This guidance document provides information to assist researchers planning to conduct research with children.
Steps to complete when submitting an application for review:
Subpart D of the HHS regulations at 45 CFR 46 provides additional protections for children who are participants in research with human subjects.
Obtaining Parental Permission
Whenever possible, parental permission should be documented in a manner similar to that used to document informed consent. Depending on the risk level, the permission of one or both parents must be obtained before conducting research with children, unless the research qualifies for a waiver of parental permission. The IRB may waive the requirement for parental permission under two circumstances:
In cases where the requirement for parental consent is waived, the IRB may still require a plan for parental notification. For example, for some studies, it may be appropriate to send notification letters home to parents, informing them about the research and giving them instructions on how to opt-out if they do not want their child to participate in the research. For additional information, please see the decision tree on obtaining parental permission.
Obtaining Assent of Children
Assent refers to a child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent. When determining the appropriate method for obtaining assent, the IRB takes into account the ages, maturity and psychological states of the children involved in the research. For younger children (typically up to 7 years old), a verbal process explaining the experience of participating in the research may be the most appropriate method of obtaining assent. Older children (ages 8-17 years old), who are capable of reading, can be provided with a written assent form that explains what the research entails. Please see the HRPP website for additional guidance on writing assent forms.
The IRB may waive the requirement for assent under the following three circumstances:
1. The capability of some or all of the children is so limited that they cannot be reasonably consulted;
2. The intervention or procedure involved in the research holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of the research;
3. The research meets the same conditions as those for waiver or alteration of informed consent in research involving adults(outlined in 1a-c in the parental permission section above.)
Children cannot participate in research without parental permission unless a waiver of parental permission is granted by the IRB. However, parental permission cannot override a child’s refusal to give their assent, unless the research holds a potential life-saving benefit to the child.
If the child reaches the legal age of consent during the study, the investigators should then obtain consent from the participant.
Exempt Research Categories for Research with Children
With one exception, the categories of exemption that are applicable to research with adults can also be applied to research with children. Research with children that involves interview or survey procedures, or the observation of public behavior if the investigators participate in the activity being observed, will be reviewed by an expedited procedure or at a convened meeting of the board.
Enrolling Children who are Wards of the State or any other Agency, Institution, or Entity
Additional laws apply when enrolling children who are wards of the state or any other agency, institution, or entity. Please refer to the Policy and Procedures Manual on the HRPP website and contact the office for consultation.