FAQs for Veterans
What is a biospecimen bank (biobank) and data repository (biorepository)?
A biobank is a repository that collects, stores, manages, and distributes biological specimens, or biospecimens, for use in research. A data repository is a library or archive that stores and manages data for use by researchers to analyze.
How long has the biorepository, VA SHIELD, been in operation?
VA SHIELD was established in fall 2020 to provide the Veterans Health Administration with a comprehensive repository related to COVID-19. While COVID-19 inspired the creation of a VA-wide biorepository, VA SHIELD is designed to collect other specimens and associated data related to other emerging diseases. In all cases, the goal is to advance scientific understanding in support of strategies for immediate deployment in clinical environments to improve Veterans’ health.
What is the purpose of VA SHIELD biorepository?
VA SHIELD is the VA’s Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases. The purpose of this biorepository is to provide a comprehensive repository of specimens and associated data of emerging diseases for research studies to advance scientific understanding of infectious and other diseases.
What health data is being collected by VA SHIELD?
VA SHIELD may collect the following types of health data with specimens: a unique identifier, study ID, patent code, first name, last name, date of birth, gender, last four SSN, diagnosis/test code and COVID-19 test status. Upon collection, specimens will be de-identified, given a unique identifier and will be recorded with data into the VA SHIELD LIMS.
Confidentiality, Privacy, and Security
How will health information be protected?
The VA Central IRB approved protocols and standard operating procedures that define the processes to protect PHI and PII. VA SHIELD Executive Steering Committee and Honest Broker oversee the activities of the VA SHIELD Director and VA SHIELD Programmatic and Scientific Review Board. Research Centers and Investigators are trained on VA SHIELD protocols and SOPs. Additionally, they must maintain current training to participate in the program, including HIPAA and professional ethics training.
What role does the “honest broker “play?
The “honest broker” mechanism is the process used to de-identify requested data and/or relink specimens with Private Health Information (PHI) and/or Private Identifying Information (PII). The honest broker is an independent entity that has no vested interest in any studies being performed under the VA SHIELD program.
How will the biorepository protect personal information associated with a specimen?
VA sensitive data will be stored behind a secure VA firewall on encrypted VA servers. Specimens and health data are saved using a code - that means any information, which can identify an individual, such as name, address, SSN or date of birth, is taken off the data and specimens and stored separately. It is necessary to keep the key to the code to connect information and specimens to track health records.
Researchers using specimens collected under this protocol will be provided the minimum requested Personally Identifiable Information (PII) or Personal Health Information (PHI) needed to accomplish their research aims through a central ORD-managed honest broker system. The honest broker independently holds the key to specimen linkage and is not part of the research or clinical team. Relinkage is done when characterization of the donor/participant is necessary for research aims or project outcomes.
What happens if there is an information breach?
Any data breach, breach in confidentiality or privacy, or improper use of the data will be reported according to applicable federal, state, and local requirements. For example, reporting may occur as required by the VA Central IRB or local SRSS and in accordance with VHA Directives/Handbook 1200.05, 1200.08, and 1058.01.