Re搜索 with children as participants is more complicated than re搜索 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 re搜索 so the consent process as it is normally carried out with adults is modified. The discussion below focuses on social/behavioral/education re搜索 with children and does not address biomedical re搜索 with children. Most 科罗拉多大学 re搜索 with children falls under the educational exemption, 表格可以在 IRB主页.

Children are considered a vulnerable re搜索 population because their intellectual and emotional capacities are limited and, 如上所述, 他们在法律上没有给予有效同意的能力. (特别是在科罗拉多州, children cannot legally sign contracts and signing a consent form is equivalent to signing a contract.)此外, 在年轻的时候, 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 re搜索 project.

In place of consent, children are able to to assent to participation in a re搜索 project. “同意”这个词,联邦法规中使用的, refers to a child's affirmative agreement to participate in re搜索. 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. Re搜索ers must determine whether a particular child is capable of assenting to participate by taking their age, 成熟, 以及心理状态. 适用于六、七岁以上的儿童, a simple assent form may be used; for younger children, 口头同意过程可能更合适. 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.“ IRB主页 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 re搜索, 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, 成熟, 以及文化程度. Re搜索 carried out with young children does not require a written assent form but must still record that assent took place. Normally, re搜索 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, 请联系IRB主席Amanda Udis-Kessler咨询.

Because children are only able to give assent rather than consent, parental permission is required for all re搜索 with children unless the IRB has granted a waiver. Such waivers may be possible for minimal-risk re搜索 with children; contact IRB chair Amanda Udis-Kessler to inquire. A parental permission form template is available on the IRB主页. If children are participating in re搜索 in school contexts, parents can be reached to provide permission in a variety of ways, 包括当面(包括在学校集会上), 开放的房子, 以及通过PTA活动), 通过邮件, 通过电子邮件(学校通知), 教室公告, 学校网站上的帖子), 或者通过学习管理系统.

Re搜索 on children is subject to the Protection of Pupils Rights Amendment (PPRA). This law provides parental control over the content of third-party surveys, 教学材料, 分析, 以及对学生能力的评估. 父母 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 re搜索er's obligation to be aware of this regulation and to communicate with institutions where the re搜索 will be conducted to ensure that there are PPRA-compliant policies at the institutions. PPRA适用于调查研究, 分析, or evaluation that concerns a number of sensitive topics. 在相关的, re搜索ers 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 re搜索er 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. 有关更多信息，请参见 这个链接.

Re搜索 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, 安全, and the integrity of personal information collected from children. 这项法律不适用于非营利组织, but the 科罗拉多大学 IRB treats it as non-negotiable for relevant projects. 更多信息请访问 http://www.ftc.gov/tips-advice/business-center/privacy-and-security/children%27s-privacy.