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Gaps in medical research ethics

The flaws of the National Institutes of Health's review board model hinder ethics protections. The White House's new panel will provide a chance to rewrite the regulations.

October 08, 2010|By Laura Stark

President Obama apologized last week for medical experiments funded with U.S. taxpayer money during the 1940s in which American scientists infected Guatemalans with sexually transmitted diseases without their consent. Today these studies would be illegal. Even so, the current U.S. regulations governing research review are full of gaps.

The Presidential Commission for the Study of Bioethical Issues will now convene a panel of global experts to examine U.S. research rules. But the panel will need to do more than churn out a statement about how far we have come in the last 60 years. It needs to fix the current flawed ethics review system.

To see the problem, consider the National Institutes of Health's virus research on federal prisoners during the 1960s at the NIH Clinical Center in Bethesda, Md. Although it was common at the time to do such studies in prisons, convicts had never been used as subjects at America's own research hospital. That changed in 1960.

With the Bureau of Prisons, the NIH crafted a policy to make it legal to take federal prisoners from places like the Atlanta Federal Penitentiary to the NIH Clinical Center, as long as the hospital's review board approved the work and endorsed the scientists' consent plan. By 1964, more than 1,000 prisoners from 16 penitentiaries had come to live at the center for weeks or months.

To be admitted, the men had to sign consent forms. In my research, I have not been able to find copies of the prisoner consent forms, so it is unclear what the men were told in print (assuming they were literate) and in person. The center's archived records show that the prisoners were infected with viruses, including ones that caused pneumonia, influenza and the common cold, as well as simian-virus 40, which had contaminated batches of polio vaccine given to millions of Americans. Scientists were trying to observe the effects of the viruses and to develop new treatments.

Our current ethics review system is based on the review-board model that the NIH first put in place to manage legal liability at the center. But that review board had two problems, and its legacy continues to handicap the system.

The first was that having the board in place discouraged public questioning of studies. For example, NIH leaders knew that government-sponsored intentional-infection experiments on prisoners, while technically legal, might seem unsavory to the public. Tellingly, Surgeon General Luther Terry explained to NIH employees in a 1964 internal newsletter that the prisoner program was "little known to the general public because it is carried on quietly. But we in the Public Health Service are keenly aware of the value of the research projects."

The NIH used the existence of the review board to show — in human-subject recruiting fliers, for instance — that others confirmed their scientists' good judgment.

And so NIH leaders did not feel compelled to tell the public precisely what scientists were doing with the hundreds of healthy prisoners, conscientious objectors, unemployed people and students living in their hospital as subjects. When the NIH did work with journalists and filmmakers, archived records show, administrators worked hard to manage the agency's public image, including the image of their seemingly odd "healthy patient" program.

The second problem with the review board was that it drowned out dissenting voices among scientists. NIH scientists did debate the ethical propriety of studies and rejected a few proposals. Yet minority dissent was never enough to force a reconsideration of studies. As archived meeting minutes show, one scientist who opposed the simian virus studies on prisoners was told that the virus was safe because millions of Americans had already (accidentally) been exposed to it, though the point of the research was to learn more about the virus' effect on people.

The review board tended to override internal dissent from scientists and to play down the need for public inquiry. It sustained questionable research rather than curbing it. This is not what we want out of our review system today.

Yet U.S. research regulations are a direct descendant of the original NIH policy. In 1966, the NIH required universities and hospitals it funded to adopt its review-board model. The NIH was trying to deflect potential lawsuits away from the agency and toward these local institutions. In 1974, the NIH's local review-board model was written into federal regulation.

Although the system has been modified since then, the basic flaws of the NIH model continue to hamper ethics protections. The convening of the White House's new panel offers an opportunity to rebuild the regulations from the ground up. New rules should include these changes:

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