UK Office of Research Integrity

IRB Application: Vulnerable Populations

Research Involving Children

If you are proposing research involving individuals under the age of 18, read the UK IRB Policy on Children in Research, check mark the "Children" attribute in the Subject Demographics section of your E-IRB application, and complete the questions as prompted under the Children subsection.

When conducting research with children, the IRB recommends that you take the following issues into consideration in order to meet the highest standards of human research protections. 

  • The child’s previous experience with illness and medical interventions (Some children may be able to cope with the stress of research better than others as a result of previous experience with medicine. Younger, “less experienced” children may be unprepared for participation in medical research).
  • Are the proposed research interventions the least invasive (both physically and psychologically) in order to obtain the necessary data?
  • Whenever feasible, appropriate studies should be conducted on animals, adults and older children before young children are involved as research subjects.
  • Whether personnel working with children are familiar with the State laws requiring the reporting of suspected abuse. 

For definitions of "child/children", "legally authorized representative", "guardian", "assent", "permission", and discussion of emancipated individuals, assent, and waiver of parental permission, see the ORI/IRB Informed Consent Standard Operating Procedure.

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