Download Sample Adolescent Assent - UCSD HRPP

PATIENT INFORMATION
Rady Children’s Hospital – San Diego
and University of California, San Diego
Adolescent Assent Form
(ages 13-17)
Title
[Please note, it is suggested that the adolescent assent form be written at the sixth-grade reading
level. Although the format is similar to the parent, this assent form should be further
simplified and defined accordingly.]
This is a research study. Research studies include only subjects who choose to take part.
You are being asked to take part in this study because you have ………….. Please take
your time to make your decision. Talk to your family about it. Be sure to ask any questions
that you may have.
STUDY INVESTIGATOR AND SPONSOR
Investigator:
Sponsor:
WHY IS THIS STUDY BEING DONE?
This study is being done to find out……..
WHAT MAKES THIS DIFFERENT FROM THE USUAL TREATMENT?
The experimental part of this study is ………(example: using the drug called _____. This is
an experimental drug because the Food and Drug Administration has not approved this
drug to be used for ______ or in children).
Study number
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[If randomization is used to assign subjects to a study group include] You will be assigned
by chance to a study group. Your chance of being assigned to each group is [fill in with the
chance of assignment such as 1 in 3]. Neither you nor the researcher(s) can choose the
group to which you will be assigned. [For each study group, fill in with an explanation of
what will happen in the group indicating clearly the interventions that are different from
standard of care].
[If a standard of care procedures are associated with the study, the following guidelines
should be used to describe those standard procedures:
a) If the standard procedure is not explicitly required by the study protocol, the
consent form need not describe the procedure; or
b) If the standard procedure is the main focus of the study (e.g., one or more of the
study groups are randomized to standard of care) or is explicitly required by the
study, the consent form must include a full description of the procedure.]
Another experimental part of this study is ……..(example: that you will be randomized into
one of three study groups. Randomization is determining by chance such as by tossing a
coin to make a choice. Neither you or the study doctor will choose your study group.)
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
___ subjects will be in this study. [Please include the number of subjects to be enrolled at
RCHSD, UCSD, and total nationwide, as applicable.]
HOW LONG WILL YOU BE IN THE STUDY?
You will be in the study for _____.
You can stop being in the study at any time. But, if you decide to stop, we encourage you
to talk to the research doctor first.
WHAT IS INVOLVED IN THE STUDY?
This is what will happen if you are in this study: [Please add the anticipated duration of
each study visit.]
Study Visit 1: (please indicate time point such as Day 7 or Week 2): These tests will be done at
this visit.
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Study Visit 2: (please indicate time point such as Day 7 or Week 2): These tests will be done at
this visit.
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WHAT ARE THE RISKS OF THE STUDY?
The most common side effects seen with _____ are:
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Side effects seen less often are:
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If you get sick or have any problems from taking the study drug you should call your study
doctor right away. If necessary, using the study drug may be stopped and other therapy
may be started.
[If the study involves randomization include] You will be assigned to a study group at
random (by chance). Your assignment is based on chance rather than a medical decision
made by the researchers. The study group you are assigned to might not be the group you
would prefer to be in. It might also prove to be less effective or have more side effects
than the other study groups(s), or other treatments available for your condition.
[If a standard of care procedures are associated with the study, the following guidelines
should be used to describe the risks associated with those standard procedures:
a) If the standard procedure is not explicitly required by the study protocol, the
consent form need not describe the risks associated with the procedure; or
b)
If the standard procedure is the main focus of the study (e.g., one or more of the
study groups are randomized to standard of care) or is explicitly required by the study,
the consent form must include a full description of the risks associated with the
procedure.]
Possible side effects from blood drawing include:
 faintness,
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irritation of the vein, such as swelling or redness
pain,
bruising
or bleeding at the blood draw site.
There is also a slight possibility of infection or fainting.
Using the numbing cream used for blood draws may cause skin irritation, the skin may
temporarily turning red, white or developing a rash.
Other risks in this study include the following:
 Your condition may not improve, it may stay the same or it may get worse while you
are in this study.
 There may be side effects or discomforts associated with this study that we don’t
know about yet.
 [If there is a placebo, state the risk (e.g. If you receive the placebo (inactive
treatment) your condition may stay the same or worsen).]
For more information about these risks and side effects, ask your study doctor.
ARE THERE RISKS TO THE REPRODUCTIVE SYSTEM OR A DEVELOPING FETUS?
[Sample wording if the child is of child-bearing potential and the study procedures may
pose some unforeseeable risks to the reproductive system or developing fetus]
The effects of the study procedures and study drug may pose some unforeseeable risks
on the reproductive system (sperm, eggs) or to the developing fetus. For this reason, while
in this study, you should not become pregnant and agree to either abstain from sexual
intercourse or use a reliable, effective contraception for this period, such as hormonal
contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge
or use of condom by the partner [revise list of reliable, effective contraception, as
appropriate].
After you are enrolled in this study and during the research, pregnancy testing will be
performed. The results of the pregnancy test are confidential and will be told to you by one
of the study nurses or doctors in private. Every effort will be made to maintain
confidentiality regarding positive pregnancy test results. Our policy is that we would not tell
your parent(s) or guardian(s) without your permission. However, under certain
circumstances, we might be compelled to reveal this information. For example, if your life
or someone else's life was at risk or if abuse was suspected, it may be necessary to
inform your parent(s) or guardian(s) of a positive pregnancy test. If we believe it's
necessary to tell your parent or guardian of a positive pregnancy test without your
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permission, we would meet with you first in private to discuss our concerns prior to
divulging any information regarding pregnancy.
During the research, if you do have a positive pregnancy test, we may withdraw you from
the study. This means that even if we do not reveal the results, your parent(s) or
guardian(s), may suspect that you are pregnant despite our best efforts to maintain
confidentiality. If you become pregnant or if there is any chance that you might be
pregnant (late menstrual period, broken condom, missed oral contraceptive pills, etc)
please contact the study personnel immediately so that we may provide medical
assistance and counseling. The phone call will be strictly confidential, and we will not
notify your parent(s) or guardian(s) without your permission.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
[Please indicate whether or not there is a prospect of direct benefit for the subject. If there
is not, please clearly state such. If there is, please specify the benefit. Please elaborate
upon how society/others may benefit from the conduct of this research. In addition, please
note that compensation should not be viewed as a benefit of study participation.]
WHAT OTHER OPTIONS ARE THERE?
If you choose not to be in this study there are other options available that you can talk
about with the doctor. Some other options are:

[If this is not a treatment study, please state such and indicate that the only alternative is
not to participate in this study. Also, if there is no other available treatment, please state
such, (e.g., Currently there is not an approved method of treatment for your condition.
Your alternative to this study is not to participate.”)]
CAN YOU BE REMOVED FROM THE STUDY WITHOUT YOUR CONSENT?
[If the subject can be removed with regard to consent, please list the possible reasons for
removal (e.g., adverse reaction to the drug, not following study procedures, sponsor ends
the study, condition worsens). If the subject will not be removed, please either state “You
will not be removed from this study by the study team” or remove this section.]
WHAT ABOUT CONFIDENTIALITY?
Every reasonable effort will be made to keep your records confidential. [Please state how
the data will be stored (e.g., in a locked file cabinet only accessible to the study team,
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password protected computer.). However, while you are in this study we do have to let
some people look at your records. These people can see your records:
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(sponsor)
The FDA (US Food and Drug Administration) or governmental agencies in other
countries where the study drug may be considered for approval
The UCSD Institutional Review Board (for the protection of human subjects in
research)
Other regulatory agencies responsible for overseeing research, such as the federal
Office for Human Research Protections
Others please list
We will keep your records confidential unless we are required by law to share any
information.
[If the study includes possible knowledge or suspicion of child abuse, please use the
following:]
We will not tell anyone what you tell us without your permission unless there is something
that could be dangerous to you or someone else. If you tell us that someone is or has
been hurting you, we have to tell that to people who are responsible for protecting children
so they can make sure you are safe.
WHAT ARE THE COSTS?
[Specify whether there are any costs associated with participation. If there are none, state
that there are no costs.]
WHAT IF YOU ARE INJURED IN THE STUDY?
If you are injured or become ill as a direct result of this research study, you will be
provided with medical care.
WILL YOU GET COMPENSATED TO BE IN THIS STUDY?
[Indicate whether or not subjects will be compensated to participate (e.g., $10 gift
certificate).]
WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
For questions about the study or a research-related injury, please call the researcher:
Name and phone number
Study number
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WHAT ARE YOUR RIGHTS AS A RESEARCH SUBJECT?
Being in this study is voluntary. You don’t have to be in this study if you don’t want to or
you can stop being in the study at any time. Your decision will not result in any penalty or
loss of benefits that you have now. If you have questions about your rights you may call:
University of California, San Diego
Human Research Protections Program
858-246-HRPP (858-246-4777)
You will be told about any new information that may affect your health, welfare, or
willingness to stay in this study.
AGREEMENT TO BE IN THE STUDY
Your signature below means that you have read the above information about the
____________ study and have had a chance to ask questions to help you understand
what you will do in this study. Your signature also means that you have been told that you
can change your mind later if you want to. You will be given a copy of this assent form and
a copy of the Subject’s Bill of Rights. By signing this assent form you are not giving up any
of your legal rights.
________________________________________________
NAME OF SUBJECT
_______________
AGE
________________________________________________
SIGNATURE OF SUBJECT (13 YRS - 17 YRS)
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DATE
_________________________________________________
SIGNATURE OF PERSON WHO EXPLAINED THIS FORM
_______________
DATE
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Form Date 9/30/13
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ADOLESCENT SUBJECT’S BILL OF RIGHTS
It is important that the purpose and procedures of the research study are fully understood
and that consent is offered willingly. A subject in a research study has the right to:
1.
Be told about the nature and purpose of the research.
2.
Be told about all procedures to be followed and of any drug or device to be used.
3.
Be given a description of any risks or discomforts, which can be reasonably,
expected to happen.
4.
Be told about any benefits that may be expected as a subject of this research.
5.
Be told about any other appropriate options instead of this research and of their
risks and discomforts.
6.
Be told about any medical treatments that are available if there are complications
from this research.
7.
Be encouraged to and given a chance to ask any questions concerning the study or
the procedures involved in this research.
8.
Be told that you can stop being in this research study at any time and that the
decision to stop will not affect medical care in any way.
9.
Be given a copy of the signed and dated written assent form.
10.
Not be pressured in any way to be in this research study or to choose not to be in
this research study.
If you have any further questions or concerns about your rights as a research subject,
please contact your research doctor or UCSD’s Human Research Protections Program at
858-246-HRPP (858-246-4777).
Study number
Version DATE
Form Date 9/30/13
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