VA Launches Genomic ResearchSecurity Provisions for Project Spelled Out
Launched in January at one VA medical center, the VA hopes to recruit 1 million participants nationally within five to seven years. The VA is now enrolling veterans in nine cities and will invite veterans elsewhere to participate over the course of the coming year.
The program will use genetic, military exposure, health and lifestyle information. Researchers within the VA, other federal health agencies, and U.S. academic institutions will use the information to conduct health and wellness studies to determine which genetic variations are associated with particular health issues, according to the VA. "By identifying gene-health connections, the program could consequentially advance disease screening, diagnosis and prognosis and point the way toward more effective, personalized therapies," a VA release states.
"We have a research establishment that is embedded in an integrated healthcare system with a state-of-the-art electronic health record, fully equipped genomic laboratories with the latest in technology, and top-caliber investigators, most of whom also provide direct patient care," says Joel Kupersmith, M.D., the VA's chief research and development officer.
A number of other smaller-scale personalized medicine research projects are already under way, including one led by the Coriell Institute for Medical Research (see: Personalized Medicine and Privacy).
Security MeasuresAmong the security measures listed on a website for the Million Veteran Program are:
- Blood samples and records will be labeled with a bar code, and only a few authorized VA staff will have access to the key for the barcodes that enables identifying the veteran. Researchers accessing the samples, as well medical data in the research database, will not receive the name, address, Social Security number or date of birth of participating veterans.
- Researchers must access the data within the VA's secure GenISIS (Genomic Informatics System for Integrated Science) computing environment.
- MVP has applied for a Certificate of Confidentiality from the National Institutes of Health. With this certificate, MVP researchers would be able to avoid being forced, even by a court subpoena, to disclose information that may identify the participants.
- Researchers must have their projects approved by a VA oversight committee. They can use the information in the database only for studies of the causes and treatments of disease that meet all ethical, scientific and regulatory criteria established by the VA and other agencies.