"Consumer Reports: Volunteer Your Bodies for the Greater Good"

Dianne N. Irving
Copyright May 25, 2011
Reproduced with Permission

There's nothing like history to put things in perspective.

As I read the e-news letter from Consumer Reports Health.org today, I must say I did a double-take on one of the "health and safety" tidbits offered therein. Apparently, according to Consumer Reports, "From Our Health Experts - 'Volunteering for a clinical study', by Dr. Marvin Lipman, clinical professor emeritus of medicine at New York Medical College and Consumer Reports' chief medical advisor", is a must read for health and safety enthusiasts. A trip to the website for this article [http://www.consumerreports.org/health/doctors-hospitals/clinical-trial-volunteer/overview/index.htm?EXTKEY=NH15S00H] finds Dr. Lipman's full article, "When the research subject is you" (May 2011). Among the "medical advice" tidbits he offers the readers one finds the following:

Although my mother warned me never to volunteer, I always raised my hand in class - and I have always been a sucker for a good clinical trial. ... Not everyone shares my enthusiasm for volunteerism, and research investigators are finding it increasingly difficult to recruit people for clinical studies. ... Perhaps the simplest barrier to enrollment is that people don't know that clinical trials exist. That's too bad, since participation in that research is an ongoing need for the benefit of society. A lack of evidence from well-designed trials would result in poor and even inappropriate uses of drugs and procedures - and put us back in the dark ages of practicing medicine with hunches and intuition." (emphases added)

So, if we all don't "volunteer" our bodies to take part in purely experimental research "for the greater good of society" - i.e., research that by definition will provide no direct medical benefits to us as individual persons -- then medicine will inevitably collapse back into the dark dark ages of the medical dinosaurs? Sounds truly horrific!

But I do have to wonder if readers would agree that all citizens of a society should volunteer for participation in purely experimental research for the "greater good"? Would you? And just what is "the greater good"? How do we know? And is this "ethical"? And who decides? And could it be legally required?

I'm sure that this proposal for "volunteerism" is genuinely enthusiastic, and that the intentions are sincere, but the reason why this proposal struck me so oddly is that what Dr. Lipman is promoting is not really new, although it sounds new. Rather, the dictum comes straight out of the document that resulted in the formal "birth" of bioethics - the 1978 Belmont Report, mandated by the U.S. Congress. Yet no one seems to even know about the "birth" of bioethics over 35 years ago - they think that 'bioethics" IS "ethics" per se (even though there are at least 20 different kinds of "ethics" throughout the history of ethics). And no one seems to know that the kind of "ethics" promoted by "bioethics" is a form of "utilitarian" ethics (expressed in various bioethics formulations including "principlism", "communitarianism", and Peter Singer's type called "preference utilitarianism). Isn't there a little more to consider about this "volunteerism"?

Do Dr. Lipman's readers understand that before the formal "birth" of bioethics such "volunteerism" was grounded for decades on the Nuremberg Code, followed by the Declaration of Helsinki (which actually consists of gradual dilutions of the universal ethical standards inherent to the Nuremberg Code)? Indeed, many of the clinical trials approved today would directly violate one or more of these international ethics guidelines. So if people don't know this history, if they don't know what bioethics really is (we used to call it "federal ethics" or "the Georgetown Mantra"!), if they don't know what "utilitarian ethics" is, etc., then bioethics now must surely be delighted at having a wonderful new "clean slate" of potential human subjects of research to draw on!

This is not the place to cover these critical issues in depth, but perhaps readers might at least find the following historical fact about bioethics to be interesting - or at least relevant - or at least put a different perspective on the "volunteerism" that Dr. Litman addresses. The 1978 Belmont Report represents the formal "birth" of bioethics, and contains a very odd definition of one of its three new bioethics principles - "beneficence" - the same definition that caused me to do such a double-take when reading Dr. Litman's call for human volunteers to participate in medical research "for the greater good". Quoting directly from 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. [The Belmont Report, note 60 supra, pp. 6-7] (emphases added)

So much for the Hippocratic Oath.

As I've noted in one of my articles on "bioethics", this "strong obligation" of the utilitarian-defined Belmont Report 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]. [Declaration of Helsinki 1993 (revised 1964, 1975, 1983, 1989), as published in United States Department of Health and Human Services (1993), Office for the Protection from Research Risks: Protecting Human Research Subjects: Institutional Review Board Guidebook (1993), pp. A6-4 to A6-6. See also: The Nuremberg Code, ibid., pp. A6-1 to A6-2; United Nations (1947) Universal Declaration of Human Rights; United Nations (1991) Principles for the Protection of Persons with Mental Illness and for the Improvement of Mental Health Care; and International Covenant on Civil and Political Rights (ratified, Sen. Comm. on Foreign Affairs 1992)]. (emphases added)

Clearly, then, the utilitarian bioethics principle of "beneficence" would contradict these traditional international guidelines for the use of human subjects in research. And 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" or any minority is clearly not top priority.

Apparently, Dr. Lipman fully embraces the very utilitarian "ethics" of the bioethics principle of "beneficence", and I suppose that is his choice. But would you? Note that so far this "injunction" to volunteer your body "for the greater good" is still voluntary per Dr. Litman's appeal. But should one worry that it might become law, where it would be legally required to do so? No way, you say?

Indeed, this merging of bioethics and the law was precisely one of the main concerns among these Bioethics Founders early on. There was an undercurrent about the makeup of the various new bioethics "commissions" (especially the National Commission and the President's Commission), the definition of "ethics" they used, their insistent use of false science, and the roles such Commissions should play in this "multicultural, pluralistic, democratic" society. Should the federal government even determine what is "ethical" or not?

This concern was articulated sometimes by referring to such efforts as "commissioning ethics", or "federal ethics", and best summed up earlier by one of the original scholars of the Hastings Center, Robert Morison. Quoting Morison's incisive concern about bioethics becoming law, as noted in Albert Jonsen's now-classic book, The Birth of Bioethics:

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. [in Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), pp. 109-110] (emphases added)

Indeed, history has demonstrated that Morison's concerns were well-placed. The recommendations of these two major bioethics commissions did indeed form the explicit basis of many regulations and laws on most "bioethics" issues over the last 35 years -- both private and public, national and international. No question that the same could happen with "volunteering" your body "for the greater good".

There's nothing like a little history to put things in perspective.

Suggested Reading:

For in-depth historical background with extensive references on "bioethics" and on the use of human subjects in research, see articles by Dianne N. Irving, M.A., Ph.D.: