Quality Assurance Auditors: How to Survive Between a Rock and a Hard Place

Dianne N. Irving
Quality Assurance: Good Practice, Regulation, and Law
Vol. 3, No. 1, March (pp. 33-52, 1994)
Reproduced with Permission


The professional rage today seems to be to rapidly incorporate ethics courses into every field. How much derives from a genuine concern to "do the right thing", or from a fear of litigation, remains to be sorted out. One fairly concise and plausable explanation was well articulated recently in an article by Greenberg et al, quoting a senior scientist: "Years ago I probably would have said common sense and the golden rule are sufficient. I don't think that will do anymore. I think the almighty dollar has taken over so much of what we do that we need formal training." (Greenberg et al., 1991, p. 253). Are things so out of control now that in order to care about morality -- or even to know the difference between right and wrong -- one must take a formal course on it? None the less, the "Age of Ethics" is at hand, and all are scrambling to comply as quickly and "ethically" as possible.

There are ethical theories and guidelines available. But it is naive to depend solely on some ethics "guru" to tell you what is right or wrong, or what the "ethical" thing to do is. And it is simplistic to expect text books or seminars to tell you "how to be ethical" in your professional activities. It is also important to know how to critically evaluate them. Only after evaluating ethical theories should they be incorporated into your professional activities.

For example, is an ethical claim merely posited, with no reasonable proof or argumentation? Does a claim seem counterintuitive or lack objective foundations? Are there invalid philosophical (or political) presuppositions which render some claims ridiculous or even potentially harmful? Does this ethical theory resolve the obvious conflict of interests which constantly arise in your daily practice (Shamoo and Annau 1989; Shamoo and Davis 1990; Shamoo 1991; Shamoo 1992A; Irving and Shamoo 1993)? Does this theory only address complex issues in terms of abstract concepts and principles, or does it also successfully relate those abstract concepts and principles to real-life situations? Does this theory relate its theoretical structure to the character and integrity of the individual human actor? After all is said and done, your individual personal character and integrity will also be an important ethical guide for professional decisions and activities.

Why should QA auditors be "ethical"? Because there is a lot at stake. As the literal bridge between science and compliance, your personal and professional successes and failures will in turn determine that of the regulatory compliance of industry and research, in turn determining the success or failure of regulatory bodies to protect society from harm, abuse and exploitation. This surely places you between a governmental rock and a scientific hard place. As many bench scientists strongly reject the very notion of the federal government intruding into their inner-sanctums of "freedom of inquiry", corporate management often strongly rejects the very notion of QA auditors violating their inner-sanctum of "the free-market enterprise" -- snooping into their research scientists' protocols, data and conclusions, or into the reliability and safety of their products or devices.

Thus to help bridge the gap between science and compliance -- and between QA auditors and management -- I will consider briefly professionalism and ethics, the evaluation of ethical theories that you may come across in some of the ethics text books, and moral professional decision making. I will start with a brief consideration of how such fields as philosophy, ethics and bioethics (the terms are not necessarily co-extensive) and even research science might fare as "professions", in the usual sense of the term. As a comparison, I will indicate the professional requirements that accountant auditors must meet before they are allowed to practice before the public. QA auditors might want to consider incorporating some of their professional auditing requirements where applicable.

A. What is a professional?

Generally, there are at least four features an occupation must have if it is to be considered a profession: general and systematic knowledge, orientation to community interest and well-being, self-monitoring through internalized codes of ethics and rewards that symbolize accomplishments in work and that are sought as ends in themselves (Barber 1963; Sokolowski 1991). What distinguishes a "profession" from other occupations is particularly that their activities have a serious and considerable impact on the "social good", or the well-being of our society. In order to protect society from harmful decisions and practices, and to assure the public's trust in their decisions and practices, professionals are required to have mastered a uniform formal system of knowledge and information (Langan 1991; Pellegrino 1991). It must be emphasized that it is ultimately for the protection of our society from harm that "professionals" are expected and required to have met certain criteria before they are allowed to practice before the "public bar".

My first question is: Are research scientists, philosophers, ethicists and bioethicists to be considered as professionals? These persons are increasing used as "experts" in courtrooms, congressional hearings, governmental panels and the media. Particularly in light of their consequent impact on the "social good" (Irving 1993A, 1993B), how do these persons compare "professionally", say, to accountant auditors?

Interestingly, research scientists, philosophers, ethicists and bioethicists are not even listed in the Codes of Professional Responsibility -- although accountant auditors are (Gorlin 1991). Noting only a few of the qualifications required one finds the following:

1) In terms of accountability and responsibility, accountant auditors are required by their professional associations to conform to specific "codes of professional conduct" or "codes of ethics". They are thus held accountable for their professional activities and are censored and/or excluded from practicing if their own judicial body determines ethical infractions. In other words, their Code of Ethics is enforced. Researchers, philosophers, ethicists and bioethicists have no formal professional code of ethics, and no formal professional standards of behavior. E.g., there is no "code of ethics" for ethicists or bioethicists! Nor are they held accountable by any professional organization, or responsible for unethical decisions, inaccurate translations or faulty arguments.

2) In terms of competence and qualifications, auditors must master a defined body of knowledge and attain professional degrees which reflect similar uniform requirements. On the other hand, although the sciences generally have a fairly uniform selection of courses and course content, philosophers, ethicists and bioethicists must only meet the idiosyncratic requirements of their own individual degree institutions. They also have no "professional" organization which requires of them any uniform standards of coursework or course content which would assure the public of any common degree of competence or mastery of a similarly defined body of knowledge. Philosophers, ethicists or bioethicists do not even agree on how to define the subject-matters of their own disciplines!

This is sometimes difficult to understand by persons who are not in these fields. But if you were to put 15 philosophers in a room together, and ask each of them to define the subject matter of philosophy, you would get 15 different answers. Again, one ethics panel on which I recently served was commissioned to write a simple, general "ethics manual" for public policy makers. After three days, none of the 12 ethicists could agree on how to define "ethics" -- the result of which was that not one word was recorded for such an "ethics manual".

Of equal concern is that sometimes these "experts" practice and teach others about related disciplines without the proper formal educational requirements or standards. For example, basic researchers do not necessarily know how to do medical research; and clinical physicians and nurses do not necessarily know how to do basic research. Metaphysicians are teaching bioethics, ethicists are teaching metaphysics and bioethicists are teaching metaphysics and ethics with no previous coursework. Wouldn't it be odd to find a lawyer teaching organic chemistry, or a QA auditor teaching molecular biology or genetics, with no previous coursework?

3) Auditors are required to undergo constant professional up-dating of information under formal, systematic conditions, as well as competence in specific training and a clear demonstration of effective experience. However, researchers, philosophers, ethicists and bioethicists are not required to continue formal course work under formal systematic conditions, or to up-date or demonstrate any specific training. Nor are they bound by any local, national or international professional oversights or requirements for demonstrating effective experience.

4) There is one area in accountant auditing practice, however, which does possibly deserve reconsideration. Accountant auditors are licenced, certified and accredited -- but only through their professional organization -- not, as in many other professions, by county, state or federal requirements. Given the increasing complexity, responsibilities and liability of both accountant and QA auditors, it may be prudent to investigate a requirement for local, state or federal licensing, certification and/or accreditation. Needless to say, there are no such legal licencing or accreditation requirements restricting the practice of philosophers, ethicists or bioethicists. Imagine a philosopher being required to obtain a licence before he can contemplate, or a bioethicist being sued in a court of law for interpreting Plato, Aristotle, Kant, Hegel or Descartes incorrectly!

The point is that QA auditors should realize the lack of consistency inherent in the educational and training backgrounds of "professional" philosophers, ethicists and bioethicists when participating in any educational up-dating in ethics. Although I would argue vigorously for acknowledging the superlative contributions these fields have made to personal guidance and social enrichment, an advanced degree in philosophy, ethics or bioethics -- I would also argue -- does not necessarily an "expert" or a "professional" make, in the usual sense of the term (Irving 1993A, 1993B).

B. Problematic philosophical groundings of current ethical and bioethical theories

Since a part of the current "ethics rush" seems increasingly to involve the simple transferance of "established" biomedical ethics theory to business, journalism, the environment, bench research and other fields, it might be prudent to be aware of some of the problematic philosophical groundings of these ethical and bioethical theories. As any historian of philosophy knows, no philosopher is all right, and no philosopher is all wrong. They also realize that there is no such thing as a "neutral" ethics -- including utilitarianism (Irving and Shamoo 1993). In fact, there is no such thing as a "neutral" logic (Gilson 1963; Copleston 1962)! Given these historical facts, consider for a moment the recent origins of the field of biomedical ethics.

"Ethical" behavior in the practice of medicine had long been established within that profession -- as articulated in the Hippocratic Oath. Current theories of medical ethics -- or of bioethics -- were developed relatively recently as a formal academic discipline. As bioethics "theories" began to take shape and stabilize, three major guiding principles of bioethics emerged: autonomy (actually, a reduction from the originally proposed principle of "respect for persons"), beneficence and justice.

But these guiding principles were derived basically from only two philosophers -- either Kant or Mill (Beauchamp and Walters 1978, 1982, 1989; Beauchamp and Childress 1979, 1989). Kant's theory (deontology) was supposed to represent the defense of the interests of the individual. Mill's theory (utilitarianism) was to represent the defense of the interests of society. Although the identification and application of these three theoretical bioethical principles was initially quite helpful, slowly a practical concern about some of their inadequacies and inconsistencies began to emerge. For example, these three bioethical principles were held to be prima facie -- that is, no one principle held precedence over either of the others. Yet in real-life medical situations these theoretical principles would often come into conflict -- with no theoretically structured means by which to resolve the conflict, or to really balance them (Pellegrino 1993; Shamoo and Irving 1993A; McIntosh 1992; Simon 1989; Destro 1989, 1992; Thomasma 1991; Harmon 1990; Blake 1989; Agich 1990, 1991; Churchill 1990; Capron 1992; Glendon 1991; Weston 1992). For example, should a physician beneficently impose a medical treatment on a patient who has autonomously chosen to refuse it? Which bioethical principal should take precedence here -- autonomy or beneficence? How is this conflict between abstract principles resolved when applied to real actors and real situations?

Each of these principles began to take on a life of its own, each approaching an "absolute", and separated or split from the other two. For example, autonomy was claimed as the ethical ground for a patient to make any medical decision he or she wanted, since they held a prima facie right to make their own "autonomous" decisions -- including expensive and "heroic" medical treatment. Yet in our increasing concern about abusive relativism, are there no limits to autonomous choices and actions? What about the responsibility for our choices and actions? What about the consequences of our "autonomous" choices and actions on our spouses, children, parents, grandparents, neighbors, communities -- including the professional communities -- and our commonly shared environment?

Such questions gave rise to a kind of empirical ethics which began to take shape within the bioethics community itself, prompting some bioethicists to question these early foundational principles of bioethics -- or "principlism", as the theory came to be known. By "principlism" is meant the simple deduction of what is ethical or unethical from these three principles of autonomy, beneficence and justice. As Hamel states:

In the past few years, bioethicists and others have increasingly realized the limitations of principlism and are calling for the development of alternative approaches. Principlism is ailing and, in a sense, has itself become a patient. ...The problems are many, and they range from the theoretical to the more concrete. ...(Principlism) is too narrow in scope. In focusing so much on principles and the resolution of problems, principlism tends to neglect other crucial aspects of situations ... as well as other aspects of the moral life. There is also a sense that principlism places too much emphasis on individual autonomy and on rights, that it is too dominated by philosophy and law, and that it virtually excludes religious considerations and theological language from discussions of issues and cases. (Hamel et al, 1993)

Or, as Meilander comments:

[There has been] a widespread dissatisfaction with an understanding of the moral life which focuses primarily on duties, obligations, troubling moral dilemmas and borderline cases.... An ethic of virtue [on the other hand] is motivated in part by a desire to focus attention on continuities in the development of character, .... -- a turn toward simplicity and away from complex ethical systems. (Meilander 1984, pp. 4-5)

Consequently, Hamel, DuBose, O'Connell and others (Irving 1993C) are calling for a move beyond principlism in the way that bioethics is conceived and practiced. At minimum I would argue that the simple transfer of the guiding principles of one discipline to another discipline -- even assuming that they are viable principles -- is overly simplistic, sometimes unworkable, and can lead to conflicting and erroneous ethical judgments and conclusions.

C. Evaluating ethical theories: The historical roots of the definition of a "human being"

But are these triple principles of bioethics really viable? I would agree with Hamel's basic complaints, as well as his characterization of "principlism" as an ailing "patient". But I would like to take my own purely philosophical concerns a bit further. Basic to any critique of ethical or bioethical theory (and therefore of its constitutive principles) is the correct philosophical definition of a "human being" (Irving 1991) -- a major focus of philosophical anthropology. Thus any thorough "diagnosis" of the "principlism patient" would necessarily require a brief historical explication and evaluation of the various definitions of a "human being". Perhaps there are metaphysical and anthropological presuppositions systematically inherent in them which are theoretically invalid and problematical. This, in turn, could lead to invalid ethical theories whose practical application could result in harm rather than in beneficence. If an ethical theory won't work theoretically or can cause real concrete harm when practically applied -- why use it?

1. Roots of the mind/body split in principlism

Throughout the history of philosophy, each "school" or framework of philosophy defined "being" or reality differently (Gilson 1963). And if one defines "being" differently, then the definition of "human being" is different. And if one defines "human being" differently, then the ethics or bioethics is almost always different. So I will burden you with a short investigation into one of the most critical definitions required for any sound and viable theory of ethics by taking you through a slice of the history of philosophy. You will then see how several philosophers or "schools" of philosophy came to define a "human being" so radically differently. These are the same historical sources for many of the present-day contemporary theories of ethics and bioethics. Inherent in many of these current definitions is the very problematical theoretical construct of a "mind/body split" (Wilhelmson 1956; Fox 1989; Meilander 1987).

Briefly sketching the history of philosophy, early Greek Milesians defined "being" or reality in terms of matter only [Table 2]. Thus, a "human being", or the "self", was defined only in terms of the material body. The Pythagoreans on the other hand defined "being" only in terms of forms -but for them forms were still really material and in fact were actually numbers. A "human being" for the Pythagoreans, then, was defined only in terms of his material form (or soul) -- which was really a material fragment of the material divine cosmos (Kirk and Raven 1964; Brumbaugh 1981).

Plato defined "Being" or reality in terms of non-material Forms -- which were also really numbers [Fig. 1]. What was "really real" and really existed were these Forms or Essences -- which somehow subsisted separate and apart from the physical world and the material things of which they were the Essesces. This included the Form of a human being's soul (or Nous). The physical world was defined as "matter" only; and for Plato matter was simply an illusion, appearances only -- non-being. Since he rejected the validity of any sense knowledge, all our true knowledge was gained only by an intellectual "intuition" of the separated Forms (Jowett 1937; Vlastos 1978; Gilson 1963).

Thus Plato defined a "human being" as two separate substances -- soul (or Form) and body. But if a human being is composed of two separate substances, then there is a real separation or split between the soul and the body, and therefore no interaction is really objectively possible or explainable. And if the body (as matter) is non-being, and if non-being doesn't really exist, but is an illusion or appearance only, then the body of a human being does not really exist but is also simply an illusion or appearance only. So Plato ultimately defined a "human being" only in terms of the immaterial and immortal rational part of the soul. The other two parts -- the appetitive or desiring, and the spirited parts -- were material and mortal. Eventually even Plato himself acknowledged that his "mind/body split" was both theoretically and practically devastating to his own philosophy and wouldn't work. For example, no interaction of any kind is possible between the non-material mind and the material physical body. But despite Plato's own self-effacing warnings, philosophers throughout the history of philosophy have perpetuated these problematic Platonic metaphysical and anthropological presuppositions -- even if both theoretically and practically they won't work.

Aristotle strongly argued against Plato's metaphysics and anthropology [Fig. 2]. He defined "being" as both non-material and material, and a "human being" as a single composite of soul (or form, or powers) and body, constituting one concrete substance (Aristotle, De Anima, in McKeon 1941; Veatch 1974). There is no mind/body split, and no split between the powers of the soul. So interaction was possible and explainable. Since there was no split, the soul or powers of a human being were in every part of the human being, not just in the heart or in the brain. Although there are still some troubling Platonic streaks in a few of his treatises (Gill---Irving 1991), the framework for objectively determining definitions is still viable, and it is identifying frameworks which really work which is more important than the championing of any one philosopher rather than another.

Historically, there were many variations on these themes, and eventually we encounter Descartes [Fig. 3]. Descartes defined all of reality or "being" in terms of only two separate and different substances, i.e., immaterial mind and physical extension (or continuous matter) (Descartes in Cottingham et al 1984). A "human being" was, like Plato, theoretically defined as composed of these two substances, but ultimately again only as "a thinking thing", distinct and separate from his body. This is the source of the modern mind/body split, and I would argue, the source of the current preoccupation with the principle of "autonomy". For what is now really definitive of a human being is his or her active mind -- the source of present-day so-called "rational attributes" of personhood, e.g., self-consciousness, reasoning, willing, choosing, relating to the world around one and sensing, etc. (sensing was really a mode of thought for Descartes) . But again, as with Plato, Descartes cannot explain any interaction between his immaterial mind and his physical body. His famous attempt with the pineal gland as the "mediator" between the two simply doesn't work, since the pineal gland is also part of the physical body -- and is therefore also separate from the Mind.

Rather rapidly Descartes metaphysics and anthropology (and much of his physics, I might add; Irving 1993B) fell into academic disrepute. Theoretically and practically his system simply didn't work, and so philosophical academicians hurried to rectify Descartes' massive theoretical problems. But interestingly the split still seems to be around. For example, in the philosophical "schools" which followed Descartes, one common claim is that a real distinction -- i.e., a real split -- will be made between a human being and a human person. Watch the logical extension of their distinctions:

For example, some modern philosophers (e.g., Kant and other rationalists) defined a "human being" as only one of the two above "Cartesian" substances -- e.g., reason (or mind). But if a human being or human person is defined only in terms of "rational attrubutes", then the following list of human beings are not persons: the mentally ill, Alzheimer's and Parkinsonian patients, stroke victims, patients who are comatose or in a persistent vegetative state, drug addicts, drunks and alcoholics. Empirically we know that self-consciousness, autonomy, etc., are not actually present until early childhood, so some contemporary rationalists logically argue for the permissibility of the infanticide of perfectly normal human infants and very young children. They are only human beings and not simultaneously also human persons. Only human persons, they claim, are due ethical or legal rights and protections (e.g., Engelhardt 1985; Tooley 1974).

Other modern philosophers (e.g., Mill and other empiricists) defined a "human being" as only one of the other two "Cartesian" substances -- e.g., body or matter. Some came to equate "personhood" with sentience (or the ability to feel pain and pleasure). They argue that some higher primates (e.g., dogs, pigs, monkeys, etc.) are highly sentient, i.e., are persons, and some human beings who are less sentient are not persons. Empirically we know that full brain integration and sentience are also not completed until several years after birth. So logically they argue for the permissibility of infanticide and the killing of young children (e.g., Peter Singer 1981, 1987; Kuhse 1985, 1986).

Can one really "split" a human being from a human person -- other than just conceptually? And what are the concrete consequences if one tries? Such claims that a "person" is only defined in terms of either "rational attributes" or "sentience" can be easily transferred to many adult human populations. I often wonder how aware the average American citizen is of what is transpiring in the bioethics literature. I wonder if they realize that these bioethical "theories" are being taken seriously, and are being applied to them through local, state, national and even international legislation and regulations (Irving 1993B; Shamoo and Irving 1993A).

Part of my diagnosis of the "principlism patient" is that some of the critical sources of our present difficulties with the bioethical principle of autonomy (as well as with the others) can be traced back to these historical problematic metaphysical and anthropological presuppositions systematically inherited from and inherent in these various definitions of a "human being". Particularly problematic is the development of a systematically inherent mind/body split -- a split that predates either Kant or Mill -- and which, by the way, was successfully refuted pre-Kant and pre-Mill!

I would like to suggest that the original formulation of the bioethical principle of "autonomy" was meant to protect the inalienable integrity and value of each human being -- autonomous or not. It was first named "Respect for Persons" in the Kantian sense, denoting the source of moral responsibility. But the Kantian meaning of "human being" was reduced to the Millsean sense of "person", i.e., a human being who could exercise "rational attributes", or who was purely autonomous:

The first principle deserving mention is one commonly referred to as the principle of respect for persons [Kant], by which is usually meant something like the following. Because humans act morally and have a capacity for rational choice, they possess value independently of any special circumstances conferring value, and because all human beings and only human beings have such unconditional value, it is always inappropriate to treat them as if they had merely the conditional value possessed by natural objects...

... For purposes of this discussion, the import is that individuals should be allowed to be self-determining agents, making their own evaluations and choices when their own interests are at stake [Mill]. This narrowed version of "respect for persons" will be referred to here as respect for the autonomy of persons -- or more briefly, as the principle of autonomy. (Beauchamp and Walters 1982, pp. 26-27) (emphasis added)

... Autonomy is a form of personal liberty of action where the individual determines his or her own course of action in accordance with a plan chosen by himself or herself [Mill]. The autonomous person is one who not only deliberates about and chooses such plans but who is capable of acting on the basis of such deliberations... A person's autonomy is his or her independence, self-reliance, and self-contained ability to decide. (Beauchamp and Childress 1979, p. 56)

... The second aspect [Mill's] follows from Kant's position: in evaluating the self-regarding actions of others we ought to respect them as persons with the same right to judgments as we have to our own. This aspect of the principle of autonomy is often referred to as the principle of respect for persons, because it demands respect not for a utilitarian or any other reason except that another is a person, and therefore rightly a rational determiner of his or her own destiny... In the end these two very different philosophers present views of autonomy which are both acceptable and in no major respects incompatible. (Beauchamp and Childress, 1979, p. 59) (Emphasis added)

Such a simplistic equation between Kant-the-rationalist and Mill-the-empiricist could only be accomplished amid the theoretical chaos that is typical of philosophising within frameworks systematically containing a mind/body split. Since there really are several "aspects" to a human being, historically what we sometimes see is one school defining a human being only in terms of one of these aspects (e.g., matter); sometimes in terms of another of these aspects (e.g. form, or "soul"). Thus different "parts" of a human being become, variously, different definitions of a whole human being. Some will try to simply dodge the entire issue by reducing ethics to the consideration of pure isolated actions only -- another kind of mind/body split. For example, one ethics text book insists: "Some ethical theories have featured the traits of the autonomous person, but our interest in acts such as consenting and refusing leads us to focus on autonomous choices. Consents and refusals are actions, not persons" (Beauchamp and Childress 1989, p. 68).

It is true that ethics is about the rightness or wrongness of our actions, but those actions are the actions of something -- i.e., of a human being. They are specifically human actions, executed by human agents who can know right from wrong -- and therefore have moral responsibility for those actions. That is why it would be absurd to do an "ethical" analysis of the actions of dogs, or pigs, or monkeys! Autonomy is simply about responsibility for one's actions. Non-autonomous human beings are not thereby to be relegated to "non-person" status. Their non-autonomy simply refers to a lack of responsibility for their non-autonomous actions.

Next Page: 2. Roots of pure deduction in principlism
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