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Copyright 1998 by The Johns Hopkins University Press. All rights reserved.
Kennedy Institute of Ethics Journal 8.3 (1998) 233-273
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A Theory of International Bioethics: The Negotiable and the Non-Negotiable

Robert Baker
Abstract. The preceding article in this issue of the Kennedy Institute of Ethics Journal presents the argument that "moral fundamentalism," the position that international bioethics rests on "basic" or "fundamental" moral principles that are universally accepted in all eras and cultures, collapses under a variety of multicultural and postmodern critiques. The present article looks to the contractarian tradition of Hobbes and Locke--as reinterpreted by David Gauthier, Robert Nozick, and John Rawls--for an alternative justification for international bioethics. Drawing on the central themes of this tradition, it is argued that international bioethics can be rationally reconstructed as a negotiated moral order that respects culturally and individually defined areas of nonnegotiability. Further, the theory of a negotiated moral order is consistent with traditional ideals about human rights, is flexible enough to absorb the genuine insights of multiculturalism and postmodernism, and yet is strong enough to justify transcultural and transtemporal moral judgments, including the condemnation of the Nazi doctors at Nuremberg. This theory also is consistent with the history of the ethics of human subjects experimentation and offers insights into current controversies such as the controversy over changing the consent rule for experiments in emergency medicine and the controversy over exempting certain clinical trials of inexpensive treatments for preventing the perinatal transmission of AIDS from the ethical standards of the sponsoring country. The Preamble to the Council of Europe's (1997) Convention on Human Rights and Biomedicine, the most recently ratified code of international bioethics, is noteworthy because it never mentions "principles," the concept most frequently cited by the fundamentalists as basic to international bioethics. Instead it stresses rights, a concept that has been utterly ignored by the fundamentalist theorists of international bioethics. The Preamble exemplifies a conception of international [End Page 233] bioethics as an ethics of covenants and conventions grounded in human rights. In the full text of the Preamble, the term "rights" appears eight times and the expressions "convention" and "covenant" are used six times; the term "principle" does not appear at all. In this essay, I develop a theoretical framework for international bioethics based on conventions, covenants, and areas of "nonnegotiability"--a concept that serves as a functional analogue to the traditional notion of "human rights." I also shall argue that, unlike the theory of basic principles central to moral fundamentalism, the theory of negotiated morality appears immune to the multicultural and postmodern critiques of international bioethics that were analyzed in the preceding article in this issue of the Kennedy Institute of Ethics Journal (Baker 1998).
Negotiated Moral Order: A Model for International Bioethics

Reconsidering Contractarianism
The linkage of "conventions" and "covenants" with human rights that is evident in the Council of Europe's Convention on Human Rights and Biomedicine traces back directly to the moral and political theories of Thomas Hobbes and John Locke. Such philosophers as David Gauthier (1986),
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Robert Nozick (1974), and John Rawls (1971, 1993) recently have reinvigorated this classic contractarian line of analysis. In this section, I shall reconsider classical contractarian theory from a perspective informed by these more recent analyses. The most riveting feature of all forms of contractarian theory is the metaphor of the contract itself, particularly the legitimating role it accords to assent. Because contractarians look to the assent of those who would be bound by a moral norm as ultimately the sole source of a norm's legitimacy, the most important corollary of contractarian moral theory is that moral norms are illegitimate insofar as agents either in principle could not, hypothetically would not, or actually will not rationally assent to be bound by them. Contractarians also argue that because legal norms are legitimated by acceptance of the authority of those who promulgate them, the authority of such norms is bounded by the actual or hypothetical assent of the governed. These features of contractarian analysis generate the correlative concepts of human rights and civil rights. Less often remarked, but nonetheless integral to the metaphor of the social contract, is the contractarian recognition that the interests of the [End Page 234] parties who contract to form civil society are naturally in conflict (or, as Hobbes put it, at war with each other); for were there no conflict, there would be no need to state terms of agreement. Modern moral and political philosophy, in point of historical fact, arose as a response to civil war and to the revoltingly uncivil massacres provoked by the seeming irreconcilable clash of values between Catholics and Protestants, Anglicans and Puritans, and, lest one forget the socioeconomic aspects of these clashes, between the titled and the untitled, the landed and the landless, the moneyed and the moneyless. The basic challenge facing modern moral and political philosophy was that of fashioning a theoretical foundation for cooperation between agents whose principles and interests conflicted with each other. Contractarian moral and political theory concludes that cooperation between such agents is possible--despite fundamental conflicts of interests, principles, and values-provided that the conflicting parties appreciate their own rational self-interest in enjoying the advantages of cooperation. Hobbes and Locke fully appreciated, however, that agents embroiled in conflict will not sacrifice everything that they value in order to enjoy the advantages of mutual cooperation. Some goods, principles and values are nonnegotiable. More specifically, the classical contractarians held that agents would not negotiate away (or "alienate") certain basic or primary, interests, values, and goods, such as life, liberty, health, or property (the ability to support life). Appropriating the popular political rhetoric of the period, they referred to these nonnegotiable or "unalienable" goods as "rights." Since contractarian theory stipulates that only assent legitimately can bind someone to moral norms; and since rights are, by definition, those interests, values, or goods, that no agent rationally would assent to alienate; contractarian theory straightforwardly entails that no moral (or legal) norm can legitimately violate human rights--i.e., nonnegotiable goods common to all humans. Rights violations thus are illegitimate in any and all possible moral or political frameworks; their illegitimacy is not contingent upon the norms of any particular moral or legal framework; rights violations are necessarily immoral, so to speak.
Negotiating A Moral Order: An Example

Consider, as an example of negotiated moral order, the case in which a common resource, such as a lake, is contested by parties with radically opposed values, say, a colony of puritans and a colony of nudists. To [End Page 235] exacerbate the conflict, let us suppose that both groups value sunbathing and swimming and that there is but one beach on the lake. Simultaneous sharing of the beach seems impossible since, were the two groups to sunbathe and swim on the same beach at the same time, the puritans would be offended by the nakedness of the nudists, while the nudists would be offended by the reactions of the puritans. The conflict between the two seems irresolvable on any moral or political theory that shares with moral fundamentalism the presupposition that such conflicts can be resolved only in terms of shared "basic" moral principles. One might offer the two colonies a "techno-fix," in which technology is deployed to eliminate the physical constraints that exacerbate the value conflict--for example, building a separate beach or somehow building a wall dividing the one beach into two--but in the absence of some shared principle, there seems to be no solution to the conflict in purely moral terms. Since postmoderns and multiculturalists deny the existence of shared or bridging principles, they would anticipate that such conflicts can be resolved only through intractable power struggles--culture wars--fought on battlefields that can range from the economic to the legal. In this forthrightly Darwinian struggle, the strongest dominate and in dominating dictate values and norms.
Contractarian theory offers the alternative possibility of a negotiated morality. The theory contends that agents who have opposing values, interests, or principles can accept and enforce common norms, provided that the norms: (1) address situations that are mutually recognized as problematic; (2) offer solutions that resolve these problems in a way that is acceptable to all the parties; and thus (3) respect those areas of nonnegotiable primacy recognized by each party--i.e., the value of nakedness for the nudists and of asexuality for the puritans. A shared understanding of the problem and a shared appreciation that a set of norms resolves a problem in a mutually acceptable manner is thus a sufficient condition for a negotiated morality--even between agents who do not share common principles or values. Thus, in the case of the puritans and the nudists, they can share the same beach if they develop a norm for sharing in which each has exclusive use of the beach for set periods of time. Such a norm might stipulate that puritans have exclusive use of the beach on Tuesdays, Thursdays, and Saturdays; while nudists have exclusive use of the beach on Wednesdays, Fridays, and Sundays; Mondays might be used alternately, first by one group, and then by the other. The point to appreciate is that, on the negotiation model, morality is not a matter of one group imposing its values upon another, but of rendering [End Page 236] conflict quiescent by negotiating a set of norms that permits each party to use common resources while respecting the other party's primary areas of nonnegotiability. It might be thought that conflict would be preferable to morality because the "winners" enjoy hegemony over the disputed resource. One of the most important insights offered by contractarian theorists is that the conflict itself characteristically carries costs that typically outweigh the presumed benefits of "winning." In the present case, the costs of energy, time, and resources needed to gain hegemony over the beach would probably outweigh the benefits of monopolizing the beach. Even were it not true in any particular case, contractarians argue, morality--the ability to negotiate conflict-resolving norms--is a form of life that characteristically enriches the lives of moral agents by enabling them to live less conflicted and thus freer lives. A life of negotiated constraints respectful of the areas that others hold primary is likely to be freer than a life of perpetual struggle and conflict. If one doubts the value of respecting human rights, compare the sunny, prosperous, and tolerant Lebanon of yesteryear, in which Christians and Muslims shared the same coastal country through carefully negotiated norms, with the war-torn country created by a quest for hegemony. In countries like Northern Ireland, Bosnia, and other states of the former Yugoslavia, the failure to respect human rights has destroyed once rich lands and cultures, reaffirming the contractarian claim for the superiority of morality as a form of life. Conflict-quiescing norms promote human flourishing.
Negotiated Morality and the Postmodern Critique

Moral fundamentalists presume that transcultural and transtemporal moral judgments are justifiable only if there are "basic" or "fundamental" cross-cultural and cross-temporal moral principles that are universally accepted by all cultures and in all eras. They are thus led to postulate the existence of universal principles common to both the Nazis and their victims, even as they admit that in deviant eras individuals may be "ignorant of" such principles or "culturally blind" to them. As argued in the preceding article, such postulated universal principles are subject both to the multiculturalist claim that no such principles ever have been discovered and to the postmodern critique in which principles are interpreted through perspectives or "gazes" that undercut the presumption of universality. There is also the straightforward analytic criticism that it is meaningless to suggest assent or "agreement" to principles of which one is [End Page 237] "ignorant" or to which one is "blind"--especially when, as in the case of the Nazi doctors, one expressly protests the principle in question. Contractarianism inverts the presumptions of moral fundamentalism and openly recognizes the intractability of conflict over principle. Historically, contractarian theory was invented as a response to bloody Catholic-Episcopalian-Puritan civil wars in Britain that destroyed any hope of finding common moral principles. Hobbes and Locke sought to construct common moral and political frameworks for agents whose interests and interpretive frameworks were presumed to be conflicted at the outset--like nudists and puritans. They used contractarian theory to avoid postulating prior acceptance of universal principles and consequently invented a justificatory strategy for ethics that is resistant to the multicultural and postmodern critiques. Consider the world of the clinic as interpreted in postmodern theory. As observed in the preceding article, postmoderns characterize the clinic as a contested sphere in which the managed care administrator's gaze (or perspective or narrative), the physician's gaze, the nurse's gaze, the patient's gaze, the family's gaze, the researcher's gaze, and the ethicist's gaze strive for hegemony. Postmodern theorists conclude that only the most powerful gaze ultimately prevails in
the clinic and that the norms of the clinic are, therefore, a reflection of the interests of the hegemonic party or parties. By contrast, from a contractarian perspective, clinical ethics is a negotiated moral order designed to resolve conflicts in a mutually acceptable manner (see Moreno 1995). All parties in the clinic share common interests; none can afford to alienate any of the other parties to the extent that they will withdraw from the clinical enterprise; consequently each party has an interest in fashioning cooperation-facilitating norms acceptable to all other parties and in assuring that these norms are interpreted in essentially similar ways by each conceptualinterpretive-perspectival "gaze." Differences in perspectives, like differences in interests, are thus constrained by a mutual need to function cooperatively in a commonly shared world. Power may aspire to, and may attain, hegemony, but the contractarian insight is that insofar as hegemony cannot assure cooperation, power is impotent. The conditions that hold in the micro-world of the clinic also obtain in the world of international medicine and science. Like the Nuremberg Code for Permissible Medical Experiments from which it descends, the Council of Europe's Convention on Human Rights and Biomedicine is a negotiated [End Page 238] moral order that responds directly to fundamental conflict between "progress in biology and medicine" and the tendency toward the "misuse of biology and medicine . . . lead[ing] to acts endangering human dignity." It recognizes a shared interest in "us[ing medicine] for the benefit of present and future generations," and thus offers a negotiated moral order in which researchers' freedom to experiment is constrained by their "conscious[ness] of the need to respect the human being both as an individual and as a member of the human species." The Council believes that this order will serve as the basis of "international co-operation so that all humanity may enjoy the benefits of biology and medicine" (Council of Europe 1997, p. 277).
Human Rights and Primary Goods

There are two aspects to contractarian theory: "morals by agreement," David Gauthier's (1996) felicitous characterization of negotiated ethics, and areas of nonnegotiability or "primary goods," John Rawls's (1971, 1993) equally felicitous characterization of what are popularly known as "human rights." The idea of morals by agreement readily accommodates the claims of multiculturalism, but it raises the question of whether any mutually-agreed standards--for example, the principles for human subjects experimentation that the Nazis might have negotiated, had they been victorious in World War II--would have to be deemed "moral." To answer this question one needs to explore the other aspect of contractarian theory, the area of nonnegotiability, primary goods, "human rights," or, to put the point slightly differently, one needs to explore the metaethics of "unacceptability."
The Framework Independence of Nonnegotiable Primary Goods, or Human Rights

Contractarian theory distinguishes between two types of impermissible actions: those that are impermissible because they violate norms that have been negotiated and accepted in some particular moral framework and those that are impermissible because they are unacceptable irrespective of moral framework. The classic name for the latter form of impermissibility is "human rights violations." In his Second Treatise of Government--a work so controversial in its own time that John Locke only acknowledged his authorship posthumously, in his will--Locke (1690) gives one of the earliest arguments for the categorical impermissibility of slavery. [End Page 239] The freedom from absolute, arbitrary power is so necessary to, and closely joined with a man's preservation, that he cannot part with it but by what forfeits his preservation and life together. For a man...cannot, by compact or his own consent, enslave himself to anyone, nor put himself under absolute or arbitrary power of another, to take away his life when he pleases. (Locke 1690, p. 84) Slavery cannot be countenanced in any possible moral framework, argues Locke, because no rational person, in any society, would willingly accept the condition of being enslaved. Put differently, since contractarian theory requires assent as a prerequisite of legitimization, if there is no conceivable situation in which anyone would assent to being enslaved, slavery is ethically impermissible in all conceivable moral frameworks. Notice that, unlike other abolitionists, for example, Christian abolitionists, Locke does not claim the impermissibility of slavery by virtue of some moral principle, such as the Golden Rule; instead he
claims that the impermissibility of slavery is a "self-evident truth" since one "cannot, by compact or his own consent enslave himself." Slavery thus is morally impermissible because it is incompatible with the "compacting" or "consenting" presupposed by morality itself. Thus Locke is not claiming that slavery is morally impermissible--and, conversely, that freedom is morally necessary--because there is some mutual agreement between particular agents to respect one another's freedom, his argument is that since moral norms are only legitimated by the "compact" or "consent" of those whom they would bind, norms legitimating slavery cannot exist in any possible moral framework. Slavery is inconsistent with the very precondition on which morality itself rests, assent, rather than with some specific cultural or cross-cultural moral principle or norm. In more recent versions of contractarian theory, John Rawls and others have responded to the multicultural and postmodern critique of moral realism by replacing Locke's realist conception of human rights with the notion of "primary goods." 1 The expression "primary goods" designates whatever goods, interests, or values are held to be nonnegotiable in the construction of a moral order. Locke, for example, held that there are four inalienable natural human rights: life, liberty, health, and "property"--i.e., the means for supporting life or making a livelihood. Hobbes, on the other hand, believed in only one inalienable right--life. Rawls insightfully observes that it is irrelevant which items are on anyone's list of rights or "primary goods," what matters is that each party negotiating morality holds some goods, interests, or values to be so fundamental that [End Page 240] he or she will not accept any norm that intrudes upon them. Locke, a practicing physician throughout his life, valued health more highly than Hobbes, a classicist who made his living tutoring the children of aristocrats. Yet both held that some goods, interests, or values, are nonnegotiable, and they treated these goods as "inalienable rights": that is, as nonnegotiable primary goods. The point to appreciate is that for any set of agents, some goods, interests, or values will be primary, even though the content of what is considered primary may vary. A rights violation may thus be said to have occurred if any good considered primary by a (rational or capacitated) agent is violated. To appreciate the difference between Locke's realist conception of a right and Rawls's conception of primary goods, consider again the question of slavery. Locke held it to be a self-evident truth that "a man . . . cannot, by compact or his own consent, enslave himself to anyone." In contrast, Rawls leaves open the question of whether anyone can consent to enslave himself, being content to claim instead that slavery would be morally impermissible for anyone who considered liberty to be a nonnegotiable good. Slavery thus becomes morally impermissible in any society in which those enslaved do not accept their status as such. What counts as a rights violation, therefore, may vary between and within cultures; nonetheless, rights violations, in the sense of violations of primary goods, are impermissible in any possible moral framework and in all cultures. Whether liberty is a primary good may thus vary from society to society, but primacy always is privileged regardless of which goods are considered primary. One might wonder whether the framework-independence associated with classical human rights theory is preserved once classical (realist) conceptions of rights are replaced by Rawls's more flexible concept of primary goods. In fact, it is. Consider the role of an Untermensch (a subhuman, and hence an entity without human rights. Locke would have considered the Nazi doctors' utilization of Untermenschen as human subjects in the Dachau decompression experiments to be immoral, not because the doctors' actions violated particular norms accepted in American or international morality, or even some cross-cultural principle, but because no rational agent can consent to becoming an Untermensch; that is, no agent can assent to being under the "absolute and arbitrary power of another to take away his life when he pleases." Thus, since morality is a form of life governed by norms to which agents assent and since no one can assent to the role of Untermensch, it is inherently immoral. [End Page 241] Rawls's conception of primary goods preserves this feature of Locke's analysis. Consider again the bermensch-Untermensch relationship, this time from the perspective of Rawlsian nonnegotiable primary goods. Since bermenschen assert the permissibility of violating goods held primary by Untermenschen, the relationship remains morally impermissible, independent of any particular moral framework. The fundamental insight underlying all theories of negotiated morality, classical and contemporary alike, is that morality is a form of life in which conflict is negotiated through mutually acceptable norms. Willful trespasses on aspects of life considered so primary that they are nonnegotiable always will violate the fundamental presuppositions of morality because such trespasses always will be unacceptable to the persons whose primary goods are being violated. Thus, to invoke the example of the Nuremberg Trial discussed in the preceding article, the Tribunal was right to condemn the Nazi doctors for the Dachau decompression experiments even though
the doctors' actions did not violate the letter of Nazi law or morality. The moral impermissibility of violations of primary goods derives, not from particular moral or legal norms, but from the nature and limits of morality itself. Willful violations of primary goods are unacceptable from any moral perspective because, to paraphrase Locke, no one, in any possible moral framework, would willingly accept intrusions on areas they consider primary. In a deep sense, therefore, it is the values of the victims rather than the victimizers that establish the immorality of trespasses on primacy, on human rights. Thus Locke held that enslaving Africans was a rights violation because Africans would never voluntarily accept the role of American plantation slaves. Similarly, what the Nazi doctors did was morally impermissible, irrespective of their norms and values, because no gypsies, homosexuals, or Jews would voluntarily accept either the role of Untermensch or the role of Nazi experimental research subject. In negotiated moral theory, it is not the values and perspectives of the victimizers that defines the sphere of the unacceptable, it is the areas of nonnegotiablity valued by those whom they would victimize. 2
Human Rights and Primary Goods: Some Differences

To this point the thrust of the argument has been that primary goods play a role in postpostmodern and post-multicultural moral and political theory comparable to that played by human rights in classical moral and political theory. There are, however, significant differences between the two conceptions of nonnegotiability. The most significant of these is that, [End Page 242] in contrast to human rights, there is no standard list of primary goods. Primary goods are those interests, principles, and values considered primary and hence nonnegotiable by specific individuals and cultural groups. Thus primary goods can and do vary from culture to culture, from subculture to subculture (as in the case of the puritans and the nudists), and from individual to individual. It is the variability of primary goods that immunizes them against much of the multicultural and postmodern critiques and that marks the most significant difference between primary goods and classical human rights. Recognition that other cultures hold different goods to be primary should neither undermine one's own conceptions of primacy, nor permit one to violate one's own conception of primacy in dealings with cultures that do not share it. Some non-Western societies, for example, do not recognize the primacy of privacy, consequently, as Ruth Macklin (1992, p. 249) has observed, privacy is not a primary good for them. Consider the question of whether Westerners may abandon their ideal of privacy when interacting with cultures that do not share it. One might suppose that, insofar as contractarians view morality as negotiated, they would limit it to those areas where a particular moral covenant is accepted. This supposition, however, overlooks the central role of acceptance in contractarian theory, as well as the distinction often drawn in contractarian theory between moral and legal norms. Moral norms are held to be binding precisely because the norms themselves are accepted as such by those who would be bound by them. In contrast, legal norms are binding because those affected by them accept the authority of those who enact them; and, to complete the distinction, norms of etiquette are held to be binding out of respect for the groups who accept them. Thus, whereas legal norms (and etiquette), have jurisdictional (and reference group) bounds set by the authority of those who promulgate them (and by the groups who accept them), moral norms are binding by virtue of the acceptance of the persons whom they bind; consequently, they have no jurisdictional boundaries. These differences are illustrated by a tale George Annas used to tell to amuse bioethicists in the era before "brain death" was recognized almost universally. He would imagine an ambulance carrying a body that satisfied the Harvard criteria for "brain death" as it traveled cross-country, from state to state. As the body passed from one jurisdiction to another it would be declared first "dead," then "alive," then "dead," then "alive," then "dead-unless-of-orthodox-Jewish-background," and so forth. The [End Page 243] humor in the example derives from the fact that the physiological state of a body lacking responses and reflexes and having an isoelectric EEG remained unchanged as it passed through the various jurisdictions. Annas's imaginary ambulance journey is thus an apt illustration of the jurisdictional boundedness of law. By contrast, morality in contractarian theory is not jurisdictionally bounded because it rests on something "internal" to the individuals to whom it applies, their acceptance of a norm. Jurisdictions are irrelevant: if a person accepts a moral norm prohibiting lying or adultery, entry into a national or cultural jurisdiction in which lying or adultery is culturally acceptable should be irrelevant to a person's acceptance of the norm. In the example of the puritans and the nudists: were a puritan inadvertently to visit the beach on a day designated for naked sunbathing and swimming and were the puritan then to join the nudists in naked sunbathing and swimming, the puritan's acceptance of puritan values would be suspect.
To return to the question of privacy: Western biomedical scientists should respect privacy rights, even in non-Western cultures, but for reasons quite different from those they have for respecting such rights in the West. In the West, researchers should respect privacy because they, their subjects, their peers, and their culture accept it as a primary good; outside of the West, they should respect privacy--even when it is not considered a primary good by their subjects or in the subjects' culture--because a failure to respect privacy is a failure to respect their own values. Like the puritan-turned-nudist, if Western researchers strip themselves of their own values when conducting research in non-Western countries, their belief in the value of privacy is suspect, and they rightly may be chastised by their peers. 3 Classical human rights and primary goods also differ in that the former are considered immutable, whereas conceptions of primacy can and do change. Indeed, they should change, for to deny such fundamental moral change is to deny persons and cultures the right to reconceptualize themselves and their values--in a sense, it would deny humanity its nature. Recall that American bioethics was born, in part, because Joseph Quinlan decided to terminate life-support on behalf of his daughter Karen Ann Quinlan, thereby alienating the one right that Hobbes and Locke both accepted as inalienable and immutable--the right to life. Privacy rights became important, in large measure, because modern technology, like Karen Ann's ventilators, led, first the Quinlan family, and later American [End Page 244] culture generally, to reconsider what was valuable and primary about remaining alive. 4 The reflective reconsideration of values evident in the Quinlan case is integral to being a person or a culture. Respecting persons and cultures, therefore, means respecting this process for other individuals and for other cultures. One can and should challenge other conceptions of primacy, but one cannot condemn other cultures, subcultures, or individuals simply for holding alternative conceptions. Finally, unlike classical human rights, primary goods must be asserted if they are to be claimed. Interests, principles, and values assume a status of nonnegotiable primacy only when some individual, group, or culture that has the capacity to negotiate lays claim to their primacy; in the absence of such a claim, there is no reason to recognize those interests, principles, or values as primary. 5 Consequently, in striking contrast to classical human rights theory, no matter how deeply one may value something as a "right," unless other persons who have the capacity to negotiate assert its primacy, it is unreasonable to believe that they consider it to be primary. Consider, for example, the current debate over female Pharonic circumcision (clitorectomy) and female genital infibulation. These operations are indigenous to many African cultures and are performed by older women on younger, prepubescent girls. Unlike male circumcision, these operations are uncommon in the West; they also deprive individuals of more sensations of sexuality than does male circumcision, and they typically have a more deleterious impact on health. Since conceptions of primary goods are susceptible to change, it is reasonable and proper for African feminists, for African-American feminists, and for Western feminists generally to challenge the custom of female Pharonic circumcision and infibulation as forms of male chauvinism garbed in the robes of tradition (Walker and Parmar 1993). Challenge and dialogue are welcome since it is only through the continual reinterrogation of primacy that one discovers what one truly values. Some Westerners and "human rights activists," however, condemn these operations as "barbaric" or "sick" and appeal to the United Nations Declaration of Human Rights to urge their suppression (Edgerton 1992). This sort of coercive response is precisely the misuse of the U.N. Charter feared by the American Anthropological Association (1948) in its statement on the Declaration. Insofar as female Pharonic circumcision is truly a voluntary activity, a rite of passage through which women introduce their daughters to womanhood, Western attempts to prohibit it-essentially because it offends Western sensibilities about [End Page 245] the primacy of sexuality-infantilizes Africans by failing to recognize the most fundamental of all human rights, the right to define primacy for oneself. Thus, to reiterate a point made earlier, unlike classical human rights, primacy is something one understands and asserts for oneself. Insofar as human rights are interpreted as primary goods, therefore, one must respect this process of self-understanding and not impose one's own understanding of primacy on others. To quote a fellow post-postmodern post-multicultural theorist, Jrgen Habermas (1994, p. 116): Rights that are supposed to guarantee [individuals] the autonomy to shape their private lives cannot even be appropriately formulated unless those affected articulate and justify in public discussion what is relevant. . . . Safeguarding the private autonomy of citizens must go hand in hand with activating their autonomy as citizens of the nation. A "liberal" version of the system of rights that fails to take this
connection into account will necessarily misunderstand the universalism of basic rights as an abstract leveling of distinctions, a leveling of both cultural and social differences. As Habermas emphasizes, primacy must be affirmed publicly and acknowledged through a process of public discourse; for it is only through such a process that a society can articulate the correlative obligations through which rights receive protection. One cannot, assert rights on behalf of capacitated individuals, groups or cultures; only they themselves can accept and articulate rights, or conceptions of primacy.
Rethinking the Legacy of Nuremberg

The Fundamentalist Challenge
One significant barrier to the acceptance of a negotiation model of international bioethics is the received fundamentalist conception of the legacy of the Nuremberg Code and the correlative fear that to permit any negotiation in the area of fundamental moral principles and human rights will open the door to their marginalization. Thus, in the concluding chapter of The Nazi Doctors and the Nuremberg Code, George Annas and Michael Grodin (1992, p. 307) remark: When we began this project, we assumed it would demonstrate the centrality of the Nuremberg Code and its place in all ethical discussions involving human experimentation. The contributors seem to agree.... [yet] although most discussions begin with Nuremberg, almost none end there, and there [End Page 246] has been a consistent and insistent movement away from the directness of the Code towards more flexible forms of judging the conduct of human experimentation. Annas and Grodin object to this drift away from Nuremberg fundamentals, staking out a position that might be called "Nuremberg fundamentalism," they urge sticking to the letter of the Nuremberg Code and resisting all alterations. They characterize attempts to change the Code as "marginalizing" and suggest that: efforts to marginalize this Code rest primarily on a failure of physicians to take informed consent seriously and on a belief, perhaps a societal one, that when it is impossible or difficult to obtain consent, ways to get around this requirement should be found if the research is potentially important to society. (Annas and Grodin 1992, p. 310). Annas and Grodin's analysis can be read as a challenge to the negotiation model to develop a theoretical framework that can distinguish reforms from efforts to "marginalize" moral norms. To respond to this challenge, I shall review the legacy of Nuremberg and show that, like its precursors, the Prussian and German bureaucratic regulations of 1900 and 1931, and like its successors, the reforms of the 1970s, the Code was a negotiated response to unacceptable intrusions into areas that subjects/patients deemed primary and nonnegotiable. I shall also show that the legacy of the Nuremberg Code lies not in any particular moral principle--not even the principle of informed consent--but rather in the recognition that the researcher-subject relationship is properly regulated by ethical ideals that transcend the jurisdictional authority of legal codes. Finally, I shall use this historical review to develop a profile that distinguishes marginalizing rebellions from enhancing reforms.
Judgment at Nuremberg
To approach the Nuremberg Code afresh, one must step back in time to see the Code, not as the document displayed so proudly within the black borders on page two of Annas and Grodin's The Nazi Doctors and the Nuremberg Code, not even as the document accorded the all important imprimatur "bioethics" in the historic first edition of the Encyclopedia of Bioethics (Reich 1978, pp. 1764-65), which announced the new field of bioethics and provided the initial definitions of its subject matter and history, but as just a few paragraphs in a relatively obscure legal [End Page 247] judgment buried in a massive set of government documents: the judgment of Justices Beal, Seabring, and Crawford against Karl Brant and others indicted for warcrimes because of their involvement in certain medical experiments (Nuremberg Tribunal 1948). 6
Originally, the 10 Nuremberg principles were simply moral comments, obiter dicta, judicial remarks irrelevant to the legal judgment, since, legally, the judgment rested on "the laws and customs of war [and] the general principles of criminal law, as derived from the criminal laws of all civilized nations" (see Katz 1972, p. 305). Yet the Tribunal had reasons for inserting this statement of moral principles into its legal judgment. The defense lawyers had tried to establish the legitimacy of the Nazi doctors' experiments by adducing evidence that the German researchers had acted no differently than researchers in America and other allied countries. One could not condemn German physicians, the defense argued, without simultaneously indicting the medical research establishment in America and throughout the world. In support of this claim, the defense cited papers published in leading medical journals describing research in which it was apparent that people had been subjected to experiments without their knowledge or consent. Some of these experiments had even garnered experimenters the Nobel Prize (Katz 1972, p. 301). "Experiments which time and again have been described in the international literature without meeting any opposition," charged the defense, "do not constitute a crime from the medical point of view" (Katz 1972, p. 300, see also p. 302). Moreover, the defense noted, there was "an almost complete lack of written legal norms" on human subjects experiments throughout the world (Katz 1972, p. 300), except for an American Medical Association policy statement adopted on 11 December 1946--a date that, as the defense observed derisively, fell after the Nuremberg trials had commenced. To counter these charges, the prosecution turned to two American medical advisers, Colonel Leo Alexander, M.D.--a neurologist and psychiatrist who had treated concentration camp survivors and who acted as an advisor to the U.S. Secretary of War--and Professor Andrew C. Ivy--former scientific director of the Naval Medical Research Institute in Bethesda, Maryland, and the official observer for the American Medical Association. Both men testified with relatively clean hands about American military medical practice, since the American military typically adhered to the traditions of volunteerism and auto-experimentation initially established by Walter Reed. To the defense charge that there were no [End Page 248] universally accepted standards regulating human subjects research, however, they could only offer a strained reading of some lines in the Hippocratic Oath (Ivy, cited in Katz 1972, p. 300; see also Shuster 1997). Yet the defense charges stood: no previously stated principles would provide a clear justification for condemning the Nazi doctors. At no time prior to the Nuremberg indictments had there been an official statement, either by American medical organizations, or by international medical organizations, of an explicit policy restricting biomedical research to volunteers who had given informed consent. 7 The judges and their expert medical witnesses thus had a problem. The defense had placed the entire biomedical research enterprise in the dock: to convict the Nazi doctors was to indict Western medical science as well. Dr. Ivy was particularly sensitive to the threat of delegitimation posed by the defense arguments. He believed that to admit "the performance of experiments on human subjects without their consent," even upon subjects already "condemned to die," "would undermine the faith that ordinary patients have in the profession" (Ivy 1947). Ivy and his medical colleague, Alexander, reacted to the threat of delegitimation by articulating moral principles to distinguish permissible biomedical research from impermissible research. Ultimately the judges accepted these principles and, by introducing them into their judgment, promulgated the outlines of a social contract between researchers, society, and the public.
The German Origins of the Nuremberg Principles

Since American judges propounded the Nuremberg principles, Americans are often given credit for inventing them. Yet, in a piece of trailblazing historical research, "The Historical Origins of the Nuremberg Code," Michael Grodin (1992) established that the substance of the principles offered by the judges was German in origin. They derive from 1931 German governmental regulations, which, in turn, are based on Prussian research regulations published in 1900. Pre-war German medical science was the most advanced in the world. Not unnaturally, therefore, it was German society that first formally recognized and responded to the problematic tension between researcher and subject. Awareness of the problem surfaced, as it typically does, through scandal. In 1896, Dr. Albert Neisser, a professor of dermatology and venereology, and discoverer of the leprosy bacillus, publicly announced his concern about the possible dangers to children and adolescents whom he had inoculated with an experimental "immunizing" serum drawn from syphilitics, without informing [End Page 249] them, or their parents, about its experimental nature. Neisser, who was particularly vulnerable to censure because of anti-Semitism (Lederer 1995, p. 18), ultimately was fined by the Prussian Ministry of Religious, Educational, and Medical Affairs for performing experiments without consent. The Ministry then promulgated regulations--"the first reported regulatory action relating specifically to the field of human experimentation" (Grodin 1992, p. 127)-that restricted human subjects experimentation to competent consenting adults to whom the
Robert Baker - A Theory of International Bioethics: The Negotiable and the Non-... Pgina 10 de 23
"adverse consequences that may result from the intervention" had been explained (Grodin 1992, p. 127). As regulations, the Prussian administrative rules were binding only in Prussia, setting the stage for a repetition of the Neisser case in another German jurisdiction. Not unexpectedly, therefore, in the 1920s history repeated itself when 75 children died because their pediatricians injected them with an experimental tuberculosis vaccine--again without their parents' knowledge or consent. In response to this scandal, the German governmental bodies issued regulations in 1931 that, following the Prussian precedent, required physicians to secure the informed consent of patients as a prerequisite for initiating any experimental investigations (Grodin 1992, pp. 128-32; Sass 1983). The informed consent doctrine was thus originally a regulatory innovation created by Prussian bureaucrats; it was not an artifact of American legal or philosophical culture but of German bureaucratic culture. It was a German solution to problems created by the advances of German biomedical science. 8
Transforming Bureaucratic Regulations into Universal Morality

In the political climate of 1946-1947, however, German regulations seemed tainted. Thus, although Drs. Alexander and Ivy drew directly from the German regulations in the memos they sent to the Nuremberg judges and to the prosecution outlining possible moral principles for governing research on human subjects, neither explicitly noted the source of their principles. Ivy's memo restated the three German rules he had persuaded the American Medical Association (AMA) to adopt as ethical precepts in 1946 (informed consent of the subjects, proper medical supervision, and prior experiments on animals). Alexander's memo condenses and simplifies the elaborate 14-point 1931 German Reich Health Council regulations into six rules (informed voluntary consent of the subject, humanitarian intent of the experimenter, exclusion of fatal or disabling interventions, proper supervision, humanitarian benefits that outweigh any risks to the [End Page 250] subjects, and scientific-grounding and a basis in animal experiments). The prosecution reiterated the AlexanderIvy rules in its summation; thereby officially putting the Alexander and the Ivy memos before the judges. The Tribunal's judgment reformulated the rules in the memos as 10 ethical, moral, and legal principles. The number "10" echoes the Judeo-Christian decalogue, giving the principles moral resonance while providing a natural background to the claim that, like the decalogue, they were "moral, ethical and legal" principles upon which "all agree"--an expression that seems to refer neither to Alexander's memo, nor to Ivy's, nor to the prosecution's summary, nor to the AMA's standards, nor to the 1931 German Reich Health Council's regulations, nor to the 1900 Prussian regulations, but to some "universal" atemporal moral-ethical-legal concord on standards for research on human subjects. The claim to universality must have been aspirational for the evidence at the trial belied it. Yet, once parsed in the language of ethics and morality, the claim removed the restriction of jurisdictional boundaries, giving the judges' decalouge a stature independent of any specific codification of law. The legacy of Nuremberg thus is not the discovery of some set of international laws, but rather the transubstantiation of jurisdictionally-bounded administrative and legal regulations into jurisdictionally-free moral principles that can serve as the basis for renegotiating the researcher-subject relationship.
Revisions and Rebellions: The Ethics of Experimentation after Nuremberg

As noted earlier, one apparent motivation underlying Annas and Grodin's fundamentalist reading of the Nuremberg Code is the fear that once one allows fundamental principles, like the principle of informed consent, to become the subject of negotiation, they are likely to become marginalized over time. Unfortunately, this ultraconservative stance requires resistance to any deviation from the Nuremberg Code, even to reforms that enhance the development of science without significantly increasing risks to subjects. Fundamentalism thus foments an unnecessary tension between ethics and science, since, as I shall show, a careful analysis of the history of post-Nuremberg human subject regulation indicates that historically-based criteria can be used to distinguish reformist renegotiations from rebellions. To develop these criteria, I shall review two different attempts to revise the Nuremberg Code: the surrogacy rule and the therapeutic exception. [End Page 251] The 1954 Surrogacy Rule: Profile of a Reform In 1954, the World Medical Association (WMA) issued formal Principles for Those in Research and Experimentation that reiterated the main themes of the Nuremberg principles, 9 even as they
revised the first principle, the principle of informed consent. The revision empowered "the individual who is legally responsible for the patient" to consent to research on behalf of the incapacitated patient (Beecher 1970, p. 240). There had been no provision for surrogate decision making in the Nuremberg Code or in its German progenitors, and, in the absence of such a provision, a great deal of promising clinical research was prohibited as "unethical." Yet, in certain cases, such as trials of new remedies for otherwise incurable conditions, experimentation seemed to be in the best interests of the patient. Revising the Code to include a surrogacy provision thus appeared to serve the interests of both researchers and patients. Although any such revision would change the Nuremberg Code's prime directive, that there be an "affirmative decision by the experimental subject," the WMA went ahead and modified the first principle to permit surrogate consent. What happened? Contrary to fundamentalist expectations, instead of marginalizing the Nuremberg Code, this first instance of what Annas and Grodin (1992, p. 307) condemn as the "consistent and insistent movement away from the directness of the Code toward more flexible forms of judging the conduct of human experimentation" became the historical bridge that transformed an obscure legal judgment into the founding document for all codes governing human subjects research, and for international bioethics generally. The 1954 surrogacy revision permitted the Nuremberg Code to enter into the real world of clinical research, thereby making research ethics a practical clinical possibility. Indeed, the revision actually forced the researchers either to accept moral regulation--or to rebel. They initially chose the latter, but were eventually forced to accept the former. The 1954 revision is a paradigm of an optimizing revision--i.e. one that protects subjects but is ultimately acceptable to researchers. Four characteristics seem associated with the success of the 1954 revision: (1) it surfaced in response to a generally recognized limitation in the first Nuremberg principle; (2) the limitation was resolved in terms of a general principle; (3) the new principle had proven successful in other contexts; and (4) the new principle was sensitive to the fundamental conflict of interests between researchers and subjects. Consider these seriatim. The [End Page 252] first Nuremberg principle had required the informed consent of the subject, yet, since minor and incapacitated patients are incapable of consent, (1) the first Nuremberg principle denied them the right to participate in experimental treatments, even if the treatment promised direct therapeutic benefit and even if those who would normally speak for them--their parents and guardians-believed it would be in their best interests to participate. The first Nuremberg principle thus seemed overprotective of the incapacitated. The surrogate consent revision remedied this problem in terms of a (2) a general principle that (3) was well-tested and that still (4) provided protection against the central problem addressed by Nuremberg, the imperiousness of the researchers' gaze. Oversight of researchers was tightened further a year later, in 1955, when the Public Health Council of the Netherlands (1955) issued guidelines that implemented the WMA Principles in clinical contexts. The guidelines were to be applied by "a permanent advisory committee" to stem any "deterioration of ethical standards in experimentation" (Beecher 1970, p. 241); these advisory committees were later called "institutional review boards" or "IRBs." The 1960s Therapeutic Exclusion: Profile of A Rebellion In striking contrast to the 1954 surrogacy revision, the 1960s quest for a general therapeutic exclusion of the consent requirement is not characterized by a reaction to a specific problem, or by a search for alternative principles or procedures, or even by sensitivity to the tension between researcher and subject. It thus serves as a paradigm case of how principles of medical ethics can be marginalized and undercut by the imperious presumptions of the researcher. In the 1960s, researchers around the globe resisted the WMA's Principles by emphasizing Nazi exceptionalism: "These codes [are] necessary for barbarians but [not for] fine upstanding people," remarked one researcher (ACHRE 1996, p. 86). "The events . . . at Nuremberg were not perceived by researchers . . . to be directly relevant to the American scene," observes historian David Rothman (1991). "The violations had been the work of Nazis, not doctors; the guilty parties were Hitler's henchmen, not scientists. . . . Madness not medicine was implicated at Nuremberg . . . the prevailing view was that [the defendants] were Nazis first and last; by definition nothing they did, and no code drawn up in response to them, was relevant to the United States" (Rothman 1991, pp. 62-63). Thus, the research community tried to rescind the Nuremberg-style reforms, condemning [End Page 253] the new regulations promulgated by governments and medical societies as a bureaucratic impositions that offended their sense of integrity. In the United States, the researcher rebellion went public around 1961. Fittingly, the primary spokesperson for the researchers was America's premier research university, Harvard. As noted
earlier, the upper echelons of the American government and military had been receptive to the Nuremberg principles from the beginning. In 1954, the Army Office of the Surgeon General reissued the Nuremberg principles as a set of rules regulating all military and all military-funded research on human subjects, including, as it turned out, research at the Harvard Medical School. The Harvard researchers objected. At a meeting 8 June 1962, the Board of Administrators of Harvard Medical School, responding to the complaints of the medical faculty, rejected the Surgeon General's 1954 regulations as overly stringent. The Harvard Board adopted in its place a set of principles, drafted by Dr. Henry Beecher, that retained a strong informed consent requirement and provision for peer review (Beecher 1970, p. 283), but that applied only to so-called "nontherapeutic contexts," that is, to those experiments that conferred no potential "therapeutic" benefit to subjects. Beecher argued that in therapeutic contexts obtaining informed consent was "folly . . . difficult . . . to the point of impossible" and that the patient-subject would be protected by the "character, wisdom, experience, honesty, imaginativeness and sense of responsibility of the investigator, who in all cases of doubt or where serious consequences might remotely occur, will call in his peers and get the benefit of his counsel" (ACHRE 1996, p. 91). As a practical matter, however, since most biomedical research on human subjects is performed in clinical environments with the aim of developing new therapies, a therapeutic exclusion would exempt almost all biomedical research from the requirement of informed consent. On 12 July 1962, representatives from Harvard met with the Army Surgeon General. Harvard won. The researchers were granted permission to exempt themselves from the Surgeon General's regulations, and Harvard's own principles were inserted into its contract with the U.S. army. In the aftermath, the U.S. Surgeon General's Office revised its regulations on human subjects research to accommodate the Harvard position by recognizing an exemption for "therapeutic" research. Researchers around the globe demanded an exclusion similar to Harvard's. In 1963, both the British Medical Association and the British [End Page 254] Medical Research Council issued research guidelines exempting "therapeutic experiments" from stringent constraints of informed consent. Provided . . . the medical attendant is satisfied . . . that a particular new procedure will contribute to the benefit of that particular patient . . . he may assume the patient's consent to the same extent as he would were the procedure entirely established practice. (Medical Research Council of Great Britain 1963, p. 263) The World Medical Association (1964) also adopted a strong therapeutic exemption clause at its meeting in Helsinki in 1964; the research guidelines that issued from the meeting are often referred to as the Declaration of Helsinki, or Helsinki I, to differentiate them from later declarations. In the 1960s, therefore, the balance shifted away from formal codified ethics, back to a noncodified ethic of personal conscience, especially for therapeutic research. Where Nuremberg had offered itself as a universal code of ethics, Helsinki I presented itself simply as a "guide to each doctor in clinical research;" where the Nuremberg Code had declared "essential" the "voluntary consent of the human subject," Helsinki I proclaimed that "the doctor must be free to use a new therapeutic measure if in his judgment it offers hope of saving life, re-establishing health, or alleviating pain" (emphasis added). Yet, genuflecting in the direction of Nuremberg, Helsinki I urged clinicians, "if at all possible, consistent with the patient's psychology, [to] obtain the patient's freely given consent after the patient had been given a full explanation" (Beecher 1970, p. 278 ). In a little over one-and-one-half decades, the moral rights of the patient-subject that had been so firmly pronounced at Nuremberg had been negotiated away to become a conditional prerogative of the clinician-researcher. The ethics of informed consent had been marginalized in precisely the manner that fundamentalists most fear.
The 1970s: The Re-Problematization of the Researcher-Subject Relationship

The question of whether researchers' honor would suffice to protect patient-subjects ultimately was an empirical one. Beecher and his fellow researchers were, in effect, conducting a moral experiment. Evidence of the failure of their hypothesis began to accumulate even before the ink dried on the Declaration of Helsinki. Ironically, the victims again were Jews. This time, however, the perpetrator was a gentleman who was self-evidently neither a "barbarian," nor a Nazi, nor any sort of "fringe researcher." [End Page 255] He was an eminently respectable medical scientist, a member of the research elite who conducted important cutting-edge scientific research (for which he was later awarded the presidency of the American Cancer Research Society). His name, Dr.
Chester Southam; his home base, the Sloan-Kettering Institute--the Harvard of cancer research. The experiments in question were part of a series that Southam was conducting to challenge a widely accepted viral theory of cancer. Southam's hypothesis was that, although viruses might be responsible for some cancers, tumors tended to develop only in organisms with impaired immune systems. To confirm this hypothesis Southam conducted a series of experiments designed to demonstrate that an organism with a healthy immune system will reject implants of live cancer cells, even if it is fatigued, has just undergone surgery, is sick, or is dying. Southam's initial data were derived from research animals, but he quickly advanced to humans. His subjects were prisoners, women who had just undergone hysterectomies, and dying Jewish patients. Southam and his colleagues usually obtained consent from the patients or their surrogates, but they seldom informed them of the cancerous nature of the cells to be implanted. Instead they typically characterized the experimental implants as "tests for immunity." No one objected to Southam's experiments until 1963, when he and his colleagues began to experiment on dying patients at Brooklyn Jewish Chronic Disease Hospital. Jews had reason to remember Nuremberg, and two young Jewish physicians protested to the hospital's trustees, citing the Nuremberg Code. Eventually one of the trustees, again Jewish, and again motivated by the Nuremberg precedent, took the case to the New York Times, and ultimately to the New York State Board of Regents, which suspended Southam's license to practice medicine, for one year. His suspension did not impress the American Cancer Research Society, which proceeded to make Southam its president. (For a comprehensive account of the case, see Katz (1972), pp. 9-65.) The importance of the Southam case is not merely the arrogance of the medical research elite-who embraced Southam as their representative even after his methods of recruiting "volunteers" became public knowledge--but the evident failure of the moral experiment with the ethics of researcher honor. The American Cancer Research Society may have missed this point, but it was not lost on the administrators at the U.S. Public Health Service who had funded Southam's research. In 1965, the Director of the National Institutes of Health (NIH) recommended a system of mandatory peer review designed to assure an independent determination [End Page 256] that the "rights" of research subjects were being respected for all research funded by NIH or by the Public Health Service. It was becoming evident to those funding medical research that the research elite could not police itself and that, at a minimum, personal virtue and honor must be accountable to peer review and patients rights. Research's own Henry Beecher recognized the problem, but he saw it not in systemic terms, but as a problem of insufficient virtue among researchers, the problem of "a few bad apples," so to speak. In a process memorably portrayed by David Rothman (1991), Beecher "blew the whistle" on these "bad apples," first at a professional meeting in March 1965, and later in an article published in the New England Journal of Medicine (Beecher 1966a; interestingly, this article had been rejected earlier by JAMA, Journal of the American Medical Association). The article analyzed the treatment of human subjects as reported in 22 research papers published in such leading medical journals as Circulation, JAMA, Journal of Clinical Investigation, and the New England Journal of Medicine between 1948 and 1965. These papers had been written by researchers at such distinguished institutions as Harvard Medical School, the National Institutes of Health, and Sloan-Kettering, and had been funded by the National Institutes of Health, the Surgeon General's Office, the U.S. Armed Forces, and the U.S. Public Health Service, as well as by Merck, Parke-Davis, and other leading pharmaceutical companies. All of the papers cited reported practices that were morally questionable, comparable to Southam's injection of live cancer implants into patients without their knowledge. And the scandals kept unfolding. In 1967, Dr. M. H. Papworth published a Beecheresque study demonstrating that the British research elite and National Health Service hospitals were as incapable of self-policing as their American counterparts (Papworth 1967). In the early 1970s, it was revealed that between 1932 and 1972 the United States Public Health Service center at Tuskegee conducted a study of untreated syphilis, without informing the subjects whom they studied that they had syphilis. The study was continued in the post-war era, even though effective treatments for the disease were by then inexpensive and readily available. What made this experiment particularly scandalous was that the researchers were almost all middle-class whites, while the subjects were uniformly poor black African-American males from the rural South. Almost simultaneously came the revelation that researchers at Willowbrook, an institution for the mentally handicapped in New York, deliberately had infected inmates [End Page 257] with hepatitis. It began to appear that the voice of conscience in the affluent, well-educated, middle-aged, white, male elite that made up the American medical research establishment tended to be silent about the rights of research subjects who were poor, or elderly, or African-American, or Jewish, or post-
reproductively female, or uneducated, or in prison, or mentally handicapped. The victims of American medical science, like the victims of German medical science, seemed to mirror the prejudices of the scientific elite. The research scandals created a national outcry that threatened to undermine human subjects research entirely, leading either to an outright prohibition, or to limited public funding. In response both to the scandals and to the threat of delegitimation, a number of investigative committees were formed, including the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1979). The Commission's (1978) Belmont Report is an elaborate exploration of the ethics of human subjects research that ultimately endorses a revised version of the WMA Principles. Shortly after the report was issued, the U.S. government implemented its recommendations as policy. Internationally, there was a parallel re-endorsement of the Principles, starting with Helsinki II in 1975. Perhaps even more influential than these code revisions were the lessons drawn from the failed moral experiment with virtue ethics in research. Tom Beauchamp, a philosopher who served on the National Commission, coauthored a textbook with James Childress (1979) in which the virtue ethics of the clinical-research elite was rechristened "paternalism" and subjected to a powerful philosophical challenge. In that text, Beauchamp and Childress argue that moral problems in medicine are best understood in terms of four, sometimes conflicting and sometimes convergent, principles: autonomy, beneficence, nonmaleficence, and justice. The virtue ethics of the clinicalresearch elite problematically prioritized beneficence, presuming "paternalistically" that clinicians, by virtue of their expertise and experience, could unilaterally determine the best interests of their patients. Yet, Beauchamp and Childress argue compellingly that clinicians can offer no valid reasons for prioritizing beneficence over autonomy, nor for the claim that they can determine their patients' interests better than those patients can themselves. In the light of Beauchamp and Childress's "bioethical" critique, the Nuremberg Code was reconceptualized as a defense of patient-subject autonomy (Beauchamp and Childress 1979, pp. 62-64). This reading reinforced [End Page 258] the fundamentalist interpretation of Nuremberg and so, ironically, a Code, written in the 1940s, that was surreptitiously based on German administrative rules issued in 1931, which, in turn, had refined a Prussian bureaucratic precursor from 1900, was appropriated as a foundational document for the American bioethics reform movement of the 1970s. More irony: once research reform had been reconceptualized as "bioethics," the European research elite resisted it as "American cultural imperialism." Ideals of "informed consent" invented in Prussia, concepts of "autonomy" and "human rights"--perhaps the proudest achievements of the European Enlightenment--somehow had been reconceptualized as uniquely American.
Distinguishing Reform from Rebellion

The fundamentalist reading of the Nuremberg Code is partially a triumph of fear over fact: fundamentalists fear that if they were to admit the successful revision of "fundamental principles," they would be defenseless against attempts to marginalize medical morality. Yet this view saddles fundamentalists with the historically indefensible position that revisions of the Nuremberg Code always marginalize moral protections, and it forces them to fritter away their moral energies in a struggle against optimizing reforms, instead of conserving them for the struggle against truly marginalizing rebellions. A better strategy is to develop criteria to distinguish between successful reforms--like the WMA's 1954 revision of the first Nuremberg principle--and marginalizing rebellions, like the failed foray into researcher virtue ethics. In retrospect, the profiles of the two attempts to revise the Nuremberg principles differ strikingly. The 1954 revision (1) addressed a specific problem with the first Nuremberg principle (the total prohibition of therapeutic research on incapacitated patients); whereas, the 1962 rebellion did not arise in response to a specific problem. In 1954, (2) general principles and procedures resolved the specific problem identified; in contrast, in 1962, since there was no problem, no alternative procedure or principle was formulated to replace the principle of informed consent. In 1954, the principle and the procedure proposed to remedy the problem--surrogate consent and peer review-(3) had proven successful in other contexts, and (4) were sensitive to the problems addressed by the first Nuremberg principle; in contrast, in 1962, there were no alternative principles or processes--researchers were blind to the problem. Thus, post-1962, the relation between researcher and subject returned to what it had been pre-Nuremberg, [End Page 259] and not unexpectedly, the problems that had been resolved by the Nuremberg Code and the WMA
revisions swiftly reasserted themselves.
Analyzing Controversial Contemporary Revisions

The profiles developed in the previous sections help to distinguish optimizing revisions from marginalizing rebellions. Consider, for example, two reforms currently being debated in the bioethics literature: (1) a new regulation that weakens the requirement of surrogate consent in order to permit research with promising therapeutic interventions in emergency medicine, and (2) the suspension, in certain cases of U.S.-sponsored trials in developing countries, of the Council for International Organizations of Medical Science (CIOMS (1993, in Spicer 1995, pp. 2797-800)) rule that requires a country that sponsors research outside of its borders to abide by the same ethical standards that would pertain at home. Both of these "reforms" have provoked protests, especially by fundamentalists, and both have been defended by researchers. Using the profile criteria developed in the preceding sections, however, they seem strikingly different. The revision of the emergency room standards (see Federal Register; 1997; Wolpe and Merz 1997) has the profile of an optimizing reform: (1) the reform is a direct response to a specific problem, the likelihood that surrogates will be unavailable to consent to therapeutic experiments on incapacitated patients admitted to hospital emergency departments; (2) the solution involves a general procedure for monitoring therapeutic experiments in the emergency department; (3) some of the procedures to be implemented, such as heightened IRB scrutiny, have been successfully employed in the past; and (4) innovative aspects of the new procedures--such as notification to the community that experiments are being tried in certain hospital emergency departments--indicate sensitivity to the problematic nature of the researcher-subject relationship. The revised emergency medicine research protocols thus fit the profile of an optimizing reform, one that will extend the perimeters of research without marginalizing subjects' rights. The attempt to revise the CIOMS "home country standard," on the other hand, has a profile remarkably similar to the 1962 researcher rebellion. In the 18 September 1997 issue of the New England Journal of Medicine, Drs. Peter Lurie and Sidney Wolfe, wrote a Beecheresque expos. At issue are trials being conducted in developing countries of less expensive alternatives to the standard ACTG 076 treatment regimen (effective in [End Page 260] more than 50 percent of all cases) used to reduce the rate of perinatal transmission of AIDS in the U.S. and other developed countries. Developing countries are interested in a less expensive regimen because an estimated 6 million pregnant women in those countries will be HIV positive by the year 2000. Yet, as currently administered, a full course of the ACTG 076 treatment regimen costs between $1,000 and $1,500-sums well beyond the limits of the health care budgets of developing countries. By 1998, 18 randomized controlled trials of less expensive alternatives to the ACTG 076 regimen were under way: two were being conducted in the United States and 16 were being conducted in the developing world. As required by U.S. research regulations, since there is a known effective treatment regimen (the ACTG 076 regimen or some other antiretroviral treatment), the two U.S. trials employ these known treatments as controls against which the effects of alternative treatments are measured. Yet in 15 of the 16 trials conducted in developing countries placebo controls were substituted for effective therapy. Nine of the studies using placebos, moreover, were funded by the U.S. government, either through the Centers for Disease Control or the National Institutes of Health. Thus, Lurie and Wolfe (1997) charged--and Dr. Marcia Angell (1997) concurred--that these nine studies violate U.S. regulations that prohibit the use of federal funds for research that "unnecessarily exposes subjects to risk" (45 CFR 46.111(a)(1), cited at Lurie and Wolfe 1997, p. 853), as well as CIOMS Guidelines 14 and 15. Guideline 14 quotes Article II.3 of the Helsinki Declaration, "In any medical study, every patient--including those of a control group, if any--should be assured of the best proven diagnostic and therapeutic method." Guideline 15 ("Obligations of sponsoring and host countries") states that "the ethical standards applied" in host country research "should be no less exacting than they would be in the case of research carried out in [the sponsoring] country (CIOMS 1993, in Spicer 1995, p. 2800 ; cited at Lurie and Wolfe 1997, p. 853). Guideline 15 prohibits "double standards." It does not stipulate any particular standard as ethically minimal, instead it requires that experiments conducted in host countries meet the standards accepted as ethical in the sponsoring country. The Guideline thus operationalizes the insight that ethics is not jurisdictionally bounded. As argued earlier, just as someone who believes in privacy in their own culture is obligated to respect the privacy of others--even others from cultures that do not respect privacy--someone who comes from a culture that believes that it is unethical to use placebo controls when known effective interventions are available, [End Page 261] is ethically-bound to apply this moral norm to others, even if the others do not accept that dictate as an ethical norm.
The upshot of Lurie and Wolfe's criticism is that the CDC-NIH's use of placebo-controls for experiments conducted in developing countries was prohibited, first by the standards of the Declaration of Helsinki, and second, since the U.S. accepts this prohibition for experiments conducted within its borders, by CIOMS Guideline 15, which extends the U.S. prohibition to U.S.funded experiments in the developing world. Thus the nine CDC- and NIH-funded placebocontrolled experiments violated international bioethical standards. How did the CDC and NIH respond to these charges? Dr. Harold Varmus, Director of the National Institutes of Health, and Dr. David Satcher, Director of the Centers for Disease Control, issued a formal statement in July 1997 (Varmus and Satcher 1997a) and wrote a slightly shorter response published in the 2 October 1997 issue of the New England Journal of Medicine (Varmus and Satcher, 1997b). In their responses, Varmus and Satcher, call attention to the developing world's need for an inexpensive alternative to the ACTG 076 regimen and to a recommendation from a 1994 WHO-sponsored meeting on the Mother-to-Infant Transmission of HIV that was "attended by over 50 scientists and representatives from funding agencies, drug regulatory agencies, and pharmaceutical companies" (WHO Meeting 1994, p. 2: N.B. no bioethicists attended). The researchers issued a report stating that "placebo-controlled trials offer the best option for obtaining rapid and scientifically valid results." Varmus and Satcher also cite a statement by the researchers that, in developing countries, "the choice of a placebo for a control group of a randomized trial would be appropriate as there is currently no effective alternative for HIV-infected pregnant women," since women in developing countries cannot afford these drugs (Varmus and Satcher 1997a, p. 2, emphasis added). In short, the directors argued that the CDC and NIH followed the program recommended by an WHO-sponsored meeting of researchers and that they were unaware that, in following the recommendations for placebo-controls, they seemed to be in violation of both U.S. regulations and the CIOMS guidelines. Errors and mistakes are as commonplace in ethics as they are in all other areas of life. The character of persons is not measured by an infallible ability to avoid moral errors and mistakes, but by how individuals handle them, when they are called to their attention. Varmus and Satcher had several options: they could have admitted that they inadvertently had [End Page 262] breached the CIOMS sponsoring-country guideline, apologized, and promised future compliance; or, they could have admitted the inadvertent breach, suggested that they were troubled by the application of the rule in this particular case, and recommended some process--perhaps another international symposium (perhaps involving bioethicists)--for reevaluating the rule (Bloom 1998). 10 Alternatively, they might have proposed a revised rule, 11 or a new procedure for sponsoring-countries to use when they believe that circumstances require that the rule be waived. They did none of the above. Instead, the directors defended their use of placebo controls in developing countries. They argued that placebo controls were right and proper because non-placebo studies would impede research and therefore "fail the test of beneficence" (Varmus and Satcher 1997b, p. 1005). Their agencies, they argued, thus were justified in funding placebo-controlled experiments, and they, as Directors, were blameless. As dismaying as this belligerently unapologetic defense of U.S. violations of international bioethics guidelines is, even more disheartening is the suspicion that the directors' aggressive rhetoric actually heralds a U.S. campaign to trash Guideline 15. This suspicion is based on the NIH's handling of an application for NIH funding by Harvard School of Public Health researcher Marc Lallemant. Lallemant sought funding for a study of ACTG 076 alternatives to be conducted in Thailand. Acting in compliance with CIOMS Guideline 15, he proposed using the ACTG 076 regimen as a control in the trial. The NIH pressured him to use a placebo instead. Lallemant, however, refused to treat Thai research subjects differently from U.S. subjects. His language is worth quoting. "The conduct of a placebo-controlled trial in pregnant women in Thailand would be unethical and unacceptable, since an active controlled trial is feasible." Thus Lallemant refused to change his ethical standards merely because he was operating in a non-U.S. jurisdiction. Ultimately the NIH relented and funded the study, but without acknowledging Lallemant's ethical stance; instead, to quote the Director of the NIH, the study was considered justified because, when coupled with a CDC placebo-controlled Thai study, it formed part of a "two-armed" study (Varmus and Satcher 1997a, p. 4). In an odd reversal of priorities, the directors here offer a scientific apology for doing what, from an ethical perspective, appears to be the right thing. An interesting comment on the CDC-NIH position comes from a Thai physician, Praphan Phanuphak, of the Thai Red Cross. In an article published in the New England Journal of Medicine in March 1998, Phanuphak [End Page 263] agreed, in principle, with Varmus and Satcher's position that "placebo-controlled trials are sometimes justified in countries where treatment is
otherwise totally unavailable, because at least half the patients (those receiving active treatment) will probably benefit . . . if the trial will generate results that will directly benefit the patient population under study." Phanuphak observes, however, that the practices of U.S. researchers in Thailand violated that principle. Starting in 1996, the Thai Red Cross had made zidovudine (ZVT) available to poor HIV-infected women. Since the use of placebos in developing countries was justified by the unavailability of effective treatments, once the Red Cross had made zidovudine available, placebo use was no longer justifiable--at least according to the principle cited by Varmus and Satcher. Thai researchers at Chulalongkorn University Hospital in Bangkok recognized the logic of this position and ceased to use placebos; however, placebos continued to be used in the research projects sponsored by the CDC and the Walter Reed Institutes. Phanuphak reiterated that those researchers who justify using placebos on the grounds that alternative resources are not available must be willing "to change their approach as circumstances change" and resources become available. 12 Phanuphak's observations both underlines the suspicion that the "unavailability" rationale really masks a double standard for research in developing countries and highlights the instability of the ethical platform urged by the WHO researchers and embraced by Varmus and Satcher. Were the "unavailability" criterion taken seriously it automatically would make the moral status of experiments based on it hostage to the vagaries of charitable inclination and financial fortune, which, as the Thai cases illustrates, is an ethically insecure platform for international scientific research. The controversial use of placebo controls in research on ACTG 076 alternatives came to a halt in February 1998 when a trio of U.S. and international organizations announced that the Thai studies had demonstrated the efficacy of a shortened and inexpensive course of zidovudine (DHHS 1998). In early March, the Wall Street Journal reported that Glaxo-Wellcome was renegotiating the price for short-course ZVT treatments, lowering it to as little as $50 per course. Researchers used the occasion to claim a victory for the efficacy and ethics of placebo trials in developing countries, even as critics claimed a moral victory for shutting down placebo experiments throughout the developing world from Cote d'Ivoire to Uganda (Marshall 1998). [End Page 264] Yet, even as the controversy abated, the questions that it raised about the ethics of research in developing countries remain unresolved. Any developing country concerned enough about the health and lives of its citizens to host experiments designed to find inexpensive remedies to preserve their health and to prevent their untimely deaths must value health and life (perhaps as primary goods). This value structure calls into question the inclination, repeatedly evinced by researchers from the developed world, to use placebos as cost-saving expedients at the expense of the health and lives of citizens from the developing world. Moreover, as Dr. Phanuphak observed, the cost of providing AZT/ZVT to subjects in the control groups in Thailand would have amounted to only a small fraction of the cost of the entire experiment. The profile of the CDC-NIH position on the CIOMS-Helsinki guidelines is strikingly similar to the 1960s researchers' revolt against the Nuremberg-WMA guidelines. In both cases: (1) the revolt was precipitated, not by a specific problem or defect in the received standards, but by researcher impatience with ethical constraints on their "beneficently-motivated" research. (The original and primary reason for recommending placebo trials was that they would be "more rapid" than nonplacebo controlled trials--cost, though frequently cited, appears not to be a factor since pharmaceutical companies usually donate drugs for experimental trials.) (2) because the elite-led rebellion was prompted by irritation with ethical constraints, no specific principle or procedure has been proposed as an alternative to the norm in question--what is on offer is simply a return to preethical status. Finally, the directors of the CDC and NIH show no sensitivity whatsoever to the problem addressed in Guidelines 14 and 15--the fear that, unless the ethical standards are applied as "exactingly" in the host country as in the sponsoring country, citizens of host countries that have not had sufficient historical experience with scientific research to develop exacting standards of their own will become the unwitting Untermenschen of international biomedical research. The historical outcome of the 1960s revolt should have taught researchers that the exploitation of research subjects anywhere threatens to undermine the legitimacy of biomedical research everywhere. There is, however, an even greater reason to be concerned about the revolt against the CIOMS sponsoring-country standard. In their comments, the Directors of the CDC and NIH treat constraints on experimentation as jurisdictionally-bounded "rules" or "regulations," not as jurisdictionally-unbounded [End Page 265] ethics. In contrast, Dr. Lallemant saw the issue in terms of "ethics" and therefore refused to apply different standards to the subjects for whom he was responsible, merely because they happened to live outside the jurisdiction of the U.S. government. When the Directors of the Center for Disease Control and the National Institutes of Health embraced a double standard for research on human subjects who reside outside the jurisdiction of
the U.S. government, they reveal that they have come to think of research standards simply as rules and not as ethical principles or matters of human rights. They thus have abandoned the central legacy of Nuremberg: the idea that the rights of human subjects are ethically-grounded and nonnegotiable and, thus, are not limited by the jurisdictional boundaries of governments--whether the government is that of Germany in the 1940s or America in the 1990s. One way to respond to the moral arrogance of certain members of the research community is to reassert not the moral legacy of Nuremberg, but the legal letter of the Nuremberg, Helsinki, and CIOMS codes. Fundamentalism of this sort-i.e., sticking to so-called "fundamental" principles and to the letter of the standards spelled out in current codes--has profoundly moral motives. It is, nonetheless, mistaken. As argued in the previous article, there are no principles whose acceptance is "fundamental" to all cultures; moreover, as argued in the present article, the history of international bioethics is one of continual renegotiation. It is entirely conceivable that the AIDS crisis requires a rethinking of certain provisions of the Helsinki and CIOMS guidelines in order to find effective AIDS treatments and vaccines for the developing world. Yet, if international standards are renegotiated, it must be done openly in public fora in which bioethicists, researchers, and physician and patient advocacy groups from both the developed and the developing world participate actively. Whatever standards emerge from these negotiations should be subjected to public review and criticism before they are used to justify, or to excuse, a lower standard of scrutiny for research subjects in the developing world.
Conclusion
International bioethics hitherto has looked to fundamentalism for its foundations. Yet, as established in the preceding article, fundamentalism has been bankrupted by the multiculural and postmodern critiques. In the current article, I have outlined an alternative theoretical basis for international bioethics, a theory of negotiated morality that recognizes and respects self-defined areas of nonnegotiable primacy comparable to what [End Page 266] have traditionally been called "human rights." A review of the history of the Nuremberg Code and related documents reveals that they never have achieved the level of immutable principle envisioned in fundamentalist theory, and are, as a matter of historical fact, articulations of mutable precepts that are continually being refined and renegotiated in precisely the manner envisioned in a model of negotiated morality. Finally, in an attempt to assuage fundamentalist fears that a theory that recognizes any level of mutability might open the door to the marginalization of patients' and subjects' rights, a profile is developed to distinguish marginalizing rebellions from genuine reforms. International bioethics always has been a matter of negotiated conventions. The theory of negotiated ethics outlined in this paper recognizes the actual historical nature of international bioethics and is supple enough to acknowledge cultural differences yet strong enough to protect the "rights" of research subjects and patients in all cultures. Robert Baker, Ph.D., is Professor of Philosophy, Union College, Schenectady, NY, and a Visiting Scholar at the Center for Bioethics, University of Pennsylvania.
Notes
1. The particular reading of Rawls offered here views A Theory of Justice (1971) from the perspective of Political Liberalism (1993). There are, however, different and equally plausible readings of A Theory of Justice--including one offered by Rawls himself (1980) that interprets the book as a quasi-Kantian essay in moral realism. One important issue is whether the concept of rationality can vary from society to society. I believe that the answer that Rawls offers in Political Liberalism is "yes." This means that, since primary goods are those goods that "rational persons may be presumed to want," Rawls breaks with the realist tradition and recognizes that the concept of rationality does not determine the content of primary goods; or, to put the point differently, it means that one cannot deduce the nature of primary goods/human rights from the concept of rationality. Rights, that is, areas of nonnegotiability or primacy, thus are not universals. On the other hand, if one sees Rawls's conception of rationality as strong enough to determine the content of primary goods, one converts Rawls into a classical human rights theorist, and, in my view at least, diminishes the power of his theory. 2. To argue otherwise is to commit what philosophers call a category mistake, one might call it "the principlist fallacy." The fallacy arises when one conflates contingently impermissible acts-acts
whose impermissibility derives from the content of the norms or principles accepted as moral at particular times and places--with necessarily impermissible acts, or "rights violations," whose impermissibility derives from the fact that they violate the conditions of morality itself. The conflation is fallacious because it involves treating areas of nonnegotiable primacy, the unacceptable, as if they were derived from the ethics of the accepted and the negotiable. Fundamentalists commit the principlist fallacy by treating morality unidimensionally, in terms of accepted principles alone. They are thus forced to fabricate "fundamental" principles shared by victimizers and their victims, in order to justify transcultural and transtemporal judgments. This implicitly lets the victimizer negotiate the standards that define the violation. Yet in human rights theory, it is the victims who properly set the standards of primacy. 3. It is important to appreciate that bioethical concepts like "privacy" developed in response to the exponential growth in scientific research and technological advance in the latter part of the twentieth century (see Rothman 1991). Cultures that lack indigenous scientific medicine, however, have not shared this experience and thus tend to lack indigenous moral constraints on human subjects experimentation. In the absence of such constraints, the highest minimal standards for research commonly accepted as applicable to human subjects experimentation in the developed world are properly extended to protect members of cultures in the developing world. 4. The right to privacy initially was established to protect individuals from state intrusions into their bedrooms (Griswold v. Connecticut 381 U.S. 479 (1965)) and was extended in Roe v. Wade (Roe v. Wade 410 U.S. 113 (1973)) to protect against state intrusions into abortion decisions made by women in consultation with their physicians, prior to the point of fetal viability. The Quinlan (In re Quinlan 70 N.J. 10, 355 A.2d 647 (1976))case (complimented by the Cruzan decision (Cruzan v. Director, Missouri Dept. of Health 110 S.Ct. 2841 (1990))) extended these protections in response to a paternalistically intrusive form of hospital-based medicine. Had medicine not been so insistently and self-righteously intrusive at the end of life, there would have been no need to "invent" a right to privacy right at the end-of-life care. 5. The term "capacity" plays a role similar to that played by "rational" in classical human rights theory. "Capacity" is used to distinguish individuals, groups, and perhaps even cultures with the physical and mental capacities to assert a sense of primacy from others who lack those abilities. However, in cases where individuals or societies lack the capacity to assert primacy--perhaps because they are enslaved or suppressed or because they are irrational--nonassertion is not an accurate indicator of the absence of primacy. Thus, as in conventional rights theory, the incapacity of mentally handicapped or mentally ill persons to assert the primacy of being respected as a person should not be used as an excuse to deny their rights to personhood; for were they capable of articulating their primary goods or were they to recover the ability to articulate their sense of primacy, they probably would identify respect as a person as a primary good. Unlike conventional rights theory, however, a theory of primary goods opens the possibility that persons with various physical and mental handicaps could articulate a sphere of primacy markedly different from that of nonhandicapped persons. 6. The original judgment is most authentically reproduced in Jay Katz's (1972) compendium, Experimentation with Human Beings. 7. Since the eighteenth century, Anglo-American law had considered medical interventions performed without consent to be battery, but there was no requirement that the consent be documented or that the person giving consent be informed about the risks of the intervention. Justice Cardozo's classic formulation of the pre-Nuremberg American legal conception of consent, for example, states that "every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault" (Scholendorff v. Society of New York Hospital, 211 N.Y. 2d (914)). The operative notion was voluntary, not informed. It was not until 1957, a decade after the Nuremberg Code, that the notion that consent must be informed entered into American case law (Salgo v. Leland Stanford, Jr., University Board of Trustees, 317 P.2d 170 (1957); see Faden and Beauchamp 1986). 8. It is indeed ironic that the 1931 German position on informed consent to research on human subjects was considerably more advanced than anything in Anglo-American ethical or legal theory at the time of the Nuremberg trial. Compounding the irony, the Nuremberg Tribunal may be the first American court to introduce the German idea of informed consent into American law and thus into American and international medical ethics.
9. Originally no consensus existed about the meaning of the Nuremberg principles. In France and the United Kingdom they were viewed as legal regulations addressing the problem of coerced experimentation on inmates of total institutions. These governments looked to Nuremberg as a precedent for prohibiting experiments on involuntary subjects, such as prisoners (Perley et al. 1992, p. 153). American regulators took a broader view. As early as 1947, key administrators in various branches of the U.S. civilian government and in the military attempted to reformulate the Nuremberg Code as administrative regulations applicable to government-supported experimentation on any human subject, not merely on prisoners (ACHRE 1996, Chapter 1). In 1948, the World Medical Association opted for the broader American reading and adopted the Declaration of Geneva, a new version of the Hippocratic Oath--the preeminent icon of medical ethics--that required physicians to respect the laws of humanity, including the moral principles alluded to in the Nuremberg Code and the U.N. Declaration of Human Rights. It was this broad reading of the Nuremberg Code that ultimately became the basis for international bioethics. 10. In striking contrast to the belligerently defensive stance of the CDC and NIH, UNAIDS, an organization created by the United Nations to coordinate all U.N. agency activities with respect to the AIDS epidemic, responded to questions raised about the ethics of using placebos by convening an international conference of representatives of CIOMS, bioethicists, human rights lawyers, community activists, physicians, agency heads, and researchers. The UNAIDS recommendations had not been released when this article went to press, but one participant in the process (Bloom 1998) recommends that controversial cases be vetted by an independent international review board--a solution more typically characteristic of an optimizing revision than a marginalizing rebellion. 11. An editorial in Lancet, for example, suggested that the controversy revealed the need to revise the CIOMS and Helsinki guidelines (Editorial 1998). 12. A response by the researchers is printed in the same issue of the New England Journal of Medicine (Robb et al. 1998).
References
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Robert Baker - A Theory of International Bioethics: The Negotiable and the Non-N...

Kennedy Institute of Ethics Journal 8.3 (1998) 233-273

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A Theory of International Bioethics: The Negotiable and the Non-Negotiable

Negotiated Moral Order: A Model for International Bioethics

Negotiating A Moral Order: An Example

Negotiated Morality and the Postmodern Critique

Human Rights and Primary Goods

The Framework Independence of Nonnegotiable Primary Goods, or Human Rights

Human Rights and Primary Goods: Some Differences

Rethinking the Legacy of Nuremberg

The German Origins of the Nuremberg Principles

Transforming Bureaucratic Regulations into Universal Morality

Revisions and Rebellions: The Ethics of Experimentation after Nuremberg

The 1970s: The Re-Problematization of the Researcher-Subject Relationship

Distinguishing Reform from Rebellion

revisions swiftly reasserted themselves.

Analyzing Controversial Contemporary Revisions

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