Office of Research & Development

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BLRD/CSRD Resources For the VA Research Community

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I. Introduction

II. Funding Award Mechanisms

A. Merit Review Award Program
B. Career Development Award Program
C. Special Funding Solicitations
D. Research Career Scientist
E. Other Office of Research and Development (ORD) Services

III. Eligibility for Research Funding

A. Eligibility Rules
B. Application for Eligibility

IV. Application Process

A. Prior to Application Submission (e.g. Letters of Intent)

1. Career Development
2. Career Development Clinical Trial
3. Merit Review Clinical Trial
4. Merit Review Applications for Drug Development
5. Collaborative Merit Review Applications
6. BLRD Merit Review Award for Validation of Studies of Importance to Veteran Health (I01)
7. Permission to Exceed Merit Review Budget Cap

B. Electronic Submission of Application
C. Appeals of Funding Decisions

V. Scientific Review of Research Applications

A. Scientific Review Calendar
B. Scientific Review Contacts
C. List of Scientific Review Subcommittees
D. Purview of BLRD and CSRD Scientific Review Groups
E. Scientific Review Success Rates

VI. Initiation of Research Funding

A. Just-In-Time
B. Start Dates

VII. Management and Oversight of Active Research Funding

A. Data Monitoring Committee
B. Progress Reports
C. Modification Requests
D. Final Report

VIII. Special Circumstances

A. Clinical Trials
B. Offsite Research Waivers
C. Participation of Non-Veterans
D. Certificates of Confidentiality
E. Cooperative Research and Development Agreement (CRADA)
F. Biosafety and Laboratory Safety

IX. Shared Equipment Evaluation Program (ShEEP) and Laboratory Animal Major Equipment (LAMb) Programs

X. Research Recognition Awards

A. William S. Middleton Award (BLRD)
B. Distinguished Medical Research Scientist (DMRS)
C. John Blair Barnwell Award (CSRD)

XI. Policies, Handbooks, and Guidance Documents


I. Introduction

Biomedical Laboratory Research and Development (BLRD) and Clinical Science Research and Development (CSRD) services have distinct missions, but share many resources, staff, and processes. Most of the information on this page applies to both BLRD and CSRD.

BLRD supports laboratory and animal research to better understand the causes of and develop or improve treatments for injuries and illnesses that afflict Veterans.

CSRD supports research focusing on intact human beings as the unit of examination. Examples include interventional and effectiveness studies, clinical, epidemiological and technological studies.

If you have questions, see our staff directory, which includes contact information for individuals who manage each of the programs and processes below.

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II. Funding Mechanisms

A variety of funding mechanisms are available to BLRD and CSRD investigators. RFAs and Program Announcements are available on the VA Research Intranet (available only from within the VA network).

Merit Review Award Program: The Merit Review Award Program is an intramural funding mechanism to support investigator-initiated research conducted by eligible VA investigators at VA medical centers or VA-approved sites. This is the principal mechanism for BLRD and CSRD funding of basic, preclinical biomedical and behavioral studies as well as clinical studies of disorders and diseases of importance to the health of Veterans.

The documents listed here are specific to the Merit Review Award Program. Information about eligibility for funding, the application process, scientific review of applications, special circumstances, and management of active research funding may be found below.

  1. ORD Program Guide 1202.01 Merit Review Award Program
  2. Overview of the Merit Review Award Process

Career Development Award Program: The Career Development program is intended to attract, develop, and retain talented researchers working in areas of particular importance to improve the health and care of our nation's Veterans. The Biomedical Laboratory Research & Development Service (BLRD) and the Clinical Science Research & Development Service (CSRD) have a rich history of supporting investigators during their early research careers who have gone on to serve as long-standing, independently funded VA scientists, Center Directors, and research administrators such as ACOS/R, etc. The current Career Development program provides opportunities for clinician and non-clinician biomedical and clinical researchers, including biostatisticians and clinical trialists.

BLRD and CSRD are currently offering the Career Development Award-2 (CDA-2) as a mentored investigator award and Career Development Enhancement Award (CDEA) for senior investigators to obtain additional research training.

The CDA-1 mechanism (similar to early research fellowship) is available for selected priority areas: psychiatry, applicants from HBCUs, and Veteran scientists.

C. Special Funding Solicitations: At times, special funding mechanisms are made available. These may be based on portfolio needs, opportunities to work with partner agencies, etc.

D. Research Career Scientist: BLRD and CSRD recognize the critical contributions that non-clinician scientists make to our research program. The intramural nature of VA research encourages our investigators to make VA their primary professional focus. This includes participation in local and national committees, leadership of research core facilities, collaboration with clinician scientists, teaching, mentoring, and supervising junior investigators, and stewardship of shared resources.

In recognition of these efforts, we offer a funding mechanism to support the salaries of non-clinician scientists who have demonstrated extraordinary contributions to VA research beyond their own funded studies and programs: the Research Career Scientist (RCS) award.

The RCS award provides 5-years of salary support. The Senior Research Career Scientist (SRCS) award is provided to highly productive international leaders, who have achieved wide recognition of accomplishments in their research area, and provides 7-years of salary support. For more information about the RCS program, please refer to the documents below.

RCS applications are accepted electronically via Grants.gov. Submission deadlines may be found in Table 3 of the RCS funding opportunity document (RFA). The RCS RFA must be used in conjunction with the VA version of the SF424 (R&R) Application Guide.

Inquiries about the RCS Program should be directed to rcs.materials@va.gov.

1. Office of Research and Development Program Guide 1200.20: Research Career Scientist

2. Template for RCS Mid-Term Reports for BLRD and CSRD Services

3. Format for Curriculum Vitae for Research Career Scientist Applications

4. Tips On Preparing Your Research Career Scientist Application

5. RCS Frequently Asked Questions

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III. Eligibility for Research Funding

A. Eligibility Rules: Unless otherwise specified in a funding opportunity, the following rules govern eligibility for research funding:

BLRD

  1. Licensed clinicians must have a VA-paid clinical appointment of at least 5/8ths time to receive BLRD research funding. If you are a clinician who is interested in conducting research, please contact the Chief of Staff at your local VA Medical Center to learn about available opportunities.
  2. Non-clinicians(anyone who does not hold a VA-paid clinical appointment, to include current VA employees) must apply for eligibility before applying for BLRD funding. If a non-clinician's application is selected for funding, the investigator must become a 5/8 or higher VA employee before funds are distributed. To learn about opportunities in VA research, contact the Associate Chief of Staff for Research (ACOS/R) or Administrative Officer of Research (AO/R) in the research office at your local VA Medical Center.

CSRD:

Investigators must have a VA-paid clinical appointment of at least 5/8ths time and dedicated VA research space to conduct their VA-funded research by the time the funding begins.

B. Non-Clinician Eligibility Documents

  1. Guidance For Requesting Acceptance into the Biomedical Laboratory R&D Program for Non-Clinician Scientists (Updated 4/15/2018)
  2. Request For Acceptance Into The Non-Clinician Intramural Program Template

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IV. Application Process

A. Prior to Application Submission: Before submitting an application for certain funding opportunities, investigators must provide a Letter of Intent (LOI) for review. This allows BLRD and CSRD staff to ensure the proposed work fits our portfolio goals.

Applications that must include an approved LOI include:

1. Career Development

Before submitting a CDA-1, CDA-2 or CDEA application, applicants must have an approved letter of intent (LOI) that is valid for the review cycle.  Instructions may be found in guidance documents linked below.  Separate instructions for CDA-2 Clinical Trials may be found in the next section.

Additional information about the Career Development LOI may be found here:

We now require the Citizenship Certification (fillable pdf) as part of all CDA-2 LOI submissions. Failure to include this will result in automatic disapproval of the LOI.

Nominees need to work closely with the local VA R&D Office to prepare the LOI and subsequent application. Inquiries concerning the program and LOIs must be submitted by the local VA R&D Office to the BLRD/CSRD Career Development mailbox (VHACADEReview@va.gov).

The deadlines for LOI submission to BLRD and CSRD are May 1 and November 1.

2. Career Development Clinical Trial

Applicants to the Career Development program who intend to conduct a clinical trial should consider the same CDA-2 guidance linked above, as well as these specific instructions relating to Career Development Clinical Trial Letters of Intent. Note: A clinical trial may not be proposed in a CDA1 award.

- Instructions for Submitting a Career Development Clinical Trial LOI to CSRD

A Decision Tool has been created to help you determine whether your proposal fits our definition of a clinical trial.

3. Merit Review Clinical Trial

The application process for a CSRD Merit Review Clinical Trial or a CSRD Combined Proof of Concept and Clinical Trial (PCCT) begins with the preparation and submission of a Letter of Intent (LOI). Please note that a full clinical trial proposal may not be submitted without an approved LOI. The primary purpose of the LOI is to provide CSRD with the opportunity to determine if a proposed trial will address a critically important disease that is prevalent in the Veteran population or is an individually tailored treatment that will directly improve the healthcare of Veterans. In addition, submission of the LOI allows CSRD to assess and provide feedback on the clinical focus and design of the trial, the proposed innovation and overall impact and translational potential of the proposed trial, and the apparent feasibility of enrolling the proposed Veteran population. If the proposed trial does not meet the CSRD definition of a clinical trial, a recommendation will be made that the applicant utilizes a non-trial RFA. Similarly, if the proposed trial does not fall under the research purview of CSRD, a recommendation will be made that the proposed project be redirected to a research service other than CSRD (e.g., Health Services Research and Development).

Additional information about the Clinical Trial LOI may be found here:

A Decision Tool has been created to help you determine whether your proposal fits our definition of a clinical trial.

4. Merit Review Applications for Drug Development

The application process for a BLRD Merit Review Award for Lead Isolation and Optimization and Pre-IND studies of Drugs and Biologics BLRDbegins with the preparation and submission of a Letter of Intent (LOI). Please note that a full proposal may not be submitted without an approved LOI. The primary purpose of the LOI is to provide BLRD with the opportunity to determine if proposed studies will jointly address a critically important area of concern that is prevalent in the Veteran population; and whether or not the proposed studies fit within the BLRD purview. In addition, submission of the LOI allows BLRD the opportunity to access and provide feedback on the clinical and/or scientific focus and design of the collaborative merit reviews, the proposed innovations, and the overall impact on the veteran population.

The goal of this funding opportunity is to accelerate translation of research from demonstration of efficacy in vivo to submission of an investigational new drug application (IND) to the FDA. To accomplish this mission, BLRD will provide resources to support pharmacological and toxicological testing or manufacturing services for a lead agent.

In order to be eligible to apply for funding under this opportunity, an investigator must have a validated target and at least one lead agent (or no more than 3 optimized lead agents for a target) with a pending patent. The lead agent must have the potential for commercial licensing and to be developed further for clinical use.

Additional information about the Drug Development LOI may be found here:

5. Collaborative Merit Review Applications

The application process for a BLRD and CSRD Collaborative Merit Review award begins with the preparation and submission of a Letter of Intent (LOI). Please note that a full proposal may not be submitted without an approved LOI. The primary purpose of the LOI is to provide BLRD and CSRD with the opportunity to determine if proposed studies will jointly address a critically important area of concern that is prevalent in the Veteran population; and whether or not the proposed studies fit within the BLRD or CSRD purview. In addition, submission of the LOI allows BLRD and CSRD the opportunity to access and provide feedback on the clinical and/or scientific focus and design of the collaborative merit reviews, the proposed innovations, and the overall impact on the veteran population.

The purpose of this funding opportunity is to invite applications for collaborative I01 projects from multi-disciplinary teams to expand, improve, or transform the understanding of the etiology, pathogenesis, and/or genetics of suicidality, suicide prevention, posttraumatic stress disorder, traumatic brain injury, pain, and opioid addiction. For a collaborative set of collaborative I01s, each site has its own Program Director(s)/Principal Investigators(s), and the program provides a mechanism for cross-site coordination and communication. Collaborative studies are appropriate to address research questions beyond the capacity of a single-site investigation, particularly to accommodate collaborations among sites with diverse expertise, perspectives, and contributions.

At least 3 applications must be submitted as part of the collaborative research application. A shared Overall Research Strategy is required for the linked applications.

Additional information about the Collaborative LOI may be found here:

6. BLRD Merit Review Award for Validation of Studies of Importance to Veteran Health (I01)

The application process for a BLRD Validation of Studies of Importance to Veteran Health Merit Review award begins with the preparation and submission of a Letter of Intent (LOI). Please note that a full proposal may not be submitted without an approved LOI. The primary purpose of the LOI is to provide BLRD with the opportunity to determine if proposed studies will jointly address a critically important area of concern that is prevalent in the Veteran population; and whether or not the proposed studies fit within the BLRD purview. In addition, submission of the LOI allows BLRD the opportunity to access and provide feedback on the clinical and/or scientific focus and design of the collaborative merit reviews, the proposed innovations, and the overall impact on the veteran population.

Applications submitted to this RFA should be for validation studies involving animal models, human biological samples collected using minimally invasive procedures, previously acquired tissue specimens or previously acquired phenotypic and -omic data. Further, the studies to be validated must have important implications in terms of the etiology, pathogenesis, and/or genetics of service related illness and injury in or illnesses which are common in US military Veterans. Validation studies on the identification of therapeutic targets leading to the development of new treatments for service related illness and injury is encouraged.

7. Permission to Exceed Merit Review Budget Cap

Information about permission to exceed the Merit Review Budget Cap may be found here:


B. Electronic Submission of Application: Applications for funding are submitted electronically. The process is the same for all ORD services, and can be found here.

C. Appeals of Funding Decisions: To ensure the fairness of the Merit Review process, BLRD and CSRD have a mechanism to formally appeal the recommendation of a Merit Review Subcommittee if the Principal Investigator (PI) has evidence of serious flaws in the review of a Merit Review proposal. The process is described in this document: Merit Review Appeal Process.

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V. Scientific Review of Research Applications

The Joint BLRD and CSRD Services Scientific Review Board is the Federal Advisory Committee responsible for the scientific review of BLRD and CSRD funding proposals. The Committee is comprised of subcommittees that serve as the review groups. The Portfolio Manager of each subcommittee is the designated Federal Official in charge of the Panel meeting and is responsible for conducting the meeting in accordance with the policies of VHA, ORD, BLRD, CSRD, and the Federal Advisory Committee Act.

A. Scientific Review Calendar (Updated: Fall 2019)

B. Scientific Review Contacts

C. List of Scientific Review Subcommittees

  1. Spring 2019 Merit Review Subcommittee Aggregate Roster
  2. Fall 2018 Merit Review Spring Roster
  3. Spring 2018 Merit Review Spring Roster
  4. Fall 2017 Merit Review Subcommittee Aggregate Roster
  5. Spring 2017 Merit Review Subcommittee Aggregate Roster

D. Purview of BLRD and CSRD Scientific Review Groups

E. Scientific Review Success Rates Merit Review Success Rates

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VI. Initiation of Research Funding

Once applications have been selected for funding, we will notify your Research Office and begin the Just-in-Time (JIT) process. This allows investigators and Research Office staff to wait to prepare certain required documents until after the scientific review process.

Details about using JIT may be found here: Just-in-Time (JIT) Forms, Templates, and Instructions

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VII. Management of Active Research Funding

A. Progress Reports: BLRD and CSRD utilize the Research Performance Progress Report (RPPR) module of the NIH Electronic Research Administration (eRA) Commons site. While the specific questions asked may vary based on the funding service and opportunity type, the process is the same for all ORD services, and may be found here: Federal-wide Research Performance Progress Report (RPPR) for VA Investigators.

B. Project Modification Requests

  1. Administrative Changes: The process to request administrative changes (e.g. extension of performance period, change of investigator or station, addition of performance site, funding amount or salary changes) is detailed here: Administrative Modifications to BLRD/CSRD Projects
  2. Scientific Changes: Changes to active, ORD-funded research that are scientific in nature only, and do not include any administrative changes should be submitted to your portfolio manager.
  3. Questions: If you have questions about a modification to your active (funded) award, please contact the portfolio manager responsible for your topic area. If you are not sure who to contact, email VHABLRD-CSRD@va.gov, and your request will be routed appropriately.

C. Data Monitoring Committee: The CSRD Data Monitoring Committee (DMC) monitors certain CSRD funded studies that include human subjects, and may involve randomization. The DMC provides an ongoing independent evaluation of the progress of studies, including participant accrual and retention, adverse events monitoring, and analysis plan. DMC review is separate and distinct from Institutional Review Board (IRB) review and approval. The DMC will not evaluate the scientific merit, methodology, or overall design, and budgetary constraints of an IRB approved protocol under review, except where changes to the protocol may result in a change in safety level or monitoring. Additional information is available here: CSRD Data Monitoring Committee

D. Final Reports: If your award requires a final report, your research office will be notified.

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VIII. Special Circumstances

A. Clinical Trials: Investigators interested in conducting clinical trials may apply for funding through a number of mechanisms, including Career Development and Merit Review. Most clinical trials require submission and approval of a Letter of Intent (LOI) prior to the full proposal submission.

The following documents apply to clinical trials:

B. Off-site Research Waivers: It is expected that research funded by BLRD or CSRD will be on-site at a VA Medical Center or other VA location. Investigators who wish to conduct all or part of their research activities offsite must request a waiver using the process outlined on the Off-Site Research page in ORD Policies and Guidance Documents.

C. Participation of Non-Veterans: It is expected that all participants enrolled in a BLRD or CSRD funded study be Veterans. Investigators may wish to enroll non-Veterans must request permission to do so, using the memo template below.

D. Certificates of Confidentiality: Although VA does not issue certificates of confidentiality, we have assembled a FAQ to explain when a certificate might be needed and where to apply for one.

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IX. Shared Equipment Evaluation Program (ShEEP) and Laboratory Animal Major Equipment (LAMb) Programs

The purpose of the ORD Shared Equipment Program is to review proposals and make recommendations for funding of common resource shared equipment or core animal facility major equipment to be used in Department of Veterans Affairs (VA) medical centers to support biomedical research on behalf of investigators associated with all ORD services.

Applications must now be submitted through grants.gov. Please refer to the RFA for detailed instructions.

The ShEEP RFA is available on the VA Research Intranet, available only from within the VA firewall. If you are viewing from within the VA network, copy and paste this URL http://vaww.research.va.gov/funding/rfa.cfm into your browser.

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X. Research Awards

A. William S. Middleton Award (BLRD)

B. Distinguished Medical Research Scientist (DMRS)

C. John Blair Barnwell Award (CSRD)

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XI. Policies, Handbooks, and Guidance Documents

A. Guidance for requesting acceptance (eligibility) for non-clinician scientists

B. Conflict of Interest, Confidentiality and Non Disclosure Rules

C. Publication Notification

D. Purview of BLRD and CSRD Scientific Review Panels

E. ORD Program Guide 1202.01 - Merit Review Award Program

F. VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research

G. ORD Program Guide 1200.16 - Off-Site Research

H. VHA Directive 1200.19 - Presentation Of Research Results

I. VHA Directive 1200.08 - Safety of Personnel and Security of Laboratories Involved in VA Research

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