Informed Consent

Attachment 5
Informed Consent and Other Procedural Forms

Informed Consent Form for Adult Survey Participation
Health Center Patient Survey

About the Survey
The Health Center Patient Survey is a research study being conducted by RTI International. The survey is sponsored
by the Bureau of Primary Health Care within the Health Resources and Services Administration (HRSA). The survey
is about people who receive health care at places like this health center. The survey will try to find out what kinds of
health problems people have and how well the health centers are meeting the needs of the people who use them. You
are one of about 6,600 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 center. Some of the questions may be personal, such as questions about drug or alcohol use and your
emotions and 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 75 minutes
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 gift of equal value to thank you for your time. On average,
the interview will take about 75 minutes to complete.
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 the computer. As mentioned, your answers will be linked to a number instead of
your name so no one else will know 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 center. [FOR SPANISH VERSION ONLY: We will not ask you about your
legal or immigration status.]

1

Exceptions to Privacy Pledge
There is one exception. If I learn through the course of the interview that your life or health, or another person’s life
or health could be in danger, I am required to tell the clinic staff or the proper authorities..
Questions
If you have any questions about this study, you may call Azot Derecho at 1 (800) 334-8571 Ext 27231. 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: ________Public Burden
Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for this project is 0915-0368, expiration date 09/30/2016. Public reporting
burden for this collection of information is estimated to average XX hours per response, including the time for reviewing instructions,
searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600
Fishers Lane, Room 10-29, Rockville, Maryland, 20857

2

Informed Consent Form for Parent/Guardian
Survey Participation in Proxy Interview for Accompanied Children
Health Center Patient Survey

About the Survey
The Health Center Patient Survey is a research study being conducted by RTI International. The survey is sponsored
by the Bureau of Primary Health Care within the Health Resources and Services Administration (HRSA). The survey
is about people who receive health care at places like this health center. The survey will try to find out what kinds of
health problems people have and how well the health centers are meeting the needs of the people who use them. Your
child, CHILD’S NAME, is one of 6,600 people that RTI has chosen 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 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 feelings.
Most of the questions, however, are about 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 40 minutes.
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 not any direct benefits to you or your child. 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 gift of equal value to thank you for your time. On
average, the interview will take about 40 minutes to complete.
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. Also, we will create and use a number and
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 the computer. As mentioned, your answers will be linked to a number instead of
your name so no one else will know 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 center. [FOR SPANISH VERSION ONLY: We will not ask you about your
child’s legal or immigration status.]

3

Exceptions to Privacy Pledge
There are two important exceptions. (1) If I learn through the course of the interview that your child’s life or health
is in danger, I will inform the appropriate county or state agency. (2) If I think that your life or health could be in
danger, I am required to tell the clinic staff or the proper authorities.
Questions
If you have any questions about this study, you may call Azot Derecho at 1 (800) 334-8571 Ext 27231. 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.
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
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.
Parent/Guardian’s Signature: ________________________________________Date: ________
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. The OMB control number for this project is 0915-0368, expiration date 09/30/2016. Public
reporting burden for this collection of information is estimated to average XX hours per response, including the time for reviewing instructions,
searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600
Fishers Lane, Room 10-29, Rockville, Maryland, 20857

4

Parent/Guardian Permission Form for
Accompanied Adolescent (Ages 13–17) Survey Participation
Health Center Patient Survey
About the Survey
The Health Center Patient Survey is a research study being conducted by RTI International. The survey is sponsored
by the Bureau of Primary Health Care within the Health Resources and Services Administration (HRSA). The survey
is about people who receive health care at places like this health center. The survey will try to find out what kinds of
health problems people have and how well the health centers are meeting the needs of the people who use them. Your
child is one of 6,600 people that RTI has chosen 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
emotions or feelings. Most of the questions are about less sensitive things like health care received and whether 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 30 minutes.
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 you or your child. However, he/she 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 gift of equal value to thank him/her
for his/her time. On average, the interview will take about 30 minutes to complete.
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, 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 also
create and use a number instead of your child’s name to identify your child’s interview. 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 the computer. As mentioned, your child’s answers will be
linked to a number instead of his/her name so no one else will know he/she answered the questions. Everyone
involved in this research has signed an agreement stating they will protect the privacy of the information provided.
The information that your child tells me will not be shared with you or anyone at this health center. [FOR SPANISH
VERSION ONLY: We will not ask your child about his/her legal or immigration status.]

5

Exceptions to Privacy Pledge
There is an important exception. If I learn through the course of the interview 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 or the proper authorities.
Questions
If you have any questions about this study, you may call Azot Derecho at 1 (800) 334-8571 Ext 27231. 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 give permission for 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 your child nor I 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 your child’s interview?
By signing below, you are agreeing we may use this quality control system.
Parent/Guardian’s

Signature: ________________________________Date: ________

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. The OMB control number for this project is 0915-0368, expiration date 09/30/2016. Public
reporting burden for this collection of information is estimated to average XX hours per response, including the time for reviewing instructions,
searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600
Fishers Lane, Room 10-29, Rockville, Maryland, 20857

6

Assent Form for Accompanied
Adolescent (Ages 13 – 17) Study Participation
Health Center Patient Survey

About the Survey
The Health Center Patient Survey is a research study being conducted by RTI International. The survey is sponsored
by the Bureau of Primary Health Care within the Health Resources and Services Administration (HRSA). The survey
is about people who receive health care at places like this health center. The survey will try to find out what kinds of
health problems people have and how well the health centers are meeting the needs of the people who use them. You
are one of 6,600 people that RTI has chosen 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 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 your emotions or feelings. 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 30 minutes.
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 gift of equal value to thank you for your time. On average,
the interview will take about 30 minutes to complete.
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 the computer. As mentioned, your answers will be linked to a number instead of
your name so no one else will know 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 center. Your parent/guardian will not see your answers, and we will not
discuss any of your answers with them.

7

Exceptions to Privacy Pledge
There is an important exception. If I learn through the course of the interview that your life or health, or another
person’s life or health could be is in danger, I am required to inform the clinic staff or the proper authorities.
Questions
If you have any questions about this study, you may call Azot Derecho at 1 (800) 334-8571 Ext 27231. 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: ________
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. The OMB control number for this project is 0915-0368, expiration date 09/30/2016. Public
reporting burden for this collection of information is estimated to average XX hours per response, including the time for reviewing instructions,
searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600
Fishers Lane, Room 10-29, Rockville, Maryland, 20857

8

Short Blessed Scale Exam

ERROR SCORES
SB-1. What year is it now? __________
4 FOR ANY ERROR ................................................................................. 0 4
SB-2. What month is it now? _______________
3 FOR ANY ERROR ................................................................................. 0 3
Please repeat this phase after me: John Brown, 42 Market Street, Chicago.
NO SCORE --- FOR ITEM SB-6.
SB-3. About what time is it? __________
3 FOR ANY ERROR ................................................................................. 0 3
SB-4

Please count backwards from 20 to 1
[20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1]
2 PER ERROR ........................................................................................... 0 2 4

SB-5. Please say the months of the year in reverse order.
[DEC, NOV, OCT, SEP, AUG, JUL, JUN, MAY, APR, MAR, FEB, JAN]
2 PER ERROR ........................................................................................... 0 2 4
SB-6. Please repeat the phrase I asked you to repeat before.
[JOHN BROWN/ 42 MARKET STREET/ CHICAGO]
2 PER ERROR ........................................................................................... 0 2 4 6 8 10
TOTAL NUMBER OF ERRORS IN SB-1 TO SB-6: _____

IF THE TOTAL NUMBER OF ERRORS IS GREATER THAN 10, TERMINATE THE
INTERVIEW.

OMB# 0915-0368

Exp. 09/30/2016

Critical Incident Form
Health Center Patient Survey Participants
If a study respondent has become distressed, expressed that he/she is considering suicide, expressed that he/she
is considering harming another person, or discloses that he/she has been the victim of child abuse or neglect, this
form must be filled out and the instructions on this form must be implemented.
1.

Which of the following have been expressed/revealed by the respondent during this interview?
(CIRCLE ALL THAT APPLY)
EMOTIONAL DISTRESS .................................................................. 1
SUICIDAL IDEAS OR INTENT ........................................................ 2
HOMICIDAL IDEAS OR INTENT .................................................... 3
VICTIM OF ABUSE AND/OR NEGLECT ........................................ 4

2.

What, specifically, did you learn/observe?
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

3.

ON-SITE INTERVIEW  At the end of your interview session, accompany the respondent to meet
with [DESIGNATED SITE STAFF] before you leave the health center.* She/he will refer the
respondent to a psychologist or psychiatrist, as appropriate, and/or initiate a report to Child Protective
Services, as warranted.
OFF-SITE INTERVIEW  Follow procedures in off-site critical incident protocol and instructions on
this form.

4.

DATE REFERRED : ___________________
INTERVIEWER’S SIGNATURE: ______________________________
ON-SITE ONLY:
[SITE STAFF MEMBER’S] SIGNATURE: __________________________________

5.

Within 24 hours of having invoked this procedure, contact your Field Supervisor and your Regional
Supervisor (Name of Supervisor) at XXX-XXX-XXX or (Name of Regional Supervisor) at XXX-XXXXXXX.
CASE ID # ____ ____ ____ ____

* If an emotionally distressed respondent indicates he/she does not want to meet with or talk to a site staff member please
respect his/her wishes unless his/her emotional distress is caused by suicidal ideas/intent, homicidal ideas/intent, or
abuse/neglect.