Infants are unable to make their own decisions or express their own wishes about medical procedures and treatments. They rely on surrogates to make decisions for them. Who should be the decision-maker when an infant’s biological parents are also minors? In this paper, we analyse a case in which the biological mother is a child. The central questions raised by the case are whether minor parents should make medical decisions on behalf of an infant, and if so, what are the (...) limits to this decision-making authority? In particular, can they refuse treatment that might be considered best for the infant? We examine different ethical arguments to underpin parental decision-making authority; we argue that provided that minor parents are capable of fulfilling their parental duties, they should have a right to make medical decisions for their infant. We then examine the ethical limits to minor parents’ decision-making authority for their children. We argue that the restricted authority that teenagers are granted to make medical decisions for themselves looks very similar to the restricted autonomy of all parents. That is, they are permitted to make choices, but not harmful choices. Like all parents, minor parents must not abuse or neglect their children and must also promote their welfare. They have a moral right to make medical decisions for their infants within the same ‘zone of parental discretion’ that applies to adult parents. We conclude that adult and minor parents should have comparable decision-making authority for their infants. (shrink)

This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, assent (...) and dissent to assess the individual’s judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis. (shrink)

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research (...) incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, risk thresholds serve to demarcate risk (...) categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk. (shrink)

Society and social structures play an important role in the formation and evaluation of concepts and practices in clinical ethics. This is evident in the ways the authors in this issue explore a wide range of arguments and concepts in clinical ethics including moral distress and conscience based practice, phenomenological interview techniques and gender dysphoria, continuous deep sedation (CDS) at the end of life, the notion of patient expertise, ethically permissible medical billing practices, the notion of selfhood and patient centered (...) care in dementia patients, and the definition of minimal risk as used in research regulations. (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)

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler and Christine Grady to (...) animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

Research risks have to meet minimal risk requirements in order for the research to qualify for expedited ethics review, to be exempted from ethics review, or to be granted consent waivers. The definition of “minimal risk” in the Common Rule (45 CFR 46) relies on the risks-of-daily-life and risks-of-routine-tests as comparators against which research activities are assessed to meet minimal risk requirements. While either or both comparators have been adopted by major ethics codes, they have also been criticized. In response (...) to criticisms, elaborations, and alternative comparators have been proposed. In this paper, I approach the search for workable comparators from the point of view that ethical reasoning about minimal risk involves analogical reasoning using comparators. In this regard, I develop two necessary conditions for an adequate minimal risk conception, which I use to assess three comparators. I conclude that the risks-of-routine-tests best fits the analogical reasoning operating in minimal risk assessments. (shrink)

Dealing with situations where parents’ views about treatment for their child are strongly opposed to doctors’ views is one major area of ethical challenge in paediatric health care. The traditional approach focuses on the child’s best interests, but this is problematic for a number of reasons. The Harm Principle test is regarded by many ethicists as more appropriate than the best interests test. Despite this, use of the best interests test for intervening in parental decisions is still very common in (...) clinical settings and can lead to confusion. In this paper, I propose the Zone of Parental Discretion as a means of putting into practice the key ideas of the Harm Principle, in a clear, step-by-step process. The Zone of Parental Discretion provides a tool for ethical deliberation by clinicians and ethicists about all situations in which parents and doctors disagree about treatment of a child, whether parents are refusing medically recommended treatment, or requesting non-recommended treatment. (shrink)