This guidance document provides information to assist researchers planning to conduct research with children.
Steps to complete when submitting an application for review:
1. In the consent section of the protocol, describe the process by which parental permission will be obtained and submit the consent form or guide. Include the number of parents from whom consent will be sought (e.g., at least one parent per child or both parents for each child)
2. In the assent section of the protocol, describe the process by which assent will be obtained from children and submit the assent form or guide
3. If research will be conducted in a daycare, child development center, school, or similar setting, submit a letter of support from the facility and/or school district (the latter is required for public schools).
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:
1. A) The research involves no more than minimal risk to the subjects, and B) The waiver or alteration will not adversely affect the rights and welfare of the subjects, AND C) The research could not practicably be carried out without the waiver or alteration, and whenever appropriate, the subjects will be provided with additional pertinent information after participation.
2. Parental permission is not a reasonable requirement to protect the children, provided that a
mechanism is in place to protect the children, and the waiver is not inconsistent with
federal, state, or local law
If the study does not meet the above circumstances, but is eligible for the FLEX initiative, the IRB may permit a waiver of the requirement for parental permission if adequately justified by the Principal Investigator and consistent with any relevant requirements from the research site if minors are being recruited from or studied in a school, camp, or other similar setting. When appropriate, parental notification with a reasonable opt-out period should be utilized. A waiver can only be permitted if it is also consistent with the requirements under FERPA and PPRA.
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 applied to research with adults can also be applied to research with children. Research with children involving interviews or survey procedures, or involving 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 unless the research meets the criteria for the FLEX initiative.
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.