Consent/Assent Form
Att 4a-c ConsentAssent.docx
NCHS Questionnaire Design Research Laboratory
Consent/Assent Form
OMB: 0920-0222
Attachment 4a – Adult Informed Consent (for respondents aged 18 years and older)
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Centers for Disease Control and Prevention
National
Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland 20782
Informed Consent Form for
One-on-one Interviews
You are being asked to take part in a research study. This consent form tells you about the study and what you will be asked to do. You can choose to take part in the study or not. If you choose to take part, you will need to sign this form.
Purpose of the Research
Surveys are used to collect information on the health and wellbeing of Americans. The surveys help to develop programs to improve the health and health care of people living in the United States.
Before health surveys are conducted, the questions are tested with people of different backgrounds. It is important that the questions make sense, are easy to answer, and that everyone understands the questions the same way. The National Center for Health Statistics conducts these tests for the surveys it sponsors and for other survey programs. If you agree to take part in this test, we will ask you to answer the survey questions. Then, we will ask you to explain what you were thinking and how you came up with your answers.
The questions that we are working on today are about health topics including teen alcohol and marijuana use. Some of the questions are about behaviors that may be illegal in your State. Some of the questions ask about things you have done, and others ask for your opinions.
Your interview will show us how to improve these questions. In the future, we may also study your interview along with interviews from other projects. This type of study will teach us about the different kinds of problems people have answering survey questions. The study will help us write better questions in the future.
Procedures
An interviewer will ask you some survey questions. Then, the interviewer will ask you to explain what you were thinking as you answered the questions. The interviewer will ask you if there were any words that were confusing and if you understood what was being asked.
The interview will last no more than 60 minutes, and we will give you $40. You will also be asked to fill out a personal information sheet.
You may find that some of the questions we are testing are sensitive. You may choose not to answer any question for any reason. If you do not want to answer a question, say so, and we will move on to the next one. You may also stop the interview at any time. While the interview is going on, researchers from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) who are working on the project may listen the interview
If you have questions about how the project works, contact Ms. Karen Whitaker by phone at (301) 458-4569, or by mail at NCHS, Room 5448, 3311 Toledo Rd., Hyattsville, MD 20782.
Recordings
We would like to audio record your interview. The recording allows us to more carefully study and improve the questions. At the bottom of this form, you will be asked if you are willing to have the interview recorded. If you agree, you may still ask to stop the recording at any time, and we will turn off the machine. If you decide to stop recording, we will ask your consent to retain the portion already recorded. When the interview is finished, you may listen to the recording.
If you agree to record the interview, we will keep it in a locked room either in a secure storage cabinet or on a password-secured computer that is not connected to the internet. Only researchers from the Collaborating Center for Questionnaire Design (CCQDER) working on the project will be allowed to listen to the recording in a secured room. When in use all recordings will be in the safe keeping of a staff person from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER).
Privacy
We are required by law1 to tell you what we will do with the recording. We must also tell you how we will protect your privacy.
Audio recordings are stored in a locked room or secured by a password. All recordings are labeled by a code number, date, time, and project title. The recording is never labeled with your name or other personal facts.
Materials with personal facts (such as names or addresses) are also stored in a locked room. Only CCQDER staff has access to this material.
Your name or other personal facts that would identify you will not be used when we discuss or write about this study. People working on this project, however, may recognize you or your voice.
If you have questions about National Center for Health Statistics privacy’ laws and practices, contact the NCHS Confidentiality Office by phone at 888-642-4159 or 301-458-4601, or by email at [email protected].
Benefits and Risks
There are no direct benefits from taking part in this study.
The possible risks of taking part in this study are minimal. We will take all possible steps to protect your privacy. You do not have to give us any information that you do not want to, and you can choose not to answer any question in the interview. You may also stop at any time and still receive the full $40.
Conducting an interview at a mutual location2
In order for you to take part in the study today, we agreed to meet at this location. Meeting at this location is your choice. However, you are urged to choose a place that is private so that you will feel comfortable answering the questions. We will protect any materials that contain your personal information and transport them to the National Center for Health Statistics.
If you have any questions about this study, please call the office of the Research Ethics Review Board at the National Center for Health Statistics, toll-free at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol #2016-16-XX [Note: The amendment number will be inserted into the form once NCHS ERB approval has been received]. Your call will be returned as soon as possible.
Please Read and Sign Below if You Agree
I freely choose to take part in this research study.
I allow NCHS to audio record my interview. I also allow NCHS to play my audio recording to other people working on this project either in the CCQDER or in another location under the direct supervision of CCQDER staff.
Yes No
IF YES:
I allow NCHS to retain my audio recording for future research on how people react to survey questions and how survey questions can be hard to understand or hard to answer.
Yes No
______________________________ __________________________ __________
Respondent Signature Print name Date
1The Public Health Service Act provides us with the authority to do this research (42 United States Code 242k). All information which would permit identification of any individual, a practice, or an establishment will be held confidential, will be used for statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or the establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).
2This paragraph will be included in the consent form for those interviews conducted offsite.
Attachment 4b - Form for informed consent for minors/Parental & Guardian form
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Centers for Disease Control and Prevention
National
Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland 20782
Informed Consent Form
Parental/Guardian Permission
One-on-one Interviews
Your child is being asked to take part in a research study. This consent form tells you about the study and what your child will be asked to do. You can choose to have your child take part in the study or not. If you permit your child to take part, please sign this form. Your child will also have a consent form to read and sign.
Purpose of the Research
Surveys are used to collect information on the health and well being of Americans. The surveys help to develop programs to improve the health and health care of people living in the United States.
Before health surveys are conducted, the questions are tested with people of different backgrounds. It is important that the questions make sense, are easy to answer, and that everyone understands the questions the same way. The National Center for Health Statistics conducts these tests for the surveys it sponsors and for other survey programs. If you permit your child to take part in this test, we will ask your child to answer the survey questions. Then, we will ask your child to explain what he/she was thinking and how he/she came up with their answers.
The questions that we are working on today are about health topics including teen alcohol and marijuana use. Some of the questions are about behaviors that may be illegal in your State. Some of the questions ask about things your child has have done, and others ask for your child’s opinions.
Procedures
An interviewer will ask your child some survey questions. Then, the interviewer will ask your child to explain what he/she was thinking as he/she answered the questions. The interviewer will ask your child if there were any words that were confusing and if he/she understood what was being asked.
The interview will last 60 minutes, and we will give your child $40. We also ask that you fill out for your child a personal information sheet.
Your child may find that some of the questions we are testing are sensitive. He/she may choose not to answer any question for any reason. If he/she does not want to answer a question, he/she can say so, and we will move on to the next one. Your child may also stop the interview at any time. While the interview is going on, researchers from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) who are working on the project may listen to the interview. Information your child provides during the interview will not be shared with anyone else without his/her permission.
If you have questions about how the project works, contact Ms. Karen Whitaker by phone at (301) 458-4569, or by mail at NCHS, Room 5448, 3311 Toledo Rd., Hyattsville, MD 20782.
Recordings
We would like to audio record your child’s interview. The recording allows us to more carefully study the questions. At the bottom of this form, you will be asked if you are willing to have your child’s interview recorded. If you agree, your child may ask to stop the recording at any time, and we will turn off the machine. If your child decides to stop taping, we will ask his/her consent to retain the portion already taped. When the interview is finished, your child may listen to the recording. You will not be allowed to listen to the interview while it is being recorded or listen to the recording at a later time.
If you agree to record your child’s interview, we will keep it in a locked room either in a secure storage cabinet or on a password-secured computer that is not connected to the internet. Only researchers from the Collaborating Center for Questionnaire Design (CCQDER) working on the project will be allowed to listen to the recording in a secured room. When in use all recordings will be in the safe keeping of a staff person from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER).
Privacy
We are required by law1 to tell you what we will do with your child’s recording. We must also tell you how we will protect your child’s privacy.
Audio recordings are stored in a locked room or secured by a password. All recordings are labeled by a code number, date, time, and project title. The recording is never labeled with your child’s name or other personal facts.
Materials with personal facts (such as names or addresses) are also stored in a locked room. Only CCQDER staff have access to this material.
Your child’s name or other personal facts that would identify your child will not be used when we discuss or write about this study. People working on this project, however, may recognize your child or your child’s voice.
If you have questions about National Center for Health Statistics privacy’ laws and practices, contact the NCHS Confidentiality Office by phone at 888-642-4159 or 301-458-4601, or by email at [email protected].
Benefits and Risks
There are no benefits from taking part in this study.
The possible risks of taking part in this study are minimal. We will take all possible steps to protect your child’s privacy. Your child does not have to give us any information that he/she does not want to, and he/she can choose not to answer any question in the interview. He/she may also stop at any time and still receive the full $40.
Conducting an interview at a mutual location2
In order for you to take part in the study today, we agreed to meet at this location. Meeting at this location is your choice. However, you are urged to choose a place that is private so that you will feel comfortable answering the questions. We will protect any materials that contain your personal information and transport them to the National Center for Health Statistics.
If you have any questions about this study, please call the office of the Research Ethics Review Board at the National Center for Health Statistics, toll-free at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol #2016-16-XX [Note: The amendment number will be inserted into the form once NCHS ERB approval has been received]. Your call will be returned as soon as possible.
Please Read and Sign Below if You Agree
I allow my child to take part in this research study.
I allow NCHS to audio record his/her interview. I also allow NCHS to play his/her audio recording to other people working on this project either in the CCQDER or in another location under the direct supervision of CCQDER staff.
I do not allow NCHS to record his/her interview.
______________________________ __________________________ __________
Parent or Guardian Print name Date
1The Public Health Service Act provides us with the authority to do this research (42 United States Code 242k). All information which would permit identification of any individual, a practice, or an establishment will be held confidential, will be used for statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or the establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).
2This paragraph will be included in the consent form for those interviews conducted offsite.
Attachment 4c - Form for informed consent for minors/Minor form
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Centers for Disease Control and Prevention
National
Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland 20782
Informed Assent Form
Teens/Young Adults (aged 15-17)
One-on-one Interviews
Your parent or guardian says you can take part in a research study. This consent form tells you about the study and what you will be asked to do. You can choose to take part in the study or not. If you choose to take part, you will need to sign this form.
Purpose of the Research
One way that the National Center for Health Statistics learns about health in this country is to ask people questions on surveys. Before we do that, we want to test the questions out on people like you. We are interested in learning how well the questions work. Whether they make sense, are easy or hard to answer. There is no right or wrong answer to these questions.
The questions that we are working on today are about health topics including teen alcohol and marijuana use. Some of the questions are about behaviors that may be illegal in your State. Some of the questions ask about things you have done, and others ask for your opinions.
Procedures
An interviewer will read the survey questions and have you answer. Then, the interviewer will ask you some follow-up questions about how you came up with your answers. The interviewer will ask you if the questions were clear, and if any terms were confusing.
The interview will last no more than 60 minutes, and we will give you $40.
You may find that some of the questions we are testing ask about sensitive issues. You may choose not to answer any question for any reason. If you do not want to answer a question, say so, and we will move on to the next one. You may also stop the interview at any time. While the interview is going on, researchers from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) who are working on the project may listen the interview. Information you provide during the interview will not be shared with anyone else without your permission.
If you have questions about how the project works, contact Ms. Karen Whitaker by phone at (301) 458-4569, or by mail at NCHS, Room 5448, 3311 Toledo Rd., Hyattsville, MD 20782.
Recordings
We would like to audio record your interview. The recording allows us to review what you said about the questions. At the bottom of this form, you will be asked if you are willing to have the interview recorded. If you agree, you may ask to stop the recording at any time, and we will turn off the machine. If you decide to stop taping, we will ask your consent to retain what we have already taped. When the interview is finished, you may listen to the recording. Your parents/guardians are not permitted to listen to the recording.
If you agree to record the interview, we will keep it in a locked room either in a secure storage cabinet or on a password-secured computer that is not connected to the internet. Only researchers from the Collaborating Center for Questionnaire Design (CCQDER) working on the project will be allowed to listen to the recording in a secured room. When in use all recordings will be in the safe keeping of a staff person from the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER).
Privacy
We are required by law1 to tell you what we will do with the recording. We must also tell you how we will protect your privacy.
Audio recordings are stored in a locked room or secured by a password. All recordings are labeled by a code number, date, time, and project title. The recording is never labeled with your name or other personal facts.
Materials with personal facts (such as names or addresses) are also stored in a locked room. Only CCQDER staff have access to this material.
Your name or other personal facts that would identify you will not be used when we discuss or write about this study. People working on this project, however, may recognize you or your voice.
If you have questions about National Center for Health Statistics privacy’ laws and practices, contact the NCHS Confidentiality Office by phone at 888-642-4159 or 301-458-4601, or by email at [email protected].
Benefits and Risks
There are no benefits from taking part in this study.
The possible risks of taking part in this study are minimal. We will take all possible steps to protect your privacy. You do not have to give us any information that you do not want to, and you can choose not to answer any question in the interview. You may also stop at any time and still receive the full $40.
Conducting an interview at a mutual location2
In order for you to take part in the study today, we agreed to meet at this location. Meeting at this location is your choice. However, you are urged to choose a place that is private so that you will feel comfortable answering the questions. We will protect any materials that contain your personal information and transport them to the National Center for Health Statistics.
If you have any questions about this study, please call the office of the Research Ethics Review Board at the National Center for Health Statistics, toll-free at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol #2016-16-XX [Note: The amendment number will be inserted into the form once NCHS ERB approval has been received]. Your call will be returned as soon as possible.
Please Read and Sign Below if You Agree
I freely choose to take part in this research study.
I allow NCHS to audio record my interview. I also allow NCHS to play my audio recording to other people working on this project either in the CCQDER or in another location under the direct supervision of CCQDER staff.
I do not allow NCHS to record my interview.
______________________________ __________________________ __________
Participant Signature Print name Date
1The Public Health Service Act provides us with the authority to do this research (42 United States Code 242k). All information which would permit identification of any individual, a practice, or an establishment will be held confidential, will be used for statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or the establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).
2This paragraph will be included in the consent form for those interviews conducted offsite.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Whitaker, Karen R. (CDC/OPHSS/NCHS) |
| File Modified | 0000-00-00 |
| File Created | 2021-01-22 |
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