Standards for Consent and Assent Procedures in Human Subjects Research with Children

The Montana State University Institutional Review Board requires the following for human subjects research with children, where children are defined as individuals who are under age 18. Requirements are drawn from the recommendations of The National Commission for the Protection of Human Subjects of Biomedical and Social Science and from the National Institutes of Health. Although these guidelines use age as the primary criteria in determining the appropriate form of consent to be obtained, additional factors (e.g., literacy, psychological state, developmental level) must also be considered. The primary concern for any consent process will be the ability of the participant to understand the explanation that is presented in order to make a decision about participation.

Individuals who are married, who are or have been pregnant, or who have been declared emancipated minors are exceptions to the general definition of children and may provide consent for their own participation.

    1. Written consent is required from a parent or legal guardian for children who are participants in non-exempt human subjects research.
    2. Verbal or written assent is required from children who are 6 years of age or older. Assent is defined as the child's affirmative agreement to participate and requires active agreement rather than a mere failure to object. Assent from children can be obtained only after parental consent is given. Methods for obtaining assent will vary based on the age of the child.
      1. Children under age 6: No verbal or written assent is required from child.
      2. Children ages 6-12: Children must be provided an age-appropriate oral description of the research. Verbal assent is requested and should be documente4d on the informed consent by a witness.
      3. Children ages 13-18: Written consent should be obtained from both parent and child.