CITI - Research with Children

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent.

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by DHHS

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

The research must pose no more than minimal risk.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?

This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.