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What is a biospecimen bank (biobank) and data repository (biorepository)?
A biorepository 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?
The purpose of the VA SHIELD 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 disease test status, and other data. 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.
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 requirements. VA has implemented the use of the following standards to ensure ethical and regulatory compliance:
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 the 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.
Am I at risk for genetic discrimination?
There may be a risk that genetic information obtained as a result of participation in research could be used to discriminate with regard to a person’s health insurance or their job. However, VA will not disclose VA SHIELD partners’ genetic information to health insurance companies, group health plans, or employers. In addition, researchers who will have access to your genetic information will take strict measures to maintain your confidentiality. In the rare event of a security breach, there are state, federal, and VA protections that prevent health insurance companies, group health plans, and most employers from discriminating against you based on your genetic information.
Can insurance companies or employers find out about the results of research on a sample?
No, they cannot. Your samples and information are stored using a barcode - that means any information which can identify you, such as your name, address, SSN, and date of birth, are taken off your data, and samples are stored separately. VA SHIELD only grants access to this data for ethically and scientifically approved research into the causes and treatment of disease in accordance with the applicable regulations.
What happens to me if I become seriously ill or die?
Once you have joined VA SHIELD, your information will be collected and used up to and after your death, unless you withdraw from VA SHIELD. It is important that researchers have access to information on people who have died to help them understand how a disease progresses or the cause of death.
What are the key reasons why I might choose to volunteer for the VA SHIELD study?
While you will not directly benefit from this study, you might choose to volunteer due to the importance of the research. The study will enable research in the prevention, diagnosis, and treatment of diseases of urgent priority to Veterans and VA Healthcare.
What are the key reasons why I might choose not to volunteer for the VA SHIELD study?
You might choose not to volunteer since biospecimen collection may cause discomfort or pain. For example, blood draws may cause pain, bruising, and infection (rare). You might also not volunteer due to concerns about entering the hospital and being exposed to people and illnesses. However, donating these biospecimens from home may be an option to consider.
Can I discuss joining VA SHIELD with my relative/partner/friend/PCP before deciding?
Yes, you may, and we encourage you to discuss joining VA SHIELD with your relatives and friends.
What happens if I change my mind about providing a sample to VA SHIELD?
You are free to withdraw from VA SHIELD at any time without reason.
Can my relative or Legally Authorized Representative (LAR) or Power of Attorney withdraw consent after my death?
Only you and your authorized representative can withdraw your consent to participate in the VA SHIELD.
What are the VA SHIELD study procedures?
If you decide to participate in the VA SHIELD study, you will be provided with a consent form and be able to ask questions. If you wish to participate, then you will sign the form indicating your consent to biospecimen donation and use of your records.
You may be asked simple questions about your health so the study doctor can determine if it is safe for you to participate. You may also be asked to take a pregnancy test.
Completion of a baseline survey may be required for participation in this program.
You may also be asked to complete a longer questionnaire called; this survey is optional. It has more detailed questions about your exercise habits, mental health, environmental exposures, and dietary habits. It will take about 30-45 minutes to complete. You may be provided with a pre-addressed postage-paid envelope for returning the survey.
At the time of enrollment, you may also be asked if you would be willing to have an optional health assessment for research purposes. The health assessment will be performed by study personnel using routine procedures at your convenience. The procedures in this exam may include but are not limited to:
It is expected that these procedures will take no longer than 20 minutes to complete.
There is no treatment involved in the study. The only procedures participants will complete are those required for biospecimen donation. All biospecimens are collected by procedures commonly used in routine medical practice.
The types of biospecimens being collected at your VA Medical Center may include the following.
Swabs of the:
Other biospecimen types:
Biospecimens will only be collected by a qualified clinician, and this may occur at a hospital, outpatient clinic. Additionally, some facilities offer at-home collection.
What possible risks or discomforts might I have if I take part in the VA SHIELD study?
Any procedure has possible risks. The procedures you will undergo as part of this program may cause all, some, or none of the risks or side effects listed. Rare, unknown, or unanticipated risks also may occur.
Some of the risks of the study procedures are specified below:
Pregnant women may not be allowed to participate in certain procedures and may be tested by the study prior to participation.
What are the costs to me if I take part in the VA SHIELD study?
You will not be charged for the procedures that are part of this study. If you usually pay co-payments for VA care and medications, you will still pay these co-payments for VA care and medications since your medical care is separate from this study.
What will happen if I am injured because of my being in the VA SHIELD study?
If you are injured because of taking part in the VA SHIELD study, the VA will provide necessary medical treatment at no cost to you unless the injury is due to non-compliance by a study participant with study procedures or if the research is conducted for the VA under contract with an individual or non-VA institution.
The VA has made no provisions for compensation should an injury occur due to your participation.
If you have a medical concern or get hurt or sick because of taking part in this study, you may contact a VA SHIELD representative by:
Email: VASHIELD@va.gov
If I am a VA patient, do I have to take part in the VA SHIELD study?
Participation in the research is voluntary. Your refusal to take part in the study will involve no penalty or loss of benefits to which you are otherwise entitled. There are no consequences to you should you stop your participation.
If you are a VA patient, you will still receive the same standard of care that you would otherwise have received, and you should continue to attend those appointments.
If you are a VA employee, refusal to take part in the study will not influence your job employment, performance ratings, or recommendations.
You may withdraw your donated biospecimens and health information from use by the study at any time without penalty or loss of benefits to which you are otherwise entitled.
If you leave the program and end your authorization, researchers can continue to use health information that has already been collected on you. No further health information will be collected after you end authorization.
If you leave the program and end your authorization your biospecimen(s) including DNA or any other molecules derived from it will be destroyed so that they cannot be used in future research and no further testing can be performed on them. However, de-identified biospecimens (where the link to your identity has been removed) that have been sent to researchers at other Federal health agencies or academic institutions cannot be recalled.
To withdraw from the study please contact a representative of VA SHIELD by:
Email: VASHIELD@va.gov
Can VA SHIELD remove me from the study?
VA may remove you from participation and/or destroy the specimens you donated based on its judgment without your or your legally authorized representative’s consent. No particular circumstances under which your participation may be terminated are anticipated.
Who do I contact about the VA SHIELD study if I have questions?
If you have questions, complaints, or concerns about the study, you may contact a representative of the VA SHIELD program by:
Email: VASHIELD@va.gov
If you have questions about your rights as a study participant, or you want to make sure this is a valid VA study, you may contact the VA Central Institutional Review Board (VA-CIRB). The VA-CIRB is responsible for overseeing the safety of human participants in this study. You may call the VA-CIRB toll-free at 1-877-254-3130 if you have questions, complaints, or concerns about the study or if you would like to obtain information or offer input.
Will I be told new information about the VA SHIELD study?
The VA SHIELD study does not expect to discover new findings that would affect your willingness to allow continued use of your biospecimens and information or affect your willingness to provide future donations. However, the study will perform extensive testing on the biospecimens you donate. If a test result occurs that has important clinical significance to your health, those findings may be provided to you so that you may seek additional medical evaluation.
Who could profit from the VA SHIELD study results?
Use of your biospecimen may lead to inventions or discoveries that could become the basis for new products or treatments. These inventions, discoveries, or products could become commercially valuable and be patented and licensed. Commercially available products could also be developed directly from your biospecimens or DNA. However, by signing the consent form you agree that no profits or any other material benefits from these inventions, discoveries, or products will be shared with you.
Does this study involve genetic research and how will my genetic information be protected?
The donated biospecimens will likely undergo genetic testing that may include whole-genome sequencing. This information will be protected for confidentiality by only being shared with authorized individuals for the purposes of the approved research. Genetic testing is often for discovery, meaning the test results have no validated clinical use that would make it important for the study to contact you with test results. However, approval of that research would mandate any circumstances under which you must be informed of genetic test results.
Federal laws and policies provide you with protection from discrimination by health insurance companies, group health plans, and most employers based on your genetic information. A federal law called the Genetic Information Nondiscrimination Act (GINA) generally will protect you in the following ways:
Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. It also does not prohibit discrimination on the basis of already known genetic diseases.
How will VA use the data of the research, and will VA officials contact me after I donate biospecimens?
The VA SHIELD biorepository will be utilized for future research that may not be defined or approved at this time. However, that research must be approved prior to permission for access to the VA SHIELD biorepository. The authorized members of the national and local study teams who manage the biorepository will have access to the biorepository health information.
Since the biorepository will be used for future research, VA scientists or a research coordinator may desire to contact you for additional biospecimen donation or recruitment for follow-up studies. Potential research may include phone calls, surveys, in-person visits, and/or providing another biospecimen. Your decision to participate in additional research will be entirely voluntary. If you are interested, you will be asked to provide additional consent at that time.
Significant new findings developed during the course of the research that may relate to your willingness to continue participation will be provided to you, and you may choose not to consent to some specific research studies.
You will not be informed of the details of any specific research studies that might be conducted using your identifiable private information or identifiable biospecimens, including the purposes of the research. Results of the studies may not be disclosed to you.
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: VAShield@va.gov.
What is the name of the protocol under which specimens and health data will be collected?
The name of the protocol is: Establishment, Specimen Collection, and Specimen Use within the VHA Biorepository, VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD). 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), “consented specimens” (specimens be obtained through an informed consent process), 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.
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. VA SHIELD also collects specimens through an informed consent process.
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 ESC and the Programmatic Scientific Review Board (PSRB). Each request for specimen 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 requirements. 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 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 Specimen 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 helps 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, Specimen Collection, and Specimen Use within the VHA Biorepository, VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD).
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 a VA Pathology and Laboratory Medicine Service or Clinical Laboratories staff contribute to VA SHIELD specimen collection?
VA staff – researchers, clinicians, or research coordinators are invited to participate in the approved VA-CIRB protocol to collect and 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 regulates populating VA SHIELD with a ‘Sweep’ of remainder/discard clinical blood, body fluids, and/or tissues in VHA clinical or research laboratories. This consent exempt provision of the protocol allows VA SHIELD facilities and personnel to accept specimens and data from Pathology and Laboratory Medicine and others across the VA healthcare system.
The protocol also allows for the collection of specimens of interest, such as for emerging diseases, under informed consent.
What is the role of Clinical Laboratories in supporting VA SHIELD?
Relevant specimens will generally be collected under the authority of local Clinical Laboratories. Most immediately, VA SHIELD requests the assistance of Clinical Laboratories to help preserve the remainder of clinical specimens from patients exposed to emerging diseases; prepare and deliver these specimens to the VA SHIELD central biorepository locations in the VA Southern Arizona or VA Palo Alto Health Care System. 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 the VA Southern Arizona or VA Palo Alto Health Care System.
What kind of support will VA provide to Clinical Laboratory staff to adequately support the biorepository?
Personnel resources will be available to assist Clinical Laboratory staff with collecting and shipping human biological specimens and data.
VA SHIELD personnel will share developed SOPs and other protocol documents with Clinical Laboratory staff to support the shipment of specimens and accompanying data.
Other site needs will be identified, and support will be provided as needed. Please contact VASHIELD@va.gov for additional information. VA research team members may also visit the VA SHIELD internal VA SHIELD SharePoint site: https://dvagov.sharepoint.com/sites/vacovashield (VA network access only).
How will VA SHIELD determine which VA sites of care can participate in VA SHIELD?
Clinical Laboratory staff 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 VASHIELD@va.gov 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 remaindering specimens to the central biorepositories?
VA SHIELD works with site Pathology and Laboratory Medicine leadership to identify existing personnel capacity to be able to prepare and ship specimens to the central biorepository locations at the VA Southern Arizona or VA Palo Alto Health Care System. VA SHIELD will also work with Pathology and Laboratory Medicine leadership to determine budgeting needs, budget approvals, and disperse funding as identified.
What next steps can responsive and participating Clinical Laboratories 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 VASHIELD@va.gov with questions related to supporting this effort.