Attachment 5 - Informed Consent Forms

Attachment 5 - Informed Consent Forms.pdf

Bureau of Primary Health Care Patient Survey

Attachment 5 - Informed Consent Forms

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Informed Consent Form for
Adult Survey Participation

Informed Consent Form for Adult Survey Participation
Primary Health Care Patient Surveys

About the Surveys
The Primary Health Care Patient Surveys are research studies being conducted by RTI International. The
surveys are sponsored by the Bureau of Primary Health Care within the Health Resources and Services
Administration (HRSA). They are about people who receive health care at places like this health care
center. The surveys will try to find out what kinds of health problems people come to health centers with
and how well the health centers are meeting the needs of the people who use them. You are one of about
4,000 people that RTI has selected to participate.

Participation
If you agree to participate, you will be asked some questions about your health and the services that you
receive at this health care center. Some of the questions may be personal, such as questions about drug or
alcohol use and your feelings. There also may be questions about HIV/AIDS. Most of the questions are
about less sensitive things like health care received and whether you have certain health conditions like
asthma or diabetes. Some people will get a shorter interview, while others will take a bit longer. The
interview may last about an hour.

Voluntary Participation
You may choose whether or not you would like to participate. If you choose not to participate it will not
affect any services you may receive at the health center or from any other programs. If you do not want to
answer some of the questions you are asked, that is okay. If you decide not to finish the questions, that is
okay too. It is possible that some questions may make you uncomfortable or feel various emotions. If you
need to take a break at any time, just let me know.

Benefits
There are no direct benefits to you. However, you will be helping us learn more about the health needs of
people who use health centers like this one.

Compensation for Participation
If you participate, you will be provided with $25 cash or a $25 gift card to thank you for your time.

Risks of Study Participation
There are two risks involved in study participation. One risk is that the questions we ask might make you
feel uncomfortable or upset. If you feel uncomfortable or upset, you may ask the interviewer to take a
break or skip any of the questions. The other risk is that someone might find out what you tell us during
the interview. To avoid that, we will do the interview in private where no one can hear your answers. We
will also create and use a number instead of your name to identify your interview. This will prevent
anyone from finding out what your answers were.

Your Privacy
Anything you tell me is private. The privacy of your answers is very important, so let me say a little more
about it. I am going to enter your answers into this computer. As mentioned, your answers will be linked
to a number instead of your name so no one else will know how you answered the questions. Everyone
involved in this research has signed an agreement stating they will protect the privacy of the information
you provide. The information that you tell me will not be shared with anyone at this health care center.

Exceptions to Privacy Pledge
There is one important exception to this promise of privacy. If I learn during our talk that your life, or
another person’s life or health could be in danger, I am required to tell the clinic staff.

Questions
If you have any questions about these studies or the pretest, you may call Ann Burke at (NUMBER) or
Tim Flanigan at (NUMBER). If you have any questions about your rights as a study participant, you may
call RTI’s Office of Research Protections toll-free at (1-866-214-2043).
Do you have any questions that might help you decide whether or not you want to participate in the
study?
By signing below, you are agreeing to participate. Please sign only if:

You understand the information about the research described in this consent form,
You have had all of your questions answered fully, and
You want to participate.
You will be given a copy of this consent form to keep.
Respondent’s Signature: ___________________________________________ Date: _________
Interviewer’s Signature: ___________________________________________ Date: _________

Recordings
We are using a special quality control system on this project. The system runs on the computer and will
record what we say to each other during several different parts of the interview. Neither of us will know
when the computer is recording what we say. The recording will be reviewed by people at RTI to
monitor my work, and will be kept private. You may participate in the interview even if you do not
consent to the recordings. May we use this quality control system during your interview?
By signing below, you are agreeing we may use this quality control system.
Respondent’s Signature: ___________________________________________ Date: ________

Informed Consent Form for Parent/Guardian
Participation in Proxy Interview for
Accompanied Children

Informed Consent Form for Parent/Guardian
Participation in Proxy Interview for Accompanied Children
Primary Health Care Patient Surveys

About the Surveys
The Primary Health Care Patient Surveys are research studies that are being conducted by RTI
International. The surveys are sponsored by the Bureau of Primary Health Care within the Health
Resources and Services Administration (HRSA). They are about people who receive health care at places
like this health care center. The surveys will try to find out what kinds of health problems or questions
people come to health centers with and how well the health centers are meeting the needs of the people
who use them. Your child, CHILD’S NAME, is one of about 4,000 people that RTI has selected to be
included. Because CHILD’S NAME is less than 13 years old, we would like to ask you to answer
questions about his/her health and the services that he/she receives at this health care center.

Participation
If you agree to participate, you will be asked some questions about your child’s health and the services
that he/she receives at this health center. Some of the questions may be personal, such as questions about
your child’s drug or alcohol use and his/her feelings. There also may be questions about HIV/AIDS.
Most of the questions, however, are about less sensitive things like health care received and whether or
not your child has certain health conditions like asthma or diabetes. Some people will get a shorter
interview, while others will take a bit longer. The interview may last about an hour.

Voluntary Participation
You may choose whether or not you would like to participate. If you choose not to participate it will not
affect any services your child or your family may receive at the health center or from any other programs.
If you do not want to answer some of the questions you are asked, that is okay. If you decide not to finish
the questions, that is okay too. It is possible that some questions may make you uncomfortable or feel
various emotions. If you need to take a break at any time, just let me know.

Benefits
There are no direct benefits to you. However, you will be helping us learn more about the health needs of
people who use health centers like this one.

Compensation for Participation
In addition, if you participate, you will be provided with $25 cash or a $25 gift card to thank you for your
time.

Risks of Study Participation
There are two risks involved in study participation. One risk is that the questions we ask might make you
feel uncomfortable or upset. If you feel uncomfortable or upset, you may ask the interviewer to take a
break or to skip any of the questions. The other risk is that someone might find out what you tell us
during the interview. To avoid that, we will do the interview in private where no one can hear your
answers. We will also create and use a number instead of your name to identify your interview in the
computer. This will prevent anyone from finding out what your answers were.

Your Privacy
Anything you tell me is private. The privacy of your answers is very important, so let me say a little more
about it. I am going to enter your answers into this computer. As mentioned, your answers will be linked

to a number instead of your name so no one else will know how you answered the questions. Everyone
involved in this research has signed an agreement stating they will protect the privacy of the information
you provide. The information that you tell me will not be shared with anyone at this health care center.

Exceptions to Privacy Pledge
There is one important exception to this promise of privacy. If I learn during our talk that your child’s life
or health, or another person’s life or health could be in danger, I am required to inform the clinic staff.

Questions
If you have any questions about these studies or the pretest, you may call Ann Burke at (NUMBER) or
Tim Flanigan at (NUMBER). If you have any questions about your rights as a study participant, you may
call RTI’s Office of Research Protections toll-free at (1-866-214-2043).
Do you have any questions that might help you decide whether or not you want to participate in the
study?
By signing below, you are agreeing to participate. Please sign only if:

You understand the information about the research described in this consent form,
You have had all of your questions answered fully, and
You want to participate.
You will be given a copy of this consent form to keep.

Respondent’s Signature: ___________________________________________
_________

Date:

Interviewer’s Signature: ___________________________________________
_________

Date:

Recordings
We are using a special quality control system on this project. The system runs on the computer and will
record what we say during several different parts of the interview. Neither of us will know when the
computer is recording what we say. The recording will be reviewed by people at RTI to monitor my
work, and will be kept private. You may participate in the interview even if you do not consent to the
recordings. May we use this quality control system during your interview?

By signing below, you are agreeing we may use this quality control system.
Respondent’s Signature: ___________________________________________
_________

Date:

Parent/Guardian Permission Form for
Accompanied Adolescent (Ages 13–17) Survey
Participation

Parent/Guardian Permission Form for
Accompanied Adolescent (Ages 13–17) Survey Participation
Primary Health Care Patient Surveys

About the Surveys
The Primary Health Care Patient Surveys are research studies being conducted by RTI International. The
surveys are sponsored by the Bureau of Primary Health Care within the Health Resources and Services
Administration (HRSA). They are about people who receive health care at places like this health care
center. The surveys will try to find out what kinds of health problems people come to health centers with
and how well the health centers are meeting the needs of the people who use them. Your child is one of
about 4,000 people that RTI has selected to participate.

Participation
If your child agrees to participate, he/she will be asked some questions about his/her health and the
services that he/she receives at this health center. Some of the questions may be personal, such as
questions about your child’s drug or alcohol use and his/her feelings. There also may be questions about
HIV/AIDS. Most of the questions are about less sensitive things like health care received and whether or
not your child has certain health conditions like asthma or diabetes. Some people will get a shorter
interview, while others will take a bit longer. The interview may last about an hour.

Voluntary Participation
Your child may choose whether or not he/she would like to participate. If you choose not to give us
permission or if your child chooses not to participate, it will not affect any services your child or your
family may receive at the health center or from any other programs. If your child does not want to answer
some of the questions he/she is asked, that is okay. If your child decides not to finish the questions, that is
okay too. It is possible that some questions may make your child uncomfortable or feel various emotions.
If he/she needs to take a break at any time, he/she should just let me know.

Benefits
There are not any direct benefits to your child. However, your child will be helping us learn more about
the health needs of people who use health centers like this one.

Compensation for Participation
In addition, if your child participates, he/she will be provided with $25 cash or a $25 gift card to thank
him/her for his/her time.

Risks of Study Participation
There are two risks involved in study participation. One risk is that the questions we ask might make your
child feel uncomfortable or upset. If your child feels uncomfortable or upset during the interview, he/she
may ask the interviewer to take a break or to skip any of the questions. The other risk is that someone
might find out what your child told us during the interview. To avoid that, we will do the interview in
private where no one can hear his/her answers. We will create and use a number instead of your child’s
name to identify your child’s interview in the computer. This will prevent anyone from finding out what
your child’s answers were.

Your Child’s Privacy

Anything your child tells me is private. The privacy of his/her answers is very important, so let me say a
little more about it. I am going to enter your child’s answers into this computer. As mentioned, his/her
answers will be linked to a number instead of his/her name so no one else will know how he/she answered
the questions. Everyone involved in this research has signed an agreement stating they will protect the
privacy of the information your child provides. The information that your child tells me will not be
shared with you or anyone at this health center.

Exceptions to Privacy Pledge
There is one important exception to this promise of privacy. If I learn during my talk with your child that
his/her life or health, or another person’s life or health could be in danger, I am required to inform the
clinic staff.

Questions
If you have any questions about these studies, you may call Ann Burke at (NUMBER) or Tim Flanigan at
(NUMBER). If you have any questions about your child’s rights as a study participant, you may call
RTI’s Office of Research Protections toll-free at (1-866-214-2043).
Do you have any questions that might help you decide whether or not you want your child to participate
in the study?
By signing below, you are giving permission for your child to participate in the research described above.
Please sign only if:

You understand the information about the research described in this consent form,
You have had all of your questions answered fully, and
You give permission for your child to participate.
You will be given a copy of this consent form to keep.

Name of Child: ______________________________________________
Parent/Guardian’s Signature: _________________________________ Date: _________
Interviewer’s Signature: ______________________________________ Date: _________
Recordings
We are using a special quality control system on this project. The system runs on the computer and will
record what your child and I say to each other during several different parts of the interview. Neither of
us will know when the computer is recording what we say. The recording will be reviewed by people at
RTI to monitor my work, and will be kept private. Your child may participate in the interview even if
you do not consent to the recordings. May we use this quality control system during the interview with
your child?
By signing below, you are agreeing we may use this quality control system.

Parent/Guardian’s Signature: _________________________________ Date: _________

Assent Form for Accompanied Adolescent
(Ages 13–17) Survey Participation

Assent Form for Accompanied
Adolescent (Ages 13–17) Survey Participation
Bureau of Primary Health Care Patient Surveys

About the Surveys
The Primary Health Care Patient Surveys are research studies being conducted by RTI
International. The surveys are sponsored by the Bureau of Primary Health Care within the Health
Resources and Services Administration (HRSA). They are about people who receive health care
at places like this health center. The surveys will try find out what kinds of health problems
people come to health centers with and how well the health centers are meeting the needs of the
people who use them. You are one of about 4,000 people that RTI has selected to participate.

Participation
(NAME OF PARENT/GUARDIAN) said it is okay for me to invite you to talk with me about
your health and the services that you receive at this health care center. If it is okay with you, I
would like to ask you some questions. Some of the questions may be personal, such as questions
about drug or alcohol use and your feelings. There also may be questions about HIV/AIDS.
Most of the questions are about less sensitive things like health care received and whether or not
you have certain health conditions like asthma or diabetes. Some people will get a shorter
interview, while others will take a bit longer. The interview may last about an hour.

Voluntary Participation
You may choose whether or not you would like to participate. If you choose not to participate it
will not affect any services you may receive at the health center or from any other programs. If
you do not want to answer some of the questions you are asked, that is okay. If you decide not to
finish the questions, that is okay too. It is possible that some questions may make you
uncomfortable or feel various emotions. If you need to take a break at any time, just let me know.

Benefits
There are not any direct benefits to you. However, you will be helping us learn more about the
health needs of people who use health centers like this one.

Compensation for Participation
If you participate, you will be provided with $25 cash or a $25 gift card to thank you for your
time.

Risks of Study Participation
There are two risks involved in study participation. One risk is that the questions we ask might
make you feel uncomfortable or upset. If you feel uncomfortable or upset during the interview,
you may ask the interviewer to take a break or to skip any of the questions. The other risk is that
someone might find out what you tell us during the interview. To avoid that, we will do the
interview in private where no one can hear your answers. We will also create a number and use it
instead of your name to identify your interview in the computer. This will prevent anyone from
finding out what your answers were.

Your Privacy

Anything you tell me is private. The privacy of your answers is very important, so let me say a
little more about it. I am going to enter your answers into this computer. As mentioned, your
answers will be linked to a number instead of your name so no one else will know how you
answered the questions. Everyone involved in this research has signed an agreement stating they
will protect the privacy of the information you provide. The information that you tell me will not
be shared with anyone at this health care center. Your parent/guardian will not see your answers,
and we will not discuss any of your answers with them.

Exceptions to Privacy Pledge
There is one important exception to this promise of privacy. If I learn during our talk that your
life or health, or another person’s life or health could be in danger, I am required to inform the
clinic staff.

Questions
If you have any questions about these studies or the pretest, you may call Ann Burke at
(NUMBER) or Tim Flanigan at (NUMBER). If you have any questions about your rights as a
study participant, you may call RTI’s Office of Research Protections toll-free at (1-866-2142043).
Do you have any questions that might help you decide whether or not you want to participate in
the study?
By signing below, you are agreeing to participate. Please sign only if:

You understand the information about the research described in this consent
form,
You have had all of your questions answered fully, and
You want to participate.
You will be given a copy of this consent form to keep.

Respondent’s Signature: ___________________________________________

Date: _________

Interviewer’s Signature: ___________________________________________

Date: _________

Recordings
We are using a special quality control system on this project. The system runs on the computer
and will record what we say to each other during several different parts of the interview. Neither
of us will know when the computer is recording what we say. The recording will be reviewed by
people at RTI to monitor my work, and will be kept private. You may participate in the interview
even if you do not consent to the recordings. May we use this quality control system during your
interview?
By signing below, you are agreeing we may use this quality control system.

Respondent’s Signature: ___________________________________________
Date: _________


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File TitleMicrosoft Word - Informed Consent Forms.doc
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File Modified2009-03-03
File Created2009-03-03

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