Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...) the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)

A survey of the recent literature suggests that physicians should engage religious patients on religious grounds when the patient cites religious considerations for a medical decision. We offer two arguments that physicians ought to avoid engaging patients in this manner. The first is the Public Reason Argument. We explain why physicians are relevantly akin to public officials. This suggests that it is not the physician’s proper role to engage in religious deliberation. This is because the public character of a physician’s (...) role binds him/her to public reason, which precludes the use of religious considerations. The second argument is the Fiduciary Argument. We show that the patient-physician relationship is a fiduciary relationship, which suggests that the patient has the clinical expectation that physicians limit themselves to medical considerations. Since engaging in religious deliberations lies outside this set of considerations, such engagement undermines trust and therefore damages the patient-physician relationship. (shrink)

BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then (...) elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.ConclusionThe fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. (shrink)

Physician-researchers are bound by professional obligations stemming from both the role of the physician and the role of the researcher. Currently, the dominant models for understanding the relationship between physician-researchers' clinical duties and research duties fit into three categories: the similarity position, the difference position and the middle ground. The law may be said to offer a fourth.

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...) feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

Since the 1980’s, surrogacy has become a popular reproductive alternative for individuals experiencing infertility. The ethical and legal analyses of surrogacy have been rich and varied. Some bioethicists have charged the commercial surrogacy industry with the exploitation of global southern women or with the impermissible commodification of children and women’s reproductive capacities. Others have praised the potential for economic empowerment and bodily autonomy that surrogacy may accord to women. However, throughout these explorations of the ethics of surrogacy, comparatively little attention (...) has been paid to the moral status of a crucial actor: the fertility doctor. Without doctors willing to provide prenatal and postnatal care to surrogates and make use of assisted reproductive technologies (ARTs), commercial surrogacy would not take place. Yet, doctors’ involvement in surrogacy is far from morally neutral. In my thesis, I aim to explore what duties doctors have in the context of commercial surrogacy. To do so, I take up the framework of fiduciary obligation. I argue that doctors have fiduciary obligations to surrogates, and that these obligations shape if and when doctors can ethically facilitate surrogacy. My thesis is divided into four chapters. The first defends the view that the doctor-patient relationship is fiduciary in nature. The second chapter extends this view to the realm of commercial surrogacy, arguing that doctors also owe the surrogates they treat fiduciary obligations. The third chapter addresses a challenge posed by my view, namely that surrogacy seems to place doctors in positions where they constantly face conflicts of interest, and are therefore unable to uphold their fiduciary duty of loyalty to surrogates. I address this concern by arguing that conflicts of interest are not inherent in surrogacy, but that surrogacy arrangements must be substantially rethought in order to safeguard the doctor-surrogate fiduciary relationship. The final chapter considers the obligations doctors have to the children they help create through surrogacy and through assisted reproduction more generally. (shrink)

Professional standards in medicine and psychology treat concurrent sexual relationships with patients as violations of fiduciary trust, and they sometimes rule out sexual relationships even after a clinical relationship is over. These standards also rule out sex with research subjects who are also patients, but what about nonclinical relationships where there are not always parallels to the standards of clinical medicine? One way to treat sex in nonclinical research relationships is to treat it as sex is treated elsewhere among adults, (...) as a matter of individual choice and responsibility. Alternately, one could ask oversight bodies to draw lines between research that can safely accommodate sexual relationships and research that cannot. One could even ask researchers to avoid all concurrent sexual relationships with their research participants, as happens in clinical medicine. Each of these options has drawbacks that undermine its value as a definitive solution. The deficiencies of these options highlight the need for a professional code of conduct for nonclinical researchers. (shrink)

Clinical equipoise has been proposed as an ethical principle relating uncertainty and moral leeway in clinical research. Although CE has traditionally been indicated as a necessary condition for a morally justified introduction of a new RCT, questions related to the interpretation of this principle remain woefully open. Recent proposals to rehabilitate CE have divided the bioethical community on its ethical merits. This paper presents a new argument that brings out the epistemological difficulties we encounter in justifying CE as a principle (...) to connect uncertainty and moral leeway in clinical ethics. The argument proposes, first, that the methodology of hypothetical retrospection is applicable to the RCT design and that it can accommodate uncertainty. As currently understood, however, HR should give up its reliance on the assumption of uncertainty transduction, because the latter assumes the principle of indifference, which does not accommodate uncertainty in the right way. The same principle is then seen to distort also the received interpretations of CE. (shrink)

A standard view in legal and political theory is that, to a first approximation, (1) we should aim to bring about the most legitimate institutions possible to solve the problems that should be solved at the level of politics, and (2) individual people are required to follow the directives of legitimate institutions, at least insofar as those institutions have the authority to issue those directives, and insofar as other considerations are nearly equal.1 On this standard view, the philosophical analysis of (...) institutional legitimacy can appear to be of the utmost importance because it can seem to answer the most important questions about what we should actually do in the realm of law and politics, and because it may also seem to serve as the crucial bridge between ideal and nonideal theory, at least if institutional legitimacy is analyzed as it often is as a matter of doing well enough along dimensions that are familiar from ideal APA NEWSLETTER | PHILOSOPHY AND LAW theory (e.g., ideal justice, universal consent, respecting basic rights, social welfare maximization, and so on). In what follows I identify a number of possible counterexamples to this standard view, which suggest that there may be no straightforward connection between institutional legitimacy and facts about what reasons, rights, and duties we actually have, and what institutions we should actually try to bring about, contrary to what the standard view assumes. (shrink)

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

In this article, I present an argument that suggests neuroscience should inform judgments of decision-making capacity. First, I review key behavioral and neurocognitive data to demonstrate that neuroscientific tests might be predictive of decision-making capacity, and that these tests might inform clinical judgments of capacity. Second, I argue that, consistent with the principles of autonomy and justice, such data should inform judgements of decision-making capacity. While the neuroscience of decision-making capacity still requires time to mature, there is strong reason to (...) believe that neuroscience might assist clinicians in adjudicating difficult cases in the future. This article focuses on the assessment of capacity in brain injury patients who have profound communication impairments, however, the overarching aim of the article is to highlight the potential use of neuroscience to improve our understanding of the relationship between cognition and decision-making capacity. (shrink)

In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex (...) and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively. (shrink)

This paper highlights the need for researchers and research ethics committees to look at the implications of a research study beyond the immediate research question, and the dignity, safety and wellbeing of research subjects, going on to consider whether the results of the study could be detrimental, for example, to more vulnerable groups in society. Although the case studies described come from workplace-based psychosocial research, it is suggested that the lessons drawn from these could be applied more generally.

Severe brain injury is a leading cause of death and disability. Following severe brain injury diagnosis is difficult and errors frequently occur. Recent findings in clinical neuroscience may offer a solution. Neuroimaging has been used to detect preserved cognitive function and awareness in some patients clinically diagnosed as being in a vegetative state. Remarkably, neuroimaging has also been used to communicate with some vegetative patients through a series of yes/no questions. Some have speculated that, one day, this method may allow (...) severely brain-injured patients to make medical decisions. Yet, skepticism is rife, due in part to the inherent difficulty of assessing decision-making capacity through neuroimaging communication. In this thesis, I provide the first systematic analysis of this problem. I present and defend a strategy for assessing decision-making capacity in brain-injured patients who can only communicate through neuroimaging. (shrink)

The exploitation of participants is a significant problem in biomedical research, especially in the developing world. However, there is a gap between this problem and the theoretical literature on exploitation. This thesis will attempt to bridge it, considering Wertheimer and Sample’s theories. Whereas Wertheimer holds that exploitation is merely an unjust distribution of the “social surplus” arising from a transaction, Sample, whose approach this thesis endorses, construes exploitation as a lack of respect for a person’s true value. This thesis will (...) show that codes of ethics with legal force take a Wertheimerian approach, and that the aspirational codes, which insist that research respond to local health priorities, are more Samplian. Finally, it will argue that the current system of research funding and oversight cannot guarantee that research is responsive to the needs of the developing world and thus fails to prevent exploitation. (shrink)