Research with Children and Youth
General Principles
Children are defined as persons who have not yet attained the legal age for consent to treatment or procedures involved in research as determined by local law. In Iowa, as in many places in the United States, the law considers any person under 18 years old to be a minor. However, in some states, the age of majority is 19. Persons who have reached the age of majority may consent to participating in research and parental permission is not required. For minors, however, the permission of at least one parent or guardian is required, and as a general rule, the assent of the child as well. Permission from parents is usually indicated by signatures on a form similar to a participant consent form, constructed to request "your child" to participate, while youth assent may be oral or written, depending on the age and maturity of the children.
Questions about minimal risk studies that may include college students who are 17 years old should be addressed to the IRB Administrator.
Parental Permission - More than Minimal Risk Studies
Children are considered a vulnerable population because their physical and intellectual capacities are limited and as such, special considerations are necessary. The IRB reviewing research involving children as participants must consider the benefits, risks, and discomforts inherent in the proposed research and assess their justification in light of the expected benefits to the child-participant or to society as a whole. Thus, when the IRB reviews research involving children, it is required to classify such research as involving children in one of four categories. The four categories are:
- Research not involving greater than minimal risk
- Research involving greater than minimal risk, but presenting the prospect of direct benefit to the participant
- Research involving greater than minimal risk with no prospect of direct benefit to individual participants, but likely to yield generalizable knowledge about the participant’s disorder or condition
- Research that is not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
Federal regulations require that research on minors which involves more than minimal risk may be approved only if it is (i) of direct benefit to the participant or (ii) yields useful knowledge about a participant's problem or disorder. In the latter case, both parents must give permission. However, in some cases, the IRB may determine that it is acceptable for only one parent to provide permission, such as when one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. In certain cases where risk would be increased if parental permission is sought (i.e., studies of abuse) and where it would be unreasonable to require parental permission, the IRB may waive the requirement. If a child is a ward of the state, the IRB requires permission from an advocate appointed to function as a guardian on the child's behalf.
Parental Permission - Minimal Risk Studies
As above, a foundational principle undergirding IRB review is that participants have the right to decide if they wish to be involved in research, and by extension, parents have this right on behalf of their minor children. However, in studies involving minimal risk (no more risk than ordinarily encountered in daily life), the IRB may waive the requirement for parental permission when obtaining permission is very difficult or impossible. Researchers requesting a waiver must justify why obtaining permission is highly impractical. The need to exert extra effort is not usually seen as a sufficient reason to waive parental rights.
In minimal risk studies involving normal educational practice, the IRB may approve parental notification with an opt-out process, rather than parental permission. See also Research in K-12 Educational Settings.
Assent
In most studies, the child's assent to participate in the research must also be obtained. An assent is defined as a minor’s affirmative agreement to participate in research. Failure to object should not be construed as assent. The aims and general nature of the project must be described in language that is appropriate to the minor’s age, experience, maturity, and condition. This explanation should also include a discussion of any discomforts and inconveniences the child may experience if they agree to participate.
Parental permission overrules a minor’s decision not to participate in therapeutic settings.
If the child has the capacity (for example, over the age of 6 with sufficient communication and comprehension abilities), written, signed assent is usually preferred, although there may be situations where oral or electronic assent is more appropriate. Regardless of the format, the assent text must be written at the participants' reading level. With older adolescents, the assent form should be as detailed as the parental permission form. With elementary school children, a brief basic assent form is best (see examples at IRB Forms and Samples). It may be advisable and convenient for the parental permission form and child assent form to be combined into one document. Otherwise, obtaining parental permission before seeking child assent is advisable.
In minimal risk studies involving normal educational practice, the IRB may waive the requirement for assent for children up to 6th grade. See also Research in K-12 Educational Settings.
Sample assent, parental permission, and consent forms are available at IRB Forms and Samples.
Audio-Video Recordings
Even when parental permission is not required by the IRB for a research project, researchers are encouraged to obtain parental permission before making audio or video recordings of children and/or to consult school policy and procedure for this purpose. When permission is not given for recordings, those children should not be in view, or their images should be obscured on the recording. For further guidance, see Research Involving Audio or Video Recording.