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Should Children Be Included in Human Challenge Studies?
1Associate professor of philosophy at McMaster University.
Insights
Pediatric human challenge studies present ethical dilemmas. This research argues against both excluding and including children, advocating for a cautious approach and a strong presumption against their participation in such vital research.
Area of Science:
- Bioethics
- Pediatric Research
- Clinical Trials
Background:
- Human challenge studies intentionally expose participants to pathogens for scientific advancement.
- Ethical debates persist regarding the inclusion of children in these studies.
- Recent guidance suggests potential ethical permissibility for pediatric human challenge studies.
Purpose of the Study:
- To critically evaluate the ethical justifications for and against including children in human challenge studies.
- To propose a nuanced ethical framework for pediatric human challenge research.
- To establish guidelines for the ethical review of pediatric human challenge studies.
Main Methods:
- Analysis of existing ethical arguments for and against pediatric participation.
- Drawing parallels with ethical considerations in Phase I clinical trials for children.
- Developing an age de-escalation approach to research participation.
- Proposing a procedural framework for ethics review.
Main Results:
- Rejection of common arguments for the exclusion of children.
- Identification of pediatric human challenge studies as a complex ethical research category requiring caution.
- Establishment of a strong presumption against the inclusion of children based on necessity and vulnerability.
Conclusions:
- Neither blanket exclusion nor inclusion of children in human challenge studies is ethically well-justified.
- A cautious, necessity-driven approach is required, prioritizing children's vulnerability.
- A structured ethics review process is essential for any proposed pediatric human challenge studies.
Abstract:
Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.
