In response to growing concerns — from both the press and scientific advisory groups — over ethical standards for clinical trials in developing countries, the department has set up an Office of International Activities.

The new division, to be located within the Office for Human Research Protections (OHRP), will oversee, but not regulate, federally funded trials in developing countries and provide ethical guidance.

The OHRP already regulates federally funded scientists working abroad, although research by drug companies is controlled by the Food and Drug Administration.

A recent series of articles in The Washington Post, criticizing the way US researchers operate in developing countries, depicted large pharmaceutical companies — and some federally funded researchers — as increasingly exploiting vulnerable patient populations in poor countries.

For example, Pfizer was criticized for a 1996 clinical trial in Nigeria, in which its antibiotic trovafloxacin was tested on children and infants with meningitis. The Washington Post portrayed the company as taking advantage of a meningitis epidemic, but Pfizer rejected the charges, saying that the trial played "an important role in investigating a potential breakthrough in oral therapy for this terrible epidemic".

The Washington Post articles have prompted calls for a congressional health panel to seek hearings on the issue, and "a legislative response".

The issue is also being driven by the National Bioethics Advisory Commission and the World Medical Association, which had intensified their involvement before the newspaper series began.

The organizations were spurred into action partly by complaints that began three years ago over a Ugandan clinical trial in which HIV-positive pregnant women were given placebos even though, critics claimed, a proven therapy was available that could have saved the unborn child from infection.

The two organizations advise scientists not to use placebos in developing countries when effective treatments exist. But critics argue that without a placebo group it is often impossible to gauge the effectiveness of a new therapy.