Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...) circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals? perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research. (shrink)

Coercion by the recipient of consent renders that consent invalid. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that are legitimate. Illegitimate controlling third party (...) threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. (shrink)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 27-29, August 2011.

Some maintain that voluntariness is a value-neutral concept. On that view, someone acts involuntarily if subject to a controlling influence or has no acceptable alternatives. I argue that a value-neutral conception of voluntariness cannot explain when and why consent is invalid and that we need a moralized account of voluntariness. On that view, most concerns about the voluntariness of consent to participate in research are not well founded.

Deep brain stimulation (DBS) is currently in pivotal trials as an intervention for treatment-resistant depression (TRD). Although offering hope for TRD, DBS also provokes ethical concerns—particularly about decision-making capacity of people with depression—among bioethicists, investigators, institutional review boards, and the public. Here, we examine this critical issue of informed consent for DBS research using available evidence regarding decision-making capacity and depression. Further, we explore the implications of the nature of TRD as well as that of the intervention (invasive brain surgery) (...) for informed consent. Based on these analyses, we argue that additional safeguards specific to DBS research for TRD, beyond those that might be used in any higher risk study, are not supported by available empirical evidence. We nevertheless underscore the limited data on such invasive procedures in severely ill psychiatric patients and advocate a research agenda for the systematic study of ethical issues raised by these research endeavors. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 17-18, August 2011.

The American Journal of Bioethics, Volume 11, Issue 8, Page W1-W3, August 2011.

One moot point in bioethical debates about genetic testing concerns the conditions that have to be fulfilled to make individual genetic testing or individual participation in genetic screening programs truly voluntary. Though there is a relatively broad consensus about the non-viability of views on the extremes of the spectrum of opinions, there is considerable disagreement in the middle. This mirrors the difficulties in defining satisfactory demarcation lines between autonomous choice, pressured choice and coercion in cases in which the decision to (...) participate is triggered, wholly or partly, by factors such as material incentives, urgent health needs, massive social expectations, or moral pressure from relatives. In this contribution, some of the semantic conditions and ethical principles concerning coercion are explored with a view to applying them to genetic testing, especially in the context of insurance and participation in clinical trials. (shrink)