Overview
The Genetic Information Nondiscrimination Act of 2008 (GINA) is a Federal law that aims to prohibit discrimination in health coverage and employment based upon genetic information. This guidance is specific to research involving genetic testing. It will describe GINA and provide consent form content related to GINA.
Definitions
Genetic test is defined as an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes.
A manifest disease or disorder refers to an ailment that is apparent through the appearance of symptoms that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine.
Genetic information is defined as information about:
- An individual's genetic tests (including genetic tests done as part of a research study);
- Genetic tests of an individual's family members (defined as dependents and up to and including 4th degree relatives);
- Genetic tests of any fetus of an individual or family member who is a pregnant woman, and genetic tests of any embryo legally held by an individual or family member utilizing assisted reproductive technology;
- The manifestation of a disease or disorder in an individual's family members (family history); or
- Any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or an individual's family members.
*Genetic information does not include information about the sex or age of any individual. The results of routine tests that do not measure DNA, RNA, or chromosomal changes, such as complete blood counts, cholesterol tests, and liver-function tests, are also not protected under GINA.
Genetic Information Nondiscrimination Act (GINA)
Genetic Information Nondiscrimination Act of 2008 (GINA) is an Act of Congress in the United States designed to prohibit some types of genetic discrimination. The act restricts the use of genetic information in health insurance and employment: 1) it prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future, and 2) it bars employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions.
*GINA does not cover genetic testing for already manifest diseases and disorders or pathological conditions that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine. GINA only covers genetic testing of diseases and disorders that have not yet manifest.
Informed Consent
When investigators develop consent processes and documents for genetic research, they should consider whether and how the protections provided by GINA should be reflected in the consent document's description of risks and provisions for assuring the confidentiality of the data.
Investigators must ensure that descriptions of the reasonably foreseeable risks of genetic research and measures to protect confidentiality of records identifying the subject do not overstate the protections provided by GINA.
Note: When developing a consent form that addresses possible future genetic research or sharing with other researchers, GINA language should be included if research could be done on conditions that have not yet manifest even if the current research is only on conditions that have already manifest.
Below is suggested sample language investigators should consider including in their consent document, if appropriate:
A federal law, called the Genetic Information Nondiscrimination Act (GINA), helps to reduce the risk of discrimination by health insurers and most employers based on your genetic information. This law will protect you in the following ways:
- Health insurance companies and group health plans may not request your genetic information that we get from this research.
- Health insurance companies and group health plans may not use your genetic information that we get from this research when making decisions regarding your eligibility or premiums.
- Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it protect you against genetic discrimination by all employers. GINA also does not protect you against discrimination based on an already-diagnosed genetic condition or disease.
Additional Resources
NIH National Human Genome Research Institute GINA descrption
OHRP Guidance on GINA: Implications for Investigators and Institutional Review Boards
v. 3/29/2021