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International trials spark ethics concern

New vaccines or drugs are often tested in countries such as Thailand or Uganda where the disease being studied is common.

Although this practice helps speed research, it may exploit participating communities if they don’t later have access to the drug, said Ezekiel Emanuel, MD, PhD, of the National Institutes of Health.

Emanuel spoke Monday at the medical school about how to assess whether research in developing countries is fair and doesn’t exploit the community.

He said many people use a standard called “reasonable availability,” in which the participating community must have access to the drug being tested.

Emanuel said questions regarding who should pay for the drug and what constitutes the community remain problems with the model.

For example, is the community just the people in the trial, the local population or the entire country?

Emanuel also said that in this model, research funders are sometimes considered responsible for providing the drug when the trial ends, but the NIH, the World Health Organization and other groups cannot provide drugs internationally.

Instead, Emanuel suggested the adoption of a standard called fair benefits, in which the local population should reap rewards from the research regardless of whether they eventually receive the drug itself.

“Receiving benefit is what’s key to avoiding exploitation,” Emanuel said.

These benefits can include new jobs, additional health-care services, improved health infrastructure or education, Emanuel added.