[Please note: this article is copyrighted by the author and explains what bioethics is. We at Hospice Patients Alliance are grateful for permission to post Prof. Irving's article here. It is one of the most helpful articles available for those trying to understand how our nation's health care system, and much of society, has been taken over by a secular, utilitarian view of life. - Ron Panzer, for HPA]

[Dianne N. Irving, M.A., Ph.D., "What is 'Bioethics'? (Quid est 'Bioethics'?"),

in Joseph W. Koterski, Life and Learning X: Proceedings of the Tenth University Faculty for Life Conference (Washington, D.C.: University Faculty for Life, 2002), pp. 1-84)]

Author's copyright June 3, 2000

WHAT IS "BIOETHICS"? (QUID EST 'BIOETHICS'?)

OUTLINE:

I. Introduction

II. Different Ethics, Different Conclusions

III. Early History of "Medical Ethics"

A. Ancient History

B. Mediaeval History

C. Modern History

IV. From World War II to the National Commission

A. The Conferences, Issues, and Thinkers

B. Evolving "Ethics"

V. The Centers

A. The Hastings Center

B. The Kennedy Institute of Ethics

C. The Society of Health and Human Values

VI. The Formal "Birth" of Bioethics

A. The Congressional Hearings

B. The National Research Act and The National Commission

C. The Belmont Report

VII. The National Commission and Bioethics: A Short Analysis

A. Odd Scientific Definitions: "fetus" and "pregnancy"

B. Problems With the Principles

C. Problems in Applications

D. The Problem of "Personhood"

VIII. The Reign of Bioethics

A. The Ethics Advisory Board

B. The President's Commission

C. The NIH Human Fetal Tissue Transplant Conference

D. The NIH Human Embryo Research Panel

E. The National Bioethics Advisory Commission

F. The NIH Guidelines for Research Involving Human Pluripotent Stem Cells: The New "Pre-embryo"

IX. The Penetration of Bioethics

X. Bioethics: Discipline or Discourse?

A. Does Bioethics Have a Proper Subject Matter?

B. Does Bioethics Have a Proper Method?

C. Is Bioethics a Discourse?

D. Are Bioethicists Experts?

E. Either/Or

XI. Conclusion

[Please note: this essay is copyrighted by the author]

[Dianne N. Irving, M.A., Ph.D., "What is 'Bioethics'? (Quid est 'Bioetics'?"),

in Joseph W. Koterski, Life and Learning X: Proceedings of the Tenth University Faculty for Life Conference (Washington, D.C.: University Faculty for Life, 2002), pp. 1-84)]

Author's copyright June 3, 2000

WHAT IS "BIOETHICS"? (QUID EST 'BIOETHICS'?)

"A small error in the beginning leads to a multitude of errors in the end."

Thomas Aquinas, De Ente Et Essentia

Aristotle, De Coelo

I. INTRODUCTION

There is a strange phenomenon I have encountered over the last several years which I hope to at least identify with this essay. It is the apparent belief that bioethics is somehow the same as, or to be equated with, ethics per se, or at least with medical ethics per se. I have even heard it referred to as Roman Catholic medical ethics per se. Repeatedly, when I ask a group to define "bioethics", I usually get the same sort of response. I hope with this essay to disenfranchise people of this belief.

Contrary to "popular opinion", bioethics, as predominantly practiced today -- especially as embedded in formal governmental regulations, state laws and a myriad of other documents, committees, guidelines, guidebooks, etc., around the world[1] -- is not the same thing as "ethics per se". Academically it is actually a sub-field of ethics, and stands alongside many other theories of ethics, e.g., Kantian deontology, Millsean utilitarianism, casuistry, natural law, egoism, situation ethics, relativism, and various forms of theological ethics, etc. And like all ethical theories, bioethics is by no means "neutral" -- there is no such thing as a "neutral ethics".[2] In fact, bioethics defines itself as a normative ethical theory -- i.e., it takes a stand on what is right or wrong.[3]

Nor is bioethics to be equated with "medical ethics", as that term is still generally understood.[4] Nor is it the same as Roman Catholic medical ethics, or any other such subsystem of ethics that could be used to determine the rightness and wrongness of human actions within the medical or research contexts.

As we will see, bioethics understood as "principlism" is an academic theory of ethics which was formally articulated for the first time in 1978 by the Congressionally-mandated 11-member National Commission in their Belmont Report.[5] That Report, as Congressionally mandated, identified three bioethics principles: respect for persons, justice and beneficence. (As will be demonstrated below, the Commission defined these three bioethics principles in less-than-traditional terms). Nor is bioethics restricted to the medical context, but extends to all of the 'bios", or "life" issues. Nor has bioethics ever even considered abortion a serious issue of debate[6] (although the definitions of a "human being" and of a "human person" concretized in the Roe v. Wade decision has reverberated throughout the bioethics and legal literature since then -- especially in the issues concerning human embryo and fetal research, human cloning, and human embryonic and fetal stem cell research). At least this much must be clear before anyone enters these public "bioethics" dialogues.

My purpose in this paper is simply to provide historical confirmation of what bioethics is, who the Founders, theorists and practitioners are, identify just some of the major issues addressed (particularly those concerning research using human embryos and fetuses), and touch on some of the more salient inherent problems of and concerns about this "theory". As the formal body of bioethics literature is enormous -- extending over 30 years or more -- it will be impossible in this essay to properly evaluate in detail all of the ramifications of this "bioethics edifice".

My method will be primarily historical -- in terms of relating, only in the briefest of outline form, the short but extensively referenced and hectic history leading up to the actual articulation of the three bioethics principles of autonomy, justice and beneficence in the National Commission's Belmont Report. Because many of you are probably not familiar with those who have and still play major roles in bioethics, I will list as many of them as is reasonably feasible in the main text.

II. DIFFERENT ETHICS, DIFFERENT CONCLUSIONS

To put my endeavor into sharp focus, consider for a moment the strikingly different conclusions reached by secular bioethics and Roman Catholic medical ethics on an array of issues. Secular bioethics generally considers the following as ethical: contraception; the use of abortifacients; prenatal diagnosis with the intent to abort defective babies; human embryo and human fetal research; abortion; human cloning; the formation of human chimeras (cross-breeding and "back-breeding" with other human and animal species); human embryonic stem cell research; "brain birth; purely experimental high risk research with the mentally ill; euthanasia; physician-assisted suicide; living wills documenting consent to just about anything; and, withholding and withdrawing food and hydration as extraordinary means.[7] In contrast, Roman Catholic medical ethics, as expressed in the National Conference of Catholic Bishops' Ethical and Religious Directives for Catholic Health Care Services,[8] as well as in the Charter for Health Care Workers published by the Vatican, considers all of these unethical. Probably the only issues on which they both agree is that the use of extraordinary means, e.g., a ventilator, is not morally required if a treatment is medically futile, and that even high doses of pain medication may be given if medically appropriate.

How is it that these two different ethical systems lead to such opposite and contradictory ethical conclusions? The answer is rather predictable. Every academic ethical theory has its own idiosyncratic ethical principles. Deducing from different ethical principles necessarily leads to different ethical conclusions. For example, Roman Catholic medical ethics is grounded on the ethical principles embedded in the Moral Law (a combination of natural law philosophical ethics, the Divine Law, and the teachings of the Magisterium).[9] Secular bioethics, as predominantly understood and applied, is grounded in the three bioethics principles of respect for persons (now referred to as autonomy), justice and beneficence as articulated in 1978 by the National Commission in their Belmont Report.[10] Deducing from these two very different sets of ethical principles leads inexorably to the different ethical -- and therefore medical ethical -- conclusions noted above.

In short, there is really no such thing as just "ethics per se", or as just "medical ethics per se". There are different kinds of ethics, and therefore there are different kinds of medical ethics -- each with its own unique ethical principles, subject matter, method (epistemology), and squadrons of "experts". It is these inherently different characteristics of different ethical theories that are compared and contrasted in ethics or medical ethics classrooms (or at least should be).

Likewise, different ethical or medical ethical theories have their unique historical records. The "history" of bioethics is no exception, although its "history" is rather recent. To understand how bioethics is not ethics per se, or even medical ethics per se, it is helpful to start by tracing some of its historical roots in the ancient medical tradition of Hippocrates.

III. EARLY HISTORY OF "MEDICAL ETHICS"

Several of the Founders of the field of bioethics are now busily writing books containing their own various accounts and versions of the history of the new "field" of bioethics. One example is the recent book by philosopher-Founder Albert Jonsen, The Birth of Bioethics[11] (well worth reading). Although Jonsen presents the history of bioethics from within his own idiosyncratic perspective and his own important role in that history, his book is a wealth of historical information and extensive, often unique and difficult to access, documentation. The book does help to explain a great deal of some of the historical roots of bioethics, precisely what bioethics is, and the "experts" who founded it and are currently plying this trade.

Jonsen (a trained philosopher and former Jesuit priest) starts his "history" of bioethics by outlining its roots in the ancient Hippocratic tradition, and then moves chronologically through the mediaeval and modern periods of medical ethics. He marks the contemporary events leading to the formal "birth" of bioethics as beginning about 1947, and extends his depiction of bioethics to 1987. It is of note that he stops the "history" there -- and the burning question is "why"? "I chose 1987 as the terminus of this history, ... [T]he leading ideas that form the discipline have come under scrutiny; the theory, principles, and practices that evolved during the first decades do not seem to measure up to the new questions."[12] Just what are these "new questions" which caused this abrupt end to such a glorious "history"?

A. Ancient history:

Jonsen's presentation of the "pre-history" is already familiar enough to many of you, so I will only reiterate it quite briefly and in simplistic outline here. He traces the literature of "medical ethics" back to the Hippocratic School between 400-300 B.C. -- the tradition of "medical ethics" which has basically continued until modern times. It was concerned with the qualities of "the good physician", the decorum and deportment a doctor should exhibit towards patients. The "good physician" was the "virtuous physician" -- gentle, pleasant, comforting, discreet, firm, etc. In other words, physicians should reflect true virtues. The duties of a good physician were incorporated in oaths, and in rules dictated by church, state or profession. They included benefiting the sick and doing them no harm, keeping confidences, refraining from monetary and sexual exploitation of patients, and showing concern for those in need of medical help even at risk to one's own health and wealth. The paradigm of these duties is found in the Hippocratic Oath[13] -- an oath, by the way, which is no longer usually required of our contemporary medical students upon graduation; or students often just create their own "modified version" of it.

B. Mediaeval history:

By the middle ages, a more social view of medical ethics was incorporated in which the physician also defined himself in society. Physicians must show themselves as worthy of social trust and deserving of social authority and reward. The marks of the profession of medicine included now the privilege to educate, examine, license and discipline their members, and the tacit pledge of public service.[14]

C. Modern history:

The first book with the title of "Medical Ethics", written in 1803 by the English physician Thomas Percival, combined the traditional virtues of medical decorum with new injunctions about the behavior of physicians among themselves. Still, social concerns in medical ethics were to be found in the ethical codes of the American Medical Association since its establishment in 1847.[15]

In the United States, Dr. Richard Cabot initiated what has been termed "an ethics of competence", especially in the practice of medicine in the hospital setting. For example, he stressed the need for extensive cooperation between physicians and all other professionals involved in the care of patients; he required accurate record keeping of the number of patients and the evaluation of their care; and he required a limit to the number of patients per physician so as not to compromise good patient care. Patients should be informed of their diagnoses, and their treatments should be explained to them by their physicians. Patients should not be exploited for teaching purposes, nor should senior physicians exploit junior physicians, etc. For Cabot, moral practice was competent; incompetent practice was unethical. And in the rapid advance of scientific medicine, the practitioner's highest moral duty was mastery of that science for the benefit of the patient.[16]

Dr. Chaunsey Leake (1896-1978) insisted that medical ethics should be concerned with the ultimate consequences of physicians' work on their individual patients and toward society as a whole. Professional ethics would be relocated in a foundation of moral philosophy![17] Of course, the question should arise as to which moral philosophy the profession of medicine should use as its foundations, given that by then there were multiple theories of ethics from which to choose?

IV. FROM WORLD WAR II TO THE NATIONAL COMMISSION

The contemporary history of medical ethics began after World War II, especially over controversies involving medical research. Medical ethics found itself increasingly confounded as medical science advanced and medical interventions became increasingly technical. As Jonsen notes, the important bonds of the physician/patient relationship began to suffer, and it was no longer clear what was "benefit" and what was "harm". Is it "harm" to experiment on a dying person to generate better ways of curing disease for the "benefit" of other patients, even if it wouldn't "benefit" that individual patient? How should the growing intimacy of medical practice and medical research with government, commerce, and the new technologies be handled? If some patients cannot pay for medical care, who should? Who should live, and who should die? How should the limited resources of health care be justly distributed? How should the benefits and burdens of research be justly distributed? How far could individual physicians, medical investigators and the government go in advancing scientific knowledge and providing for our national security? And, of course, who should decide the answers to these difficult questions?[18]

These were, after all, issues that philosophy, theology and the law had previously pondered, rather than medicine. These disciplines were about to find their new home in the new field of secular bioethics,[19] but with a difference. There would be a major shift from considerations of standard medical care and practice to those of cutting-edge medical scientific research, thus eventually blurring the distinction between the respective subject matters, methods and goals of these two very different fields of endeavor, and between the roles of physician and researcher. Further, the traditional roots of "medical ethics" in the Hippocratic Oath, religion and theology would be drastically cut as attempts to secularize "ethics" were rapidly articulated -- especially for use in our "pluralistic, multicultural, democratic" societies.

A. The conferences, issues, and thinkers:

Starting in the 1960's, important conferences took place which provided much of the materials, subject matter and debates later conceptualized in contemporary bioethics. The shift in theorists and in interests was dramatic. Of particular concern at these conferences were issues such as population control, eugenics, artificial reproduction, thought control, sterilization, cloning, artificial insemination, and sperm banks.[20]

For example, the conference, "Great Issues of Conscience in Modern Medicine", held at Dartmouth College in 1960, hosted distinguished medical scientists "to examine the issues of conscience in medical and scientific progress ... not simply the question of the survival or the extinction of man, but what kind of survival? a future of what nature?"[21] [Emphasis in original]. The conference was chaired by Rene Dubos, a scientist at Rockefeller Institute who had just published a popular book entitled, Mirage of Health: Utopias, Progress and Biological Change.[22] [Dubos was to become an original member of the yet-to-be-organized Hastings Center bioethics think-tank.]

The "savants" who participated included several Nobel Prize winners, and such distinguished scientists as: Sir George Pickering, (Oxford University), Brock Chisholm, (WHO), Wilder Penfield ("father of neurosurgery"), Walsh McDermott, M.D., Hermann J. Muller, (Nobelist in physiology and medicine for his work in genetic effects of radiation), and George Kistiakowsky, (Assistant to President Eisenhower for Science and Technology). C.P. Snow and Aldous Huxley represented the humanities.[23]

Issues at this conference included: the effects of ionizing radiation; the pollution of water and air; chemical adulteration of food; and, the "conquest of infectious disease" and its converse problem of over-population. As Jonsen notes, "The claim that medical advances had contributed to the population explosion and to the pollution of the gene pool became a common theme of the conferences during the 1960s."[24] Genetics and eugenics loomed very large. Soon-to-be common themes of later secular bioethics debates emerged. It is worth quoting Jonsen directly:

Rene Dubos called "prolongation of the life of aged and ailing persons" and the saving of lives of children with genetic defects "the most difficult problem of medical ethics we are likely to encounter within the next decade ... To what extent can we afford to prolong biological life in individuals who cannot derive either profit or pleasure from existence, and whose survival creates painful burdens for the community? ... It will be for society to redefine these ethics, if the problem becomes one that society is no longer willing or able to carry." Geneticists worried that the gene pool was becoming polluted because the early death of persons with certain genetic conditions was now preventable; in addition to antibiotics, insulin for diabetes and diet for phenelkytonuria were frequently mentioned. A unique solution was offered by Nobelist Hermann J. Muller, who promoted his concept of a bank of healthy sperm, together with the "new techniques of reproduction" to prevent the otherwise inevitable degeneration of the race." [25] [Emphasis mine.]

Of note too was the attitude of elitism exuded on all sides in the face of such complex dilemmas. Dubos explained: "We are not assembled here to solve problems. Our purpose is to air problems ... to state our problems as clearly and thoughtfully as we can, so that they can be better analyzed by the scientific community and so that the community at large -- lay people -- can struggle under our guidance to form its own opinions ... ." As Sir Charles Snow concluded, the way to deal with such problems is by foresight and intelligence and, above all, by scientists telling the truth. But "it is not enough for scientists to make statements of the greatest possible truth; [scientists] must have the courage to carry those statements through because they alone know enough to be able to impress their authority upon a world which is anxious to hear." And as Jonsen notes, "The public was only rarely invited to partake in resolving these great problems. ... for the most part, the public is seen as an audience, waiting for scientists to bring solutions to the problems they have created."[26]

Similar themes and speakers were repeated at the conference, "Man and His Future", sponsored by the Ciba Foundation in London in 1962. Among the speakers and illuminaries were: Dr. Brock Chisholm, Dr. Hermann Muller, Aldous Huxley and his scientific brother Julian Huxley, Joshua Lederberg, J.B.S. Haldane, Albert Szent-Gyorgyi, Francis Crick, Jacob Bronowski, and Peter Medawar. Themes also included agricultural productivity, world resources, environmental degradation, genetics and brain science. Of special note were the similar concerns with evolution, eugenics and population control:

Sir Julian Huxley opened the conference with a wide-ranging lecture entitled, "The Future of Man -- Evolutionary Aspects." He painted a picture of evolution that for the first time had become conscious of itself in human kind and thus was responsible for its population, economics, education, and above all, for the exploration of "inner space -- the realm of our own minds and the psychometabolic processes at work in it." The problems of overpopulation and the dysgenic effects of progress had to be overcome to assure the realization of human fulfillment: "Eventually, the prospect of radical eugenic improvement could become one of the mainsprings of man's evolutionary advance." Man was, he triumphantly proclaimed, "the trustee ... of advance in the cosmic process of evolution.[27] [Emphasis mine.]

Scientists took sides for and against programs of eugenics and thought control. J.B.S. Haldane described a vision of his own "utopia", imagining the biological possibilities in the next ten thousand years. His "utopia" included broad control of physiological and psychological processes, achieved largely by pharmacological and genetic techniques, including cloning and deliberate provocation of mutations, to suit the human product for special purposes in the world of the future.[28]

Several other conferences delved into the implications of science in the modern world, e.g., the series of Gustavus Adolphus Nobel Conferences in Minnesota, in which many Nobel winners again participated. The first Nobel Conference in 1965 was devoted to "Genetics and the Future of Man." Dr. William Shockley, who had won the Nobel prize for physics, presented his views on eugenics, suggesting that, since intelligence was largely genetically determined, serious efforts to improve human intelligence should be pursued by various means, including sterilization, cloning, and artificial insemination. He praised Hermann Muller's advocacy of sperm banks.[29]

B. Evolving "ethics":

Evolving too during this period were the different concepts of "ethics", and the possible roles which ethicists and theologians should play in such critical discourse. In the Ciba conference, most speakers espoused ethical relativism. As Francis Crick expressed it, although there might be some agreement of values, "they do not necessarily coincide ... for practical purposes ... there is bound to be a conflict of values. ... I think that in time the facts of science are going to make us become less Christian."[30] However, Paul Ramsey, in his Nobel conference presentations and later debates, was undaunted, analyzing the issues from his position of distinctly expressed theological principles and values.[31] Similarly, theologian James Gustafson pushed hard for broader participation in deliberations about scientific advances (the term "broader" meaning "with theologians and other academics"), and he called for a clearer formulation of values to be served by those advances, preparing the way for one of the major methods to be used in bioethics -- "consensus ethics".[32]

In short, such weighty issues should not be left up to just the scientists and physicians. Input from experts in philosophy and theology should be brought to the tables to provide an evaluation of the "broader values" involved. In that spirit, many conferences that were to follow incorporated distinguished speakers who lectured on the possible roles of theologians and philosophers in these debates.

However, the ultimate conclusions of such discussions seemed to lead instead to the secularization of those very same traditional philosophical and theological values -- under the misguided assumption by some that a "secular ethics" could not in any way be "normative" (i.e., take a principled stand on what is right or wrong). The search was on for a "neutral" ethics (even though there is no such thing), identifiable through the use of "consensus".[33] For example, in 1966 Reed College of Portland, Oregon, held a conference entitled, "The Sanctity of Life", featuring sociologist Edward Shils' lecture, "The Secular Meaning of Sanctity of Life, and St. John-Stevs's lecture, "Law and Moral Consensus".[34] On the other hand there were those like Daniel Callahan who suggested a non-theological normative formulation along moral philosophy lines, as in his early article, "The Sanctity of Life".[35] The secularization of religious and theological values, the use of "consensus" in moral discourse and in law, and the emerging skills of the secular philosophers -- especially modern and contemporary American and British analytical philosophers -- would become major characteristics of the new field of normative "secular" bioethics yet to come.

V. THE CENTERS

In the 70's, the debates, and their participants, moved from conferences to permanent centers with the founding of the Hastings Center, the Kennedy Institute of Ethics at Georgetown University, and the Society for Health and Human Values. The ideas, literature and people involved in these early "think tanks" eventually identified the nature, the subject matter, and the methods peculiar to the new field of secular bioethics as we know it today, and especially how and when it is to be applied in public policy.

A. The Hastings Center:

In 1969, Willard Gaylin and Daniel Callahan (who later was on the board of the Society for the Study of Social Biology, the re-named American Eugenics Society)[36] founded the Hastings Center, funded primarily by the individuals John D. Rockefeller III and Elizabeth Dollard, as well as by the National Endowment for the Humanities and the Rockefeller Foundation. Pioneers of the field who came to work at and with the Hastings Center included: Henry Beecher, Robert Coles, Theodore Dobzhansky, Andre Cournand, Rene Dubos, Renee Fox, Robert Morison, Art Caplan, Paul Ramsey, James Gustafson, Robert Veatch, Marc Lappe, Robert Neville, Peter Steinfels, Bruce Hilton, Martin Golding, and Senator Walter Mondale (who would soon hold Congressional hearings resulting in the formal "birth" of bioethics). The first 4 "research groups" at the Hastings Center addressed issues such as death and dying, behavior control, genetic engineering, genetic counseling and population control, and the conjunction of ethics and public policy. In 1971 the first volume of the Hastings Center Report appeared -- a publication which was to become the early bible of secular bioethics. As Jonsen noted, "The index of the Hastings Center Report over the next years defined the range of topics that were becoming bioethics and constituted a roll call of the authors who would become its proponents."[37]

B. The Kennedy Institute of Ethics:

The Kennedy Institute of Ethics at Georgetown University was also spawned during this time period. Andre Hellegers was a Jesuit-trained Dutch physician who was working at Johns Hopkins in research in fetal physiology and the reproductive sciences -- eventually earning him a Fellowship from the Joseph P. Kennedy, Jr. Foundation. In 1967 he came to Georgetown University School of Medicine, and was also the Director of Georgetown's Center for Population Research which was funded by a Ford Foundation Grant.[38]

Hellegers excitedly discussed with Fr. Henle, then President of the college, the need for founding a center at Georgetown to study the ethical issues surrounding his own areas of research. Henley enthusiastically endorsed such a mission. In 1970 a proposal to fund such an institute was submitted to the Kennedy Foundation -- funds later came from the NIH National Library of Medicine (where Jonsen later served as a Fellow). The institute was originally called the Kennedy Center for the Study of Human Reproduction and Development. In 1971 the name changed to The Joseph and Rose Kennedy Center for the Study of Human Reproduction and Bioethics, and finally changed to the Kennedy Institute of Ethics. It opened with 2 research scholars -- LeRoy Walters, a Mennonite theologian, and Warren Reich, a Catholic theologian from Catholic University. Soon to follow were: Charles Curran, Richard McCormick, Gene Outka, John Connery, Tom Beauchamp, Terry Pinkard, Robert Veatch, William May (Protestant theologian), Tris Engelhardt, James Childress, and later Edmund Pellegrino.[39]

Since 1974 the KIE at Georgetown University has sponsored very popular "intensive summer courses" in bioethics for health care workers, hospital administrators, politicians, lawyers, public policy makers, philosophers, theologians, sociologists, indeed scholars from across the academy, government and the private sector. [There are now "advanced" programs, and programs specifically for German, Latin American, Asian and other nationalities. The KIE even offers extensive courses on "bioethics for high school students".] Of significance also was their creation of the National Reference Center for Bioethics Literature, the Encyclopedia of Bioethics, The Bibliography of Bioethics, a joint J.D./Ph.D bioethics program between the Law School and the Department of Philosophy/KIE at Georgetown University, and a Ph.D. program in the Department of Philosophy with a concentration in bioethics.[40] (Leaving my career as a bench research biochemist/biologist at NIH, this is where I entered this new field in 1979, as a doctoral graduate student in philosophy and future member of what is now referred to as the "First Generation" of bioethicists.)

C. The Society of Health and Human Values:

Discussions by the Committee on Medical Ethics and Theology of the United Ministries in Education (a collaboration of the Methodist and Presbyterian Churches) initiated in 1965 eventually led to the Society of Health and Human Values in 1970. It was funded by the National Endowment for the Humanities (the "munificent benefactor of bioethics", as Jonsen notes)[41] and the Russell Sage Foundation. The Society soon established its Institute on Human Values in Medicine, with Dr. Edmund Pellegrino as Chairman of its first Board of Directors. Others included Thomas McElhinney, Ron Carson, Larry Churchill, Lorretta Kopelman, Mark Ziegler, David Thomasma, Peter Williams, Warren Reich and Larry McCullough.[42]

All three of these organizations contributed influential scholars and ideas to the federal activities in bioethics that ushered in the formal birth of "bioethics".[43] Many of them provided "expert" testimonies at influential Congressional and Senate hearings to come, and served on a plethora of similar governmental and private commissions, committees, conferences, and other organizations and activities.

VI. THE FORMAL BIRTH OF BIOETHICS

The formal "birth of bioethics" was preceded by several years of hearings before Congress, hearings which were called to address an increasing number of knotty and bewildering problems especially being generated by medical research and the abuse of human subjects.

A. The Congressional hearings:

The formal birth of bioethics really began by Congressional mandate! Hearings by Sen. Mondale,[44] (a founding Hastings Center scholar) in 1968 were designed to commence a national debate on the directions that medical science would take in America. These hearings were particularly concerned with such issues as genetic engineering and organ transplantation, behavior control, experiments on humans, and the financing of research -- and later, with research using live fetuses and in vitro fertilization (IVF) research[45] (a form of human embryo research).

Experts in the various disciplines were called before the Committee to testify, including many of those already mentioned before, as well as others who would also take their place in the brave new world of bioethics, e.g., Tris Engelhardt, Alexander Capron, Bernard Barker, Kenneth Vaux, Fr. Albert Moraczewski, Jay Katz, Michael Debakey, James Watson, Arthur Kornberg, Joshua Lederberg, Christian Barnard, Henry Beecher, etc.[46]

Another series of Senate hearings to take up these same rapidly emerging and controversial issues were called by Senator Ted Kennedy during 1973. One of the most contentious issues involved research using live whole fetuses. A Washington Post story had reported that the NIH had released a recommendation from one of its advisory panels, the Human Embryology and Development Study Section, that "encouraged the use of newly delivered live fetuses for medical research before they died."[47] Although initially NIH tried to deny the report, several research projects using live whole human fetuses funded by NIH to American scientists in Finland, Denmark and Japan were being reported.[48] The news spurred Eunice Kennedy Shriver to contact Georgetown's Dr. Hellegers, a member of that NIH advisory panel, to solicit his support to stop this research.[49] To add to the urgency, several hearings began investigations into the abuse of human subjects in medical research during the Tuskegee Syphilis Study (a Public Health Service research project). Senator Ted Kennedy held a series of hearings on these same issues. Eventually there were calls from several House and Senate committees for the establishment of some sort of a governmental commission to respond to these continuous reports of research abuse of human subjects. Various and numerous bills from both House and Senate subcommittees were drafted and redrafted.[50]

B. The National Research Act and The National Commission:

Despite disputes between the House and Senate versions of the bill,[51] eventually these hearings resulted in Congress passing The National Research Act in 1974, which among other things Congressionally mandated the establishment of an 11-member National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Research Act mandated this Commission "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines that should be followed in such research.".[52] As Jonsen, a member of that National Commission, profoundly noted, "No legislation had ever before charged a government body 'to identify basic ethical principles', as did Public Law 93-348." [53]

And the inevitable questions arise. By what Constitutional or other power or authority can the Congress of the United States mandate the appointment of any federal commission or group to identify "what is ethical"? Why should the normative ethical positions of Kant, Mill, Sidgwich, Lonergan, Gustafson, Beauchamp, Childress, Callahan, Clouser, Hellegers, McCormick, Jonsen, Ramsey, Veatch, Engelhardt, Pellegrino, Thomasma, or any of the many other ethical "theories" proposed[54] be imposed undemocratically by the government on any members of a pluralistic multicultural democratic society?

Nevertheless, that is precisely what was done. By mandate of The National Research Act (1974), the 11-member National Commission[55] (1974-1978) was appointed by the then-Secretary of Health and Human Services, Casper Weinberger. The membership of this new National Commission which was to determine what was "ethical" consisted of three physicians, two biomedical researchers, three lawyers, one public member and two philosophers.[56] The appointed members, and some staff and consultants, of the National Commission were:

Chairman Kenneth Ryan (Chief of Staff at Boston Hospital for Women); Robert Cooke (Vice Chancellor for Health Sciences at University of Wisconsin); Donald Seldin (Professor and Chairman of the Department of Internal Medicine at the University of Texas at Dallas); Joseph Brady (Professor of Behavioral Biology at The Johns Hopkins University); Eliot Stellar (Provost of the University and Professor of Physiological Psychology at the University of Pennsylvania); Patricia King (Associate Professor of Law at Georgetown University); David Louisell (Professor of Law at the University of California at Berkeley); Robert Turtle(Attorney at VomBaur, Coburn, Simmons & Turtle, Washington, D.C.); Dorothy Height (President of National Council of Negro Women, Inc.); Karen Lebacqz (Assistant Professor of Christian Ethics at Pacific School of Religion); and Albert Jonsen (Adjunct Associate Professor of Bioethics at the University of California at San Francisco). Many of the staff were also to become influential in bioethics as well: Charles Lowe (NIH), Michael Yesley (Department of Commerce), Duane Alexander (NIH), Edward Dixon, Bradford Gray, Miriam Kelty, Robert Levine, Barbara Mishkin, Anne Ballard, Bernice Lee, Mary Ball, Pamela Driscoll, Lisa Gray, Marie Madigan, Erma Pender, Susan Shreiber, Charles McCarthy, William Dommel, Anthony Buividas, Tom Beauchamp, and Steven Toulmin.[57]

This legal mandate required the Commission to study the ethical questions raised in the use of several particular populations in research: the fetus, children, the institutionalized mentally infirm, prisoners, and psychosurgery. To aid their deliberations on fetal research, reports were commissioned by: Paul Ramsey, Joseph Fletcher, Richard McCormick, S.J., Arthur Dyck, Sissela Bok, Seymour Siegel, Leon Kass, Richard Wasserstrom, Stephen Toulmin, LeRoy Walters, Marc Lappe, Maurice Mahoney, Richard Behrman, and Alexander Capron.[58] To further aid the Commission in identifying the "ethical principles" to be used by the federal government, in 1976 a meeting was held at Belmont House, a conference center of the Smithsonian Institution in Elkridge, Maryland. Among those requested to present essays were: Kurt Baier, Alasdair MacIntyre, James Childress, Tris Engelhardt, LeRoy Walters, Stephen Toulmin, and Tom Beauchamp. The final three "bioethics principles" were, according to Jonsen, a combination of suggestions by Engelhardt and Beauchamp.[59]

C. The Belmont Report:

In its final report, The Belmont Report (1978),[60] the National Commission satisfied one part of its Congressional mandate by identifying three ethical principles for the government to use in evaluating issues concerning research using human subjects: respect for persons (which rapidly evolved to mean pure absolute autonomy), justice and beneficence -- otherwise known as "the Belmont principles", "the Georgetown Mantra",, "principlism", or "bioethics". In 1981 these three bioethics principles were used as the basis for the new federal regulations for use in government-sponsored research using human subjects -- the OPRR federal regulations[61] -- satisfying yet another part of that same Congressional mandate. Thus in 1978 bioethics was officially "born" -- by Congressional fiat -- and immediately applied to the federal government's regulations to determine the "ethics" of the use of human subjects in research.

THIS IS "BIOETHICS" --, and the bioethicists and organizations who helped to found it. Bioethics, by definition, is clearly not "ethics per se", and hardly the same as the traditional Hippocratic medical ethics of Drs. "A", "B", "C", "D" or "E". Nor is it the same as Roman Catholic medical ethics. This is a brave new "bioethics", in which physicians and researchers -- along with members of medical centers and other health care facility staffs, hospital ethics committees, institutional review boards, hospices, government public policy makers, Congressional members and staffs, members of the legal bar and judiciary across the country, state legislators, politicians, university and college faculty and students "across the curriculum", journalists, administrators, bioethics committee members in organizations around the world, etc. -- would be taught and trained in order to be prepared to determine what was "ethical" or "unethical" on a host of issues (not all of them strictly "medical").

VII. THE NATIONAL COMMISSION AND BIOETHICS: A SHORT ANALYSIS

A. Odd scientific definitions: "fetus" and "pregnancy"

Of note, the National Commission used several "odd" scientific definitions in its individual reports, e.g., in its Report on Fetal Research. Even the Commission acknowledged this:

For the purposes of this report, the Commission has used the following definitions which, in some instances, differ from medical, legal or common usage. These definitions have been adopted in the interest of clarity and to conform to the language used in the legislative mandate" [referring to The National Research Act 1974].[62] [Emphases mine.]

Among such "unique" scientific definitions used by the Commission was its definition of "fetus" as "the human from the time of implantation [5-7 days] until a determination is made following delivery that it is viable or possibly viable."[63] Similarly, the new OPRR federal regulations (also part of the same Congressional mandate, and based on the same "bioethics principles" identified by the National Commission) contained two "unique" scientific definitions. "Fetus" is again defined there as "the product of conception from the time of implantation ..."; and "pregnancy" is also defined as "the period of time from confirmation of implantation ...".[64]

Of course, such "definitions" are rather bizarre, as the single dissenting report by Commissioner Louisell pointed out.[65] Indeed, as far back as the 1800's, long before the "birth of bioethics", human embryology textbooks had defined the "fetus" as beginning much later in development -- at about the ninth week after fertilization,[66] not as beginning at implantation (5-7 days after fertilization). Similarly, "pregnancy" had always been defined as beginning at fertilization.[67]

So how was it that in 1978 the definitions of such basic and critical scientific terms as both "pregnancy" and "fetus" came to be so erroneously defined as "beginning at implantation" (5-7 days after fertilization)? How could such blatantly scientifically erroneous definitions have passed Congressional scrutiny? This is, after all, Biology 101.[68] Clearly, such "odd" scientific definitions -- or re-definitions -- in the National Commission's Report would serve the purpose of removing "flushed" human embryos, and artificially produced human embryos, from any sort of governmental protection or oversight. From the National Commission onward, these human embryos have never been acknowledged by the federal government as "human research subjects" to be protected from research abuse, and none of the federal regulations to follow would apply to them -- right up to the present day. Nor has the correct Biology 101 yet been used with reference to the definition of "early human embryos" or "human fetuses".

The rationales of some of the papers presented to the Commission on this issue are interesting, and might provide some insight. Many of those who were members of or who testified before the National Commission did not consider the early human embryo or even the early human fetus as a human being, or as a human person, and therefore these embryos and fetuses did not warrant federal protection as research subjects.

For example, Richard McCormick, S.J., had already argued earlier that defective newborns could be allowed to die. Applying the "Catholic" moral theology distinction of the Principle of Double Effect, McCormick concluded that the term "extraordinary" was large enough to justify the omission of life-sustaining treatments on the basis of expected diminished quality of life, defined in terms of the potential for human relationship.[69] McCormick had also agreed with the May 1979 DHEW Ethics Advisory Board recommended approval of federal funding of research on the safety and efficacy of IVF research and embryo transfer in the treatment of infertility -- departing from the Vatican's position against any technologically assisted pregnancies, even in lawfully married couples.[70] Now, following similar work by Andre Hellegers[71], McCormick seriously questioned the "moral status" of early human embryos (or, "pre-embryos" as he referred to them), as did several others within the Catholic Health Association.[72] Furthermore, McCormick reluctantly agreed that since some abortions are acceptable, then some fetal research would also be acceptable. He had reasoned that children have a moral obligation to participate in non-therapeutic experimentation where there is no discernible risk or undue discomfort, and therefore their parents may give proxy consent for their children's participation in such research that would not benefit them personally. He grounds this moral obligation in social justice -- i.e., "to contribute to the benefit of the human community." The same moral obligation, argued McCormick, can now be extended to the fetus.[73] Paul Ramsey also had qualms about the "moral status" of the early embryo, accepting the McCormick/Grobstein "pre-embryo", and therefore also reluctantly sanctioned fetal research.[74] Thus these presenters, as many others, claimed that morally relevant characteristics were not present in the early developing embryo until "segmentation", or the attainment of "individuality" about 14-days, or even later, during human development.[75]

As we shall see, the arbitrary use of "ethical principles", the use of erroneous human embryology, and the use of still highly-contested and controverted philosophical conclusions about the "moral status" (or, "personhood") of the early human embryo and human fetus, would play major roles in building up the growing bioethics edifice, which was soon to become a "mantra" in its own right.

B. Problems with the principles:

The Belmont principles were supposedly ultimately derived from the normative ethical systems of various moral philosophers -- e.g., Kant, John Stuart Mill, and John Rawls. In effect, they quite selectively took bits and pieces from different and contradictory ethical theories and rolled them up into one ball. Furthermore, each of these principles were referred to as prima facie[76] -- i.e., no one principle could over-rule any of the others. And the way we come to know these bioethics principles is by taking courses, attending conferences, and listening to bioethicists lecture at conferences.

However eventually, and inevitably, theoretical cracks began to form in the very foundation of this new "bioethics" theory. For example, because bioethics was derived from bits and pieces of fundamentally different and even often contradictory theoretical philosophical systems, the result was theoretical chaos, rendering it academically indefensible. More problematic, when people tried to apply the theory, it didn't work because practically speaking there was no way to resolve the inherent conflicts among these three prima facie principles. Paul Ramsey had complained about this specific problem early on, when such a suggestion (by Jonsen and Hellegers) was submitted at an early conference: "Within the amplitude ... of general ethics, our authors fail to address clearly and rigorously the issue: which of these moral principles has priority (e.g., in the case of conflict)?"[77] The inherent contradictions and conflicts between and among these prima facie bioethics principles would slowly erode the confidence of even those stalwarts within the field itself.

Even each of the bioethics principles individually is riddled with similar inherently contradictory conflicts and theoretical problems. For example, while the Commissioners of The Belmont Report gave a nod to the traditional Hippocratic understanding of "beneficence" in one definition as "doing good for the patient" (or at least, doing no "harm"), their "second" and much longer definition of "beneficence" is essentially utilitarian -- in terms of the good for society at large (or roughly, "the greatest good for the greatest number of people"). Obviously these two different and opposite definitions of "beneficence" could easily contradict each other. How can the "bene" refer to the good of an individual patient in the standard medical or the research settings, and at the same time in the same case refer to the good of society -- calculated in the crude terms of utilitarian "risks and benefits"? What physician, who has sworn the Hippocratic Oath, would even recognize the following definition of "doing good" that is found in the Belmont Report:

Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. The Hippocratic maxim "do not harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. ... In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.[78] [Emphases mine.]

Doesn't sound terribly "Hippocratic", does it? Nor does this Belmont claim that all individuals of society have a strong moral duty to participate in purely experimental research "for the good of society" or "the advancement of scientific knowledge". Yet it was The Belmont Report's utilitarian definition of "beneficence" which was to be quickly perpetuated throughout the emerging bioethics literature, e.g., as defended in the first bioethics textbooks by Beauchamp, Childress and Walters,[79]incorporated in the OPRR federal regulations, and assumed as a standard by virtually every bioethics conference, committee, panel and commission to come -- up to and including the current National Bioethics Advisory Commission appointed by President Clinton[80] (see below).

This "strong obligation" of the utilitarian-defined Belmont principle of "beneficence" blatantly contradicts the long-held international codes of research ethics, e.g., the Nuremberg Code and the Declarations of Helsinki, in which the protection of the individual patient always outweighs the needs or "good" of science or society. As stated unambiguously in the Declaration of Helsinki:

Concern for the interests of the subject must always prevail over the interests of science and society [Basic principles]... The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient [Medical research combined with clinical care - clinical research]... In research on man, the interests of science and society should never take precedence over considerations related to the wellbeing of the subject [non-therapeutic biomedical research involving human subjects - non-clinical biomedical research].[81] [Emphases and inserts mine.]

Even The Belmont Report itself admits this inherent contradiction in its own definition of "beneficence": "Here, again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices."[82] Choices based on what, one might ask? The normative ethical theory of utilitarianism?

Utilitarianism has always had serious problems with defining in practice what "good" is,[83] but it is generally very roughly reduced to some sort of lack of physical or mental pain or pleasure -- or inversely, as "sentience". One thing is clear, however. All utilitarian formulas, by definition, leave minorities and the vulnerable out in the cold. There are no moral absolutes here -- only "rules" or mathematical risk/benefit ratios, which are by definition relative to "the greater good". As utilitarian, the general norm or standard against which one determines if an individual action is right or wrong is "utility"; i.e., if that action is useful to achieving good consequences, those also being defined in terms of "the greatest good for the greatest number". (Even more problematical to come would be the deconstruction of these classical forms of utilitarianism into what would be termed "preference" utilitarianism, where what would be weighed and balanced would be "preferences" or "interests" -- as developed in the works of British eugenicists such as Jonathan Glover and R.M. Hare, and Australian bioethicists Peter Singer, Helga Kuhse, Daryl Macer, etc.; see below).

The bioethics principle of "justice" in The Belmont Report is also ultimately defined along utilitarian lines, in terms of "fairness" -- i.e., fairness in the distribution of the benefits and burdens of research.[84] This is not your classic definition of "justice", e.g., in the Aristotelean sense of communitive or distributive justice, but rather in terms strongly influenced by Harvard Graduate School philosophy professor[85] John Rawls, as articulated in his then-new book, A Theory of Justice.[86] Rawl's "theory" of justice also profoundly influenced the theory-makers of bioethics from several other different academic disciplines. For example, it would later be adapted by his student Norman Daniels and applied to health care[87]; it began to "creep into law", e.g., through lawyer/bioethicist John Robertson, who quoted from Rawls in influencing the justices' decision in the Saikewicz case -- resulting in the still controversial legal concept of "substituted judgement"[88]; it has also been applied by Arthur Dyck in international population policy issues.[89]

Even the bioethics principle of "respect for persons" eventually ends up serving "the greatest good". Now, how on earth could that have happened, one might perceptively ask? Well, as noted above, it is The Belmont Report that explains that "respect for persons" includes the duty to participate in non-therapeutic research for the greater good of society. And the question arises: How could the principle that was supposed to ground an inviolable respect for each individual human being be defined in terms of a utilitarian respect for "society"?

Perhaps it has to do with some of the more influential participants in the Commission's original proceedings. Even Jonsen, in his description of the National Commission, admits the clear prejudicial nature of the leanings of the members of the Commission and its staff: "Most of the commission and staff were of a liberal bent!"[90] Translated into scholarship, the classic moral philosophy traditions were barely blinked at, and even the selection and interpretations of modern and contemporary moral philosophies were essentially open to considerable deconstruction. For example, as Jonsen noted, "When Beauchamp and Childress formulated the principle of autonomy, they fused the Kantian concept of respect for persons with John Stuart Mill's quite different notion of liberty ... Folding together the distinct views of Kant and Mill blurred the edges of both the Kantian and the Millsean notions."[91] It also, of course, blurred the edges of the metaphysical, epistemological, and anthropological presuppositions inherent in those diverse and contrary theories of ethics. Hence, Kant's "respect for persons" evolved rapidly into the Millsean utilitarian version of "respect for autonomy" (pace Tom Beauchamp) -- where "autonomy" referred only to "persons", and "persons" were defined only as "moral agents". Most unfortunately, what it also did therefore was turn non-autonomous human beings into non-persons (since they are not "autonomous moral agents").

At any rate, after all is said and done, bioethics is ultimately reduced more or less to some form of utilitarianism or relativism, where "the good of society" is the morally relevant principle, and the "good of the individual person" is clearly not top priority.

C. Problems in applications:

Eventually, practical cracks too began to form in the foundations of this brave new bioethics, cracks which seemed to widen deeper the more the "theory" was applied -- as admitted in publications by even many of the Founders themselves - the best kept secret in bioethics! For example, The Hastings Center's Daniel Callahan conceded in the 25th anniversary issue of The Hastings Center Report celebrating the "birth of bioethics", that the principles of bioethics simply had not worked. But not to worry, he said, we might try communitarianism now: "The range of questions that a communitarian bioethics would pose could keep the field of bioethics well and richly occupied for at least another 25 years"![92] Jonsen himself devotes considerable space to the critics of bioethics in his book, The Birth of Bioethics, and even courageously admitted years earlier, in his "Preface" to the first serious book confronting the myriad inadequacies of "bioethics principlism", that there were only two real ethicists on the National Commission, and that they had essentially made up the bioethics principles. Jonsen also agrees with the premise of that book that bioethics should now be regarded somewhat as "a sick patient in need of a thorough diagnosis and prognosis":

A fairly widespread perception exists, both within and without the bioethics community, that the prevailing U.S. approach to the ethical problems raised by modern medicine is ailing. Principlism [bioethics] is the patient. The diagnosis is complex, but many believe that the patient is seriously, if not terminally, ill. The prognosis is uncertain. Some observers have proposed a variety of therapies to restore it to health. Others expect its demise and propose ways to go on without it.[93]

Gilbert Meilaender's early and incisive suspicions about the consequences of the several philosophical "mind/body splits" inherent in bioethics theory emerged in yet another important book, Body, Soul and Bioethics, in which he explained "how easily the 'soul' -- attention to the meaning of being human, a meaning often illuminated by religious and metaphysical insight -- can be lost in bioethics."[94] Other controversies and battles over the validity of the bioethics principles on many levels are documented and collected in an already classic 1195-page tome edited by Rannan Gillon,[95] in which 99 scholars from around the world jump into the fray over bioethics -- by far the majority of them arguing against bioethics "principlism".

One of the strongest critiques of "bioethics" came from another one of the early Founders, Renee Fox, a sociologist. Referring to "American bioethics" as isolated from the relationships, communities, and values of real life in sickness and health, she argued that the isolation produced an uneasy relationship between the social sciences and bioethics. Bioethics, she wrote, confined in its individualism and American chauvinism, rendered an "impoverished and skewed expression of our society's cultural tradition (which), in a highly intellectualized but essentially fundamentalistic way, thins out the fullness of that tradition and bends it away from some of the deepest sources of its meaning and vitality."[96] As Jonsen puts it, Fox perceived a genuine gap in the theory and method of bioethics. There is no easy and consistent flow of empirical data into ethics. Methods for gathering that sort of data, for interpreting it and fitting it into normative analysis are seldom familiar to ethicists. And the methods of ethicists are seldom known to behavioral scientists. Additionally, Fox argues that the data of the behavioral sciences often reveal situations as more complex than ethicists perceive them to be, rendering a straightforward ethical analysis more difficult.[97] In a scathing article against bioethics, "Leaving the Field", Fox and Swazey responded in depth and detail to the horrendous ethical dilemmas they considered posed by organ transplantation, especially on an international scale.