Pregnancy Testing in Minor Research Subjects
Guidance on the pregnancy testing of minor subjects
Version Date: August 3, 2011
Research involving minors requires special consideration on the part of both the research team as well as the IRB. This is particularly so if the study requires pregnancy testing of minor subjects, either to confirm eligibility or as part of routine safety monitoring, for example, before the administration of study drug. Researchers must consider how results of such tests will be handled and to whom they will be disclosed. This plan must be clearly outlined in the application as well as in any consent and assent documents.
If pregnancy is an exclusion criterion and screening procedures to determine eligibility require a pregnancy test, the IRB typically recommends that the results of screening tests be disclosed to the minor subject only and not their parent(s)/legal guardian. Once the subject has entered the study, however, the results of any subsequent pregnancy tests would be disclosed to both the subject and their parent(s)/legal guardian. This is based on the fact that the child may be in a study which 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) and, once enrolled, it would be harder to remove the child from the study and/or secure follow-up care without any explanation to the parent.
While this is the general guidance, there are factors that may necessitate disclosure to parents even for a screening pregnancy test, or that may make reporting to parents after enrollment inappropriate. Researchers may consider both the age and maturity of the minor subjects, as well as any other factors that may impact the reporting decision, such as developmental delays or other relevant physical or mental characteristics of the subject population being studied. For example, if a researcher is enrolling autistic subjects, a positive pregnancy test in this population, regardless of age, would almost certainly need to be disclosed to the parents whether it was a screening test or not. 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 parents.
Reporting Minor Pregnancy to Authorities
Researchers should be aware that there is no age at which the researcher becomes required to report the pregnancy of a minor under state law. Rather, the child abuse laws state that healthcare providers or persons receiving information about a child who has received healthcare services do not have to report sexual intercourse involving a child unless:
- The intercourse occurred with a caregiver
- The child suffers from a mental illness or mental deficiency that renders the child unable to understand the consequences of his/her actions
- The child, because of age or immaturity, was incapable of understanding the consequences of his/her actions
- The child was unconscious at the time of the act or otherwise unable to communicate unwillingness to participate
- Another participant in the sexual intercourse was exploiting the child
Language in Consent Form
Regardless of the specifics of the reporting plan, both the parental 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 they may be any exceptions to this.