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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 in their studies.
What is the purpose of the 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.
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 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 central Laboratory Information Management System (LIMS).
Why should this research be conducted at the VA?
The VA Office of Research and Development has over 90 years of research experience and has helped advance knowledge and treatment of conditions commonly seen in the Veteran population. The VA healthcare system is ready and able to put VA SHIELD’s collections and healthcare research findings into practice.
How is the health information protected?
The VA Central IRB approved protocols and standard operating procedures that define the processes to protect Private Health Information (PHI) and Private Identifying Information (PII). VA SHIELD Executive Steering Committee and Honest Broker oversee the activities of VA SHIELD. Research Centers and Investigators are trained on VA SHIELD protocols and standard operating procedures. Additionally, they must maintain current training to participate in the program, including HIPAA and professional ethics training.
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 VA-managed honest broker system.
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.
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, a 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.
Who and how can get access to VA SHIELD specimens and health data?
At this time, only study team members at VA sites have access to specimens and associated health data. For general information on how to get access to the specimen database, specimens, and associated data please contact VA SHIELD via e-mail: [email protected].
What is the name of the protocol under which specimens and health data will be collected?
The name of the protocol is: Establishment of the VHA Biorepository, VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD), with One Time Sweep of Existing Remainder Clinical Specimens and Data to Develop Assays, Laboratory Tests and Conduct Future Research on COVID-19. This protocol is a VA Central Institutional Review Board (VA CIRB)-approved mechanism to obtain, store, and distribute human biological specimens and data.
From where are the specimens and data collected?
VA SHIELD houses “remainder specimens” (specimens such as blood or tissue left over from a medical appointment) and health data collected for the biorepository. 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.
In the future, specimens from patients and research subjects will also be obtained through an informed consent process and will be added to VA SHIELD.
What specimens is VA SHIELD collecting?
VA SHIELD populates the biorepository with a “Sweep,” or collection, of blood, body fluids, and/or tissues for which remainders exist in VHA clinical or research laboratories. In the future, specimens obtained through an informed consent process will be added to VA SHIELD.
Study team members at VA sites can get access to the VA SHIELD database of the specimens available for research.
How long does VA SHIELD biorepository keep the specimens?
Specimens and health data are stored indefinitely and distributed for use until consumed, or until the specimens are no longer usable or of adequate quality for research purposes.
Who is responsible for oversight of VA SHIELD?
The disposition of biospecimens will be overseen by the Executive Steering Committee (ESC) and the Programmatic Scientific Review Board (PSRB). Each request for specimen use and data access is reviewed by the PSRB. The review process is facilitated by VA SHIELD executives, who conduct the initial request review for completeness, prepare the requests for PSRB review, and prepare a response to the requestor.
The VA Central IRB ensures adherence to all ethical and regulatory standards. VA has implemented the use of the following standards to ensure ethical and regulatory compliance:
Is there an inspector general for VA SHIELD?
VA SHIELD is overseen by the Office of Research Oversight. The VA Inspector General has a purview over VA SHIELD.
What is the VA SHIELD Executive Steering Committee (ESC)?
The Executive Steering Committee (ESC) oversees and sets the strategy for VA SHIELD. Among its roles are to provide oversight of the management, strategic planning, and general guidance of VA SHIELD.
What is the VA SHIELD Programmatic and Scientific Review Board?
The Programmatic and Scientific Review Board (PSRB) reviews proposals and requests for specimen and data access and use.
How is the health information protected?
The VA Central IRB approved protocols and standard operating procedures that define the processes to protect Private Health Information (PHI) and Private Identifying Information (PII). VA SHIELD Executive Steering Committee and Honest Broker oversee the activities of VA SHIELD. Research Centers and Investigators are trained on VA SHIELD protocols and standard operating procedures. Additionally, they must maintain current training to participate in the program, including HIPAA and professional ethics training.
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 VA-managed honest broker system.
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.
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 and the relinkage is approved by PSRB in accordance with the applicable regulations.
What is the VA SHIELD Biobank and Data Repository?
VA’s Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD) was established to provide the Veterans Health Administration (VHA) with a comprehensive specimen and data repository related to emerging life-threatening diseases. VA SHIELD is a group of central and local biorepositories managed under the single Laboratory Information Management System (LIMS).
What are the benefits of providing specimens to a biorepository?
Providing specimens to VA SHIELD is a part of building blocks to a large collection of a comprehensive repository that is available to advance scientific understanding and development of diagnostic, therapeutic, and preventative strategies to be readily used in clinical environments that directly impact Veterans’ health.
Donating specimens also help VA SHIELD to support the VA’s fourth mission, “to improve the Nation’s preparedness for national emergencies and to support emergency management, public health, safety, and homeland security efforts.” As the largest integrated health care provider in the country and through its geographic breadth and size, VA is uniquely positioned to play a critical role in accelerating research efforts for future outbreaks.
What is the name of the protocol under which specimens and health data will be collected?
The name of the protocol is: Establishment of the VHA Biorepository, VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD), with One Time Sweep of Existing Remainder Clinical Specimens and Data to Develop Assays, Laboratory Tests and Conduct Future Research on COVID-19.
This protocol is a VA Central Institutional Review Board (VA-CIRB)-approved mechanism establishing the biorepository to obtain, store, and distribute human biological specimens and data.
How can VA pathologists contribute to VA SHIELD specimen collection?
Pathologists leading select VA Pathology laboratories are invited to participate in the approved VA-CIRB protocol to collect – and in conjunction with appointed research staff – send remainder biospecimens and associated health data to VA SHIELD biospecimen bank and data repository.
What activities and specimens are approved for collection under the VA SHIELD protocol?
The protocol proposes to populate VA SHIELD with a ‘Sweep’ of remainder/discard clinical blood, body fluids, and/or tissues in VHA clinical or research laboratories. This consent exempt protocol allows VA SHIELD facilities and personnel to accept specimens and data from Pathology laboratories and others across the VA healthcare system.
More urgently, VA SHIELD is responding to the COVID-19 pandemic by assembling blood serum specimens for assessment of immunological and other chemical assays necessary for confirming recovery from COVID-19 illness or response to treatment and primary nasopharyngeal or bronchial washing specimens for initial diagnostic assessment.
Plans are being implemented to amend the protocol to allow the prospective collection of specimens of interest, such as for COVID-19 or other emerging diseases, under informed consent. In the meantime, VA SHIELD activities are limited to the collection of remainder specimens and accompanying data under the currently approved protocol.
What is the role of Pathology labs in supporting VA SHIELD?
Relevant specimens will generally be processed under the authority of local VA Pathologists. Most immediately, VA SHIELD requests the assistance of Pathologists to help preserve remainder clinical specimens from SARS-CoV-2 infected and COVID-19 convalescent patients; prepare and deliver these specimens to the VA SHIELD central biorepository locations in Tucson or Palo Alto. Preparation and delivery of specimens will be primarily performed by appointed research staff.
How should VA SHIELD specimens be labeled and stored?
As part of the effort to collect remainder specimens from participating VA sites of care, VA SHIELD has established a set of standard operating procedures (SOPs) that provide guidance for how specimens should be labeled and prepared for VA SHIELD use. Additionally, VA SHIELD requests that any clinical remainders identified for VA SHIELD inclusion be kept separate from other specimens for security reasons.
Specimens and data will also be managed under a LIMS designed specifically to support VA SHIELD needs regarding data management and protection. Specimens will be accessioned at the central biorepository locations in Tucson and Palo Alto.
What kind of support will VA provide to Pathologists to adequately support the biorepository?
Personnel resources will be available to assist Pathologists with collecting and shipping human biological specimens and data.
VA SHIELD personnel will share developed SOPs and other protocol documents with Pathologists to support the shipment of specimens and accompanying data.
Other site needs will be identified, and support will be provided as needed. Please contact [email protected] and visit the VA SHIELD webpage for additional information: https://www.research.va.gov/programs/shield/default.cfm.
How will VA SHIELD determine which VA sites of care can participate in VA SHIELD?
Pathologists with relevant specimens under their authority or who are willing to be poised to participate in VA SHIELD are strongly encouraged to contact the national office at [email protected] to initiate training and assess readiness.
VA SHIELD personnel are working closely with leadership at specific initially identified VA sites, first, to implement VA SHIELD in a series of pilot projects and, second, to apply the criteria to assess the readiness of additional sites for specimen and data collection.
Site readiness criteria include support from site local research and development committees, support from site leadership and personnel, local site budgeting, equipment, and consumable needs, and capacity to support information management systems.
Upon site approval, who will be responsible for sending the remainding specimens to the central biorepositories?
VA SHIELD work with site Pathology leadership to identify existing personnel capacity to be able to prepare and ship specimens to the central biorepository locations at Tucson, AZ and Palo Alto, CA. VA SHIELD will also work with Pathology leadership to determine budgeting needs, budget approvals, and disperse funding as identified.
What next steps can responsive and participating VA Pathology labs expect?
Once the local VA site expresses interest in participating in the VA SHIELD program, VA SHIELD personnel will reach out to selected VA sites to determine site willingness, support needs, and capacity to participate in the protocol. From there, VA SHIELD and site personnel will collaborate to determine the next steps including local research and development approval, personnel, and monetary needs.
Please contact [email protected] with questions related to supporting this effort and please visit the VA SHIELD webpage for general VA SHIELD information:
https://www.research.va.gov/program/shield/default.cfm
We thank the VA Pathologists for all you do to help keep us all safe.
If you have additional questions related to data access, please contact [email protected].