Appendix A: Example consent and assent forms

APPENDIX A:
EXAMPLE CONSENT AND ASSENT FORMS

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Example Voluntary Parent/Guardian Consent for Youth to Participate in the Sexual Risk Avoidance Education National Evaluation (SRAENE)

Study description and purpose

We invite your child to participate in the Sexual Risk Avoidance Education National Evaluation programs, also called SRAENE. SRAENE is an evaluation of programs such as [PROGRAM NAME], funded by Sexual Risk Avoidance Education (SRAE) grants, designed to improve youth outcomes, such as healthy behaviors and relationship skills. In addition to offering the [PROGRAM NAME] program, your child’s school is participating in SRAENE. [INSERT ADDITIONAL STUDY DETAILS ONCE DESIGNS ARE FINALIZED].

This is a permission form with information to help you decide if your child can participate in the study.

Mathematica, an independent research firm, is conducting this study for the Administration for Children and Families (ACF). ACF is an agency in the federal government within the U.S. Department of Health and Human Services that supports the health and well-being of youth and administers the SRAE grant program.

What will my child be asked to do?

• Your child will be asked to complete [NUMBER OF SURVEYS AND TIMELINE]. The survey questions will be about [FILL SURVEY TOPICS]. Your child will complete the survey(s) on the web during the school day, and each survey takes about [XX] minutes to complete. If your child is unable to complete a survey at school, Mathematica staff may contact your child to complete the survey over the phone or on the internet. Your child will receive [$XX] gift card for completing [XX] survey(s).

• [IF DESIGN INCLUDES COLLECTION OF EXIT TICKETS: We will ask for information about your child’s involvement in the [PROGRAM NAME]’s daily lessons. Your child will be asked to fill out a very brief survey after each lesson of [PROGRAM NAME]. These short surveys will have a few questions about your child’s reaction to the lesson.]

• [IF DESIGN INCLUDES YOUTH FOCUS GROUPS: Your child may be asked to participate in a focus group to learn more about their experience with the [PROGRAM NAME] program. A focus group is a discussion Mathematica staff will guide with youth participating in [PROGRAM NAME]. During the focus group, your child and the other youth can share their thoughts about the [PROGRAM NAME] program. Your child will not be asked about their own behavior. Not everyone will be selected to participate in the focus groups, but if your child does participate, they will receive a [$XX] gift card. Please note: your child may still participate in the study even if you do not give permission for them to be in the focus group. If you do not want your child to be part of the focus group, you can opt them out of that activity when you complete the form.]

What are the risks and benefits to participating?

• There are no known risks associated with this study. Some people might feel uncomfortable answering some of the questions in the survey or in the focus group. However, your child does not need to answer any questions that make them uncomfortable.

• Your child’s participation is entirely voluntary. Even if you give permission for your child to participate, they can choose for themselves whether they want to participate or not. There are no consequences if your child decides not to participate in this research study.

How will my child’s privacy be protected?

• For all data collection activities, the responses your child provides will be combined with the responses from hundreds of other youth participating in SRAENE.

• Your child’s name and responses will not be disclosed or used, in identifiable form.

• [IF THE DESIGN INCLUDES FOCUS GROUPS: With your child’s permission, we will audio-record the focus group discussion to help us catch everything the participants say. If any child in the focus group does not agree to be audio-recorded, we will not record the group. If we do record, we will destroy the recording after we check our written notes.]

• All information collected will be securely stored and will not be shared with anyone outside of the study team.

• We are required by law to report your child’s name to authorities if:

• We suspect child abuse or neglect.

• Your child says something that suggests they are likely to harm themselves, harm another person, or that someone is likely to harm them.

How will the information collected from the survey be used?

The study team will write a report for ACF that summarizes the findings from the data collection activities. Your child’s name and responses to the survey will not be disclosed or used, in identifiable form.

In the future, data collected may be securely shared with qualified individuals for additional learning purposes to better understand youth programming. This information will not include any information identifying individuals or participating organizations.

Who can I contact for more information?

The Health Media Lab Institutional Review Board has approved this work. If you have any questions about your child’s rights as a study participant, please contact the Health Media Lab Institutional Review Board at (202) 246-8504 or by email at info@hmlirb.com. If you have questions about the SRAENE study, please call [CONTACT NAME], toll-free at [XXX-XXX-XXXX] between 9 a.m. and 5 p.m. Eastern Time, Monday–Friday. You may also contact us by email at [EMAIL ADDRESS].

Agreement to participate

• If you agree, then your child will decide on their own whether to participate. They will be asked to sign their own agreement form.

• You must indicate you give permission for your child to participate by checking the box below and submitting this form.

Please complete and sign the enclosed permission form and return it to [LOCATION/CONTACT PERSON] within [TIME FRAME]. Thank you!

S exual Risk Avoidance Education National Evaluation (SRAENE)

EXAMPLE Parent or Guardian Permission Form

We need your answer, whether it is yes or no.

Please fill out the form and have your child return it to school.

In giving permission for my child to participate, I understand my child will be asked to complete [number of surveys and timeline] [and collect information on their involvement in daily lessons at each [PROGRAM NAME] session.] [My child may also be asked if they would like to participate in a focus group.] By giving permission for my child to be in the study, I agree that this information can be collected, and that my child may receive an email or text message to the numbers provided to arrange for them to participate in the follow-up survey. I understand participation is voluntary, and my child can stop at any time with no consequences. I also understand that all information on my child will be kept private and used only for the purposes of the study. If I have questions about my child’s rights as a study participant, I can call the Health Media Lab toll-free at (202) 246-8504.

I have read the information sheet describing the study. By signing this form, I am saying (CHOOSE ONE):

Yes, I permit my child, _________________________________, to participate in surveys and focus groups

(Print child’s name)

Yes, I permit my child, _________________________________, to participate in surveys only

(Print child’s name)

No, I do not permit my child, _____________________________________, to participate in the study.

(Print child’s name)

[IF REQUIRED FOR STUDY DESIGN: Child’s Date of Birth: _____ / ______ / _____]
Month Day Year

Parent/Guardian Signature: Date:

PLEASE TURN PAGE

If you said YES, please fill in the following information. We will use your contact information only if we need your help in contacting your child to complete a follow-up survey. We also ask you to provide contact information for someone who would know how to reach you in case you move and we cannot contact you. If we contact this person, we will not reveal any information about your child or the study, other than to say we need to locate your child to complete a survey. Thank you.

Parent or Guardian Name: _____________________________________________________________

Street Address: _______________________________________________________ Apt: ___________

City: _______________________________________ State: ________ Zip Code: _________________

Telephone: (______)_____ - ___________ Home (_____) _____ - ____________ Cell

Email: _______________________________

Alternate Contact Name: _____________________________________________________________

Street Address: _______________________________________________________ Apt: ___________

City: _______________________________________ State: ________ Zip Code: __________________

Telephone: (______)_____ - ___________ Home (_____) _____ - ____________ Cell

Email: _______________________________

Parents please be aware that under the Protection of Pupil Rights Act. 20 U.S.C. Section 1232(c)(1)(A), you have the right to review a copy of the questions asked of your child. If you would like to do so, you should contact your child’s school to obtain a copy of the questions.

Example Youth Participation Agreement Form for Sexual Risk Avoidance National Evaluation (SRAENE) (for youth under 18)

Study description and purpose

We invite you to participate in the Sexual Risk Avoidance Education National Evaluation, also called SRAENE. Your parent or guardian has already provided permission for you to participate, but you can now decide for yourself. SRAENE is an evaluation of programs such as [PROGRAM NAME], funded by Sexual Risk Avoidance Education (SRAE) grants, designed to improve youth outcomes, such as healthy behaviors and relationship skills. In addition to offering the [PROGRAM NAME] program, your school is participating in SRAENE. [INSERT ADDITIONAL STUDY DETAILS ONCE DESIGNS ARE FINALIZED].

This is a permission form with information to help you decide if you want to participate in the study.

Mathematica, an independent research firm, is conducting this study for the Administration for Children and Families (ACF). ACF is an agency in the federal government within the U.S. Department of Health and Human Services that supports the health and well-being of youth and administers the SRAE grant program.

What will I be asked to do?

• Your will be asked to complete [number of surveys and timeline]. The survey questions will be about [survey topic descriptions].

• You will complete the surveys on the web during the school day, and each survey takes about [XX] minutes to complete. If you are unable to complete a survey at school, Mathematica staff may contact you to complete the survey over the phone or on the internet.

• [IF DESIGN INCLUDES COLLECTION OF EXIT TICKETS: You will also be asked to fill out a very brief survey after each lesson of [PROGRAM NAME]. These short surveys will have a few questions about your reaction to the lesson.]

What are the risks and benefits to participating?

• There are no known risks associated with this study. You might feel uncomfortable answering some of questions on the survey. If that happens, you do not need to answer any questions that make you uncomfortable.

• If you choose to participate, you will receive a [$XX] gift card for completing [XX] survey(s).

Do I have to participate?

No. You can choose to participate or not participate without any consequences. You can still participate in the [PROGRAM NAME] program even if you do not agree to the study.

How will my privacy be protected?

• Nothing will be shared with your parents, teachers, or anyone outside of the study team. However, we are required by law to report your name to authorities if:

• We suspect child abuse or neglect.

• You say something that suggests you are likely to harm yourself, harm another person, or that someone is likely to harm you.

• All information collected will be kept in a secure location for the study team to use, and we will destroy the information at the end of the project.

How will the information from the surveys be used?

The study team will write a report for ACF that summarizes the findings across all participating youth. Your name and the information you provide through the surveys will not be shared or used in any way that identifies you.

Who can provide more information about this study?

• The Health Media Lab Institutional Review Board has approved this work.

• If you have any questions or concerns, please contact [study point of contact to be inserted].

Agreement to participate

• By signing below, you agree to participate in the study and to complete [number of surveys and timeline].

• Your signature means that your questions have been answered, and that you have read and understood the information provided above.

I accept the terms described above and will voluntarily participate [NUMBER OF SURVEYS AND TIMELINE].

________________________________________________________

Print your name

____________________________________ _______________________

Your Signature Date

Example Youth Participation Agreement Form for a Focus Group

Study description and purpose

We invite you to participate in a focus group discussion to share your thoughts and experiences with the [PROGRAM NAME] program. [IF UNDER 18: Your parent or guardian has already provided permission for you to participate, but you can now decide for yourself.] If you agree to participate, you will join a [XX] minute, [in-person/virtual] focus group.

This form provides information to help you decide if you want to participate in this focus group.

Mathematica, an independent research firm, is conducting this study for the Administration for Children and Families (ACF). ACF is an agency in the federal government within the U.S. Department of Health and Human Services that supports the health and well-being of people, including youth.

What will I do?

• If you agree to participate, you will join a [XX] minute [in-person/virtual] focus group session.

• The focus group will include a small group of youth around your age.

• The focus group will be led by a researcher from Mathematica.

• Your name or feedback will not be disclosed or used, in identifiable form.

• You will be asked to share your thoughts about your experience with the [PROGRAM NAME] program.

What are the risks and benefits to participating?

• There are no known risks associated with this study. Some people might feel uncomfortable talking about some of the focus group topics. You do not need to answer any questions or talk about any topics that make you uncomfortable.

• The focus group is a group discussion. There is a chance others might share information from the discussion with people who did not participate. We ask all participants to respect the privacy of others in the group by not discussing specifics with others outside the group, but we cannot guarantee that will happen.

• If you choose to participate, you will receive a [$XX] gift card

Do I have to participate?

No. You can choose to participate or not participate without any consequences.

How will privacy be protected?

• With all participants’ permission, the discussion will be audio-recorded so the study team can review the recording later to make sure their notes are accurate. No one will hear the recording except for the study team. We will store the recording in a secure location and our study team will destroy it at the end of the project. You can still participate in the discussion if you do not agree to the recording.

• We will keep any notes from our conversation in a secure location for the study team to use, and we will destroy the notes at the end of the project.

• Nothing will be shared with your parents or any other people outside of the study team conducting this study. However, we are required by law to report your name to authorities if:

• We suspect child abuse or neglect.

• You say something that suggests you are likely to harm yourself, harm another person, or that someone is likely to harm you.

How will the information from the discussion be used?

The study team will write a report for ACF that summarizes the findings across all focus groups. Your name and feedback will not be shared or used in any way that identifies you.

Who can provide more information about this study?

• The Health Media Lab Institutional Review Board has approved this work.

• If you have any questions or concerns, please contact [study point of contact to be inserted].

Agreement to participate

• Please indicate your response by checking the boxes below and signing the form.

• By signing below, you agree to participate in the focus group to give feedback about your thoughts and experiences with the [PROGRAM NAME] program.

• Your signature means that your questions have been answered, and that you have read and understood the information provided above.

I accept the terms described above and will voluntarily participate in the focus group session.

I agree to the audio-recording to ensure notes are accurate.

________________________________________________________

Print your name

____________________________________ _______________________

Your Signature Date