In the article “Nudging and Informed Consent”, Cohen argues that the use of “nudging” by physicians in the clinical encounter may be ethically warranted because it results in an informed consent where obligations for beneficence and respect for autonomy are both met. However, the author's overenthusiastic support for nudging and his quick dismissal of shared decision-making leads him to assume that “soft” manipulation is un-problematic and that “wisdom” on the side of medical professionals will suffice to guard against abuse. Opposing (...) this view, we propose that: 1) patient preferences and values should not be boiled down to rational or irrational decisions based on cognitive reasoning alone, 2) potential threats to the physician-patient must be mitigated and could be minimized by employing alternative strategies that acknowledge the impact of cognitive heuristics in shaping decision-making but maintain transparency and trust, and 3) patient preferences and values can be legitimately influenced only under specific circumstances. The latter include: (1) exhaustion of other means; (2) evidence that nudging is effective in a specific context; (3) evidence of clear and active public misinformation (e.g., industry promoting smoking); (4) explicit pubic dialogue between various stakeholders including medical professional societies about nudging; (5) upholding shared decision-making as a preferred approach; and (6) a rich understanding of clinical reality beyond the simple dichotomy of beneficence-autonomy. (shrink)

Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions for how (...) relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

BackgroundResearch ethics and the measures deployed to ensure ethical oversight of research are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.MethodsWe examined approved consent forms for Magnetic Resonance Imaging and functional Magnetic Resonance Imaging studies approved by Canadian research ethics boards .ResultsWe found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of (...) incidental findings exposed extensive variability between and within research sites.ConclusionThe causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. (shrink)

International media have reported cases of pregnant women who have had their children apprehended by social services, or who were incarcerated or forced into treatment programs based on a history of substance use or lack of adherence to addiction treatment programs. Public discourse on the biology of addiction has been criticized for generating stigma and a diminished perception of self-control in individuals with an addiction, potentially contributing to coercive approaches and criminalization of women who misuse substances during pregnancy. We explored (...) whether this is the case based on literature from social psychology, ethics, addiction research, science communication, and philosophy. The literature shows that the relationship between public discourse on biological aspects of addiction and issues such as stigma and perceptions of diminished self-control are unclear, largely due to the complexity of these phenomena. However, concerns about the biological approach are nevertheless legitimate given the broader social and policy context of women’s health. (shrink)

Deep brain stimulation (DBS) has been proposed as a potential treatment of drug addiction on the basis of its effects on drug self-administration in animals and on addictive behaviours in some humans treated with DBS for other psychiatric or neurological conditions. DBS is seen as a more reversible intervention than ablative neurosurgery but it is nonetheless a treatment that carries significant risks. A review of preclinical and clinical evidence for the use of DBS to treat addiction suggests that more animal (...) research is required to establish the safety and efficacy of the technology and to identify optimal treatment parameters before investigating its use in addicted persons. Severely addicted persons who try and fail to achieve abstinence may, however, be desperate enough to undergo such an invasive treatment if they believe that it will cure their addiction. History shows that the desperation for a cure of addiction can lead to the use of risky medical procedures before they have been rigorously tested. In the event that DBS is used in the treatment of addiction, we provide minimum ethical requirements for clinical trials of its use in the treatment of addiction. These include: restrictions of trials to severely intractable cases of addiction; independent oversight to ensure that patients have the capacity to consent and give that consent on the basis of a realistic appreciation of the potential benefits and risks of DBS; and rigorous assessments of the effectiveness and safety of this treatment compared to the best available treatments for addiction. (shrink)

Stigma can influence the prevention and identification of fetal alcohol spectrum disorder, a leading cause of developmental delay in North America. Understanding the effects of public health practices and policies on stigma is imperative. We reviewed social science and biomedical literatures to understand the nature of stigma in FASD and its relevance from an ethics standpoint in matters of health practices and policies. We propose a descriptive model of stigma in FASD and note current knowledge gaps; discuss the ethical implications (...) of stigma based on two distinct criteria ; and describe two cases and the concerns associated with inadvertent stigmatization by public health initiatives for FASD. We recommend further empirical and ethical analyses to examine whether public health policies and practices inadvertently stigmatize and impact the success of public health initiatives and programs for FASD. (shrink)

Neuroscientists are increasingly put into situations which demand critical reflection about the ethical and appropriate use of research tools and scientific knowledge. Students or trainees also have to know how to navigate the ethical domains of this context. At a time when neuroscience is expected to advance policy and practice outcomes, in the face of academic pressures and complex environments, the importance of scientific integrity comes into focus and with it the need for training at the graduate level in the (...) responsible conduct of research . I describe my experience teaching RCR in a graduate neuroscience program and identify three personal reflections where further dialogue could be warranted: mobilizing a common set of competencies and virtues standing for professionalism in the neurosciences; tailoring RCR for the neurosciences and empowering students through the active engagement of mentors; soliciting shared responsibility for RCR training between disciplines, institutions and governmental or funding agencies. (shrink)

Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans mandates that all research involving human subjects be reviewed and approved by a research ethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application to be exempt from review. (...) Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on the research projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisite research projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)