IRB: Assent of Children
Policy number:
704
References:
45 CFR 46.408 Subpart D
21 CFR 55.55 Subpart D
AAHRPP II.3.F and G
AAHRPP II.4.B
Date: 05/16/14
Policy Owner:
Executive Director, HRPP
Cross References:
501 Vulnerable Populations
501D Requirements for Research Involving Children
Appendix Y
Definitions:
Assent – a child’s affirmative agreement to participate in research.
1.0 Reason for Policy
To describe the University of Minnesota IRB requirement for assent of children.
2.0 Scope of Policy
The scope of this policy is the University community and its healthcare components.
3.0 Policy Statement
Assent of the child is required in most research involving children who have the capacity to comprehend
aspects of the research project. Though children under the age of eighteen cannot legally “consent” to
participate, most children 8 years of age and older have the cognitive and emotional maturity to
understand aspects of a research project and to decide whether or not they want to participate in it. Mere
refusal to object cannot be construed as assent to participate.
The IRB determines that adequate provisions are made for soliciting the assent of the children when in
the judgment of the IRB the children are capable of providing assent. In consultation with the IRB and
with the professional judgment of the investigator, assent may be waived in certain circumstances.
Page 1 of 2
In determining whether children are capable of providing assent, the IRB takes into account the age,
maturity, and psychological state of the children involved. This judgment may be made for all children
to be involved in the research under a particular protocol, or for each child, as the IRB deems
appropriate.
The assent of the children is not a necessary condition for proceeding with the research if the IRB
determines that either of the following is true:


The capability of some or all of the children is so limited that they cannot reasonably be
consulted or
The intervention or procedure involved in the research holds out a prospect of direct
benefit that is important to the health or well-being of the children and is available only in
the context of the research clinical investigation
Even where the IRB determines that the participants are capable of assenting, the IRB may still waive
the assent requirement if it finds and documents that




The research involves no more than minimal risk to the participants;
The waiver will not adversely affect the rights and welfare of the participants;
The research could not practicably be carried out without the waiver;and,
Whenever appropriate, the participants will be provided with additional pertinent
information after participation
4.0 Required approvals for this document
Title
Executive Director, HRPP
5.0 Revision History
Revision
05/16/14
11/09/09
06/22/09
09/29/06
Reason for change
AAHRPP update
Update AAHRPP references
Reformat
Policy Development
Date of release
09/02/14
11/09/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
Page 2 of 2