To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal (...) risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (shrink)

Volume 20, Issue 4, May 2020, Page 102-103.

Most agree that clinical research offers one of the best prospects of improving pediatric medicine. Most also agree that children may be exposed to some degree of risk while participating in clinical trials. But the degree of risk that should be permitted and the reasons for which it should be permitted remain controversial. In this paper, I examine a central risk threshold in research with children—the threshold constraining risks that do not offer research subjects the prospect of direct medical benefit. (...) That is, the threshold for research risks undertaken in the interests of deriving valuable knowledge that may benefit future children, but not the research subjects themselves. I examine competing... (shrink)

Mainstream moral theories deal with situations in which the outcome of each possible action is well-determined and knowable. In order to make ethics relevant for problems of risk and uncertainty, moral theories have to be extended so that they cover actions whose outcomes are not determinable beforehand. One approach to this extension problem is to develop methods for appraising probabilistic combinations of outcomes. This approach is investigated and shown not to solve the problem. An alternative approach is then developed. Its (...) starting-point is that everyone has a prima facie moral right not to be exposed to risk. However, this right can be overridden if the risk-exposure is part of an equitable system for risk-taking that works to the advantage of the individual risk-exposed person. (shrink)

Volume 20, Issue 4, May 2020, Page 108-110.

Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable projects can benefit individuals in (...) two ways. First, individuals may come to ?embrace? the contributions they made as children. Second, contributing to valuable projects can lead to a better overall life. Because these potential benefits can outweigh small research risks, they provide a justification for pediatric research without the potential for clinical benefit, when it poses low risks and has the potential to benefit others in important ways. (shrink)

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than “minimal” risks, according to guidelines accepted around the world. We need a new standard for what “minimal” risks are, however—one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.

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.

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (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)

Volume 20, Issue 4, May 2020, Page 106-108.