BCCBN e-Consent Form |
PARTICIPANT INFORMATION AND CONSENT FORM
BRITISH COLUMBIA COVID-19 BIOBANK NETWORK
H21-00472
Principal Investigator: Dr. Darryl Knight
Director, BC COVID-19 Biobank Network
Vice President, Research and Academic Affairs
Biobank administration e-mail address: bc.biobanknetwork@ubc.ca
INVITATION
Doctors and scientists at the University of British Columbia and partner regional health authorities have created the BC COVID-19 Biobank Network (BCCBN) referred to as the "Biobank Network". The Biobank Network is a province-wide network of biobanks that aims to support as many COVID-19 research studies as possible. The Biobank Network will collect samples and medical information from people to create a bank (or library) of samples for use in health research. If you agree to donate samples and medical information to the Biobank Network, researchers will be able to use them for their studies. The Biobank Network will only allow research studies that have undergone research ethics review (if applicable) and have the required agreements in place to receive samples from the biobank.
You are invited to participate in the Biobank Network to help researchers better understand COVID-19. Should you agree to participate your samples and data will be stored indefinitely. In the unlikely event that the Biobank Network closes, you will be informed of this and the decisions regarding what will happen to the samples and data. You will have the opportunity to request your samples and data are destroyed, if you do not agree with the decisions that are made.
YOUR PARTICIPATION IS VOLUNTARY
Your participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you may still choose to withdraw from the Biobank Network at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving.
Please review the information presented here carefully when deciding whether or not you wish to be part of the Biobank Network.
WHO IS IN CHARGE OF THE BIOBANK NETWORK?
The Biobank Network is governed by the ethical standards of the University of British Columbia (UBC) Clinical Research ethics Board (CREB) as well as the governing bodies of the Biobank Network. The Biobank Network governing body will be made up of health authority representatives and leaders at UBC as well as biobanking experts. The custodians or persons responsible for looking after the samples and data held within the biobank are Dr. Darryl Knight and Dr. Michael Chen, who are the co-Directors of the Biobank Network.
Governance is essential for biobanks. The Biobank Network Steering Committee will determine how the Biobank Network operates, how your samples and information is stored and shared, and who makes decisions about your samples. If you decide to become a Biobank Network participant and sign this consent form you may be invited to become a part of the Biobank Network governance and help steer the biobank towards its research goals. This is entirely optional but if you are interested you will have the option at the end of this form to find out more about becoming involved in the governance of the Biobank Network.
BIOBANK NETWORK PARTNERS
The Biobank Network is working with multiple research partners in British Columbia to collect samples from participants from various locations. We refer to these partners as sites. The Biobank Network will continue to add partner sites to increase the collection of participant samples across the province
WHO CAN PARTICIPATE IN THE BIOBANK NETWORK?
You may participate in the Biobank Network if you would like to contribute to COVID-19 research. You may participate regardless of whether you have been tested, or if your test result was positive or negative.
WHAT DOES THE BIOBANK NETWORK INVOLVE?
Collection of biological samples
If you agree to take part in the Biobank Network, you will be asked to donate approximately 4-15mL (1-3 teaspoons) of blood based on your body weight (1 tube is approximately 3 teaspoons). If you are already having blood collected, this may be done at the same time to minimize the number of 'pokes'.
Once samples have been collected, they will be sent to one of the BCCBN sites for processing and storage. The BCCBN sites are located at:
- Victoria General Hospital, Victoria, BC
- Vancouver General Hospital, Vancouver, BC
- St Paul's Hospital, Vancouver, BC
- BC Children's Hospital, Vancouver, BC
At all sites, samples are stored in a secure area in an access limited facility. Only Biobank Network staff will have access to this facility. Samples will be stored with the Biobank Network until they are requested for future, currently unknown research.
Collection of personal and medical information
If you agree to take part in the Biobank Network you will be asked to complete the Biobank Network Participant Questionnaire which asks if and when you had COVID-19 as well as demographic information such as your age, month/year of birth, sex, and ethnicity. In an addition you will be asked when you tested positive for COVID-19 (if applicable) and your vaccination status. The data from the Biobank Network Participant Questionnaire will be copied into the Biobank Network database. The Biobank Network database is housed at UBC and is maintained by the Faculty of Medicine Digital Solutions Team. The Biobank Network database is maintained in compliance with the university information security and technical standards and is governed by the Biobank Network's Steering Committee. The samples you have collected will also be recorded in a secure database.
If you agree to participate in the Biobank Network the information from the Biobank Network Participant Questionnaire described above will be copied into the Biobank Network database. The Biobank Network database is housed at The University of British Columbia and is maintained by the Faculty of Medicine Digital Solutions Team. The Biobank Network database is maintained in compliance with the university information security and technical standards and is governed by the Biobank Network's Steering Committee.
HOW DO RESEARCHERS GET TO USE SAMPLES AND MEDICAL INFORMATION FROM THE BIOBANK NETWORK?
Researchers who want to use samples and medical information from the Biobank Network will have to apply to the Biobank Network. Part of the application process is to show that their research is worthwhile and to show that they have the appropriate approvals for their research. If the researcher requires additional medical information that is stored in other databases they will have to complete a data access request form and obtain approval by a data steward before this data is released. A data steward is someone who is responsible for how medical information is used in research.
WHO IS ALLOWED TO USE THE BIOBANK NETWORK?
Your information may be used for various research purposes. These could include genetic research and whole genome sequencing (mapping the entire genome), treatment, prevention, machine learning [1] and other research. Technology advances may allow for new uses of your samples and medical information that are not known at this time. The Biobank Network has rules and restrictions that governs who can request your samples and medical information and for what purpose.
It is possible that a commercial company could request samples and medical information from the Biobank Network. These companies are important partners as they are the organizations that make vaccines and medicines. The Biobank Network will only share samples and data with organizations that it has determined are trustworthy. Should your sample and medical information be shared with a company, neither you or the Biobank Network will receive any commercial value or profit derived from the use of your samples and/or information obtained from them. However, the Biobank Network may be reimbursed for the costs associated with sharing these samples and information.
Any study related data and/or samples, sent outside of Canadian borders may increase the risk of disclosure of information because the laws in those countries, dealing with protection of information may not be as strict as in Canada. However, all study related data [and/or samples], that might be transferred outside of Canada will be coded (this means it will not contain your name or personal identifying information) before leaving the study site. By signing this consent form, you are consenting to the transfer of your information and/or samples, to organizations located outside of Canada.
Your samples and medical information will be assigned a unique Biobank ID. It is VERY important to understand that when samples and medical information are given out to researchers, they will be de-identified, which means that all the information that could be used to easily identify you such as your name are removed. Nothing that identifies you will be transferred to the researchers.
[1] Machine learning is a type of Artificial Intelligence where computer programs learn from data automatically to see patterns that would be difficult or impossible for humans to observe on their own.
WHAT TYPE OF RESEARCH WILL MY SAMPLES AND MEDICAL INFORMATION BE USED FOR?
Your samples and medical information will be used for research to help us understand COVID-19 as well as other diseases related to COVID-19 such as seasonal flu and health topics that are unknown at this time. Our goal is to allow researchers to use COVID-19 samples from participants alongside their medical information so that less people get sick in the future from this virus and those that do get sick can be treated more quickly. In addition, the study of COVID-19 may help us understand other similar diseases.
It is possible that a research question might arise that goes above and beyond the goals of the Biobank Network. If this is the case, with your permission, we will allow researchers to contact you and ask if you want to be included in such research. If you are willing to be contacted for other research, you will be able to provide an email address at the end of this form.
WHAT ARE THE POSSIBLE HARMS AND SIDE EFFECTS OF PARTICIPATING?
Blood Sample Collection
Drawing blood may cause some slight pain and a small risk of bleeding and/or bruising at the puncture site. Other risks include temporary lightheadedness and rarely an infection at the site of the needle puncture may occur.
Risks Related to Genetic Testing and Incidental Findings
Cells in your body contain a type of molecule called deoxyribonucleic acid, or DNA for short. DNA is often referred to as "the genetic code" as it is the coding for your genes and determines that you are who you are. Your cells also contain another type of molecule called Ribonucleic acid (RNA for short) that works closely with your genes. Changes in DNA or RNA may affect a person's chance of developing certain diseases. These changes may be inherited (i.e. passed on in families from parents to children) or they may be somatic (arising in a single body cell at some point during life and generally cannot be passed on to children). "Genetic research" is a type of research that studies both of these types of changes, and will hopefully provide a better understanding of the links between the genetic changes and specific diseases, and eventually develop new ways to prevent, detect and treat these diseases. When you donate your blood or tissue for genetic testing or research, you are not only sharing genetic information about yourself, but also about biological (blood) relatives who share your genes or DNA.
It is possible that during genetic research the researcher may discover a finding that they were not looking for, such as a genetic change being present that indicates that you (or a family member who may carry the same genetic change) are at greater risk for developing a condition for which screening or prevention strategies are available or which presents an important risk to your health. This is called a "clinically relevant incidental finding" or an incidental finding for short.
If an incidental finding of this type is discovered, you have the right to know but you may choose whether or not you want to know. If you become aware that you have a disease-related genetic change, this knowledge may provide you or your family with important information that could be used to either prevent the disease (if possible) or to inform other health care decisions related to the finding. However, there is also a risk that simply having this knowledge may cause anxiety or distress and alter your decision to have a child or other lifestyle decisions for you or a family member who may have the same genetic change. Incidental findings that are found during participation in a research study will be confirmed in a medical laboratory that is not associated with the research study before they are used for your health care and other important decisions. If an incidental finding is discovered about you then your family doctor or primary healthcare provider will contact you and discuss the finding. At the end of this consent form, we will ask you for your primary healthcare provider's name. If you do not wish to provide us with this information then we will not be able to pass on any findings to you. At the end of this consent document, you will be offered the option of being told if an incidental finding of this type is discovered. Whatever your choice is now, you may change your mind at any time by telling the study doctor or another member of the research team (for example, study nurse or genetic counsellor).
Risk of Re-Identification
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, there is a risk that someone could get access to the information we have stored about you, it could be revealed inappropriately or accidentally, and the risk of someone identifying you may increase in the future as people find new ways of tracing information. Depending on the nature of the information, such a release could upset or embarrass you, or be misused. The risk of your information being accidentally released in this study is estimated to be extremely low. A Federal (Canada-wide) law now prohibits anyone such as an employer or an insurer from requiring you to disclose the results of a genetic test or to take a genetic test as condition of providing services. In addition, discrimination against individuals based upon genetic characteristics is now prohibited by the Canadian Human Rights Act.
WHO WILL KNOW I PARTICIPATED IN THE BIOBANK NETWORK?
If you agree to participate in the Biobank Network, your health care provider may be notified. If required by law, your medical information may also need to be given out. If this should happen, the study doctors and staff will do their best to make sure that any information that is shared will not directly identify you.
WHO WILL HAVE ACCESS TO MY STUDY-RELATED DATA?
The Research Ethics Board or regulatory authorities and auditors may also look at your study-related data for the purpose of overseeing the conduct of the study. By signing this form, you are authorizing such access.
COMBINING YOUR PATIENT QUESTIONNAIRE INFORMATION WITH OTHER HEALTH INFORMATION OR PERSONAL
Some of the researchers applying to use samples and health information in the Biobank Network may need additional information for their study. In order to combine these different sets of information we will follow strict guidelines designed to maximize the privacy and security of the information about you that will be used in the research study. An example data set that may be of interest to researchers are health care and other data held by Population Data BC (PopData). PopData is a BC-based organization dedicated to data access, protection and privacy of research data. Together, the Biobank Network and PopData will ensure that your confidentiality is maintained. We require your permission to transfer personal health information from the Biobank Network to PopData so that we can combine the data we collect from the Biobank Network with PopData .
We may also need to combine your Biobank Network Participant Questionnaire responses with other health information data that may be stored in your medical records, for example the results of a chest x-ray. We would request this data from individuals called data stewards (whose job is to protect data) in such a way that would protect your privacy and confidentiality at all times. At the end of this consent form you will have the opportunity to check a box to indicate that you are ok with this combining of data.
All requests for data combining will be reviewed by a Research Ethics Board and by data stewards who are responsible for the relevant data sets.
WHAT ARE THE POSSIBLE BENEFITS OF PARTICPATING IN THE BIOBANK NETWORK?
There is no direct benefit to you. The knowledge gained from the research may help others with COVID-19 in the future and potentially how to anticipate and be better prepared for other pandemics should they arise in the future.
WHAT HAPPENS IF I DECIDE TO WITHDRAW MY CONSENT TO PARTICIPATE IN THE BIOBANK NETWORK?
You may withdraw from the Biobank Network at any time without giving reasons. If you choose to take part in the Biobank Network and then decide to withdraw at a later time, you have the right to request the withdrawal of your information and/or your samples. This request will be respected to the extent possible.
Please note however that there may be exceptions where this is not possible, 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. In these cases of total withdrawal being impossible, your identity will still be protected. If you would like to request the withdrawal of your data and/or samples, please email the Biobank Network at bc.biobanknetwork@ubc.ca.
RIGHTS AND COMPENSATION
By signing this form, you do not give up any of your legal rights and you do not release the Biobank Network or other participating institutions from their legal and professional duties. There will be no costs to you for participation in this study. You will not be charged for any research procedures. If you become ill or physically injured as a result of participation in this study, medical treatment will be provided at no additional cost to you. The costs of your medical treatment will be paid by your provincial medical plan. In order to allow the Biobank Network to remain sustainable the Biobank Network will charge researchers, companies, and other organizations a small cost recovery fee to obtain samples and medical information.
WHO DO I CONTACT IF I HAVE OTHER QUESTIONS ABOUT THE BIOBANK NETWORK?
If you have any questions or desire further information about this study, you can contact the Biobank Network Manager by emailing bc.biobanknetwork@ubc.ca
WHO DO I CONTACT IF I HAVE ANY QUESTIONS OR CONCERNS ABOUT MY RIGHTS AS A SUBJECT DURING THE STUDY?
If you have any privacy concerns or 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 H21-00472 when calling so the Complaint Line staff can better assist you.