Washington

The US National Bioethics Advisory Commission may recommend that protocols for US clinical trials carried out in developing countries should be adapted to the local health infrastructure so the host country can gain maximum benefit from the trials.

The commission is expected to issue guidelines this summer on US researchers' obligations to host developing countries and to their research subjects. A panel of the commission met last week to discuss the extent to which the United States should assist host countries. Proposed involvement ranged from tailoring trials to a developing nation's biomedical capacity to building up the country's infrastructure to match the needs of the research.

“It does no good to develop therapies that the host country cannot continue to use,” Robert Levine, a professor at Yale University School of Medicine, told the panel. For example, a trial in sub-Saharan Africa on how to minimize the spread of HIV from pregnant mothers to their fetuses would seem a worthy effort in the short term, but would not necessarily be of long-term help to the community.

If the community wished to continue the research after the US clinicians had left, it would need prenatal facilities to allow doctors to identify HIV-positive mothers and the equipment and trained personnel necessary to administer the anti-AIDS drug AZT intravenously. It would also need ample supplies of baby formula and clean water to provide an alternative to breast-feeding, as infants would otherwise face an even greater health risk from diarrhoea.

To justify carrying out clinical research in developing countries, US research goals should match the health needs of the host country and should provide the country with the “highest attainable and sustainable” benefits possible after the end of the trial, Levine suggested. For example, a trial of an AIDS vaccine in a developing nation should include provision for further distribution of the vaccine should the trial prove successful.

Ruth Faden, director of the Bioethics Institute at Johns Hopkins University, told the panel that scientists change the community where the studies take place merely by setting up clinical trials, as they introduce — sometimes temporarily — higher levels of health care. As a result, they have an obligation to help that community after the trial ends. “You can't leave the place the way you found it,” said Faden, adding that the US government should provide aid to build up infrastructure in developing nations where US-sponsored research takes place.