Ethics and Clinical Research by Henry K. Beecher
One of the Most Influential Articles on Human Experimentation Ethics
Aug 3, 2009
In 1966, the New England Journal of Medicine published an article by Dr. Henry K. Beecher entitled "Ethics and Clinical Research." Beecher's article exposed shortcomings in U.S. medical research since the end of World War II in 1945. Some 40 years after its appearance, Beecher's article is still one of the most provocative papers about human experimentation ever written. Almost singlehandedly, Beecher focused attention on clinical research abuses. Even today, the article is required reading in many bioethics programs around the world.
Medical Research Before 1966
Prior to 1966, human experimentation was governed loosely by the Nuremberg Code (1947); the Declaration of Geneva (1948); the Federal Food, Drug and Cosmetic Act (amended 1962); and the Declaration of Helsinki (1964).These guidelines recognized certain basic truths — among them the right of a patient to understand and agree (i.e., the simplest definition of ‘informed consent’) to treatment before research begins.
Despite these guidelines, Beecher had a growing suspicion that ethical abuses in clinical research continued. Beginning in 1965, he decided to put his suspicions to the test.
Ethical Abuses in Clinical Research
The research question posed by Beecher was deceptively simple: “Would American researchers meet the standards of the Nuremberg Code?” To answer this question, Beecher reviewed 10 years of published papers in U.S. medical journals. At first, Beecher identified 50 examples of unethical research (which he claimed could be extrapolated to 186 further examples by cross-referencing links to other articles) and tried to have the results published in the Journal of the American Medical Association; his article was rejected as too inflammatory. Indifferent to criticism, Beecher narrowed his focus to 22 examples and published the results in the New England Journal of Medicine on June 16, 1966.
Beecher arranged his examples in six distinct groups, varying from “known effective treatment withheld” to research conducted merely to “improve understanding of disease.” Only two of the 22 cited experiments even mentioned informed consent, although Beecher rightly doubted if consent could ever be judged to be ‘informed’ when risks to patients were never thoroughly explained and permission to participate in an experiment was seldom sought. He concluded that unethical medical procedures were common, that ethical errors had been increasing since 1945 despite ethical codes, and that unethical experiments would harm the medical profession unless stopped. His recommendations for change included obtaining informed consent from human subjects, employing knowledgeable and compassionate investigators, assessing the benefits of research against known risks, and forbidding unethical research from ever being published.
Beecher's Article Inspired Praise and Criticism
Praise and condemnation followed. Within three weeks of its initial publication, Time magazine commended Beecher’s findings in its July 8, 1966, issue. Ironically, Time chose to begin its assessment with a quote from Hippocrates and then wondered openly whether physicians always acted for the benefit of their patients, or if sometimes actual harm resulted from experiments like those Beecher cited.
Beecher's article, however, is not without its faults. First, Beecher does not identify the doctors involved in the experiments or the places where the research took place. In public, he defended his silence by saying that his intention was to condemn abusive practices — not punish individuals. In private, he freely admitted that he wanted to block criminal investigation of professional colleagues. Second, Beecher was not always accurate with his facts. In one example, Beecher condemned military researchers for not administering penicillin as a “known effective treatment” for rheumatic fever, even though penicillin’s effectiveness in that area was not proven until three years after the experiment ended.
Beecher's Article Led to Improvements in Clinical Research Ethics
Beecher's article eventually resulted in new legislation (e.g., National Research Act of 1974) as well as improved guidelines in clinical research ethics that he never fully supported. For example, Beecher thought that ethical review boards were a hindrance and true informed consent was unobtainable in research. He never questioned the ethics of using humans in research, but only the means by which data were obtained. Sadly, recent evidence suggests that Beecher himself had performed many of the same ethical abuses in his own experiments as the ones he condemned, thereby calling into question his integrity as a critic.
Beecher's contribution to bioethics cannot be overstated. He refocused attention on human experimentation abuses, reinforced the ethical definition of informed consent, inspired new reforms, unwittingly encouraged the creation of ethical review boards, and recommended peer review of all future research. For this, his contribution to bioethics will never be forgotten.
References
Beecher HK. 1966. Ethics and clinical research. New England Journal of Medicine. 274:1354-1360.
Harkness J, Lederer SE, & Wikler D. 2001. Laying ethical foundations for clinical research. Bulletin of the World Health Organization. 79(4):365-366.
Moreno J. 1999. Undue Risk: Secret State Experiments on Humans. New York: W.H. Freeman.
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