

by Michael Cook | 12 Aug 2017 | 1 comment

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.”

Sunday, August 13, 2017

In a recent article in the American Journal of Bioethics, bioethicist Art Caplan and three colleagues call for a complete overhaul of the venerable Belmont Report (see below). This is the 1979 US government report which set out three famous principles which have governed human research ever since: respect for persons, beneficence, and justice.

Most government reports are already gathering dust within a few months after their publication. But the Belmont Report’s influence has been enormous, as it shaped the bioethical framework for clinical and research decision-making in the US and many other countries as well.

Caplan & Co make a good case for revising the standards in the light of experience and changing times. But it comes at an awkward moment: the Trump Presidency. What kind of commission would Mr Trump create to study this issue? Perhaps a noisy and truculent one, a bull in the bioethics china shop. Be careful what you wish for?