AAP’s guidelines for pediatric-based research
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The Elk Grove Village, IL-based American Academy of Pediatrics (AAP) provides very specific guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations, and these may be generally applicable to any pediatric research. The AAP’s guidelines state that research studies may be considered ethically permissible when they demonstrate a potential benefit to the individual child or provide a general knowledge. Also, the potential benefits must outweigh the potential risks. The U.S. Department of Health and Human Services (HHS) has published risk/benefit categories for when products requiring FDA approval are part of research that involves minors, and the AAP’s guidelines follow the same four-part criteria. The AAP guidelines note:
1. Research that does not involve greater than minimal risk, including research with or without direct benefit to children of all ages, should have an IRB finding that appropriate provisions are made for soliciting permission/assent/consent.
2. Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual subject, should be assessed by an IRB for the following:
- whether the risk is justified by the anticipated benefits;
- whether the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches;
- whether appropriate provisions are made for soliciting permission/assent/consent.
3. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield a general knowledge about the subject’s disorder or condition should also be assessed by the IRB. The IRB’s findings should include the following points:
- that the risk represents a minor increase over minimal risk;
- that the intervention or procedure presents experiences that are similar to those inherent in their actual medical, social, psychological, and educational situations;
- that the intervention or procedure is likely to yield a general knowledge about the subjects’ disorder or condition which is of vital importance;
- that appropriate provisions are made for obtaining permission/assent/consent.
4. Research that is not otherwise approved may present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, and this will be conducted only when the following occurs:
- the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
- HHS or another appropriate governmental agency, after consultation with a panel of experts, has determined that the research meets all of the conditions of the first three categories or that the research meets the IRB finding above, and that the research will be conducted in accordance with sound ethical and scientific principles and will have appropriate provisions for soliciting the permission/assent/consent of children and the permission of their parents or guardians.
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