If your research involves children (children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted – see UW Health guide here), review the HRP 416-CHECKLIST-Children to ensure that you provide sufficient information in your protocol or application to justify enrollment of children. Consider whether parental permission and assent should be obtained (refer to HRP 416 for guidance) and incorporate this information in your protocol or application. For information on state law implications for enrolling children, see HRP 013-SOP-Legally Authorized Representatives, Children, and Guardians.

It possible that a child will reach the age of majority during the course of the study. The Office for Human Research Protections (OHRP) notes that informed consent should be viewed as an ongoing process throughout the duration of a research project. When a child who was enrolled in research with parental or guardian permission subsequently reaches the legal age of consent to the procedures involved in ongoing research, the subject’s participation in the research is no longer regulated by the requirements of 45 CFR part 46.408 regarding parental or guardian permission and subject assent. Unless requirements for obtaining informed consent can be waived, minors who were initially enrolled with parental/guardian permission and then reach the age of majority must provide legally effective consent if the project continues to meet the definition of research involving human subjects. This includes interacting or intervening with the subject or having access to private identifiable information.

Pregnancy testing of children who may participate in research requires special consideration. Such testing could be performed either to confirm eligibility for the study or as part of routine safety monitoring, such as before the administration of a study drug. Researchers must consider how results of such tests will be handled when they involve children and to whom they will be disclosed. This plan must be clearly outlined in the IRB materials as well as in any consent and assent documents.

Under Wisconsin law, certain health care providers must report to law enforcement or child protective services if they have reason to suspect that a child seen by them in the course of professional duties has been abused.

Reportable child abuse does not include consensual sexual activity by an individual 16 years of age or older. Additionally, health care providers who provide health care services to a child and individuals who obtain information about a child who is receiving health care services from a health care provider are not required to report, unless the following is suspected:

• The sexual intercourse or sexual contact occurred or is likely to occur with a caregiver.
• The child suffered or suffers from a mental illness or mental deficiency that rendered or renders the child temporarily or permanently incapable of understanding or evaluating the consequences of his or her actions.
• The child, because of his or her age or immaturity, was or is incapable of understanding the nature or consequences of sexual intercourse or sexual contact.
• The child was unconscious at the time of the act or for any other reason was physically unable to communicate unwillingness to engage in sexual intercourse or sexual contact.
• That another participant in the sexual contact or sexual intercourse was or is exploiting the child.

“Health care services” includes pregnancy testing, as well as family planning services, obstetrical health care or screening, and diagnosis and treatment for a sexually transmitted infection.

If in the course of clinical research a minor has a positive pregnancy test and there is a reasonable suspicion of abuse, the Principal Investigator or a member of the research team should report to law enforcement or child protective services. Nothing in the law requires reporting to a child’s parents/guardians. Researchers should use their judgment in determining whether parents/guardians should be notified of the test results and/or notified of a report to law enforcement or child protective services.

An executive order issued by the governor in 2012 makes all UW employees mandatory reporters of child abuse. For questions pertaining to Wisconsin’s mandatory reporting statute and the executive order, please contact the UW-Madison Office of Legal Affairs at 608-263-7400.

For guidance on assent, the Assent Process and Documentation section.