NIH limits gene experiments done abroad.

NIH limits gene experiments done abroad

Nobody will ever know exactly what happened after researchers inoculated 20 cows with an experimental rabies vaccine in Argentina nearly three years ago. Accordingly to the Philadelphia-based Wistar Institute, which conducted the trials with the Pan American Health Organization (an arm of the World Health Organization), everything went according to plan. Cows vaccinated with the genetically engineered rabies-virus protein developed antibodies to the deadly virus as intended, and the cows and handlers showed no ill effects.

But the researchers conducted the experiments without first obtaiing permission from the Argentine government. And according to Argentine government scientists and others, some workers and unvaccinated cows became infected with the experimental vaccine--though with no apparent ill effects. The Argentine government halted the experiment, destroyed the cows and provided the impetus for a series of meetings of U.S. scientists and policymakers over the issue of performing U.S.-government-funded genetic engineering experiments in foreign countries. At issue was whether scientists receiving funds or materials from the National Institutes of Health (NIH) must follow the same safety and notification guidelines in foreign countries as they must in the United States when performing experiments with recombinant DNA. The trick lay in ensuring that developing nations would not become cheap testing grounds for controversial experiments, without dictating to other countries what they may or may not do in terms of hosting scientific trials that could benefit them directly.

Now, after more than two years of debate triggered by a petition from the Washington, D.C.-based Foundation on Economic Trends, the NIH has revised its guidelines regarding recombinant DNA research in foreign countries. The new guidelines preclude the foreign testing in humans or animals and the deliberate release into the environment of materials containing recombinant DNA developed with NIH funds unless the experiments comply with the host country's rules regarding such experiments. If the host country has not developed such rules -- and many have not -- the proposed experiments must be reviewed by an HIH-approved board, then accepted by an appropriate national authority in the host country. In any case, the new guidelines say, NIH-associated researchers in foreign countries must use safety practices "reasonably consistent" with NIH guidelines governing similar experiments conducted in the United States.