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.
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