Are the exemptions different for research involving children?
One of the six exemptions of research involving human subjects is narrowed in scope by Subpart D’s additional protections for research involving children. The other five exemptions apply to research involving children as human subjects in the same way that they apply to research involving adults. The narrowed exemption is the exemption at 45 CFR 46.101(b)(2), which generally applies to research involving educational tests, interviews or survey procedures or observation of public behavior, if the data are recorded without individual identifiers, or if disclosure of the recorded responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. Where children will be involved as research subjects, however, the use of survey or interview procedures is eliminated from this exemption, and so is research involving the observation of public behavior if the investigators partici
