Consent to participate in a research study

Introduction
You are being asked to take part in a research study. Please read this explanation about the study and its risks and benefits before you decide if you would like to take part. You should take as much time as you need to make your decision. You should ask the study staff to explain anything that you do not understand and make sure that all of your questions have been answered before signing this consent form. Before you make your decision, feel free to talk about this study with anyone you wish. Participation is voluntary.

What is the purpose of the study?
To determine how many people working in the public elementary and secondary schools in Ontario develop COVID-19 infection and the risk factors for infection, to describe the changes to antibodies against SARS-CoV-2 over time, the incidence of re-infection, the uptake of vaccines against COVID-19, and the psychological impact of working during the COVID-19 pandemic.

Who is being asked to participate?
People working for or with a publicly-funded school board in Ontario. This includes English or French, Catholic or non-denominational schools and school boards. You are eligible if you:

• are 18 to 74 years old, inclusive
• work in any capacity for an elementary or secondary school or associated school board in Ontario
• work for 8 or more hours per week, on average, and
• plan to be available for at least the next 3 months (not retiring or going on leave)

Because we require blood samples, you are NOT eligible to participate if you:

• have a bleeding disorder (e.g., hemophilia or Von Willebrand disease),
• have had chemotherapy with the past 4 weeks, or
• have had a bilateral mastectomy.

What do I need to do if I decide to participate?

1. A survey at enrolment to assess your current risk factors (it takes about 15 minutes)
2. Short bi-weekly surveys (about 2 minutes)
   • One of every 6 bi-weekly surveys will be longer to ask about exposure to ill people (about 5 minutes)
3. Every time you are tested for COVID-19, complete a report (about 5 minutes)
4. Every time you have symptoms of a cold or influenza, complete a report (about 5 minutes)
5. Complete a stress/distress survey every 13 weeks (about 3 minutes) and
6. Self-collect blood spot samples a) when you join, b) every 13 weeks after joining, c) before receiving a COVID-19 vaccine dose(s), and d) 30 days after your final dose of vaccine

Blood spot self- collection is similar to how people with diabetes check their blood sugar: a finger prick and a collection card on which you place 5 blood drops. You then mail it to the study office in a postage paid envelope.​ 

Results of the blood tests will be mailed to you several weeks after your first sample arrives at the study office, after your final dose of vaccine (if you are vaccinated), and after your final sample at the end of the study (which will include all results of all samples submitted). 

Study Requirements 
 

Timing	Requirement
Start of study	Consent Baseline questionnaire K10 stress questionnaire Intent to be vaccinated questionnaire Blood spot sample (mailed)
When / if tested or ill	Illness report
When / if vaccinated	Vaccination report  Blood spot samples: one before each dose and one 30 days after final dose (mailed)
Every second week	Bi-weekly questionnaire (reminder is emailed); 1 of 6 is a longer questionnaire
Every 13th week	K10 stress questionnaire  Blood spot sample (mailed)
Week 26	Intent to be vaccinated questionnaire (if not vaccinated)

How long will the study last?
The study will last for 12 months after you join

Are there any benefits or risks to participating in the study?

• You may have some very short-lived pain and minor bruising at the site of blood collection; it is occasionally necessary to prick a second finger. The K10 questionnaire may prompt feelings of distress. 
• There is no direct benefit to being in the study beyond having access to test results.

Expenses associated with participating in the study

• There is no cost to taking part in the study. All supplies are provided by the study.
• If you collect your first blood spot sample with 14 days of completing your baseline questionnaire, you will be offered a $20 gift card from a list of retailers (e.g., coffee, gas, home products) that will be emailed to you. 

Voluntary participation
Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now and then change your mind later. You may leave the study at any time without affecting your employment status. You may refuse to answer any question you do not want to answer, or not answer an interview question by saying “pass”. We will give you new information that is learned during the study that might affect your decision to stay in the study.

By signing this form you do not give up any of your legal rights against the investigators, COVID-19 Immunity Task Force, or involved institutions.

Confidentiality
Your data will be kept confidential. You will not be named in any reports. Your name, address, and phone number can only be accessed by the study staff and are needed to send supplies to you. The information collected for the study will be kept on secure servers using encryption software for up to 120 days after the end of the study. It will then be transferred to the Sinai Health server and kept there for 10 years before being destroyed. The following people may look at your personal health information to check that the information collected is correct: Representatives of Sinai Health.

No personal information will be shared outside the study except as required by law.

The COVID-19 Immunity Task Force (sponsor of the study) is funded by the Government of Canada to research COVID-19. Some of the data collected (COVID-19 infection status, underlying health conditions, social distancing practices, age, sex, ethnicity, education, living conditions, and travel experiences will be shared with researchers in Canada and internationally to better understand immunity, infection rates, and health outcomes relating to COVID-19. These data will be stored in a database at McGill University indefinitely. All identifying (personal) information will be stripped from the data and replaced with a study code prior to sharing your data with them. General information about the research performed with these data will be available on the COVID-19 Immunity Task Force website, see https://www.covid19immunitytaskforce.ca

Who can I talk to if I have questions?
If you have any questions, concerns, or would like to speak to the study team for any reason, please contact Dr. Brenda Coleman, PhD, at ccs.2@sinaihealth.ca or call (416) 294-6383 or, if long distance charges apply 1-888-307-3357 (weekdays 8 AM to 6PM Eastern time).

If you have any questions about your rights as a research participant or have concerns about this study, call the Chair of Sinai Health Research Ethics Board (REB) or the Research Ethics office number at 416-586-4875. The REB is a group of people who oversee the ethical conduct of research studies. These people are not part of the study team. Everything that you discuss will be kept confidential.