PPA - Baseline - OMB ICR - Attachment E - Parent Letter and Consent-final-5-4-2010

Attachment E

Sample of PARENT Letter and
Parent Statement of Consent Form

New language on focus group participation is highlighted

Important note: The eight different survey sites may modify the Sample Parent Letter that explains the study as well as the Sample Statement of Consent in order to meet the requirements of their local Institutional Review Boards (IRBs). ACF will provide these documents as models of the most basic content that should be included in the letter and Consent Form that the sites will submit to their IRBs.

SAMPLE PARENT LETTER

EVALUATION OF ADOLESCENT PREGNANCY PREVENTION APPROACHES (PPA)

Sponsored by the United States Department of Health and Human Services

Dear Parent or Guardian:

Hello! The Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (DHHS) is conducting an important study of the effectiveness of ways to reduce teen pregnancy and STD infection. The Pregnancy Prevention Approaches (PPA) evaluation will provide communities like yours with sound scientific findings on program effectiveness. We are requesting your permission for your child [name] to participate in the study.

The [school/program] is taking part in this study and students in [his or her class/the community], including your child, are invited to participate. The lead contractor for this research, Mathematica Policy Research (MPR), will survey youth on attitudes, beliefs, and activities three times over the next few years, beginning with a first survey in (month). These surveys will ask about families, friends, communities, and schools, and about attitudes, knowledge and activities in school and with their peers, including sexual activity, drug use and alcohol use. The study team will also gather information from participants’ school records, including grades, attendance, and test scores. The researchers may also invite your child to participate in a focus group to discuss his/her experiences in the program.

All information collected through the surveys and from school records will be kept strictly confidential. If you choose to let your child participate, the information from [your son/daughter] will be combined with information from other youth to determine the effectiveness of pregnancy prevention programs. No one will ever see the answers your child gives on the interview or know whose they were. Names are not kept with the answers to the surveys. A Certificate of Confidentiality from the National Institutes of Health provides a strong guarantee that information about your child will not be released to anyone outside the study.

Participation in the study is voluntary. It is important that you let us know whether or not you will allow your child to be in the study. You or [your child] can refuse to participate. If you agree that your child can participate, you or your child can still choose later to stop participating, and your child can decide to complete only parts of the surveys. But we hope you agree with us that it is important to learn about effective ways to prevent teen pregnancy through studies like this. Please complete and sign the attached form, noting whether you consent or do not consent to your child’s participation, and return it to [place] no later than [date].

The only risk to your child connected with the study is that he/she may be uncomfortable answering some questions in the surveys. If that happens, your child can refuse to answer those questions.

The enclosed brochure answers questions you may have about the study. If you have other questions about the PPA study or about your child’s participation, please call [contact], the school coordinator, at [number] or call me, toll-free, at Mathematica Policy Research at 800-[number] between the hours of 9 a.m. and 5 p.m. eastern time, Monday through Friday.

Sincerely,

[Name]

Study Director

SAMPLE STATEMENT OF CONSENT

EVALUATION OF ADOLESCENT PREGNANCY PREVENTION APPROACHES (PPA)

(Sponsored by the United States Department of Health and Human Services)

I have read the attached information cover letter describing the PPA study. If I give permission for my child to participate in the study, it means:

• I give permission for my child to participate in the study surveys and in a focus group discussion if invited.

• I give permission for the study team to collect information from my child’s school records, including grades, attendance, and test scores.

• 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, and does not have to participate in a focus group.

• I understand that all information will be kept strictly confidential, except as required by law or if I request otherwise in writing. Only the research team will be able to look at the information my child provides. The information will be used only for the study.

• I can call (survey director) at Mathematica Policy Research toll-free at 1-800-[number] between the hours of 9AM and 5PM eastern time, Monday through Friday to get an answer about any questions on the study I may have.

• If I have questions about my rights as a parent or my child’s rights as a research volunteer, I can call [name] at Public/Private ventures toll-free at 1-800-[number].

By signing this form, I am:

____ giving my permission

____ not giving my permission

for my son or daughter,________________________________, to participate in the study.

(child’s full name, printed)

Parent/Guardian Name _________________________________

(Printed)

Signature ____________________________________ Date ________________

Street Address ________________________________ Apartment # ________

City ___________________ ZIP________

Telephone Home (____) ____ - ___________

Work (____) ____ - ___________

Cell (____) ____ - ___________

WE NEED YOUR ANSWER, WHETHER IT IS YES OR NO.PLEASE RETURN THIS FORM TO [PLACE] BY [DATE], THANK YOU.