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Conducting research with children
- Guidance Contact:
IU Human Subjects Office
Conducting research with children requires special consideration and additional safeguards, especially when obtaining informed consent/assent. Please see the IU HRPP Policy on Children in Research for specific requirements. Additional guidance on some topics is provided below.
Under Indiana law, the following minors have authority to consent for themselves:
- Legally emancipated minors;
- Minors at least 14 years old who are not dependent on a parent for support, who live apart from their parents or an individual in loco parentis, and who manage their own affairs;
- Minors who are married; and
- Minors in the military.
In addition, minors have authority to consent for themselves in the following special circumstances:
- Minors who are at least 17 years old may donate blood without parental permission.
- Minors who have, suspect they have, or have been exposed to a venereal disease may consent to research related to treatment.
As such, minors may consent to research which involves these procedures without parent or guardian consent, and waiver of parental consent is not required for these minors to participate in research. No special permission is required from the IRB for these minors to provide informed consent on their own behalf; however, the circumstances surrounding the determination that such a minor has legal authority to consent on his/her own behalf should be documented in detail in the research record.
The IU HRPP Policy on Children in Research allows for the IRB to waive the requirement to obtain parental permission in one of two situations: (1) when consent is not practicable, and (2) when parental permission is not a reasonable requirement to protect the subjects. The second situation is very rare, usually involving a subject population that is especially vulnerable to abuse or neglect. Please ensure that a request for this waiver is accompanied by a thorough description of the circumstances that make consent an unreasonable requirement.
Under Indiana law, if there is no parent or guardian, or if a parent or guardian is not reasonably available, consent may be obtained from the minor’s grandparent or adult sibling. This requires a single subject amendment to be submitted to the IRB before the exception can be made. If such a submission occurs, please contact the HSO directly to ensure that the submission receives immediate attention.
Mandatory reporting of potential child abuse or neglect
Some research may collect information or include a population which may lead to study teams becoming aware of potential child abuse or neglect. Study teams should be aware of mandatory reporting requirements and should include relevant information in the informed consent if the research collects data which could trigger mandatory reporting. Under Indiana law, individuals with reason to believe that a child has been abused or neglected are required to report that suspicion to the individual in charge of their institution, facility, or agency and to local law enforcement or child protection services.
Assent is a child's affirmative agreement to participate in research. Obtaining assent includes explaining the research to the child in terms that he/she can understand, and obtaining his/her agreement to participate. Study teams describe their plans for obtaining assent in the human subjects application. Plans for assent vary by study based on the complexity of the research and the age, maturity, and psychological state of the potential subjects. When deciding on a plan for assent, consider the guidelines for each age group below, then draft a plan which is appropriate for your research and your subjects.
- Younger than age 7: Children younger than age 7 are generally not considered capable of providing assent, since their age affords limited ability to understand research procedures, risks, and benefits, and to make an informed decision.
- Ages 7-13: Research personnel should have a conversation in age-appropriate language with children, and they should affirmatively assent to participate. If the study team believes that a written assent document will provide value to the assent process, it must be written using language that can be understood by the youngest potential subject and approved by the IRB. Consider using non-text elements like pictures or icons to describe your study.
- Ages 14-17: Since informed consent documents are to be written in 8th-grade language, children between the ages of 14 and 17 should be able to understand the content in the IRB-approved informed consent document. Study teams are encouraged to use the informed consent document to obtain assent from adolescents in this age group, including them in the informed consent conversation with the parent/guardian, and having them indicate assent by signing the informed consent document.
Similarly to obtaining informed consent from adults, obtaining assent from children is a process and not just a document. Research personnel should ensure that the child has all of his or her questions answered and understands the research before agreeing to participate.
Please note that the electronic stamp is not applied to assent documents, effective July 9, 2015.
Adolescents ages 11 to 17 are considered to be of childbearing potential. Use of contraceptives must be carefully considered in drug studies using potentially teratogenic medications and enrolling adolescents.
Adult data suggests that counseling and brief interventions, such as clinical decision supports are only marginally effective in getting adult women onto effective family planning. This is likely to be even more difficult with adolescents, who may have concerns about confidentiality, more limited access to contraceptives, or may not yet see a need for contraceptives in their lives.
While some have advocated to require contraception for all adolescents participating in drug studies of potentially teratogenic drugs, this is problematic for the following reasons:
- Abstinence is common, and developmentally normal at younger ages. Very few 11-14 year olds are sexually experienced. Less than 25% of 15 year olds and only 50% of 17 year olds are sexually experienced.
- Requiring effective contraception may expose these adolescents to additional physical harms (e.g. clotting risks estrogen containing contraceptives) or social harms (e.g. disclosure of sexual behaviors to parents/guardians).
Having said this, there are certainly sub-groups of adolescents at higher risk for unintended pregnancies.
Given the developmental nuance of this population, the IRB may consider the following factors in determining whether the study team’s proposed contraceptive plan is appropriate for studies enrolling adolescents of childbearing age:
- Teratogen: What does the FDA data say about the teratogencity of the medication itself? Are there animal or human data? Is it a teratogen for just females or both males and females?
- Participants: What are the ages, developmental level, and behavioral risk profile of the participants in the study? Older adolescents, adolescents with other risk behaviors, and adolescents who are already sexually active will be at higher risk for unintended pregnancy.
- Risk screening: Are participants asked about menstrual history, sexual history, contraceptive history, intention to engage in sexual activity, and fertility desires? The CDC’s 5Ps provides a good basis for history taking for teens.
- For those who are at potential risk for pregnancy, is there a mechanism for contraceptive provision?
- For longitudinal studies, is there an appropriate plan for repeating screening to ensure sexual history and contraceptive needs have not changed over time?
When research procedures include pregnancy testing of minors, research personnel should define a plan for sharing results of positive pregnancy tests, and inform participants and their parents of that plan in the informed consent and/or assent. For children 14 and older, pregnancy test results should be provided directly to the minor, and parents should be informed only with the minor’s permission or if there is an immediate life-threatening health condition.
For children 13 and younger, parents must be informed of any positive pregnancy test. Additionally, this test result may trigger mandatory reporting requirements.
Learning of an unintended pregnancy can be extremely difficult for both minors and their parents. Research personnel are encouraged to consider involving a social worker to help facilitate the discussion between minors and their parents and provide information about available resources.
Consent issues can be infinitely more complex when children who are wards of the state are involved in research. However, assuming that regulatory requirements are met, these children should not be excluded from participating in important research simply because the consent process may be difficult. As such, investigators should consider the following guidelines when attempting to create a consent plan for wards of the state, but should contact HSO for case-specific guidance and recommendations.
Who are wards of the state?
Wards are children who are placed in the legal custody of the state or other agency, institution, or entity, consistent with applicable federal, state, or local law.
In Indiana, wardship happens when the responsibility for temporary care and custody of a child and the rights and obligations of the child’s parent, guardian, or custodian are transferred to the state of Indiana. After wardship, the state of Indiana is responsible for making decisions regarding physical custody, care and supervision, visitation with parents or other relatives, and medical care and treatment of the child. Practically speaking, this includes:
- children who are placed with foster parents and have not yet been adopted;
- children who are placed in a group home; OR
- children who have been designated as CHINS (Children In Need of Services) but remain in the custody of their parents.
Who can consent for wards?
Identifying the correct person to provide consent for a child who is a ward of the state may be difficult. Consent may need to be obtained from one or more of the following:
- Biological parent(s), especially in situations where placement in foster care is considered temporary or in situations where the child still remains in parental custody;
- Case worker or social worker; or
- Judicially appointed guardian.
In Indiana, the child's Department of Child Services case worker or social worker must be contacted, as they are given authority to determine who may provide consent for medical procedures.
Investigators should be prepared to obtain consent from multiple parties and should be aware that, in some situations, a judge's permission may be required to allow the child to participate in a particular research study.
If a child's familial status changes after enrollment in a study (the child is adopted, placed in a different foster home, returned to his/her biological parent[s], etc.), the investigator may need to seek re-consent from the new parent/guardian if that person did not provide consent at initial enrollment. The investigator or a member of the research team should contact HSO for guidance if he/she becomes aware of a possible change in status.
Enrolling wards in categories 406 and 407
The IU HRPP Research on Children in Research, section 2.4, allows enrollment of wards into research approved under Categories 406 or 407 only if the IRB makes specific findings. In addition, an advocate must be appointed for each ward participating in the research. The advocate cannot be the child's foster parent or any other person acting in the role of a parent (in loco parentis) for the child. The advocate also cannot be associated in any way with the research, the investigator(s), or the guardian organization (such as the Department of Child Services). The advocate must be an individual who has the background and experience to act in the best interests of the child for the duration of the child's participation in the research, and the advocate must agree to act in this way. While each participating child must have an advocate, the same advocate may be appointed to represent multiple children.
In Indiana, all children designated as CHINS should have a court-appointed Guardian Ad Litem (GAL) or Court Appointed Special Advocate (CASA) whose responsibility is to represent the best interest of the child. If a ward does not have a GAL appointed, a member of the research team should contact the HSO for assistance in obtaining an advocate.
The advocate should be involved in the initial consent/assent process and any re-consenting/assenting that occurs during the course of the study. For studies that obtain written documentation of informed consent/assent, the advocate should sign and date the consent document in addition to the person who is legally capable of providing consent for the ward. Additionally, if at any time new or important information is discovered that may affect the ward's health, welfare, or willingness to continue in the study, this information should be communicated to the advocate.
The IU Policy on Programs Involving Children applies to all research activities, in addition to many other ongoing or planned events designed to include children. Investigators are obligated to meet the requirements of this policy in addition to the regulatory requirements described in the IU HRPP Policies.