The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument is not radical, it provides a (...) useful way to determine how the right should be applied in various cases. (shrink)

Most codes of research ethics and the practice of Institutional Review Boards (IRBs) allow human subjects to withdraw from research at any time. Consent forms invariably make a statement to this effect. So understood, a subject's right to withdraw from research is inalienable; she cannot, through her consent, surrender this right. Recently critics have argued that in selected circumstances the right to withdraw from research is alienable; subjects have the moral authority, through their consent, to obligate themselves not to withdraw. (...) Two kinds of cases have been cited to support this. In one case, there will be great benefits lost if subjects are permitted to withdraw before the completion of the protocol. In the other case, there will be harm to third parties if subjects withdraw from the experiment. In this paper, I defend the inalienability of the right to withdraw from research. I argue, first, that securing the desired benefits and avoiding the feared harms can be achieved without allowing waiver. Second, I show that permitting waiver in these cases does not guarantee that the ends sought will be achieved. And third, I articulate positive reasons for conceiving subjects' right to withdraw from research as inalienable. (shrink)

This article examines the ethical basis for the patient's duty to adhere to the physician's treatment prescriptions. The article argues that patients have a moral duty to adhere to the physician's treatment prescriptions, once they have accepted treatment. Since patients still retain the right to refuse medical treatment, their duty to adhere to treatment prescriptions is a prima facie duty, which can be overridden by their other ethical duties. However, patients do not have the right to refuse to adhere to (...) treatment prescriptions if their non-adherence poses a significant threat to other people. This paper also discusses the use of written agreements between physicians and patients as a strategy for promoting patient adherence. (shrink)

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not imply (...) that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

Background Tuberculosis is a major cause of morbidity and mortality globally. Recent scholarly attention to public health ethics provides an opportunity to analyze several ethical issues raised by the global tuberculosis pandemic. Discussion Recently articulated frameworks for public health ethics emphasize the importance of effectiveness in the justification of public health action. This paper critically reviews the relationship between these frameworks and the published evidence of effectiveness of tuberculosis interventions, with a specific focus on the controversies engendered by the endorsement (...) of programs of service delivery that emphasize direct observation of therapy. The role of global economic inequities in perpetuating the tuberculosis pandemic is also discussed. Summary Tuberculosis is a complex but well understood disease that raises important ethical challenges for emerging frameworks in public health ethics. The exact role of effectiveness as a criterion for judging the ethics of interventions needs greater discussion and analysis. Emerging frameworks are silent about the economic conditions contributing to the global burden of illness associated with tuberculosis and this requires remediation. (shrink)

As an alternative to rights theory, John Ladd proposes an ethics of responsibility based on interpersonal relationships. These relationships, described as friendships, are personal in nature, founded on trust, and obtain between doctor and patient, parent and child, etc. Ladd presents his views in a most appealing way – helping the needy, being friends with the doctor. We argue that Ladd's ethics of responsibility is plausible only because he ignores the facts of power which rights theory was designed to take (...) into account, and that rights and the corresponding institutional model of medicine are indeed appropriate to the physician/patient relationship. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

The incident in May-June 2007 involving a U.S. citizen traveling internationally while infected with drug-resistant tuberculosis involved the U.S. federal government's application of its quarantine and isolation powers. The incident and the isolation order raised numerous important issues for public health governance, law, and ethics. This article explores many of these issues by examining how the exercise of quarantine powers provides a powerful lens through which to understand how societies respond to and attempt to govern threats posed by dangerous, contagious (...) pathogens. The article considers historical aspects of governmental power to quarantine and isolate individuals and groups; analyzes the current state of quarantine and isolation law in the United States in light of the recent incident with drug-resistant tuberculosis; and explores global aspects of public health governance and law highlighted by this incident. (shrink)

Despite the prominence of healthcare-relatedconcerns in public debate, the ground remainsinfertile for the idea of conscripting citizensinto medical research. Reluctance to entertainthe thought of a system where nearly everyonecould be selected for service might reflectuncertainty about what the project wouldinvolve. There might also be a fear that themore crucial issue is how to protect researchsubjects within current, voluntary systems. Nodoubt reluctance to explore a system ofuniversal service results from the common hopethat each of us might avoid research in anycapacity besides (...) researcher. A system of fullcivic participation might, however, avoid manyof the usual objections. Ethics regulations,including informed-consent guidelines, couldfor the most part remain in force. Though thesystem would compel people to serve, it couldremain responsive to principles of autonomy andjustice if it centered on broad publiceducation, community representation, and alottery-type selection process. The systemcould draw from the largest possiblecross-section of society, and offer conscriptsthe widest possible range of service. In thisway, a compulsory system might reconcile theexpectations about healthcare with researchneeds. (shrink)