A Commentary on Reports by the Presidential Commission for the Study of Bioethical Issues
In 2011, the Presidential Commission for the Study of Bioethical Issues released two reports of great importance to the public and to the medical and public health research communities.
The first report, issued in September 2011 and titled “‘Ethically Impossible’: STD Research in Guatemala from 1946 to 1948,” was the result of a comprehensive investigation into studies conducted by the U.S. Public Health Service in Guatemala, in which several groups of people were deliberately exposed to sexually transmitted diseases. The second report, issued in December and titled “Moral Science: Protecting Participants in Human Subjects Research,” surveyed the current laws and standards for human subjects research, and made several recommendations to improve current practices.
The Commission found that the Guatemala studies “involved unconscionable basic violations of ethics” and that “the individuals who approved, conducted, facilitated and funded these experiments are morally culpable to various degrees.”
The studies were approved and conducted by the U.S. government and by individuals acting on behalf of the U.S. government. As reported by the Commission, several individuals in prominent academic positions at American universities served either as expert volunteers or employees of the government on the government-appointed committees that reviewed and recommended approval of and funding for the studies.
Among those identified in the Commission’s report as serving in such roles on the government’s behalf were several individuals associated with Johns Hopkins. The Commission did not report that Johns Hopkins as an institution had any role in the Guatemala studies, nor that any employees working on behalf of Johns Hopkins had any role in the studies. The Commission’s report stated that the U.S. surgeon general approved the grant, which was awarded to the Pan American Sanitary Bureau.
The studies were not approved by any Johns Hopkins entity or Johns Hopkins institutional review board or committee, and to the best of our knowledge, no funds for the Guatemala experiments came to Johns Hopkins.
Ethical medical research involving people (human subjects) is a vital part of the process of research. It is through such research that new discoveries are made to improve the health of people and communities around the world. Johns Hopkins was an active participant in the development of the universal ethical, legal and moral safeguards in place today, such as institutional review boards and informed consent, which would preclude such a study being conducted today.
Taken together, the Commission’s two reports present a stark contrast between deeply disturbing research involving human subjects undertaken by the U.S. government in the late 1940s — which was conducted in violation of even the standards of the time — and today’s ethical and research standards, which would never permit such a study to be conducted.
For more on the reports, visit http://bioethics.gov/
1 These include Dr. Joseph E. Moore, who at the time held the title of professor at the Johns Hopkins University School of Medicine and was director of the Venereal Disease Division; Dr. Harry Eagle, a commissioned officer and employee of the U.S. Public Health Service and director of the government’s USPHS Venereal Disease Research Laboratory, which was located at Johns Hopkins in what was then the School of Hygiene and Public Health; Dr. Lowell Reed, who at the time was a Johns Hopkins professor and statistician and also served as dean of the School of Hygiene and Public Health and later as president of the University; and Dr. Thomas B. Turner, who at the time was a professor in the School of Medicine and later became dean of the School of Medicine. The Commission’s report also identified Dr. Reed and Dr. Kenneth Maxcy, a Johns Hopkins epidemiologist, as members of the government’s National Advisory Health Council, which recommended funding for the proposal to the U.S. surgeon general. The report listed Dr. Lewis Weed, who earlier served as dean of the Johns Hopkins University School of Medicine, as holding government positions on the National Research Council and on the Committee on Medical Research.
Questions and Answers
Q: Were these Johns Hopkins studies?
A: No. The studies were organized, funded, approved and carried out by the U.S. Public Health Service.
Q: Did Johns Hopkins researchers administer the study protocol in Guatemala?
A: No. Johns Hopkins researchers were not involved in administering the protocol to participants, and the Commission did not find that Johns Hopkins personnel had any role in conducting the studies.
Q: Does Johns Hopkins condone or approve of these Guatemala studies?
A: Absolutely not.
Q: Could this type of study be approved today in the U.S.?
A: It is unimaginable that a proposal for such a study would be seriously reviewed, let alone approved and implemented today. The universal ethical, legal and moral safeguards in place today, such as institutional review boards and informed consent requirements, would preclude such a study being conducted.