Are there any risks to privacy or confidentiality?
Because your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small but may grow in the future as technology advances. Researchers will always have a duty to protect your privacy and to keep your information confidential.
A federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination based on an already-diagnosed genetic condition or disease.
Genetic Testing
Your blood and tissue samples contain genes that are made of DNA unique to you. Early Check tests your baby’s DNA for serious health conditions. Only the screening tests described here will be done on your baby’s sample. No other tests will be done on your baby’s DNA unless your doctor requests it.
Your doctor may request further DNA testing based on a change in your child’s health status. The Early Check research team will consider this request and will only test further if we agree with your doctor’s request.
Sharing and Storing Genetic Information
If you agree to take part in this study, Early Check may share de-identified genetic information with other researchers and partnering companies. De-identified means that the information cannot be traced back to you or your baby. This allows Early Check and our partnering companies to help research and provide better sequencing for people all over the country. We will not share anything that can connect de-identified information to you or your baby.
Baby's data (individual data) will be stored for at least 5 years and no more than 10 years.
The Early Check lab partner, will store and backup genomic data (cram and vcf) on a HIPAA-compliant cloud-based platform.
The blood sample will be processed and stored in a certified clinical laboratory according to the Clinical Laboratory Improvement Amendments (CLIA) regulatory guidelines. Leftover samples may be used for quality control and to try to improve future lab tests. It is possible that these uses could indirectly lead to commercial profit which participants would not share.
Early Check Lab Partner
Revvity Omics, Inc (Revvity): Revvity is a genetic testing company and a leader in delivering improved health outcomes through genetic testing. In partnership with Early Check, Revvity will provide DNA sequencing, analysis, and interpretation of the results. Revvity does not provide the risk calculation for type 1 diabetes; this is calculated by Early Check.
Scientific Databases
To do more powerful research, it is helpful for researchers to share information they get from studying human samples. They do this by putting it into one or more scientific databases, where it is stored along with information from other studies. Researchers can then study the combined information to learn even more about health and disease.
Researchers who have access to a scientific database may be able to see and use your de-identified information, along with information from many other people. Your name and other information that could directly identify you, like address or social security number, will never be placed into a scientific database.
There are many types of scientific databases. Some are maintained by this institution. Some are maintained by the federal government or private companies.
For example, the National Institutes of Health (NIH, an agency of the federal government) maintains a database called “dbGaP.” A researcher who wants to study information in dbGaP must apply to the database. Different databases have different ways of reviewing such requests. Another database is called ClinVar. ClinVar is a freely accessible, public archive of reports of the relationships among human variation and phenotype evidence.
