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This guidance document provides information to assist researchers planning to conduct research with children.
Steps to complete when submitting an application to the IRB:
1. Complete the submission process, paying special attention to sections regarding children in the application and protocol
2. Describe the process by which parental permission will be obtained within the consent section of the protocol and submit the consent form or guide
3. Describe the process by which assent will be obtained from children within the assent section of the protocol, and submit the assent form or guide
4. If research will be conducted in a formal setting (daycare, child development center, etc.), submit letters of support from the facility. If research will be conducted in a public school, submit a letter of support or formal permission from the school district.
Subpart D of the HHS regulations at 45 CFR 46 provides additional protections for children who are participants in research with human subjects.
For protocols involving children, the federal regulations identify four categories of research. Three of the four categories can be reviewed by the IRB. These categories are as follows.
• §46.404 Research not involving greater than minimal risk.
• §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
• §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
A fourth category of review requires review beyond the IRB. This review is conducted by the Secretary of Health and Human Services.
• §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
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,
B) The waiver or alteration will not adversely affect the rights and welfare of the
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
There is no such thing as “passive” consent. However, under some circumstances, parental notification is sufficient. 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
As defined by the federal regulations, ‘assent’ means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, 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 what the experience of participating in the research will be 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 IRB website for additional guidance on writing assent forms.
Assent must be obtained from children unless it can be appropriately waived by the IRB. There are three circumstances under which a study may qualify for a waiver of assent:
1. if the capability of some or all of the children is so limited that they cannot be reasonably consulted;
2. if 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. if 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
Research with children can fall under exempt categories in the same way as research with adults, with the exception of exempt category 2 which applies to research involving educational tests, interviews or survey procedures, or observation of public behavior. 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.
Enrolling Children who are Wards of the State or any other Agency, Institution, or Entity
a. Children who are wards of the state or any other agency, institution, or entity can be included in research involving greater than minimal risk with no prospect of direct benefit only if such research is:
1. Related to their status as wards; or
2. Conducted in schools, camps, hospitals, institutions, or similar settings in which the
majority of children involved as subjects are not wards.
b. If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.