Paul J. Litton

A Normative Justification for Distinguishing the Ethics of Clinical Research from the Ethics of Medical Care

n the research ethics literature, there is strong disagreement about the ethical acceptability of I placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists.’ Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research.2 Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects. Some commentators and ethics documents claim that physicians, whether acting as care givers or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson’s disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.”3 The Declaration of Helsinki, a leading code of ethics for clinical research, also appears to accept this ethical view when it embraces the physician’s oath, “The health of my patient will be my first consideration”4 We, however, argue that researchers owe significant moral obligations to patient-subjects, but do not have the same duty of therapeutic beneficence that binds physicians treating patients. Thus far, while both sides have provided reasons for their respective views and critiques of contrary perspectives, neither side has shown how its view is rooted in and justified by a more general account of what we morally owe to each other. This paper provides that needed, theoretical

What Physician-Investigators Owe Patients Who Participate in Research

VIDENCE-BASED MEDICINE PRESCRIBES THAT CLINICAL practice should be guided by the results of rigorous research. The close connection between clinical research and patient care, coupled with the need for researchtobeconductedbyphysician-investigatorswithpatients who participate in research (patient-participants), makes it difficult to appreciate how the ethical obligation of investigators differ from those of physicians. Moreover, clinicalresearchcreatesethicaltensionsbyexposingpatientparticipants to risks of harm for the sake of generating scientific knowledge. This has been obscured and assuaged by the prominent tendency to view the ethics of clinical research through the lens of the patient-physician relationship. 1 According to this therapeutic orientation, physicianinvestigatorsretainafiduciarydutyofloyaltytothemedical best interests of patients, characteristic of clinical practice, in the context of conducting clinical research. In contrast, this fiduciary loyalty does not cohere with the socially valuable enterprise of clinical research. To be sure, researchers owe significant and extensive ethical obligation to patientparticipants. However, the ethics of clinical practice does not provide an accurate account of the dual obligations of investigators to promote valuable science and protect human research participants. Unquestionably, research participants place trust in physician-researchers. For example, patient-participants trust investigators to assess their eligibility for a protocol, to explain clearly the study’s risks and potential benefits, to keep private information confidential, and to monitor their wellbeing. Moreover, some patients who participate in research are especially vulnerable to exploitation because of illness. Accordingly, physician-researchers owe these patients significant duties, although the scope of these duties must be evaluated. Can these duties to patients be defined by fiduciary loyalty, akin to the physician’s relationship to patients, requiring the researcher to promote each patientparticipant’s best interests? Or do these duties need separate elucidation? Widelyacceptedaspectsofclinicalresearchwouldbeunethical if physician-researchers’ duties to patientparticipants were identical to those of physicians in clinical care. These research practices are tied to the distinctive goal of research, ie, producing generalizable knowledge. In the medical care setting, treatments and diagnostics must beprescribedbasedoneachpatient’sindividualneeds.However, because controlled experimentation is necessary for valid scientific results, treatments within clinical trials are limited by protocols, not personalized. Moreover, valid scientific results often require that nontherapeutic procedures pose some risk to patient-participants without being offset by individual benefits. For example, performing a biopsy, lumbar puncture, and imaging procedure is justified in clinical care only if the procedure contributes to diagno

Physician Participation in Executions, the Morality of Capital Punishment, and the Practical Implications of Their Relationship

Evidence that some executed prisoners suffered excruciating pain has reinvigorated the ethical debate about physician participation in executions. In widely publicized litigation, death row inmates argue that participation of anesthesiologists in their execution is constitutionally required to minimize the risk of unnecessary suffering. For many years, commentators supported the ethical ban on physician participation reflected in codes of professional medical organizations. However, a recent wave of scholarship concurs with inmate advocates, urging the law to require or permit physician participation. Both the anti- and pro-physician-participation literature share a common premise: the ethics of physician participation should be analyzed independently from the moral status of capital punishment. This considerable literature implausibly divorces the ethics of physician participation from the moral status of the death penalty. Any ethical position on physician involvement requires some judgment about the moral status of capital punishment. The article examines anti- and pro-participation arguments to show that each one either is unpersuasive without discussion of the death penaltys moral status or implicitly assumes a view on the social worth of the death penalty. The article then articulates the practical implications of its arguments for both lawmakers and professional medical organizations.

ADHD, Values, and the Self

*The opinions expressed are the views of the author and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

A more persuasive justification for pediatric research.

No one produces more thoughtful and insightful work on the ethics of pediatric research than Dave Wendler. I claim, though, that there is a more persuasive justification for pediatric research that...

The undue influence of causation.

Robert Nelson and colleagues (2011) claim that no useful analysis of “voluntariness” appears in the academic literature and identify their goal as “fill[ing] the gaps left by inadequate and incomplete conceptual analysis” (6). They describe scholarly work on exploitation and undue inducement as “impoverished.” The authors thereby promise a useful, adequate, complete, and robust analysis of “voluntariness.” Unfortunately, they do not succeed in this ambitious project. This commentary highlights some ways their analysis fails due to their closely associating involuntariness with causally determined. The authors claim that an agent acts voluntarily when she “wills [her] action without being under the controlling influence of another person or condition” (6). How do the authors define “controlling”? They describe an alcoholic who appears to drink voluntarily, but write that his drinking is involuntary “if his volition and desire to drink red wine are causally determined by a desire over which he has no effective control” (6). On their view, his desire is a controlling influence if it (i) causally determines his act and (ii) is outside his effective control. When does an agent lack effective control over his desires? The authors do not explicitly discuss desires, but their discussion of motives and passions is applicable. They write that if an agent’s action is caused by motives or passions that are, themselves, caused, then such a “resultant action, so caused, is not a voluntary act” (6). An influence is controlling, and thus voluntarinessundermining, in their view, if it causes the agent’s act and was, itself, caused by factors outside the agent’s control. This account of voluntariness echoes the view that free will is incompatible with causal determinism. Given this resemblance to incompatibilism, questions arise. For example, how is voluntary action possible if it requires control over the causal influences of one’s act? Infinite causes (including my childhood experiences, my genes) determine how I perceive the world, the reasons I find persuasive, my desires and dispositions, etc.; thus, my actions are caused by influences outside my control. Perhaps the authors endorse some libertarian (in the free will sense) account of agent-causation and believe in agents as “uncaused causes” (Kane 2005, 47). If their analysis entails a commitment to agent-causation, it requires explanation, given how strange the notion seems metaphysically. Related to this claim, the authors argue that an act is involuntary if it is significantly controlled by others. Given their association of control with the absence of causation, the view must be that an act could be voluntary if it is only somewhat caused, but not to a significant degree, by other

Crime, Punishment, and Causation: The Effect of Etiological Information on the Perception of Moral Agency.

Moral judgments about a situation are profoundly shaped by the perception of individuals in that situation as either moral agents or moral patients (Gray & Wegner, 2009; Gray, Young, & Waytz, 2012), Specifically, the more we see someone as a moral agent, the less we see them as a moral patient, and vice versa. As a result, casting the perpetrator of a transgression as a victim tends to have the effect of making them seem less blameworthy (Gray & Wegner, 2011). Based on this theoretical framework, we predicted that criminal offenders with a mental disorder that predisposes them to antisocial behavior would be judged more negatively when the disorder is described as having a genetic origin than when it is described as environmentally caused, as in the case of childhood abuse or accident. Further, we predicted that some environmental explanations would mitigate attributions of blame more than others, namely, that offenders whose disorder was caused by childhood abuse (intentional harm) would be seen as less blameworthy than offenders whose disorder is caused by an unfortunate accident (unintentional harm). Results from two vignette-based studies designed to test these predictions, conducted with participants recruited from Amazon Mechanical Turk (N = 244 and N = 387, respectively), confirmed the first prediction but not the second. Implications of this research for three areas—the psychology of moral judgment, philosophical debates about moral responsibility and determinism, and the practice of the law—are discussed in the sequel.