Parental or Guardian Consent for
Survey Participation of a Minor Back to top
The purpose of this form is to provide you (as the parent or guardian of a prospective survey participant) information that may affect your decision as to whether or not to let your child participate in this survey. The designated survey staff implementing the survey will describe the survey to you and answer all your questions. Read the information below and ask any questions you might have before deciding whether or not to give your permission for your child to take part. If you decide to let your child participate in this survey, this form will be used to record your consent.
Survey Title: Washington Coronavirus Exposure Survey - WAVES
Survey Investigators
This survey is a collaboration between The University of Washington (UW) and The Washington State Department of Health. It is funded by the Paul G. Allen Family Foundation, as well as select local health authorities. The principal investigators for this study are Dr. Keith R. Jerome and Dr. Mark Wener from The University of Washington.
Introduction
This is a survey about the SARS-CoV-2 virus, also known as coronavirus, which is the cause of the current COVID-19 pandemic. This is a survey in Washington State (WA) to measure the percent of people who have COVID-19, also known as prevalence, in the state. During the survey, we will also measure changes in the percent of people who have signs of a previous COVID-19 infection. We are inviting people up to the age of 85 who live in one of fifteen selected counties to enroll. Addresses were selected by chance from these counties. We plan to enroll up to 8000 WA residents. People who take part will have up to three visits, about two months apart. Individuals living in invited households are able to participate whether or not they have received a COVID-19 vaccine. You do not have to decide today whether or not you will allow your child to participate.
Purpose of the Survey
The purpose of this survey is to understand more about COVID-19, a coronavirus. Some people infected with the virus have mild or no symptoms. People infected with the virus might develop antibodies, even if they do not feel sick. People who have been vaccinated might also develop certain antibodies. Antibodies are substances made by your immune system that help your body fight infection. We want to measure how many people are infected with COVID-19 right now, and how many have been infected in the past. We will look for coronavirus antibodies in the blood of participating individuals selected at random using their addresses. This activity is called public health surveillance, used to inform local and state public health officials about the amount and nature of COVID-19 among different people. The data we collect from this survey will help these officials with decisions surrounding COVID-19. It may also help answer health science questions. Surveillance is not the same as treatment or medical care. Surveillance is used to provide scientific information to those who make policies to take public health action. Your child has been invited to participate in this statewide survey.
What is my child going to be asked to do?
If you agree to allow your child to participate in this survey, they will be asked to do the following:
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Minors aged 13-17 may choose to complete a questionnaire that will ask questions about their sex, gender, address, race, ethnicity, their general health, members in your household, whether they have had coronavirus symptoms, and where they may have been exposed to coronavirus. This survey will be completed online, by phone, or in-person with our designated survey staff. If responding on behalf of your child, required for ages 0-12 and acceptable for ages 13-17, it is important that you answer your child’s questionnaire accurately and completely.
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After completing the questionnaire, contact our call center at 1-866-816-5196 to schedule a window of time for specimen collection during the days our staff will be in your area.
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You will be called to ask if your child or anyone in your home is feeling sick prior to our visit. To collect the sample, we will place a swab (like a long Q-tip) into each nostril and gently swab your child’s nose. This type of swab is from the front of the nose. For children aged 10 years and above, we will also take blood from your child’s arm using a syringe and needle. We will take 5 mL (about 1 teaspoon) of blood.
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For those aged 10 years and above, in about 1 to 2 months from the day your child’s first blood sample is taken, you will receive a notice asking you to fill out a second survey. This survey will ask follow-up questions including any coronavirus diagnoses from the last survey visit, vaccination, activities outside the home, and symptoms.
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Your child will then be scheduled for a second and third blood draw, two months apart, after their first specimen collection.
What will be done with my child’s samples?
Your child’s samples will be sent to the Virology lab at UW where they will be tested. With your child’s nasal swab sample, we’ll use a Food and Drug Administration (FDA)-approved test to find out if your child is currently infected with coronavirus.
If your child’s nasal swab test is positive for coronavirus, you will be contacted by one of our health staff within 3 business days of the test result. UW Medicine staff will be available to answer your questions. Negative and positive findings, name, demographic, and contact information (phone and address) will be reported to local health authorities, which is required by law. Positive cases will be contacted by their local health authorities to follow up on any possible contacts with other individuals during the period one is able to transmit the virus.
With your child’s blood sample, an FDA-approved lab test will be used to determine whether antibodies to coronavirus can be detected in their blood. The test results will be available on our website using a unique code for each test we provide to you at the time we collect your child’s blood and/or nasal swab.
Please note that the presence of antibodies to coronavirus in your child’s blood does not mean that they are immune to the virus.
Please continue to follow all recommended precautions by your local, state, and federal health officials to protect yourself and your child against contracting and spreading coronavirus in your community. We will store leftover samples when they are no longer needed for this study. Your child’s samples may also be shared with investigators at other institutions for research on coronavirus and other related viruses. The samples will not be sold.
Will this hurt my child?
When the swab is placed in your child’s nose, they may feel a tickle or mild discomfort. Bleeding from the nose afterwards is rare, but if any bleeding continues you should contact your child’s doctor.
Your child will feel a pinch or sting when the needle enters their arm while your blood is taken, which can be painful. Your child may have a bruise or slight bleeding at the needle insertion site. We will do all we can to make sure your child is comfortable while we draw blood. Rarely, taking blood may cause fainting or a skin infection.
What are the risks involved in this survey?
Participating in this survey does not change your child’s risk of getting coronavirus.
Although the risk is very low, it is possible that your child’s personal information could be given to someone who should not have it. We will take steps to protect your child’s personal information by storing data on a secure server.
What are the possible benefits of this survey?
By participating in this survey, children under 10 providing a sample will have their choice of a small gift. Children 10 and over who participate will receive a $20 gift card during first and second specimen collection and $30 for the third specimen collection. This survey may help scientists understand how coronavirus is spread in Washington State. It may also contribute to scientific knowledge about the body’s response to coronavirus in older children and teenagers.
Does my child have to participate?
No, your child’s participation in this survey is entirely voluntary. Your child may decline to participate or to withdraw from participation at any time. You can agree to allow your child to be in the study now and change your mind later. If you or your child decide they would no longer like to participate, please contact one of the people listed in the “Who to Contact” section below.
What if my child does not want to participate?
In addition to your permission, your child must agree to participate in the survey if they are between the ages of 13-17 and read the participation assent form. If your child does not want to participate, they will not be included in the survey and there will be no penalty. If your child initially agrees to be in the survey, they can change their mind later.
How will my child’s privacy and confidentiality be protected if they participate in this survey?
Survey staff from The University of Washington and The Washington State Department of Health will have access to your child’s information. The University of Washington will receive your child’s name, your child’s test results, and your child’s contact information in order to return your child’s test results. We will not share your child’s identity with anyone else.
The information that we collect will be kept confidential. Information described above on testing for active COVID-19 infection will be shared with WA State Department of Health, as required by law (WAC 246-101). Public health entities are covered under 45 CFR 164.510(b) to disclose to a spouse, family members, friends or other persons identified by the participant information determined to be in the patient’s best interest given professional judgment. Public health entities are also permitted to disclose necessary private health information under a minimum necessary standard to persons at risk of contracting or spreading a disease (45 CFR 164.512(b)(iv). This is employed in what is known as contact tracing.
Information about your child that is collected during the survey will be stored in a secure database that is only accessible to survey staff, but we cannot guarantee total confidentiality.
Who to Contact
If you have any questions regarding this survey, please call 1-866-816-5196. Survey staff will be on-hand to respond to most questions on behalf of investigators, Dr. Keith Jerome & Ms. Cheryl Dietrich.
If you have any questions or complaints concerning your rights as a survey participant, you may contact 206-685-8280.
