IRB Guidance: Research with Minors

This page addresses the special requirements when including human subjects under the age of 18 years as research subjects.

Minors are considered a protected class of participants in research and are afforded additional protections in the Common Rule under 45 CFR 46 Subpart D – “Additional Protections for Children Involved as Subjects in Research.”

When conducting research with minors, some of the additional protections are: 

Minimal risk
Research must present minimal risk to participants. Only minimal risk research will be approved by the ED/SBS IRB.

Exemptions
The IRB is often asked why all education-based research is not considered Exempt—citing the exemption for 45 CFR, 46.101 (b) (1): Research conducted in established or commonly accepted educational settings, involving normal educational practices. What many researchers are not aware of is that, as noted above, research involving minors is also reviewed under Subpart D of the regulations, “Additional Protections for Children Involved as Subjects in Research.” Per 46.401 (b): The exemption for research involving survey or interview procedures, or observations of public behavior does not apply to any research covered by Subpart D. Because most proposals that are submitted with minors as participants also include survey and/or interview procedures—the exemption does not apply.

In addition, research that is exempt under 45 CFR 46 is still subject to other federal regulations, such as FERPA. Educational records pertaining to minors are never “exempt” from FERPA and consent or a data use agreement is always required.

Reporting Requirements
Reported, suspected, or observed abuse or neglect of a minor must be reported to the study’s PI and campus Legal Affairs.  Wisconsin Executive Order #54: Supplemental Mandatory Reporting Requirements of Child Abuse and Neglect requires all UW System personnel to report abuse/neglect of minors (this would include students when working in the role of a researcher).
  • “Abuse” includes physical, emotional, or sexual abuse; treatment without consent; confinement or restraint;
  • “Neglect” means failure to provide adequate food, shelter, clothing or medical care.

Consent/Assent
Minors, under the age of majority, may not legally consent to participate in research. For participants under the age of 18 years old, parental consent must be obtained. Waivers of parental consent may only be applied if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children).

In addition, as all human subjects research must be voluntary, child assent must be obtained in addition to parental consent. Assent can only be obtained after parental consent is obtained. Both parental consent and minor assent are required; a minor may decide not to participate even if their parents have provided consent.

Participants between the ages 11-17 must sign an assent form (unless an appropriate justification is provided for a waiver of the signature). The assent form contains the same information as the parental consent form,  written at an age-appropriate level.  For participants under age 11, an oral assent process is often most appropriate.

As noted above, if the IRB feels that participants may disclose information that requires reporting, consent forms may have to include text that informs participants that confidentiality may be broken in those situations. An example of that text might be:
"While it is in the intention of the Study Team to keep all of the information you provide confidential,  per Executive Order 54, if we become aware of abuse or neglect of a minor, that confidentiality will be broken."





Keywords:minors, children, assent, parental consent, parents, Executive Order 54   Doc ID:42989
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-19 11:44 CSTUpdated:2018-11-01 09:17 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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