Applying contemporary psychoanalytic principles to enhance the ethical functioning of contemporary institutions is a complicated but worthwhile challenge. It is a challenge that I have assumed over the past year since I began psychoanalytic training at the Boston Psychoanalytic Institute and became co-chairman of the institutional review board (IRB) at McLean Hospital in Belmont, Mass.
The IRB performs ethical review of all the research studies that involve human subjects at McLean, which houses the largest and most highly funded psychiatric research program of any private hospital in the world. My background in psychiatric ethics, which I acquired through my Ph.D. work in philosophy and a faculty fellowship at the Harvard University Center for Ethics and the Professions, sparked my interest in this work but only partially prepared me for the challenge it represents.
An IRB is charged with ensuring that research on human subjects in American health care facilities complies with ethical and regulatory standards. The development of federal regulations to ensure ethical research methods arose in part from anger and outrage caused by the infamous Tuskegee experiments, in which 400 African-American men in the rural South were followed over several decades (beginning in the 1930s) to observe the progression of their syphilis. The researchers intentionally did not inform the subjects of their disease, provided no treatment (even after penicillin became available in the 1940s), and prevented their being drafted into the armed forces, where they likely would have been diagnosed and treated. In reaction to this tragic abuse, a federal advisory panel was appointed and wrote the Belmont Report, which stated that research on human subjects must adhere to ethical principles of informed consent, favorable risk/benefit ratios, and fair selection of subjects.
Since 1974, the U.S. government has mandated that all such research be reviewed and approved by IRBs, which are responsible for protecting human subjects' rights, assessing the risk/benefit ratio of the research, and ensuring a process of valid informed consent. IRBs must include people from varying social and professional backgrounds who have no conflict of interest with the research under review. Institutions receiving federal funding must follow rules and procedures described in the “Common Rule” under title 45 of the Code of Federal Regulations.
Like the healthy and well-adapted ego of an individual, a well-run IRB acknowledges and integrates wishes, moral scruples, and reality factors.
It is in the practical, day-to-day functioning of the IRB that psychoanalytic principles can come into play. The IRB can be thought of as serving some important ego functions for research institutions such as McLean. Clinical investigators are motivated by the wish to acquire new knowledge about psychotropic medications and other interventions that may advance our capacity to diagnose and treat mental disorders. Grant support, patents, and academic advancement may depend on the successful conduct of research with human subjects. While the vast majority of medical and psychiatric researchers can balance their desire to conduct research with the needs and interests of persons who participate in it, academic zeal may at times cloud their thinking about its possible drawbacks or dangers. More objective individuals, who appreciate both the promise and the pitfalls of clinical research, are needed to evaluate its ethical status.
Here is where IRBs assume a critical role in addressing ethically sensitive questions about clinical research. Is use of a placebo control justifiable in a study of a new antipsychotic medication? Should young children be allowed to serve as healthy control subjects in studies that use powerful new magnetic resonance imaging of the brain? Can subjects be exposed intravenously to drugs of abuse or very high doses of prescribed medications in order to assess their behavioral and physiological responses? Is it necessary to inform potential subjects in an antidepressant drug trial that alternative treatments (e.g., psychotherapy) are available and have a very different risk/benefit profile?
As IRB members deliberate such questions, they must keep in mind that the risks of undertaking research on human subjects must be clear to potential subjects (or to their proxy decisionmakers) and must be outweighed by potential benefits to subjects or to other people with similar conditions. The IRB fails in its mission if it becomes a punishing superego for the institution by simply rejecting research proposals that carry any risk whatsoever. Research on human subjects always carries some degree of risk, and an overly rigid or uncompromising stance on the part of the IRB could threaten to shut
David H. Brendel, M.D., Ph.D., is an instructor in psychiatry at Harvard Medical School and practices at McLean Hospital, where he co-chairs the institutional review board (IRB) and has a private psychotherapy practice. He is a second-year candidate at the Boston Psychoanalytic Institute.
down research programs that ultimately might benefit large numbers of people suffering with mental disorders. Such a restriction on research activity would be entirely inconsistent with the mission of institutions like McLean. The IRB should work closely with clinical investigators to ensure development of well-designed studies that can answer pressing clinical questions while guaranteeing the protections of informed consent and other relevant ethical imperatives. Interaction between researchers and IRB members ought to be collaborative and non-adversarial.
In the end, psychiatric researchers and IRB members share the same fundamental value: to advance scientific knowledge and improve treatment options while protecting people from undue coercion to participate in research and undue harm that may result from such participation. Like the healthy and well-adapted ego of an individual, a well-run IRB acknowledges and integrates wishes, moral scruples, and reality factors. In the case of the IRB, factors that must be kept in balance are the human impulse toward scientific discovery; the reality that financial and academic success of individuals and institutions rides on conducting clinical research; and the ethical values of respect for persons, their autonomy, and their basic rights.
Training in ethics and psychoanalysis has given me conceptual tools to approach these issues, but unforeseen challenges keep me on my toes each time I examine a new research proposal and consider how to integrate these various scientific, practical, and ethical concerns.