Institutional Review Board Practices Regarding Assent in Pediatric Research
* Department of Clinical Bioethics National Institutes of Health, Bethesda, Maryland
National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland
Emmes Corporation, Bethesda, Maryland
Objective. To assess how Institutional Review Boards (IRBs) implement the assent requirement for research with children.
Methods. Telephone interviews were conducted with 188 chairpersons of IRBs from a range of institutions nationwide. Respondents were queried on 4 topics: 1) which children are considered capable of assent, 2) which information investigators must provide pediatric research subjects, 3) whether IRBs favor the enrollment of children who are capable of assent, and 4) how chairpersons view payment for children’s research participation.
Results. Half of IRBs have a method that they require investigators to follow when determining which children are capable of assent, most commonly an age cutoff. Half of IRBs do not have a method, and the majority rely on investigators’ clinical judgment. IRBs largely follow the adult research regulations when determining which information should be provided to an assenting child. A total of 58% of IRBs would enroll a child who is incapable of assent in a nonbeneficial study, even if children who are capable of assent could be enrolled instead. Almost half (46%) of chairpersons believe that it sometimes or always acceptable to offer incentive payments to children, and more than one third (35%) thought it acceptable to offer payment to the parents.
Conclusion. When possible, IRBs follow the federal regulations for research with adults when implementing the assent requirement. For considerations that do not have analogs in the adult regulations, IRB practices vary widely. These data suggest that IRBs need guidance on how to implement the assent requirement in a way that provides appropriate protections for pediatric research subjects.
Key Words: child • IRB
Abbreviations: IRB, Institutional Review Board • OR, odds ratio
Received for publication Oct 6, 2003; Accepted Feb 10, 2004.
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