Traditionally, genetic tests have been available only through healthcare providers, such as physicians, nurse practitioners, and genetic counselors. Healthcare providers ordered the appropriate tests from a laboratory, collected and sent the samples, and interpreted the test results, so that patients would receive the support they needed when their results were disclosed.

Because there is little regulation of these commercialized tests, there is the risk of obtaining inaccurate results and unsupported clinical interpretation, since physicians do not yet know how to assess results from home tests. Furthermore, the clinical utility of these results remains undetermined (Khoury, et al., 2008).

If left unaddressed, the use of direct-to-consumer genetic testing may become increasingly problematic. The general public and health professionals at all levels need further understanding of genetics overall, as well as genetic testing and its implications, to adequately prepare our society for personalized medicine (Ojiha & Thertulien, 2005).

Biobanks are used to process and store collections of human biological tissue specimens and related health data. These biospecimens are important in increasing the understanding of the many aspects of disease, including disease risk prediction, prevention, identification, diagnosis, and treatment. As noted previously, there are numerous ethical, social, and legal considerations that must be taken into account concerning biobanks including, but not limited to, informed consent, confidentiality, secondary use of sample data over time, return of results, and data sharing (Hawkins, 2010).

Although there is strong societal support for innovative medicine like genomics and pharmacogenomics, they cause major concern around potential loss of privacy and social discrimination (Hawkins, 2010). Additional considerations surround the collection, use, and storage of biospecimens.

For example:

• How will donors be protected if there is accidental release of information?
• Once a sample is donated, who has the right to ownership?
• What occurs if a biobank closes or is bought out by another company?

Though these important questions remain unanswered, technological advances in personalized medicine will continue to increase the need for biospecimens.