Office of Research & Development

BLR&D;/CSR&D; 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. Epidemiology Research Program
5.Merit Review Applications for Drug Development
6. Collaborative Merit Review Applications
7. Permission to Exceed Merit Review Budget Cap
8. Point of Care Research

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 BLR&D; and CSR&D; 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 (BLR&D)
B. John Blair Barnwell Award (CSR&D)

XI. Policies, Handbooks, and Guidance Documents

I. Introduction

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

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

CSR&D 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 BLR&D and CSR&D investigators. RFAs and Program Announcements are available on the VA Research Intranet (available only from within the VA network).

A. 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 BLR&D and CSR&D 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. VHA Handbook 1202.1, BLR&D and CSR&D Merit Review Award Program

2. Overview of the Merit Review Award Process

B. 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 (BLR&D) and the Clinical Science Research & Development Service (CSR&D) 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.

BLR&D and CSR&D 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.

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: BLR&D and CSR&D 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 BLR&D and CSR&D 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:

BLR&D

  1. Licensed cliniciansmust have a VA-paid clinical appointment of at least 5/8ths time to receive BLR&D 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 BLR&D 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.

CSR&D:

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 BLR&D and CSR&D 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-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:

-Guidance on Submission of a CDA-2 LOI to BLR&D and CSR&D

- Guidance on Submission of a CDEA LOI to BLR&D; and CSR&D;

- Instructions for Submitting a Career Development LOI (Non-Trials)


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 BLR&D/CSR&D Career Development mailbox (VHACADEReview@va.gov).

The deadlines for LOI submission to BLR&D and CSR&D 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.

- Instructions for Submitting a Career Development Clinical Trial LOI to CSR&D;


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 CSR&D Merit Review Clinical Trial 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 CSR&D 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 CSR&D 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 CSR&D 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 CSR&D, a recommendation will be made that the proposed project be redirected to a research service other than CSR&D (e.g., Health Services Research and Development).

Additional information about the Clinical Trial LOI may be found here:
- Guidance for Merit Review Clinical Trials LOI
- CSRD LOI Template for Clinical Trials

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

4. Epidemiology Research Program

The application process for a CSR&D Merit Review Epidemiology application begins with the preparation and submission of a Letter of Intent (LOI). The primary purpose of the LOI is to provide CSR&D with the opportunity to determine if a proposed study will address a critically important disease that is prevalent in the Veteran population, and whether or not the proposed study fits within the CSR&D purview.

Epidemiology applications typically fall within the purview of the Epidemiology Merit Review Panel (EPID). EPID includes traditional population-based epidemiology projects as well as projects in the clinical epidemiology discipline that focus on questions that arise in the clinic or at the hospital "bedside." The proposed clinical topic would not be restricted by the specialty or subspecialty designation of a disease, but must address a health-related problem that is prevalent in the Veteran population.

Additional information about the Epidemiology LOI may be found here:
- Guidance for Merit Review Epidemiology: Letter of Intent (LOI)
- CSRD LOI Template for Epidemiology Proposals

5. Merit Review Applications for Drug Development

The application process for a BLR&D; Drug Development 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 BLR&D; 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 BLR&D; purview. In addition, submission of the LOI allows BLR&D; 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, BLR&D; 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:

6. Collaborative Merit Review Applications

The application process for a BLR&D; 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 BLR&D; 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 BLR&D; purview. In addition, submission of the LOI allows BLR&D; 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, post-traumatic 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:

7. Permission to Exceed Merit Review Budget Cap

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

Instructions for Preparing and Submitting a Letter of Intent (LOI) to Exceed Budget Caps

8. Point of Care Research

Eligible VA investigators who wish to start a POC-R study must submit a Letter of Intent (LOI) to the program office. This document serves as a request for planning, and includes:

  • Study objectives
  • Importance of the research to VA and its patients
  • Feasibility of conducting the research as a POC-R study
  • Summary of preliminary research and data to support further investigation

Please refer to the POC-R LOI Submission Guidelines for specific instructions.

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, BLR&D and CSR&D 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 BLR&D and CSR&D Services Scientific Review Board is the Federal Advisory Committee responsible for the scientific review of BLR&D and CSR&D 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, BLR&D, CSR&D, and the Federal Advisory Committee Act.

A. Scientific Review Calendar (Updated: Fall 2018)

B. Scientific Review Contacts

C. List of Scientific Review Subcommittees

  1. Spring 2018 Merit Review Spring Roster
  2. Fall 2017 Merit Review Subcommittee Aggregate Roster
  3. Spring 2017 Merit Review Subcommittee Aggregate Roster
  4. Fall 2016 Merit Review Subcommittee Aggregate Roster
  5. Spring 2016 Scientific Review Subcommittee Rosters
  6. Fall 2015 Scientific Review Subcommittee Rosters

D. Purview of BLR&D; and CSR&D; 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. Data Monitoring Committee: The CSR&D Data Monitoring Committee (DMC) monitors certain CSR&D 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: CSR&D Data Monitoring Committee

B. Progress Reports: BLR&D and CSR&D 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.

Additional instructions are available for clinical trials progress reports.

C. 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 BLR&D/CSR&D 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.

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 BLR&D; or CSR&D; 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 BLR&D or CSR&D funded study be Veterans. Investigators may wish to enroll non-Veterans must request permission to do so, using the memo template below.

FAQs on the Participation of non-Veterans in CSR&D-Funded Studies

Memorandum template for requesting a waiver to enroll non-Veterans (fillable pdf)

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 (BLR&D)

B. John Blair Barnwell Award (CSR&D)

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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 BLR&D and CSR&D Scientific Review Panels

E. VHA Handbook 1202.1 - Merit Review Award Program

F. VHA Handbook 1200.5 - Requirements for the Protection of Human Subjects in Research

G. VHA Handbook 1200.16 - Off-site Research Handbook

H. VHA Handbook 1200.19 - Presentation Of Research Results

I. Control of Hazardous Materials in VA Research Laboratories, VHA Directive 1200.6

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