A U.S. presidential advisory commission provided a public forum in which experts in various fields could identify issues, reach conclusions, and make recommendations concerning ethical and legal matters related to biomedical and behavioral research and medicine.
Traditionally, ethical issues in American medical practice were resolved privately by the patient, his or her family, and the physician. Expansions in scientific and technological capabilities have fundamentally transformed medicine’s role in American social and political life, creating new rights for society and new responsibilities for biomedical science. As medical care has become more sophisticated, difficulties have grown more complex for policy makers, professionals, and citizens. Systematic work in biomedical ethics is a recent phenomenon, although discussion on bioethical topics has taken place among philosophers and theologians for centuries.
for the Study]
Despite demands for greater public accountability in government, American citizens have historically had little or no direct voice in biomedical policy. Most health-related policy matters are decided by administrative agencies. These agencies rely heavily on scientific experts on their staffs and those in universities and private industry. The budget for biomedical research is controlled largely by Congress.
The growing gap between technical achievements and society’s capacity to deal with them has been recognized for some time. Creation of a presidential advisory commission is one way in which the federal government can study, investigate, and make recommendations on matters of critical importance. Advisory commissions exist for not more than three years and are composed of people generally considered to be experts in their fields. They are chosen to represent a cross-section of the views on particular issues under consideration, for their superior knowledge of the subject matter, and for the likelihood that they favor presidential policies in the area at issue. The objective of a commission is achievement of consensus.
Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Efforts to transform that commission into a permanent government body were unsuccessful, and the commission terminated in 1978. Shortly afterward, the U.S. Department of Health, Education, and Welfare created its Ethics Advisory Board to advise the department on ethical issues raised by research on humans. The board’s principal report was a study of ethical concerns in the area of in vitro fertilization and embryo transfer. Because of its limited scope, the board could not address the broad range of ethical issues involved in medical practice and delivery of health care. It became apparent that further study was warranted to address the full range of ethical questions associated with health care and to enable public participation in the discussion of medical ethics. In 1978, therefore, Congress proposed creation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. The enabling legislation was enacted in 1979, and the commission began its work in 1980.
The commission was charged with articulating and establishing a consensus, with an aim toward clarifying divergent trends, on issues concerning the physician-patient relationship, the delivery of health care, and biomedical research. The commission, possessing no regulatory authority and no power beyond persuasion, served as an educational tool for the citizenry and a watchdog for the professions. The duties of the commission included studying the ethical and legal implications of the requirements for informed consent to participation in research projects and medical procedures; the matter of defining death, including the advisability of developing a uniform definition of death; voluntary testing, counseling, and information and education programs with respect to genetic diseases and conditions; the differences in the availability of health services; current procedures designed to safeguard the privacy of human subjects, ensure the confidentiality of patient records, and ensure appropriate access of patients to information contained in such records; and other matters as designated by the president. The commission was also granted latitude to investigate other appropriate subjects if necessary.
President Jimmy Carter appointed the eleven initial commissioners, whose terms of appointment were limited by statute: three from biomedical or behavioral research, three from medicine or health care, and five from ethics, theology, law, natural sciences, social sciences, humanities, health administration, government, or public affairs. President Ronald Reagan appointed four replacement commissioners and four additional commissioners. It is thought that the bipartisan composition of the commission resulted in compromise language in the final reports. Although proposals for a continuing or permanent bioethics commission were promulgated, none was immediately enacted. Proposed legislation was vetoed by President Reagan.
During its thirty-nine-month existence (its life was extended three months beyond its term of three years), the commission held approximately thirty two-day public meetings in Washington, D.C., and in regional centers around the country. Attendance ranged from twenty-five to two hundred persons. Testimony was elicited from philosophers, physicians, biologists, lawyers, clergy, political and social scientists, university and hospital administrators, members of the insurance industry, federal government representatives, and representatives of special interest groups such as the Association of American Medical Colleges, the American Psychological Association, and the American Council on Education. Members of the public, as health care consumers, were also allowed to testify. Advice was sought from panels, convened by the commission staff, consisting of nursing groups; philosophers; medical experts including neurologists, neurosurgeons, anesthesiologists, pediatricians, and other clinicians; biologists; lawyers; and social scientists. The minutes of these panels were distributed to fifteen hundred individuals and organizations.
The commission concluded its work in March, 1983, and made public its conclusions in eleven volumes, including nine reports, the proceedings of a workshop on whistle-blowing in research, and a guidebook for local committees that review research with humans. Chairman Morris B. Abram, in his letter of transmittal with the final report to the president, mentioned the basic values which the commissioners sought to uphold: “liberty, fairness, compassion, and respect for human dignity.” The commission, he wrote, addressed the following issues: when, if ever, life-sustaining treatment should be forgone; who should bear the costs of injuries to human subjects in research; whether society should ensure that everyone gets health care and, if so, how much; whether physicians ought to tell their patients the truth, even if it is unpleasant; and what should be done about attempts to remake human genes. These are among the most troubling ethical issues confronting modern medicine. The commission’s recommendations provide guidance and a yardstick against which citizens, physicians, scientists, and political leaders can measure morally acceptable answers to difficult dilemmas.
The commission examined certain pressing bioethical issues that seemed ripe for resolution and clarified their status. More than three years of study and analysis did not exhaust the scope and breadth of these important concerns. The commission, therefore, constituted a link in the biomedical continuum.
The commission’s most influential report, Defining Death (1981), urged the law to recognize new criteria for establishing the occurrence of human death. The troubling question of defining death has become even more perplexing because of technology that can keep patients “alive,” maintaining heartbeat and respiration in someone whose probability of recovery to a normal existence is unlikely. Also problematic is the patient in a permanent vegetative state. The commission recommended adoption of the Uniform Determination of Death Act, which defines as dead those people who have sustained either irreversible cessation of circulatory and respiratory functions or irreversible cessation of all functions of the entire brain. The commission also discussed issues related to the so-called right to die.
Partly in response to Nazi medical experimentation and atrocities which came to light during the Nuremberg trials, the commission’s predecessor body gave considerable attention to informed consent requirements in the research setting. The commission focused on informed consent in medical treatment rather than in research, and it concluded that informed consent is an “ethical imperative” and a “process of shared decision-making based upon mutual respect and participation.”
The commission stressed the importance of communication in the relationships between patient and health care provider. It recommended that health care providers should not ordinarily withhold unpleasant information from patients simply because it is unpleasant, and that “patients should have access to the information they need to help them understand their conditions and make treatment decisions.” The commission recognized the importance of patient autonomy and assimilation of the information contained in a consent form, a shift from the paternalism of the past in which the physician alone was the decision maker. The commission also considered cases in which patients would be incapable of making decisions for themselves.
The commission suggested that people have a right to “equitable access” to an “adequate level” of health care and suggested that further study was needed of the requirements of indigent people and the uninsured. In response, the U.S. Bipartisan Commission on Comprehensive Health Care, known as the Pepper Commission, defined a “minimum benefit package.” The commission listed such items as hospital care, physician office visits, diagnostic tests, and preventive services as parts of the minimum benefit package.
Reports of the president’s commission have been integrated into professional curricula in medicine and nursing within the context of courses in ethics and health law. The commission’s reports have had a significant impact on matters of law and public policy, as well as on the public’s understanding of bioethical issues. Thousands of people requested copies of several or all of the commission’s reports, and the reports have been quoted widely in medical, legal, and philosophical circles.
-
Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. 5th ed. New York: Oxford University Press, 2001. A classic work in applied bioethics. A nontechnical, explanatory, and thorough introduction to ethical theory, with emphasis on moral and social problems. -
Blank, Robert H. Rationing Medicine. New York: Columbia University Press, 1988. Places the health care crisis in context. Discusses problems clearly and contains many references and an extensive bibliography. -
Dutton, Diana B. Worse than the Disease: Pitfalls of Medical Progress. Reprint. New York: Cambridge University Press, 1992. Discusses the social, ethical, and economic dilemmas faced by society as a result of medical innovation. Focuses on four cases: the drug diethylstilbestrol (DES) and drug safety in general, the artificial heart, the swine flu immunization program, and genetic engineering and recombinant DNA research within the context of social policy analysis. Written for a general audience, with notes and references. -
Katz, Jay. The Silent World of Doctor and Patient. Rev. ed. Baltimore: The Johns Hopkins University Press, 2002. Katz is a well-respected physician and ethicist and an authority in the area of informed consent. His book covers the field thoroughly, providing historical analysis, examples of problems in decision making, and well-reasoned suggested solutions. Numerous references to case law. -
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Summing Up. Washington, D.C.: Author, 1983. The final report of the commission, containing summaries of the individual reports. The reports are clearly written, frank, and thought-provoking. -
Weir, Robert F. Abating Treatment with Critically Ill Patients: Ethical and Legal Limits to the Medical Prolongation of Life. New York: Oxford University Press, 1989. Careful discussion of ethical and legal issues contained in decisions to terminate life-sustaining treatment of terminally ill patients. Contains numerous references to recommendations of the commission. Detailed notes with references to case law and other sources. Appendix contains a sample of a living will and a state-by-state chart of statutory requirements. -
Wolanin, Thomas R. Presidential Advisory Commissions: Truman to Nixon. Madison: University of Wisconsin Press, 1975. This book is an important contribution to the scarce literature on presidential advisory commissions. Contains a thorough overview of commissions, their functions, and the rationale for their creation. Written for the general reader, with numerous references and meticulous detail.
Nixon Signs HMOs into Law
DeVries Implants the First Jarvik-7 Artificial Heart
United Nations Issues Principles of Medical Ethics
Oregon Guarantees Basic Health Care for the Uninsured
U.S. Supreme Court Upholds the Right to Refuse Medical Treatment
Oregon Voters Legalize Physician-Assisted Suicide
Clinton Rejects Federal Support for Human Cloning