The IRB follows the U.S. Department of Health and Human Services (HHS) federal regulations, which requires that "adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent." Additional HHS regulations state: "In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity and psychological state of the children involved."
Division of Research
Children Involved in Research
Allowable Research Involving Children
Federal regulations list four categories of allowable research involving children (noted in 45 CFR 46.404-407):
- Research not involving greater than minimal risk
- Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
- Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition
- Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
HHS Resources
Brown University Policies
- Policy for Determination of Decisional Capacity to Consent by Adult Persons for Human Subjects Research
- Targeting Persons with Known Interpersonal Relationships for Human Subjects Research
Children in Exempt Research
Exemptions under the federal Exempt categories may be applied to research involving children with two exceptions.
Research involving surveys, questionnaires and observation of public behavior can only be exempt if it involves educational tests or the observation of public behavior when the investigator does not participate in the activities being observed.
Research involving benign behavioral interventions and the collection of information does not fall under the exemptions.
Documenting Assent
There is no absolute regulatory or ethical standard for documentation of assent. Federal regulations state: "When the IRB determines that assent is required, it shall also determine whether and how assent must be documented." That being said, there’s a strong implication that documentation would be the usual requirement. That is, the regulations give the IRB the authority to waive the requirement for assent in certain circumstances. That level of regulatory oversight suggests that failure to solicit assent is considered to be a serious violation; that, in turn, suggests that there should be a mechanism for knowing whether such a violation has occurred.
The IRB expects investigators to describe what they are doing about the assent of children in research, and how they’re documenting it. The board often encourages (or even requires) the use of a written assent form for several reasons, including one important reason: It is the child’s right to be involved in this process.
The form satisfies the documentation issue, is a useful tool in explaining the study to a child and serves as a reference source for that child. In addition, making the investigator think through a study well enough to be able to write a clear and simple assent form may make the researcher actually understand the study better and do a better job on the adults’ consent form, too.
A verbal assent process with less detailed documentation may also be acceptable. Researchers may wish to propose this option.
Additional Guidance for Parental Permission
Just as with assent requirements, the HHS has a parental permission requirement for each of the four categories of allowable research, and the IRB has the same ability to waive the requirements as outlined above.
There are circumstances in which getting parental permission may be against the best interests of the child. The specific example cited in federal regulations is a study of abused or neglected children. In that case, the IRB may waive the requirement for parental permission, provided that an appropriate mechanism is substituted to protect the rights and welfare of the children.
Contact HRPP staff in cases where applicability of the requirement for parent or guardian permission is not clear.
Permission from Parents or Guardians
Though research approved under certain categories of research requires permission from both parents, in some situations this is not always possible as both parents or guardians may not be “reasonably available.” There may be only one parent or guardian, one parent may have sole custody after a divorce or one parent may be unavailable. The regulations allow for single-parent or single-guardian permission in such circumstances.
A simplified way to read this requirement is that, if there are two parents in the picture, the child may not be enrolled in the research unless both parents agree to grant permission. Researchers should document in the subject’s file the reasons for deciding that one parent or guardian is not “reasonably available.”
It is important to note that the wishes of a parent or guardian do not override a child’s. If a child does not wish to participate in a research study or does not want to continue participating after enrollment, the child’s wishes prevail.
The requirements for parental permission, and documentation of such permission, are exactly the same as those for a consent process when the prospective subject is a competent adult.
Pregnancy Testing of Child Participants
The Institutional Review Board (IRB) is occasionally presented with research protocols in which the investigator proposes to conduct pregnancy testing of children to protect the health and well-being of the child participant, the health of a fetus and/or the integrity of the research.