STUDY TITLE:
______________________________________________________________
[A] are doing
a research study on [B]. Please
read the attached booklet, Informed Consent: Taking Part in Population-Based
Genetic Research. We would like
to include a sample of your ______ in this research study because [C]. We think that about ______ people will give samples for our study.
A. Identify the organizations conducting the research.
B. Identify the object of the study.
C. Explain how prospective participants have been chosen.
Examples:
The Centers
for Disease Control and Prevention (CDC) and the Heart Alliance are doing
a research study to find out more about how genes affect a person's risk
of getting heart disease. Please
read the attached booklet, Informed Consent: Taking Part in
Population-Based Genetic Research. We are asking you to provide a blood sample for this study because
you are one of about 5,000 people between the ages of 45 and 65 who we
selected at random from the community.
We are doing
a research study to learn more about how genes and other factors lead to
heart problems. This study is
being done by the Centers for Disease Control and Prevention (CDC) and the
Heart Alliance. Please read
the attached booklet, Informed Consent: Taking Part in Population-Based
Genetic Research. We are
asking everyone who comes to this clinic with certain kinds of heart
disease to give a blood sample for our study. We are also asking some people who do not have heart disease.
We think about 500 people will take part.
This study is
being done because [D]. The purpose
of this study is to [E].
D. Summarize the problem and/or explain the disease.
E. Explain the research question(s) to be addressed.
Example:Heart disease causes serious health problems for many people.
We know that a person's risk for heart disease is related to factors
like diet, exercise, and smoking. Scientists
have also found many genes that may be linked with heart disease and we expect
they will find more in the future. [Add
one of the following:]
For gene
prevalence studies: The purpose of our study is to estimate how many
people have some of the genes that may be related to heart disease. This is a first step in finding out how important these genes are
for heart disease.
For
gene-disease association studies: The purpose of our study is to find out
which genes are the most important for heart disease. This may help us begin to learn why some people get heart
disease and others do not.
For
gene-environment interaction studies: The purpose of our study is to learn
more about which genes are the most important for heart disease. We also want to know how factors like diet, exercise, and smoking
affect people who have those genes. This
will help decide if changing these factors can prevent heart disease or
keep it from getting worse.
If you choose
to provide a ______ sample for this study, we will [F]. This process will take approximately [G].
You will not need to [H].
[Add the
following paragraph only if leftover specimens will be stored without
identifiers (unlinked) for future testing. See "What will happen to my sample after the study is over?"
below if specimens will be coded or identified.] We would like to store any ______ that is left over after
we do your test. We plan to use
this sample for studies we will do in the future. We will store your sample with some data about you, such as your age,
race, sex, and about your health problems. But we will not put your name on the sample and there will be no way for
anyone, including us, to know it is yours. You can decide to not let us store your ______ and still be in this
study.
F. Describe the procedure for obtaining a biological sample and what will be
done with the sample. Describe also
any questionnaires or interviews, and whether participants will be asked to
grant full or partial access to their medical records.
G. Estimate the amount of time participation will entail.
H. Describe procedures that will not be done, if appropriate.
Examples:
If you
decide to provide a sample for this study, we will draw about 30 ccs (2 to
2-1/2 tablespoons) of blood from a vein in your arm. The blood will be sent to the CDC in Atlanta, Georgia to
study genes that may play a role in why some people get heart disease.
We will also
ask you to fill out a survey about your health, diet, and exercise, and your
use of tobacco, alcohol, and medicines. It is all right to skip any question you don't want to answer.
We will need
less than 5 minutes to take the blood sample. The survey will take about 30 minutes.
There will be no medicines to take and no experimental
treatments to undergo in this study.
If you
choose to be in this study, we will collect a sample of your cells by
brushing the inside of your cheek with a cotton swab. This sample will be sent to the CDC in Atlanta, Georgia for
processing.
We will also
need to check with your doctors to confirm whether you have had any of the
heart diseases we are studying. To
do this, we will ask you to sign a form to let your doctor give us a copy of
your medical record.
Nothing else
is required. We will compare
the results with tests on other people who have heart disease and on people
who do not have heart disease. The
only genetic testing performed on your cell sample will be for conditions
associated with heart disease.
Once we take
your ______ sample, we will assign it a code number. We will separate your name and any other information that points to you
from your sample. We will keep files that link your name to the code number
[I]. [J]. No one who reads or hears a report about this study will be able to
identify you because, before any facts are given out, we combine your facts with
those of other people in this study.
I. Describe security measures.
J. Describe the extent to which confidentiality of records identifying the
participant will be maintained.
Example: Once we take your blood sample, we will assign it a code number.
We will separate your name and any other information that points to you
from your sample. We will keep
files that link your name to the code number in a locked cabinet. Only the study staff will be allowed to look at these files.
[Add one of the following:]
For
legally unprotected research: We will keep private both the test
results and the information you tell us in the survey. We will only release study information if ordered to by a court of
law. Your name or other facts
that might point to you will not appear when we present this study or
publish its results.
When a
Certificate of Confidentiality has been obtained: Records that
identify you in this study are strictly private. No one other than study staff can ever look at them unless you
agree to it. This is because
the study has been granted a Certificate of Confidentiality under a
federal law (Section 301(d) of the Public Health Service Act). This means that the records of this study may not be disclosed,
even under federal, state, or local court order, without your OK. No one who reads or hears a report about this study will be able to
identify you because, before any facts are given out, we combine your
facts with those of other people in this study.
When an
Assurance of Confidentiality has been obtained: Your test results at
CDC are kept private by an Assurance of Confidentiality under the Public
Health Service Act (Section 308(d)). This means that CDC will not let results out with information that
identifies you for any reason unless you agree. The records of what you tell us on the survey will be kept at the
Heart Alliance here in Anytown. We
will release them only if it is ordered by a court of law. No one who reads or hears a report about this study will be able to
identify you because we will combine your facts with those of other people
in this study.
The physical
risks to you for providing a ______ sample for this study are [K]. [L].
[M].
K. Describe relevant physical risks.
L. Describe the informational risks based on the types of information
expected and the identifiability of the sample.
M. Describe potential groups harms.
Example: The risks of drawing blood include brief pain, slight bruising, and
rarely, infection where the needle went in. We take every precaution to prevent infection.
Some people feel dizzy when they have blood drawn, but this goes away
when the person lies down.
The kind of
information we will look for in this study is not likely to tell you anything
specific about your personal health. Even
so, there is a risk that if people other than the researchers got your genetic
facts they could misuse them. We
think the chance of this ever happening to you is very small. To protect your information, we will not keep your name and address
with the sample, only a code number. As
we said, files that link your name to the code number will be kept in a locked
cabinet and only the study staff will be allowed to look at them. Although no one can absolutely guarantee confidentiality, using a code
number greatly reduces the chance that someone other than the study staff will
ever be able to link your name to your sample or to your test results.
Although your
name will not be with the sample, it will have other facts about you such as
your race, ethnicity, and sex. These
facts are important because they will help us learn if the factors that cause
heart disease to occur or get worse are the same or different in men and
women, and in people of different racial or ethnic backgrounds. Thus, it is possible that study findings could one day help people of
the same race, ethnicity, or sex as you. However, it is also possible through these kinds of studies that
genetic traits might come to be associated with your group. In some cases, this could reinforce harmful stereotypes.
You will not
get any direct benefit for giving a ______ sample for this study. The major benefit of the study is [N].
N. Insert the object of the study.
Examples:
You will not
get any direct benefit for providing a blood sample for this study, but
you will help us learn more about genes and other factors that may lead to
heart disease.
You will get
no direct benefit from being part of this study. But the information and results from these kinds of studies may
help prevent and treat heart disease in the future.
It does not
cost you anything to provide a ______ sample for this study and you will not be
charged for any research tests. [O]. In the unlikely event that you are physically hurt during the process of
providing a ______ sample, [P].
The aim of our
research is to improve the public health. [Q].
O. Explain whether participants will be reimbursed for things such as time,
travel, and inconvenience.
P. Explain what compensation or medical treatment is available if injury
occurs.
Q. Explain arrangements regarding the development of products with
commercial application and value.
Examples:
It does not
cost you anything to provide a blood sample for this study and you will
not be charged for any research tests. You will not be paid for participation in this study.
In the unlikely event that you are injured while giving a blood
sample, we will give you first aid and direct you to proper health
treatment. We have not set
aside funds to pay for this care or to compensate you if a mishap occurs.
The aim of
our research is to improve the public health. Your blood will never be used to develop a process or
invention that will be sold or patented.
There are no
dollar costs to you for being in this study. We will give you $25 to reimburse you for your time and
effort. If you are physically
hurt because of this research project, we will help you to get medical
care through your usual doctor. You
or your health insurer will need to pay for any such care that you get.
The aim of
our research is to improve the public health. Sometimes, such research may result in findings or inventions
that have value if they are made or sold. We may get a patent on these.
We
may also license these, which could give a company the sole right to make
and sell products or offer testing based on the discovery. Some of the profits from this may be paid back to the researchers and
the organizations doing this study, but you would not receive any financial
benefits.
The studies we
do on the samples we collect are to add to our knowledge of how genes and other
factors affect health and disease. We are gathering this knowledge by studying groups of people,
and the study is not meant to test your personal medical status. For these reasons, we will not give you the results of our research on
your sample. However, [R]. We will also share what we learn with other health professionals through
medical publications. If you have
questions about whether any genetic tests would be useful to you, you should ask
your doctor.
R. Describe any general communication (e.g., newsletters) about the study
that will be provided.
Example:
The studies we do on the samples we collect are to add to our knowledge of how
genes and other factors affect health and heart disease. We are gathering this knowledge by studying groups of people, and the
study is not meant to test your personal medical status. For these reasons, we will not give you the results of our research on
your sample. However, you can choose to get a newsletter that will tell
you in general about the research studies we are doing. This newsletter will not announce your results or anyone
else's, but it will tell you what we are learning about genes and heart
disease. We will also publish
what we learn in health journals. If
you have questions about whether any genetic tests would be useful to you, you
should ask your doctor.
After this
study is over, we will throw away all the ______ samples.
[OR]
After our
study is over, we would like to keep any unused ______ left over for future
research. [S]. We don't have specific research plans at this time but we would like to
use the samples for studies [T]. We
will store the sample under a code number and we will keep the file that links
the code number to your name private. We
may share the samples with other researchers for [U], but we will not give other
researchers any information that would allow them to identify you. We will always know which sample belongs to you, but other researchers
will not.
An
Institutional Review Board, like the one that helps protect you during this
research project, will review and approve all future projects.
You can choose
not to have your sample stored for future research and still be part of this
study. You will have the chance to
state your choice about this at the end of this form.
S. Describe how the samples will be stored, where, and for how long.
T. Clarify plans for future research to the extent possible.
U. Clarify the types of research that other investigators may be permitted
to do.
Example: After our study is over, we would like to keep any unused blood left
over for future research. [Insert one of the following:]
For
frozen samples: We will keep it frozen in a specimen bank at CDC and
use it for as long as it lasts.
When cell
lines will be created: We will create a living tissue sample (called a
"cell line") from which we can get an unlimited supply of
genetic material in the future without the need to get more blood from
you. Cell lines will be
stored at CDC.
We don't have
specific research plans at this time but we would like to use the samples for
studies of heart disease as well as other diseases. We will store the sample under a code number and we will keep the file
that links the code number to your name private. We may share the samples with other researchers for studies of genes
and disease, but we will not give other researchers any information that would
allow them to identify you. We will always know which sample belongs to you, but other
researchers will not.
An
Institutional Review Board, like the one that helps protect you during this
research project will review and approve all future projects.
You can choose
not to have your sample stored for future research and still be part of this
study. You will have the chance
to state your choice about this at the end of this form.
You are free
to take part in this study or not. No
penalties or loss of benefits will occur if you refuse to take part.
If you decide
to take part in this study, you may withdraw at any time. You may choose not to have your sample stored for future research and
still be part of this study. [V].
We will give
you a copy of this consent form to keep for your records.
V. Describe withdrawal following storage for future research.
Example: You are free to take part in this study or not.
No penalties or loss of benefits will occur if you refuse to take part. If you decide to take part in this study, you may withdraw at any time.
You may choose not to have your sample stored for future research and
still be part of this study. [Add
one of the following:]
For
unlinked storage: If you agree to have your sample stored, you can
change your mind up until the end of the study, when we store the
remaining samples. At that
time we will remove all information that identifies you. After that we will not be able to withdraw your sample because we
will not know which one is yours.
For coded
or identified storage: Also, you may agree to have your sample stored
and later decide that you want to withdraw it from storage. If so, you should call the study person listed in this consent form
and tell her to discard your sample. She will discard your sample, but any data from testing your sample
until that point will remain part of the research.
We will give
you a copy of this consent form to keep for your records.
I agree to
give a ______ sample for this study. I
have been given a chance to ask questions and feel that all of my questions have
been answered. I know that giving a
sample for this study is my choice. I understand that my individual results from the study will
not be given to me. I have been
given a copy of this consent form to keep.
I have read
the part of this form about storing my sample for future research. My choice about having my sample stored and used for future research
under the conditions described is (please check ONE box):
_____ I refuse to have my ______ sample stored or used for [W].
_____
It is OK to store my ______ sample with a code number and to use it for [W].
W. Summarize parameters of future research, e.g., "future research on
genes and heart disease" or "any kind of future research."
I would like
to receive a newsletter that will tell me about the research study and what
researchers are learning in the future studies about genes and disease. Please circle ONE:
Yes / No
[Add the
following if the signature will be witnessed:] I observed the process of
consent. The prospective
participant read this form, was given the chance to ask questions, appeared to
accept the answers, and signed to enroll in the study.
