Title: Canadian COVID-19 Vaccine Registry for Pregnant & Lactating Individuals (COVERED): An Evaluation of Safety, Effectiveness & Acceptability
Dr. Deborah Money, MD, FRCSC, Professor, Depts. of Obstetrics & Gynecology, Medicine, SPPH, University of British Columbia, Clinician Scientist, Women's Health Research Institute
(tel) 604-875-2194 | email@example.com
Dr. Chelsea Elwood, B.M.ScH, M.Sc, MD, FRCSC (University of British Columbia) Dr. Arianne Albert, PhD (Women’s Health Research Institute) Dr. Elisabeth McClymont, PhD (University of British Columbia) Dr. Eda Karacabeyli, M.Sc, MD (University of British Columbia) Dr. Julie Bettinger, MPH, PhD (Vaccine Evaluation Centre, University of British Columbia) Dr. Lori Brotto, PhD (Women’s Health Research Institute, University of British Columbia) Dr. Manish Sadarangani, MRCPCH, DPHIL, BM. BCh, MA (Vaccine Evaluation Centre, University of British Columbia) Dr. Tatiana Sotindjo, MD, FRCPC Adolescent Medicine Specialist/Pediatric HIV Specialist, Department of Pediatrics, University of British Columbia
Alberta: Eliana Castillo, MD (University of Calgary) Saskatchewan: George Carson, MD, FRCSC, FSOGC, CCPE, MCFP(Hon.) (Reginal General Hospital) Manitoba: Vanessa Poliquin, MD, FRCSC (University of Manitoba) Ontario: Deshayne Fell, PhD, MSc, BSc (University of Ottawa) Ontario: Rohan D’Souza, MD, PhD, FRCOG, FCPS, MBBS (Mount Sinai Hospital) Quebec: Isabelle Boucoiran, MD, MSc (Department of Obstetrics and Gynaecology, CHU Sainte-Justine) Newfoundland & Labrador: Joan Crane, MD, MSc, FRCSC (Depart. of Obstetrics & Gynecology, Memorial University) Prince Edward Island: Krista Cassell, MD (Charlottetown, Prince Edward Island) Nova Scotia: Heather Scott, MD, FRCSC (Department of Obstetrics & Gynecology, Dalhousie University; Reproductive Care Program of Nova Scotia) New Brunswick: Lynn Murphy-Kaulbeck, MD (Perinatal New Brunswick Health Program) Yukon: Sarah Saunders, MD, FRCSC (Whitehorse General Hospital) Northwest Territories: Andrew Kotaska, MD, FRCSC (Women’s & Children’s Health, Northwest Territories Health and Social Services Association) Nunavut: Mark Hansen, MD
COVID-19 Immunity Task Force (CITF)
Public Health Agency of Canada (PHAC)
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You are being invited to take part in this study because you are pregnant, recently pregnant, and/or lactating.
YOUR PARTICIPATION IS VOLUNTARY
Your participation in this study is completely voluntary. If you decide not to participate, you do not have to give a reason. If you choose to take part in the study, you will be asked to sign an online consent form. If you decide to take part in the study now and later change your mind, you are free to withdraw at any time without any consequences.
WHO IS CONDUCTING THE STUDY? This study is being done by a national team hosted by the University of British Columbia (UBC) and the Women’s Health Research Institute (WHRI) that is located at the BC Women’s Hospital. The funding to do this study has been provided by the Public Health Agency of Canada. The Investigators will not receive personal payments for doing this study. WHAT IS THE BACKGROUND OF THE STUDY?
COVID-19 is a new disease caused by a coronavirus (SARS-CoV-2) that was first identified in December 2019 and declared a global pandemic in March 2020. Pregnant women and individuals who have COVID-19 appear more likely to develop complications, including difficulty breathing that can require being hospitalized and/or requiring intensive care compared to women and individuals who are not pregnant. Pregnant women and individuals with COVID-19 are more likely to have a premature birth and caesarean delivery, and their babies are more likely to be admitted to a newborn intensive care unit.
So far, there is some information about the use of COVID-19 vaccines in pregnant or lactating women & individuals but further information is needed. Given the concern about the risk of COVID-19 to pregnant women & people and the general safety of vaccines in pregnancy, these vaccines are being offered to pregnant women & people in Canada. It is particularly important to fully understand the safety, effectiveness & acceptability of COVID-19 vaccines in pregnant & lactating women & individuals in Canada.
To learn more about COVID-19 vaccinations and pregnancy, we are inviting up to 15, 000 pregnant, recently pregnant and lactating women and individuals to enrol in the registry.
WHAT IS THE PURPOSE OF THE STUDY?
The purpose of this study is to collect data from pregnant, recently pregnant, and lactating women & individuals, regardless of whether they have received a COVID-19 vaccine, to assess the safety and effectiveness of COVID-19 vaccines and to examine attitudes towards COVID-19 vaccination in this population.
WHO CAN PARTICIPATE IN THIS STUDY?
You may be able to participate in the study if: You are an adult aged at least 19 years of age at time of the study You are pregnant or recently pregnant and lactating at the time of the study Your pregnancy will or has concluded after March 1, 2020
WHO SHOULD NOT PARTICIPATE IN THIS STUDY?
You will not be eligible to participate in this study if you are unwilling to sign the consent form.
WHAT IS A REGISTRY?
The COVERED registry is a research study that uses self-administered surveys to collect data on outcomes of pregnant, recently pregnant, and lactating women and individuals.
WHAT DOES THE STUDY INVOLVE?
If you agree to take part in this study, you will be asked to complete an online baseline survey. Depending on your answers, you may be asked to fill out one or more additional surveys outlined below. A short follow up survey will be sent every two months after the first baseline survey to determine if any events have occurred. Each survey takes between 5-20 minutes to complete.
Surveys are as follows:
(1) Baseline survey: Pregnancy status, vaccination status, demographics (eg. month & year of birth, gender*, ethnicity*) health history, COVID-19 history & pregnancy history.
(2) Vaccine Attitudes: Feelings, opinions & attitudes towards vaccines
(3) Pregnancy Outcomes: Pregnancy & infant outcomes, if pregnancy concluded after March 2020
(4) Vaccine Outcomes – Dose 1: Answered if first dose of a COVID-19 vaccine received, and will ask about date vaccine received and experience post vaccination.
(5) Vaccine Outcomes – Dose 2: Answered if second dose of a COVID-19 vaccine received, and will ask about date vaccine received and experience post vaccination.
(6) Health Event: Significant health events resulting in a visit to the emergency department or hospitalization
(7) Follow-up survey: This survey will determine if a pregnancy, health or vaccine outcome survey is required.
(8) Vaccine Outcomes – Booster: Answered if a third or more dose of COVID-19 vaccine received, and will ask about date vaccine received and experience post vaccination.
(9) Infant Outcomes – 6 month survey: Answered 6 month after delivery, and will ask about infant development and health outcomes
(10) Child Outcomes – 12 month survey: Answered 12 months after delivery, and will ask about child development and health outcomes In the event that further health information is required due to a particular health event or experience, we may contact you by phone call or email to ask for more information. You can decline giving additional information than what you have provided within a survey. DISCLOUSURE OF RACE/ETHNICITY
Studies involving humans now routinely collect information on race and ethnic origin as well as other characteristics of individuals because these characteristics may influence how people respond to different medications. You should be aware that providing this information is not mandatory.
WHAT ARE THE POSSIBLE HARMS OR DISCOMFORTS?
There are no expected harms or discomforts associated with participating in the study. There may be a risk of loss of confidentiality, but this consent form will tell you in the later sections all the steps that will be taken to minimize the chance of this happening.
WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATING?
There is unlikely to be any direct benefit to you for taking part in this study. Results from this study may benefit pregnant and lactating women & people in the future by helping to guide their decision making process around receiving a COVID-19 vaccine. Results from this study may also provide researchers and policy makers information about how to best use COVID-19 vaccines in pregnant women & people in the future. This may improve your own care in the future if you need to receive a COVID-19 vaccine again.
WHAT WILL HAPPEN AFTER THE STUDY IS FINISHED?
All study related documents will be maintained at UBC and WHRI, or in an off-site secure storage location for a total of 10 years, after which the documents will be destroyed.
Based on summary information that would not identify any participant or their experience, this project expects to provide the Canadian public, the Public Health Agency of Canada, the COVID-19 Immunity Task Force and provincial/territorial vaccine advisory committees with Canadian data on COVID-19 vaccines in pregnant and lactating women and individuals. This information will be used to guide recommendations and decisions regarding COVID-19 vaccinations. Vaccine safety events will be coordinated with the National Vaccine Safety Network (CANVAS) and will include adverse events as detailed in the survey such as, severity and duration of adverse event, medical visits (e.g. emergency department or hospitalization), and treatments administered.
We will also actively distribute our findings and a summary of results to the public and participants on our website and via email. The results will not include information that can identify you. Results will be reported as soon as it is available and a complete report will be generated by December 2023.
WHAT IF NEW INFORMATION BECOMES AVAILABLE THAT MAY AFFECT MY DECISION TO PARTICIPATE?
Since this study does not involve a treatment protocol, it is unlikely that new information will become available that could potentially affect your willingness to remain in the study. If changes do occur in the future, you may be asked to sign an amended consent form to indicate your continued consent to participate.
WHAT HAPPENS IF I DECIDE TO WITHDRAW MY CONSENT TO PARTICIPATE?
You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, the study investigators will keep the information already collected about you until that point. You have the right to request the destruction of your information collected during the study, and may do so by emailing the study investigators at firstname.lastname@example.org If you choose to have the data collected about you destroyed, this request will be respected to the extent possible. Please note that there may be exceptions where the data will not be able to be withdrawn for example where the data is no longer identifiable (meaning it cannot be linked in any way back to your identity) or where the data has been merged with other data. HOW WILL MY TAKING PART IN THE STUDY BE KEPT CONFIDENTIAL?
The research staff at the UBC and WHRI respect your confidentiality and will keep all personal information collected about you confidential. Federal and provincial privacy laws give safeguards for privacy, security, and authorized access to information. We will not give information that identifies you to anyone without your permission, except as required by law. However, research records may be inspected by designated representatives of the Principal Investigator or the UBC Research Ethics Board for the purpose of monitoring research. No information or records that disclose your identity will be published without your consent, and any records that identify you will not be removed or released from the study office without your consent, unless required by law.
You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (e.g., it will not include your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The personal information that is collected within this consent form will be kept in a separate REDCap database from your survey responses. The list that matches your name to the unique study number that is used within the survey response database will not be removed or released without your consent unless required by law.
The data we collect from you will be entered into “REDCap”, a secure online database that is designed for collecting, managing and reporting clinic research data. When your data is entered into REDCap, it is immediately encrypted during transmission and can only be accessed by username and password. The research team will have access to the database. This information is collected using your unique identifier and is not linked to your personal information collected in the consent form.
We are asking to collect your email address to send you a notification for a survey follow up or to contact you for more information regarding your responses.
Although you may not be aware of this fact, emails sent to some webmail services (e.g. Gmail, Hotmail, etc.), may be stored/routed outside of Canada (for example, in the United States). Due to the fact that future emails will contain personal information about you, including your name, the Freedom of Information and Protection of Privacy Act requires that we obtain your consent before we continue. We will only send your personal information to the email address you have provided to us. All of the information which you provide to us will be kept completely confidential. Providing your email address means that you voluntarily agree and give your consent for the study team to email your personal information to you.
Your rights to privacy are legally protected and will always be respected. You also have the legal right to access any of the information that we collect about you. You can always ask for more details about these laws if you want to know more details. While every effort will be made to protect the privacy of your information, absolute confidentiality cannot be guaranteed. This does not limit the duty of researchers rand others to protect your privacy.
WHAT HAPPENS IF SOMETHING GOES WRONG?
Signing this consent form does not limit your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties.
WHAT WILL THE STUDY COST ME?
There is no cost for taking part in this study and you will not be paid or reimbursed for taking part.
IF I HAVE QUESTIONS DURING MY PARTICIPATION, WHO SHOULD I SPEAK TO?
If you have any questions, would like further information, or if you experience any adverse events throughout the duration of the study, you can contact the Principal Investigator (Dr. Deborah Money) or the Study Coordinator at 604-875-2194.
WHO DO I CONTACT IF I HAVE CONCERNS ABOUT MY RIGHTS AS A PARTICIPANT? If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by phone at 604.822.8598 (Toll Free: 1.877.822.8598). Please reference the study number (H21-01224) when contacting the Complaint Line so the staff can better assist you. PARTICIPANT eCONSENT
By clicking “yes” to the e-consent, it means: I have read and understood the information in this consent form. I understand that I can email or phone the study team to ask any question regarding the study. I understand that all of the information collected will be kept confidential and that the results will only be used for scientific purposes. I understand that my participation in this study is voluntary. I understand that I am completely free at any time to refuse to participate or to withdraw from this study at any time, and that this will not change the quality of care that I receive. I understand that I am not waiving any of my legal rights as a result of signing this consent form.
I will receive a copy of this consent form for my own records to the email address that I have designated.
I consent to participate in this study.
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