Tighter rules urged on clinical trials

[Bethesda, United States] Tougher rules are needed to reduce the exploitation of research participants in clinical trials carried out by US-government sponsored researchers and pharmaceutical companies in developing countries, according to the top bioethics advisory panel to the US government.

One proposal is that members of any control group in a clinical trial should be provided an established effective treatment, "whether or not such treatment is available in the host country". Another is that US sponsors and researchers "should develop and implement strategies that assist in building local capacity for designing, reviewing, and conducting clinical trials".

The recommendations come in a report, 'Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries', released in Washington on Monday (30 April), by the National Bioethics Advisory Commission (NBAC), a body set up in October 1995 to advise the US government on bioethical issues arising from research on human biology and behaviour.

They come in response to growing public concern over the way that some trials are currently being conducted. This was highlighted by the controversy that surrounded report in 1998 around large-scale trials conducted in developing countries to test the use of zidovudine (AZT) to prevent the mother-to-child transmission of HIV.

The commission, made up of physicians, theologians, ethicists, scientists, lawyers, psychologists, and members of the public, proposes a series of measures to ensure that trials are responsive to the health needs of the country in which they are carried out, and that post-trial access to successful research products is improved.

"While we cannot remove all of the risks from research at home or abroad, we can reduce the risk of exploiting vulnerable populations," the chair of the commission, Harold T. Shapiro, president of Princeton University, said on presenting the report to President George W. Bush. "The potential for exploitation is cause for a concerted effort to ensure that protections are in place for all persons participating in international clinical trials."

The NBAC report comes at a time of increasing interest in international research ethics, as both individual countries and international organisations review their own guidelines and procedures. In particular, NBAC looked at whether existing US regulations are appropriate in the context of the increasing number of collaborative projects involved scientists from developing host countries.

This trend has raised concerns because of the potential for researchers and sponsors from more prosperous countries to exploit participants from developing countries heavily burdened by disease.

Some critics have questioned the motivations of researchers and sponsors when the product being tested is unlikely to be available to those in the host country, or the trial could instead have been conducted in the United States. Others question whether it is appropriate to "export" US research regulations without taking into account local context.

"Though no simple answers emerge, we have identified principles that ought to govern such research," said Shapiro.

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