Databases & Tissue Banks
Advances in bioinformatics and genetics have made collections of biologic specimens and medical information valuable for many efforts in biomedical research. As a result, many large-scale data and biological materials banks for genomics have emerged in the United States and abroad.
There are a number of issues to consider as these efforts build: their scientific justification, their practicalities and costs, their openness and accessibility, and the ethical and legal issues associated with privacy, confidentiality, and intellectual property.
In the United States, a patchwork of repositories is building, often redundant and of varying quality. While the federal government supports some of these efforts, there is growing activity in the private sector to collect large amounts of data and materials. In the United States a number of biotechnology companies are amassing samples—millions of them, in some cases—in private tissue banks.
The National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration have been discussing the need for and a scientific approach to a large population-based study that would examine genotype/phenotype correlations across a normal population. Such an evidence base could provide information crucial to translating genomic information into clinical application. It would require the collection of as much as 1 million samples and accompanying medical information from the U.S. population. The Marshfield Clinic (Wisconsin) and others have started discussions about initiating similar studies in U.S. populations, enrolling as many as .5 to 1 million people.
The possibility has been raised of asking the Institute of Medicine (IOM) to conduct an expedited review of such an undertaking to provide scientific and other perspectives, but the results of that analysis could be several years off. The complexity of the design of such a large study, as well as the attendant ethical and legal concerns, deserves careful consideration and this seems to be creating a great deal of hesitancy among U.S. agencies.
Issues that remain unclear are whether a series of databanks and studies would be more desirable than one large effort, whether subpopulations will be identified, and the extent to which associated medical and environmental data would be collected. In addition, such a study would be costly, requiring funding by multiple agencies, even beyond the Department of Health and Human Services, and requiring support from the private sector.
Beyond cost and management, other significant issues facing efforts in the United States are: compliance with the Privacy Act and HIPAA maintenance of resources and commitment level across fluctuations in the fiscal and political environment, and intellectual property issues concerning discoveries that emerge from research using the databanks.
FasterCures wants to ensure that these efforts to create DNA databases and tissue banks facilitate, rather than impede, the mining of genomic data to improve health. FasterCures will contribute to this effort by creating a forum for public-private sector interaction, and possibly acting as a broker, in clarifying and ensuring that requirements for funding, sharing, collaboration, and adherence to standards are met.
