U.S. Department of Health & Human Services
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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 participate in the activity being observed.
In other words, the only research activities involving children that may fall under this exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed. To be exempt, these activities must also meet the condition that the data are recorded without individual identifiers, or the condition that disclosure of the recorded responses would not place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. Otherwise, all the requirements of the human subjects regulations apply.
Last Reviewed: 01/20/2011
Related Questions:
- What is parental permission in the context of research involving children?
- Can parental or guardian permission for research involving children be waived?
- How should parental permission for research involving children be documented?
- Do both parents need to provide permission for their child to participate in research?
- What is child assent, and how do the requirements vary with the age of the research subjects?
