SMART2 Cohort Project Consent Form 23MAR2015

Approval Date: March 19, 2015
Approved Consent Version No.: 2
PI Name: Derek Cummings
IRB No. 00005474

P.I. Derek Cummings
IRB #5474

Version 12, March 16, 2015

Surveillance, Monitoring Absenteeism And Respiratory Transmission in Schools
(SMART2) Project
Consent form
PURPOSE: The purpose of this research is to figure out how influenza and other
respiratory diseases are spread in schools and from schools out into the community.
This will provide a firm base of scientific data for school policy and practice in response
to communicable disease outbreaks.
WHO IS DOING THIS RESEARCH: SMART Schools is being conducted by Johns
Hopkins University (Hopkins) and University of Pittsburgh (Pitt), School of Medicine.
Hopkins has received a grant from the US Centers for Disease Control and Prevention
from which Pitt receives funding. The research is under the direction of Derek
Cummings PhD MHS MS (Hopkins) and Shanta Zimmer MD (Pitt).
WHAT IS BEING DONE: Parents will be asked to provide basic information about who
is in your family, including some basic characteristics, such as age, sex and role in the
family (mother, father, etc.) This will take about 12 minutes or less. Parents will be
asked to login to a website each week for 12 weeks to report if anyone has had
symptoms of the flu. This will take less than 5 minutes per week. Other members of
the household will be asked to provide information to parents on illnesses to report.
Members of the household will be asked to provide a nasal swab sample to be tested
for flu whenever you are any other member of the household has a flu-like illness. We
will send you a kit and ask you to place a foam swab inside your nostril and gently
sweep the inside of your nose. Then you are asked to return this swab in the mailing
envelope that will be provided to you. Results of these tests will not be returned to you
but will inform the study.
COSTS/BENEFITS: There is no cost to anyone for participating in this study. There
are no direct benefits.
RISKS: There is minimal risk involved with this study. All records are private. All data
will be analyzed anonymously. All data will be kept on secure computers. Paper forms
will be kept in locked cabinets in locked rooms. Flu testing involves taking a small
sample of mucus from the nose. There is a small risk that the privacy of your data may
be lost (i.e. data may be revealed to others by theft or loss). There may be some
discomfort associated with the nasal swab, but the discomfort is momentary.

Page 1 of 3
University Of Pittsburgh
Institutional Review Board

Approval Date: «Approval Date»
Renewal Date: «Renewal Date»

IRB #: «IRBNo»

Approval Date: March 19, 2015
Approved Consent Version No.: 2
PI Name: Derek Cummings
IRB No. 00005474

P.I. Derek Cummings
IRB #5474

Version 12, March 16, 2015

PARTICIPATION: Participation is voluntary. We are asking all students at your school
and their families if they would like to participate. There is no penalty for not
participating. Not participating will not affect your child’s normal privileges and activities
in school, or your relationship with the University of Pittsburgh or any other institutions
associated with this research. You may also refuse any study-related activity without
penalty. Participates can withdraw at any time. There is no penalty for withdrawing.
PAYMENT: Households will be given a $20 gift card for enrolling in this study. Each
week when you provide information, you will be entered into a drawing for a $200 gift
card. Your chances of winning this are approximately 1 in 30. You will be given any
additional $20 gift card if you complete 5 of the first 6 weekly reports. You will be given
an additional $20 gift card if you complete 5 of 6 weekly reports in weeks 7-12. All
cards will be sent at the conclusion of the 12 weeks. Gift cards will be provided to
parent or guardian providing information for families.
QUESTIONS: There are numerous people who are available to answer your questions.
1. Please contact Project Manager Chuck Vukotich at 412-246-6957 or
[email protected] with your questions about SMART Schools.
2. If you have any questions or concerns about participating in research, or if you
have questions about your/your child’s rights as a research participant, please
contact Human Subject Protection Advocate of the University of Pittsburgh
Institutional Review Board at 1-866-212-2668 or the Johns Hopkins University at
1-888-262-3242.
3. If you have questions about the study or feel you/your child may have been
harmed by participating in the study please contact the PI of the study, Derek
Cummings at 410-502-9319.
4. If you would like to contact the funder of this research, the US Centers for
Disease Control and Prevention, contact Jeanette Rainey, Senior Epidemiologist
and Project Officer 404-639-0689

Page 2 of 3
University Of Pittsburgh
Institutional Review Board

Approval Date: «Approval Date»
Renewal Date: «Renewal Date»

IRB #: «IRBNo»

Approval Date: March 19, 2015
Approved Consent Version No.: 2
PI Name: Derek Cummings
IRB No. 00005474

P.I. Derek Cummings
IRB #5474

Version 12, March 16, 2015

For parents,
I agree to participate in SMART2 research project as defined above to provide
information about my family members and their illnesses as well as my own and
consent to my child(ren) participating.
Name Printed: __________________________
Signature: _____________________________ Date: _____________
Names of children ________________________
Names of children ________________________
Names of children ________________________
Names of children ________________________
Names of children ________________________
Names of children ________________________
Names of children ________________________
For members of household 18 and over who are not parents,
I agree to participate in SMART2 research project as defined above to provide
information on my illnesses and to provide a nasal swab if asked.
Name Printed: __________________________
Signature: _____________________________ Date: _____________

For children in the household 13 and over,
This research has been explained to me and I agree to participate. I will provide
information to my parents when I am sick and provide a nasal swab if asked.
Name Printed: __________________________
Signature: _____________________________ Date: _____________

SMART2 Signature: _______________________
Page 3 of 3
University Of Pittsburgh
Institutional Review Board

Approval Date: «Approval Date»
Renewal Date: «Renewal Date»

IRB #: «IRBNo»