Data Governance
What will happen to my data?
Genomic sequencing allows us to test a person’s DNA and find variations in DNA sequence for thousands of their genes at the same time. Your genomic sequencing data is unique to you and will have important health information about you. Your de-identified genomic sequencing data may be used in future research studies. This includes storage of your de-identified information in future databanks.
Your de-identified DNA samples and genetic sequencing data may be shared with researchers as approved by a local research ethics board (REB). This information may be shared by Controlled-access Database for Coded Genomic and Research Data. Your de-identified genetic and phenotype data may be available to anyone who is approved to access the data bank. Because genetic and phenotype data may contain potentially rare or sensitive information, which when taken together increases the chance of identification, we will review the applicant and put signed contracts in place.
Using a Data Governance Framework established by Genome Canada, all applications for access to data will be reviewed to verify that the proposed project has received ethics approval from the relevant committee (when required) and that the study fits within the objectives of the REB approved international database. During the sharing of de-identified genetic data, your de-identified genetic and phenotype data will only be shared with researchers approved to access the data bank using the Data Governance Framework mentioned above. Applicants may include researchers at universities, hospitals, government agencies and some for-profit companies around the world who may be conducting research projects not only related to the selected disorders mentions above, but also on other medical conditions. The data in the controlled-access database meets international security and safety standards and may be stored in different countries.
An industry partner/for-profit company is an organization that may be a pharmaceutical company that wants to make a new drug or test a currently approved drug for another disease or population. It may also be a biotechnology company that develops new ways to treat or diagnose disease. If you consent to participate in this project, your research information collected in this study may be used for research purposes with industry partners such as device manufacturers and pharmaceutical companies.
Genomic sequencing data
Genomic sequencing data is the detailed information gathered when scientists read your DNA. It shows the unique order of your genetic code and helps identify differences in your genes that may affect your health. This data is personal to you.
Phenotype data
Phenotype data is information about you that you can see and measure. This includes information like height, weight, and blood pressure.
De-identified data
De-identified data is information that has had all personal details like your name, address, or health card number removed to protect your privacy.
Research ethics boards
A research ethics board is a group of people who review research projects to ensure they are safe, fair, and respectful to all participants.
What if the researchers discover something about me?
The overall results of the project will be shared through this project website, scientific publication, conferences, and specially targeted community-focused information-sharing strategies. Individual findings will be shared as outlined here:
Primary Findings
We will tell you if the genetic analysis identifies a genetic variant believed to be a cause of medical conditions that you might have. The project team will then refer you to a separate practice to discuss these findings. These findings will have to be verified in a clinical lab before the information is used for your healthcare and other important decisions.
Secondary Findings
In genetic research, the researchers may learn something about you that they didn’t expect. This is called a secondary finding and these findings can be either medically actionable or medically non-actionable.
Medically Actionable
Medically actionable secondary findings mean there is a high chance of a health problem for which treatment or screening is available. We will only talk to you about medically actionable findings that we think are likely to have a major effect on health.
Medically Non-actionable
Medically non-actionable findings may indicate there is a high chance of a disease, but there is currently no treatment and or screening available. We will not return these findings to you nor place this information into your medical records.
Tertiary Findings
An unexpected genetic result, unrelated to the study’s aims and not actively sought, which may or may not have health, personal, or reproductive relevance.
Carrier Status
Some people are “carriers” of a genetic disorder. This means they have the gene that causes a disorder, but they are not affected by the disorder. Children of carriers may be at an increased risk to have that specific genetic disorder. Since knowledge of carrier status can be important for future family planning, if we discover your carrier status of a serious disorder, we can talk with you about that finding, with your permission.
Can participants choose to leave the study?
You can choose to end your participation in this project at any time, without giving a reason. If you choose to withdraw from the study, you are encouraged to contact the project staff. You may also withdraw your permission to use information that was collected about you for this project at any time by letting the project staff know. However, this would also mean you withdraw from the project.