Research with children is a sensitive topic and, as such, is subject to a variety of regulations and guidelines. Subpart D of the Code of Federal Regulations (CFR) provides specific guidelines for research involving children, including eligibility for exemption under category 2. This article will explain the requirements for exemption under this category.
Understanding Subpart D
Subpart D of the Code of Federal Regulations (CFR) is a set of regulations that apply to research involving children. It outlines the requirements for obtaining approval from an Institutional Review Board (IRB) and provides guidelines for the protection of the rights and welfare of children involved in research. It also outlines the criteria for exemption from the approval process.
Eligibility for Exemption Under Category 2
Research with children may be eligible for exemption under category 2 when:
The research involves the use of educational tests, surveys, interviews, or observation of public behavior that is not exempt under category 1.
The research is conducted in established or commonly accepted educational settings, such as schools, museums, libraries, or after-school programs.
The data collected is publicly available or will be recorded in such a manner that the identity of the children cannot be readily ascertained, directly or through identifiers linked to the child.
The research does not involve any intervention or interaction with the children, and the investigator(s) will not obtain individually identifiable private information from the children or their parents.
The research will not have an adverse effect on the children, and the risk of harm to the children is minimal.
The research is conducted in accordance with the ethical principles outlined in Subpart A of the CFR.
In order to be eligible for exemption under category 2, the research must meet all of these criteria. If the research does not meet all of the criteria, then it will not be eligible for exemption and will require approval from an IRB.
Research with children is a sensitive topic and is subject to a variety of regulations and guidelines. Subpart D of the Code of Federal Regulations (CFR) outlines specific requirements for exemption from the approval process under category 2. To be eligible for exemption, research must meet all of the criteria outlined in the CFR. It is important for researchers to be aware of these requirements in order to ensure that their research is conducted in a responsible and ethical manner.