Conducting research with vulnerable populations involves careful attention to the interests of individuals. Although it is generally understood that informed consent is a necessary prerequisite to research participation, it is less clear how to proceed when potential research participants lack the capacity to provide this informed consent. The rationale for assessing the assent or dissent of vulnerable individuals and obtaining informed consent by authorized representatives is discussed. Practical guidelines for recruitment of and data collection from people in the middle or (...) late stage of dementia are proposed. These guidelines were used by research assistants in a minimal risk study. (shrink)

ver since the traditional criteria for medical decision-making capacity (understanding, appreciation, reasoning, evidencing a choice) were formulated, they have been criticized for not taking sufficient account of emotions or values that seem, according to the critics and in line with clinical experiences, essential to decision-making capacity. The aim of this paper is to provide a nuanced and structured overview of the arguments provided in the literature emphasizing the importance of these factors and arguing for their inclusion in competence evaluations. Moreover, (...) a broader reflection on the findings of the literature is provided. Specific difficulties of formulating and measuring emotional and valuational factors are discussed inviting reflection on the possibility of handling relevant factors in a more flexible, case-specific, and context-specific way rather than adhering to a rigid set of operationalized criteria. (shrink)

Decision-making capacity is the gatekeeping element for a patient’s right to self-determination with regard to medical decisions. A DMC evaluation is not only conducted on descriptive grounds but is an inherently normative task including ethical reasoning. Therefore, it is dependent to a considerable extent on the values held by the clinicians involved in the DMC evaluation. Dealing with the question of how to reasonably support clinicians in arriving at a DMC judgment, a new tool is presented that fundamentally differs from (...) existing ones: the U-Doc. By putting greater emphasis on the judgmental process rather than on the measurement of mental abilities, the clinician as a decision-maker is brought into focus, rendering the tool more of an evaluation guide than a test instrument. In a qualitative study, the perceived benefits of and difficulties with the tool have been explored. The findings show on the one hand that the evaluation aid provides basic orientation, supports a holistic perspective on the patient, sensitizes for ethical considerations and personal biases, and helps to think through the decision, to argue, and to justify one’s judgment. On the other hand, the room for interpretation due to absent operationalisations, related ambiguities, and the confrontation with one’s own subjectivity may be experienced as unsettling. (shrink)

A patient’s decision-making capacity or competence is among the prerequisites for valid consent to medical treatment, and is regarded as the gatekeeping element in ensuring respect for patients’ self-determination. The issue is especially relevant in the case of vulnerable persons, such as patients who are cognitively or mentally impaired, and where medical decisions carry far-reaching consequences. As a grounding principle, DMC is a priori assumed, and challenged only when substantial doubts arise owing to observed or assumed deficiencies of the capacities (...) commonly considered relevant for competent decision making ; in this sense, the onus is on... (shrink)

Editorial introduction to series of papers resulting from a European Commission Project on mental capacity.

The primacy in modern medical ethics of the principle of respect for autonomy has led to the widespread assumption that it is unethical to change someone’s beliefs, because doing so would constitute coercion or paternalism., In this Viewpoint we suggest that persuasion is not necessarily paternalistic and is an essential component of modern medical practice.

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)