OBTAINING THE PERMISSION OF MINORS
TO PARTICIPATE IN RESEARCH:
ASSENT AND CONSENT
In the past, researchers and regulatory bodies assumed that the age of consent for
research was the age of majority. People who are not adults because they are under
18 years of age are known as “minors”. When researchers seek the participation of
minors in their research, they have sought consent from the adult parents or guardians;
from the minors, themselves, they have sought assent.
Yet the most recent version the Tri-Council Policy Statement (2014) has taken a new
direction suggesting that, for some minors, it is appropriate for the researcher to ask for
consent. The TriCouncil advocates that researchers should adopt a decision-making
capacity approach when determining whether they should seek assent or consent from
minors.
The following guidelines developed by the Conjoint Health Research Ethics Board aim
to assist researchers in determining when they should seek consent from minors, and
when seeking assent is more appropriate.
Research decision-making capacity assessment
As a general rule, when proposed participants are minors under 14 years of age, the
investigator should seek assent from the child and consent from the parent(s) or legal
guardian.
When the proposed participants are minors 14 years and older, researchers must
assess the child’s capacity to make a decision about his or her research participation.
To have research decision-making capacity requires that:
1. The minor is competent in the sense that he or she has the ability to reason, and
can understand and appreciate the risks and benefits of participating and of not
participating;
2. The minor has the benefit of full information about the risks and potential benefits
of participating and of not participation; and
3. The minor feels no compulsion, and fears no reprisal, for accepting or refusing to
participate
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To assess the minor regarding the first criterion, the researcher must generally
consider these factors:
a) the intelligence of the minor;
b) the minor’s ability to appreciate the reasonably foreseeable consequences
of his or her actions;
c) the stage of the minor’s ’s physical, emotional and mental development;
d) the degree of responsibility the minor has assumed in his/her life; and
e) the inherent risk level of the research protocol.
Alberta Health Services has drafted a document to guide the assessment of mature
minor status in the clinical setting. This additional information might be useful to guide
such assessment in the research setting.
Please see http://www.albertahealthservices.ca/3084.asp (Procedure: Minors/Mature
Minors; 1. Summary Sheet for the Minors/Mature Minors Procedure)
When researchers have found that minors have research decision-making capacity,
then the minors’ consent for study participation should be obtained using the CHREB
standard consent template. Please note that the reading level of a consent form should
be appropriate for Grades 6-8 regardless of the age of the intended participant.
Assent forms – minors without research decision-making capacity
Researchers typically use assent forms with children who are 7 to 14 years of age.
Therefore, the target language level is the reading level of pupils in Grade Four.
Researchers will need to read the assent form to some very young children. For these
reasons, the biggest challenge in writing assent forms is to keep the language and
concepts appropriately simple.
Children 15 years of age and older who do not have research decision-making capacity
are generally expected to give assent by signing the consent form used by their parents.
However, an investigator may choose to use an assent form for this age group if he or
she believes it appropriate because of the complexity of the study or the nature of the
study population.
Confidentiality
Sexuality and use of illegal substances are two areas in which adolescents may
struggle to be truthful if they believe information will be shared with their parents;
nevertheless, such information can be essential to the treating physician/physician
investigator.
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Under the Health Information Act of Alberta (s 104), adolescents with capacity are
entitled to control the release of their health information.
It can be difficult for parents to understand or accept that they will not be privy to
information that their child gives to another adult. One approach described later in this
document, is to discuss the study with the teen first, informing him or her of any limits to
confidentiality. If a teen declines to participate in the study, then the researcher should
not approach the parent(s) with the information. If investigators are concerned about
the challenges of keeping a minor’s health information private, then the investigators
should seek guidance/assistance from the Chair of the CHREB or a delegate.
Elements of the Assent Form
There are no formal requirements for the elements that must be present in an assent
form, (though this is not true for consent forms). This means that the investigator can
propose assent content that he/she believes will best inform the 7 to 14 year old
participants about the study. The length of the assent form should be proportionate to
the complexity of the study and the age of the participants.
The signature block needs lines only for the child to write his/her name and for the
person obtaining assent to sign his/her name. The person who seeks assent from the
minor must be the Principal Investigator or someone delegated by the Principal
Investigator.
If the child is not able to read the assent form, and oral assent is obtained using the
content in the assent form, then the person who received assent should place in the
chart or research record a statement with the following content:
I have discussed this research study with [name of child] using language that
is understandable and appropriate for the participant. I believe that I have
fully informed him/her of the nature of the study and its possible risks and
benefits. I believe the participant understood this explanation and
appreciates the risks and benefits of agreeing or refusing to agree to
participate. I do not believe that the child feels obligated to participate or
fears any negative consequences for refusing to participate.
Below are two templates that researchers may use as a basis of developing an age
appropriate assent. The first is more suitable for a younger child. The second may be
more suitable for an older child; researcher should use the second assent form example
also for those girls who are approaching sexual maturity.
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Example #1 – Assent for Younger Child (7-10 years old)
Project Title:
Principal Investigator:
We want to tell you about a research study we are doing. A research study is a way to
learn more about something. We would like to find out more about [insert topic and
describe goals in simple language]. You are being asked to join the study because
[insert name of condition or other reason(s) for inclusion].
If you agree to join this study, you will be asked to [describe procedures, (e.g.,
questionnaires, activities) in words a child would know and understand. Also include
number of visits and time frame in words easily understood by a child].
Describe possible risks (e.g., discomforts) in simple language.
Use any of the following statements that are appropriate to describe benefits:
We do not know if being in this study will help you.
We expect that the study will help you by [describe how].
We may learn something that will help other children with [insert name of condition or
topic under investigation] some day.
This study will help us learn more about [topic under investigation].
You do not have to join this study. It is up to you. You can say okay now. You can also
say no. If you say okay and then you change your mind later. If you want to stop, then
all you have to do is tell us you want to stop. No one will be mad at you if you don’t
want to be in the study or if you join the study and then change your mind later and
stop.
Before you say yes or no to being in this study, we will answer any questions you have.
If you join the study, you can ask questions at any time. Just tell the researcher that
you have a question.
We will also talk to your parents about this study. You can talk this over with them
before you decide.
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If you have any questions about this study please feel free to contact
contact name and contact #]
[Insert Study
Would you like to be in this research study?
_____ No, I don’t want to do
this.
__________________________
Child’s name
___________________
Signature of the child
____________
Date
__________________________
Person who received assent
___________________
Signature
____________
Date
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Example #2- Assent for Older Child (11 years or age or older, or female of
reproductive potential)
Project Title:
Principal Investigator:
What is a research study?
A research study is a way to find out new information about something. Children do not
need to participate in a research study if they don’t want to participate.
Why are you being asked to be part of this research study?
You are being asked to take part in this research study because we are trying to learn
more about [Insert name of what is studied here]. We are asking you to be in the study
because [state why the child is being asked to participate]. About (enter #) children will
be in this study.
If you join the study what will happen to you? [describe what takes place from the
child’s point of view]
 We want to tell you about some things that will happen to you if you are in this
study. EXAMPLES BELOW
 You will be in the study for [insert duration of participation].
 We will use a needle to take some blood from your arm [#] times.
 We will need you to take [name of procedure] that will last [duration]. This is [a
simple explanation of what will happen]. Your [mother/father/other] can be
present in this [location].
 We will ask you to sit with us and [talk about some things/look at some pictures].
It will take about 1 hour to do this
 We will ask you to answer some questions about X.
Will any part of the study hurt? [describe risks and discomforts using terms a child
would know and understand; take into account a child’s fears]
Will the study help you? [describe any benefits to the child from participation in the
research or if there are none omit this section].
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Will the study help others? [describe any benefits to society from the research].
This study might find out things that will help other children with [insert name of
condition being studied] some day.
Do your parents know about this study?
We will talk to your parents about your participation in this study as well. You can talk
this over with them before you decide.
Who will see the information collected about you?
The information collected about you during this study will be kept safely locked up.
Nobody will know it except the people doing the research. The study information about
you [will, will not] be given to your parents [or teachers]. The researchers will not tell
your friends or anyone else
Reproductive Information (please include if applicable)
If you are a girl, then it is important that you understand that the medication or medical
tests that will be done in this study might harm a baby. We do not make assumptions
about any girls’ activities and just have a standard way of doing things. We will be
testing you to see if you are pregnant before and at intervals during the study. If you
are pregnant, then you cannot take part in the study. If you become pregnant during the
study, then you will be withdrawn from the study. If you are, or become, pregnant, then
we will do our best to protect your confidentiality. We will tell your parents only that you
are not suitable for the study. We will tell you where you can get advice and help with
your pregnancy.
If you are a girl and having sex with a male, then you will be required to use effective
contraception during this study. We would like to discuss the best methods of
contraception with you do not become pregnant. Again, we will not give this information
to your parents, and we will do our best to protect your confidentiality.
If you are a boy, and having sex with a female, then it is important that your partner
does not get pregnant. You are required to use effective contraception. If you are
sexually active, then we will keep this information confidential. We would like to discuss
the best methods of contraception with you so that a pregnancy does not occur. If your
partner does become pregnant, then please tell us as soon as possible, because the
study medicine may be harmful to your sperm and therefore to the fetus. Again, we will
make every effort to keep your information on contraception and pregnancy confidential.
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What do you get for being in the study?
You will get [enter amount or item] for [each visit/entire study].
Do you have to be in the study?
You do not have to be in the study. No one will be upset if you don’t want to do this
study. If you don’t want to be in this study, you just have to tell us. It’s up to you.
You can also take more time to think about being in the study.
What if you have any questions?
You can ask any questions that you may have about the study. If you have a question
later that you didn’t think of now, either you can call or have your parents call (insert
study telephone number). You can also take more time to think about being in the study
and also talk some more with your parents about being in the study.
What choices do you have if you say no to this study?
There are other ways to help your [insert name of condition being studied] if you don’t
want to be in this study. Examples are …….
This study is extra, so if you don’t want to do it [nothing else will change/there are no
other choices].
Other information about the study.
If you decide to be in the study, then please write your name below. You can change
your mind and stop being part of it at any time. All you have to do is tell the person in
charge. It’s okay. The researchers and your parents won’t be upset.
You will be given a copy of this paper to keep
Would you like to take part in this study?
_____ Yes, I will be in this research study.
_____ No, I don’t want to do this.
__________________________
Child’s name
___________________
____________
Signature of the child Date
__________________________
Person who received assent
___________________
Signature
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____________
Date