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When is Human Research in Children Ethical or Unethical?

January 4, 2022

In the US and many other countries, human research that involves children can only be approved by institutional review boards if:

  • There is no more than minimal risk (in other words, the risk is not greater than what would be typically encountered in daily life) to the child
  • There is more than minimal risk to the child, but the research (for example, an experimental treatment) also has the potential to be of direct benefit to the child
  • There is a little bit more than minimal risk to the child (in other words, if the risk is consistent with experiences that the child would typically have with their medical, psychological, social, or educational situations,) but there is potential for important knowledge to be gained about the child’s disorder or condition

There is a 4th category (45 CFR 46.407), which allows pediatric research that is more than minimal risk to the child when there is potential for addressing “serious problems” that affect the health of children. Research in this category has to be approved by the US Secretary of Health and Human Services.

There is much controversy about this 4th category, and some believe that this type of research is unethical. However, it is unclear what the general public thinks about this type of research.

Will Schupmann, Dr. Xiaobai Li, and Dr. David Wendler from the Department of Bioethics and the Biostatistics and Clinical Epidemiology Service, NIH Clinical Center, conducted a survey to better understand public opinion about pediatric research, and their results are being early released this week in a Pediatrics article entitled, “Acceptable Risks in Pediatric Research: Views of the US Public" (10.1542/peds.2021-052687).

The authors sought to determine the answers to two questions:

  • Is it acceptable to expose children to some research risks if the research will benefit other children?
  • If research has greater social value, does that justify exposing children to greater risk?

In their survey, they presented scenarios that involved one of 4 procedures with increasing levels of risk:

  • Blood draw (minimal risk)
  • Bone marrow biopsy
  • Kidney biopsy
  • One dose of an experimental drug.

Each scenario described the procedure in 3 separate scenarios with increasing social benefit:

  • Development of treatments with fewer side effects
  • Development of treatments that extend life by several months to several years
  • Development of treatments that are curative

Each survey participant was randomized to receive scenarios with one of the procedures and told to imagine that they had a 10-year-old child with advanced cancer who had a high chance of dying in the next few months. However, the child was eligible for a study that would not directly benefit the child, but the information from this study could potentially benefit other children with this type of cancer. They were asked if it was appropriate to enroll children in these studies and whether they would enroll their child. They were also asked general questions about enrolling children in studies that would not directly benefit them but would benefit other children.

A total of 1,658 adults participated. Nearly all approved of the blood draw in all circumstances. As the social benefit increased, more participants approved, regardless of the risk of the procedure.

There are more details (you’ll have to read the article!) than we can discuss in this blog. Cara Coleman, an attorney who is Director of Public Policy and Advocacy for Family Voices, Associate Editor for Family Partnerships for Pediatrics, and most importantly, the parent of a child with medical complexity, wrote an important commentary that is a must-read for all of us who care for children and who conduct pediatric research (10.1542/peds.2021-054429). She discusses the importance of partnering with communities (including those with disabilities, Black and American Indian individuals) who have been exploited in research. She also points out that hypothetical scenarios are not equivalent to real-life situations, and that one may make very different decisions when confronted with the question.

Please take a look at both the article and the thoughtful commentary. Even if you are not a researcher, both of these will impact how you think about these issues.

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