Bioethics

The term "bioethics" is derived from the Greek words bios, meaning life, and the Greek word ethos, meaning character. The meaning is essentially "life character." Today, ethics might be better described as applied morals or the philosophy of being moral, with bioethics being the discussion or application of morals within the diverse fields of the life sciences.

The quest for better health has guided scientists and researchers to develop many tools for analysis including organic chemical synthesis and improved genetic engineering. A significant aspect of contemporary medical research is the use of animals as test subjects. Many advances in personal care products, pharmaceutical drugs, and life-saving medical treatments have come about through the use of animals for testing and research. However, this practice is controversial.

Many people feel that animals are abused and mistreated for unnecessary research. The use of animals to test the safety of household or personal care products angers those who feel that humans are unfairly abusing animals for commercial gain. In contrast, scientists point out that animals are the most reliable indicators of potential human response to certain diseases and treatments, and that many successful, life-saving treatments and medical breakthroughs have emerged only because it is possible to test treatment options using animals, rather than human beings.

Unfortunately, some of these discoveries have come at the cost of the natural or induced death of test animals. So the ethical situation arises: Does the benefit of the new data outweigh the risk to the organism, or is the risk greater than the benefits? What may be considered unacceptable to one person may be an acceptable trade-off to another. To address this dilemma, bioethicists attempt to set reasonable restrictions and limits on experimentation so as to maintain a balance between the suffering of experimental animals and the research benefits that may be derived from animal experimentation.

Ethics itself has long been coupled to philosophy and religion. Each person's moral viewpoint is constructed from a host of factors, including education, family background, religion, personal experiences, social level, economic standing, and profession. So if every researcher and every consumer can, hypothetically, hold different views about the relationship between risk and benefit, who is responsible for setting guidelines? And what is the foundation for such guidelines?

Bioethics and Research Institutions

A first step toward establishing ethical guidelines for animal testing has been taken by institutions in the United States that fund research, such as the National Institute for Health, the Food and Drug Administration, and the Agriculture Department. Their policies are primarily set by the public in the form of political action initiated by their elected representatives. The directors and boards of these institutions consider the opinions of their constituents when deciding what types of research to support.

Private institutions such as the Howard Hughes Foundation and Rockefeller Foundations set their policies through committee discussion groups and professional panels that make recommendations to the directors of the respective foundations. Their opinions are reflected in the programs the foundations choose to fund.

Finally, private businesses and corporations that fund this type of research generally use a board or panel approach and approve of experiments within the guidelines set forth in both state and federal law, with an eye to accommodating the general will of the public.

In each of these three cases, an advisory committee is usually composed of senior researchers of a particular discipline—for example, biotechnologists to examine biotechnology questions—plus a philosopher to provide some historical depth and background, and members of interest groups or other public representatives. These panels make their recommendations based upon consideration of current circumstances as well as the potential future impact of the relative costs and benefits of the proposed research.

What sorts of issues does a panel consider when looking at a given experiment? With regards to animal testing for a new pharmaceutical, the dialog generally contains several crucial elements. The first step is to identify an experimental need. For example, a company may wish to test a new drug that would destroy fatty deposits in coronary (heart) arteries. The pharmaceutical company needs to conduct experiments to ensure drug safety and identify any possible side-effects for humans. Since federal law requires that any drug be thoroughly tested with an accurate experimental model to understand its effects before it is approved, one of the first questions to consider is how this may be best accomplished.

A variety of systems are available to model a drug's behavior. These include microbial models (not suitable in this case); tissue models (the heart tissue model might provide very good information with no apparent negative effects); computer modeling (not always appropriate for finding actual data); and finally, animal models—which have the potential to provide the most accurate information about the drug's likely effect on human beings.

The question of ethics arises during this process. In contemporary American culture, we tend to value human life above the lives of animals. Supporting this view are such culturally accepted practices as the consumption of certain animals as food, the production of drugs such as insulin from animals, and the pursuit of the longstanding hobbies of hunting and fishing for recreation and relaxation. Not everyone agrees that all of these practices are acceptable, however.

Animal Rights vs. Human Lifestyle

The widespread use of animal life to maintain human life or lifestyle is a growing point of controversy . An increasing number of consumers are voicing the opinion that the use of animals in the development of products for human use should be restricted. This is especially true in regard to the cosmetics industry where products are used for appearance rather than health purposes. For example, many consumers, investors, and animal rights activists are offended by the ways in which a product like mascara may be tested on animals before it can be approved for human usage.

There are those who believe that animal testing may be acceptable if used to develop new drugs that may save human lives. The necessary data regarding performance and safety cannot be gathered any other way. But the practice of killing an animal every time a shampoo changes its color is disturbing to many of these same people. While this may seem extreme, this happens under current law because every time something is added to an existing formula the new combination must be retested for safety and effectiveness, and animals do not always survive such testing.

At first, one might question why it is necessary to go to such lengths to test a nonmedical product. But what if a shampoo's new color proved to harmful to human skin? Or caused hair to fall out? Most consumers agree that it is not acceptable to have less stringent safety standards for such products, and yet there is disagreement about what this means in regard to the ethics of animal testing. It is impossible to set absolute moral guidelines, since each case is unique, but for a variety of reasons, current law is set to err on the side of physical human safety.

Questions in Bioethics

Bioethics requires the asking of questions that go beyond current legal requirements. Are there ways to guarantee safe cosmetics and personal care products that do not involve the use of animals? If animal testing is the only sure way to guarantee product safety, are there ways to keep from harming animals in the process? One option gaining in popularity is to restrict animal testing to the most humane and painless tests possible. Restricting the use of animals to the final stages of testing is another way researchers are trying to balance human safety with animal comfort.

Another issue confronting bioethicists has to do with the removal of animals from the wild for research purposes. In particular, the use of wild chimpanzees and other primates is under scrutiny. The dilemma arises because the public does not appear to support continued harvesting of primates from wild habitats for research purposes, yet the chimpanzee, for example, is the animal most closely related to humans, and thus most desirable for testing potential medicines.

There is little disagreement that creative minds are needed to explore alternative methods of assessing the effects of chemicals on human beings. Increasing knowledge about the human genome, and the promise of genetic treatments for human disease, suggest that animals will continue to have a role in medical research. Those involved in the field of bioethics will constantly be challenged to assess how and when to use animals for this research.

The field of bioethics addresses more than just the question of how to manage conflicting priorities and approaches to animal testing. Now that geneticists have created clones of nonhuman species of vertebrates, there are increasing questions regarding the ethical use of human genetic material. Should researchers be allowed to try to clone human organs for life-saving transplants? Should human embryonic tissue be made available for stem-cell research? Should doctors be allowed to test gene therapy on human patients who have exhausted all other treatment options?

Scientists search for ways to apply a growing body of knowledge to the betterment of human life. Philosophers and others pose ethical questions concerning scientific advancement. Sellers of goods and services depend on the advancements of science to create and fill market needs. Bioethics is the field where life science, philosophy, and commerce meet, where practitioners negotiate boundaries, wrestle with guidelines, and seek balance within the natural world in the quest to improve the quality and quantity of human life.

see also Animal Rights; Animal Testing.

Brook Ellen Hall

Bibliography

Kuhse, Helga, and Peter Singer, ed. Bioethics: An Anthology. Malden, MA: Blackwell Publishers, 1999.

Shannon, Thomas A. Bioethics: Basic Writings on the Key Ethical Questions that Surround the Major, Modern Biological Possibilities and Problems. Mahwah, NJ: Paulist Press, 1994.

Veatch, Robert M. The Basics of Bioethics. Upper Saddle River, NJ: Prentice Hall, 1999.

BIOETHICS

BIOETHICS addresses the moral and ethical issues arising from clinical practice, medical and biological re-search, resource allocation, and access to biomedical technology. Van Rensselaer Potter at the University of Wisconsin and Andre Hellegers at the Kennedy Institute of Ethics independently coined the term "bioethics" in the early 1970s to describe different concepts, and its exact definition remains contested today. However, it is nonetheless possible to discern the growth of a professional bioethics industry and discipline intimately tied to cultural mores and new advances in biomedical technology and techniques. Indeed, the field of bioethics underwent explosive growth and institutionalization in the 1970s as challenging issues such as euthanasia, in vitro fertilization, organ transplantation, and genetic engineering attracted the public's attention and concern. Because questions over appropriate science and social policies exist at the crossroads of legal, political, and moral disputes, the history of American bioethics is one of contentious debate, government regulation, and continuing growth.

The history of medical ethics dates to antiquity, and the Hippocratic Oath to "do no harm" remains at the core of modern medical ethics. The American Medical Association (AMA) established a code of ethics in 1846 to regulate medical practice; a hundred years later, revelations about Nazi medical experimentation led to the Nuremberg Code, requiring "informed consent" from human subjects involved in research. In the 1960s the introduction of dialysis machines, and the resulting "God committees" to decide who would receive the life-saving treatments, strained the medical community's ethical consensus. At the same time, a cultural emphasis on individual rights merged with growing concerns over medical and biological advances to require government intervention. For example, the definition of "brain death," the ethics of organ transplantation, and the potential for prenatal genetic discrimination led to the first Senate hearings on bioethics in 1968. These issues also led to the establishment of the Institute of Society, Ethics, and the Life Sciences (also known as the Hastings Center) in 1969; the National Science Foundation's Ethics and Human Values Implications of Science and Technology (EHVIST) program in 1971; and the Joseph and Rose Kennedy Center for the Study of Human Reproduction and Bioethics (later the Kennedy Institute of Ethics) in 1971.

Throughout the 1970s a professional bioethics industry developed in response to numerous ethical and medical dilemmas. The wide assortment of issues attracted attention from diverse groups. Many religious communities felt genetic screening might increase abortions of "defective" babies, while the Roe v. Wade decision and questions regarding fetal research ensured the active participation of women's groups. The disclosure of improper medical conduct and a lack of informed consent in the Tuskegee, Alabama, syphilis study heightened awareness about the regulation and control of research, as the public questioned whether researchers could be trusted with ethical responsibilities. These questions resurfaced in disputes over the morality of "gene splicing" throughout the decade, while the Karen Ann Quinlan case thrust the "right to die" movement into the spotlight. The birth of Louise Brown, the first "test-tube" baby, also ignited public interest, as the government and the public struggled to address the plethora of issues. By 1980, many medical schools had established programs and journals to discuss the challenging new issues and prepare students for their future careers; the first Encyclopedia of Bioethics appeared in 1978.

In 1974 the United States Congress, led by Massachusetts Senator Edward Kennedy, established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission released a series of reports over the next four years that provided the "official" positions necessary to create uniformity in American policies on the various complex legal and ethical issues. Given the religiously pluralistic fabric of American society, the committee's primary position, as outlined in The Belmont Report, relied on the three principles of beneficence, justice, and autonomy as acceptable, and secular, bioethical guidelines. Early treatises on medical ethics, such as Joseph Fletcher's Morals and Medicine (1954) or Paul Ramsey's The Patient as Person (1970), had often combined Christian theology with a liberal philosophy to help reconsider the doctor-patient relationship in light of the latest medical developments. Indeed, some observers credit the rise of bioethics with revitalizing philosophical ethics, as the new challenges demanded a fresh approach and a resolution.

However, the guidelines failed to quell public uneasiness and led many groups to question the official principles throughout the 1970s and 1980s. Christian fundamentalists and Christian Scientists were especially vocal and litigious in challenging the emphasis on individual autonomy. Critics often charged that the Belmont Report's principles downplayed the importance of community and family and argued against the autonomy of children and mentally handicapped patients in making decisions regarding abortion, euthanasia, or life-saving medical treatments. Similar disagreement followed the 1982 release of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Re-search (est. 1980) report Splicing Life because it advocated the patenting of genetically-altered organisms and stated that future debates on biological research could rely on professional bioethicists, rather than theologians, for moral and ethical perspectives.

By the early 2000s bioethics was internationally recognized and interdisciplinary, drawing participants and perspectives from philosophy, medicine, biology, theology, and history. By 1990, over 100 organizations and institutions dedicated to bioethics had been established, many of them in the United States, an acknowledged leader in the field. Indeed, responding to ethical concerns over human gene therapy and experimentation with human subjects, President Bill Clinton established the National Bioethics Advisory Commission in 1996. Chaired by Harold Shapiro, former president of Princeton University, the commission produced the influential report Cloning Human Beings, which outlined the ethical issues related to the emerging technology. The commission's charter expired in October 2001, leaving empty that critical nexus where specialists in medical, clinical, or research ethics could address the latest bioethical developments, from reproductive techniques and access to artificial organs to cloning, stem cell research, and genetic privacy and discrimination. As the sophistication of medical technology and biological research increases, the field of bioethics continues to grow, preparing to meet the unforeseen challenges of the twenty-first century.

BIBLIOGRAPHY

Engelhardt, H. T. The Foundations of Bioethics. Oxford: Oxford University Press, 1986.

Jonsen, Albert R. The Birth of Bioethics. New York: Oxford University Press, 1998.

Reich, Warren, ed. The Encyclopedia of Bioethics. New York: Simon and Schuster, 1995.

Stevens, M. L. Bioethics in America: Origins and Cultural Politics. Baltimore, Md.: Johns Hopkins University Press, 2000.

J. G.Whitesides

See alsoClinical Research ; Euthanasia ; Medical Research .

Bioethics is the study of the moral dimensions of the life sciences and health care, including medicine, nursing, and the allied health professions.As an academic discipline, bioethics emerged in the 1960s and 1970s amid public controversies involving the misuse of human subjects in medical research and disquiet about the morality and safety of recombinant DNA research. Subsequent media coverage of such issues as xenografting and human cloning made bioethics and bioethicists familiar to many Americans.

Before the advent of bioethics (a term coined in 1970–1971), such ethical issues as truth‐telling and the confidentiality of the doctor–patient relationship comprised part of a tradition of medical ethics going back to the Hippocratic oath of ancient Greece. In the United States, physicians had adopted ethical codes to guide practitioners in their relations with one another, with their patients, and with society. When physicians established the American Medical Association (AMA) in 1847, they followed the example of such earlier medical societies as the Boston Medical Association and the College of Physicians of Philadelphia in ratifying ethics codes for their members. Based on the ethical code written by the English physician Thomas Percival in 1792, the AMA code particularly addressed the relationships among physicians and offered explicit rules for consultations with nonorthodox practitioners, who actively competed for patients with AMA members.

In the nineteenth and early twentieth centuries, the ethical dimensions of medicine received little attention outside the medical profession. The clergy, especially Catholic theologians, occasionally offered ethical analyses of such practices as abortion and contraception. In the 1910s and 1920s, the leaders of the medical profession grew concerned about public accusations against physicians who performed experiments on such vulnerable groups as orphans and inmates of mental‐health institutions. But proposals to restrict such practices, introduced at both the state and federal levels, generally failed because most Americans trusted the medical profession to protect patients' interests and well‐being. Buoyed by startling medical breakthroughs—insulin (1920s) and penicillin (1940s)—the American medical profession continued to enjoy popular esteem and respect.

During the 1960s and 1970s, this trust eroded. In this era of the civil rights movement and the women's rights movement, proponents of the rights of patients challenged the medical profession's traditional authority to oversee patients' interests and to police itself. Revelations of scandalous abuses in human‐subject research, especially the forty‐year study of untreated syphilis in four‐hundred African American men (the Tuskegee Experiment) shocked the public and the U.S. Congress. In the wake of public hearings, President Richard M. Nixon in July 1974 signed the National Research Act, requiring institutions receiving federal aid to form institutional review boards to monitor proposals involving human research subjects. The act also created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines to protect human participants in biomedical research. Including physicians, lawyers, clergy, philosophers, and social scientists, the commission issued several reports from 1975 through 1978.

The broad spectrum of bioethical concerns in the 1970s and 1980s, including issues relating to brain death, severely “defective” newborns, and the maintenance of comatose patients on respirators prompted Congress to authorize a second commission. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, appointed by President Jimmy Carter in 1978, produced a series of papers between 1980 and 1983 on such issues as health‐care decision‐making, defining brain death, genetic screening, and decisions involving life‐sustaining treatment. In 1995, in the wake of revelations of human radiation experiments sponsored by the federal government during the Cold War, President Bill Clinton formed the National Bioethics Advisory Commission. Reflecting the growing interdisciplinary nature of bioethics, the eighteen‐member board comprised people trained in medicine, law, nursing, religious studies, history, and bioethics, as well as an advocate for the mentally ill. As one of its first duties, the board reviewed the ethical and legal implications of human cloning, prompted by the successful cloning of an adult sheep by Scottish researchers.

As an academic discipline, bioethics flourished in American medical schools and in such private institutions as the Hastings Center for Bioethics in Briarcliff Manor, New York, during the last quarter of the twentieth century. As interest in bioethics burgeoned, the courts increasingly played a role in medical decision‐making; between 1976 and 1988, for example, U.S. courts addressed fifty‐four cases involving the right to refuse life‐prolonging therapies. Another measure of the growing status of bioethics was its prominence in the media; by the 1990s, journalists routinely consulted bioethicists for pronouncements on biomedical issues.

A bioethics issue with political overtones involved medical researchers' use of human stem cells. Since stem cells are harvested from very early‐stage human embryos (called blastocysts) used in vitro fertilization, a method employed by couples experiencing reproductive problems, the issue became enmeshed in the abortion debate. In 2001 President George W. Bush, advised by his newly created President's Council on Bioethics, barred federal funding of medical research on stem cells harvested in the future.
See also Biotechnology Industry; Birth Control and Family Planning; Genetics and Genetic Engineering; Medical Education.

Bibliography

Donald E. Konold , A History of American Medical Ethics, 1847–1912, 1962.
Ruth R. Faden and and Tom L. Beauchamp , A History and Theory of Informed Consent, 1986.
George Weisz, ed., Social Science Perspectives on Medical Ethics, 1990.
David J. Rothman , Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making, 1991.
Susan E. Lederer , Subjected to Science: Human Experimentation in America before the Second World War, 1995.
Robert Baker et al., eds., The American Medical Ethics Revolution, 1999.

Susan E. Lederer

Paul S. Boyer

Bioethics

BIBLIOGRAPHY

The field of bioethics, as distinct from medical ethics, has existed since the 1960s. Unlike medical ethics, which for centuries has examined the duties and responsibilities of physicians to their patients and to other doctors, the development of bioethics can be traced to the rapid progress in technology and science experienced in the United States in the 1960s. Organ transplantation, chemotherapy, kidney dialysis, respirators, the contraceptive pill, genetic screening, and intensive care units were extraordinary medical breakthroughs that were seen as highly beneficial but also costly and sometimes harmful. This explosion of technological success brought in its wake a set of daunting ethical dilemmas that medicine, academics, legislators, and the public had never previously been forced to face.

In the wake of these developments, issues of healthcare access and rationing, withdrawal and withholding of lifesaving care, dignity in dying, and how to define death and manage the high cost of medical care now loomed large as urgent ethical quandaries. At the same time, societal changes placed greater emphasis on individual autonomy and rights, which prompted the public to press the field of medicine for more patient involvement and control over medical treatment. The ethical dilemmas generated by these advances in science and medicine required interdisciplinary study and reflection that traditional academic disciplines were ill-equipped to handle. In response to these pressing ethical problems, scholars began to venture outside of their traditional subject matter to discuss, debate, and write about these new dilemmas, and bioethics became a new area of academic attention.

Some of the original dilemmas are still at the core of bioethics today. The field now focuses ethical problems in clinical, preventive, and research medicine that involve truth telling, informed consent, confidentiality, end-of-life care, conflicts of interest, nonabandonment, euthanasia, and substituted judgment for incompetent persons. Bioethics has established both the right to informed consent and the right to control one’s medical treatment as key tenets of American law and ethics. With each new technological breakthrough, the field of bioethics expands its scope to address new ethical dilemmas, most recently those involving the human genome project, stem cell research, artificial reproductive technologies, the genetic engineering of plants and animals, the prospect of human reproductive cloning, preimplantation genetic diagnosis of embryos, nanotechnology, and xeno-transplantation. Bioethics has also more recently begun to reflect on the health-care challenges faced in developing nations, such as whether national or local standards should govern the conduct of medical research or the problems of rationing access to innovative treatments in nations besieged by devastating epidemics such as malaria or AIDS.

Since the 1960s, the field of bioethics has gained legitimacy as an independent academic discipline, and that new status has brought significant changes in the structure and institutions of the field. Originally, the institutions of bioethics were independent think tanks. Today, the trend is the creation of academic bioethics departments, either within a medical school or school of arts and sciences. The professionalization of bioethics has taken it from the academic margins to an accepted place within universities, hospitals, regulatory bodies, the media, and industry.

SEE ALSO Medicine

BIBLIOGRAPHY

Callahan, Daniel. 1973. Bioethics as a Discipline. Hastings Center Studies 1 (1): 66–73.

Fox, Daniel. 1985. Who Are We: The Political Origins of the Medical Humanities. Theoretical Medicine 6: 327–341.

Jonsen, Albert. 1998. The Birth of Bioethics. New York: Oxford University Press.

Potter, Van Rensselaer. 1971. Bioethics: Bridge to the Future Englewood Cliffs, NJ: Prentice Hall.

Reich, Warren, ed. 1978. Encyclopedia of Bioethics. New York: Free Press. 3rd ed., 2004. Ed. Stephen G. Post. New York: Macmillan.

Reich, Warren. 1994. The Word “Bioethics”: Its Birth and the Legacies of Those Who Shaped Its Meaning. Kennedy Institute of Ethics Journal 4: 319–336.

Arthur Caplan
Autumn Fiester

bioethics in philosophy, a branch of ethics concerned with issues surrounding health care and the biological sciences. These issues include the morality of abortion , euthanasia , in vitro fertilization , and organ transplants (see transplantation, medical ). In the 1970s bioethics emerged as a discipline with its own experts, often professional philosophers, who developed university courses on the subject. Many hospitals now employ experts on bioethics to advise on such issues as how to treat terminally ill patients and to allocate limited resources. Advances in health care, the development of genetic screening , and the new research in genetic engineering , including gene therapy , have also given rise to questions in bioethics.

Bibliography: See W. T. Reich, ed., Encyclopedia of Bioethics (4 vol., 1978); H. T. Engelhardt, The Foundations of Bioethics (1986); R. Macklin, Mortal Choices: Bioethics in Today's World (1987).

bioethics. The term was coined in 1971 to describe ethical reflection on issues arising within the sphere of the biological and medical sciences. For Christians it is a part of moral theology and is governed by its principles, including the sacredness of human life, love of neighbour, and respect for the sovereignty of God. For discussion of some branches of bioethics, see CONTRACEPTION, PROCREATION, AND ABORTION, ETHICS OF; and DYING, CARE OF THE.

bioethics (by-oh-eth-iks) n. an area of applied ethics relating to moral behaviour in the life sciences. Medical ethics is now often considered a subspecialty of bioethics (biomedical ethics).

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