Obama’s bioethics commission reports on international research protections

A US standing Presidential Commission, asked to assure “that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally”, has concluded that current regulations in the US provide adequate protections and that ethically dubious work could not happen today. The concluding report is now published, and the investigations were stimulated by acknowledgement that the US Public Health Service supported research done in Guatemala in the 1940s which involved infecting individuals, without their consent, with bacteria that cause syphilis and gonorrhea.

Although the committee set up to investigate these transgressions did find that current protections were adequate, they summarise a set of fourteen recommendations to strengthen the rights of human research participants in the US. These recommendations range from issues such as improving public access to information about research studies involving human participants, to finding better ways of compensating individuals who are harmed in the course of research, to expanding teaching about bioethics in undergraduate and further training.

However, the remit of the investigation covers only federally funded research. Issues relating to research funded by the pharmaceutical or other industries, or by non-governmental organisations, were not considered at all. Given that the majority of trials (the type of research raising the greatest risks for participants) are thought to be industry-funded, this is a serious omission. Although the Guatemala studies were funded by a public agency, industry-funded studies come with a substantial conflict of interest that may distort the way research studies are set up and how those studies are monitored – they may be more likely to use placebo rather than an established therapy, for example. Research done by industry may be regulated by for-profit ethics boards, so they are not as independent of the companies whose research they regulate as would ideally be the case.

In the press conference announcing the report, Amy Gutmann explained that the committee had confidence that research done in other countries did not raise any special ethical issues. This may be true for studies funded through a government agency, which will be protected by ethics committees set up by those agencies. However the picture could be very different, and far more complicated, for studies done by a myriad of other companies and organisations, where the patchwork of protections may be less stringent, robust, or even lacking in some countries entirely.