Parent Opt-Out Letter

P.I. Derek Cummings, IRB #5474, Version 11, Aug. 29, 2014

School/School District Letterhead

Date

Dear Parents/Guardians:

Our school, Johns Hopkins University and the University of Pittsburgh have been working together on a new research project called the Surveillance, Monitoring Absenteeism and Respiratory Transmission - “SMART²”. This is sponsored by the U.S. Centers for Disease Control and Prevention (CDC). This research may help us determine how the flu and other respiratory diseases affect absenteeism. SMART² can also help us understand how flu is spread in school, and between schools and homes.

This research aims to more quickly spot the start of flu season by monitoring schools, families, and communities. The more advanced warning we can get, the better prepared services and healthcare can be, and ultimately reduce the number of people who get sick and suffer serious health problems from the flu.

We are excited to be partnering with Hopkins and Pitt and believe this study will provide useful data on how often children have respiratory diseases, especially seasonal and pandemic influenza. All students in your school are being asked to participate.

SMART look for signs of influenza in our school, and monitor absences for influenza symptoms, in the following ways:

1. Parents of absent students will be contacted by telephone or email to determine if their student has the flu or flu-like symptoms.

2. Children with flu-like symptoms may be tested for the flu using a nasal swab (a foam tip swab that will be used to gently swab the inside of your child’s nose).

3. Parents may be asked if their children have had a flu shot.

4. Parents may be asked to join a family study of influenza like illness. This will have a separate consent.

All of this will be done confidentially. Students will be assigned code numbers to maintain confidentiality.

Please contact Chuck Vukotich at 412-246-6957 or [email protected] or Derek Cummings at 410-502-9319 [email protected], if you have questions about the study, your/your child’s rights as a research participant or study related harm. A full disclosure statement is attached.

The study will be conducted over the next three seasons in your child’s school. Once again, you do not need to do anything to participate in this project. However, if you do not wish for your child to participate, please indicate this below and return the form to your school. Not participating will not affect your child’s normal privileges and activities in school. You may also refuse any study-related activity without penalty. Participants can withdraw at any time. There is no penalty for withdrawing.

All students who participate in the study (i.e. do not opt out) will be eligible to win a free iPad provided by the University of Pittsburgh. Students will have a ~1 in 300 chance of winning an iPad if they participate in the study. The University will also provide various educational activities to the entire school population throughout the year.

Sincerely,

XXXX

School official

 I DO NOT want my child to be involved in the SMART Schools Project.

Child Name Printed: ____________________

Parent Name Printed: ___________________

Parent Signature: _______________________ Date: _______

For students 18 and over,

 I DO NOT want to be involved in the SMART Schools Project.

Child Name Printed: ____________________

Child’s Signature: _______________________ Date: _______

For parents or students who are opting out, if you would like, please share your concerns regarding your child’s participation: