Does the Moral Philosophy of the Belmont Report Rest on a Mistake?Author(s): Ernest MarshallSource: IRB: Ethics and Human Research, Vol. 8, No. 6 (Nov. - Dec., 1986), pp. 5-6Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564238 .

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November/December 1986

Does the Moral Philosophy of The Belmont Report Rest on a Mistake? by Ernest Marshall

The Belmont Report is an advisory report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in 1974, to the Secretary of what was then (in 1979) Health, Education and Welfare. 1 It does not have the force of law. However, because it is the commission's statement of basic ethical principles, it carries a great deal of ethical weight; as such, it serves as an important basis for further regulations and deliberations, especially as these pertain to the decisions of Institutional Review Boards. There are, nonetheless, some serious difficulties in the Belmont Report.

The basic ethical principles identified by The Belmont Report are "respect for persons," "beneficence," and "justice." These principles in turn are said to apply to the conduct of research with human subjects in the requirements of informed consent, risk-benefit assess- ment, and fair selection of research subjects, respectively. The principle of respect for persons and the consequent requirement of informed consent single out the research subject as the focus of moral concern, that is, the person whose rights or welfare* is paramount. The same is true concerning the prin- ciple of justice and the requirement of fair selection of research subjects. Although this topic is often considered in terms of special groups, hospital and prison populations, the poor, the men- tally retarded, and so forth, such persons qua research subjects are the only concern.

However, the principle of beneficence and the requirement of risk-benefit assessment are different. Here the welfare of the research subject is not the sole interest, primarily for two reasons: First, the research in question is not intended to benefit the research

subject; "research" is defined as "an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge"',p-3 (as distin- guished from diagnosis or treatment designed to enhance the well-being of the subject). Hence, the research is "neutral" as regards the subjects' own welfare.

Second, the research may also be detrimental to his or her welfare. The beneficence principle is basically the utilitarian rule that we maximize bene- fits and minimize harms irrespective of which individuals (as part of a consid- ered aggregate) are affected and in what way. "Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantive benefits that might be gained from research."1,P.7

The differences between the princi- ples of respect for persons and justice, on the one hand, and that of benefi- cence, on the other, are often summed up by pointing out that the former are deontological or Kantian principles and the latter is teleological or utilitarian. This is indeed the case, but of further and greater importance is the consid- eration that this theoretical difference carries with it corresponding differ- ences of application. The most signif- icant difference is that respect for persons and justice serve the good of the research subject; beneficence seeks the good of some aggregate, of which the research subject is at best merely a part. Indeed, I regard this as the crucial difference between a Kantian versus a utilitarian standpoint and the one I shall pursue. Put very succinctly, the two main formulations of Kant's categorical imperative, enjoining us to act only on universalizable maxims and to treat persons as "ends in themselves," pre- scribe justice and respect for person (respectively), and require the consid- eration of individuals as such and as not to be sacrificed even for the sake of other and even "greater" goods.**

This divergence among these ethical principles is, I believe, partially con- cealed by two further conceptual

confusions in The Belmont Report. Respect for persons is said to incorpo- rate two "ethical convictions": "first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection,"'1,p4 and also that beneficence likewise encompasses two components: "do not harm and max- imize possible benefits and minimize possible

harms."1,p'4 Regarding the first,

either persons are to be respected by virtue of the value we place upon autonomy, in which case those with diminished autonomy do not require our respect and thus are not entitled to protection; or it is primarily the protection of individuals from harm that the principle intends and it is also presumed that the individual, when autonomous, is his or her own best judge of how to avoid harm.

Other ways of understanding the relationship between these two compo- nents of the principle are of course possible, e.g., that autonomy is to be respected because of its value but persons in general are also to be thus treated by virtue of the value of other human traits or capacities. Nonetheless as the principle is stated it is not clear that it is the good of the research subject per se (by virtue of his or her autonomy, or whatever) that one is enjoined to treat with respect.

Regarding the second confusion, two distinct principles are conflated, that of "beneficence" and "nonmaleficence."2 The former principle allows us to sacrifice the good of the research subject for a greater aggregate good but the latter does not, or at least the latter principle is ordinarily regarded as "overriding" the former whenever they conflict.3 The Belmont Report defends combining these principles by arguing that "even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm."b,p.4 However, this manner of argument simply begs the question by way of treating risks of harm to research subjects and benefits resulting from research according to a common calculus, because the persons (research

*Throughout this article I use "rights" and "welfare" interchangeably. Some confusion would be avoided if I had reserved the term "rights" to refer to what is sought by respecting persons and promoting justice, and "welfare" to maximizing benefits or considerations of beneficence. Given my argument, however, less confusion should be created by not following this usage, since I contend that the most significant difference between the former and latter sorts of ethical concerns has to do not with the purported distinction between rights and welfare, but between the welfare and/ or rights of the research subject and the good (welfare, etc.) of some human aggregate.

Ernest Marshall is Associate Professor of Philos- ophy, East Carolina University, Greenville, NC.

"Since I am concerned here only with broad theoretical distinctions I do not differentiate between consequentialist, utilitarian, and teleolog- ical views, or between a deontological view such as Kant's and those of Ross, Rawls, etc. What cuts across these finer distinctions is that which I refer

to above and by means of the common labels of "utilitarian" and "Kantian." My understanding of the utilitarian position (and its limitations) is essentially that expressed by John Rawls in part 5 of Chapter 1 of his A Theory of Justice (although my understanding of the Kantian position is different from his).

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D

subjects) exposed to risks and those benefited are not necessarily, or ordi- narily, the same persons. In other words, the reasoning would be sound only if it were instead a case of an "experimen- tal"'1,p4 medical procedure whereby the person, that is, patient, not research subject, must be exposed to some risk of harm in the attempt to provide for him or her an effective treatment.

It may not at first seem a significant objection that the ethical principles of The Belmont Report place the good of the research subject in opposition to that of the knowledge the research is expected to yield or the good for others this in turn may produce. After all life commonly calls for compromises among competing claims and also allows for satisfactory solutions. But such solutions are forthcoming only if we know how to go about adjudicating such conflicts in such a way as to achieve solutions.

What then does The Belmont Report suggest as to resolving such conflicts? Although it offers no general advice it makes frequent use of the concept of "balancing" for such a purpose. This is done not only with regard to the application of the principle of benefi- cence in the assessment of risks and benefits. ("It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio."l'P-7), but also regarding other principles ("Respecting persons in most hard cases, is often a matter of balanc- ing competing claims urged by the principle of respect for persons."",p.4). Most significantly, such "balancing" is suggested for reconciling conflicts between principles, e.g., concerning respect for persons it says that "the extent of protection afforded should depend upon the risk of harm and the likelihood of benefit" and "when the risks are more serious, the obligation increases."IP-6

Yet what any "balancing" as to respect for the person of the research subject and justice on the one hand, and the maximization of some aggregate good, on the other, means or consists of is far from clear. It is difficult enough to make sense of a "balancing" of risks versus probable benefits, or benefits for a research subject versus those for others, much less the "balancing" of different kinds of ethical considerations (i.e., different principles) that is called for here. In terms of the metaphor of balancing that is conceptually employed, the situation is rather like weighing an object on a balance scale using metric weights and expecting the weight readings to be equally accurate as cited in standard units. But the

feasibility of "balancing" these different types of ethical considerations seems even less promising than this, since the point of the Kantian principles (at least as I understand them) is precisely to say that certain things cannot be "balanced out;" i.e., if certain actions are unjust or disrespectful of persons then they are wrong and therefore simply should not be done.

The Belmont Report may of course be construing its principles in some other way, but the point is that it bears the burden of proof in showing that they are commensurable or otherwise cap- able of being "balanced." Until such is forthcoming, in attempting to apply the three basic principles of The Belmont Report in concert we create more conceptual havoc than harmony.

Finally, in any attempt to "balance" the rights or welfare of the research subject against the aggregate good, the former must surely lose, i.e., respect for the person of the research subject and his or her just treatment must be sacrificed, given the vast amount of good that can be expected to accrue from biomedical discoveries over the long term. Horrors comparable to those perpetrated by Nazi researchers that gave rise to the Nuremberg Code can be "justified" (on utilitarian grounds) for discoveries such as that of penicillin and polio vaccines. Would it really be some "mad scientist" (i.e., from a utilitarian perspective alone) who would treat research subjects so, if he were hot on the trail of, let us say, an effective cancer vaccine? The less dramatic but much more likely example to be cited here is that in which the rights or welfare of research subjects are compromised in perhaps small yet significant ways as researchers overzealously pursue what they take to be some "greater good."

What do these theoretical consider- ations have to say regarding the outlook and activities of IRBs? I offer the following conclusions: (1) IRBs should be specifically and predominantly the moral advocates of the research sub-

ject, and only to a lesser degree con- cerned with the advancement of research and its public goals. Not only is such a body needed, given the utilitarian tendency to opt for some greater good (i.e., that "outweighs" that of the research subject) but also speci- fying the role of this body in this way mitigates conceptual quandaries. (2) The presently stated principles of The Belmont Report not withstanding, IRBs should be guided more by Kantian principles such as respect for persons and justice than utilitarian ones, since the former are more directly concerned with the rights and welfare of the research subject. (3) In place of attempt- ing to "balance" different ethical con- siderations as these pertain to the evaluation of a protocol, considerations as to the protection of the rights or welfare of the research subjects should be defined so that these constitute specified necessary conditions that it must meet to be ethically acceptable. In other words, such questions as, how great must the predicted benefits be in order to make what level of subject risk acceptable?, should be recast as: what level of subject risk is ethically accept- able, regardless of expected benefits?

To some extent the Department of Health and Human Services regulations takes this approach, for example, regarding research involving prisoners and children as subjects.

REFERENCES 'The National Commission for the Protection of

Human Subjects, The Belmont Report, 1979. 2For a treatment of nonmaleficence and benefi-

cence as separate ethical principles see, for example, Tom Beauchamp and James Childress, Principles of Biomedical Ethics (Oxford Univer- isty Press, 1983), Chapters 4 and 5.

3The view that duties as to nonmaleficence take precedence over those as to beneficence is one of long standing in ethics. Kant accords with this in his distinction between "perfect" and "imperfect" duties. In her classic essay, "Abor- tion and the Doctrine of the Double Effect," Philippa Foot does also (referring to "negative duties" and "positive duties" and the rule that the former are the stricter duties).

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CALENDAR

June 4-5, 1987: A conference titled Animal Pain: Its Recognition, Alleviation, and Avoidance will be held in Chicago and jointly sponsored by the Scientists Center for Animal Welfare and The University of Chicago. Practical, ethical, and philosophical issues of animal research that involve pain will be addressed. This conference will be one of a series on animal pain organized by the Scientists Center for Animal Welfare in conjunction with major universities. For more information on the Chicago conference, contact Dr. F Barbara Orlans, Director, Scientists Center for Animal Welfare, 4805 St. Elmo Avenue, Bethesda, MD 20814, (301) 654-6390; or Dr. Lee Cera, Director of Animal Care, The University of Chicago, 5801 Ellis Avenue, Chicago, IL 60637, (312) 962-9361

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