April 18, 2024

Presidential commission to examine clinical trial ethics

Michael Cook

President Obama’s bioethics commission has formed an international research panel to examine protections for human subjects in clinical trials.

President Obama’s bioethics commission has
formed an international
research panel to examine protections for human subjects in clinical trials.

The President requested a report after scandalous
revelations last October that the US Public Health Service had supported dubious
research on syphillis in Guatemala from 1946 to 1948. This involved the
intentional infection of soldiers, prisoners and prostitutes.

“It
does not go without saying that a civilization can be judged by the way it
treats its most vulnerable populations,” said Commission Chair Dr Amy Gutmann.
“There’s no position of greater vulnerability than to be a subject of a medical
experiment.”

She
continued: “We have a problem on our hands …. What happened in Guatemala, what
happened in Tuskegee, in Willow Brook … whether these people look like us, or
they don’t look like us, they are human beings with rights that doctors and
scientists are expected to respect and should go by the highest standards.”

The new panel includes experts from a
number of countries, including Argentina, Brazil, China, Egypt, Guatemala,
India, Russia, Uganda, Belgium, and the United States.

The panel’s brief is to examine:

  • The
    dominant norms, and competing alternatives, driving the ethics of medical
    research outside the US.;
  • The
    conflicts, if any, between US norms and international standards;
  • The
    challenges facing researchers conducting US-funded research in global
    settings; and
  • How to
    address major differences in regional norms for medical research.

The commission – whose official name is the
Presidential Commission for the Study of Bioethical Issues – has already
started holding public meetings.

At one of them this week, Robert M. Califf,
Vice Chancellor for Clinical Research at Duke University, stressed that high costs and red tape in
the US was driving research to countries like India, China, Brazil, and South
Africa, as well as developing nations. He cited a 2008 study that found if a
drug company moved 50% of its trials from high-cost places and had 60,000
people in clinical trials, it would save $600 million a year. ~ blog.Bioethics.gov, Mar 1;



Michael Cook
bioethics commissions
clinical trials

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