The first installment of our latest continuing education program for IRB reviewers. We’ll have a new topic each month that we’ll post about on the blog and discuss briefly at that month’s IRB meetings. We’re starting with research involving children.
Our affiliation with Arkansas Children’s means we not infrequently review human subject research involving child subjects. Additional protections and regulatory requirements apply to children as research subjects. Here’s a recap of what reviewers need to keep in mind as they review these studies.
In Arkansas, children are those who have not yet reached their 18th birthday and who have not been legally emancipated. Events such as marriage or incarceration do NOT result in automatic emancipation, but they may allow minors to provide consent for their own health care. Studies involving married or incarcerated minors will receive close scrutiny in the office before being forwarded to the board.
The risk categorizations for children’s research differ from those for research enrolling only adult subjects. Children’s research can be categorized into one of four categories, according to the regulations:
- Not involving greater than minimal risk — Category 1
- Involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. — Category 2
- 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
- Not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (This category requires input from outside the institution, and we have never seen one of these in all our time here.) — Category 4
And there are a couple of additional potential complications in these risk determinations:
- Sometimes children become adults when they’re involved in research. For those studies, the IRB must make risk determinations for both children AND adults
- The FDA has indicated that for studies under its purview, the IRB should consider the risk level for different study arms individually. For example, in a study involving both a placebo or an intervention, the placebo arm will likely not have any prospect for direct benefit, but the intervention arm might. So we have to make two risk determinations for that type of study.
Consent and assent for research involving children:
Unless consent is waived entirely, child subjects’ parents or legal guardians must provide permission for their child to participate in research. The IRB may determine that a single parent’s consent is adequate for category 1 and 2 research. Both parents must provide permission for category 3 research, unless one parent is deceased, unknown, incompetent, or not reasonably available. The parent(s) would provide permission for a minor child, but if the minor turns 18 while still on study, the minor must then be reconsented on their own behalf.
Children capable of signaling their agreement to participate in research are asked to give their assent to joining the study. The UAMS IRB typically requires assent beginning at age 7. We have no specific requirements for how assent should be documented. Some researchers add a short assent section to the main consent document. Others create a separate assent form for children. Still others create more than one version of the assent form, each tailored to a different age range if the study will enroll both elementary and high school-age children.
Mothers who are minors can provide permission for their children’s research participation, but generally can’t for themselves (unless the study relates directly to the pregnancy or birth).
Another twist is that the IRB can waive the requirement to obtain parent or guardian permission if the study is designed for a condition or subject population for which such a requirement is not a reasonable one to protect the subjects, such as neglected or abused children.