Program for Collection of Biospecimens in CSRD Clinical Trials
Introduction. VA’s Clinical Science Research & Development Service (CSRD) is announcing an opportunity for VA investigators to request support for the collection of biospecimens in CSRD-funded clinical trials. This program is initially being made available as a supplement to ongoing trials, irrespective of topic area. This opportunity is available only to studies that will generate a minimum of 100 specimens.
This program involves a collaboration between the CSRD Service and the VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD add link). A centralized biorepository, managed by the VA SHIELD coordinating center, is part of a program-wide effort to standardize the methods for research with, and storage of, biospecimens across VA studies focused on the broad range of diseases/conditions of significance to Veterans.
The biospecimen repository will enable generation, storage, and analysis of molecular and other associated data making it available for research to advance scientific understanding in support of improving diagnosis, treatment, preventative strategies, and outcomes of care for Veterans.
If approved for funding, CSRD will provide guidance related to the National Multicenter VA Specimen Collection Protocol for VA SHIELD which has been approved by the VA Central Institutional Review Board (CIRB). VA SHIELD will provide protocols/training on sample collection, consent form, processing, local storage, and shipping to ensure standardization and consistent specimen quality.
Mechanism. CSRD will provide supplemental funding to ongoing CSRD clinical trials for costs associated with collection of biospecimens, pre-processing, storage at generating VA facility, and shipment to VA SHIELD biorepository. Once stored within VA SHIELD, the study PI will be provided with guidance on planning for future analyses and accessing specific trial specimens/data.
Applications must consist of:
- A one-page CSRD Biospecimen Supplement Summary to include:
Background. Provide relevant background information including a brief description of the specimens to be collected, type of biomarkers to be analyzed and their potential relevance.
Approach. Summarize the study design and the approach to identifying and confirming clinically relevant biomarkers as diagnostic, prognostic, and therapeutic indicators in diseases/disorders relevant to Veterans.
References. Provide key relevant references.
Please use typeface Arial, Georgia, Helvetica, or Palatino Linotype with font size 11 points or larger.
- The completed CSRD Biospecimen Intake Document (Attachment 1),
- A summary budget worksheet indicating the budget request (Attachment 2). Allowable budget items include: salary support for a staff member to collect/store/package samples, supplies for specimen collection, storage, and shipping, etc. The budget is not capped but is expected to strongly justified.
- Budget justification (Attachment 3). One page limit.
Applications (consisting of the summary document and Attachments 1-3 combined into a single PDF) should be submitted by the PI’s local VA Research Office via email to VHABLRD-CSRD@va.gov. The email should have the following subject line: “CSRD Biospecimen Supplement Request” and should contain a statement from a representative of the R&D Service (with title) confirming the availability of VA space to manage the requirements related to the collection and storage of samples until shipped to VA SHIELD. Incomplete applications or applications submitted directly by the PI will be returned without review.
General Criteria for Review and Scoring of Supplement Requests.
CSRD staff will conduct first level review of biospecimen supplement requests based on criteria including the generation of clinically relevant biomarkers as diagnostic, prognostic, and therapeutic indicators in diseases/disorders relevant to Veterans and capacity to share specimens and study data for future analyses by other ORD PIs (after an embargo period when the PI and study team have priority). Second level review will be conducted by the VA SHIELD Programmatic and Scientific Review Board, which will recommend approval/disapproval to the Director/CSRD.
Timeline for Submission and Review.
CSRD will accept applications at any time until further notice. Awards will be announced on a rolling basis.
Issued: September 20, 2021