GINA is a federal law that prohibits discrimination in health coverage and employment based on genetic information. GINA defines genetic information as information about:
Genetic information does not include information about the sex or age of any individual.
GINA defines a genetic test as an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes. Under GINA, genetic tests do not include analyses of proteins or metabolites that are directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.
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 any statements describing the extent to which confidentiality of records identifying the subject will be maintained do not overstate the protections provided by GINA (45 CFR 46.116(a)).
The GINA language that should be included as applicable can be found in the Sample Consent Form found on the Forms page of the UAB IRB website.