IRBs Determine Acceptable Risk for Pediatric Studies
There is ongoing, significant debate about the ethics of exposing minors to research risks to benefit others.1 “Many people in research ethics have written on this and offered their view. But we were not aware of any attempt to find out what a representative sample of the public thinks,” says David Wendler, MA, PhD, head of the section on research ethics at the NIH Clinical Center.
“Net-risk” research involves interventions that do not offer participants a potential for clinical benefit that justifies the risks and burdens they face. “Some people argue that exposing children to risks for the benefits of others is unethical,” Wendler says.
Wendler and colleagues wanted to learn more about these attitudes, including what might constitute acceptable risks and how the social value of research affects opinions on risk. A total of 1,658 U.S. adults were given one of four hypothetical scenarios, describing procedures with varying levels of risk and social value.2
Overall, 84.5% of respondents said it can be appropriate to expose children to risks if the study might benefit others. Only 15.5% said it was never appropriate. Most respondents (60.9%) said it was acceptable to expose children to somewhat higher risks if the study offers greater benefits, such as a possible cure for cancer. Generally, 91% approved of pediatric research participants submitting to blood draws. About 69% approved of participants undergoing a bone marrow biopsy.
However, respondents would be less inclined to enroll their own children in clinical trials. About half of respondents supported clinical trials posing more serious risks (including a 1% chance of death in children with short life expectancies) if the study could lead to treatments that would extend life for future patients. Still, only one-quarter said they would be willing to enroll their own child in that hypothetical study.
Notably, the proportion of participants who agreed a procedure was acceptable expanded as the social value of the study increased. “There was very strong support for net-risk pediatric research and willingness to accept somewhat higher risks than are typically regarded as acceptable,” Wendler notes.
IRBs may be disinclined to approve study protocols based on the mistaken belief there is little public support for net-risk pediatric research. “We don’t know for sure, but I suspect they are mostly allowing very low-risk studies and not approving study protocols when the risks are higher,” Wendler offers.
In light of this, researchers are going to show IRBs data on the risks of the interventions in question. “Don’t just claim a procedure is minimal risk. Provide data to show that it is,” Wendler urges.
To demonstrate the study’s social value, researchers could explain how the approach under investigation could help address an important health condition.
“IRBs should be aware that the vast majority of the U.S. public supports net-risk pediatric research, provided it has the potential to collect data that have social value and the risks are not excessive,” Wendler says.
- Wendler D. The ethics of net-risk pediatric research: Implications of valueless and harmful studies. IRB: Ethics & Human Research 2018;40:13-18.
- Schupmann W, Li X, Wendler D. Acceptable risks in pediatric research: Views of the US public. Pediatrics 2022;149:e2021052687.
IRBs may be disinclined to approve study protocols based on the mistaken belief there is little public support for net-risk pediatric research. Thus, researchers should show IRBs data on the risks of the interventions in question. To demonstrate the study’s social value, researchers could explain how the approach under investigation could help address an important health condition.
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