Attachment C Parental Consent

ATTACHMENT C

STUDY PARENTAL CONSENT FORM 

Form approved 

OMB Number: XXXX-XXXX 

Expiration Date: XX/XX/XXXX

CONSENT LETTER AND FORM

REAL Essentials Advance Study

Conducted on behalf of the U.S. Department of Health and Human Services

We invite your child to take part in the Components Study of REAL Essentials Advance (REA). REA is a relationship education program that teaches youth critical relationship skills and practical approaches for navigating the social dynamics of friendship and love. [Your child’s school/CBO] is participating in the REA study during the [2021-2022/2022-2023] school year. The purpose of this study is to learn about the components of programs like REA that matter most for promoting positive health behaviors and relationship skills in adolescents. The study is sponsored by the Office of Population Affairs in the U.S. Department of Health and Human Services, and is being conducted by Mathematica, an independent research company.

If you agree for your child to participate in the study…

• Your child will be asked to complete up to three surveys over the next year. The surveys will include questions about their background, attitudes towards relationships, social and emotional wellbeing, and behaviors. Information collected through the surveys will be used to understand the effect of the REA curriculum on attitudes and skills around healthy relationships and positive health behaviors. The surveys are web-based and will each take about 40 minutes to complete. The first survey will be completed over the next few weeks, prior to the start of the REA program. The next survey will be completed immediately after they finish the REA program. The final survey will be conducted about 6 months later. All surveys will be administered at [school/NAME OF CBO]. If we are unable to complete a survey with your child [in school/at NAME OF CBO] Mathematica staff may attempt to contact your child to complete the survey over the phone or via the web. Your child will also receive a [INCENTIVE] for completing the survey immediately after they finish the REA program. Lastly, if your child completes the final survey 6 months later, they will receive a [INCENTIVE].

• We will also gather information about your child’s attendance and engagement in the REA program. Your child will be asked to fill out paper and pencil surveys after each classroom session of REA. These short surveys will include a few questions to assess your child’s engagement in the class.

• Your child may be asked to participate in a focus group to learn more their experience with the REA curriculum. Focus groups will be led by trained Mathematica staff and are expected to last 1 hour. Not everyone will be selected to participate in the focus groups, but if your child participates then they will receive a $25 gift card. To assist with note taking, focus groups will be audio-recorded with the permission of all participants. If a participant does not wish to be recorded, we will not record the focus group. All recordings will be stored on a secure network that can only be accessed by a limited number of study team members. Recordings will be destroyed as soon as notes have been completed. Please note youth may still participate in the study even if you do not give permission for them to participate in the focus group. You will be given the option to opt your child out of the focus group activity when you complete the form.

• [ONLY FOR STUDENT ENGAGEMENT PILOT DISTRICTS WHERE PARENTAL APPROVAL IS REQUIRED] Your child’s class may be video/audiotaped to learn more about student interest and engagement in the REA curriculum. This audio/video will only be used for the purposes of research (e.g., analysis of responses, and transcriptions of responses) and will not be available to anyone aside from the research team and their partners. The audio and video data will grouped at the classroom-level, not tied to any individual student.

We will follow all public health and social distancing requirements when collecting data for the study. This means that data may be collected in person or virtually. The specifics will be determined at the time of data collection in consultation with [your child’s school/NAME OF CBO].

You can choose whether your child will be part of the study. Participation in the study is voluntary. If you agree that your child can participate, you or your child can choose to stop participation at any time with no consequences. The only risk to your child connected with the study is that they may be uncomfortable answering some questions in the surveys. If that happens, your child can refuse to answer those questions. Your child can still receive the REA curriculum even if they opt out of the study.

Privacy Protections. All information collected through the study will be kept private to the extent allowed by law. If you let your child participate, information from your child will be combined with information from other youth participating in the study. Your child’s name will not be attached to the answers they give. No one outside the study team will see their answers. We have a Certificate of Confidentiality from the National Institutes of Health. This helps us protect your child’s privacy. This means no one can force the study team to give out information that identifies your child, even in court. The United States government may still request information for an audit.

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

We need your response whether it is “yes” or “no.” Please complete, sign, and return the attached [COLOR] form to your [your child’s teacher/NAME OF SOMEONE AT CBO] within one week by [RETURN DATE]. Your child will receive a small gift for returning the completed form, regardless of whether your answer is “yes” or “no.” Please keep the [COLOR] form for your records. If you have questions about the REA Study please call Melissa Thomas, Mathematica’s Survey Director, toll-free, at 1-8XX-XXX-XXXX between 9 a.m. and 5 p.m. Eastern Time, Monday-Friday. You may also contact us via email at [email protected].

The REA study has received approval from Health Media Lab Institutional Review Board (HML IRB). If you have any questions about your child’s rights as a research participant, please contact HML IRB at XXX-XXX-XXXX or by email at [HML EMAIL].

Please complete and sign the enclosed permission form and return it to [your child’s school/NAME OF CBO] within one week. Thank you!

REAL Essentials Advance (REA) Study

Parent or Guardian Permission Form

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

YES, I agree to all YES, I agree but opt out of focus groups NO, I do not give permission

for my child, _____________________________________, to participate in the study.

Print Child’s Name

In giving permission for my child to participate, I understand that Mathematica staff will administer three surveys to my child over the next year. 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 participation in the follow-up survey. I understand that participation is voluntary and may be withdrawn at any time for any reason without penalty. I further 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 research volunteer, I can call the Health Media Lab (HML), toll-free at [FILL NUMBER].

Child’s Date of Birth: _____ / ______ / _____
Month Day Year

Parent/Guardian Signature: Date:

Sponsored by the U.S. Department of Health and Human Services

If you said YES above, please fill in the following information. We will use your contact information only if we need your help in contacting your child to schedule a follow-up study survey. We also ask you to provide contact information for someone who would know how to reach you in the event 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/CBO] to obtain a copy of the questions.

WE NEED YOUR ANSWER, WHETHER IT IS YES OR NO. PLEASE SIGN THIS [COLOR] FORM AND RETURN IT TO YOUR CHILD’S SCHOOL/CBO] WITHIN ONE WEEK. KEEP THE [COLOR] SECOND COPY FOR YOUR RECORDS. THANK YOU!