Bioethics: How the Discipline came to be in the United States

Dr. James F. Drane

Profesor Emeritus
University of Edinboro Pennsyvania


It's hard to specify with exactness the beginning of an historical period or a cultural development or even an academic discipline. In most cases beginnings are too far in the past and become lost. Even when relatively few years have passed from the start of something new, initiating events may be diverse, and distinguishing a first step from background influences is always problematic. To talk about the beginning of bioethics, inevitably, is to speculate.

Speculation begins with an attempt to define the term, bioethics. In a very preliminary way, we can say that bioethics is a systematic study of moral conduct in the life sciences and medicine. A case can be made for the claim that bioethics is a new and indeed a paradigmatic discipline for our era. No other discipline or field reflects our contemporary age more faithfully. Medicine and the life sciences are to our age what religion and salvation were in medieval times. They are the focus of enormous societal resources and central concerns for most modern people. Bioethics pulls together under a single discipline the many ethical dilemmas associated with bioscientific research and its application in medicine. The discipline is paradegmatic because the dilemmas force us all to grapple with the essential lfe and death problems: who are we? why are we here? what is the meaning of family; integrity, identity, kinship; freedom, love, community?

The issues with which bioethics is concerned are the focus of our literature and our law. They are the topics of news stories and editorial comment. Churches and universities struggle with them because young and old alike are interested. People want to understand the right thing to do for an impaired newborn or a dying elderly parent, because everyone passes through birth and death, and most families have some problems related to one or the other stage. This enormously expanding field began only recently in developed countries which had to face many new ethical challenges generated by expanding biosciences. But the same ethical problems now challenge people everywhere.

Developments in life sciences that gave impetus to the field of bioethics in developed countries now are part of life in developing nations as well. Modern hi-tech medical centers can be found in major cities all over the world. People everywhere face the same ethical problems associated with human experimentation. Journalists in Europe and Latin American and Japan now give the same prominence to ethical problems in medicine as do their colleagues in the United States. Physicians in other countries are equally as aware of the need to understand the ethical issues generated by their practices and to update their professional codes. Foreign and domestic politicians alike grapple with direct government involvement with health care regulation, and this means involvement with ethical choices and issues of justice. In just a few decades, bioethics has become a major concern worldwide and will continue to reflect the ethos of our 20th and 21st century bioscientific civilization.

Because of its critical place in contemporary societies, the field of bioethics has undergone a meteoric development in the last three decades. First, bioethics centers, institutes, commissions and boards were established in the U.S. and Canada. European nations and the European community followed quickly with their own initiatives. Scholars from Japan and Southeast Asian countries spent time in Canada or the U.S. or Europe and returned to direct the establishment of bioethics institutes in their own countries. Bioethics conferences have already been held in Eastern Europe, and work has started on the development of bioethics centers there. Even recently independent countries in the former Soviet Union and emerging nations in the former Yugoslavia are organizing conferences on bioethical problems and planning bioethics institutes. International bioethics exchanges have begun to take place, and already the field is changing as a result of efforts to develop international agreements. An origianlly dominant North American style of bioethics is now changing under the influence of European, Asian, and Latin American perspectives.

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Contemporary Bioethics: The Beginning Stage

In its initial stages, bioethics was concerned with ethical issues generated by developments in medicine. In the beginning, bioethics was almost synonomous with medical research and clinical ethics (e.g. Nazi experiments and the Karen Ann Quinlan case). Later the subject matter was broadened to include other aspects of medicine and then all the biosciences. Clinical and research ethics, however, remains a core part of this new larger field, Difficult as it is to identify precisely the beginning of bioethics, several events can be recognized as important contributors to its rapid rise.

German medicine in the late 19th and early 20th centuries provided the model for modern medicine. It was linked to laboratory science, which meant that medical practice required proven effectiveness of interventions based on rigorous experimentation inevitably involving human subjects. The misuse of human subjects for medical experimentation created the first modern ethical crises and the first calls for a new medical ethics. The Nuremberg Code responded with what came to be one of the foundations of this new ethics; an informed consent requirement.

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.(1)

The violation of traditional medical ethical standards by misusing patients created widespread moral outrage. The persons used as subjects trusted that doctors were doing something beneficial for them. Vulnerable, weak, and needy human beings suffered dehumanization and even death, and this called for new ethical standards. Quickly the new ethical standards were extended from medical experimentation to medical treatment because vulnerable patients required protection there as well. Benefit balancing and disclosure of dangers and voluntary consent became as much a part of treatment as of experimentation.

News of grossly unethical behavior by some Nazi physicians during World War II was followed in the U.S. by a series of revelations of similar ethical failures (Willow Brook School, Jewish Hospital in New York, and the Tuskegee Syphilis Study). In 1966 Henry K. Beecher, a Harvard physician, published an article in the New England Journal of Medicine in which he exposed common patterns of unethical conduct in medical research.(2) Beecher's article on the misuse of human subjects by U.S. physicians was widely publicized and contributed substantially to public interest in revising the ethics of medicine. Ethical failures associated with research launched a new field of study which later came to be called bioethics. Concern about ethics in experimentation is as strong today as it was at the beginning with modern medicine. This is as true elsewhere in the world as it is with the U.S.

The imperative to make scientific progress in medicine is present anywhere contemporary medicine is practiced. Because the authority of physicians tends to be stronger in foreign countries than it is in the U.S., conditions exist there as well for similar ethical failures. Only a well-developed and widespread bioethics can keep ethical tragedies associated with research from occurring. No society can afford to leave the balancing of individual patient rights with scientific progress, solely in the hands of medical scientists. Standards for the conduct of human experimentation need to be developed everywhere modern medicine is practiced. This is true in the great medical centers certainly, but even small community hospitals in developing countries have become places where testings of medicine and other research occurs. Research forced changes in medical ethics and forced national and international health care organizations to be concerned with educating and then monitoring medical professionals.

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Bioethics and Government Involvement

After World War II, many of the developed nations put great emphasis and large amounts of money into the medical field. Consequently, greater attention had to be given to the ethical issues which inevitably accompanied medical advances. In the United States, the U.S. Public Health Service (an agency of what later would be called Health and Human Services (HHS)) was made responsible for protecting the rights and welfare of human research subjects. In the 1960s, it promulgated ethical standards for the conduct of research. In the 1970s, a National Commission for the Proteciton of Human Subjects of Biomedical and Behavioral Research was formed. Members of the commission worked for four years and made 125 recommendations for improving protection of the rights and welfare of research subjects. This commission also published the Belmont Report. In it were identified the basic ethical principles (respect, beneficence, justice) which guide contact with patients and subjects. Subsequently, the federal government under the auspices of the same Public Health Service continued to update regulations and to require assurances of ethical compliance from any group carrying out research on human beings. The U.S. government, through its financial support of medical projects, became a source of bioethics policy and rules. It established commissions which articulated ethical justifications for a new ethical approach in the conduct of medical practice. The U.S. government played a major role in the development of modern bioethics.

After the National Commission's work, the U.S. government continued its involvement, now in the form of a President's Commission for the Study of Ethical Problems in Biomedical Research. This commission was formed in the 1980s and mandated to provide reports to the President, the Congress, and relevant departments of government in order to guide politicians in developing legislation. In addition, its work provided guidance to health professionals, health educators, and the general public. The President's Commission published eleven volumes, nine reports, the proceedings of a workshop on whistle blowing in research, and a guidebook for local committees that review research with human beings. The work of this government commission has had an enormous influence on U.S. bioethics. A list of the commission's works provides some indication of just how bioethics expanded in the first few decades: Compensating for Research Injuries; Deciding to Forgo Life Sustaining Treatment; Defining Death; Implementing Human Research Regulations; Making Health Care Decisions; Protecting Human Subjects; Screening and Counseling for Genetic Conditions; Securing Access to Health Care; Splicing Life; Whistle Blowing in Biomedical Research.

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Bioethics and Medical Technology

Flowing from government investment in medical science were all sorts of new medical technologies and therapeutic interventions. The linkage of medicine with science which had begun in the late 19th century now began to pay off handsomely in the form of new medicines, dialysis machines, organ transplant techniques, mechanical organ support systems, medically delivered alimentation techniques, ICUs, lifesaving surgeries etc. Each new development created new ethical problems. In the 1960s an ethics committee in the state of Washington tried to make ethically defensible decisions about who would receive dialysis when the scarce technology could not be provided to all. Modern bioethics is not just concerned with medical experimentation on human subjects and with humane medical treatment. From the very beginning it has been concerned with the participation of patients and communities in decisions about socio-economic issues of access and distribution of scarce resources.

Historically the medical profession always accepted moral responsibility for the exercise of physician power over patients. Traditionally medical ethics expressed this responsibility in professional medical codes and ethical treatises published by medical associations. All socially authorized professional power requires public accountability, and this is especially true of medical professional power. The right to practice medicine is associated with moral restrictions on that practice imposed either from within the profession or from outside by the government. As medical interventions became mroe powerful, ethical problems associated with medical practice proliferated. The range of things physicians could do for patients expanded along with the intrusiveness of their interventions. Micro problems arose with each intervention. Macro problems concerned with the relationship of technology and human life also had to be addressed. In both developed and developing nations, physicians became pressed to update their ethical codes. They were not leaders in developing the new discipline of bioethics, but gradually they began contributing to the field.

Scientific and technological medicine moved medical treatment procedures into the public forum. Medical treatment moved out of the privacy of an office or a home and began to take place principally in public hospital settings where ethical responses had to be publicly defensible. The technologies of the next millennium will make earlier therapeutic interventions look primitive and uncomplicated, but we can see in early breakthroughs the driving force behind the new focus on ethics and the emergence of this new discipline called bioethics.

Before the 1950s, "doctors know best" captured the attitude most people had toward medicine and summarized a traditional paternalistic medical ethics. After the Nuremberg trials and the increased influence of experimentation on practice, this older paternalistic ethics gradually gave way to different standards of right and wrong. Other attitudes, different norms, and different principles coalesced to create the beginnings of modern bioethics.

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Role of Nongovernmental Institutes

The disicpline of bioethics developed from more than government initiatives. Nongovernmental institutes and centers also sprang up to respond to the pressing new medical problems.

As early as the 1950s, the Institute of Religion at Texas Medical Center in Houston, started working on ethical issues in medicine. A Society for Health and Human Values was formed by religious thinkers interested in promoting the humanities in medical education. In the 1960s the first Department of Medical Humanities was formed at Pennsylvanian State University Medical Center in Hershey, PA, with a faculty weighted toward medical ethics. The 1970s witnessed the appearance of the Hastings Center in Hastings, NY (late 1969) and the Kennedy Institute of Ethics at Georgetown University (1971). All these initiatives attempted to bring depth and rigor to the new discipline referred to now as bioethics.

The Kennedy Institute followed a university model. It developed a National Reference Center for Bioethics Literature which, in effect, became the best library resource in the world for an expanding new literature. Its scholars came from many different disciplines, worked somewhat independently of one another, and served as faculty for a doctoral program in Bioethics at the university. One of the first scholars, Warren Reich, a Catholic theologian, put together the Encyclopedia of Bioethics, which became a major literary resource for the discipline. A Protestant scholar, Leroy Walters, started an annual Bibliography of Bioethics and developed "Bioethics Line," an on-line computer database. As new areas of the expanding field of bioethics emerged, scholars from the new areas who were interested in ethics came to the Kennedy Institute to study, to write and to teach.

The Hastings Center was started by Daniel Callahan, a Catholic layman with a background in philosophy and theology. At the Hastings Center scholars were brought together to work both independently and in groups in order to develop sound ethical policies for specific problems. The Hastings Center continues to publish policy recommendations and topical reports and to influence government responses both directly and indirectly. The Hasting Center Report, founded in 1971, carried articles on ethical issues in medicine, the life sciences, and the professions. It was the first and has remained the most important journal in the field.

Since these nongovernmental bioethics institutes were founded, literally hundreds of centers, programs, journals, and newsletters concerned with bioethics have sprung up. Every year books and articles on bioethical subjects number into the tens of thousands. From a small and recent beginning, bioethics has become a major field of study. The American Hospital Association in 1987 published a list of 77 bioethics organizations. In 1994 the National Reference Center for Bioethics Literature at Georgetown University published an International Directory of Bioethics Organizations and the number of entries more than doubled in just five years. Now they have doubled again and number over 300.

In the early 1970s, supported by grants from the National Endowment for the Humanities, the Institute on Human Values in Medicine and the Society for Health and Human Values inaugurated a project to develop bioethics in medical education. A prominent physician/humanist, Dr. Edmund Pelligrino, and some staff members visited over 80 medical schools to introduce faculty and students to the new discipline and to set up an educational program for future generations of doctors. They wanted to make sure that bioethics moved from literary texts and reports and commissions to changes in the clinical practice of ordinary physicians.

The Pellegrino effort was directed toward a promotion of the relationship between medicine and the humanities. When the effort began, very few medical school offered courses on human values in medicine. When it ended, after ten years, almost every medical school and many schools of nursing were offering courses in bioethics and other medical humanities. These visits to medical schools and personal contacts with medical school faculty made the big difference. After Pelligrino, bioethics became a practice as well as an academic discipline.(3)

Government commissions, academic centers and nongovernmental institutes combined to contribute to the development of bioethics in the U.S. Interest on the part of professionals stimulated them to go to a growing number of bioethics education institutes. Academically based bioethics centers trained professionals for teaching posts in the new field. Hospitals sometimes hired their own bioethicist for education and consultation, thereby creating job opportunities for trained bioethicists. Bioethics committees were organized in health care settings, and committee members needed education in a field which now had an extensive literature. Attitudes of resistance and skepticism towards a humanities component in scientific medicine gradually gave way to acceptance on the part of medical faculties, students and practicing professionals. The thousands of articles and books annually on bioethics (many of which now written by physicians) testify to what this field has become over the last few decades.

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Bioethics and the Law

Bioethics is not just a new field of study. It is a topic the general public reads about in newspapers and sees on television. Famous cases in bioethics like the Karen Ann Quinlan case are as well known as movie stars and prominent politicians. Widespread public interest in complex and conflict ridden problems meant that politicans, legislators, and lawyers were also interested. The propensity in the U.S. is to look for legal solutions to life's problems and this led to an immediate involvement of bioethics with the law.

When issues raised by experimentation and treatment could not be resolved at the patient-physician-family level, they were taken to the courts. The first court cases involved tragic situations with dying patients. Families and hospital staffs disagreed about whether to withdraw life-sustaining technologies, and courts were asked to make life and death decisions. The disputes attracted the media and created front page stories. People wanted to hear about the tragic case which touched concerns and worries in every family. Court decisions in the highly publicized cases contained arguments that themselves stimulated further arguments. Later court decisions either approved or overturned earlier ones, and a whole corpus of legal bioethics literature came to be.

The combination of media attention and public interest made bioethics important to politicans who saw the need for creating statutes to defend patient and family rights in health care settings. Now every state and province in North America has laws covering bioethical concerns. New laws and new cases continue the active involvement of politicans and judges. Other nations are facing the same pressures. Lawmakers and judges outside the United States, will look to the U.S. experience for help in developing sound legislation.

In Europe and North American, the law adopted many of its positions from ethics. For centuries Catholic moral theology held that patients have a right to refuse any treatment, even life-sustaining treatment, if it is burdensome, risky, costly, or in the language of theological ethics "extraordinary." Statutory law and court cases upheld this moral teaching. And the influence went both ways. Secular and religious bioethicists adopted standards for decision-making which were developed in law: e.g., subjective standard (what the patient actually choses), substitute judgement (what the patient would have chosen), then best interest (what is considered medically best for the patient).

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The Expansion of Bioethics

At the beginning stage, bioethics addressed the ethical problems associated with research and medical practice but quickly expanded to social issues related to healthcare access, animal welfare, and environmental concerns. Every bioscientific advance or change in the healthcare system contributed to the expansion of bioethics.

The first ethical problems with which bioethics began have not disappeared. Experimentation, the humane use of technology, questions about death and dying, abortion and contraception, all are still very much a part of bioethics in the 1990s. Allocation of medical resources too was a problem at the start of modern bioethics. The first ethics commissions in the 1960s tried to bring defensible ethical standards to allocation decisions about scarce medical technologies. Later the allocation issues expanded as states and governments struggled to decide how equitably and justly to distribute ever more scarce medical resources. Some idea of the breadth and complexity of the field today can be gained by looking at the classification scheme of the National Reference Center for Bioethics Literature, or the multiple volumes of the Bibliography of Bioethics (edited by Leroy Walters and Joy Kahn).

Bioethics has undergone an incredible development corresponding to the expansion of biosciences. The original bioethical issues expanded to value-related problems in all health professions: nursing, allied health, mental health, hospice, home health care, etc. A broad range of social issues are now included under the term "bioethics": public health, occupational health, international health, popualtion control, women's issues and environmental concerns. The clinical issues have expanded to include issues related to reproductive technologies, transplants, genetics, cloning and molecular biology. The connection between the concerns of contemporary bioethics and contemporary culture is obvious. Bioethics is considered a paradigmatic discipline in the U.S. because it reflects who we are and what worries us as Americans facing the new millenium.

The expansion of bioethics to address the ethical dilemmas so characteristic of modern culture provided crucial assistance to societal leaders, both political and professional. But society and societal leaders were not the only ones to benefit. Ethics itself benefitted from bioethics. In 1973 Stephen Toulmin argued that medical ethics had saved ethics from decline and disinterest.(4) The problems with which medical ethics grappled not only created a new interest in ethics, but saved academic ethics from an irrelevance created by an overly abstract, rationalistc, linguistic approach. Philosophers, theologians, lawyers, doctors and social scientists suddenly found the ethical aspects of medicine and biosciences to be areas of fascination and started studying them. Their challenge was to make ethical concepts and arguments applicable to clinical contexts and relevant to persons working in clinical medicine.

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The Future of Bioethics

Will the astounding expansion and central importance of bioethics continue into the next century? A quick and clear response to this question arises from considering two recent bioethics issues: the genome project and AIDS.

Once the human genome is mapped, and information locked in human genes is opened, the ethical problems generated by this new information will explode. This has already started to happen with every discovery of genetic links to disease. The information developed by genetic research has ominous as well as hopeful potential. Data banks of individual DNAs could be established. Government agencies, police, employers, and insurance companies could literally categorize human lives and destroy human initiatives if they were to gain access to the data. Only with well thought out ethical standards and judiciously developed ethical policies can the worst results imaginable be avoided. The very dignity and freedom of human life swings in the balance between ethical and unethical handling of this one bioscientific project.

The genome project is the life science project of the 1990s and can easily be compared with the physics project to unlock the power of the atom in the 1940s. The potential for good is great, but unless the associated ethical issues are openly discussed and thought through in advance, human life as we know it today in a civilized, free and democratic society may be undermined. The sheer numbers of ethical complexities are hard to imagine, but the ominous consequences of not attending to the bioethical dimensions of this project are even more ominous. With good reason a percentage of the money allocated for the genome project is committed to bioethics. Ethical questions generated by genetic developments are already present in clinical settings but in nowhere near the intensity which will develop once the new knowledge turns into new therapies.

AIDS is another biomedical challenge shot through with ethical dilemmas. LIke so many other diseases with which physicians have battled over the years, waging an effective and aggressive campaign against AIDS requires attention both to its biological and bioethical dimensions. Sound strategy has from the start considered scientific and ethical dimensions of the disease. Committements to find vaccines and therapies have been joined with campaigns to protect the human rights and dignity of people with HIV and AIDS. Efforts to stop transmission of the disease are combined with efforts to stop discrimination against disease bearers in employment, travel, housing, access to heatlh care, and in hospital-based medical care provided by doctors and nurses.

AIDS, like the genome project, shows the inevitability of bioethics in contemporary life as well as the ever expanding complexity of this field. On the pragmatic, concrete level, there are problems of confidentiality; allocation of resources; use of human subjects for research; health policy development for schools, work place, prisons, and society at large; education and public campaigns; privacy; screening; informed consent; and on and on. No single aspect of the AIDs epidemic is devoid of its bioethical dimension.

Bioethics will continue to expand and to be considered important as far as we can see because biological sciences will remain critical and the two are inseparable. Ethical policies will be required in every institution. Codes and laws, both national and international, political and professional, will have to be developed, then continually improved and updated. No end is in sight for new roles for clinical professionals who are conversant with modern medical ethics. The discipline which emerged in the last half of the 20th century in the U.S. and Europe is now a world wide enterprise. It is hard to imagine that it will not still be with us long into the coming millenium.


  1. Nuremburgh Code. Cited by Robert J. Levine, Ethics and Regulation of Clinical Research, Second Edition (New Haven: Yale University Press, 1988), Appendix 3, 425.
  2. Henry K. Beecher, "Ethics and Clinical Research," The New England Journal of Medicine, 274 (1996) 1354-1360.
  3. Edmund D. Pellegrino and Thomas K. McElhinney. Teaching Ethics, the Humanities and Human Values in Medical Schools: A Ten-Year Overview, (Washington, DC: Institute on Human Values in Medicine Society for Health and Human Values).
  4. Stephen Toulmin, "How Medicine Saved the Life of Ethics," Perspectives in Biology and Medicine, 25, (4) Summer 1973, 736-750.