Beecher's 'Ethics and Clinical Research'

In 1963 doctors studying immunity to cancer injected live cancer cells into the skin of 22 chronically ill, debilitated patients who did not have cancer. The patients were not told what the injections contained; the investigators said they did not want to stir up unnecessary anxiety. The experiment, at the Jewish Chronic Disease Hospital, became number 17 on a list that Henry K. Beecher published in the New England Journal of Medicine on June 16, 1966.

Beecher was a senior member of the anesthesiology faculty at Harvard Medical School. For 'Ethics and Clinical Research' he examined 22 studies by respected investigators, all published in leading journals, and found ethical problems in every one, among them missing informed consent and added risk to the people studied. Number 7 was a study of cyclopropane anesthesia in 31 patients: carbon dioxide was fed into a closed breathing circuit until cardiac arrhythmias appeared, and toxic levels were held for long periods.

The point of the list was less to blame individual researchers than to call attention to abuses so they could be corrected. He called informed consent the most important element of ethical research and argued that results obtained unethically should not be published. The paper appeared two years after the World Medical Association adopted the Declaration of Helsinki, and it set off a debate about research ethics inside American medicine.

Six years later Jean Heller's reports on the Public Health Service syphilis study at Tuskegee reached the Washington Star and the New York Times. A 2024 review of informed consent credits the two exposures together with prompting legislative change and the creation in 1974 of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report in 1979. The Bulletin of the World Health Organization reprinted Beecher's paper in 2001, and in 2016 the New England Journal marked its fiftieth anniversary with an essay by the historians and bioethicists Jones, Grady and Lederer.