When may research with children be eligible for exemption according to Subpart D?

Research involving children may be eligible for exemption according to Subpart D when it uses educational tests, provided the tests are not designed to reveal sensitive information about the child. This aspect of research is addressed under specific regulations that allow for exemptions in situations where the risk to children is minimal, and the research methods are not invasive. Educational tests typically fall into a category where the benefits of the research and the level of risk are balanced, permitting exemption status.

In this context, while parental consent is crucial for research involving minors, the act of requiring consent alone does not determine exemption eligibility. Similarly, claiming that research guarantees no risks to participants is overly broad and unrealistic, as all research carries some level of risk, albeit minimal. The involvement of physical interventions often increases the risk for child participants, making such research less likely to qualify for exemption. Therefore, educational tests are particularly notable in this regard, as they represent a methodology that can align with exemption criteria when conducted ethically and responsibly.