This overview describes the breadth of topicscovered in this volume devoted to children inresearch. It summarizes how these articles areinterrelated and how they all respond to thechallenge proposed by the Children's Health Actof 2000: to consider what modifications, ifany, are necessary to current regulations ``toensure the adequate and appropriate protectionof children participating in research.''.

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had (...) disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies. (shrink)

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had (...) disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...) public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

United Stated federal regulations allow participation of children in greater than minimal risk research with no potential for direct benefit under narrowly defined circumstances. This type of research is controversial, as it runs contrary to the best interest standard, on which we base most decisions made on behalf of children. I argue that such research is ethically defensible if a fully informed, scrupulous, and virtuous parent would choose to enroll his or her child in the study. Further, I defend the (...) current regulations, which allow local Institutional Review Boards to approve more than minimal risk, nontherapeutic research when the research involves children with the medical condition being studied, but requires federal review for similarly risky studies that involve healthy children. Because families of children with medical diseases tend to be more familiar with the health care system and with medical procedures, they are more able to make informed decisions about the burdens of research participation. Further, parents of children with medical conditions have a morally significant interest in advancing medical knowledge about their child's condition. It is appropriate to take this interest into account when evaluating the ethical status of a research study. (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)

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 essay examines conceptual difficulties with one of the ways in which justice has been understood and applied the ethical and regulatory review of human research. Justice requires the fair distribution of the benefits and burdens of research. Class membership is seen as justifying inclusion in higher hazard-no benefit research from which members of potentially vulnerable classes, such as children, typically would be excluded. I argue that class membership does not do the justificatory work it is thought to do and (...) that the use of class membership to justify inclusion in higher hazard-no benefit research leads to unjustified discrimination of sick children and offers special protections to healthy children. (shrink)

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the (...) Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was appointed in 1974 as part of the National Research Act in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. (shrink)

Das Wiskott-Aldrich-Syndrom (WAS), ein genetisch bedingter Immundefekt mit klinischer Manifestation im Kleinkindalter, wird voraussichtlich in näherer Zukunft erstmals versuchsweise durch eine somatische Gentherapie behandelt werden. Im vor- liegenden Beitrag werden die wichtigsten medizinisch-naturwissenschaftlichen Fakten dieses Krankheitsbildes sowie die bisherigen Erfahrungen mit somatischen Gentherapien bei anderen Immunmangelsyndromen ausführlich dargestellt. Sodann erfolgt eine ethische Analyse eines möglichen gentherapeutischen Eingriffs bei WAS-Patienten, bei der die spezifischen Aspekte des Wiskott-Aldrich-Syndroms – insbesondere die fast ausschließliche Betroffenheit von Kindern sowie die unterschiedlich aussichtsreiche Alter- nativoption einer (...) allogenen Knochenmarktransplantation–wesentliche Aspekte der Beurteilung sind. Im Ergebnis zeigt sich, dass ein gentherapeutischer Eingriff im vorliegenden Fall nicht im Rahmen einer Forschungsstudie, d.h. als Humanexperiment, gerechtfertigt werden kann, sondern allein als individueller Heilversuch. Gleichwohl las- sen die besonderen Risiken und die Innovativität eines solchen Eingriffs es notwendig erscheinen, diesen Heilversuch – anders als andere Heilbehandlungen mit bislang unerprobten Mitteln – in streng kontrollierter Form durchzuführen. Der neuartige Gedanke eines kontrollierten individuellen Heilversuchs zeichnet sich daher für den vorliegenden Fall, und womöglich auch für vergleichbare risikoreiche Behandlungsansätze namentlich im Bereich der Gentherapie, als geeignetes Instrument der Konzeption und Beurteilung ab. (shrink)

The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on the body and vulnerability. It (...) is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent. (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 meaning of valid proxy consent for children has recently been the subject of an important debate between Richard McCormick and Paul Ramsey on the ethics of experimenting with children. Ramsey is willing to agree with McCormick that parental consent for a child to undergo some medical procedure is valid only if parents consider what the child would consent to if he could. But beyond this, Ramsey has a fundamentally different conception of the child from McCormick, and therefore gives a (...) very different interpretation to this standard for valid proxy consent. In Ramsey's view, McCormick's basic mistake is to think of the child as a small adult, thereby overlooking the child's peculiar vulnerabilities and needs. In particular, McCormick fails to attend to the child's needs for "preservation in life and healthful growth". In this paper, the author pursues Ramsey's suggestion that a correct analysis of valid proxy consent for children would replace the "language of consent" with the "language of need". He does this by sketching a theory of parenthood that rests on two central notions: that of primary goods, as found in the writing of John Rawls, and that of autonomy. (shrink)