659result in large databases of genomic information. The magnitude of the genomic
scans, implications of the inclusion of genetic information about relatives, security
of storage and ease of dissemination of data present greater challenges to privacy
compared to traditional, self-limited and often transient medical information.
Genetic Information Nondiscrimination Act in the US
In 2008, the US Congress passed the legislation, known as the Genetic Information
Nondiscrimination Act (GINA), which prohibits the following (Hudson et al. 2008 ):
(1) group and individual health insurers from using a person’s genetic information
in determining eligibility or premiums; (2) an insurer from requesting or requiring
that a person undergo a genetic test; and (3) employers from using a person’s genetic
information in making employment decisions such as hiring, fi ring, job assign-
ments, or any other terms of employment. GINA does not prevent health care pro-
viders from recommending genetic tests to their patients or mandate coverage for
any particular test or treatment.
As a result of GINA, more people are expected to take advantage of genetic test-
ing and to participate in genetic research. However, the health insurance measure
would not go into effect until a year after, and the employment measure would take
effect only after 18 months. Even then, there may be reason to be cautious. The bill
may be hard to enforce and it does not address discrimination by long-term care
insurers or life insurers. The use of genetic information that the bill is likely to
encourage may raise still more questions about how it should be used. These protec-
tions offered by GINA do not, however, extend to the disease manifestations of
genetic risks. Although genomic information showing a predisposition to cancer
would be protected under GINA, other clinical signs or symptoms indicative of
cancer are not protected. Provisions of the Affordable Care Act set to go into effect
in 2014 go a step further and will preclude consideration of all preexisting condi-
tions, whether genomic or not, in establishing insurance premiums. Current federal
laws, however, do not restrict the use of genomic information in life insurance,
long-term care insurance, or disability insurance.
Genotype-Specifi c Clinical Trials
Genotype-specifi c clinical trials would likely include subjects likely to respond to a
drug. The inclusion of subjects known to be unlikely to respond would pose ethical
problems:
- Genetic variations of pharmacological signifi cance among ethnic groups might
be a barrier to participation in clinical trials for fear of stigmatization - Genetic testing of populations as a part of development of personalized medicine
raises ethical issues
Ethical Aspects of Genetic Information