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Office of Research & Development

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Governance

Guiding Principles

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 Board (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) and VA SHIELD Programmatic and Scientific Review Board (PSRB).  ESC is designed to provide general guidance of VA SHIELD operations, while PSRB reviews requests for specimen use and data access.  The VA SHIELD Directors oversee the implementation of protocols, standard operating procedures, and best practices in specimen and data collection, registration, shipping, and distribution.

Desired Outcomes

VA is focused on achieving outcomes and measuring impact as part of its effort to establish and implement the use of an internal biobank biospecimen and data repository.  VA SHIELD is committed to:

  • Effectively utilize, analyze, and store collected specimens and other accompanying health data
  • Increase the number of collaborations between VA sites, key partners, and external collaborators and engage in harmonizing efforts between VA entities, biobank biospecimen, and data repositories
  • Increase the scientific impact of VA research efforts including supporting the careers of junior/trainee careers
  • Maintain VA SHIELD as a recognized program considered for cooperative grants and funding
  • Develop VA SHIELD efforts into a foundational entity for specimen and data storage across the VA research community
  • Secure VA SHIELD to be the premier resource of health data and information that can be utilized by all VA entities and key external partners
  • Adhere to the established quality standards
  • Contribute to the improvement of patient outcomes through the facilitation of studies resulting in the development of diagnostic, therapeutic, and preventative strategies for immediate deployment in clinical environments

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 Board (VA CIRB)
  • The VA SHIELD ESC oversees general principles of VA SHIELD’s operations, including the 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



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Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.