Supplement to Privacy Impact Assessment for the Canadian COVID-19 Antibody and Health Survey for Cycle 2

Date: March 2022

Program manager: Director, Centre for Population Health Data
Director General, Health, Justice, Diversity and Populations

Reference to Personal Information Bank (PIB):

Personal information collected through the voluntary Canadian COVID-19 Antibody and Health Survey (CCAHS) is described in Statistics Canada's "Health Surveys" PIB, (Bank number: StatCan PPU 806) which is published on the Statistics Canada website for Information about Programs and Information Holdings. The PIB refers to information collected on a voluntary basis through Statistics Canada's health surveys under the authority of the Statistics Act. The CCAHS collects a variety of personal information such as: name, contact information, gender, pregnancy, sexual orientation, disability status, education, ethnic origin,  general health, chronic symptoms, chronic conditions, COVID-19 status, COVID-19 vaccination, medication/drug use, smoking as well as biospecimen(s) (dried blood spot sample and possibly a saliva sampleFootnote 1). Other information such as household income will be linked via administrative data. Blood samples that are not needed to test for the COVID-19 antibodies are stored in Statistics Canada's Biobank.

Description of statistical activity:

Statistics Canada conducted CCAHS Cycle 1 from November 2020 to April 2021, for which a specific Privacy Impact Assessment (PIA) was conducted. The randomly selected respondents for this survey participate in a household interview and in biospecimen(s) collection from their home on a voluntary basis. For Cycle 2 of data collection (April 2022 to August 2022), the survey will target approximately 100,000 Canadians, aged 18 and over, from the provinces only. The content of the Cycle 2 questionnaire is slightly different, and this supplement to that PIA describes these changes; in addition to gathering information on COVID-19 status and related health concerns, questions on use of the health care system, prescribed medications, active infections (nucleic acid-based testing) and previous infections (antibody testing) were added. The collection of the capillary blood sample from a self-administered finger prick to apply blood drops to a filter paper to produce dried blood spot (DBS) samples will be used to measure antibody levels. This specimen collection aimed to determine previous infection status will be the same as in Cycle 1; with slight changes in the shipping process. New to this cycle, participants may be asked to participate in a self-administered collection of microbial nucleic acids from saliva. The collected specimen would be used to assess current SARS-CoV-2 infection status via a polymerase chain-reaction (PCR) test. Only with informed consent (see Appendix 1) from respondents, results from the PCR test will be sent to the respondents and local health authorities may be notified when results are positiveFootnote 2. All other personal information collected is the same as in the previous cycle of the survey, which have been described in the Canadian COVID-19 Antibody and Health Survey (CCAHS) - Privacy impact assessment and in the Generic Privacy Impact Assessment for Statistics Canada's statistical programs operating under the authority of the Statistics Act. The Health Canada (HC) and Public Health Agency of Canada's (PHAC) Research Ethics Board will have reviewed and approved Cycle 2 collection before the start of collectionFootnote 3.

Detailed overview of the changes:

  1. Sample
    • The sample size has increased from 48,000 respondents recruited in the three waves of Cycle 1 (4,000, 22,000 and 22,000) to 100,000 respondents to be recruited in three waves of 33,333 on April 1st, May 1st and June 1st 2022.
    • Cycle 2 of the CCAHS has reduced the population to Canadians aged 18+, removing the 1 to 17-year-old population found in Cycle 1.
    • Cycle 2 of the CCAHS has further reduced the population to only the Canadian provinces, contrary to Cycle 1 which also included the territories.
  2. Change in questionnaire content
    1. New: Chronic symptoms
      Respondents are asked questions about long-term health symptoms. These are physical or mental symptoms which are expected to last or have already lasted 6 months or more. They may be related to a health condition, or be of unknown cause.
    2. Modified: Chronic conditions
      Respondents are asked questions about long-term health conditions. These are physical or mental symptoms which are expected to last or have already lasted 6 months or more and have been diagnosed by a health professional. More answer categories have been added to this cycle; duration of the chronic condition will be established, and there will be a question related to the limitation that their conditions (or symptoms) may have on their daily activities.
    3. Modified: COVID-19 status / COVID-19 Testing Methods
      Respondents are asked questions related to COVID-19 status. Questions were modified from Cycle 1 to reflect the evolution of the COVID-19 virus as well as the new testing methods. It consists of a series of questions to understand the COVID-19 status of the respondent, i.e., ever tested (PCR or rapid COVID-19 test), result of the test, date of the test and why they were tested. Respondents are also asked if they think that they ever had COVID-19. If respondents do not report a confirmed or suspected COVID-19 infection, they are asked if they have experienced unexplained symptoms lasting 2 or more months since March 2020. If respondents report a confirmed or suspected COVID-19 infection, they are asked a series of follow up questions to determine if they may have post-COVID-19 condition. This will provide data to study the association between previous COVID-19 results, and the presence of antibodies.
    4. Modified: COVID-19 vaccination
      Respondents are asked a series of questions regarding whether they have been vaccinated against COVID-19, how many doses, date and type of vaccinations. Questions were added to Cycle 2 about 2nd and 3rd doses.
    5. New: Interactions with the health care system
      Respondents are asked about their specific interactions with the health care system within the last 12 months, including type of appointment and reason for appointment. They are also asked about whether they experienced difficulties getting access to health care services, and conditionally are asked if these difficulties getting access were related to the chronic symptoms or conditions they have, or were related to a confirmed or suspected COVID-19 infection they had.
    6. New: Medication use
      Respondents are asked questions regarding use of prescribed medications, and are asked conditionally if their use of prescribed medications is related to the chronic symptoms or conditions they have, or were related to a confirmed or suspected COVID-19 infection they had. Respondents are also asked about the use of over-the-counter medications.
    7. Removed: Reason why tested/not tested for COVID-19
      Questions from CCAHS Cycle 1 asking respondents why they decided to get tested or why they did not go get tested where removed.
    8. Removed: COVID-19 vaccination intention and reasons
      Questions from CCAHS Cycle 1 asking respondents if they had the intention to go and get vaccinated and the reasons why have been removed.
  3. Sharing with McGill University
    A sharing agreement with McGill University is in discussion as the University would like to have the capacity to employ the data in improving its modeling of the COVID-19 pandemic to support reason-based policy development. McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). The CITF is a group of scientists and experts who use data to support decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19 pandemic. Along with PHAC and HC, the CITF are contributing partners to the CCAHS. Accordingly, a sharing question has been added to the electronic questionnaire asking respondents for their consent to share with McGill. Personal information for respondents who do not consent will be removed from the file(s) shared with McGill. Additionally, no personal information will be shared without an appropriate and approved data sharing agreement in place (see Appendix 2).
  4. Change in dried blood spot (DBS) sample shipping
    The DBS shipping process will be the same as outlined in the PIA, with two possible minor changes:
    1. The middle party recipient might change, from the National Microbiology Laboratory (NML) (Cycle 1) to the Statistics Canada head office (Cycle 2 – to be confirmed). Statistics Canada (or NML) will be responsible for receiving the DBS, and shipping them to the reference laboratories responsible for the analysis of the samples using the same process outlined in the CCAHS Cycle 1 PIA.
    2. The shipping method might change from Canada Post to a private shipping carrier.
  5. New - PCR Test
    One of the purposes of Cycle 2 of the CCAHS is to determine the prevalence of active COVID-19 infection at the time of collection. Respondents will be asked to collect a body fluid sample (saliva) using a non-invasive painless and intuitive collection method relying on a resealable small tube. This receptacle will be mailed back following the same procedures outlined for the DBS sample. Instructions on how to proceed, contraindications and consent questions were added at the end of the questionnaire accordingly. The module in the electronic questionnaire will only be implemented for the second and third wave of CCAHS if/when the inclusion of the PCR test is confirmed.
    To be able to include PCR testing, the following requirements must be met:
    1. PCR kit approved by Health Canada;
    2. PCR kit deemed safe for self-administration by the respondent;
    3. the sample to be mailed to the reference laboratory cannot be categorized as a dangerous goods and fall under the 'Transport of Dangerous Goods (TDG)' regulation.
    The first wave of CCAHS Cycle 2 will be the questionnaire and DBS only. With consent, PCR results will be sent to respondents using a similar method outlined for the DBS. Local authorities may be notified for respondents that tested positive for an active COVID-19 infection only with respondent consent. Statistics Canada will not disclose positive infections without first identifying legal authority, and this SPIA will be updated accordingly.

Reason for supplement:

While the Generic Privacy Impact Assessment (PIA) addresses most of the privacy and security risks related to statistical activities conducted by Statistics Canada and the Canadian COVID-19 Antibody and Health Survey (CCAHS) - Privacy impact assessment addresses specific privacy and security risks related to CCAHS Cycle 1, this supplement describes the changes to Cycle 2 and demonstrates the necessity and proportionality of collecting this additional information. As is the case with all PIAs, Statistics Canada's privacy framework ensures that elements of privacy protection and privacy controls are documented and applied.

Necessity and Proportionality

The collection of personal information for the program can be justified against Statistics Canada's Necessity and Proportionality Framework:

  1. Necessity:
    1. Sample
      Increase in sample size
      The increase in sample size from 48,000 respondents in Cycle 1 to 100,000 in Cycle 2 is necessary to ensure adequate final sample to meet the objectives identified in the survey purpose. This was a challenge in Cycle 1 as evidenced by the low response rate (25%). The increase in sample size will also contribute to the Disaggregated Data Action Plan (DDAP) to increase Statistics Canada's capacity to disaggregate statistical information for various populations. The final sample should allow for more robust analyses with sub-population groups and measure conditions or symptoms for which the prevalence is very low, thus requiring a larger sample.
      Removing 1 to 17 years old
      One of the main purposes of the survey is to gather information on chronic conditions, symptoms and access to care. Since chronic conditions appear to be less prevalent in children and youth, Cycle 2 focuses on respondents aged 18+.
      Removing territories
      Although it would be preferable to include the territories in this survey, there are several challenges that preclude doing so. These include:
      • Small population size and high sampling fractions mean that some participants may be sampled for several Statistics Canada surveys in a given year, adding undue response burden;
      • Participants may be asked the same questions in multiple surveys, adding to the fatigue when they are selected for multiple surveys;
      • Level of education, literacy and cultural considerations, such as trust in government, may affect the perceived burden;
      • Studies by the Methodology Branch at Statistics Canada have shown that being selected for multiple surveys can negatively impact someone's likelihood of participating in subsequent surveys;
      • Response burden is an important aspect of respondent relations which can have an impact of the quality of the data produced through surveys. This must be managed strategically, alongside other communications and engagement initiatives;
      • Additional survey burden in the territories poses a risk to the success of mission-critical surveys such as the Labour Force Survey (LFS);
      • Challenges exist in maintaining up-to-date and representative sampling frames for the three territories. High mobility rates, high turnover in cellular phone numbers, and a lack of civic addresses in remote communities mean Statistics Canada's sampling frames likely contain a fraction of the actual number of households in each territory;
      • Many dwellings in Nunavut and in remote communities do not have a mailable address, making it impossible to send a survey invitation letter;
      • Lack of Internet infrastructure and connectivity means that internet access in the territories is expensive and that high-speed Internet is not as widely available. In-person interviews are the recommended collection mode for surveys throughout Nunavut and in other remote areas to improve response rates. The pandemic, however, has imposed a moratorium on in-person survey collection;
      In an effort to reduce response burden and restore relationships with Canada's northern populations, Statistics Canada has developed a new platform to serve as the main collection vehicle for cost-recovery surveys in the North: the Northern Social Survey. This collection vehicle will allow for a better coordination of survey activities in the North, and strengthened engagement with external stakeholders will be pursued in order to ensure that the content selected for each cycle of the survey is meaningful and relevant to northerners. The NSS will allow data collection for various subject-areas in one questionnaire, as opposed to conducting multiple standalone surveys in the North, thus reducing burden on Northern households.
    2. Changes to questionnaire content
      Changes to the questionnaire content were partly to align with emerging public health issues and to align with other initiatives in the Center for Population Health Data (CPHD) such as the Health Care Access, Experiences and Related Outcomes (HC-AERO). The HC-AERO program aims to establish a comprehensive and integrated data strategy around experiences with health care services in Canada and impacts on health outcomes such as social impacts, hospitalization, and death in some cases. Changes to the questionnaire for the second cycle of the CCAHS  may result in the survey being used as a frame to conduct more in-depth exploration of issues pertaining to the use and access of health care services. Changes were also made to answer information needs from the Canadian COVID-19 Immunity Task Force.
      More precisely, the objectives of the change in questionnaire and additions to the survey purposes are to:
      • evaluate the extent of health status associated with the COVID-19 pandemic such as the prevalence of active infections and immunity to COVID-19 in a representative Canadian population;
      • provide a platform to explore emerging public health issues associated with experiences of living with chronic conditions and symptoms, including those with post-COVID-19 condition, as well as the use and barriers to health care services;
      • assist in the development of programs and services to respond to the needs of the current pandemic.
      Changes include:
      1. New: Chronic symptoms
        Gather information on chronic symptoms prevalence in the Canadian population, to have an understanding of their impact on the quality of life, challenges with access to care as well as to determine the proportion of Canadians who have chronic symptoms in the absence of a medically diagnosed chronic condition, and possibly determine the prevalence of Canadians with these symptoms and their interactions with post-COVID-19 condition (COVID-19 symptoms lasting three months or more). To clarify temporal factors, the survey asks follow-up questions about the length of time the respondent has had these symptoms.
      2. Modified: Chronic conditions
        Gather information on chronic conditions prevalence in the Canadian population, to have an understanding of their impact on the quality of life, challenges with access to care as well as possibly determine the prevalence of Canadians with conditions and their possible interactions with post-COVID-19 condition (COVID-19 symptoms lasting three months or more). To clarify temporal factors, the survey asks follow-up questions about the length of time the respondent has had these conditions.
      3. Modified: COVID-19 status
        Questions from the first cycle were modified to reflect the evolution of the COVID-19 virus as well as the new testing methods. Canadians reporting unexplained symptoms lasting 2 or more months, as well as a confirmed or suspected COVID-19 infection, are asked several follow up questions about what the symptoms were, their durations, and their impacts of day-to-day activities. Canadians reporting a confirmed or suspected infection are asked about the severity of their initial infection, and if symptoms existed 3 or more months after initial infection date. This information will allow us to determine the prevalence of post-COVID-19 condition in the population using the World Health Organization working definition of post-COVID-19 condition.
      4. Modified: COVID-19 vaccination
        New questions were added to Cycle 2 asking about 2nd and 3rd doses. This was not part of Cycle 1 because at the time, most Canadians had not even received their first dose. Since Cycle 2 will be in collection in the spring and summer of 2022, the majority of Canadians will have received their second dose and possibly even a third dose.
      5. New: Interactions with the health care system
        To align with information needs on health care services.
      6. New: Medication use
        To align with information needs on medication use.
      7. Removed: Reason why tested/not tested for COVID-19
        These questions were removed because they are not part of the Cycle 2 objectives. COVID-19 testing accessibility and willingness was a concern prior to Cycle 1 but is no longer relevant with the distribution of rapid antigen tests that can be done at home, and widespread availability and use of PCR testing.
      8. Removed: COVID-19 vaccination intention and reasons
        These questions were removed because they are not part of the Cycle 2 objectives. Vaccination for the general population had not started when Cycle 1 was launched and having data on the intention and perception of Canadians towards vaccination was relevant at the time. These questions have been asked in many Statistics Canada surveys since then and results are now available. Given that the majority of the Canadian population has at least received two doses, this information is not relevant for Cycle
      9. Removed: Risk Acquisition, Occupation and Health Behavior change
        These questions were removed because they are not part of the Cycle 2 objectives. Enough information is now available through various data sources (Cycle 1, Cohort of incarcerated man, etc.) determining association between occupation, travel and health behaviours and the risk of having a COVID-19 infection and antibodies.
    3. Sharing with McGill University
      Statistics Canada plans to sign agreements to share the data from this survey with McGill University. McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). The CITF is a group of scientists and experts who use data to support decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19 pandemic. Sharing the Cycle 2 data with them will complement other data sources (Canadian Blood Services data, study on Antibody Responses to Third-Dose mRNA Vaccines in Nursing Home and Assisted Living Residents, study on Seroprevalence and Risks Factors for SARS-CoV-2 Among Incarcerated Adult Men in Quebec, Canada, etc.) that they have access to and allow them to have a more complete understanding of the COVID-19 pandemic status and long-term effects in Canada. Along with the Public Health Agency of Canada and Health Canada, the CITF are contributing partners to the CCAHS.
    4. Change in DBS Shipping
      As outlined in the CCAHS PIA, it is necessary to track the flow of the dried blood spot samples (DBS) from the respondents to the reference laboratories to (1) be able to track who sent a sample, which will allow us to monitor response rates and follow-up with respondents that participate in the electronic questionnaire but do not complete the DBS, and (2) to ensure that all samples received are sent to the reference laboratories for analysis and that the results are sent to Statistics Canada. Cycle 2 may change the middle party recipient and/or shipping vehicle from NML to Statistics Canada, but this does not affect the necessity, effectiveness, proportionality, alternatives and mitigations outlined in the CCAHS PIA.
    5. New - PCR Test
      A molecular test using a saliva sample is necessary to measures active COVID-19 infections. Given the recent changes in the provinces' testing strategies with the deployment of the rapid antigen tests that can be administered at home (which are not reported to provincial/territorial/federal authorities/databases), it is challenging to determine the prevalence of active COVID-19 infection in Canada, at a national and provincial level. Including this component to wave 2 and 3 of Cycle 2 will give accurate estimates of COVID-19 infections in Canada at the time of collection.
  2. Effectiveness - Working assumptions:
    1. Sample
      For CCAHS cycle 2, it is hypothesized that a 45% response rate will be achieved for the completion of the electronic questionnaire and a 30% response rate for the completion of the testing kits where participants will receive testing kits in the mail and will be asked to return the biological samples via pre-paid courier for laboratory analysis. Moreover, it is hypothesized that the current prevalence of Canadians aged 18 and over with antibodies to COVID-19, which suggests that a person has previously had the infection or been vaccinated, is approximately 90%. Previous data sources (Canadian Community Health Survey, 2016) shows that 44% of adults aged 20 and over have at least 1 of 10 common chronic conditions, with a range from 7% for dementia to 25% for hypertension. With such hypotheses and using previous data sources, it is predicted that the 100,000-unit sample will yield reliable estimates at the provincial level for age groups by sex. It should also yield reliable national level estimates for at least three ethno-cultural groups or by visible minority status.
    2. Change in questionnaire content
      Cycle 2 has updated questionnaire content in order to effectively determine the prevalence of chronic symptoms, conditions, challenges with access to care, etc. as determined by the CITF.
    3. Sharing with McGill University
      The CITF, legally represented by McGill, are the scientific experts in Canada and better positioned than anyone else to use and analyse COVID-19 related data to support decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19 pandemic.
    4. Change in DBS Shipping
      The procedures put in place for the first cycle of the CCAHS to ensure the confidentiality of the samples being shipped will remain the same in the second cycle of the CCAHS. Even, if a PCR test is added to collection for wave 2 or 3, and there is a change in the middle party recipient and/or shipping vehicle, the procedures to ensure confidentiality of the samples will be maintained. Therefore, it does not affect the necessity, effectiveness, proportionality, alternatives and mitigations outlined in the CCAHS PIA.
    5. New - PCR Test
      Performing a molecular test using a saliva sample (or alternatively a nasal swab)is the only way to measure active infections with COVID-19. Given the survey sample size and expected response rates, it is expected that the results of the molecular testing will inform decision makers, including the Canadian Immunity Task Force on the prevalence of COVID-19 infection at the time of collection, at a national and provincial level, by age and gender and for other sub-population groups.
  3. Proportionality:
    1. Sample
      The change in sample size and inclusion criteria (age and provinces) will allow for more precise and disaggregated results by sub-population groups and provinces. A larger sample size is the only way to be able to estimate characteristics of symptoms or chronic conditions with lower prevalence and positive PCR tests. This change adds to the proportionality identified in the PIA to further examine the potential impact on vulnerable populations or subsets of populations through disaggregated data analysis.
    2. Change in questionnaire content
      The changes in questionnaire content do not impact the data sensitivity identified in the CCAHS PIA. Cycle 2 is still a voluntary survey. While it still collects sensitive health data, careful consideration was made to limit the number of questions being asked of respondents so as to not adversely impact their privacy when the content was updated. There were no changes from Cycle 1 as to personally identifying information asked and how it will be stored.
    3. Sharing with McGill University
      Respondents will be asked for permission to share their information from this survey with McGill University. McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). Direct identifiers such as name, address, telephone number and health card number will not be shared. This sharing is proportional to the benefits gained by Canadians through the work of the CITF using this data.
    4. Change in DBS Shipping
      The procedures put in place for the first cycle of the CCAHS to ensure the confidentiality of the samples being shipped will remain the same in the second cycle of the CCAHS even if there is a change in the middle party recipient and/or shipping vehicle. Therefore, it does not affect the necessity, effectiveness, proportionality, alternatives and mitigations outlined in the CCAHS PIA.
    5. New - PCR Test
      Procedures for the handling and storage of the PCR sample will follow similar protocols to that of the Canadian Health Measures Survey, which has been collecting blood, urine, saliva, and hair samples from a representative sample of Canadians since 2007 and methods follow approved national and international standards upon which the DBS protocol for Cycle 1 was modeled. The PCR protocol will be submitted for review and approval by the Public Health Agency of Canada-Health Canada Research Ethics Board (REB) in order to make sure all ethical issues are being considered, to ensure that internationally recognized ethical standards for human research are met and maintained and to ensure minimal respondent burden while maximizing the data potential. The information being collected as part of this survey is essential to better understand the prevalence of active SARS-CoV-2 infection in Canada, since provinces have changed their testing strategies.
  4. Alternatives:
    1. Sample
      As identified in the CCAHS PIA, there are currently no other surveys on the impacts of the COVID-19 pandemic that are able to estimate the prevalence of antibodies and infection at a national and provincial level by age and sex (gender) other than the CCAHS. There is also no other survey or data sources looking at prevalence of chronic conditions and symptoms, post-COVID-19 condition and challenges with access to care..
    2. Change in questionnaire content
      As stated above, there are no other data sources looking at prevalence of both chronic conditions and symptoms, as well as post-COVID-19 condition and use of, and challenges with access to health care.
    3. Sharing with McGill University
      McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). As stated above, there are no other surveys or sources of information that are statistically representative of the Canadian population's antibody and active infection prevalence that could be used by the CITF to support decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19 pandemic at a national level.
    4. Change in DBS Shipping
      The procedures put in place for the first cycle of the CCAHS to ensure the confidentiality of the samples being shipped will remain the same in the second cycle of the CCAHS even if there is a change in the middle party recipient and/or shipping vehicle. Therefore, it does not affect the necessity, effectiveness, proportionality, alternatives and mitigations outlined in the CCAHS PIA.
    5. New - PCR Test
      There are currently no other surveys that are able to estimate the prevalence of active COVID-19 infection at a national and provincial level by age and sex (gender). In order to meet this objective, a molecular test is required to detect an active infection.

Mitigation factors:

The overall risk of harm to the survey respondents has been deemed manageable with existing Statistics Canada safeguards that are described in Statistics Canada's Generic Privacy Impact Assessment, as well as with the following measures:

  1. Sample
    The changes in the survey sample did not increase or create new privacy or security risks. The overall risk of harm to the survey has been deemed manageable with existing Statistics Canada safeguards that are described in Statistics Canada's Generic Privacy Impact Assessment, as well as in the CCAHS PIA.
  2. Change in questionnaire content
    The changes in the survey content did not increase or create new privacy or security risks. The overall risk of harm to the survey has been deemed manageable with existing Statistics Canada safeguards that are described in Statistics Canada's Generic Privacy Impact Assessment, as well as in the CCAHS PIA.
  3. Sharing with McGill University
    McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). Data will be securely transmitted and stored in a protected and limited access environment as stipulated in Statistics Canada's signed data sharing agreement with McGill University. Data will not be shared without a signed agreement.
  4. Change in DBS Shipping
    The procedures put in place for the first cycle of the CCAHS to ensure the confidentiality of the samples being shipped will remain the same in the second cycle of the CCAHS even if there is a change in the middle party recipient and/or shipping vehicle. Therefore, it does not affect the necessity, effectiveness, proportionality, alternatives and mitigations outlined in the CCAHS PIA.
  5. New – PCR Test
    Informed consent will be granted by the respondent prior to completion of the PCR Test (Appendix 1).
    The flow of information for the PCR test will be the same as the DBS test outlined in the CCAHS PIA, with the possible change outlined in point 4 – Change in DBS Shipping throughout this document. The addition of this self-administered test does not increase or create new privacy or security risks beyond those addressed for the DBS in the CCAHS PIA. The molecular samples will be stored in the Biobank for future analysis (like the DBS). A similar service agreement will be signed between Statistics Canada and the reference laboratory(ies) to outline the security requirements for the handling of Statistics Canada biospecimens and associated data. The same safeguards as outlined in 'Principle 9: Safeguards, 'Analysis at the reference laboratory(ies)'' of the CCAHS PIA will remain in effect. Results will be reported to respondents via mail, following the same procedure as the DBS reporting.
    The Threats and Risk Assessment Grid from the CCAHS PIA related to the DBS can also be applied to the PCR test, which does not create additional threats. Other current working assumptions:
    1. It is being explored to have a Statistics Canada medical advisor contact the respondent if a result is positive to notify them in a more timely manner. The medical advisor would be a Statistics Canada employee under oath and would only have the information necessary to call the respondent (name, telephone number, test results). This information would be stored on Statistics Canada's protected drives with need-to-know access.
    2. Statistics Canada's CCAHS team is consulting with Statistics Canada's legal team to understand the authority of reporting positive cases to the local health authorities. Since the test administered within the CCAHS survey is for statistical purposes rather than diagnostic purposes, and that the results will not be timely (minimum of 7 days to receive result from laboratory – infection may no longer be active), the working assumption is that Statistics Canada will not have to report to local authorities. If legal authority is identified that supports reporting positive infections to local authorities, only the name, telephone number, address and test result of the respondent would be shared by phone. To mitigate risk, this is the same process that is used for the respondents from the province of Quebec that participate in the Canadian Health Measures Survey (CHMS) and test positive for 'les maladies à déclaration obligatoire ( MADO)'Footnote 4.

Conclusion:

This assessment concludes that with the existing Statistics Canada safeguards, any remaining risks are such that Statistics Canada is prepared to accept and manage the risk.

Appendix 1 - PCR testing, consent and reporting

The following contains content from Cycle 2 notification statements and questions related to PCR testing, consent and reporting:

You received a testing kit from Statistics Canada with the letter that invited you to complete this questionnaire. A purpose of the kit is to collect saliva sample from all survey respondents for the purpose of a PCR (molecular) COVID-19 test. Your saliva sample will be used to detect whether you are currently infected by SARS-CoV-2, the virus that causes COVID-19. It is very important to carefully read all the instructions provided in the kit before attempting the PCR COVID-19 saliva test.

Reporting process related to an active SARS-COV-2 infection

Public health authorities in some regions of Canada require reporting of active SARS-CoV-2 infections. To be able to have your saliva sample tested, we require your consent to have your result reported to public health authorities in your area, including your contact information, if your test result is positive.

Q74. I understood the instructions provided in the kit and the risks associated with testing. I have also read and understood the steps taken for the secure storage of my saliva sample. I am choosing to consent or not consent to the following:
  Yes, I consent (1) No, I do not consent (2)
Participating in the PCR COVID-19 saliva test    
Receiving results for the PCR COVID-19 saliva test    
Having my PCR COVID-19 saliva test result, if positive, shared with public health authorities in my area    
Storage of my leftover saliva and extracted SARS-CoV-2 RNA if applicable, for future health studies    

I understand that even though I have answered "Yes" to some or all of the items above, I can still withdraw from any part of this survey or subsequent studies at any time.

Appendix 2 – Consent to Share with McGill University

MSH_R01

To avoid duplication of surveys, Statistics Canada has signed agreements to share the data from this survey with McGill University. McGill is the legal entity representing the COVID-19 Immunity Task Force (CITF). The CITF is a group of scientists and experts who use data to support decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19 pandemic.

With your consent, your survey responses and postal code will be shared with McGill and the CITF. Names, addresses, telephone numbers, email addresses and health card numbers will not be shared.

Q65. McGill and the CITF have agreed to keep the data confidential and use it only for statistical purposes.

Do you agree to share the data provided?
MSH_Q01

  1. Yes
  2. No
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