This essay reflects on arguments by Paul Ramsey, in The Patient as Person: Explorations in Medical Ethics (1970) and elsewhere, that continue to challenge policy‐makers and those doing clinical and translational research involving children. Ramsey argued that parents cannot morally authorize their child's participation in research unless the research is designed to benefit the child. He acknowledged that abiding by this position could have adverse impacts on improving child health, and he concluded, in a 1976 Hastings Center Report piece, that (...) researchers must “sin bravely.” Many philosophers and theologians, including Richard McCormick, have argued against Ramsey. The Ramsey‐McCormick debate played out in the bioethics literature and, by invitation, at the deliberations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with developing an ethics framework and policies for human subjects protections. Although in its final recommendations, the commission sided with McCormick, the strict limitations on risks and harms to which a child can be exposed were clearly influenced by Ramsey. (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)

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 problems presented by the use of named child patients and their medical histories in television, radio and newspapers is discussed. It is suggested that it is not acceptable to regard this as comparable to their participation in non-therapeutic research, and that no one, not even the parent has the authority to give consent to such use.

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)

The public often believes that parents have a right to make medical decisions about their child. The idea that, in respect of children, doctors should do what parents tell them to do is problematic on the face of it. The effect of such a claim would be that a doctor who acted deliberately to harm a child would be making a morally correct decision, providing only that it is what the child’s parents said they wanted. That is so obviously nonsense (...) that it cannot be what people who claim it actually mean. In this paper, I suggest that the claim actually represents either or both of two misunderstandings. It can be a result of wrongly appealing to the principle of respect for autonomy, or a belief that doctors are not committed to acting in the interests of the child. In this paper, I show that, while neither belief is entirely justified, there are elements of truth in both. I argue that if ethically correct decisions are those that are directed to improving the quality of a child’s existence, then neither parents nor doctors are in a position to make ethically correct decisions about a child except in discussion with one another. Where such discussion is not possible, I suggest there should be a national Children’s Interests Panel to agree on the child’s interests. The panel should include, but not be limited to, paediatricians and lawyers and its decisions should be legally binding on all parties. (shrink)

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...) all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive. (shrink)

We argue that the current ethical and regulatory framework for permissible risk levels in pediatric research can be helpfully understood in terms of children’s moral right to adequate protection from harm. Our analysis provides a rationale for what we propose as the highest level of permissible risk in pediatric research without the prospect of direct benefit: what we call “relatively minor” risk. We clarify the justification behind the usual standards of “minimal risk” and “a minor increase over minimal risk” and (...) explain why it is permissible to impose any risks at all on child participants who do not stand to benefit directly from enrollment in research. Finally, we illuminate some aspects of the concept of “best interests.”. (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)