For Researchers/Collaborators

Guiding Principles

Dr. Mark Holodniy at the Palo Alto VA biorepository site. (Photo by Adan Pulido)

VA’s approach to the development and implementation of a national biospecimen bank and data repository is grounded in key guiding principles and values.  VA will adhere to the appropriate protocols and ethical standards established by research safety boards, such as the VA Central Institutional Review Boards (IRB), as well as to all applicable laws and regulations guiding the protection of human subjects in clinical trials.  Furthermore, VA is committed to ongoing monitoring of its procedures and engaging in surveillance of the field as it pertains to the use of patient data in clinical research. To that end, VA will oversee the development and application of relevant standard operating procedures (SOPs) and internal audit processes.  VA SHIELD is committed to:

• Maximizing collection of high-quality specimens and data ethically and efficiently;
• Harnessing clinical and scientific strengths of the VA in order to create synergistic effects with pre-existing efforts;
• Providing an effective mechanism to review, approve, and distribute specimens and data to scientific partners;
• Leveraging the administrative and regulatory capabilities of VA to ensure accountability and compliance with applicable laws and regulations.

Governance/Oversight

The disposition of biospecimens is overseen by the VA SHIELD Executive Steering Committee (ESC)(Committee) and VA SHIELD Programmatic and Scientific Review Board (PSRB)(Board).  ESC is designed to provide general guidance of VA SHIELD operations, while PSRB reviews requests for specimen use and data access.  The VA SHIELD Director oversees the implementation of protocols, SOPs and best practices in specimen and data collection, registration, shipping, and distribution.

Desired Outcomes

VA is committed to improving clinical outcomes for Veterans through the establishment of the biobank biospecimen and data repository.  VA SHIELD is established to:

• Effectively collect and store specimens and other accompanying data for research, test validation, and clinical purposes;
• Increase scientific impact and integrate VA research efforts organized through the VA Office of Research and Development (ORD);
• Facilitate research that leads to immediate use in clinical environments when appropriate, including improved diagnostic, therapeutic, and prevention strategies;
• Promote collaboration (internal and external to VA);
• Provide infrastructural and foundational support to facilitate research;
• Serve as a premiere resource for scientific and health research data that can be used by VA entities and investigators in future research studies.

Compliance

Compliance statement:

• VA SHIELD performs its operations in full compliance with applicable ethical and regulatory standards;
• VA SHIELD is committed to appropriate oversight and monitoring of its research and development efforts;
• The operations of VA SHIELD programs are overseen and approved by VA Central Institutional Review Boards (VA CIRB);
• The VA SHIELD Executive Steering Committee oversees general principals of VA SHIELD’s operations, including adoption of material transfer agreements, data use and sharing agreements, memoranda of understandings, inter-agency agreements, and business associate agreements, as well as biospecimen and data ownership decisions and clarifications.