The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for (...) the informed consent of the subject. (shrink)

This chapter explores the foundation and content of the duty to respect persons. The authors argue that it is best understood as a duty to recognize people’s rights. Respect for persons therefore has specific implications for how competent and non-competent persons ought to be treated in research. For competent persons it underlies the obligation to obtain consent to many research procedures. The chapter gives an analysis of the requirements for obtaining valid consent. It then considers respect for persons as it (...) relates to four common topics: the therapeutic misconception, research with children and adolescents, the use of deception in research, and research on competent adults without their consent. (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)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical (...) and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention as such. It has (...) been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

The topic of consent in paediatrics is made more difficult, and at the same time more interesting, by the complexity of the issues involved and the consequent diversity of viewpoints. In a teaching session for senior medical students on consent in paediatrics it proved necessary to reinstate previous learning from a range of disciplines. Philosophical medical ethics, developmental psychology, communication skills and the appropriate legal definitions all contributed to a proper understanding of the cases presented. The two most important additional (...) components appeared to be a) a basic knowledge of cognitive development and how to apply it, and b) an awareness of the need to balance an individual child's rights or best interests, with those of the family unit, as well as the wider society. (shrink)

Section 47 of the 1948 National Assistance Act allows incompetent people, usually old people, to be removed from their homes. It can be considered as a repressive tool, designed to infringe personal liberty, but in this article it is argued that it can also be considered as being legislation which governs and controls professional practice and protects the old person from public prejudice.

Ethical issues about children’s rights in respect of matters concerning resource allocation or treatment opportunities are now a matter for public consumption and concern. Alongside this exists a long-frustrated desire by children’s nurses to promote children’s health. Long-held assumptions about the legal and moral status of children within the health care system in this country are now rightly scrutinized and challenged. Those of us who claim to represent children now possess an opportunity to exploit public attention for the benefit of (...) these children. This article will explore selected major relevant legal and moral concepts that relate to children with the aim of making transparent some of the important and often confusing information available. It is anticipated that debates about the legal and ethical status of children may be stimulated and fuelled from the following discussion. It is strongly recommended that entering into dialogue with families and children about their perceived needs will go a long way towards advancing thoughtful nursing care of individual children, their families and the general population. (shrink)

Definition of the problem: Medical research with children, especially non-therapeutic research, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of minimal risk, criteria for evaluating (...) risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed. (shrink)

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)

Assent to medical research or treatment may be an intuitively attractive way to address the area between incapacity and capacity that might otherwise be subject to a best interests assessment. Assent has become a widely disseminated concept in law, research, and clinical ethics, but little conceptual work on assent has so far occurred. An exploration of use of assent in treatment and research in children and people with dementia suggests that at least five claims are made on behalf of assent. (...) Since at least some of these may lead to tensions with others, assent requires firmer conceptual underpinning. Whether assent remains primarily a local approach to research in children in the United States, where it appears to fit with legal background conditions, or develops its promise to overturn the dominant, binary, approach to (in)capacity will depend on the strength of future philosophical work to improve the theoretical foundations to assent. (shrink)