In a pediatric study who should sign the ICF? One or both parents/guardians? When is it acceptable to only have one signature?
For research that is federally funded (45 CFR) and for FDA regulated research (21 CFR), the IRB relies on the respective regulation: 45 CFR 46 Subpart D—Additional Protections for Children Involved as Subjects in Research or 21 CFR 50 Subpart D–Additional Safeguards for Children in Clinical Investigations , in determining whether one or both parents are to sign the consent (permission) form.
The IRB may determine that consent (permission) of one parent is sufficient. In making this determination, the IRB considers the research to involve either:
- No greater than minimal risk to children; or,
- Greater than minimal risk but presenting the prospect of direct benefit to individual subjects
In all other cases, the federal regulations require the researcher to obtain consent (permission) from both parents unless the other parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. These other cases are when the IRB determines the research is:
- Greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition; or,
- Not otherwise approvable that present(s) an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
In all four types of research, the IRB is to find that adequate provisions for soliciting the assent of the children and permission of their parents or guardians are met. As regards the signature for legal guardians*, generally the signature of one legal guardian is sufficient; however, the investigator should be familiar with state or local law requirements that may be more stringent.
The requirement of two parent signatures is intended by the IRB and the federal regulations as an additional safeguard and protection for children and not as an obstruction for researchers.
The regulations state, for the latter two cases of research, that both parents must sign the consent form to enroll the child unless “…one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.”
As there is no regulatory definition for “not reasonably available,” the investigator must ultimately make the determination that a parent is not reasonably available to be consulted, with respect to parental permission and he/she should document the reasons supporting that decision in the study file.
*21 CFR 50.53(s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.