BC Children's Hospital BioBank Maternal Information and Consent Form
COLLECTION AND BANKING OF MATERNAL SERUM, BLOOD SPECIMENS, PLACENTA, CORD BLOOD, AND CLINICAL DATA
Principal Investigator: Dr Jonathan Bush 604-875-3057
BioBank Administration: (604) 875 2000 ext 7497 biobank@cw.bc.ca (604) 875-2161 24 hours/day, 7 days a week Toll Free Number (BC only): 1-888-300-3088
YOU'RE INVITED! Advances in medical research have significantly improved the quality of life for millions of people and has lead to effective treatments for common conditions and diseases that were once long standing or life-threatening.
The BC Children's Hospital BioBank samples are used in research to understand the how and why of disease in women and their families. In order to continue improving treatments, researchers need access to health information and biological samples, such as blood, from a wide variety of people.
A single sample collected at BC Children's Hospital or BC Women's Hospital has the ability to fuel many research projects, any one of which might lead to an important medical breakthrough. If there are current research projects that require samples from mothers and/or babies, a summary of these studies is included at the end of this consent form. Your sample may be used for some or all of these projects, and may also be stored for use in future research which as of now, is undefined.
Please note that this consent form relates to you and your unborn child together, once your child is born you may be invited to sign an additional BioBank consent form on their behalf.
ABOUT THE BIOBANK The Goal
The BioBank would like to collect samples and clinical data from women and sometimes their families to create a bank (or library) of samples for use in research to better understand how and why diseases progress in women and families, with the ultimate goal of improving treatment and preventing diseases.
Who?
The BioBank is run by doctors and scientists at BC Women's Hospital and BC Children's Hospitals. Scientists worldwide can apply to the BioBank to ask for samples and health information to use for their research. Samples and coded health information is only given to a scientist if the BioBank and Research Ethics Board (if applicable) confirm that the research is worth doing and safe.
Coded Health information is de-identified by removing information like your name or birthdate, to protect your identity 1
Research Ethics Board :A research ethics board is a group of people that review and monitor research involving human participants to make sure it is ethically acceptable.
1 : For more information about the strict privacy and security standards for data at PHSA, please visit the PHSA Data Governance Framework
What?BioBanking is the collection, storage, and use of human body samples and personal health information for research. The BioBank collects and stores samples such as blood, placenta, and cord blood from participants with their consent. . The Information about the participants such as date of birth, hospital number, and any pregnancy-related information are also collected and stored in a securely 1 . This information can be collected from your medical chart or from other research data bases if you have agreed to share such data with the BioBank.
All women who are seeking medical care or participating in a study in the past or present at BC Women's Hospital are eligible to contribute samples to the BioBank. You can take as much time as you need to decide whether you will donate a sample to the BioBank. If you change your mind at any point in the future, you may choose to destory previously collected samples. However, the BioBank will not be able to retrieve samples or information that have already been sent to researchers. Whether you choose to participate or not, you are not waiving any of your legal rights as a result of signing this consent form. This will not affect the care you receive at BC Children's and Women's Hospital.
If you agree to donate, samples and health information that are collected throughout this pregnancy, along with you and your baby's clinical data, could be stored in the BioBank. You will not be asked to consent again. The samples and information will be stored in the BioBank until a time when they are requested for use by researchers. If there comes a time where the samples are on longer of scientific value, they will be respectfully disposed of.
The amount of sample taken from you has been carefully considered and it is unlikely that there will be any harm. Because certain demographics, specifically your date of birth, hospital number, and pregnancy-related information are being collected, there is a risk of your identity being revealed, but all efforts will be made to prevent this.
Incidental (Unexpected) Findings Risk
The BCCH BioBank supports studies that may be unknown at this time. This research is typically not designed to find information that is important for your care. However, it is possible that researchers using your samples will unexpectedly discover information that, once checked, could affect decisions about your health care. For example, they may find that you have an unexpected change in a gene that makes you more susceptible to another disease. This is called an incidental finding
Hereditary Genetic Analysis Research Risk When you donate your samples, you are not only sharing genetic information about yourself, but also about biological (blood) relatives who share your genes or DNA. Genetic information may include whole genome or exome sequencing of the DNA from your sample and your genetic data. In most cases, the research that is planned is designed to analyze features related only to you and your health. However, some research studies may be proposed that involve genetic analysis that identifies features in your genes that may affect the health of people related to you and that may be inherited (passed on in families).
Incidental finding Discovery of an abnormality that the researchers were not looking for
Participation in the BioBank does not require any time on your part except if you agree to donate extra samples (at times when you do not normally have samples collected). This may require 5 to 15 minutes extra. You will not be paid for donating samples and you will not financially benefit from discoveries or commercial products developed from your samples. No profit will be made by the BioBank but researchers may be charged a fee to collect and process samples and data.
We hope the samples and health information in the BioBank can be used to improve treatment and prevent diseases in future generations. While you may not directly benefit from donating samples to the BioBank, results of research might show something that could be important to you or your child's health. If this occurs, your health care team will be consulted to discuss whether these results are of benefit. If so, someone from your health care team will discuss them with you.
Privacy
Your confidentiality will be respected, and your information will be coded1 'for-profit' private companies
Data may be shared and stored outside of Canada (including in cloud servers
Some grant funding institutions or scientific journals may request that your coded data may be deposited into a publicly accessible location at the time of publication. This can allow outside groups to check the data, and prevent mistakes and fraud. It also allows others to re-analyze the data or to do other kinds of analyses in the future beyond those described in the study. This future use of your data may not be subject to oversight by a research ethics board. Even though the identifying information will be removed from the data it is possible that others may be able to find out who you are. The chance of this is currently thought to be quite low.
'For-profit' private companies: We do provide private companies samples to be able to develop new drugs and tools. Companies cannot sell your sample, but they may use your samples in commercial activities. Cloud servers: Cloud servers allow sharing of data between different researchers, using virtual (as opposed to physical) servers and can be located anywhere. They often have better computational capabilities, among other things, when compared to physical servers. The BioBank carefully considers whether sharing of the data is needed for important research and will not share information if it feels it is not safe or needed and the activity does not meet the strict privacy and security standards of PHSA
If you have any questions about donating, contact the BioBank Director or the BioBank Administration at 604-875-2000 ext. 7497 . If you have any questions about your privacy or rights as a research participant and/or your experiences while participating in the BioBank, contact the Research Participant Information Line of the University of British Columbia Office of Research Ethics at RSIL@ors.ubc.ca or call 604-822-8598 (Toll Free: 1-877-822-8598 ). Please reference the study number H23-02299 when contacting the complaint line, so the staff can better assist you.
A summary of relevant BC Women’s Hospital research studies which currently require biological specimens is provided below. If you agree to take part in the BioBank, a portion of your biological sample(s) may be utilized for some or all of these studies, depending on the suitability and specific study requirements. In addition, remaining samples will be stored in the BioBank for future research.
If you are interested in obtaining more detail about any of the following studies, please contact the investigator, as indicated.
STUDY: Understanding the immunological basis for early-life infections in preterm infants
Normal umbilical cord blood contains primitive blood cells. After your baby is born, the umbilical cord is cut and the placenta, or “afterbirth,” is delivered soon thereafter and usually discarded. However, at this time, the blood can be collected from the cord and then used for research. Understanding how normal blood cells are produced is important because it helps us better understand disease processes. For instance, from studying normal blood cells in healthy full-term infants we can detect vulnerabilities in a premature baby’s immune system, or learn how to better treat blood diseases, or improve transplant therapies The goal of this project is to understand how the immune system of healthy babies born at term differ from babies born earlier or from healthy adults Umbilical cord blood Everyone Dr. Pascal Lavoie - plavoie@cw.bc.ca
STUDY: A new role for the molecule ADA2 in the development of human immune cells (ADA2 Study)
Background & Purpose: We study a rare childhood disease called Deficiency of Adenosine Deaminase (DADA2). DADA2 causes a range of health issues, the most serious being the inability to make immune cells that keep us healthy. We know that children with DADA2 have defects in a protein called ADA2 but we don't know how ADA2 is involved in immune cell development. In entirely new areas of research like this, scientists would typically use laboratory mice to tackle such questions, but mice don't have ADA2. Therefore, we plan to use human umbilical cord blood to obtain immature blood cells that can be used to model the development of human immune cells in the lab.
This is the first study to look at how, when and why ADA2 is produced during immune cell development, and we hope our findings will help us better understand the unique and devastating symptoms in children with DADA2 and many other immune cell disorders.
What's required? Umbilical cord blood
Who's eligible? Everyone
Principal Investigator: Dr. Kelly Brown kbrown@bcchr.ca http://kbrownlab.ca/
Primary contact: Stephanie Hughes sthughes@bcchr.ca 604-875-2000 x7625
STUDY: Blood antigen regeneration kinetics after enzymatic cleavage: kidney vascular system in-vitro model (IVARM)
Background & Purpose: Drs. Kizhakkedathu and Withers' groups at UBC have developed an innovative new enzyme that can convert A blood group cells to O blood group ones. Since majority of tissues in human body express blood group antigens, this discovery carries hope to create a universal organ donor supply for transplantation, including kidney transplantation. We will use the cells from placenta to design a new lab tool, called microfluidic chamber, to perform a series of new experiments that will help us test the enzyme for the future transplantation studies.
What's required? Donation of placenta
Who's eligible? Women with deliveries at 20 - 42 weeks gestation
Principal Investigator: Dr. Jayachandran Kizhakkedathu Co-Investigators: S. Withers, C. Nguan
Contact for more information: jay@pathology.ubc.ca
I consent to participate in the BioBank.
* must provide value
Yes
No
Yes, I would like to have my identifiers stored in the BioBank database, as I do not want to be re-contacted in the future.
No, I do not want to have any identifiers stored in the BioBank database. I understand that I may be re-contacted in the future.
Yes, I would like to have my identifiers stored in the BioBank database, as I do not want to be re-contacted in the future.
No, I do not want to have any identifiers stored in the BioBank database. I understand that I may be re-contacted in the future.
Leftover Samples Sometimes, after medical tests are completed, there is a portion of sample leftover. These samples can be useful but are often older and might not be as valuable for research as fresh samples. For example, there might be some blood leftover after a blood collection is complete. We ask your permission to donate leftover samples
Leftover samples may include• Blood (including a prenatal screening sample or routine blood tests) • Placenta after your baby’s delivery • Blood from the umbilical cord (cord blood) after your baby’s delivery *All cord blood collections are compatible with Canadian Blood Service’s (CBS) public cord blood banking program
I consent to donating leftover samples
* must provide value
Yes
No
Baby's Medical Information With your permission, the BioBank would like to collect your baby's hospital number and information from the first month of life (i.e.: newborn screening results, Apgar scores, birth weight, and the presence of any health conditions that are diagnosed in the newborn period)
* must provide value
Yes No
Blood from the umbilical cord (cord blood) after you baby's delivery. See details above in regard to BioBank and CBS.
Yes
No
N/A
Placenta after your baby's delivery
Yes
No
N/A
I agree to be contacted * about other research opportunities, unrelated to the research carried out with samples from the BioBank. PHSA conducts research and other activities as permitted by law. Some research studies require your consent. There are many ways that you can be approached for studies, including during clinical visits or after you leave the hospital. Saying 'yes' here means you would like to put your name and contact information into our database of people who want to participate in research. This does not guarantee that you will be contacted, but it may increase your chances of being asked to join a study.
* must provide value
Yes No
I would like newsletters (2-4x per year) by email * , with features about recent studies and/or researchers that we have been working with.
* must provide value
Yes No
I agree to be contacted * by a member of my healthcare team if researchers identify an incidental finding and I understand that I may change my decision at any time by contacting the BioBank.
* must provide value
Yes No
* If you provide your email, the research team will use best efforts to keep your information confidential. However, there are always some risks of disclosure when using email and you should be aware that some email services may store the contents of your email account outside of Canada, where privacy and data security standards may be different than they are in Canada. If you have questions or would like to stop receiving research communication via email, please contact the BCCH BioBank at biobank@cw.bc.ca or 604.875.2000 x7497.
You have the option to allow the biobank to transfer potentially identifiable personal health information collected about you to federal or provincial databases (such as Population Data BC) so that the data collected about you by the biobank (described in this form) can be linked with their administrative databases. Their databases include information such as hospital visits, physician services, home care services and medications you received. Your personal health information from this study may also be linked with data about social services that you receive, immigration status, and interactions with the justice system.
Linkage of your data will allow researchers to explore a range of studies that are not known at this time. The linked data will be stored by approved databases and only accessed according to their strict security and privacy standards and as approved by a Research Ethics Board.
Linking of data will be done in a way that your identity is protected and is unlikely to be known by anyone other than those directly part of the approved databases. The appropriate data sharing agreements will be in place to ensure that your data privacy is protected and reduce the chance that anyone other than those working directly with the data could identify you.
Please contact the BioBank if you want to withdraw from this data linking activity or think your personal information contains an error, an omission or needs to be corrected.
Stating yes means you authorize the linking activities described in this consent form.
* must provide value
Yes I consent to my personal health information, including my personal health number and date of birth being released to federal or provincial databases so they can locate information about me for future unspecified use for qualified researchers.
No
Yes I consent to my personal health information, including my personal health number and date of birth being released to federal or provincial databases so they can locate information about me for future unspecified use for qualified researchers.
No
My signature on this consent form means I would like to donate my samples and health information to the BC Children’s Hospital BioBank.
Digital Signature
* must provide value
First name Last name
First Name
* must provide value
Last Name
* must provide value
Today D-M-Y
10 digits
Date of Consent
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Today D-M-Y Today's Date
Email address
* must provide value
Participant's Ethnicity
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Black (e.g. African, African Canadian descent)
East Asian (e.g. Chinese, Korean, Japanese descent)
Indigenous (e.g. First Nations, Inuk/Inuit, Metis descent)
Latinx (e.g. Latin American or Hispanic descent)
Middle Eastern (e.g. Afghan, Arab, Persian, Turkish descent)
South Asian (e.g. Indian, Sri Lankan, Pakistani descent)
Southeast Asian (e.g. Filipino, Thai, Vietnamese descent)
White (e.g. European descent)
Do not know
Prefer not to answer
Other (please specify)
Black (e.g. African, African Canadian descent)
East Asian (e.g. Chinese, Korean, Japanese descent)
Indigenous (e.g. First Nations, Inuk/Inuit, Metis descent)
Latinx (e.g. Latin American or Hispanic descent)
Middle Eastern (e.g. Afghan, Arab, Persian, Turkish descent)
South Asian (e.g. Indian, Sri Lankan, Pakistani descent)
Southeast Asian (e.g. Filipino, Thai, Vietnamese descent)
White (e.g. European descent)
Do not know
Prefer not to answer
Other (please specify)
If applicable
Translator & Relation to Participant
If applicable
If applicable, if the participant cannot read or sign the consent form
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