What categories of research involving children can an Institutional Review Board approve?

Three of the four categories of human research involving children may be approved by an Institutional Review Board (IRB). The four categories differ from one another according to the level of risk involved, the prospect of direct benefit to the research subjects, and the anticipated research findings. For all four categories, the proposed research activity must satisfy the requirements for parental or guardian permission and child assent.

Depending on the category, additional conditions must be met in order for the IRB to approve the research activities. The three categories approvable by an IRB are: • Section 404 of the regulations allows the IRB to approve research if the IRB finds that the risks of the research are no more than minimal. €¢ Section 405 of the regulations allows the IRB to approve research if the IRB finds that: • more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject or ... more.

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