What is required for an IRB to approve research involving children?

For research involving children, Institutional Review Boards (IRBs) are particularly stringent about the level of risk presented to the participants. The requirement that the study must pose no more than minimal risk is foundational to ethical research practices concerning vulnerable populations, such as children. Minimal risk refers to the probability and magnitude of harm or discomfort that is not greater than that ordinarily encountered in daily life or during routine physical or psychological examinations.

This principle is rooted in the ethical guidelines set forth by regulatory bodies, which emphasize the need to protect children from potential harm in research settings. Therefore, IRBs will closely scrutinize the risk levels associated with any proposed study involving children and will likely only approve research that meets this minimal risk criterion.

While control groups can be an important aspect of certain studies, their inclusion is not a prerequisite for IRB approval, especially if the primary focus is on the safe involvement of children. Similarly, the requirement for all researchers to be certified educators or the need for research to be funded by a nonprofit organization does not relate to the fundamental ethical consideration of minimizing risk to child participants. These aspects may contribute to the research framework but do not inherently affect IRB approval related to the protection of vulnerable individuals in research.