This study explores the ways in which adolescents, even so-called “mature minors”, lack adequate development of the intellectual, affective, and emotional capacities necessary morally to consent to medical research on their own behalf. The psychological and neurophysiological data regarding brain maturation supports the conclusion that adolescents are qualitatively different types of agents than mature adults. They lack full adult maturity and personal agency. As a result, in addition to the usual requirements for IRB approval, one or both parents, or a (...) legal guardian, should provide informed consent for minor children to participate in medical research. (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)

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)

The papers in this volume are largely about research ethics and cover questions of consent, reproduction, pediatric research, ethical codes, and clinical relationships. Half the papers have this common aspect: they are conservative—in the sense of supporting the standard, prevailing, or popular view—but they shift the focus—supporting the standard views in terms of moral factors generally neglected by the literature. The volume provides a diverse set of papers for the reader: variously addressing abstract and concrete problems from within different philosophical (...) traditions. (shrink)