IRB: Documentation and General Requirements of Assent
Policy number:
704 A
References:
45 CFR 46.117
21 CFR 50.27
http://www.research.umn.edu/irb/forms.html
AAHRPP II.3.F and G
AAHRPP II.4.B
Date: 05/19/14
Policy Owner:
Executive Director, HRPP
Cross References:
704 Assent of Subjects
Appendix Y
Definitions:
None
1.0 Reason for Policy
The reason for this policy is to describe the process for documentation of assent.
2.0 Scope of Policy
The scope of this policy is the University community and its healthcare components.
3.0 Policy Statement
The investigator is expected to create an assent form that is age-appropriate and study-specific, taking
into account the typical child's experience and level of understanding, and composing a document that
treats the child respectfully and conveys the essential information about the study. The form should:
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Tell why the study is being conducted
Describe what will happen and for how long or how often
Indicate that it is up to the child to participate and that it's okay to say no
Explain if it will hurt and for how long and how often
Indicate what the child's other choices are
Describe any good things that might happen
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Indicate whether there is any compensation for participating
Ask for questions
The document should be limited to one page where possible. Illustrations might be helpful, and larger
type makes a form easier for younger children to read. Studies involving older children or adolescents
should include more information and may use more complex language. Parental consent forms also may
be revised to include the assent of older children, provided the directive language is revised and the
appropriate signature and date lines are added.
Information Sheets
In circumstances where the research involves an option for a child whose illness has not responded to
other available treatments or for whom standard therapies are not suitable, it is unlikely that a child’s
refusal to participate would be honored. In such cases, it is more appropriate to provide children with an
information sheet that contains the same information as an assent form would, but without the indication
of choice. This respects the child’s right to understand the research and what will happen to him/her,
while acknowledging that there are situations in which a parent’s authority must override the wishes of
the child.
4.0 Required approvals for this document
Title
Executive Director, HRPP
5.0 Revision History
Revision
05/19/14
11/09/09
06/22/09
09/26/06
Reason for change
AAHRPP revision
Update AAHRPP references
Reformat
Policy Development
Date of release
09/02/14
11/09/09
06/22/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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