Today the directors of the National Institutes of Health and the Centers for Disease Control and Prevention published a joint commentary on the 1946-48 US research project that deliberately infected vulnerable Guatemalans - prisoners, soldiers, sex workers and mentally ill patients - with syphilis. Details of the study were recently discovered among the papers of John Cutler, a US Public Health Service medical officer who worked on the Tuskegee syphilis study.
In the commentary, which appears online in the Journal of the American Medical Association, NIH director Francis Collins, MD, PhD, and CDC director Thomas Frieden, MD, write:
Ethical violations in this study clearly include the following: (1) study subjects were members of vulnerable populations including institutionalized and mentally disabled persons, prison inmates, and soldiers (who could not give valid informed consent); (2) individuals were intentionally infected with pathogens that could cause serious illness; and (3) deception was used in conducting the experiments. Correspondence between the investigators and their superiors also recognized the unethical nature of the work. A letter from Cutler's supervisor, R. C. Arnold, written in 1948, notes that, "I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke." The study was never published.
Collins and Frieden briefly describe the safeguards against unethical research that have been developed in the last 60 years, and conclude that the definition of ethical research remains a moving target:
As clinical research increases in volume and complexity and more frequently crosses country borders-often to reach the most affected populations-continued scrutiny of guidelines governing research involving human subjects remains critical. As technologies evolve, it is essential to continuously consider what new risks-physical, psychological, or informational-might be raised by research, and how investigators can best inform, engage, and protect research participants.
While effective protections against unethical research continue to evolve across the world, the past exploitations of vulnerable populations, including the subjects of the study in Guatemala in the 1940s, are regrettable and deeply saddening. For them, the basic ethical principle of respect for persons was flagrantly violated. The NIH and CDC are committed to ensuring that lessons drawn from the past help shape actions to protect all future research participants, no matter where studies are conducted. The 1946-1948 inoculation study should never have happened, and nothing like it should ever happen again.
