Appendix B_Consent letters and forms

APPENDIX B

CONSENT LETTERS AND FORMS (ACTIVE AND PASSIVE CONSENT)

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ACTIVE CONSENT

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Form Approved

OMB Number:

Expiration Date:

Dear Parent or Guardian:

The Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services is sponsoring [INSERT NAME OF PROGRAM] though the Personal Responsibility Education Program (PREP) grant program. PREP programs aim to educate youth on both abstinence and contraception to prevent pregnancy and sexually transmitted infections. Additionally, PREP programs also offer services to prepare youth for adulthood by implementing activities that address [insert specific adulthood topics ADDRESSED BY YOUR PROGRAM here].

As part of the PREP grant, our organization is required to report on performance measures to support continuous quality improvement. Some of the performance measures information is collected through two surveys administered to program participants. The first survey (the entry survey) is administered just prior to the program start, and the second (the exit survey) is administered at the end of the program.

We are asking your permission for your child to complete these two surveys. The surveys ask about demographics, attitudes, and activities, including sexual activity. The exit survey also asks about your child’s experience with and thoughts about the program. All information collected through the surveys will be kept private to the extent permitted by law. Your child’s name will not be attached to the answers he or she gives. Your child’s responses will be combined with those from other program participants for the reporting of the performance measures.

[INSERT INFORMATION HERE ABOUT HOW THE PRIVACY OF THE INDIVIDUAL RESPONSES WILL BE ASSURED]. [INSERT INFORMATION ON HOW THE PROGRAM OR GRANTEE ORGANIZATION WILL USE THE DATA].

We will submit deidentifed and aggregated data to ACF through their Performance Measures Management System. ACF may disseminate findings based on the analyses of the aggregated data at professional conferences or other venues.

Participation in the surveys is voluntary. It is important that you let us know whether or not you will allow your child to complete the surveys. Refusal to participate will not involve any penalty or affect your child’s receipt of program services. If you agree that your child can complete the surveys, you or your child can change your mind at any time with no consequences. The risk to your child is that he or she may be uncomfortable answering some survey questions. If that happens, your child can refuse to answer those questions. Potential benefits to your child are that he or she will have an opportunity to share their thoughts and feedback on the program. Additionally, the information your child provides will be used to help improve the PREP program.

Please complete and sign the enclosed form indicating whether you will allow your child to participate in the surveys and return the form to [CONTACT NAME OR LOCATION] no later than [DUE DATE].

If you have questions or concerns about the surveys, please contact [CONTACT NAME] at [CONTACT PHONE NUMBER] or via email at [CONTACT EMAIL]. If you have questions about your child’s rights as a participant in the surveys or the collection of performance measures, you can contact the [INSERT NAME OF THE LOCAL IRB, IF APPLICABLE] AT [INSERT CONTACT INFORMATION].

Thank you for your time and consideration!

Sincerely,

[TITLE]

[NAME OF ORGANIZATION]

SAMPLE STATEMENT OF ACTIVE CONSENT

[PROGRAM NAME] – Entry and Exit Surveys

Sponsored by the Administration for Children and Families, The U.S. Department of Health and Human Services

I have read the attached information cover letter describing the entry and exit surveys for [PROGRAM NAME]. If I give permission for my child to participate in the surveys, it means:

• I give permission for my child to participate in the program surveys. The entry survey is expected to take approximately eight minutes to complete; the exit survey is expected to take approximately fifteen minutes to complete.

• I understand that I may decide later that my child should stop participating in the surveys at any time, and my child can decide that also.

• I understand that my child may refuse to complete the surveys or parts of them.

• I understand that all information will be kept strictly private to the extent permitted by law. I understand that my child’s responses will be combined with those of other program participants, and he/she will not be identified in any reports. The information will be used by the program to report to ACF on performance measures for use in continuous quality improvement. The findings from analyses of the performance measures may also be disseminated at professional conferences or other venues.

• I understand the individual level data will be [INSERT INFORMATION ON HOW INDIVIDUAL-LEVEL DATA WILL BE STORED AND USED].

• I can call [PROGRAM CONTACT] at [ORGANIZATION NAME] at [PHONE NUMBER] between the hours of [X:XX] and [X:XX] to get an answer about any questions I may have about the surveys or the program.

• If I have questions about my child’s rights as a participant in the surveys and the collection of performance measures, I can call [NAME] at [IRB] at [PHONE NUMBER].

By signing this form, I am:

______ giving my permission

______ NOT giving my permission

For my child, ___________________________________________ to complete the entry and exit surveys.

(Child’s full name, printed)

Parent/Guardian Name: ____________________________________________

(Printed)

Signature: ___________________________________________ Date: ____________________

We need your answer whether it is yes or no. please return this form to [location] by [date]. Thank you!

PASSIVE CONSENT

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Form Approved

OMB Number:

Expiration Date:

Dear Parent or Guardian:

The Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services is sponsoring [INSERT NAME OF PROGRAM] though the Personal Responsibility Education Program (PREP) grant program. PREP programs aim to educate youth on both abstinence and contraception to prevent pregnancy and sexually transmitted infections. Additionally, PREP programs also offer services to prepare youth for adulthood by implementing activities that address [insert specific adulthood topics ADDRESSED BY YOUR PROGRAM here].

As part of the PREP grant, our organization is required to report on performance measures to support continuous quality improvement. Some of the performance measures information is collected through two surveys administered to program participants. The first survey (the entry survey) is administered just prior to the program start, and the second (the exit survey) is administered at the end of the program.

We are asking your permission for your child to complete these two surveys. The surveys ask about demographics, attitudes, and activities, including sexual activity. The exit survey also asks about your child’s experience with and thoughts about the program. All information collected through the surveys will be kept private to the extent permitted by law. Your child’s name will not be attached to the answers he or she gives. Your child’s responses will be combined with those from other program participants for the reporting of the performance measures.

[INSERT INFORMATION HERE ABOUT HOW THE PRIVACY OF THE INDIVIDUAL RESPONSES WILL BE ASSURED]. [INSERT INFORMATION ON HOW THE PROGRAM OR GRANTEE ORGANIZATION WILL USE THE DATA].

We will submit deidentifed and aggregated data to ACF through their Performance Measures Management System. ACF may disseminate findings based on the analyses of the aggregated data at professional conferences or other venues.

Participation in the surveys is voluntary. Refusal to participate will not involve any penalty or affect your child’s receipt of program services. If you agree that your child can complete the surveys, you or your child can change your mind at any time with no consequences. The risk to your child is that he or she may be uncomfortable answering some survey questions. If that happens, your child can refuse to answer those questions. Potential benefits to your child are that he or she will have an opportunity to share their thoughts and feedback on the program. Additionally, the information your child provides will be used to help improve the PREP program.

If you do not wish for your child to participate in the surveys, please complete and sign the enclosed form and return it to [CONTACT NAME OR LOCATION] no later than [DUE DATE].

If you have questions or concerns about the surveys, please contact [CONTACT NAME] at [CONTACT PHONE NUMBER] or via email at [CONTACT EMAIL]. If you have questions about your child’s rights as a participant in the surveys or the collection of performance measures, you can contact the [INSERT NAME OF THE LOCAL IRB, IF APPLICABLE] AT [INSERT CONTACT INFORMATION].

Thank you for your time and consideration!

Sincerely,

[TITLE]

[NAME OF ORGANIZATION]

SAMPLE STATEMENT OF PASSIVE CONSENT/INFORMED REFUSAL

[PROGRAM NAME] – Entry and Exit Surveys

Sponsored by the Administration for Children and Families, The U.S. Department of Health and Human Services

By signing this form you indicate that you have read and understood the information provided to you in the parent letter and have decided NOT to allow your child to participate in the entry and exit surveys for [PROGRAM]. If you agree to have your child participate in the surveys, there is no need to return this form. The entry survey is expected to take approximately eight minutes to complete; the exit survey is expected to take approximately fifteen minutes to complete.

If you wish to refuse participation for your child, check the box and fill in the information below.

NO, I DO NOT GIVE PERMISSION for my child _____________________________________

(Print full name of child)

to complete the entry and exit surveys.

Parent/Guardian Name: ____________________________________________

(Printed)

Signature: ___________________________________________ Date: ____________________

please return this form to [location] by [date]. Thank you!