This paper argues that liberal tenats that justify intervention to promote the welfare of an incompetent do not suffice as a basis for analyzing parent-child relationships, and that this inadequacy is the basis for many of the problems that arise when thinking about the state's role in resolving family conflicts, particularly when monitoring parental discretion in medical decision-making on behalf of a child. The state may be limited by the best interest criterion when dealing with children, but parents are not. (...) The state's relation with the child is formal while the parental relation is intimate, having its own goals and purposes. While the liberal canons insist on the incompetent one's best interest, parents are permitted to compromise the child's interests for ends related to these familial goals and purposes. Parents decisions should be supervened, in general, only if it can be shown that no responsible mode of thinking warrants such treatment of a child. Keywords: proxy medical consent, children's rights, state's protection of children, parental authority and the state's intervention, paternalism, liberalism, parental values CiteULike Connotea Del.icio.us What's this? (shrink)

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...) how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

Should the authority to make treatment decisions be extended to the competent patient's family? Neither arguments from fairness nor communitarian concerns justify such an infringement on patient autonomy.

Medical decisionmaking would be a messier but better thing if it honored what is morally valuable about patients' families. The concerns of intimates have a legitimate call upon us even when we are ill.

To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

A 78 year old married woman with progressive Alzheimer's disease was admitted to a local hospital with pneumonia and other medical problems. She recognized no one and had been incontinent for about a year. Despite aggressive treatment, the pneumonia failed to resolve and it seemed increasingly likely that this admission was to be for terminal care. The patient's husband (who had been taking care of her in their home) began requesting that the doctors be less aggressive in her treatment and, (...) as the days wore on, he became more and more insistent that they scale back their aggressive care. The physicians were reluctant to do so, due to the small but real chance that the patient could survive to discharge. But her husband was her only remaining family, so he was the logical proxy decisionmaker. Multiple conferences ensued, and finally a conference with a social worker revealed that the husband had recently proposed marriage to the couple's housekeeper and she had accepted. (shrink)

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one (...) that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research. (shrink)

The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped (...) IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)