Over the past two years, much has been made by some governments and the media about the possible callous and racist distribution of Quinacrine by two Americans to sterilize women in the Third World. The main criticism of the practice is that though Quinacrine is unapproved by the developed world's health regulatory agencies for this particular use in the developed world due to inadequate testing for long-term side effects, it is used on defenseless women in the developing world.I argue that (...) the distribution of unapproved medical and other products is morally permissible if it satisfies two conditions: agent-centered utilitarianism and Kant's Categorical Imperative. Roughly, I contend that if the situation will probably improve and no one is treated as a mere means, then it is ethical either to give or to sell the products to those who choose to have them, regardless of where in the world they live. (shrink)

I want to argue for two propositions. First, I suggest that what some researchers may take to be a simple trade-off between minor violations of the truth for the sake of access to far greater truths represents a profound miscalculation with far-reaching and cumulative reverberations. Second, I submit that today's research environment, as demanding, competitive, and sometimes bewildering as it is, offers genuine scope for what Murdoch calls truth-seeking, for imagining and questioning, and for relating to facts through both truth (...) and truthfulness; but that, in so doing, it presents hard choices with respect to methods, and, in turn, to personal integrity—not only in particular research projects but also with respect to that fragile research environment in its own right. (shrink)

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, (...) and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature. (shrink)

Assesses the ethical problems that doctors face every day and advocates a more universal code of medical ethics, one that draws on the traditions of religion and philosophy.

The practice of paternalism has changed along with developments in medicine, philosophy, law, sociology and psychology. Physicians have learned that a patient's values are a factor in determining what is best for that patient. Modern paternalism continues to be guided by the principle that the physician decides what is best for the patient and pursues that course of action, taking into account the values and interests of the patient. In the autonomy model of the doctor-patient relationship, patient values are decisive. (...) In the paternalistic model, they are but one among several factors the physician must consider in making a medical decision. Although difficult to practise because of limitations in empathising with another person, modern paternalism remains a way to achieve maximum patient benefit. (shrink)

Clinicians cannot obtain valid consent to treatment because they cannot guess which treatment option will serve a particular patient's best interests. These guesses could be made more accurately if patients were paired with providers who share their deep values.

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (shrink)

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo‐control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of (...) the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta‐ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations. (shrink)

Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of other stakeholders (...) often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued competing sets of interests the IRB must serve, rather than as the primary concern of the IRB. (shrink)

Federal policies on human subjects research have performed a near‐about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

“Run-in” and “washout” periods involving the withholding of medication are widely used in drug research trials in pursuit of both patient safety and scientific reliability. Such no-medication periods can be justified ethically provided that they are apparent to patients, who can thereby properly consent to undergoing them. Less widespread, but still common, is the practice of “single blinding” no-medication periods, concealing them from patients by means of placebo. Whilst all placebos involve a measure of concealment, their use is typically justified (...) in drug research trials by their preserving the uncertainty generated by the random allocation of different treatments within a drug trial; and by the researchers openly declaring both the randomisation process and the chances of receiving placebo. In the single blind placebo “run-in” or “washout”, neither of these conditions is met.This paper considers three possible defences of the practice of using single blind placebo “run-ins” or “washouts” and finds them all to fail; the practice appears ethically unjustified. (shrink)

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (shrink)

The notion of consent which rose to the forefront in biomedical ethics as an attempt to safeguard patients' autonomy, is relatively new. The notion itself requires qualification, for it precludes neither duress nor ignorance. More seriously, I argue here that consent is redundant except in situations where paternalism prevails. Paradoxically, these are the very situations where it may be difficult to uphold or to verify voluntary consent. I suggest that a request-based relationship has the potential to overcome these difficulties. It (...) enhances patients' participation in decision making, requires that the patients remain in command and avoids their subordination. Request is also more conducive to treatments that are representative of patients' own values and perceptions. In practice, what one wants and what one agrees to, often concur. But these are not conceptually identical issues, and they carry important differences of emphasis. (shrink)

Savulescu has recently introduced the "rational non-interventional paternalist" model of the patient-doctor relationship. This paper addresses objections to such a model from the perspective of an anaesthetist. Patients need to make their own decisions if they are to be fully autonomous. Rational non-interventional paternalism undermines the importance of patient choice and so threatens autonomy. Doctors should provide an evaluative judgment of the best medical course of action, but ought to restrict themselves to helping patients to make their own choices rather (...) than making such choices for them. (shrink)

Throughout this essay, I will consider an argument frequently used to justify paternalistic behavior toward a specific class of persons: illiterate people. The argument states that illiterate people are uneducated, lack information and understanding, and are thus unable to make decisions. Therefore, it is argued, paternalism in their case is justified. The conclusion is that illiterate persons cannot be autonomous. The justification for this view is based on an a priori attitude: since it is impossible to communicate, physicians should decide (...) which kind of treatment the illiterate patient should receive. This argument is frequently used even though its proponents may not be aware of its implications. Given the importance and uncritical acceptance this argument has in Argentina, and also in other Latin American countries, I think it is relevant to analyze carefully what it means. I propose a thorough analysis of this argument, of its implications and an evaluation of whether it is acceptable. (shrink)

All illness represents a state of diminished autonomy and therefore the doctor-patient relationship necessarily and justifiably involves a degree of medical paternalism argues the author, an American medical student. In a broad-ranging paper he discusses the concepts of autonomy and paternalism in the context of the doctor-patient relationship. Given the necessary diminution of autonomy which illness inflicts, a limited form of medical paternalism, aimed at restoring or maximising the patient's autonomy is entirely acceptable, and indeed fundamental to the relationship he (...) argues. However, the exercise of this paternalism should be flexible and related to the current 'level of autonomy' of the patient himself. An editorial in this issue comments briefly on this paper. (shrink)

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number (...) of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered. (shrink)

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may (...) provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. (shrink)

: The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to (...) the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research. (shrink)