Seattle Flu Study / COVID-19 Consent Form

UNIVERSITY OF WASHINGTON
 CONSENT FORM: Ages 18 and up
 ASSENT FORM: Ages 13-17
 SEATTLE FLU STUDY: SWAB & SEND

Researchers:
Helen Y. Chu, MD, MPH, Assistant Professor of Medicine (University of Washington)
Janet. A Englund, MD, Professor of Pediatric Infectious Diseases (Seattle Children's Hospital)
Michael Boeckh, MD, PhD, Professor of Medicine (Fred Hutchinson Cancer Research Center)

Contact:
Izzy Brandstetter, MPH, Research Coordinator (University of Washington) (206) 221-4588

We are asking you to be in a research study. This form gives you information to help you decide whether or not to be
in the study. Being in the study is voluntary. Please read this carefully. You may ask any questions about the study.
Then you can decide whether or not you want to be in the study.
This form also serves as an assent form for individuals age 13-17. This means that if you choose to take part in this
research study, you would sign this form to confirm your choice. Your parent or legally-authorized representative
would also need to give their permission and sign this form for you to join the study.

This form is also used for parents and legally-authorized representatives of subjects to provide permission to the
research team for individuals who are not capable of providing permission themselves. In such cases, the term "you"
refers to the subject or your child.

 PURPOSE OF THE STUDY

Colds are common in children and adults, and can cause a runny nose, cough, or trouble breathing. We want to
understand how people get sick with these cold germs and how they spread from person to person. Once we
understand how the germs start and spread, we can have a better plan to prevent them from making people sick. We
also want to provide people with a way to see what germs are in their neighborhood. This information will be on the
internet for everyone to see.

Seattle Flu Study researchers, Washington State Department of Health, and the Centers for Disease Control and
Prevention (CDC) are closely monitoring an outbreak of respiratory disease. This outbreak is caused by a novel (new)
coronavirus. Some person-to-person spread of this virus outside China has been detected. Because of your
symptoms today, we would like to test to see if you (or your child) have an infection caused by this new coronavirus.
This information will not be on the internet for everyone to see.

 STUDY PROCEDURES

We are testing children and adults who might have a cold. We are inviting you to participate because you have the
symptoms of a cold. This study involves:

 Answering questions about your health, who you are around, and your living situation. We think these questions will
take about 15 minutes. You may choose not to answer any sensitive question that you do not want to. Doing a swab
of your (or your child's) nose to look for germs, and mailing it back to our office. We will provide the swabbing kit and
the postage to mail it back. To test for novel coronavirus, the swab may be sent to a public health laboratory for
testing with a test that was authorized for emergency use. If the test is positive, you may be contacted by your local
health department. You might be asked to restrict your (your child's) movement. This may mean that you (your child)
would need to stay away from other people until the infection has cleared. Also, you might be asked about who you
(your child) has been in contact with since becoming ill. The people you (your child) has been in contact with might
be contacted to see if they are ill too. You may also be asked to provide additional swabs for testing. You will not be
contacted if the first test result is negative. Emailing you to ask questions about your cold in about 1 week. This
study does not replace care you would receive from your doctor, and your participation is voluntary.

 RISKS, STRESS, OR DISCOMFORT

We do not expect serious side effects from this study. Getting the nasal swab may cause mild discomfort, watery
eyes, or sneezing. Some of the questions that we might ask you are sensitive and may make you feel uncomfortable.
You do not have to answer any sensitive question that you do not want to. There is a risk that your privacy could be
breached. We will do everything that we can to make sure that this does not happen.

 BENEFITS OF THE STUDY

This study will not benefit you directly. It may help others in the future by learning what germs make people sick. We
hope that the neighborhood map helps you understand what germs are in your community. Results from the novel
coronavirus test could help identify spread of the virus in the community.

 SOURCE OF FUNDING

The University of Washington is receiving financial support from an anonymous donor.

 CONFIDENTIALITY OF RESEARCH INFORMATION

Your record will be kept secret. You will not be identified in any report about this study. Your study record will never
be used against you.

The information we collect from you as well as the germs that make you sick will be on a public website to show the
spread of germs in your community. This information will not be shared in a way that will reveal your identity.
The persons involved in these novel coronavirus testing activities and the state or local health department will know
about your personal (your child's) information and the results of testing. Beyond this, your name (and your child's
name) will be kept confidential and will not be shared.
Government and university staff sometimes review studies such as this one to make sure they are being done safely
and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will never be used against you.
Washington State law requires that we report certain conditions to local public health jurisdictions or the Department
of Health. If your sample tests positive for one of these conditions, a local health jurisdiction or the Department of
Health might contact you with more questions. They will keep your information secret.

 USE OF INFORMATION AND SPECIMENS

Characterizing Germs

We will characterize the germs that are making you sick and share information about them. Information that
identifies you would not be shared on the internet.

Returning Results to You

You may receive a link to a website where you can view the results of your nose swab test within three months of
when the swab is collected. You can enter your nose swab barcode to view your results for influenza (flu) and
Respiratory Syncytial Virus (RSV) testing when they are ready. The results may tell you what germs are making you
sick, how they are characterized, and advice on how to keep other people from getting sick. You are not required to
go to the website and look at your results if you do not want to. If you do not have access to the internet and would
like to know your results, you may bring your barcode to one of our community kiosks, or call 206-221-4588. We may
not be able to give you your results if you lose your barcode.

Using Your Data in Future Research

Storing samples so researchers can use them in the future is called "banking." Researchers also bank information
and samples so they can share it with other researchers.
The information and/or samples that we obtain from you for this study might be used for future studies. We may
remove anything that might identify you from the information and samples. If we do so, that information and
samples may then be used for future research studies or given to another researcher without getting additional
permission from you. It is also possible that in the future we may want to use or share study information that might
identify you. If we do, a review board will decide whether or not we need to get additional permission from you. It is
possible the information will be used in future public health investigations. However, these will NOT include human
genetic analysis.

By signing this consent form, you are giving your permission for these researchers to use your sample for future use.

Commercial Profit

Your data and/or samples may be used to make new products, test, or findings. These may have value and may be
developed and owned by the research team and/or others. If this happens, there are no plans to pay you.

 OTHER INFORMATION

You may refuse to participate and you are free to leave this study at any time without penalty or loss of benefits to
which you are otherwise entitled (such as your normal medical care). Please note you have the option to accept or
refuse this novel coronavirus testing. By signing this form, you do not give up any of your rights.

If you join this study, you will receive gift card of up to $10 for each nose swab that we collect. You will receive the
gift card within a month of us receiving your sample.

 RESEARCH-RELATED INJURY

If you think you have been harmed from being in this research, contact Izzy Brandstetter at (206) 221-4588. The
University of Washington does not normally provide compensation for harm except through its discretionary program
for medical industry. However, the law may allow you to seek other compensation if the harm is the fault of the
researchers. You do not waive any right to seek payment by signing this consent form.

Subject's statement

This study has been explained to me.  I volunteer to take part in this research.  I have had a chance to ask
questions.  If I have questions later about the research, or if I have been harmed by participating in this study, I can
contact one of the researchers listed on the first page of this consent form.  If I have questions about my rights as a
research subject, I can call the Human Subjects Division at (206) 543-0098 or call collect at (206) 221-5940. I will
receive a copy of this consent form.