Protection of OneDukeGen Data
Your information is put in a database which is stored and protected by Duke. Access is controlled by Duke and its Affiliates and is not openly available. This identifiable information, as well as the genetic data from your blood or saliva sample, will be protected with the same level of security as your regular health information. Your name, address, or any other information that could directly identify you will be removed before your samples or health information are made available for access by researchers outside of Duke.
Some information like dates are considered to be indirect identifiers and will be coded to protect your identity. We do this as part of the process known as de-identification. Your de-identified samples, DNA information, and health information may be accessed by researchers from other universities and institutions, the government, and drug- or health-related companies.
We also hold a Certificate of Confidentiality. This certificate is issued by the US government and adds additional levels of protection to your data. With it, we are not allowed to give research information that may identify you to a federal, state, or local government, unless you have given your permission. The only exceptions are for:
- Reporting child abuse, communicable diseases, or other information that is required by law.
- When you have given your consent for your information to be released.
- The research information is used for other research, as allowed by federal regulations protecting research subjects.
The Certificate of Confidentiality also means that we cannot share your genetic data or samples with law enforcement.
Understanding Legal Protections for Genetic Information
It is important to understand how receiving genetic results could affect your life in ways other than providing information about your health. In the United States, the Genetic Information Nondiscrimination ACT (GINA) makes certain types of genetic discrimination illegal.
🛡️ What GINA Protects
Health insurance companies cannot deny coverage or raise rates based on your genetic
information. Also, employers cannot use your genetic information for hiring, firing, or other employment decisions IF the employer has 15 or more employees.
⚠️ What GINA Does Not Cover (Limitations)
It does not protect you when obtaining life, disability, or long-term care insurance coverage. While not all of these companies will consider your genetic information, those that do could potentially use your genetic result to deny or increase premiums for you or your relatives.
Importantly, the OneDukeGen research team provides results to you directly. We will not put your results into your medical record without your permission and we cannot provide these results to these companies without your written permission.
Important note for veterans using VA healthcare (Title 38 USC). Genetic information alone cannot be used to disqualify you from service-connected health or disability benefits (VA M21-1 adjudication procedures manual V.ii.2.E.1.c).
An important exception to GINA involves active-duty military, as well as the activated guard and activated reserve (Title 10 USC).
- The military can use genetic information to make enlistment decisions.
- Access to TRICARE insurance is only given to those enlisted in the military. To enlist or maintain your status as enlisted in the military, genetic test results can be looked at, and if certain results are not compatible with service, you could be discharged, and subsequently lose TRICARE insurance.
GINA protects any research genetic results you receive from the study team. The rest of your research genetic information is protected by our data security, HIPAA, and Certificate of Confidentiality as described above and in our consent form.
Learn More Before You Decide
We encourage you to explore all aspects of receiving your genetic results. Our team is here to help you make an informed choice. For more information, email us at OneDukeGen@duke.edu.
Resources
You can learn more about these policies through the National Human Genome Research Institute (NHGRI) and at the US Department of Labor.
More information regarding GINA Title I (health care) and how it is administered and enforced is available through the US Health and Human Services agency. This includes information on the extension of privacy protections to include additional entities and health plans not originally covered by GINA Title I (VI. Modifications to the HIPAA Privacy Rule Under GINA).
More information regarding GINA Title II (employment) and how it is administered and enforced is available through the Equal Employment Opportunity Commission (EEOC).