Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)

The work of general practitioners is infused by norms from several movements, of which evidence based medicine, patient-centredness, and virtue ethics are some of the most influential. Their precepts are not clearly reconcilable, and structural factors may limit their application. In this paper, we develop a conceptual framework that explains how GPs respond, across different fields of interaction in their daily work, to the pressure exerted by divergent norms. Data was generated from unstructured interviews with and observations of sixteen Swedish (...) GPs and family medicine residents between 2015 and 2017. Straussian Grounded Theory was used for analysis. We found that GPs’ maxims of action can be characterised in terms of dichotomous responses to demands from four distinct sets of norms, or “voices”: the situation, the self, the system, and the profession. From the interactions between these voices emerge sixteen clusters of maxims of action. Based on the common features of the maxims in each cluster, we have developed a conceptual framework that appears to be rich enough to capture the meaning of the ethical decisions that GPs make in their daily work, yet has a high enough level of abstraction to be helpful when discussing the factors that influence those decisions. Our four-dimensional model of GPs’ responses to norms is a first step toward a middle-range theory of quality from GPs’ perspective. It brings out the complexity of their practice, reveals tensions that easily remain invisible in more concrete accounts of their actions, and aids the transferability of substantive theories on GPs’ ethical decision making. By explaining the nature of the ethical conflicts that they experience, we provide some clues as to why efforts to improve quality by imposing additional norms on GPs may meet with varying degrees of success. (shrink)

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of ‘autonomy’ as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles – those of autonomy, integrity and authority – to (...) better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other – to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient-centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable. (shrink)

In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different (...) set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good. (shrink)

Multidimensional property supplementation is a grounded theory method for analysis that conceives of concepts as multidimensional spaces of possibilities. It is applied in an iterative process comprising four steps: expansion, whereby vague codes are split and contraries postulated; abstraction of practically significant differences in terms of properties and dimensions; geometrization of properties to create conceptual subspaces that supplant subcategories and have additional, emergent qualities; and unification of the concept by validating it against data and relieving it of properties that do (...) not tie in sufficiently with other concepts. Multidimensional conceptual models encourage the researcher to elaborate properties that explain, predict, or guide action. Fully developed, they can be easily connected to others in a process and function, by virtue of their emergent qualities, as falsifiable hypotheses in their own right. For these reasons, multidimensional property supplementation is open to epistemological justification without presuming acceptance of techniques specific to grounded theory. (shrink)

Background Among the myriad voices advocating diverging ideas of what general practice ought to be, none seem to adequately capture its ethical core. There is a paucity of attempts to integrate moral theory with empirical accounts of the embodied moral knowledge of GPs in order to inform a general normative theory of good general practice. In this article, we present an empirically grounded model of the professional morality of GPs, and discuss its implications in relation to ethical theories to see (...) whether it might be sustainable as a general practice ethic. Methods We observed and interviewed sixteen GPs and GP residents working in health care centres in four Swedish regions between 2015–2017. In keeping with Straussian Grounded Theory, sampling was initially purposeful and later theoretically guided, and data generation, analysis and theoretical integration proceeded in parallel. The focal concept of this article was refined through multidimensional property supplementation. Results The voice of the profession is one of four concepts in our emerging theory that attempt to capture various motives that affect GPs’ everyday moral decisionmaking. It reflects how GPs appreciate the situation by passing three professional–moral judgments: Shall I see what is before me, or take a bird’s-eye view? Shall I intervene, or stay my hand? And do I need to speak up, or should I rather shut up? By thus framing the problem, the GP narrows down the range of considerations, allowing them to focus on its morally most pertinent aspects. This process is best understood as a way of heeding Løgstrup’s ethical demand. Refracted through the lens of the GP’s professional understanding of life, the ethical demand gives rise to specific moral imperatives that may stand in opposition to the express wishes of the other, social norms, or the GP’s self-interest. Conclusions The voice of the profession makes sense of how GPs frame problematic situations in moral terms. It is coherent enough to be sustainable as a general practice ethic, and might be helpful in explaining why ethical decisions that GPs intuitively understand as justified, but for which social support is lacking, can nevertheless be legitimate. (shrink)