Community-Based SARS-CoV-2 Infection Screening
Introduction
COVID-19 can spread easily and quickly in large groups of people who are close together for long periods of time. Some people do not have symptoms but can still spread the virus to others. If you participated in a protest, vigil, or other neighborhood event, you should get tested. The community testing sites being offered are specifically designed to serve those who live in most impacted neighborhoods and the immediate surrounding community.
What will happen if you take part?
On Test Day:
If you haven’t already provided this in advance of today, we will ask you some brief questions about your household, you, and your child(ren), if they are here. After the questionnaire, we will then collect a nose and/or throat swab that will be tested for COVID-19 virus infection. We will collect this sample regardless of if you have had any symptoms or not.
After testing:
If your swab test is positive:
A medical professional will contact you within 72 hours if your result or your child’s result is positive. We will again ask you about symptoms, discuss obtaining more swabs, and will recommend follow up with your health care provider if you are having symptoms.
We will have to provide this information to the state and local health departments as mandated by local government policy and procedure. This may lead to contact tracing and notification of your employer. This may allow others to know you had participated in this study and would provide them information about your health status regarding COVID.
If your swab test is negative:
Your swab results will be posted for you to access on a secure online portal or phone call-in system. We will provide you with this information, and how to access it when you test.
What side effects or risks can I or my child can expect from participating?
Potential side effects and risks include:
Upper respiratory tract swabbing may potentially cause mild discomfort and rarely may cause mild nose bleeding or cause a gag reflex.
There is risk of exposure to COVID-19 when leaving one’s home.
How will my and my child(ren)’s specimens and information be used?
Public health officials at the Minnesota Department of Health and Mayo Clinic will use your specimens and information to conduct community-level disease surveillance and inform the local public health department. We will not ask you for additional permission to share this de-identified information. There may be times when public health officials using your information and/or specimens may learn new information. The public health officials may or may not share these results with you.
Security
The data collected about you will be kept private and secure from disclosure. All information will be maintained in a database on a secured server, and on computers that are encrypted, and password protected. All computers and specimens will be maintained in a limited access building, in limited access pods behind locked doors.
How will information about me be kept confidential?
Participation may involve some loss of privacy. We will do our best to make sure that information about you is kept confidential. Your personal information may be given out if required by law.
Are there any costs to me for me to get tested?
No. The sponsor has agreed to pay for all items associated with this COVID-19 screening; you or your insurer will not be billed.
Who is paying for your test? This project is funded by the State of Minnesota. Participation is voluntary.
Health Insurance Portability and Accountability Act of 1996, Notice of Privacy Practices
This document describes how your medical information may be used and disclosed, and how you can get access to this information.
Your information may be shared with the following:
- The Mayo Clinic, a healthcare organization processing the samples in their laboratory
- Homeland Health Specialists, Inc., the company providing the requisitioning physician and nurses who will be following up with you to explain your results
- Primary Diagnostics, Inc., a company partnering with the Minnesota Department of Health to run enrollment, sample requisition, and return results to you digitally
- Applicable government agencies, such as:
- Minnesota Department of Health
- Those responsible for data safety monitoring related to the project
- To other healthcare professionals for the purpose of providing you with quality health care
- Your Health Information may also be shared as required by law
- For routine health care operations, such as medical records storage or quality review
- Your confidential information may not be released without your written authorization for purposes other than stated above.
You may revoke your permission to release confidential health care information at any time.
Your Rights
You have specific rights regarding confidential healthcare information.
- You have the right to request restrictions on the use of confidential healthcare information.
- You have the right to request we communicate with you about medical matters in a certain way or at a certain location.
- You have the right to review, inspect and receive a photocopy of your confidential healthcare information. A fee will be charged for copies and mailing.
- You have the right to request changes to your healthcare information, if you feel that information is incorrect or incomplete.
- You have the right to know who has accessed your healthcare information and for what purpose.
- You have the right to a copy of this notice.
- You have the right to decline your or your child’s participation or withdraw your participation, at any time.
Warning of Risks & Assumption of Risks
Participating in COVID-19 screening involves inherent health risks. There is a risk of exposure to COVID-19 when leaving one’s home. There is a risk that upper respiratory tract swabbing may cause discomfort, gag reflex, or nose bleed. All medical procedures have some degree of inherent risk, including unknown risk. By consenting to participate, I acknowledge that I understand the risk of participating and I voluntarily accept all health risks.
Waiver, Release, and Indemnification
I understand and acknowledge that no person or entity insurers my safety. I know that participating in this screening is a potentially hazardous activity and I hereby assume full and complete responsibility for any injury, illness, or accident which may occur during my participation. I hereby release, waive, hold harmless and covenant not to file suit against the administrators, sponsors, organizers, volunteers, employees, agents or any affiliated individuals or entities associated with this screening from any and all losses, damages, liabilities or other claims and causes of action that may arise out of my participation.
This waiver shall bind a minor participant if agreed to by that minor’s parent or legal guardian.
Consent is required to participate in this project.
I AGREE TO BE TESTED. I UNDERSTAND THIS TESTING SITE WILL NOT FOLLOW-UP WITH MY PRIMARY CARE PHYSICIAN. I UNDERSTAND I WILL BE CONTACTED WITH THE RESULTS OF THIS TEST AND IF IT IS POSITIVE I WILL NEED TO FOLLOW-UP WITH MY PRIMARY CARE PHYSICIAN DIRECTLY. I UNDERSTAND THE PERSON WHO CALLS WITH MY RESULT IS AUTHORIZED ONLY TO COMMUNICATE MY RESULT AND SHARE GUIDANCE PROVIDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND THE MINNESOTA DEPARTMENT OF HEALTH. THEY ARE NEITHER RESPONSIBLE OR LIABLE FOR ADDITIONAL FOLLOW-UP OR MY COURSE OF TREATMENT.
Participant Signature