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Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct
David Wendler1, Leah Belsky, Kimberly M Thompson
1Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, Md 20892, USA. dwendler@nih.gov
Insights
Institutional review boards (IRBs) often apply pediatric research risk standards too cautiously. Empirical data on risks from daily life, like car trips and sports, are needed to guide IRB decisions and ensure child protection.
Area of Science:
- Pediatric research ethics
- Risk assessment in clinical trials
- Regulatory compliance in human subjects research
Background:
- United States federal regulations permit institutional review boards (IRBs) to approve pediatric research with minimal risk or a minor increase over minimal risk.
- Minimal risk is defined by risks ordinarily encountered in daily life or routine examinations.
- IRB members often rely on intuitive judgment due to a lack of empirical data on pediatric risks.
Purpose of the Study:
- To provide empirical data on risks encountered by children in daily life and routine activities.
- To evaluate the consistency of IRB application of the federal minimal risk standard in pediatric research.
- To inform potential revisions of federal regulations for pediatric research oversight.
Main Methods:
- Analysis of existing data on mortality risks associated with ordinary activities, specifically car travel.
- Examination of morbidity risks associated with participation in common children's sports, using basketball as an example.
- Comparison of empirical risk data with the federal definition of minimal risk for pediatric research.
Main Results:
- Car trips represent a significant source of ordinary risk for children, with mortality risks ranging from 0.06 to 4 per million depending on age and trip type.
- Participation in sports like basketball carries higher morbidity risks, with approximately 1900 injuries per million instances, including fractures and permanent disabilities.
- Findings suggest that IRBs may be overly cautious in applying the minimal risk standard, potentially hindering beneficial pediatric research.
Conclusions:
- Empirical data on the risks of daily life and sports challenge the current conservative application of the minimal risk standard by IRBs.
- The federal minimal risk standard may require re-evaluation to ensure it adequately protects children while facilitating necessary research.
- There is a need for evidence-based guidelines to support IRB decision-making in pediatric research approval.
Abstract:
United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments. Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research. Current data reveal that car trips pose the highest risk of mortality ordinarily encountered by healthy children. On average, these risks are approximately 0.06 per million for children aged 14 years and younger, and approximately 0.4 per million for children aged 15 through 19 years. Riskier, but still ordinary, car trips pose an approximately 0.6 per million chance of death for children aged 14 years and younger and an approximately 4 per million chance of death for children aged 15 through 19 years. Participation in sports represents the upper end of the range of morbidity risks for healthy children. For every million instances of playing basketball, approximately 1900 individuals will sustain injuries, including 180 broken bones and 58 permanent disabilities. These findings suggest IRBs are implementing the federal minimal risk standard too cautiously in many cases. These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards.
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