Lived Experience, Partnership, Acceptable Risk, and Social Value in Pediatric Research.

Abstract

In this issue of Pediatrics, Schupmann et al1 detail findings of a survey of the US public regarding acceptable risks in pediatric research, specifically noting the role that high social value plays in one’s willingness to consider higher risk. The authors assessed respondents’ views of acceptable risks with 3 scenarios of increasing level of potential social value: developing treatments with fewer side effects, developing treatments to extend life, and developing curative treatments. Although US regulations permit pediatric research that poses minor increases over minimal risk, some argue that it is unethical to expose children to any research risk of nontherapeutic procedures, such as a biopsy or experimental drug, that benefit others but not the child participating in the research. In the study by Schupmann et al1, most (84.5%) respondents believed it appropriate to expose children to research risks to gather information to benefit others. Overall, ∼50% of respondents supported research with greater risk, including a 1% chance of death, to identify treatments to extend life. For example, 69% found it acceptable to have children, such as a 10-year-old with advanced cancer, undergo bone marrow biopsy, which poses a higher-than-minimal risk, if the findings might lead to the development of treatments to extend life for future patients.The authors note that future studies should include sampling of respondents with limited English proficiency. However, this type of evaluation is needed from an even broader and more representative sample with sufficient sample size so that subgroup analysis would be possible. Although there is great value in identifying the views of the public about social value as a factor in determining acceptable pediatric research risks, certain life experiences should be considered more intentionally in future studies. The authors note that because of “an unfortunate history of exploiting individuals from minority groups,” they assessed whether individuals from minority groups had different views regarding net-risk pediatric research. Perhaps the most important next step would be to partner with persons in minority groups, such as those with disabilities, Black individuals, and American Indians, who have been disproportionately exploited by research. There are many reasons why net-risk research in children is controversial, and we cannot ignore the role of history. We must be intentional in not allowing the “unfortunate history” to repeat itself. Trust and relationship building are required to make changes to acceptable risk in pediatric research and doing so requires researchers to engage meaningfully and authentically with individuals who have been exploited to identify the proper balance with acceptable risks and social value. Unfortunately, the authors report that 42% of respondents were neutral about whether researchers can be trusted. Clearly, there is distrust that must be addressed before considering pediatric research associated with added risk.The limitations of this work related to the use of hypothetical scenarios of children near the end of life also bear additional consideration. A wide chasm exists between hypothetical situations and the reality of what might occur. As a mother whose 11-year-old child with chronic conditions and disabilities died, I did consent to research with higher risk and greater social value earlier than the last few months of life. The last few months of a child’s life are not necessarily so focused on the risk of death as on providing comfort and savoring every moment. This chasm between hypothetical and real life was captured in the study, as 65.2% of respondents found a dose of an experimental drug to be an acceptable risk for the social value of curing a type of cancer but only 37% indicated willingness to enroll their own child in the same scenario of risk for social value. The key point is that families need to be further engaged to understand what an acceptable risk is and what defines social value.The next steps in exploring acceptable risk and social value in research for our children require us to take a step back from surveys and to work together. This report is another important reminder of the need for meaningful partnerships among researchers, policymakers, clinicians, youth, and families.