INFORMED ASSENT DOCUMENT TEMPLATE: NON-MEDICAL PROJECTS
IC 704-A
3/11/13
SAMPLE ASSENT FORM
FOR CHILDREN AND THE COGNITIVELY IMPAIRED
The ability of children and people who are cognitively impaired to understand the concepts and
risks involved in a research project varies from those unable to provide meaningful assent to
those whose understanding is equivalent to that of a normal adult. Thus, no single format can be
provided. One may assume that a normal subject sixteen years of age or older has the level of
understanding (if not the judgment) of a normal adult. The assent of any teenager can usually
be obtained by adding the following to the consent form of the parent(s) or guardian(s):
I have read and understood the research project explained above. Anything that
wasn’t clear to me was explained so I could understand it. If I have any other
questions later, I can have these answered too. I understand that I don’t have to
help with the project even if my parent(s) or guardian(s) say that it is all right.
Even if I decide to do the things I will be asked to do, I can change my mind later
and that will be OK. I have decided I want to help with the project.
For those who are able to read, but are 12 or younger, a separate assent form is needed. The
language of the assent form must be written at their comprehension level. This often takes some
care and imagination. A child may not be able to understand some concepts of a research
project, so they will not need to be addressed. The primary ethical element of the interaction with
the potential subject is the same as it is for legal consent, the respect of persons.
The statement of the American Academy of Pediatrics Committee on Bioethics provides
thoughtful guidance in this arena.
The ethical considerations that underlie the approach to a person who is adult, but whose
competence is temporarily or permanently impaired, are similar to those for children. Respect
for persons, except for those most profoundly limited, requires that each subject be allowed to
withdraw from a research project at any time even if participation has the continuing approval of
his or her parent(s) or legally authorized representative. This right must be clearly presented
during the interview of the potential subject and appropriately reiterated during the course of the
project.
March 2013
Assent Form
Project Title: [Title]
Investigator(s): [Name of Principal Investigator and all other individuals who will
obtain informed consent]
We are doing a research study; a research study is a special way to find out about
something. We are trying to find out [insert purpose of study in simple language]
If you want to be in this study, we will ask you to do several things. [List procedures in
simple terms, include how many contacts]
We want to tell you about some things that may happen to you if you are in this study. [List
and describe any risks or discomforts, e.g., things that take a long time etc.]
Not everyone who is in this study will benefit. A benefit means that something good
happens to you. We don’t know if you will benefit. But we hope to learn something that will
help other people someday.
Sometimes we need to show your information to other people. If you tell us that you have
been abused, or if we think that you might be a danger to yourself or other people, we will
tell someone who can help, like the police or a doctor.
When we are done with the study, we will write a report about what we found out. We will
not use your name in the report.
You do not have to be in this study. It is up to you. If you want to be in the study, but change
your mind later, you can stop being in the study.
If you do not want to be in this study, we will tell you about the other things we can do for
you.
If you want to be in this study, please sign your name.
__________________________________________________________
Your name (printing is OK)
Date
(Optional)
I certify that this study and the procedures involved have been explained in terms the
child could understand and that he/she freely assented to participate in this study.
__________________________________________________________
Signature of Person Obtaining Assent
Date
March 2013