Research with children as participants is more complicated than research with adults, not least because children are legally understood to be vulnerable participants in need of special protections. Children are also not legally able to consent to participate in research so the consent process as it is normally carried out with adults is modified. The discussion below focuses on social/behavioral/education research with children and does not address biomedical research with children. Most Colorado College research with children falls under the educational exemption, for which a form can be found on the IRB homepage.

Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and, as noted above, they are legally incompetent to give valid consent. (In the state of Colorado in particular, children cannot legally sign contracts and signing a consent form is equivalent to signing a contract.) Moreover, at younger ages, children may be more likely to defer to their parents and other authority figures such as teachers, and therefore may be less able to stand up for themselves and refuse to participate in a research project.

In place of consent, children are able to to assent to participation in a research project. The term "assent," as used in federal regulations, refers to a child's affirmative agreement to participate in research. Failure to object to participation is not equivalent to affirmative agreement; children must actively demonstrate a willingness to participate rather than (for example) simply complying with directions to do so. Researchers must determine whether a particular child is capable of assenting to participate by taking their age, maturity, and psychological state into account. For children older than six or seven years of age, a simple assent form may be used; for younger children, a verbal assent process may be more appropriate. Assent forms for older children may be almost identical to consent forms used with adults, but must legally use the word "assent" instead of the word "consent." The IRB homepage has two templates for assent forms, one for younger children and one for older children. It is extremely rare for IRBs to waive assent requirements for social/behavioral/educational research, and the only circumstance in which it would be waived would involve children with limited capacity to understand the assent process.

Documentation of assent is flexible and will depend on the child's age, maturity, and degree of literacy. Research carried out with young children does not require a written assent form but must still record that assent took place. Normally, research with older children will involve a signed assent form. The IRB can determine that documentation of assent is not necessary, using the same principles that it would use to waive documentation of adult consent, contact IRB Chair Amanda Udis-Kessler to inquire.

Because children are only able to give assent rather than consent, parental permission is required for all research with children unless the IRB has granted a waiver. Such waivers may be possible for minimal-risk research with children; contact IRB chair Amanda Udis-Kessler to inquire. A parental permission form template is available on the IRB homepage. If children are participating in research in school contexts, parents can be reached to provide permission in a variety of ways, including in person (including at school fairs, open houses, and through PTA events), by mail, by email (school announcements, classroom announcements, posts on a school website), or through a learning management system.

Research on children is subject to the Protection of Pupils Rights Amendment (PPRA). This law provides parental control over the content of third-party surveys, instructional materials, analysis, and evaluation of children in their student capacities. Parents must have the opportunity to review study materials ahead of time and must have the option to either provide permission for their children to participate or to opt out of their children's participation. It is the researcher's obligation to be aware of this regulation and to communicate with institutions where the research will be conducted to ensure that there are PPRA-compliant policies at the institutions. The PPRA applies to survey research, analysis, or evaluation that concerns a number of sensitive topics. Where relevant, researchers should include parental information documents and opt-out/opt-in sheets along with other materials submitted to the IRB. Even if the IRB otherwise waives the requirement for a researcher to secure parental permission, PPRA requires that parents must still be notified about the project and must have the opportunity to withdraw their children from participation. For more information, see this link.

Research on children younger than 13 should also take the Children's Online Privacy Protection Act (COPPA) into account. There are special requirements for websites collecting information about children 12 years old or younger, including required parental permission as well as safeguards to protect confidentiality, security, and the integrity of personal information collected from children. This law does not apply to nonprofits, but the Colorado College IRB treats it as non-negotiable for relevant projects. More information is available at https://www.ftc.gov/tips-advice/business-center/privacy-and-security/children%27s-privacy.