Subpart D of the Code of Federal Regulations outlines the requirements for research involving children. It provides information on when research involving children is eligible for exemption under Category 2. This article will provide an overview of Subpart D and explain the conditions under which research with children may be exempt from certain regulations.
Subpart D Overview
Subpart D of the Code of Federal Regulations (CFR) is a set of regulations that applies to research involving children. It was originally published in 1978 and has been amended several times since then. The regulations are designed to protect the rights and welfare of children who are participating in research. They cover a wide range of topics, including the selection of research participants, the informed consent process, and the reporting of research results.
Subpart D also contains information on when research with children is eligible for exemption from certain regulations. Exemptions can be granted when the research poses no more than minimal risk to the participants and when the exemption is consistent with the protection of the rights and welfare of the participants.
Category 2 Exemption Eligibility
Research with children may be eligible for exemption under Category 2 when:
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The research involves normal educational practices that are not likely to adversely impact the children’s well-being;
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The research is conducted in established or commonly accepted educational settings;
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The research is designed to evaluate the effectiveness of instructional strategies or curricula;
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The research does not involve any intervention or interaction with the children;
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The research does not involve any physical contact with the children; and
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The research does not involve the collection of any personally identifiable information from the children.
In order to be eligible for exemption under Category 2, all of the above conditions must be met. If any of the conditions are not met, the research may not be exempt from certain regulations.
Subpart D of the Code of Federal Regulations outlines the regulations for research involving children. It provides information on when research with children may be eligible for exemption under Category 2. In order to be eligible for exemption, the research must meet certain conditions, including that it involves no more than minimal risk to the participants and that it is conducted in an established or commonly accepted educational setting.
