Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

In “The Harm Principle Cannot Replace the Best Interest Standard: Problems With Using the Harm Principle for Medical Decision Making for Children,” Bester argues that conceptual and normative diffi...

Objective To explore the influencing factors and reasoning of parents who opt out of intramuscular vitamin K prophylaxis for their newborn. Design We conducted a qualitative study with 15 families from the Otago/Southland region of New Zealand. Semistructured interviews explored their choice to opt out of intramuscular vitamin K prophylaxis and thematic analysis was used to elucidate themes that captured important aspects of this parental decision-making process. Results Parents opt out of intramuscular vitamin K for a variety of reasons. These (...) were clustered into three main themes: parents9 beliefs and values (philosophy and spirituality), concerns about their child9s welfare (pain and potential side effects) and external influencing factors (family, friends, media and health professionals). As part of a wider family hesitancy towards medical intervention, the majority of parents also raised concerns regarding other perinatal or childhood interventions. Conclusion Many factors influence parental decision making and lead to a decision to opt out of newborn intramuscular vitamin K prophylaxis. Due to strong parallels with other common childhood interventions, these findings have relevance for vitamin K prophylaxis and for other healthcare interventions in childhood. (shrink)

Birchley9s critique of the harm threshold for overriding parental decisions is successful in demonstrating that the harm threshold, like the best interests standard, suffers from the problem of indeterminacy. However, his focus on critiquing empirical rather than normative arguments for the harm threshold means that his broad conclusion that it is ‘ill-judged’ is not justified. Advocates of the harm threshold can accept that the concept of harm to a child is indeterminate, yet still invoke strong normative arguments for this way (...) of responding to parental decisions that conflict with medical recommendations. I suggest that Birchley9s discussion, rather than showing that the harm threshold is mistaken, instead highlights the importance of developing a comprehensive account of children9s interests, for proponents of a best interests approach and for advocates of the harm threshold. (shrink)

In their account of the value of parental permission, Navin and Wasserman see families as “collective agents” who “form identities” and have interests as a “family unit” that sometimes justify subo...

In their article “Moral Hazards in Pediatrics” (2016), Brunnquell and Michaelson remind us that the child's perspective is of utmost importance when making health care decisions and express concern...

In their article “Moral Hazards in Pediatrics” (2016), Brunnquell and Michaelson remind us that the child's perspective is of utmost importance when making health care decisions and express concern...

Caring for children with life-shortening illnesses is a humbling task. While some decisions are simple and safe, the emotionally-charged choices regarding how to best care for these children often...

Participation in healthcare decision-making is considered to be an important right of minors, and is highlighted in both international legislation and public policies. However, despite the legal recognition of children’s rights to participation, and also the benefits that children experience by their involvement, there is evidence that legislation is not always translated into healthcare practice. There are a number of factors that may impact on the ability of the child to be involved in decisions regarding their medical care. Some of (...) these factors relate to the child, including their capacity to be actively involved in these decisions. Others relate to the family situation, sociocultural context, or the underlying beliefs and practices of the healthcare provider involved. In spite of these challenges to including children in decisions regarding their clinical care, we argue that it is an important factor in their treatment. The extent to which children should participate in this process should be determined on a case-by-case basis, taking all of the potential barriers into account. (shrink)

The justification for restrictive state intervention (RSI) such as criminal punishment or state reversal of parental decisions is called a limiting, or intervention (Buchanan and Brock 1989, 10), p...

In this case, the investigator should be allowed to enroll incompetent adults into this study, with certain safeguards. If an incompetent adult has an agent or a legally authorized representative (...

As social scientists with overlapping expertise in children and youth studies, inequalities, and medical sociology, we value the development of practical tools that medical professionals can utiliz...

In her article, ‘Why Parents Should Not Be Told the Sex of Their Fetus’ Tamara Browne sets herself a challenging task. She argues that, in the interest of fighting gender essentialism, parents ought not to be told the sex of their fetus even when they request it. This is a very high bar for her arguments to hurdle. Many commentators, myself included, have argued that it would be better for parents not to know, and that parents ought not to seek (...) to find out, the sex of their fetus. I have suggested, for example, that parents not be routinely provided with this information, but be required to ask for it, thus shifting the default.1 But it is one thing to claim that parents should voluntarily refrain from finding out, and another to argue that they should be barred from doing so. There are a number of perspectives from which parents could claim that they have a right to this information. If we think of the fetus as part of the woman's body (as suggested by Roe v. Wade ), then it would be as unacceptable to refuse information about the fetus as it would be to refuse information about the woman's own genetic make-up. If we focus instead on the fetus as a future child, there are again strong arguments that parents have the right to whatever knowledge exists about their child's medical records. Although sex is not exactly a ‘medical’ condition, it certainly a physical one, and one could claim that one has as much right to know that as one does the child's weight at birth or Apgar score. Professor …. (shrink)

Adolescents may often have opinions about whether they want genetic and genomic testing in both the clinic and research and about who should have access to the results. This legal analysis demonstrates that the law provides very little protection to minors' wishes.

This work clarifies the role of the best interest standard (BIS) as ethical principle in the medical care of children. It relates the BIS to the ethical framework of medical practice. The BIS is shown to be a general principle in medical ethics, providing grounding to prima facie obligations. The foundational BIS of Kopelman and Buchanan and Brock are reviewed and shown to be in agreement with the BIS here defended. Critics describe the BIS as being too demanding, narrow, opaque, (...) not taking the family into account and not suitable as limiting principle. This work responds to these criticisms, showing that they do not stand up to scrutiny. They either do not apply to the BIS, only apply to misuses of the BIS or criticise a BIS that is not seriously defended in the literature. (shrink)