With a target of one million recruitments, the United States Million Veteran Program (MVP) is already gathering an impressive data collection.1 Since the program started in 2011, numbers recruited in August 2015 stood at 397,014 veterans recruited from over 3 million invited. With two ongoing studies and four more in the approval stages, this observational cohort study and mega biobank project run by the Department of Veteran’s Affairs (VA) is set to make an impact on the world of precision medicine.
The mission of the MVP biobank is to examine how genetics, behavior and environmental impacts affect health, with a view to translating these findings into clinical practice. In addition to health care data, donors also complete lifestyle questionnaires and provide biosamples suitable for genetic analysis.
Gaziano et al. (2015) note that the VA initiated planning for the MVP biobank in 2009, granting approval the following year. Looking to existing biobanking initiatives developed within larger health care delivery systems, such as the UK Biobank, which functions within the National Health Service, and the Kaiser Permanente scheme, which draws from among its own patients, the MVP study recruits veterans actively using its health services and capable of giving informed consent to enrollment. The authors note that advantages gained from setting up biobanking infrastructure within an existing health care delivery system include ease of recruitment, follow-up and retention, in addition to facilitating sample collection and access to health care records.
At the time of writing the paper, Gaziano et al. report that the MVP runs 50 recruiting sites across the United States and has enrolled almost 400,000 participants. Of these, 92% are male and 55% in the 50- to 69-year age bracket. According to self-identification, 77.2% are white and 13.5% African-American. In terms of service, 43.8% come from the Army, 19.6% from the Navy, 15.5% from the Air Force, 11.3% are Marines, and the remainder are either dual service or unidentified. The response rate so far has been good, with managers finding that the VA community is supportive and altruistic in its participation in the biobank.
The recruitment process comprised individual invitations and follow-up to veterans actively using the VA health services in addition to posters and advertising. When accepted, potential donors received lifestyle questionnaires and other forms requesting information either in person or online. Appointments for biosample donation generally took place alongside existing health care visits at the 50 VA health care sites with standardized procedures and collection kits supplied to these centers. MVP biosample collection thus runs according to standard operating procedures (SOPs), including transport to the centralized biobanking facility, to ensure consistency and onward validity in results obtained.
Once collected, these biosamples are available to registered and approved researchers for studies that have passed ethics committee oversight. Genomic testing comprises sequencing using a custom chip array that identifies a specific set of biomarkers of health, aging, disease and mental status indicators chosen as representative for the project. The MVP biobank holds anonymized data with the GenISIS informatics infrastructure, which allows extraction with health care data while maintaining donor privacy and confidentiality. Once gathered, the individual health records are not annotated with genomic results and neither can these findings be subpoenaed by the courts.
Gaziano et al. expect that the combination of health care records, lifestyle information and genomics results will form an extremely valuable dataset, allowing researchers to draw associations between inheritance, environment and disease causation for the veterans and also the wider population. Clinicians and research expect that the MVP biobank data will contribute valuable information to precision medicine in the future.
1. Gaziano, J.M., et al. (2015) “Million Veteran Program (MVP): A mega-biobank to study genetic influences on health and disease,” Journal of Clinical Epidemiology, doi: 10.1016/j.jclinepi.2015.09.016.