Federal regulations and IRB policies require the IRB to make additional determinations when reviewing research involving minor subjects. In addition to determining which category of pediatric research a particular project fits into, the IRB must affirmatively determine how many parental signatures are required on the study’s informed consent/parental permission form.
The three* categories are:
- Research not involving greater than minimal risk
- Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
- Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition.
Category 3 studies require the signature of both the subject’s parents, unless one is not reasonably available, deceased, etc. However, under the regulations at 45 CFR 46.108(b), “the IRB may find that the permission of one parent is sufficient for research” in categories 1 and 2.
Translated, this means: The baseline requirement in the regulations is for 2 signatures for all three categories. The IRB must make an affirmative decision that one parental signature will suffice. The thought that “it’s a category 1 (or 2) so only 1 signature is required” is not sufficient.
IRB reviewers — Please consider the how-many-parent-signatures question separately in reviewing pediatric research, and justify your determination in your CLARA notes. You can consider the risks and benefits of the projects, and the description of the proposed consent process, in making this determination.
Study teams — When submitting protocols, please include a mention of how many consent/permission form signatures you plan to obtain for the research and your rationale for the number you choose. While the IRB has the authority to override your decision, having this information available will help with our reviews.
*(A fourth category, research “not otherwise approvable” and requiring a consultation with the secretary of HHS, is not done at UAMS/AC.)