Research Involving Children
What are the consent requirements for working with children?
- Generally, prior to consenting/assenting anyone under the age of 18 into a research project, investigators must seek the permission of the child’s parents/guardians through the use of a parental consent form. Assent is required of children age 12 years and younger in additional to parental permission. Assent is a child’s affirmative agreement to participate in research. Informed consent is required for children aged 13 to 18 and is required in additional to parental permissions.
Are there any other University policies I need to be aware when working with minors?
- Please be aware of and ensure your research is in compliance Kent State University Policy 5-19, University Policy Regarding On-Campus Activities Involving Minors.
What special protections for Children as Research Subjects are required?
- 45 CFR 46 requires the IRB to determine a category of research based on the degree of potential risk and benefit. The KSU IRB supports this process by the use of Appendix I, which must accompany all submissions that include child research participants.
- OHRP guidance can be found at: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/special-protections-for-children/index.html
- NIH guidance can be found at: https://humansubjects.nih.gov/children1
Do I need a letter of support to recruit children from schools?
- Yes. If you plan to recruit children form a school (inclusive of high school, middle school, elementary and pre-k schools) your submission must be accompanied by an acceptance letter from the school’s principal or superintendent. If it is not practical to obtain an acceptance letter prior to approval please notify the reviewer/Office of Research Compliance.
Does the Protection of Pupil Rights Amendments (PPRA) affect my research?
- If the research is occurring in schools, it may: https://www2.ed.gov/policy/gen/guid/fpco/ppra/parents.html
Do any of the exemption categories apply to research on children?
- Yes. All elements of Category 1, 4, and 5. Category 2 research (educational tests, surveys, interviews, public behavior observation) applies only when procedures are limited to the observation of public behavior in which the investigators do not interact with the children or educational testing. Research involving surveys or interviews with children, or observation of public behavior when investigators interact with children, does not qualify for exempt status under this category
Does the Children's Online Privacy Protection Act (COPPA) apply to research?
- It may if your study involves the online collection of personal information about children under 13. In such cases the PI needs to consult with University Counsel; the IRB should be notified of UC's requirements/recommendations. Additional information on COPPA can be found at: https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/childrens-online-privacy-protection-rule