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What are the benefits of providing specimens to a biorepository?
By providing specimens to VA SHIELD, VAMCS will be contributing building blocks to a large collection of a comprehensive repository of COVID-19 and other emerging diseases 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.
You are also helping VA SHIELD 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 to obtain, store, and distribute human biological specimens and data.
From where will specimens and data be collected?
VA SHIELD will house “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 be obtained through an informed consent process and will be added to VA SHIELD.
What specimens is VA SHIELD collecting?
VA SHIELD proposes to initially populate 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.
Who can contribute to the biorepository?
VA medical center (VAMC) clinical personnel and investigators who have unused clinical or research specimens that are no longer needed for research or in the clinic/pathology laboratory can contact VA SHIELD to donate these specimens. For information about how to potentially donate specimens to VA SHIELD, please complete the VAMC Contact Form in the “Contact us” section of the SHIELD webpage.
Who will receive access to specimens and health data?
At this time, only approved study team members at VA SHIELD sites will have access to specimens and associated health data.
How long will VA SHIELD biorepository keep the specimens?
Specimens and health data will be stored indefinitely and distributed for use until consumed, or until the specimens are no longer usable and 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 will be reviewed by the PSRB. The review process will be facilitated by the VA SHIELD Access Manager, who will conduct the initial request review for completeness, prepare the requests for PSRB review, and prepare a response to the requestor. The Associate VA SHIELD Biospecimen Director will oversee the implementation of protocols, SOPs, and best practices in specimen collection, registration, shipping, and distribution.
The VA Central IRB will ensure adherence to all ethical and regulatory standards. VA will implement the use of the following standards to ensure ethical and regulatory compliance:
The VA Central IRB is responsible for ethical and regulatory review of the protocol practices.
The Executive Steering Committee is responsible for general strategic planning and oversight of VA SHIELD, assessment of outcomes and measures, and strategic decisions regarding specimen allocation.
The Programmatic and Scientific Review Board is responsible for review of specimen use and data access request proposals in accordance with established programmatic and scientific goals. The PSRB balances limited specimen availability by prioritizing request to ensure that utilization of biospecimens occurs in accordance with the guidelines, protocols, and strategic objectives of VA SHIELD.
Working Groups are ad hoc and standing bodies focused on specific subject matter, with the responsibility to develop and vet new concept proposals and further develop concept proposals, pending final approval.
The Community Advisory Group is responsible for patient and community participation, concept proposal development, and research dissemination.
Is there an inspector general for VA SHIELD?
VA SHIELD is overseen by the Office of Research Oversight. The VA Inspector General has 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 will participants’ 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 is the role of the “honest broker?”
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.