When the signature of a parent or legal guardian is required for pediatric research, what is expected in terms of the documentation collected by the investigator to prove that the person accompanying the child and signing consent is the parent or a parent with sole custody or is a legal guardian. Are legal documents required in all cases where two parents are not accompanying the child? And even then, is legal proof required?
– Quality Manager, Clinical Trials Management Group
The requirements for permission of parents or guardians and for documentation of consent are intended by the IRB and the federal regulations (Source 1 | Source 2) as an additional safeguard and protection for children and not as an obstruction for researchers. As there is no federal regulatory requirement to provide proof of a parent or guardians’ legal authority to consent, IRBs are unlikely to set a requirement. This is consistent with respect to confirming the identity of individuals presenting themselves for inclusion in research. Sponsors or sites may impose their own requirements.
The WCG informed consent template does include the following statements below the signature lines indicating parental permission. Some sponsors choose to include this as a check box “attestation” in the parental permission/consent form.
1st signature line: Signature of adult subject capable of consent, child subject’s parent, or individual authorized under state or local law to consent to the child subject’s general medical care.
2nd signature line: When the IRB requires permission of both parents, the signature line for the second parent includes the statement that the signature is required unless this subject is an adult, the second parent is deceased, unknown, incompetent, or not reasonably available, or the parent providing consent has sole legal responsibility for the care and custody of the child.
The approach to documentation of legal authority to consent for may depend on both the research setting and on state law. State laws may vary widely. Investigators should be familiar with state or local law requirements that may be more stringent. When the research is done in a clinical care setting, the practice may already have policies in place that guide the practice of pediatric medicine. At a minimum, the clinician would have established some knowledge of the relationship between the parent and the child, and when in doubt, would have asked for additional information or documentation.
Note that the federal regulations require that when research poses greater than minimal risks with no potential benefit to subjects, both parents must give their permission “unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care of the child.” While there is no regulatory definition for “not reasonably available,” and no federal guidance on how to make the determination, the Secretary’s Advisory Committee on Human Research Protections concludes that “ultimately the responsibility of the investigator to adequately assess, document and decide whether a parent is not reasonably available given the specific facts and circumstances of each situation, including the level of that second parent’s participation in the life of the child.” In this case, the investigator could include a note to the study file documenting the assessment and decision to allow one parent’s permission to enroll in a study. Here is a link to the SACHRP recommendations for a discussion on how the term “reasonably available” should be applied and interpreted.