Comments: The Elephant in the Closet:
DHHS Celebrates 25 Years of the Belmont Report

Irving News Comments
Copyright November 15, 2004 
Reproduced with Permission

As incredulous and arrogant as it is, today (see press release below) the U.S. Department of Health and Human Services (DHHS) actually "celebrated" the 25th anniversary of the formal "birth of bioethics" established by the Belmont Report (1978), formally honoring those Commissioners and Staff involved. Many of their names will be familiar.

Yet few people still seem to realize that this legislative "feat" was originally accomplished through the Congressional mandates of the 1974 National Research Act. This Act mandated that then-Secretary Casper Weinberg of DHEW (now DHHS) appoint a "commission" to "identify the ethical principles" the U.S. government should use in issues relating to the use of "human subjects". Weinberg then appointed 11 people to the National Commission to make this auspicious decision, many of whom were honored today in this "celebration" at DHHS.

The National Commission's Belmont Report (1978) identified the normative "ethical" principles of "respect for persons" [which rapidly deteriorated into absolute "autonomy", and where "persons" were defined as only competent human beings], "beneficence" [which was primarily defined as doing "good" for society, a strictly utilitarian "ethics"], and "justice" [defined in the Report pace John Rawls as "fairness", i.e., fairness in the distribution of the risks and benefits of research]. The Belmont Report also declared that all citizens of a society have a "strong moral obligation" to take part in even purely experimental research "for the greater good of society". THIS WAS THE FORMAL BIRTH OF "BIOETHICS", as well as that of the Belmont "ethical" principles of autonomy, justice and beneficence. To the first graduate students in bioethics -- the First Generationers -- who graduated from the Kennedy Institute of Bioethics at Georgetown University -- it was known simply as "federal ethics", "principlism", or "the Georgetown mantra". But we knew it for what it was.

For example, from the very beginning there was an undercurrent of concern about the makeup of the National Commission, the definition of "ethics" they concocted, their insistent use of false science, and the roles such Commissions should play in this "multicultural, pluralistic, democratic" society. This concern was articulated sometimes by negatively referring to such efforts as "commissioning ethics", and best summed up early on by one of the original scholars of the Hastings Center, Dr. Robert Morison. Quoting some of his deep concerns:

"Director Capron drew up a plan of action that was not merely a schedule but a concept paper that reviewed the mandates in terms of leading ideas and problems. Woven into this paper were quotations from many prominent individuals in science, policy, and ethics whose views Capron had solicited about the Commission's work. Most eloquent of these comments was a long letter from Robert Morison, professor emeritus of biology at Cornell. Professor Morison sketched his views on the relation between ethics, law, and religion and reviewed the brief history of 'the infelicitously named bioethics,' the results of which he 'was reasonably happy [with], but I fear for the future.' The future he feared was one in which ethics and religion were turned into law and regulation: 'What one fears is that the Commission may become the mechanism whereby the speculations of the ethicists become the law of the land. It is already far too easy for abstract notions of right and wrong to emerge as deontological rules which begin their public life as 'guidelines' but culminate in the force of law.' Morison's letter was a sobering reminder of the anomalous role of an 'ethics commission' in a pluralistic, secular society." [Albert Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), pp. 109-110]

And DHHS is honoring and celebrating?

The second Congressional mandate of the National Research Act (1974) was that these normative federal "ethical principles" identified by the Belmont Report were to be translated into, and used as the basis for, U.S. federal regulations. This was accomplished in 1981 with the Office for the Protection of Research Risks (OPRR, now OHRP) federal regulations for the use of human subjects in research. Institutional Review Boards (IRB's) were also mandated to follow these OPRR/OHRP federal regulations while "reviewing" the "ethics" of submitted research proposals.

There are so many fundamental problems, contradictions, and hazards connected with the Belmont Report, its "ethics" (bioethics), and its OPRR/OHRP federal regulations that it is not possible to address them all here. Yet it is singularly interesting that one of the recipients of today’s honors at DHHS, Commissioner Albert Jonsen, had the following to say about bioethics several years after its "birth" in the first book in the field that dared to criticize it. Jonsen agreed 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." (emphases added) [Edwin DuBose, Ronald Hamel and Laurence O'Connell (eds.), A Matter of Principles?: Ferment in U.S. Bioethics (Valley Forge, PA: Trinity Press International, 1994), p.1.]

And DHHS is honoring and celebrating?

What is fascinating is that these are the fundamental U.S. federal "ethics", documents, and IRBs that will guide and regulate human cloning, human embryonic stem cell research, and human genetic engineering in the United States – and around the world – for probably at least another 25 years. Yet even aside from the very problematic and idiosyncratic "ethics" involved, they CANNOT EVEN APPLY to these contentious and difficult research issues.

Human embryos and fetuses are not "human subjects" under their definitions. Rather, they are objects, "biological materials". Further, there is no formal definition of "human embryo" -- which defined accurately would include the early human embryo from the first moment of his/her existence through 8 weeks -- in vitro or in utero! There is also no formal definition of "human being", or when he/she begins to exist. "Fetus" is grossly misdefined as "beginning at implantation", rather than using the accurate scientific definition of 9 weeks post-fertilization. "Pregnancy" is likewise grossly misdefined as "beginning at implantation", rather than fertilization. Indeed, these federal regulations apply only to sexually reproduced human beings -- whereas cloning, much human embryonic stem cell research, and the genetic engineering of early human embryos and fetuses involve a-sexually reproduced human beings.

And DHHS is honoring and celebrating?

Finally, the honoring and celebrating shouldn’t pass without mentioning the profound words of the only dissenting member of the National Commission’s report on fetal research. Commissioner David Louisell, who unfortunately died of a heart attach shortly afterwards, left us all with the following warning after the Commission assured us that fetal research was "ethical". I quote him here in full:

"I am compelled to disagree with the Commission's Recommendations (and the reasoning and definitions on which they are based) insofar as they succumb to the error of sacrificing the interests of innocent human life to a postulated social need. ... Although the Commission uses adroit language to minimize the appearance of violating standard norms, no facile verbal formula can avoid the reality that under these Recommendations the fetus and nonviable infant will be subjected to nontherapeutic research from which other humans are protected. ... But the good in much of the Report cannot blind me to its departure from our society's most basic moral commitment: the essential equality of all human beings. For me the lessons of history are too poignant, and those of this century too fresh, to ignore another violation of human integrity and autonomy by subjecting unconsenting human beings, whether or not viable, to harmful research even for laudable scientific purposes. ... Admittedly, the Supreme Court's rationale in its abortion decisions of 1973 -- Roe v. Wade and Doe v. Bolton, 310 U.S. 113, 179 -- has given this Commission an all but impossible task. For many see in that rationale a total negation of fetal rights, absolutely so for the first two trimesters and substantially so for the third. The confusion is understandable, rooted as it is in the Court's invocation of the specially constructed legal fiction of "potential" human life, its acceptance of the notion that human life must be "meaningful" in order to be deserving of legal protection, and its resuscitation of the concept of partial human personhood, which had been thought dead in American society since the demise of the Dredd Scott decision.

... "It seems to me that there are at least two compelling answers to the notion that Roe and Doe have placed fetal experimentation, and experimentation on nonviable infants, altogether outside the established protections for human experimentation. First, while we must abide the Court's mandate in a particular case on the issues actually decided even though the decision is wrong and in fact only an exercise of 'raw judicial power' (White, J., dissenting in Roe and Doe), this does not mean we should extend an erroneous rationale to other situations. To the contrary, while seeking to have the wrong corrected by the Court itself, or by the public, the citizen should resist its extension to other contexts. ... Secondly, the Court in Roe and Doe did not have before it, and presumably did not intend to pass upon and did not in fact pass upon, the question of experimentation of the fetus or born infant. Certainly that question was not directly involved in those cases. ... [W]e should assume that the language was limited by the abortion context in which it was used and was not intended to effect a departure from the limits on human experimentation universally recognized at least in principle.

... "For me, the chief vice of Recommendation (5) is that it permits an escape hatch from human experimentation principles merely by decision of a national ethical review body. No principled basis for an exception has been, nor in my judgment can be, formulated. The argument that the fetus-to-be-aborted 'will die anyway' proves too much. All of us 'will die anyway.' A woman's decision to have an abortion, however protected by Roe and Doe in the interests of her privacy or freedom of her own body, does not change the nature or quality of fetal life.

... "Recommendation (6) concerns what is now called the 'nonviable fetus ex utero' but which up to now has been known by the law, and I think by society generally, as an infant, however premature. ... In my judgment all infants, however premature or inevitable their death, are within the norms governing human experimentation generally [[ Stated before the formulation of the OPRR federal regulations on the use of human subjects in experimental research (see note 61, supra)]]. We do not subject the aged dying to unconsented experimentation, nor should we the youthful dying. ... I would, therefore, turn aside any approval, even in science's name, that would by euphemism or other verbal device, subject any unconsenting human being, born or unborn, to harmful research, even that intended to be good for society. Scientific purposes might be served by nontherapeutic research on retarded children, or brain dissection of the old who have ceased to lead 'meaningful' lives, but such research is not proposed -- at least not yet. As George Bernard Shaw put it in The Doctor's Dilemma: 'No man is allowed to put his mother in the stove because he desires to know how long an adult woman will survive the temperature of 500 degrees Fahrenheit, no matter how important or interesting that particular addition to the store of human knowledge may be.'

... "An emotional plea was made at the Commission's hearings not to acknowledge limitations on experimentation that would inhibit the court-granted permissive abortion. However, until its last meeting, I think the Commission for the most part admirably resisted the temptation to distort its purpose by pro-abortion advocacy. But at the last meeting, without prior preparation or discussions, it adopted Recommendation (12) promotive of research on abortion techniques. This I feel is not germane to our task, is imprudent and certainly was not adequately considered.

... "That [the Commission] has not been more successful is in my judgment not due so much to the Commission's failings as to the harsh and pervasive reality that American society is itself at risk -- the risk of losing its dedication 'to the proposition that all men are created equal.' We may have to learn once again that when the bell tolls for the lost rights of any human being, even the politically weakest, it tolls for all." [Emphases mine.] The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975; "Dissenting Statement of Commissioner David W. Louisell" (p. 77-82).

And DHHS is honoring and celebrating?


[For an extensive 70-page history and analysis of the "birth" of bioethics, see Irving, "What is 'bioethics'?", UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.: University Faculty For Life, 2002), pp. 1-84, at: http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html, and http://www.uffl.org/irving/irvwhatisbio.htm; for a shorter version, see Irving, "The bioethics mess", Crisis Magazine, Vol. 19, No. 5, May 2001, at: http://www.catholic.net/rcc/Periodicals/Crisis/2001-05/irving.html, and http://www.lifeissues.net/writers/irv/irv_37bioethicsmess.html.]


http://www.hhs.gov/news/press/2004pres/20041116.html

News Release

FOR IMMEDIATE RELEASE
HHS Press Office
(202) 690-6343
Tuesday, Nov. 16, 2004

HHS Observes 25th Anniversary of Belmont Report for Human Research Subject Protections

HHS today marked the 25th anniversary of the Belmont Report that articulated the founding principles for federal human research subject protections, with the release of an oral-history video about the report and a ceremony to honor the report's authors. The ceremony honored the members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1974-1979, which produced the Belmont Report and related seminal documents in bioethics and human subject protections.

"We owe a debt of gratitude to all of these individuals. They gave us a framework for the ethical use of research volunteers that has withstood the test of time," HHS Secretary Tommy G. Thompson said. "We honor those whose work continues to guide the research community both here and abroad in advancing science while protecting those who volunteer to take part in clinical research."

The Belmont Report's "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" along with other commission documents marked a turning point in how human research was conducted in the United States. Prior to the report, researchers independently decided what was studied and how studies were conducted. Now however, the system provides protections, including ethical review by committees independent from the research. The Belmont Report identifies three fundamental ethical principles to which all human subject research must adhere -- respect for persons, beneficence and justice -- and those principles set the parameters for the regulations that are still in force today.

"We honor the signal contributions of this extraordinary group of individuals to the field of research bioethics," said Dr. Cristina Beato, acting assistant secretary for health. "Since the time of the commission, they have shaped and strengthened research bioethics and helped ensure the welfare of all who are part of the human research enterprise."

This educational video is the first in a series of oral history-based training materials that HHS will release over the next year. These educational products will reinforce the importance of the protections now in place for all who enroll as study participants in clinical trials and other research studies.

This commemoration was organized by HHS' Office for Human Research Protections, which provides leadership on human research subject protections by supporting and strengthening the nation's system for protecting those who volunteer to participate in research that is conducted or supported by agencies of HHS.

Honorees at the commemorative event include members of the National Commission as well as staff and consultants, who are listed below with their commission title followed by their most recent professional activity:

Four of the Commissioners are deceased:

[emphases added – DNI]



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