Information Letter

The research team is recruiting participants for a study tracking COVID-19 antibodies in individuals associated with the University of Waterloo campus. You do not have to be working on campus, just a student, faculty or staff member. This can be anyone, but we are especially looking for individuals who have tested positive for COVID-19 (whether they were symptomatic or asymptomatic at the time of infection).

Participants will be asked to fill out a survey on medical history and social factors then provide 3 x 10mL (or 2 teaspoons) blood samples over 6-9 months for analysis of antibodies and memory T cell responses. This will take approximately 60 minutes of your time the first time and less than 60 minutes the second and third time. Blood draws will take place at Health Services on the University of Waterloo campus. Blood group type will be tested, and a questionnaire of risk factors will be conducted (e.g. on/off-campus housing status, time spent on campus vs. doing remote work, etc.).

Participants will be given a 5$ gift card after their first test and will have a chance to win 1 of 10 50$ gift cards after completion of their second and third tests. Your odds of winning one of the prizes is based on the number of individuals who participate in the study. We expect that approximately 1000 individuals will take part in the study. The amount received is taxable. It is your responsibility to report this amount for income tax purposes.

Participants of both sexes, ages (18+) and backgrounds are encouraged to participate but need to be faculty, staff or students of the University of Waterloo.

Procedures Involved in this Study

The participants will answer a survey and donate 3 x 10 mL (or 2 teaspoons) blood samples to be analyzed for blood type and immune responses to SARS-CoV-2 and corona viruses. Participants will need to go to Campus Wellness for blood draws, where blood will be taken by a phlebotomist. This blood will then be brought the researchers' labs and examined for immune responses to SARS-CoV-2 and coronaviruses.

Risks to Participation and Associated Safeguards

There may be bruising around the blood collection site in some participants, but blood collection is being conducted by trained professionals at Campus Health Services. The data will be anonymized so that there is a very low risk that your personal data could be re-identified once it is anonymized.

Time Commitment

Participation in this study will require approximately 60 minutes of your time or less on three separate occasions (at 0, ~ 3 months and ~6 months). The survey should require less than 15 min.

Changing Your Mind about Participation

You may withdraw from this study at any time without penalty. To do so, indicate this to the researcher or one of the research assistants by saying, "I no longer wish to participate in this study" or contacting them by email. Withdrawal of your anonymized data will not be possible if it has already been used or published. You may request withdrawal of your sample that has been collected but not yet used. Your unused sample will be destroyed upon request.

Personal Benefits of Participation

You will contribute to the understanding of the spread of COVID19 and immune responses to SARS-CoV-2 virus infection.  There are no other expected benefits to you.

Confidentiality

To ensure the confidentiality of individuals’ data, each participant will be identified by a participant identification code known only to the principal investigator and his research assistants.  The data collected by the sampling will be anonymized and aggregated with all the other participants’ data for statistical analysis.  No individual data will be identifiable or used for reporting purposes.  Once the sample collection is finished, participant identities will be permanently deleted from all data files. 

The anonymized data from this study will be shared with the grant funding agency, the COVID19 Immunity Task Force, through a controlled-access mechanism for a combined national analysis of COVID19 exposure factors. The anonymized data may be shared with international partners for future health research on COVID-19 and related health outcomes. The anonymized data many be used for commercial and non-commercial research purposes and may be stored on a server outside of Ontario or a cloud server indefinitely.

Participant Feedback

After the study is completed, you will be provided with a feedback sheet that will include summary graphs of all the collected data (all participants combined data). Upon request, you will also be provided with a copy of any public scientific articles prepared for presentation and/or publication based on this study.

Suitability for Participation

Anyone who is 18 years old or older, is a student, staff or faculty member at the University of Waterloo and does not meet the exclusion criteria can participate.

Exclusion Criteria

We will need to exclude you from this study if you: 

  • have been a participant involved in other studies related to the CITF database
  • are on medication that can affect immunoglobulin production e.g., immunosuppressants, steroids (used to treat common conditions such as asthma, inflammatory bowel disease, arthritis, etc...), Tegretol and phenytoin.
  • have a a medical condition that cause low levels of immunoglobulin, specifically: kidney disease, diabetes, and malabsorption syndromes.

Concerns about Your Participation

This study has been reviewed and received ethics clearance through a University of Waterloo Research Ethics Committee (ORE# 42840). If you have questions for the Committee contact the Office of Research Ethics, at 1-519-888-4567 ext. 36005 or ore-ceo@uwaterloo.ca

Furthermore, under the authority of the University of Waterloo Act, 1972, your personal information is processed as described herein by Brian Dixon, Marc Aucoin, Clark Baldwin and Andrea Monjo in compliance with applicable Ontario privacy legislation (e.g., Freedom of Information and Protection of Privacy Act and Personal Health Information Protection Act) and in accordance with the University of Waterloo’s policies and guidelines. Your personal information is also processed as required or authorized by other applicable law, such as Ontario Health Protection and Promotion Act. Questions about the collection, use, and disclosure of personal information as part of this initiative should be directed to bdixon@uwaterloo.ca.

Questions About the Study

For all other questions, or if you want any other information regarding this study, please contact Prof Brian Dixon at 519-888-4567 ext. 32665 or bdixon@uwaterloo.ca.