A genetic test is defined in the NYS Civil Rights Law as "any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or individual's offspring; such term shall also include DNA profile analysis."
This law has been interpreted to include research that seeks to develop or identify a genetic test. The nature of genetics research, its methods, purposes, risks and benefits, and population studied determines the extent to which regulatory and consent requirements are applied.
We require that information about genetic testing be included in the protocol summary form (PSF) and consent form (CF) of all studies in which DNA is to be collected. We require the same information regardless of whether the DNA study is the main study, a sub-study, or an add-on study
In addition to the confidentiality protections described in this consent form, 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 or by adoption agencies. GINA also does not protect you against discrimination based on an already diagnosed genetic condition or disease. If you would like to know more about it you can discuss this with the principal investigator of this study or you can go to the following website www.genome.gov/10002328