The doctrine of informed consent, borrowed from the law of torts, cannot be readily transplanted into therapeutic settings. The broader, as yet unrealized, idea of informed consent, which suggests that parties must make decisions jointly, should guide interactions between physicians and patients or investigators and subjects.
I want to pay tribute to Henry Knowles Beecher by reflecting upon the ethics of human experimentation, past and present. He, and I somewhat later, became absorbed in this topic years prior to the flowering of bioethics. By June 1966, when he published his courageous article "Ethics and Clinical Research," we had met and talked often about our hopes and fears. We knew that we were exploring uncharted territory, discovering a world whose ethical dilemmas were there to be seen but had largely been ignored. We hoped that our inquiries would persuade our colleagues to examine in depth physician-investigators' responsibilities to medicine, medical science, and patient-subjects in the enterprise of extending the frontiers of medical knowledge. At the same time, we were concerned about the reception our work would receive from the medical community.
I had become interested in human experimentation in late 1964 or early 1965. Many reasons of the heart and mind had sparked my interest. As I reflect upon these origins and my work during the subsequent thirty years, I realize that it has always been my heart that led the way. Only later did my mind begin to impose some order on intense feelings that I can trace back to a number of personal experiences.
First, while on the faculty of the Yale Medical School I had conducted research with "volunteer" subjects. I was then largely oblivious of my responsibilities to disclose to them fully the risks that their participation might entail. My colleagues and I were aware of potential risks. We had taken precautions to minimize them and, should they materialize, to repair any damage. It did not occur to us, however, to share our concerns with our subjects so that they could decide whether or not to take these risks. The unique responsibilities physicians confront in the conduct of research had not been discussed in my medical education, even though we were encouraged to do research.
Second, when I joined the faculty of Yale Law School it was my custom to attend one course or seminar each year in order to learn more about law. One afternoon in the early 1960s I witnessed an intense debate between students and their teacher about how best to protect an accused from the powerful array of forces that the State can so inexorably align against him or her. I was struck by the students' zeal to safeguard the rights of the accused. Their sense of justice and fairness made quite an impression on me. Suddenly I realized that I had stopped listening. Instead, my thoughts had taken me back to my research, and I remembered how little attention I had given to the rights of my research subjects. In subsequent months I often recalled that afternoon and the memories it had evoked. The idea of studying what transpires in human experimentation increasingly captured my imagination.
A third chance encounter reinforced my intention to study the human research process. While perusing a casebook on criminal law, I ran across the trial transcripts of the Nuremberg proceedings against the Nazi physicians. The history of the medical experiments conducted at Auschwitz, Dachau, and other concentration camps had also not been part of my medical school education. The transcripts recounted in sickening detail these medical experiments, carried out "with unnecessary suffering and injury, and... very little if any [protection of subjects from] injury, disability, or death." I had lost many of my cousins, aunts, and uncles in the Holocaust. How many of them, I wondered, had been condemned to participation in these experiments?
I began to immerse myself in the then scant literature on human experimentation conducted in the Western World. …