Children as research participants: Pregnancy Status
Research involving children requires special consideration on the part of both the research team and the IRB. The purpose of this guidance is to help researchers address the ethical, regulatory, and state law issues related to pregnancy in research subjects who are children.
Version Date: November 26, 2018
Research that excludes pregnant childrenResearch studies frequently exclude pregnant individuals due to possible risks of the research activities on the fetus.
Pregnancy testing of children who may participate in research 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.
Disclosing pregnancy test results
If pregnancy is an exclusion criterion and a pregnancy test is required to determine eligibility to participate in a study, absent a suspicion of abuse as described below, the IRB typically recommends that the results of screening tests be disclosed to the child subject only and not their parent(s)/legal guardian. Once the child has been enrolled in the study, however, the results of any subsequent pregnancy tests would be disclosed to both the child and her parent(s)/legal guardian if study procedures could harm the pregnancy and additional follow-up may be needed (e.g., a drug study where there may be teratogenic effects to the fetus).
While this is the general guidance, there are factors that may necessitate disclosure to parents/guardians even for a screening pregnancy test, or that may make reporting to parents/guardians after enrollment inappropriate. Researchers may consider both the age and maturity of the minor subjects, as well as any other factors that may have an impact on the reporting decision, such as if the child has developmental delays or there are other relevant physical or mental characteristics of the child subjects that would suggest disclosing all pregnancy testing results to parents/guardians. For example, if a researcher is enrolling severely cognitively disabled subjects, a positive pregnancy test in this population, regardless of age, would likely indicate abuse that should be reported to relevant authorities (see below) and may also be disclosed to the parent(s)/legal guardian(s) regardless of whether it was a screening test. On the other hand, a pregnancy in a 17-year-old participating in a study for which parental permission was waived (such as a smoking cessation study) would not necessarily need to be reported to parent(s)/legal guardian(s) where there is no suspicion of abuse.
What constitutes reportable child abuse
Under Wisconsin law, certain health care providers1 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.
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.
Proposed Language in Consent Form
Regardless of the specifics of the reporting plan, both the parental/guardian permission form and the assent form (they may be the same form depending on the age of the minor subjects) should clearly outline when pregnancy tests will be performed, to whom the results will be disclosed, and whether there may be any exceptions to this. For example, the consent/assent may state that pregnancy test results will be disclosed to the child only unless there is a suspicion that the child has been or is being abused. In that case, it may be necessary to disclose such suspicion to appropriate authorities.
1 E.g., physician, nurse, social worker, mental health professional, physical therapist, occupational therapist, dietitian, speech-language pathologist, audiologist, EMT.