Background
On occasion, the Brown IRB is presented with research protocols in which the investigator proposes to conduct pregnancy testing of children. Such testing may be intended to protect the health and well-being of the child participant, the health of a fetus, and/or the integrity of the research.
For the purposes of this document, pregnancy tests will be in-person urine tests conducted at Rhode Island research sites and the results will be immediate. All references in this document to “parent(s)” refer to “parent(s)/legal guardian(s).”
Principles
1. Investigators have a special obligation to protect the health and safety of children participating in research studies, which involves, as applicable:
a. pregnancy testing in children as a necessary research procedure,
b. protecting the health of pregnant child participants and their fetus regarding any specific eligibility criteria for the study,
c. abiding by local and/or State laws with regard to mandated reporting regulations, and
d. engaging child participants and their parent(s) in transparent parent permission and assent processes.
2. Communication with child participants and their parent(s) must be:
a. accessible,
b. culturally appropriate, and
c. consistent with and applicable to their level of understanding.
3. Brown IRB policies and positions will be:
a. consistently applied by Brown’s IRB,
b. consistent with Brown’s peer institutions, and
c. accessible to Brown investigators.
Considerations
1. Parent Permission and Assent Processes:
a. Investigators are responsible for informing child participants and their parent(s) that certain actions will occur if the child is found to be pregnant during the course of the study, and what those actions are.
b. In the application, parent permission form, and assent, investigators must describe:
i. procedures for testing child participants for pregnancy,
ii. if there are mandated reporting requirements to State authorities (i.e., Department of Children, Youth, and Families [DCYF]), and
iii. if they will or will not notify parent(s) of a positive pregnancy test, and
1. if investigators will not notify the parent(s) of a positive pregnancy test, the application must detail these circumstances and justify why/how notification would increase risk for the child participant.
c. Child participants ≤ 14 years of age:
i. Any pregnancy in a child participant ≤ 14 years of age is considered abuse and must be reported to their parent(s) and the State (DCYF).
ii. Mandated reporting language is required in all parent permission and assent documents.
iii. Investigators must be very clear during the parent permission and assent processes that this information will be shared with parent(s) and authorities. As part of these processes, the child participant
and their parent(s) can make an informed decision about the child’s study enrollment.
d. Child participants 15 - 17 years of age:
i. Pregnancy in child participants 15 - 17 years of age does not automatically mean abuse has occurred or require reporting to parents or the State.
1. Investigators should not probe for more information.
2. Reporting is mandatory if :
a. a child participant volunteers information about the age of the participant’s partner or the researcher otherwise knows the age of a child participant’s partner, and
b. the partner is over 18 and the child participant is over the age of 14 but under the age of 16.
3. Reporting is mandatory any time investigators have cause to know or suspect that abuse has occurred.
ii. Mandated reporting language is required in all parent permission and assent documents.
iii. Investigators must be very clear during the parent permission and assent processes what information about the child will be shared with parent(s) and authorities and what will not be shared. As part of
these processes, the child participant and their parent(s) can make an informed decision about the child’s study enrollment.
2. Reporting Requirements:
a. Investigators and mandated reporters with reasonable cause to know or suspect that any child participant has been abused or neglected must report that knowledge or suspicion to DCYF within 24 hours.
b. All licensed medical providers on a research study are expected to know and follow the guidelines applicable to their licensure for State law, including any expedited reporting requirements.
c. Particular vulnerabilities of a child participant, such as mental incapacitation, mental disability, and physical helplessness, may increase the likelihood that abuse has occurred in certain situations, and investigators
should take these characteristics into consideration when assessing the circumstances.
d. Any person who makes a report in good faith is protected from liability by law. When in doubt, an investigator should err on the side of reporting.
e. To report suspected abuse or neglect, call the DCYF statewide hotline at 1-800-RI-CHILD (1-800-742-4453). The hotline operates twenty-four hours per day, seven days per week. All calls are recorded, and you may call anonymously. More information can be found at http://www.dcyf.ri.gov/.
3. Resources:
a. There are boundaries between investigators and participants, and limits to an investigator’s responsibility in a research setting, so that investigators are expected to:
i. respect the agency of child participants,
ii. refrain from taking on the role of a parent or a healthcare provider,
iii. provide reasonable resources, and
iv. be flexible and leverage these resources if a child participant asks for assistance.
b. Investigators must describe in the application when they will provide resources to child participants (i.e. at the beginning of the study, after a positive test).
c. During the parent permission and assent processes, investigators must be explicit with the child participant and their parent(s) when discussing the scenarios under which a child and/or parent(s) will receive resources
regarding pregnancy.
d. Investigators are responsible for providing child participants with appropriate resources, applicable to their age, location, and cultural demographic.
This document was developed by a subcommittee of the IRB, and was voted on by the Full Board and adopted on September 17, 2020.