The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Ethically Impossible

From 1946-1948, a team of medical researchers in the United States Public Health Service intentionally infected more than 1,300 Guatemalan prison inmates, psychiatric patients, commercial sex workers and soldiers with sexually transmitted diseases. The team also used children in diagnostic testing. Done completely without consent, their experiments resulted in a living hell for many of their subjects.

Today the Presidential Commission for the Study of Bioethical Issues delivered a report to President Obama that details this shameful chapter in American medical history.

The Commission concludes that those involved in this research violated the ethical standards not only of our time but also of theirs. As is evident by their own internal communications—and the fact that just a few years earlier they obtained the informed consent of prisoners in Terre Haute, Indiana before conducting experiments there—these doctors also were morally culpable: they knew there was a moral requirement to obtain informed consent. But they chose not to ask for it in Guatemala. And they went to great lengths to keep their experiments as secret as possible while still obtaining funding from higher-level authorities who should have disapproved the experiments.

Why should we today care about ill conceived experiments that took place some 60 years ago? First, by shining light on this dark chapter of our history, we honor the victims. We acknowledge that American doctors denied Guatemalans the respect they deserved as fellow human beings and violated their most basic human rights.

Second, we need to learn essential practical as well as ethical lessons from the Guatemalan experiments so that nothing like this happens again. The United States now has many more rules and regulations governing medical experiments on human subjects than it had in the 1940’s and 50’s. But can we be confident that all researchers actually recognize the implications of these rules when they conduct their experiments at home and abroad?

The doctors and their superiors who approved the Guatemalan experiments obtained the informed consent of human subjects in the Indiana prison, but they applied a double standard when they left the country and shielded themselves from critical scrutiny. Yet every ethical principle that applies to how American researchers treat human subjects in this country also governs how they should treat human subjects everywhere. The first sentence of the Nuremberg Code, written in 1947 in the wake of medical experiments conducted by Nazi doctors, could not have been clearer in stating that “the voluntary consent of the human subject is absolutely essential.”

Informed consent is necessary but not enough. Sound scientific research demands that, even with informed consent, researchers not inflict harms disproportionate to prospective benefits. In Guatemala, doctors inoculated people with sexually transmitted diseases before completing the diagnostic experiments needed to determine the actual effects of the inoculations. Research design and record keeping were haphazard at best. When in April 1947, a doctor publicly noted (in the New York Times) that “to shoot living syphilis germs into human bodies” is “ethically impossible,” doctors responsible for the Guatemalan experiments took note and worked to ensure the secrecy that they needed to do the ethically impossible.

This was both bad science and egregious ethics. Today it would be much harder to shield such activities from broader scrutiny. Yet it takes only one egregious violation of ethical standards in experimentation to deter many people from volunteering for medical research that offers the best hope for path-breaking therapeutic discoveries. To fully face up to the travesty inflicted on so many individuals in the name of medical science, we first must take the overarching lesson of Guatemala to heart and then thoroughly consider what could be happening today that future generations will look back to with similar shame.

The overarching lesson of the Guatemala experiments is never to confuse rules that apply ethical principles to research with burdensome obstacles to be evaded. An important corollary is that regulations, which have proliferated over the decades, need clear–and clearly communicated–ethical purpose. Regulations that lack a compelling purpose invite the very disrespect for rules–and ultimately for vulnerable individuals–that medical ethics is intended to protect against.

These lessons are sobering calls to further action for all of us who care about the progress of science and the protection of human subjects, and also on occasion complain about burdensome government regulations. The Commission is now turning its full attention to recommending any steps needed to ensure that such ethically impossible treatment of our fellow human beings is never again repeated.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

Learn more about the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues.