The Veterans Affairs Central
Biorepository and MVP Highlights
Mary T. Brophy, MD, MPH
3rd Annual BVARI Business Meeting
August 12, 2011
Personalized Medicine
Emerging genomic technologies are critically
dependent upon:
well validated clinical data
linked to
high quality biospecimens
“Health-care systems spend billions of dollars annually on
biomarker research for personalized medicine. Success
hinges on the quality of the biobank specimens and the data
used to derive them, but a lack of quality control is
polluting the scientific literature with flawed information
that will take a long time to sort out.”
“Leading journals are trend setter when it comes to defining
publication criteria ……To uphold standards, all journals
should insist on full details of biobanked specimens ”
Simeon-Dubach, Perren A. Nature 457:454-455, July 2011
Rationale for VA Central Biorepository
• Program wide effort to standardize the
methods for research using biospecimens in
VA studies
• Goals
– To ensure the highest level of human protection
– Maximize the scientific value of the bank
VA Central Biorepository
• Located at the Boston VA
• Serves as a central biobank for VA studies
• De-identified samples stored in a state of the art
biorepository
– ISBER and NCI guidelines for biorepositories
• Assurance of the quality of the specimen and longevity
of bank beyond the study
VA Central Biorepository
Operations
• Developed standard operating procedures
for biosample collection, processing and
storage that could be used across studies
• Meeting the study specific needs
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Types of biospecimens
Specialized collection techniques
Local or central processing
Storage and analytic needs
Million Veteran Program (MVP):
A Partnership with Veterans
Million Veteran Program:
A Partnership With Veterans
Million Veteran Program
• MVP is a major research initiative that will
create a longitudinal cohort of one million
users of the VA Healthcare System to study
genes and health
• Designed to provide a better understanding
of how genes affect health and illness
• Goal of improving health care for Veterans
and the nation
MVP Background
• 2006 – Genomic Medicine Program (GMP)
• Genomic Medicine Advisory Panel comprised of
private and public health, scientific, legal experts in
field of genetics was established by the Secretary
• 2007 to 2008 – Consultation project to assess veterans’
knowledge and attitudes about genomic medicine
• Kathy Hudson, Genetics in Medicine; May 2008
• Study 931 participants
• 83% said program should be developed;
• 71% said they would participate
Genomic Medicine Protocol
• 2009 – Protocol planning and development
– Consent allows for open-ended access to medical
records, VA and non-VA databases
– HIPPA authorization for use of personal health
information
– Biospecimens (blood, tissues, salvia) stored for use in
future studies any disease
– Samples and information may be made available to VA
and other researcher
• Approved by VA oversight committees
– Participants may be re-contacted in the future
• Participation in new research studies
MVP Protocol
• 2010 –Protocol approved by VA Central
IRB
– Enroll one million veterans over 5 to 7 years
– Centralized recruitment
– Study visits at VA Medical Centers
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In person informed consent and HIPPA authorization
Baseline questionnaire
Blood sample -10ml ETDA tube
Optional lifestyle questionnaire
– Information Security
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Unique codes to identify data and specimen
• GenISIS computing environment
Sample Processing
Automated Blood Fractionation
Automated DNA Extraction
• High-throughput DNA Extraction
Freezer Space
Current freezer storage
Additional Freezer Space
Future freezer storage
MVP Governance and Oversight
• Genomic Medicine Advisory Panel
• VA Central IRB
• Genomic Cooperative Studies Scientific
Evaluation Committee
• VA Genomic Medicine Program
• MVP Executive Committee
Summary
• The Million Veteran Program is a major, new research
initiative to create one of the largest databases of
genomic, military exposure, lifestyle and health
information
• Collaborative effort of the VA research and clinical
infrastructure
• Iterative process to assure participation nationally,
optimize processes for recruitment, data/specimen
collection storage access and analysis
• Ultimate goal of integration of the emerging genomic
technologies in to the clinical healthcare system