In her recent article, "Is it civic duty to be human guinea pigs?" [April 18, 2005, in Scotsman.com, at: http://news.scotsman.com/index.cfm?id=408852005], Jennifer Veitch raises the question, "[S]hould we all be obliged - or even compelled - to become human guinea pigs in research experiments for the advancement of science and the good of society?" She then reports on the response of leading bioethicist Professor John Harris of the University of Manchester:
Writing in the latest edition of the Journal of Medical Ethics, he suggests the public should be "morally obliged" to take part in research, in a similar way to wearing a seat belt or performing jury service. Harris has called for the Declaration of Helsinki to be reviewed, arguing that research is becoming "impossibly difficult" to undertake, and that, in certain circumstances, a degree of compulsion is justified. "The argument concerning the obligation to participate in research should be compelling for anyone who believes there is a moral obligation to help others, and/or a moral obligation to be just and do one's share," he writes. "Little can be said to those whose morality is so impoverished that they do not accept either of these two obligations."
Although such "reasoning" might sound off-center for most people and echo research atrocities of the likes of the Nazi Holocaust, apparently few realize that the strong "moral obligation" of which Harris speaks for every member of society to volunteer to take part in research that is solely for the "greater good" is already part and parcel of the Belmont Report (1979) in the United States - the very same Report that ushered in the formal "birth of bioethics". What is more striking than Veitch's question or Harris' response is the fact that most people are oblivious to this. If they were, then the question and the response of Harris (and others) would not be so shocking.
I'll not cover all the pros and cons inherent in this question. Rather, in the interest of public information (and thus involvement), I have copied below a very short and brief history of the Belmont Report, followed by a full and complete official copy of that Report itself. (For those unfamiliar with the debates concerning the Belmont Report, I have simply bolded in red those sections in the Report which are of most concern). A full copy of Veitch's article is at the end of this communication.
"Bioethics" is not "ethics per se", nor "medical ethics per se". It is a new unique normative (not "neutral") "ethics" that was created out of thin air by the National Commission (11 members) in their Belmont Report (1978/9), by mandate of the U.S. Congress (National Research Act 1974). This Congressional mandate required that the then-Secretary of DHEW (now DHHS) - Casper Weinberg -- appoint a commission to identify the "ethical principles" the government should use in dealing with the issues concerning the use of human subjects in research. This was accomplished in the Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html). The same Congressional mandate also required that these "ethical principles" be transformed into federal regulations, and in 1981 this was accomplished with the federal regulations of the Office for the Protection of Research Risks (OPRR, recently changed to the Office of Human Research Protection OHRP, at: http://ohsr.od.nih.gov/guidelines/45cfr46.html).
The Belmont Report was literally copied into the first pages of the OPRR federal regulations, and is the basis for deciding which research using human subjects is "ethical" and which is not. The "Belmont Principles" are also the "ethical principles" that Institutional Review Boards (IRBs) are federally required to follow in their decisions as to whether or not a particular experiment is ethical or not, and who is to be considered as "a human subject" of research (http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf). These federal regulations, it might be pointed out, are definitely not in accord with either the international Nuremberg Code (http://ohsr.od.nih.gov/guidelines/nuremberg.html) or the various international Declarations of Helsinki (http://ohsr.od.nih.gov/guidelines/helsinki.html). The 1982, 1993 and 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects (http://www.cioms.ch/frame_guidelines_nov_2002.htm) are also explicitly and graphically grounded on the "bioethics" principles of the Belmont Report.
Against this background it at least should be noted that the three "ethical principles" of bioethics almost always come into conflict - a point noted in the Belmont Report itself. Yet bioethics "theory" provides no means by which to resolve the inherent conflicts between and among these bioethics principles - thus causing havoc or arbitrariness in their applications (whether being applied to medical practice or to medical research). Note also the formal definitions of these three "ethical" principles in the Belmont Report - hardly common understandings of these terms. The result is a very utilitarian and relativistic form of "ethics", where it is never claimed that there could be some research experiments that should never be performed regardless of any perceived "benefit to society". There are no such "absolutes".
Specifically, "autonomy" was soon restricted to those who express what Peter Singer referred to in his definition of "person" as "rational attributes" or "sentience" - resulting in the common position of most in bioethics that non-autonomous human beings were not "persons". Note how the principle of "beneficence" has two inherently contradictory definitions and is used to justify the kind of statements made by Prof. Harris. That is, the "bene" or benefit refers primarily to the "good of society" rather than to individual patients or citizens - and that citizens of society have a strong "moral obligation" to volunteer for research projects "for the greater good" of society - even if they do not directly benefit that individual citizen. Finally, the principle of justice is defined according to John Rawls - i.e., as "fairness". Fairness in what? Fairness in the distribution of the risks and benefits of research - and so elaborated in more detail in the Belmont Report. There are still no agreed upon definitions for "minimal", "more than minimal", or "high" risk research - nor for "research fraud".
For a critical and extensive analysis of "bioethics" and its "ethical principles", see Irving, "What is 'bioethics'?", at: http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html. For a mini-version of this article, see Irving, "The bioethics mess", Crisis Magazine, Vol. 19, No. 5, May 2001, at: http://www.lifeissues.net/writers/irv/irv_37bioethicsmess.html. For relatively short and easy to read histories of the recent "birth" of bioethics with extensive historical references, see Albert Jonsen (one of the 11 National Commissioners), The Birth of Bioethics (Oxford University Press, 1998); and, David Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: BasicBooks; a subsidiary of Perseus Books, L.L.C., 1991). Rothman's book especially focuses on the application of "bioethics" to medical research.
NATIONAL INSTITUTES OF HEALTH
REGULATIONS AND "ETHICAL" GUIDELINES
The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department of Health, Education, and Welfare
ACTION: Notice of Report for Public Comment
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Members of the Commission
Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes(1) intended to assure that research involving human subjects would be carried out in an ethical manner.
The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted.
Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.
This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles.
It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called "experimental" when the terms "experimental" and "research" are not carefully defined.
For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. (2) By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project. (3)
Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.
The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.
However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.
Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.
In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.
2. Beneficence. -- 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 no 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. Further, the Hippocratic Oath requires physicians to benefit their patients "according to their best judgment." Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.
The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. 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 principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children -- even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.
3. Justice. -- Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.
Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.
Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Next Page: Part C: Applications
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