The overall goal of the Ab-C is to provide crucial information on how common the COVID-19 infection is, and to thus improve the public health response to the outbreak. The biological data may help improve the well-being of Canadians.
Participants completed an online survey for Angus Reid and are part of their panel. We used that data to understand who would be a good candidate for this study and to provide a basis for this study. A home blood collection is the next step. Each blood spot will be analyzed using a validated laboratory test to determine whether antibodies to the COVID-19 virus are present. Participants will be given the option of receiving their results (see below), and then may be asked to complete a second online survey and blood sample in four to six months, following the same procedures.
Ab-C participants have the option to provide their provincial health card number so that the information contained in provincial health databases (e.g., billings for visits to doctors, hospital admissions, medication prescriptions, etc.) can be linked to study data.
With your permission, we will also store any unused blood samples to answer questions about COVID-19 in the future. We do not yet know which factors might be examined, as research on COVID-19 is still emerging, but this future work will be done entirely anonymously, without any linkage to your identity. Any future testing on the samples will be done only for research purposes, and you will not be given its results. You will be given the results of the antibody test, as described below.
Since we do not know how long COVID-19 will exist, we will keep your identifiable information, biological samples and will link to provincial and federal health databases until we have exhausted all uses related to COVID-19.
Ab-C participants have the option to provide their provincial health card number so that the information contained in provincial health databases (e.g., billings for visits to doctors, hospital admissions, medication prescriptions, etc.) can be linked to study data.
With your permission, we will also store any unused blood samples to answer questions about COVID-19 in the future. We do not yet know which factors might be examined, as research on COVID-19 is still emerging, but this future work will be done entirely anonymously, without any linkage to your identity. Any future testing on the samples will be done only for research purposes, and you will not be given its results. You will be given the results of the antibody test, as described below.
Since we do not know how long COVID-19 will exist, we will keep your identifiable information, biological samples and will link to provincial and federal health databases until we have exhausted all uses related to COVID-19.
DBS is a type of bio sampling where blood obtained by a finger-prick lancet is blotted on filter paper.
Every participant will collect dried blood spots using the self-sampling technique. The complete package mailed to each participant will include a collection kit, informed consent document, stepwise instructions, and a postage-paid return envelope. The process does not require any training. The participants will be asked to return the samples by mail using the postage-paid return envelope.
The ease of sample collection from a single finger prick has made the collection of DBS samples the preferred method of disease surveillance in population studies.
Every participant will collect dried blood spots using the self-sampling technique. The complete package mailed to each participant will include a collection kit, informed consent document, stepwise instructions, and a postage-paid return envelope. The process does not require any training. The participants will be asked to return the samples by mail using the postage-paid return envelope.
The ease of sample collection from a single finger prick has made the collection of DBS samples the preferred method of disease surveillance in population studies.
The dried blood spot collection kit will contain 1 antiseptic wipe, 2 lancets, 1 blood sample collection card, 1 card sleeve, 1 band-aid, and 1 aluminum foil bag with drying agent. In addition, you will receive printed instructions and a consent form.
Video instructions can be seen above and a link to the video will be included in the instructions.
Video instructions can be seen above and a link to the video will be included in the instructions.
The blood will be analyzed using the best available assays (laboratory tests that measure the presence and amount of a substance). Our knowledge of COVID-19 is rapidly changing so we will determine the best assay for this study when the samples have been collected. The lab results will show us how likely it is that you were exposed to the virus due to the presence of certain antibodies (markers of immune response) in your system.
This is not a diagnostic test and cannot be used to inform clinical decisions. The test does not indicate if you have and/or are immune to COVID-19.
This is not a diagnostic test and cannot be used to inform clinical decisions. The test does not indicate if you have and/or are immune to COVID-19.
The Ab-C got your contact information from the Angus Reid Forum with whom the Ab-C team is partnering to conduct this vital research. During the Angus Reid Forum polling about experiences with COVID-19 you provided consent for the Ab-C team to contact you. They transferred your contact details to us using a secure network connection (called a Virtual Private Network, or VPN) to which no others had access.
It is anticipated that about 10-14,000 adults aged 18 or older in Canada will participate in this study. The length of this study for participants is about 2-3 weeks during the first phase. The entire study is expected to take about six months to complete and the results should be known within 1 year.
You have already completed the Angus Reid poll, for which we thank you. You will now be asked to take a small sample of blood using safe, well-tested procedures (some diabetic patients do this at home every day) and then send us the sample in a safe, tamper proof postage-paid envelope along with your consent (which you can also fill in online at www.abcstudy.ca using the secure number printed on your consent form).
We will return the results of the test to you via email or mail, as you prefer. The results will tell you whether you are 'highly likely' to were infected in the past, OR 'somewhat likely' that you were infected, OR 'unlikely' that you were infected. We will not be able to tell you when or how you may have been infected.
Please note that the results are not to be used for any clinical decisions and do not prove that you have immunity to COVID-19.These results should not be used for any clinical decisions, and do not suggest, for example, that you are 'immune' to the virus. Every Canadian will need to continue following federal and public health guidelines on how to protect themselves from COVID-19 and how to protect others in case one is exposed or infected.
When we contact you with the results, we will ask you for permission to re-contact you at least once in the future, to possibly re-test using the same procedures to find out if your infection status might have changed.
We will return the results of the test to you via email or mail, as you prefer. The results will tell you whether you are 'highly likely' to were infected in the past, OR 'somewhat likely' that you were infected, OR 'unlikely' that you were infected. We will not be able to tell you when or how you may have been infected.
Please note that the results are not to be used for any clinical decisions and do not prove that you have immunity to COVID-19.These results should not be used for any clinical decisions, and do not suggest, for example, that you are 'immune' to the virus. Every Canadian will need to continue following federal and public health guidelines on how to protect themselves from COVID-19 and how to protect others in case one is exposed or infected.
When we contact you with the results, we will ask you for permission to re-contact you at least once in the future, to possibly re-test using the same procedures to find out if your infection status might have changed.
There are no medical risks to you from participating in this study. However, you may experience very minor discomfort on your finger when you do the fingerpick. The lancet used to make the small hole in your skin cannot be reused. The needle is sharp, so be careful with it around others, especially children; and we recommend that all this testing be done away from others. COVID-19 is NOT transmitted through blood (only through lung or breathing droplets) so there is virtually no risk that anyone else in the house who may touch your blood will be at risk from COVID-19, should you be infected. However, other infections can be spread through blood so you should make sure that no one else touches your blood drop during the testing or when it is drying. But please make sure that you do the test safely and away from others, and apply the gauze for 10 minutes until all bleeding stops before you resume any normal activities.
You will not benefit directly from participating in this study. The tests for those infected in the past are only for research purposes. This means that these test results are not diagnostic and are not designed to replace routine clinical care. You will be given the choice whether to get your results or not.
Participating in the Ab-C Study does not replace the Canadian government guidelines for COVID-19 reporting and testing. If you have any symptoms suggestive of COVID-19, then isolate yourself, take self-assessment at https://ca.thrive.health/covid19/en.
Although you will not benefit directly from participating in this study, your participation will be crucial for fighting this extraordinary epidemic which has affected the lives of so many around the world. This research will play a key role in helping to shape the public health and control responses to COVID-19 in Canada and internationally.
Participating in the Ab-C Study does not replace the Canadian government guidelines for COVID-19 reporting and testing. If you have any symptoms suggestive of COVID-19, then isolate yourself, take self-assessment at https://ca.thrive.health/covid19/en.
Although you will not benefit directly from participating in this study, your participation will be crucial for fighting this extraordinary epidemic which has affected the lives of so many around the world. This research will play a key role in helping to shape the public health and control responses to COVID-19 in Canada and internationally.
After the initial questionnaire and consent is obtained, you will be mailed a self-administered collection kit. We will also be in touch with the results of your test as soon as they are available. When we contact you with the results, we may also ask for your permission to contact you about follow up studies. This is because we want to see if your infections status has changed over time.
You can choose to end your participation at any time without having to provide a reason. However, if you choose to end your participation before completing the study, you will still be asked to send the home kit unused back to the study centre using the postage-paid envelope provided.
If you choose to withdraw, your choice will not have any effect on your current or future medical treatment or health care. If you withdraw voluntarily from the study, you are encouraged to contact the study coordinator 1 833- 837 8222 or AbCstudy@unityhealth.to. If you withdraw your consent, the information that was/were collected before you left the study will still be used. If you wish your sample to be destroyed, you can notify us. No new information about you will be collected and no further testing will be done without your permission.
If you choose to withdraw, your choice will not have any effect on your current or future medical treatment or health care. If you withdraw voluntarily from the study, you are encouraged to contact the study coordinator 1 833- 837 8222 or AbCstudy@unityhealth.to. If you withdraw your consent, the information that was/were collected before you left the study will still be used. If you wish your sample to be destroyed, you can notify us. No new information about you will be collected and no further testing will be done without your permission.
Participation in this study will not involve additional costs to you. You will not need to come to any study centre. All study procedures will happen in your home. All materials will be sent to you by mail, and the return mailing envelope will be postage paid.
If you become sick or injured as a direct result of your participation in this study, medical care will be provided. Financial compensation for such things as lost wages, disability or discomfort due to this type of injury is very rare and not routinely available. By signing this consent form, you do not give up any of your legal rights.
No payment is made by the Ab-C team. Angus Reid organization will provide 'Points' through their existing program.
The Ab-C Study considers the public to be its most valuable partner in research. Thus, protecting your privacy and meeting your expectations in this regard is a priority at all stages of the study. The Ab-C Study team, the different institutions involved, and the Ab-C researchers and staff are all committed to ensuring that your privacy and confidentiality are always respected. We have developed a privacy policy that is consistent with guidelines by the Canadian Institute of Health Research, our hospital's Research Ethics Board and other approved studies in Canada.
Several mechanisms are in place to ensure confidentially. The most important are:
' The collected data are stored using a unique code and not your name or other identifying information. The identifying information is stored at St. Michael's Hospital (SMH) in a secure and separate database.
' When data are collected from you, the data are automatically encrypted and transmitted with the unique ID number through a secure VPN to the central database at SMH.
' All staff involved in Ab-C are bound by a strict confidentiality agreement that prohibits them from using any information for any other purpose than what is required for their specific tasks. We maintain a log of dates and times that personnel access the identifiers.
' Data and samples are stored in highly controlled access areas where only special card holders are able to enter and a log of all entries/exits into these restricted premises is kept.
' The workstations through which the Ab-C staff are able to access the collected data (e.g., for quality control purposes) are not connected to internet, and they are password protected.
' The Ab-C will grant access only for ethically and scientifically approved future research. Approval is granted by the Ab-C Scientific Committee followed by approval from a Research Ethics Board. Approved researchers must sign confidentiality and data access agreements, which bind all users to the terms and conditions, set out by SMH. We will not release any personal or identifying information to external researchers.
' The Ab-C study design has been reviewed by the Research Ethics Board of Unity Health Toronto (St. Michael's Hospital). As part of the ethics process, any changes to the Ab-C are reviewed annually.
Several mechanisms are in place to ensure confidentially. The most important are:
' The collected data are stored using a unique code and not your name or other identifying information. The identifying information is stored at St. Michael's Hospital (SMH) in a secure and separate database.
' When data are collected from you, the data are automatically encrypted and transmitted with the unique ID number through a secure VPN to the central database at SMH.
' All staff involved in Ab-C are bound by a strict confidentiality agreement that prohibits them from using any information for any other purpose than what is required for their specific tasks. We maintain a log of dates and times that personnel access the identifiers.
' Data and samples are stored in highly controlled access areas where only special card holders are able to enter and a log of all entries/exits into these restricted premises is kept.
' The workstations through which the Ab-C staff are able to access the collected data (e.g., for quality control purposes) are not connected to internet, and they are password protected.
' The Ab-C will grant access only for ethically and scientifically approved future research. Approval is granted by the Ab-C Scientific Committee followed by approval from a Research Ethics Board. Approved researchers must sign confidentiality and data access agreements, which bind all users to the terms and conditions, set out by SMH. We will not release any personal or identifying information to external researchers.
' The Ab-C study design has been reviewed by the Research Ethics Board of Unity Health Toronto (St. Michael's Hospital). As part of the ethics process, any changes to the Ab-C are reviewed annually.
Ab-C staff: A limited number of Ab-C staff have access to your data and samples for purposes of developing the database and doing quality control tests. A more limited number of staff have access to your identifying information for purposes of contacting you in the future, for updating your information, for linking with other provincial health databases (if consent was provided), or for registering a withdrawal. Your identifying information will not be released to a non-research related third party without your consent or unless it is required by a valid court order or by law.
Researchers: Researchers in public institutions in Canada and other countries can request access to de-identified study data (but not your personal information, such as your name or address) to conduct specific research projects. Approval is granted by the Ab-C Scientific Committee and must also be approved by a Research Ethics Board. Approved researchers must sign confidentiality and data access agreements, which bind all users to the terms and conditions, set out by the Ab-C. Researchers from private businesses will not have direct access to your data and samples, but may be part of a research team.
You can always request access to your information.
Your information will not be given to non-research related third parties. In the very unlikely event that we are required by law to provide your information to a third party, we would inform you first.
Researchers: Researchers in public institutions in Canada and other countries can request access to de-identified study data (but not your personal information, such as your name or address) to conduct specific research projects. Approval is granted by the Ab-C Scientific Committee and must also be approved by a Research Ethics Board. Approved researchers must sign confidentiality and data access agreements, which bind all users to the terms and conditions, set out by the Ab-C. Researchers from private businesses will not have direct access to your data and samples, but may be part of a research team.
You can always request access to your information.
Your information will not be given to non-research related third parties. In the very unlikely event that we are required by law to provide your information to a third party, we would inform you first.
You have the right to receive all information that could help you make a decision about participating in this study. You also have the right to ask questions about this study and your rights as a research participant, and to have them answered to your satisfaction, before you make any decision. You also have the right to ask questions and to receive answers throughout this study..
The investigators have are no conflicts of interest related to this study.
If you have given us your provincial health card number and have authorized the study to access provincial health databases, the Ab-C team will have an agreement with the respective organization. The terms and conditions of access to these provincial databases will depend on each province, the provincial laws and the agreement with Ab-C.
a) All entities forming part of the overall governance structure of the Ab-C;
b) The principal investigators, co-investigators, institutions and all staff responsible for collecting data and/or samples for inclusion into the Ab-C research platform;
c) All researchers seeking access to Ab-C data for specific research projects, and as approved by relevant research ethics boards and the Ab-C Scientific Committee. These individuals are held accountable for compliance either directly (e.g. through terms and conditions in data sharing agreements, user agreements, and confidentiality agreements).
b) The principal investigators, co-investigators, institutions and all staff responsible for collecting data and/or samples for inclusion into the Ab-C research platform;
c) All researchers seeking access to Ab-C data for specific research projects, and as approved by relevant research ethics boards and the Ab-C Scientific Committee. These individuals are held accountable for compliance either directly (e.g. through terms and conditions in data sharing agreements, user agreements, and confidentiality agreements).
Unfortunately, we cannot enroll other family members unless they have been already selected to participate as part of the Angus Reid Forum. This is to make sure that we take as "random" a snap shot of adult Canadians as possible. However, we encourage your family member to sign up for the Angus Reid Forum if they are interested in being potentially asked to participate future survey.
There is a personal code in the bottom left corner of the consent form. That is the only code that should be used on the online consent form and it cannot be seen in any other part of the kit. It is an 8-character secure personal code.
We plan to have results available in November.
When the results are ready, you will receive an email indicating that the results are available and instructions on how to retrieve them. You will need to follow a link to a secure page on our website and then download them.
When the results are ready, you will receive an email indicating that the results are available and instructions on how to retrieve them. You will need to follow a link to a secure page on our website and then download them.