Consent - Case

H uman Infection with 2019 Novel Coronavirus (nCoV)

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

Consent Form – Case – Adults ≥18 years

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 patients with COVID-19 who have other people living in their household. We are asking you and members of the household to allow us to come to your home to collect a swab from the back of your nose and a blood sample, and have you collect a swab from your own nose. 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 you to answer some questions about your household and medical history. The survey questions should take no longer than 20-30 minutes. We also ask that you record your symptoms (or lack of symptoms) daily. The samples and answers that you provide will help us understand transmission of this new virus. This investigation has been reviewed and approved by CDC. You must agree to the questionnaire, swabs, and blood draws in order to participate.

If you agree to participate, we will send your 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 your 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 your genetics will be performed on your specimens. Your records, samples, test results, and interview answers will be kept private and may be shared with local health departments, state health departments, or CDC.

Because you have already been diagnosed with COVID-19, your swab results may be delayed. You will also not receive the results of your blood test because the test is not routinely used to diagnose infection with the virus.

Your participation in this investigation is your choice, and you may change your 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 [fill in local jurisdiction] Health Department at xxx-xxx-xxxx.

Do you have any questions?

Do you agree to us asking you the survey questions? ☐ Yes ☐ No

Do you agree to have us collect swabs from your nose? ☐ Yes ☐ No

Do you agree to have us collect your blood? ☐ Yes ☐ No

COMPLETE REMAINDER OF FORM ONLY IF PARTICIPANT ANSWERED ‘YES’ TO ALL CONSENT STATEMENTS. IF ONE OR MORE IS ‘NO’ PARTICIPANT IS NOT ELIGIBLE FOR THIS STUDY.

Name of participant Date (MM/DD/YYYY))

Signature of participant 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