Participant consent

Attachment F: Domestic VACS Participant Initial Information and Consent/Assent Form

Form Approved

OMB No: 0920-xxxx
Exp. Date: xx-xx-xxxx

Public Reporting burden of this collection of information is estimated at 3 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  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.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NW, MS D-74, Atlanta, GA  30333; Attn:  PRA (0920-xxxx).

Part A: Initial Information

THIS INFORMATION FORM WILL BE READ TO THE PARTICIPANT

Hello, my name is ______________. I am a survey interviewer from NORC at the University of Chicago for a research study supported by the [Baltimore City/Garrett County] Health Department in partnership with the U.S. Centers for Disease control and Prevention. We are conducting a survey across Baltimore to learn about young peoples’ health, educational, and life experiences (INTERVIEWER: IF THE PARTICIPANT SAT IN DURING THE PARENT/GUARDIAN OR HOH CONSENT (FORM B OR FORM C) THEN THERE IS NO NEED TO REPEAT THIS INFORMATION AND YOU CAN SKIP TO THE NEXT PARAGRAPH)

We are only interviewing youth in your area who are between 13 and 24 years old. We have chosen the households in your area by chance [INTERVIEWER DEMONSTRATION OF RANDOM SELECTION].

Do you have any questions about how you were chosen to participate? Y/N

I HAVE CHECKED WITH THE PARTICIPANT AND SHE UNDERSTANDS THAT SHE WAS RANDOMLY SELCTED TO PARTICIPATE. INTERVIEWER INITIALS________

We are doing this survey with you to help us make decisions about the best way to ask young people about their health, educational, and life experiences. The goal of this survey is to make health and social service programs for young people in [Baltimore/Garrett County] better. The findings from this survey may also help us find ways to decrease health problems among young people.

I want to assure you that we do not plan to share your information or your answers with anyone. All of your answers will be kept strictly confidential, and your name and address will not be connected with your survey responses. You have the right to stop the interview at any time, or to skip any questions that you don’t want to answer. There are no ‘Right’ or ‘Wrong’ answers. Your participation is completely voluntary, but your experiences could be very helpful to understand how to improve services for other young people in [Baltimore/Garrett County]. As a token of appreciation for your time, you will receive an incentive of [$20/$40 INTERVIEWER TO TAILOR BASED ON INCENTIVE METHODOLOGY BEING TESTED] cash after completing the survey.

Do you have any questions about what will happen to the information that you give me? Y/N

I HAVE CHECKED WITH THE RESPONDANT AND SHE UNDERSTANDS THAT HER ANSWERS ARE CONFIDENTIAL. INTERVIEWER INITIALS______

The interview takes about 45-60 minutes to complete.

Do you have any other questions?

Would it be alright for me to tell you more about the survey?

NOTE WHETHER THE PARTICIPANT AGREES TO DISCUSS THE SURVEY FURTHER:

Does not agree to DISCUSS Survey FURTHER. (THANK PARTICIPANT FOR THEIR TIME AND END)

agrees to DISCUSS Survey FURTHER.

It is very important that we find a place to talk where others cannot hear our conversation. This is common practice in surveys and helps to protect your information and be very sure that it is just between you and me.

Is this a good place to hold the interview or is there somewhere else that you would like to go?

Name of Interviewer Obtaining Agreement to Provide Additional Information:

_________________________________

Date:___________________

PART B: ASSENT/CONSENT

THIS INFORMATION WILL BE READ TO THE PARTICIPANT

Thank you for agreeing to learn more about the survey. There are a few things you should know before agreeing to participate:

• You get to decide if you want to participate and whatever you decide is OK. It is also OK to say ‘Yes’, start the survey, and change your mind later. You have the right to stop the survey at any time or decline to respond to any questions you do not want to answer. The survey will take 45-60 minutes total.

• The Centers for Disease Control and Prevention (CDC) is funding the survey to learn more about the health, educational, and life experiences of young people in [Baltimore/Garrett County] and the survey asks a lot of different types of questions, including questions about your family, school, community relationships as well as sexual activity and your experiences with physical, emotional and sexual violence. Because some of the questions are sensitive or private, you will complete much of the survey via computer tablet with headphones, meaning no one other than you will hear the questions and no one, not even I, will know how you respond. We know it may be difficult or uncomfortable to respond to some of the questions, but your responses will help us learn more about young people in [Baltimore/Garrett County] and how we might be able to help improve their lives.

• Your responses are confidential. Your survey responses will never be connected to your name or any other personal information. Once you complete the survey, your responses will be added to a dataset with other participants’ responses for researchers to review as a whole. No one will ever look at your response data by itself and know how you responded. Also, the tablet is password protected and encrypted, so if it is lost or stolen, no one will be able to access your responses.

You might be wondering whether bad things could happen to you or your family if you take this survey.

The chance that bad things would happen as a result of this survey is really low. As I said, some of the questions are sensitive and responding to them may be difficult or uncomfortable, but you can choose not to respond to certain questions or to end your participation at any time.

You might also be wondering if good things could happen to you or your family if you participate.

There are no direct benefits for participating. However, as a thank you and in appreciation of your time, you will receive [$20/$40 INTERVIEWER TO SELECT DROPDOWN BASED ON INCENTIVE METHODOLOGY BEING TESTED] after completing the survey. You may also benefit by learning more about different programs available for young people in your area.

There are a few more things I need to tell you due to the content of the survey and the responses you may provide.

• The only people who know the questions asked during the survey are the young people selected to take the survey and the people who work with me on the study. No one else, including the other people in your home or community, knows the exact questions on the survey so you can feel safe in responding honestly.

• I will never know what you enter into the tablet. But at the end of the survey, the survey program on the tablet may tell me to ask if you would like to be connected with the project’s social worker. You will get to decide if you want to be connected with her. I will never give her any of your information without your permission. [IF 13-15 YEARS OLD] and permission from your parent or guardian.

• Your participation is completely voluntary. You may decline to answer any questions you wish and you are free to end the survey at any time. Ending the survey or not answering certain questions will not affect you in any way, including receipt of the [$20/$40 INTERVIEWER TO SELECT]

• Also, please know, separate from the responses that you enter into the tablet, that if you tell me directly at any point during our time together that you are in immediate danger or that you may hurt yourself or someone else, I will have to tell an appropriate person so you can get help. [IF NON-EMANCIPATED 13-17 YEAR OLDS] Also, separate from the responses that you enter into the tablet, if you tell me directly that someone is hurting you I will have to tell a social worker and may have to file a report.

• You should also be aware that a Certificate of Confidentiality has been obtained from the Federal Government for this study to further help ensure your privacy. This Certificate means that the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative or other proceedings. But, if you request disclosure, we can release the information. The Certificate of Confidentiality does not prevent the researchers from disclosing, without your consent, information that would identify you as a participant in the research project if during the interview you reveal intent to hurt yourself or someone else.

[ONLY READ THIS STATEMENT IF A HEAD OF HOUSEHOLD PROVIDED CONSENT FOR THIS PARTICIPANT].

I asked your Parent/Guardian for permission to talk to you. I did not tell him/her specific details about the survey. I did say that the survey topics included “experiences in school, access to food and goods, health status, violence in the community, experiences accessing professional medical and social services, and their relationships with friends, family and community members.” I did not tell him/her that the survey contains specific questions on violence that may or may not have taken place in the home.

Do you have any questions at this time?

You have the right to contact people working on this project with any questions, complaints or concerns about the survey or your participation, either:

• [NAME] from the Baltimore City/Garrett County Health Department at XXX.XXX.XXXX, or

• [NAME] at NORC at the University of Chicago at XXX.XXX.XXXX.

[HAND PARTICIPANT CARD] Here is this contact information if you would like to call at any point. Please know that if you decide at any point after completing this survey that you would like your data destroyed and removed from analysis, we will honor that request.

I am going to read a final statement. When I am done, please respond either “Yes” if you agree to participate or “No” if you do not agree to participate.

You understand the purpose of the survey, that participating is your choice and no one will be upset if you don’t want to participate or if you change your mind, and that your responses will be confidential. Do you agree to participate in the survey?

YES, THE PARTICIPANT AGREES TO PARTICPATE IN THE SURVEY

NO, THE PARTICIPANT DOES NOT AGREE TO PARTICIPATE IN THE SURVEY

IF YES [DO NOT READ TO PARTICIPANT]: Interviewer Verbal Consent Certification

In completing the certification information below and conducting the survey, you verify that you have read the informed consent to the participant, answered any questions to the best of your ability and in-line with your training, and that all project protocols will be followed.

Interviewer Name _____________________________________________

Interviewer ID _____________________________________________

Date _____________________________________________

IF NO: Thank you for taking the time to hear more about the survey. I will not contact you again regarding the survey or for any other reason. You are welcome to have a Youth Resource Sheet, would you like me to leave you one or to scan the QR code?