Privacy and Your Information

• We use security tools like secure networks, encryption, password management policies, and multi-factor authentication.
• Personal information (like your name, address, and birthdate) is stored in a separate area on a secure and private network. This area is held to an even higher security standard known as the Federal Information Processing Standard (FIPS).

• Early Check also has Certificates of Confidentiality, which means researchers cannot be forced to disclose information that may identify you, even by a court subpoena, unless you provide written consent.
• Researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
• A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research.
• If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

There are a few exceptions:

• If child abuse is suspected, researchers may voluntarily, without your consent, share information that would identify you as a participant.
• The certificate cannot be used to resist a demand for information from personnel of the U.S. Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

• Personal information is removed from samples before sending them to partner laboratories for testing. Partner laboratories will not share these samples with anyone else.
• Samples will be destroyed at the end of the study.
• The original newborn dried blood spots (DBS) cards are stored at North Carolina Laboratory of Public Health. Early Check will get the cards and portion of the sample. Early Check will send the sample to the partner laboratory who will process the sample and perform the DNA sequencing. It is expected that the sample will be used up. Any leftover sample will be destroyed at or before the end of the study.

• Parents’ and babies’ names and contact information are never sold to anyone. They are never given to anyone outside of the Early Check team unless you provide your permission to do so.
• Early Check may share information from the study with other researchers and partnering companies, but it will not include any personal information. This means it cannot be traced back to you or your baby. Sharing this information may include presentations at conferences and publications in scientific journals and allows Early Check to help research all over the country.