Consent - Parent

H uman Infection with 2019 Novel Coronavirus (nCoV)

Household Transmission Investigation (v1.4, 4/27/20)

Consent Form – Parental Permission

Household ID: XX-___________ Participant Study ID: XX-______________

We are working with the [fill in state] Health Department, local health departments, and the U.S. Centers for Disease Control and Prevention (CDC) to investigate the spread of a new coronavirus, SARS-CoV-2, which causes the disease named COVID-19. To do this, we are approaching people who have had contact with a patient with COVID-19 in their household.

Your permission is being sought to have your child participate in this study. We are asking you to allow us to come to your home to collect a swab from the back of your child’s nose and a blood sample. We are also asking to let your child take a self-swab of the inside of their nose if you feel they are able to do so on their own. We will take one set of samples now and one set in 14 days. We may return to your household to collect more swabs if someone else in your household develops symptoms that could be COVID-19.

Additionally, we are asking your child some questions about the household, their interactions with the patient, and their medical history. The survey questions should take no longer than 20-30 minutes. The samples and answers that they provide will help us understand transmission of this new virus. We also ask that your child records their symptoms (or lack of symptoms) daily. If they are too young to record symptoms, you may record them for them. This investigation has been reviewed and approved by CDC and [local health department]. They must agree to the questionnaire and swabs in order to participate.

If your child participates in this study, we will send their swabs and blood sample to either a state or local public health laboratory or to CDC for testing. The tests on the swabs will look for the virus, and the tests on the blood sample will look for their immune response against the virus. We will store what is left of the samples for other studies that we may do in the future related to this virus. No tests of their genetics will be performed on their specimens. All records, samples, test results, and interview answers will be kept private and may be shared with your local health department and CDC.

If any of their swabs are positive for the virus, public health officials will notify you of these results, and they will be diagnosed with COVID-19. If they are diagnosed with COVID-19, public health officials will provide additional instructions to you at that time. A positive swab result could possibly require home isolation, restrictions on travel, and/or work or school restrictions. Negative test results from persons without symptoms may be delayed.

If their blood has evidence of an immune response, it means they have likely been infected with the virus in the past. It likely does not indicate current infection unless a swab is positive. You will not receive the results of their blood test because the test is not routinely used to diagnose infection with this virus.

Your child’s participation in this investigation is voluntary, and you or they may change their mind at any time and decide not to participate in any or all parts of this investigation. If you have any further questions now or later, you may call Dr. Hannah Kirking with the CDC at 404-446-7318 or the [local jurisdiction] Health Department at xxx-xxx-xxxx.

Do you have any questions?

Do you permit your child to partcipate in the following activities?

Survey questions? ☐ Yes ☐ No

Swabs of their nose? ☐ Yes ☐ No

Blood collection? ☐ Yes ☐ No

COMPLETE REMAINDER OF FORM ONLY IF PARTICIPANT ANSWERED ‘YES’ TO AT LEAST THE SURVEY AND SWABS. IF EITHER OF THESE ARE ‘NO’ THE CHILD IS NOT ELIGIBLE FOR THIS STUDY.

Name of parent or guardian Date (MM/DD/YYYY))

Signature of parent or guardian Date (MM/DD/YYYY)

Name of person obtaining consent Date (MM/DD/YYYY)

Signature of person obtaining consent Date (MM/DD/YYYY)

Version 1.4 April 27, 2020