+-----------------------------------+-----------------------------------+
| ##                                | **VHA HANDBOOK 1202.1**           |
| ## Department of Veterans Affairs |                                   |
+-----------------------------------+-----------------------------------+
| **Veterans Health                 | **Transmittal Sheet**             |
| Administration**                  |                                   |
+-----------------------------------+-----------------------------------+
| **Washington, DC 20420**          | **(Date)**                        |
+-----------------------------------+-----------------------------------+

**MERIT REVIEW Award PROGRAM**

**BIOMEDICAL LABORATORY RESEARCH AND DEVELOPMENT (BLR&D) AND**

**CLINICAL SCIENCE RESEARCH AND DEVELOPMENT (CSR&D) SERVICES**

**1.** **REASON FOR ISSUE:** This Veterans Health Administration (VHA)
Handbook clarifies policy and establishes procedures for the Merit
Review Award Program for the Biomedical Laboratory Research and
Development (BLR&D) and Clinical Science Research and Development
(CSR&D) services.

**2. SUMMARY OF MAJOR CHANGES:** This Handbook represents a complete
revision of existing policy.

**3. RELATED DIRECTIVE:** VHA Directive 1202 to be issued.

**4. RESPONSIBLE OFFICE:** The Office of Research and Development,
(BLR&D and CSR&D) is responsible for the contents of this VHA Handbook.

**5. RESCISSION:** This VHA Handbook rescinds VHA Manual M-3, Part II,
Chapter 4, Chapter 5, and Chapter 6.

**6. RECERTIFICATION:** This document is scheduled for recertification
on or before the last working date of November 2007.

  ------------------------------- ---------------------------------------
                                  

                                  Jonathan B. Perlin, M.D. MPH.

                                  Acting Under Secretary for Health
  ------------------------------- ---------------------------------------

  --------------- ------- ------------------------------------------------
  DISTRIBUTION:   CO:     E-mailed

                  FLD:    VISN, MA, DO, OC, OCRO, and 200 -- E-mailed
  --------------- ------- ------------------------------------------------

**CONTENTS**

# **MERIT REVIEW AWARD PROGRAM HANDBOOK**

**BIOMEDICAL LABORATORY RESEARCH AND DEVELOPMENT (BLR&D) AND CLINICAL
SCIENCE RESEARCH AND DEVELOPMENT (CSR&D) SERVICES**

**PARAGRAPH PAGE**

1\. Purpose 1

2\. Background 1

3\. Scope 1

4\. Questions and Inquiries 2

5\. Merit Review Applications 2

6\. Epidemiology Research Program (EPID) 7

7\. Clinical Research Program (CLIN) 9

8\. Review of Merit Review Program Proposals 10

###### APPENDICES

A Preparation and Submission of a Merit Review Program Proposal A-1

B Supplemental Instructions for Submitting an Epidemiology (EPID)

Research Proposal B-1

C Supplemental Instructions for Submitting a Clinical Research (CLIN)
Proposal C-1

D Instructions for Preparing and Submitting a Merit Review Letter of
Intent (including EPID and CLIN) D-1

E Requesting Acceptance into the

Intramural Research Program for Non-Clinical Scientists E-1

F Purview of Merit Review Subcommittees F-1

G Merit Review Appeal Process G-1

# **MERIT REVIEW Award PROGRAM** 

**1. PURPOSE**

This Veterans Health Administration (VHA) Handbook provides policy and
guidelines related to the Merit Review Award Program (Merit Review) and
instructions for submission of Merit Review proposals to the Biomedical
Laboratory Research and Development (BLR&D) and Clinical Science
Research and Development (CSR&D) services.

**2. BACKGROUND**

Merit Review is an intramural program, supporting investigator-initiated
research conducted by eligible VA investigators at VA medical centers or
VA-approved sites. It is the principal mechanism for funding basic,
preclinical biomedical and behavioral studies as well as clinical
studies of disorders and diseases of importance to the health of
veterans. The BLR&D purview includes laboratory studies, both *in vitro*
and *in vivo*, including tissue culture, animal models and studies on
human biological samples. The CSR&D purview includes studies on whole
human subjects involving interventional or exploratory procedures (with
the exception of procedures for obtaining biological samples such as
drawing blood, buccal swabs etc.) Subcommittees of the BLR&D and CSR&D
Merit Review Committee review applications for scientific merit, and
provide the Directors of BLR&D and CSR&D with evaluations of the quality
of the research proposed and make recommendations for funding, including
budgets and funding durations.

**3. SCOPE**

Merit Review is intended for fully trained independent investigators. It
is not a training program. The two training programs, Merit Review Entry
Program (MREP) and Career Development Award Program (CADE) are described
in separate handbooks (VHA Handbook 1202.2 and 1202.3, respectively).

a\. Independence means the principal investigator (PI; the individual
who actually conducts an investigation or who is the responsible leader
of a team of investigators) is competent to develop and direct a
research project without the supervision of a mentor.

b\. Evidence of independent research includes previous training and/or
experience in research and research productivity as demonstrated by
attaining independent grant support and/or refereed publications,
especially first or senior author publications in the field of the
proposed research.

c\. Paragraph 5 defines the requirements for participation in Merit
Review and provides instructions for the preparation and submission of
proposals. Merit Review has two programs that have additional
application requirements: Epidemiology Research Program (EPID) and
Clinical Research Program (CLIN), which are discussed in Paragraphs 6
and 7, respectively.

***NOTE:** If there is a possibility that the proposal fits the EPID or
CLIN guidelines, consult Paragraph 6 or 7.*

d\. Paragraph 8 describes the process BLR&D and CSR&D use to review the
scientific quality of proposals*.*

**4. QUESTIONS AND INQUIRIES**

Inquiries related to Merit Review submission or review should be
directed to the Program Review Division (121F). The PI may contact the
BLR&D and CSR&D Portfolio Managers (121E) with questions specifically
related to scientific issues raised in the Summary Statement for a
reviewed proposal or the scientific content of a proposal to be
submitted. The Associate Chief of Staff (ACOS) for Research and
Development (R&D) is to make all other contacts with BLR&D and CSR&D
staff at VA Central Office, including questions relating to budget
modifications noted in the Summary Statement.

## 

## 5. MERIT Review applications

***NOTE**: Unless specified, the policies and procedures described in
Paragraph 5 apply to [all Merit Review proposals,]{.underline} including
EPID and CLIN proposals.*

a\. **[Eligibility to Submit a Merit Review Proposal.]{.underline}**
Each proposal must have a single PI who is eligible to submit a Merit
Review proposal. A PI shall hold a M.D., Ph.D., or equivalent doctoral
degree in medical, biological, or behavioral sciences. Co-PIs are not
allowed. The Directors of BLR&D and CSR&D may grant exceptions to this
policy for compelling reasons.

\(1\) Because Merit Review is an intramural program, it only funds
research conducted by VA investigators at VA medical centers or
VA-approved sites. Eligibility to submit proposals to
[other]{.underline} Office of Research and Development (ORD) services,
i.e., Health Services Research and Development (HSR&D), Rehabilitation
Research and Development (RR&D) or the Cooperative Studies Program
(CSP), does not automatically confer eligibility to submit a Merit
Review proposal to BLR&D or CSR&D services.

\(2\) To be eligible to submit Merit Review proposals to BLR&D or CSR&D
services, the PI must have at least a 5/8ths time appointment [at the
time the Merit Review is funded]{.underline}**.** If the PI's
appointment is to start at the time of funding, the medical center
Director's letter [must]{.underline} contain a statement indicating that
the Director agrees to employ the PI at least 5/8ths time. An exception
to the eligibility requirements may be granted by the Chief R&D Officer
(refer to VHA Handbook 1200.15).

\(3\) In addition to meeting eligibility requirements, all new
non-clinician PIs must be accepted into the BLR&D /CSR&D intramural
research program. A new PI is one who has not had Merit Review, CLIN, or
EPID funding during the past 5 years.

\(a\) Because MREP is a training program, a non-clinician wishing to
submit a Merit Review proposal subsequent to an MREP award is considered
a new PI. A request for acceptance into the intramural research program
must be submitted at least 2 months prior to the Merit Review
application receipt deadline (see Appendix E).

\(4\) BLR&D and CSR&D must be informed of any change in laboratory
location, geographic commitment, paid 8^ths^, or VA employment status
(see sections n and o below). Non-clinician PIs wishing to transfer
their research programs to a new facility must submit a request through
the new facility. Off-site waivers and eligibility determinations do
[not]{.underline} automatically transfer to the new facility.

b\. **[Location of Laboratory.]{.underline}** It is expected that the PI
and VA co-investigators will perform all of the proposed research in VA
space or VA leased space. If a PI or VA co-investigator controls
laboratory space at any other location(s), a waiver to perform the
research off-site must be obtained for that investigator (refer to VHA
Handbook 1200.16). The use of an off-site core facility or a
collaborator's laboratory does [not]{.underline} require a waiver.
However, if the VA investigator is a core director, a waiver must be
requested.

\(1\) Application for an off-site waiver may be submitted at any time,
but must be received at least 2 months prior to the Merit Review
application receipt deadline. Waiver requests received after these
deadlines will be reviewed for the following round. A copy of the
off-site waiver approval letter must be included in the Merit Review
application. Once a waiver is granted, a new request for a waiver does
[not]{.underline} have to be submitted for each subsequent Merit Review
application.

\(2\) Although the use of leased space does not require an off-site
waiver, ORD must approve a plan for local VA oversight of the research
activities performed in the leased space. (refer to VHA Handbook
1200.16). A copy of the signed lease should be submitted with the
application. In the absence of formal oversight agreement, leases for
\$1 per year and "no cost" leases may not qualify as VA-leased space.

c\. **[Proposal Restrictions.]{.underline}** The Merit Review award is
not intended to be the only source of support for investigators. The PI
is encouraged to seek additional funding from other ORD services, other
agencies of the Federal Government, and other public and private funding
sources. Submission of proposals is subject to the single project rule,
whereby a PI may have only one active Merit Review from each of the two
services, BLR&D and CSR&D, and typically, each investigator may submit
only one Merit Review proposal to each of the two services, BLR&D and
CSR&D, for any review cycle.

\(1\) There are exceptions to this single project rule. An investigator
may have a second BLR&D and CSR&D Merit Review award in response to
special requests for proposals (RFP). In addition, the EPID and CLIN
programs are exceptions to the single project rule. At any point in
time, an investigator may have no more than three Merit Review awards
(combination of regular and special programs) from BLR&D and CSR&D
services together. For purposes of the single project rule, Centers and
Research Enhancement Award Programs (REAP) are not considered Merit
Reviews.

\(2\) A proposal submitted to BLR&D or CSR&D may not be submitted
simultaneously to any other component of ORD (RR&D, HSR&D, or CSP).

d.  **[Budget of Merit Awards]{.underline}****[.]{.underline}** A Merit
    Review proposal requires a budget of at least \$50,000 per year,
    exclusive of equipment and non-clinician PI salary, and at least 2
    years duration to complete the proposed research. Currently, Merit
    Review budgets are capped at an annual cost of \$150,000 excluding
    non-clinician PI salary and equipment. Merit Review equipment
    requests may not exceed a total of \$50,000. Budgetary constraints
    may reduce these caps in any given cycle. Rare exceptions to the
    budget cap may be granted for compelling circumstances. Requests for
    exceeding budget caps must be included in the letter of intent
    (Appendix D). Requests to exceed either the annual budget or
    equipment limit may be sent along with the LOI at any time, but must
    be received at least 2 months prior to the Merit Review application
    receipt deadline.

e\. **[Duration of Merit Awards.]{.underline}** Guidelines for award
duration are based on past award history and experience of the PI as a
nationally peer-reviewed PI.

\(1\) Applicants who will have less than 3 years of Merit Review funding
or other nationally peer-reviewed, non-mentored funding by the proposed
start of the award may request a 2 or 3-year duration.

\(2\) Applicants who will have a minimum of 3 years previous Merit
Review or equivalent nationally peer-reviewed, non-mentored funding by
the proposed start of the award may request a duration of 2 to 4 years.

\(3\) Applicants with a minimum of 6 years previous Merit Review or
equivalent nationally peer-reviewed, non-mentored funding by the
proposed start of the award may request a duration of 2 to 5 years.

\(4\) Proposals that do not conform to these guidelines must contain
detailed justification for the requested award duration in the
concurrence memorandum from the Chair, R&D Committee.

f\. **[Preparing the Application.]{.underline}** Deadlines for
submission of [all]{.underline} applications for new, revised, or
renewal Merit Reviews and detailed procedures for preparing the
application are listed in Appendix A.

(1) Additional requirements and supplemental instructions for EPID and
    CLIN programs are explained in Paragraphs 6 and 7 respectively.

\(2\) The PI needs to give careful attention to all instructions;
applications that fail to meet BLR&D and CSR&D requirements may be
administratively withdrawn without review. A properly prepared document
that follows the requirements and guidelines facilitates both
administrative processing and peer review of the proposal. No additional
or replacement information will be accepted after submission of the
proposal, unless requested by the Program Review Division. The only
exceptions are official letters of acceptance for publication of
manuscripts submitted by the PI. These may be sent to the Program Review
Division at any time.

\(3\) All Merit Review proposals must be evaluated and approved by the
local VA medical center R&D Committee and the Director of the medical
center prior to submission to VA Central Office. Proposals submitted to
VA Central Office without documentation of proper local review will be
withdrawn without review.

\(4\) Two weeks prior to the application deadline, the local research
service must provide the Research and Development Computing Center
(RDCC), through the PROMISE system, the names of all investigators
intending to submit Merit Review proposals. The receipt date is waived
only in compelling circumstances and any waiver must be obtained in
advance from the Program Review Division. If a proposal is withdrawn,
the Program Review Division must be notified promptly by telephone with
a written follow-up.

\(5\) Appendix A has instructions for preparing Merit Review proposals.
Supplemental instructions for EPID and CLIN applications are in Appendix
B and Appendix C, respectively.

g\. **[Proposal Review.]{.underline}** Subcommittees of the BLR&D and
CSR&D Merit Review Committee evaluate Merit Review proposals. Proposal
review is described in Paragraph 8 of this Handbook.

h\. **[Appeals.]{.underline}** There is a formal process to appeal the
recommendation of a Merit Review Subcommittee. The appeals process is
intended to ensure that the scientific review of all proposals is fair
and equitable. It is not intended as a means to resolve differences in
scientific opinion between the applicant and the reviewers, to adjust
funding decisions, or to circumvent the peer review process. The basis
for an appeal and the procedure for submitting an appeal are detailed in
Appendix G. If a PI submits a revised application and an appeal of the
previous application is subsequently sustained and funded, the revised
application will be administratively withdrawn. If the revised
application receives a fundable score and the appeal is sustained and
fundable, the single project rule applies, and only one of the two
projects will be funded.

i\. **[Research Integrity.]{.underline}** BLR&D and CSR&D are committed
to the highest standards for the ethical conduct of research.
Maintenance of high ethical standards requires that VA medical centers
and investigators applying for, and receiving, Merit Review awards have
appropriate procedures to preclude the occurrence of unethical research
practices. All research data must be retained for 5 years after
completion of a research project.

\(1\) The PI and others associated with the research must subscribe to
accepted standards of rational experimental research design, accurate
data recording, unbiased reporting of data, respect for the intellectual
property of other investigators, adherence to established ethical codes,
legal standards for the protection of human and animal subjects, and
proper management of research funds.

\(2\) Deliberate falsification or misrepresentation of research data
will result in withdrawal of an application, possible suspension or
termination of an award, and potentially, suspension of the
investigator's rights to submit proposals to BLR&D and CSR&D.

j\. **[Acknowledging VA Research Support.]{.underline}** By accepting a
Merit Review award, the PI agrees to properly acknowledge VA in all
public reports and presentations (see VHA Handbook 1200.19). Failure to
acknowledge VA affiliation and support may result in termination of the
award.

k\. [**Intellectual Property Rights**,]{.underline} By accepting a Merit
Review award the PI agrees to comply with VA policies regarding
intellectual property disclosure obligations and Federal Government
ownership rights resulting from the proposed work (see VHA Handbook
1200.18).

l\. **[Renewal Of Awards.]{.underline}** The deadline for receipt of the
renewal application in VA Central Office can be found on the monthly
Budget Allocation Report in the Office of the ACOS for R&D.

\(1\) To provide for continuity of funding, BLR&D and CSR&D will accept
renewal applications for review one round prior to the deadline. For
example, if the renewal application is due in the Spring 2005 cycle,
renewal applications will be accepted for review in the Fall 2004 cycle.
This allows the investigator to submit an application and one revision
(if the renewal is not funded) without experiencing a funding gap. If
the early submission is approved for funding, the PI may opt for one of
the following scenarios: delay the new project start date until the
[conclusion]{.underline} of the currently funded project; or start the
new project at the earliest possible start date, terminating the
currently funded project before its conclusion.

\(2\) BLR&D and CSR&D discourage submitting renewal applications
[more]{.underline} than one round early (in the example above,
submitting an application for review in the Spring 2004 cycle or
earlier). **Submitting more than one round early may jeopardize
continued funding and the investigator needs to carefully consider the
consequences.** If the new submission is approved for funding, it will
replace the ongoing project and there will be no funding gap. If the
early submission is not approved for funding, the currently funded
project will terminate prematurely at the end of September for proposals
reviewed in the Spring cycle or at the end of March for proposals
reviewed in the Fall cycle.

m\. **[Continuation of Non-clinician PI Employment]{.underline}**

\(1\) Funding for a non-clinician Ph.D. A PI's appointment may be
continued for 1 year beyond the termination date of the investigator's
funded Merit Review or EPID project provided the investigator:

\(a\) Remains employed by VA,

\(b\) Continues to meet all deadlines for applying for Merit Review
funding, and

\(c\) Continues to participate in the overall research effort at the
facility.

\(2\) Funding for the employment of the non-clinician PI of a CLIN
project terminates on the funding termination date, as the award is not
renewable.

n\. **[Change in the Location of the PI.]{.underline}** If the PI of a
funded Merit Review project transfers to another VA medical center, the
new medical center may request a transfer of unexpended Merit Review
funds. The R&D Committee (and appropriate subcommittees) at the new
medical center must evaluate and approve the project. The new medical
center must initiate the request to transfer the project. (Note: the
original medical center must submit a page 19 to identify the funds to
be withdrawn and transferred to the new medical center).

\(1\) The request shall cite the committee approval dates, the PI's
employment status (to ensure eligibility), and the location of the PI's
laboratory at the VA.

\(2\) If needed, an eligibility and/or off-site waiver must be obtained
prior to submitting a transfer request. A non-clinician Ph.D. must
request acceptance into the BLR&D and CSR&D intramural programs.
Acceptance is based upon the PI's proposed activities at the new site
(see Appendix E).

\(3\) All correspondence regarding change in the PI's location needs to
be addressed to the Director of BLR&D or CSR&D service. The Director,
BLR&D or CSR&D, must approve the transfer of funds.

o\. **[Change in PI.]{.underline}** Requests to change the PI are
discouraged. In rare cases, a request to transfer an ongoing Merit
Review award from the current PI to a new PI at the same VA medical
center for a period not to exceed 1 year may be considered. The Merit
Review project of a PI who is newly approved (funded for less than 1
year) may only be transferred to a co-investigator currently assigned to
the project.

\(1\) It is expected that during the 1-year transfer period, the new PI
will submit a renewal application for merit review.

\(2\) The request to transfer the PI must include a memorandum from the
facility Director and current PI indicating agreement with the request,
and a justification for the change. Include the curriculum vitae of the
proposed PI. The R&D Committee must approve the request to change the
PI. ***NOTE:** The proposed PI must be an eligible, qualified
investigator, currently involved in the research as a co-investigator or
active collaborator.*

\(3\) If the proposed new PI has an active Merit Review project, the
transferred project will be considered supplemental and it will end on
or before the termination date of the new PI's active project.

\(4\) All correspondence regarding change in the PI should be addressed
to the Director, BLR&D or CSR&D service. The Director, BLR&D or CSR&D
must approve the request for transfer.

######## **6. EPIDEMIOLOGY RESEARCH PROGRAM (EPID)**

The Epidemiology Research Program (EPID) is a special Merit Review
Program of BLR&D and CSR&D. This section provides policy and guidelines
regarding EPID and instructions for submission of a LOI to the program.

a\. **[Background.]{.underline}** The previous ORD program announcement
entitled "Epidemiology Research" described the opportunity for VA
investigators to submit investigator-initiated epidemiology research
proposals to ORD. ***NOTE:** This section supersedes all previous EPID
announcements.* The primary objective of EPID is to foster
epidemiological studies in areas of high relevance to the VA research
mission.

b\. **[Scope.]{.underline}** For the purpose of EPID, epidemiological
research is defined as investigator-initiated studies that employ a
population based approach in design and methodology and investigate the
prevalence, etiology, and risk factors of diseases and disorders
affecting veterans. Epidemiological studies may also assess the efficacy
of modern diagnostic, treatment, and preventive strategies. Of
particular interest to this program is the molecular epidemiology of
chronic diseases.

\(1\) All projects fulfilling these criteria shall be submitted as EPID
applications. If there is any doubt whether a study meets the EPID
definition, the PI may contact the appropriate program manager prior to
submitting a letter of intent (LOI). LOI instructions are provided in
Appendix D. EPID proposals inappropriately submitted as a standard Merit
Review may be administratively withdrawn.

\(2\) It is recommended that applicants with no previous experience in
conducting epidemiology research consult with one of the Epidemiology
Research and Information Centers (ERICs) prior to submitting an LOI and
subsequently a proposal.

c\. **[Application Requirements.]{.underline}**

\(1\) EPID is open to all BLR&D and CSR&D investigators who are eligible
to submit Merit Review proposals to BLR&D or CSR&D services. EPID is an
exception to the single Merit Review rule (see subpar. 5c and subpar.
5d), though an investigator may have only one funded EPID project at any
given time.

\(2\) Each applicant to EPID is required to submit an LOI, which may be
sent at any time, but must be received by two months before the full
application receipt deadline. LOIs received after these deadlines will
be reviewed for the subsequent round.

\(3\) An EPID budget shall not exceed \$150,000 per year, excluding
non-clinician PI salary and equipment.

\(4\) A request to exceed budget limits must be included in the LOI for
a proposal requesting any of the following (see App. D):

a\. A budget in excess of \$150,000 per year, exclusive of non-clinician
PI salary, and equipment.

b\. Equipment in excess of \$50,000 total.

\(5\) EPID LOIs must be prepared in accordance with the instructions
provided in Appendix D.

d\. **[Submission of Applications.]{.underline}** Complete EPID
applications must comply with the instructions for submitting a Merit
Review proposal in Appendix A and supplemental instructions in Appendix
B.

\(1\) An application that is disapproved may not be resubmitted.

\(2\) An application that is approved, but not funded, may be revised
and resubmitted according to the recommendations of the Epidemiology
Merit Review Subcommittee.

e\. **[Questions and Inquiries.]{.underline}** Discussion of possible
epidemiology research proposals with the Program Manager for the
Epidemiology Research Program prior to LOI submission is encouraged.

**7. CLINICAL RESEARCH PROGRAM (CLIN)**

The Clinical Research Program (CLIN) is a special Merit Review program
of CSR&D. This paragraph provides guidelines regarding CLIN and
instructions for submission of an LOI for a CLIN application.

a\. **[Scope.]{.underline}** For the purpose of CLIN, clinical research
is defined as randomized clinical trials involving veterans as research
participants, designed to assess the effects of potential biomedical or
bio-behavioral therapeutic interventions. Studies need to compare groups
receiving different treatments, or a treatment(s) versus a control
condition. Endpoints of the potential therapeutic interventions are to
be clearly defined and can be either definitive clinical outcomes or
intermediate physiological measures. A CLIN proposal is typically a
single-site or a small multi-site study. Unless noted in the following,
all Merit Review guidelines, requirements and restrictions apply to
CLIN.

\(1\) All projects fulfilling these criteria must be submitted as a CLIN
proposal. If there is any doubt about whether a study meets the CLIN
definition, the PI may contact the program manager for CLIN prior to
submitting an LOI. LOI instructions are provided in Appendix D.

\(2\) CLIN proposals that are inappropriately submitted as regular Merit
Review applications may be administratively withdrawn.

\(3\) Studies that are [not]{.underline} appropriate for CLIN include:
observational studies, correlative studies, device development,
development of diagnostic markers, gene expression profiling and studies
designed to understand mechanisms of resistance to therapeutic
interventions.

\(a\) Biphasic studies that determine the role of a factor in a disease
(cause and effect) followed by an interventional approach are considered
premature for CLIN. The cause and effect component must be submitted as
a regular Merit Review proposal.

\(b\) Studies designed to assess the best practice method or
cost-efficacy of interventions, are not appropriate for submission to
CSR&D.

\(4\) Phase I (safety) trials require prior approval from the Chief
Research and Development Officer*.*

b\. **[Application Requirements.]{.underline}** A typical CLIN proposal
should describe a single-site or small multi-site study with a budget
not to exceed \$150,000 per year, excluding non-clinician PI salary and
equipment, for up to 3-years duration. It is anticipated that funded
studies will produce a definite answer to an intermediate endpoint
related to potential therapeutic intervention, produce a definite answer
to a clinical question, or lead to a larger clinical trial. Therefore,
CLIN awards are not renewable through this program.

\(1\) CLIN is open to all BLR&D and CSR&D investigators eligible to
submit proposals to Merit Review (see par. 5) and is an exception to the
single Merit Review rule (see par. 5), though an investigator may have
only one funded CLIN proposal at any given time.

\(2\) Each applicant is required to submit an LOI, which may be sent at
any time but must be received two months before the full application
deadline. LOIs received after these deadlines will be considered for the
subsequent round.

\(a\) A request for exception must be included in the LOI package for a
proposal requesting any of the following:

[1]{.underline}. A budget in excess of \$150,000 per year, exclusive of
non-clinician PI salary and equipment, or

[2]{.underline}. Equipment in excess of \$50,000 total, duration of more
than 3 years, or

[3]{.underline}. Participation of more than one research site

\(b\) LOIs must be prepared in accordance with the instructions provided
in Appendix D.

c\. **[Submission of Applications.]{.underline}** CLIN applications must
follow the Merit Review instructions in Appendix A and supplemental
instructions in Appendix C.

\(1\) An application that is disapproved may not be resubmitted.

\(2\) An application that is approved, but not funded, may be revised
and resubmitted only if a resubmission is recommended by the Clinical
Research Program (CLIN) Subcommittee and approved by the Director,
CSR&D.

d\. **[Non-clinician PI Salary.]{.underline}** The salary of the
non-clinician PI of a CLIN project terminates on the funding termination
date.

e\. **[Questions And Inquiries.]{.underline}** Discussion of possible
clinical research proposals with the CSR&D Program Manager for the
Clinical Research Program prior to LOI submission is encouraged.

**8. REVIEW OF MERIT REVIEW PROPOSALS**

This paragraph describes the process used for review of all Merit Review
applications. It is the goal of BLR&D and CSR&D to fund only
applications that propose research that is scientifically meritorious
and relevant to the health of veterans.

a\. **Scope.** Subject matter experts review all Merit Review
applications for scientific quality. The BLR&D and CSR&D Merit Review
Committee is the Federal Advisory Committee responsible for the
scientific review of Merit Review proposals. The Committee is comprised
of Subcommittees that serve as the review groups. Subcommittees may be
further divided into panels depending on the number and scope of
applications received.

b\. **[Description of Merit Review Subcommittees.]{.underline}** The
scientific purview of the Subcommittees is provided in Appendix H.

\(1\) The Committee members are recruited from VA medical centers,
universities, industry, public and private research foundations, and
other Federal and state government agencies.

\(2\) Committee members are expected to:

\(a\) Have broad knowledge in their areas of expertise,

\(b\) Have a history of peer reviewed funding or the equivalent
scientific experience, and

\(c\) Be leaders in their fields.

\(3\) Members of the Committee serve 4-year terms that may be extended.

\(4\) Ad hoc members may be recruited as needed.

\(5\) The Secretary for Veterans Affairs appoints committee members
based on nominations from the Directors, BLR&D and CSR&D services.

\(6\) The proceedings of the Subcommittee meetings are confidential.

c.  **[Review Process.]{.underline}**

\(1\) The Merit Review Subcommittees review all Merit Review
applications including CLIN and EPID. MREP proposals are also reviewed
by the Subcommittees. Merit Review Subcommittees consist of core members
and ad hoc consultants. Each application is reviewed by three subject
matter experts: one primary and two secondary reviewers. All
Subcommittee members are present at the meeting. However, in certain
circumstances, a member may participate by teleconference or contribute
a review by mail.

[]{.mark}

\(2\) During a convened meeting, reviewers present the research proposed
and their individual evaluations. The Chair opens the discussion to the
entire Subcommittee. Following discussion and assignment of a priority
score, Subcommittee members comment on any ethical, biosafety, animal
studies, or human studies concerns. If it appears that the proposal will
fall within a possible fundable range, the budget and duration of the
award are discussed and recommendations are made. A preliminary draft
Summary Statement reflecting the discussion and the recommendations of
the Subcommittee is prepared at the meeting. A final Summary Statement
is prepared after administrative review, which may contain additional
administrative notes.

d\. **[Criteria for Review and Scoring of the Proposal]{.underline}**

\(1\) The following criteria are considered during scientific merit
review:

\(a\) Significance of the research.

\(b\) Scientific approach, including preliminary data and
appropriateness of experimental design.

\(c\) Feasibility of the proposed studies including the expertise of the
PI and collaborators and the environment available for conducting the
studies.

\(2\) All Subcommittee members, including ad hoc members, present during
the review and discussion of the proposal assign a priority score from
10-50 with 10 being the most meritorious score. Following the conclusion
of the meeting, the priority scores are averaged. The Subcommittee is
not apprised of the mean priority score voted for the proposal at the
meeting.

e\. **[Conflict Of Interest.]{.underline}** Subcommittee members do not
participate in review of proposals from their own institutions or those
proposals from investigators with whom they have a scientific or
personal relationship. Subcommittee members who have a conflict of
interest based on academic and/or research affiliations, collaboration,
or personal relationships are not present during discussion of a
proposal, do not assign a score, and are not made aware of the scoring
for that proposal.

f\. **[Disapproved Proposals.]{.underline}** A proposal may be
disapproved if the Subcommittee determines that the proposed studies are
unethical or are unlikely to yield useful information.

\(1\) Proposals that are disapproved are not given a numerical score and
may not be resubmitted.

\(2\) Studies disapproved for ethical considerations may not be carried
out in VA space, or with VA resources, even if the project is funded by
another agency.

g\. **[Director.]{.underline}** The results of the scientific merit
review process are forwarded as recommendations to the Directors, BLR&D
and CSR&D services.

\(1\) The recommendations, along with programmatic priorities, are used
by the Directors, BLR&D and CSR&D, to determine which proposals shall be
recommended for funding to the Chief R&D Officer.

\(2\) If the Merit Review Subcommittee expressed serious concerns about
the procedures described for human or animal studies, biosafety, or
administrative and/or budgetary issues, the Director will place a "hold"
on the application. If the hold is placed for human, animal, or
biosafety issues, the work described in the application may not be
initiated until the hold is lifted. This is so, regardless of whether
the work is funded or not.

h\. **[Responsibilities.]{.underline}** The Portfolio Manager of the
Subcommittee is the designated Federal Official in charge of the
Subcommittee meetings and is responsible for conducting the meeting in
accordance with the policies of VHA BLR&D and CSR&D services and the
Federal Advisory Committee Act.

## PREPARATION AND SUBMISSION OF A MERIT REVIEW PROPOSAL 

**1. GENERAL INSTRUCTIONS FOR PROPOSAL PREPARATION**: The Merit Review
Award Program (Merit Review) proposal is the principal mechanism for
funding investigator-initiated, intramural research. ***NOTE:** The
instructions in this Appendix apply to all new, resubmission and renewal
proposals and supersede all previous instructions.* The Office of the
Associate Chief of Staff (ACOS) for Research and Development (R&D), or
equivalent, at the local Department of Veterans Affairs (VA) medical
center provides assistance in proposal preparation and is responsible
for submitting proposals to VA Central Office. Before preparing an
application, consult with the office of the ACOS for R&D. While these
instructions are applicable to Merit Review, special programs such as
MREP, EPID, CLIN, and Requests for Proposals, may have additional
submission requirements.

a.  **Letter of Intent (LOI).** All Merit Review programs, including
    Clinical Research Program (CLIN) and Epidemiology Research Program
    (EPID) require a letter of intent (LOI) prior to submitting
    applications. In addition, applications in response to the
    Deployment Health Research Request for Applications (RFA), which are
    reviewed by appropriate Merit Review Subcommittees, also require an
    LOI. LOIs will [NOT]{.underline} be evaluated for scientific merit,
    but rather to assess assignments to the appropriate Service (BLR&D
    or CSR&D) and to the appropriate Merit Review Subcommittees. The
    LOIs for special programs (CLIN, EPID and Deployment Health
    Research) will also be evaluated for program-specific requirements.

> []{.mark}
>
> \(1\) If you are unsure of whether your study meets the requirements
> for a special Merit Review program or the Deployment Health Research
> Initiative, be sure to discuss submission requirements with the ACOS
> for R&D or contact the appropriate Program Manager in BLR&D/CSR&D at
> VA Central Office.
>
> \(2\) For Instructions on preparation and submission of LOIs to the
> Merit Review Program, including EPID and CLIN, see Appendix D.
>
> \(3\) LOIs will be accepted throughout the year. Early submission of
> LOIs is encouraged. The last date for submitting an LOI for the Spring
> Merit Review round is January 15 and for the Fall Merit Review round
> is July 15. LOIs submitted after these deadlines will be considered
> for the subsequent round.

+---------------------------------------+---+--------------+------------+
| # **TABLE 1                           |   |              |            |
| - Receipt, Review, and Award Cycles** |   |              |            |
+---------------------------------------+---+--------------+------------+
|                                       | * |              | **Fall     |
|                                       | * |              | Round**    |
|                                       | S |              |            |
|                                       | p |              |            |
|                                       | r |              |            |
|                                       | i |              |            |
|                                       | n |              |            |
|                                       | g |              |            |
|                                       | R |              |            |
|                                       | o |              |            |
|                                       | u |              |            |
|                                       | n |              |            |
|                                       | d |              |            |
|                                       | * |              |            |
|                                       | * |              |            |
+---------------------------------------+---+--------------+------------+
| **Receipt Dates**                     |   |              |            |
+---------------------------------------+---+--------------+------------+
| Letters of Intent for MERIT, EPID,    |   | January 15   | July 15    |
| CLIN, Deployment Health, MREP, and    |   |              |            |
| Budget Caps                           |   |              |            |
+---------------------------------------+---+--------------+------------+
| Requests for Off-site Waivers,        |   | January 15   | July 15    |
| Eligibility and Acceptance into the   |   |              |            |
| Research Program                      |   |              |            |
+---------------------------------------+---+--------------+------------+
| Intent to Submit (electronic through  |   | March 1      | September  |
| PROMISE)                              |   |              | 1          |
+---------------------------------------+---+--------------+------------+
| Merit Review Applications including   |   | March 15     | September  |
| EPID, CLIN, Deployment Health, and    |   |              | 15         |
| MREP Applications Applicationss       |   |              |            |
+---------------------------------------+---+--------------+------------+
| Suggestions for Subcommittee          |   | March 16     | September  |
| assignment and Reviewers              |   |              | 16         |
+---------------------------------------+---+--------------+------------+
|                                       |   |              |            |
+---------------------------------------+---+--------------+------------+
| **Review and Award Schedule**         |   |              |            |
+---------------------------------------+---+--------------+------------+
| Scientific Merit Review               |   | May-June     | Nov-Dec    |
+---------------------------------------+---+--------------+------------+
| Earliest Project Start Date           |   | October 1    | April1     |
+---------------------------------------+---+--------------+------------+

b\. **[Deadlines]{.underline}**. Avoid delays and misunderstandings by
reading and following the instructions carefully. Table 1 contains
deadlines that apply to the submission of Merit Review applications.
Depending on the investigator's particular circumstance, requests for
off-site waiver, eligibility determination, acceptance into the
intramural program, or approval to exceed budget limits may be needed
(see par. 5 of this handbook). The Office of the ACOS for R&D or BLR&D
and CSR&D Portfolio Managers can help determine which approvals may be
needed.

c\. **[Approvals]{.underline}**. Prior to submission to VA Central
Office, all proposals require approval by the local facility's R&D
Committee. In addition, the ACOS for R&D has to obtain letters and
concurrence from several offices at the local VA medical center. The
ACOS for R&D can provide the local submission deadlines.

\(1\) If the proposal is submitted [prior]{.underline} to receiving
approval by any required R&D subcommittees (e.g., Human Studies
Subcommittee, Animal Studies Subcommittee, etc), the R&D Committee
approval is for submission purposes only. The proposed research [may
not]{.underline} proceed until approval is received by all required
subcommittees and reviewed again by the R&D Committee for approval to
conduct the proposed research.

\(2\) Proposals lacking the required local approvals and concurrences
will be administratively withdrawn.

\(3\) No additional or replacement information will be accepted after
submission of the proposal unless requested by the Program Review
Division.

d\. **[Intent to Submit]{.underline}**. Depending on the round, the ACOS
for R&D must transmit a list of names of PIs, via the Project Management
and Information System (PROMISE), to the Research and Development
Computing Center (RDCC) by March 1 or September 1. This step is required
in addition to the submission of an LOI .

**2. SPECIFIC INSTRUCTIONS FOR PROPOSAL PREPARATION.** Obtain a Merit
Review Program packet from the ACOS for R&D. The packet should contain
all the forms necessary for completing the application and any
additional forms required for local review. Official VA research forms
in PDF and Word format can be found at
<http://www.va.gov/resdev/fr/forms.cfm>. Use a clear, black font when
filling out all forms. Font size for all text shall be at least 11
point. Certain forms must be submitted electronically through the
PROMISE system. ACOS for R&D staff will assist in printing and
submitting these forms.

a\. **[Page 1; VA Form 10-1313-1, Merit Review
Application.]{.underline}** ACOS for R&D staff, familiar with the use of
the PROMISE program, will help enter the data for 10-1313-1. The program
will generate (from the internal database) default values for a number
of the fields, so it is important to check each field for accuracy.

\(1\) [Blocks 1, 2, and 3]{.underline}. Left blank.

\(2\) [Block 4 (review date)]{.underline}. The season and the year for
the upcoming round of review. For example if the submission deadline is
March 15, 2004, the review date is Spring 2004. If the submission
deadline is September 15, 2004, the review date is Fall 2004.

\(3\) [Block 5 (facility number)]{.underline}. The number assigned to
the PI's VA medical center as listed in PROMISE.

\(4\) [Block 6]{.underline}. The location of the VA medical center by
city and state. ***NOTE:** The Research and Development Information
System (RDIS) and RDCC use this information to denote a VA medical
center rather than the facility name or a regional designation.*

\(5\) [Block 7]{.underline}. The social security number of the PI.
***NOTE:** The social security number should appear on the original form
only. It must be redacted from all copies of the proposal.*

\(6\) [Block 8]{.underline}. The last date the PI submitted a Merit
Review application regardless of its outcome. A blank indicates that no
Merit Review proposal on any topic, including EPID and CLIN, has ever
been submitted.

\(7\) [Block 9]{.underline}. The last name, first name, middle initial,
degree(s) of the PI, and VA telephone number of the PI.

\(8\) [Block 10]{.underline}. The title of the project, which may not
exceed a total of 72 characters including spaces. The title should
reflect the content of the application as accurately as possible.

\(9\) [Block 11]{.underline}. The total budget for each year of
requested funding and the total amount for all years of the program. The
amounts and duration shall agree exactly with the totals on VA Form
10-1313-3 and VA Form 10-1313-4. Amounts on the paper copy must equal
those submitted electronically. All budget totals and subtotals shall be
rounded to the nearest \$100 (see instructions for forms VA Form
10-1313-3 and VA Form 10-1313-4).

\(10\) [Block 12]{.underline}. The employment status in VA paid 8ths of
the PI at the time of application.

\(11\) [Block 13]{.underline}. The PI's source of employment at the time
of application. All VA employees are employed either through the medical
care appropriation or through the medical research and prosthetics
appropriation.

\(a\) Check with the appropriate service chief or the ACOS for R&D for
the correct appropriation.

\(b\) PIs appointed on the medical care appropriation need to check
"Patient Care." Investigators appointed on the medical care
appropriation cannot request salary in the application.

\(c\) Non-clinicians appointed on the medical research and prosthetics
appropriation and requesting salary through this proposal should
indicate cost center CC103.

\(d\) Career Development awardees need to indicate CC108 as their
employment source.

\(e\) Research Career Scientists are to indicate CC110, but may
[not]{.underline} request salary in the proposal.

\(f\) Applicants receiving salary from other ORD services (Health
Services Research and Development (HSR&D), Rehabilitation Research and
Development (RR&D), Cooperative Studies Program (CSP) must be accepted
into the BLR&D and CSR&D intramural program prior to submitting an
application (see Appendix G).

\(12\) [Block 14]{.underline}. If the PI, at the time of application,
has not had Merit Review funding in the past 5 years, the "NEW" box
should be checked; otherwise check the "ONGOING" box. The "No. Projects
in Program" may be left blank.

\(13\) [Block 15]{.underline}. Under "Program" enter "821" for BLR&D and
CSR&D and under "Cost Center" enter CC103, which is the cost center
designation for Merit Review awards.

\(14\) [Block 16]{.underline}. Primary Research Program Area and Primary
Specialty Area are selected from a list in PROMISE.

\(15\) [Block 17]{.underline}. VA Hospital Service and Section are
selected from a list in PROMISE.

\(16\) [Block 18]{.underline}. Enter PI's current academic rank, primary
academic department, and the name of the university affiliation.

\(17\) [Block 19]{.underline}. Program Use; check each block that
applies. ***NOTE:** If the inclusion of human or animal studies cannot
be correctly entered through PROMISE because of just-in-time procedures,
please correct the original and all copies of the proposal by manually
placing a large X in the appropriate yes box(es).*

\(a\) [Human Subjects.]{.underline} This box must be checked if the
research has any relation to human beings, even if the institutional
review board (IRB) has found the research to be exempt.

[1]{.underline}. Check this box if human subjects are exposed to
manipulations or interventions, interact with researchers, or can be
identified from data collected, even if the data already exists.

[2]{.underline}. Also, check this box if human tissues are obtained.
Tissues include, but are not limited to, biopsies, blood, cerebrospinal
fluid, urine, feces, saliva, nail clippings, hair, sweat, and tears.

[3]{.underline}. Check the box if human tissue is obtained from surgery
or autopsy, tissue banks, other non-profit sources, or commercial
sources.

[4]{.underline}. Work on human immortalized cell lines is not considered
research on human subjects, but does involve biohazards.

[5]{.underline}. If the research involves banking of human specimens,
gene testing, gene transfer, and/or stem cells, it must comply with all
VA policies and guidelines regulating the conduct of such activities.

\(b\) [Animal Subjects.]{.underline} The animal subjects boxes should be
checked for any proposal using animals or animal tissues using the
criteria in items (1) and (2) below. These criteria do not serve as a
basis for determining if local Institutional Animal Care and Use
Committee (IACUC) approval is required; they should be used only for the
purposes of determining if an Animal Component of Research Protocol
(ACORP) must be submitted as a prerequisite for receiving VA funding for
a Merit Review application.

 

\(1\) An ACORP must be submitted when requested if any of the following
conditions apply (the \"Yes\" box for animal subjects should be
checked):

> \(a\) Animals are requested in the application budget for use in
> proposed experiments.
>
> \(b\) Animals purchased with other VA funds or with non-VA funds would
> be used primarily or exclusively for experiments proposed in the
> application.
>
> \(c\) Animal tissues or primary cell lines purchased with other VA
> funds or with non-VA funds would be derived from animals sacrificed
> primarily or exclusively for use in the experiments proposed in the VA
> application.

 

> \(2\) An ACORP is not required for submission if the proposed animal
> use meets one of the following criteria (the \"No\" box for animal
> subjects should be checked:

 

> \(a\) Immortal animal cell lines or explants would be used in the
> proposed experiments such that no additional animals would need to be
> euthanatized to meet application objectives.
>
> \(b\) Animals on other IACUC-approved projects would be used, but
> these animals would be utilized for other projects even if the need
> for the animals by the proposed VA project did not exist.
>
> \(c\) Animal tissues, blood and other body fluids, or primary cell
> lines would be obtained from live animals on other IACUC-approved
> protocols, but samples from these animals would be collected even if
> the need for the tissues or cell lines by the proposed VA project did
> not exist.
>
> \(d\) Animal tissues, blood and other body fluids, or primary cell
> lines would be obtained from animals euthanatized while on other
> IACUC-approved protocols, but samples from these animals would be
> collected even if the need for the tissues or cell lines by the
> proposed VA project did not exist.
>
> \(e\) Animal-derived reagents or products such as serum, antibodies
> and mediators required in the application are limited to those that
> would be purchased from a USDA-licensed commercial vendor.

 

> \(3\) If guidance is needed on applying the criteria in paragraphs (1)
> and (2), the Chief Veterinary Medical Officer (CVMO) should be
> contacted.

\(c\) [Investigational Drugs or Devices.]{.underline} Check the
appropriate box if the use of investigational drugs or devices with
human subjects is proposed.

\(d\) [Radioisotopes.]{.underline} If radioisotopes are used, check the
"Radioisotopes" box and include appropriate information in the biohazard
form. The local Radiation Safety Committee must approve the use of
radioisotopes before any studies contained in the application may be
conducted.

\(e\) [Biohazard.]{.underline} Almost all research submitted to BLR&D
and CSR&D involves biohazards. Blood, however obtained, cerebrospinal
fluid, and all body secretions and excretions, e.g., urine, feces,
saliva, sweat, and tears, are biohazards. Most chemicals used in
laboratories are biohazards.

[1]{.underline}. A checklist of biohazards by category is provided on
the first page of Appendix G of

VHA Handbook 1200.8. If the research uses any of the products listed in
the appendix, the Biohazards box must be checked.

[2]{.underline}. Questions about research safety documentation are to be
directed to the VA Central Office Research Biosafety Officer.

\(18\) [Block 20]{.underline}. Summarize the PI's research support for
the last 3 fiscal years in chronological order. "Non-VA" includes all
other sources of research funding other than VA.

\(19\) [Block 21]{.underline}. Insert the date the PI entered or will
enter VA duty (all applicants must be VA employees at the time the
application is funded).

\(20\) Signatures and dates in this block must be within 6 months of the
submission due date, and the date the ACOS for R&D signed must be
subsequent to the approval date of the R&D Committee. The signature of
the ACOS for R&D signifies the completeness and accuracy of the contents
of the application. The signature of the PI signifies responsibility for
the proposal contents, the scientific responsibility for the proposed
projects, and agreement to follow VA policies for acknowledging VA
support and intellectual property rights. "Per," "by," or "for"
signatures are not acceptable.

b\. **[Page 2, VA Form 10-1313-2, Summary Description of
Project/Program.]{.underline}**

\(1\) The PI's name and project title must be exactly as written on Page
1 (VA Form 10-1313-1).

\(2\) Use keywords that describe the disease, system, mechanism being
studied, and major methods and/or techniques used. Because the keywords
are used for searches and portfolio related issues, only Medical Subject
Headings (MeSH) terms may be used. The ACOS for R&D has a MeSH terms
book, which is also available at the medical center library or may be
obtained online (<http://www.nlm.nih.gov/mesh/meshhome.html)>.

\(3\) **Summary Description.** The summary description (abstract) of the
proposal provides information about the hypotheses to be tested,
specific objectives, relevance, subject population, procedures to be
used, and the significance of potential new findings. It must include
enough information so that the proposal can be referred to the
appropriate Merit Review Subcommittee and reviewers. Use only the
allotted space.

+-----------------------------------------------------------------------+
| # **TABLE 2 -- Table of Contents**                                    |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| VA Form 10-1313-1 - front page  1[ ]{.underline}                      |
+-----------------------------------------------------------------------+
| VA Form 10-1313-2 - (abstract) [ 2 ]{.underline}                      |
+-----------------------------------------------------------------------+
| Table of Contents [ 3 ]{.underline}                                   |
+-----------------------------------------------------------------------+
| VA Form 10-1313-3 - first year budget  [4 ]{.underline}               |
+-----------------------------------------------------------------------+
| VA Form 10-1313-4 - all years budget and justification                |
|  [5 ]{.underline}                                                     |
+-----------------------------------------------------------------------+
| # Investigators' Biographic Information                               |
+-----------------------------------------------------------------------+
| Starting with PI (VA Form 10-1313-5/6, VA Form 10-1313-8;             |
+-----------------------------------------------------------------------+
| Description of any overlap                                            |
+-----------------------------------------------------------------------+
| Follow with complete sets from each co-investigator.                  |
| [    ]{.underline}                                                    |
+-----------------------------------------------------------------------+
| Text of Proposal                                                      |
+-----------------------------------------------------------------------+
| Response (resubmitted applications only, not to exceed 3 pages)       |
| [    ]{.underline}                                                    |
+-----------------------------------------------------------------------+
| List of acronyms/abbreviations [    ]{.underline}                     |
+-----------------------------------------------------------------------+
| Narrative: Parts 1-4 (not to exceed 25 pages)                         |
+-----------------------------------------------------------------------+
| 1\. Rationale [    ]{.underline}                                      |
+-----------------------------------------------------------------------+
| 2\. Background and Significance [    ]{.underline}                    |
+-----------------------------------------------------------------------+
| 3\. Work Accomplished [    ]{.underline}                              |
+-----------------------------------------------------------------------+
| 4\. Work Proposed [    ]{.underline}                                  |
+-----------------------------------------------------------------------+
| Human Studies Section [    ]{.underline}                              |
+-----------------------------------------------------------------------+
| Animal Studies Section [    ]{.underline}                             |
+-----------------------------------------------------------------------+
| Resources (1 page) [    ]{.underline}                                 |
+-----------------------------------------------------------------------+
| Publications from last funding period [    ]{.underline}              |
+-----------------------------------------------------------------------+
| Literature citations (not to exceed 4 pages) [    ]{.underline}       |
+-----------------------------------------------------------------------+
| ######## Administrative Issues                                        |
+-----------------------------------------------------------------------+
| R&D Committee approval memorandum [    ]{.underline}                  |
+-----------------------------------------------------------------------+
| VA medical center Director's memorandum [    ]{.underline}            |
+-----------------------------------------------------------------------+
| Other Letters of Endorsement [    ]{.underline}                       |
+-----------------------------------------------------------------------+
| VA Central Office Approvals: Exceptions, Waivers or Permissions       |
| letters (eligibility,                                                 |
+-----------------------------------------------------------------------+
| acceptance into program, off-site location, exceeding budget cap)     |
| [    ]{.underline}                                                    |
+-----------------------------------------------------------------------+
| For Resubmissions Only:                                               |
+-----------------------------------------------------------------------+
| Previous Reviews [    ]{.underline}                                   |
+-----------------------------------------------------------------------+
| Previous Summary Statement (VA Form 10-1313A) [    ]{.underline}      |
+-----------------------------------------------------------------------+
| Previous Summary Statement Text [    ]{.underline}                    |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+

c\. **[Page 3, Table of Contents.]{.underline}** Use Table 2 as the
format for the Table of Contents. Indicate "N/A" for not included or
non-applicable items. Consecutively number all pages in the application
and place the starting page number for each section in the Table of
Contents.

d\. **[Page 4, VA Form 10-1313-3, Current Funds and First Year Request
for Program/Project]{.underline}.**

> \(1\) All budget subtotals are to be rounded to the nearest \$100.

\(2\) Recurring budget (i.e., total budget less PI salary and equipment)
may not exceed \$150,000 per year nor may the equipment request exceed
\$50,000 unless prior approval has been obtained (see Appendix D).

\(3\) BLR&D and CSR&D services recommend requesting the following
project durations. If requesting more than a 3-year duration, include
all appropriate prior funding history on VA form 10-1313-5/6
([Investigator's Total Research/Development Support]{.underline}).

\(a\) Investigators who will have less than 3 years of Merit Review
funding or other nationally peer-reviewed, non-mentored funding by the
proposed start of the award may request a 2 or 3-year duration.

\(b\) Investigators who will have a minimum of 3 years previous Merit
Review or equivalent nationally peer-reviewed, non-mentored funding by
the proposed start of the award may request a duration of 2 to 4 years.

\(c\) Investigators with a minimum of 6 years previous Merit Review or
equivalent nationally peer-reviewed, non-mentored funding by the
proposed start of the award may request a duration of 2 to 5 years.

\(d\) If it is believed that the work cannot be accomplished within this
suggested timeframe, the transmittal memorandum from the Chair of the
R&D Committee must provide a detailed justification for the additional
years requested. Under no circumstances can more than 5 years of funding
be requested.

\(4\) **Personnel.** Starting with the PI, list all personnel involved
in the project. In the appropriate columns list their names (with Grade
and Step in parentheses), role in the research proposed, the percent
effort each will devote to the project, and whether or not salaries are
requested. Salaries are to include fringe benefits for all personnel to
be paid from BLR&D and CSR&D funds. The maximum allowable fringe
benefits rate is calculated yearly and may be found in the BLR&D and
CSR&D Merit Review program announcement that is sent out prior to the
submission deadlines for each round.

\(a\) Salary requests are to be proportional to the percent effort
listed (non-clinician PI's salaries are an exception, see subpar.
2d(4)(b)). Secretarial salaries are not allowed. Physicians and
dentists, and, in most cases, nurses may not receive salaries from the
medical research and prosthetics appropriation. PIs [cannot]{.underline}
be paid through Inter-agency Personnel Act (IPA) agreements.

\(b\) If the PI is a non-clinician, salaried by research appropriation
CC103, in the "% effort" column the PI must indicate the actual percent
effort that the investigator will expend for the research described in
this application only. However, in the "First Year Requested Funds"
column, the non-clinician PI may request salary consistent with the
total VA effort.

[1]{.underline}. Total VA effort includes the work anticipated in this
application, participation in other VA and non-VA research, service
toward core facilities, teaching, supervision of students, participation
in research centers, service on committees, etc. For example, a
non-clinician PI listing 40 percent effort for the proposed research, 20
percent effort as an uncompensated co-investigator on an National
Institutes of Health (NIH) grant, 15 percent service to research
administration, and 10 percent teaching and mentoring would request 85
percent of the investigator's full-time equivalent salary.

[2]{.underline}. Salary support may be requested [only]{.underline} for
activities that are uncompensated from other sources, such as the
academic affiliate or other funding agencies. Any differences in the
percent effort for the work proposed and total VA effort (salary
support) must be described fully in the budget justification.

\(c\) If the PI is a Research Career Scientist (CC110), list the percent
effort the person will devote to the proposed research, but no salary
may be requested. In the budget justification discuss the investigator's
contribution to the proposed research only.

\(d\) All co-investigators, collaborators, and technical staff, whether
paid or not, are to be listed in the personnel section. There are
restrictions on who can be paid directly by VA. Check with the local
Research Service to ensure that salary is not requested for a person who
cannot be paid directly by VA.

\(e\) If a person is paid through a contract for services or an IPA, put
"IPA" in the column for requested funds. List the specific costs of IPAs
in the "all other expenses" section of the budget.

\(f\) Salary compensation may not be requested for an M.D. if the person
is licensed to practice medicine in the U.S. A clear statement about
licensing must be included in the justification for any salary for M.D.
participants.

\(g\) [Other personnel.]{.underline} Check the list of unauthorized
budget items (Table 3) for personnel who may not be included in proposal
budgets.

\(5\) Include in the "Current Year Funds" column all funds allocated by
the corresponding service (BLR&D or CSR&D) to the investigator for the
12 months preceding the first year request.

\(6\) [Consultants]{.underline}. A consultant may not receive a fee of
more than \$2,500 per year and the consultant's involvement must be
fully explained in the budget justification. There are limitations on
payment to consultants; contact the office of the ACOS for R&D.

\(7\) [Equipment]{.underline}. Although the VA Form 10-1313-3 states
that all equipment in excess of \$3,000 must be listed, BLR&D and CSR&D
services require that each item of equipment, no matter the cost, be
listed separately and thoroughly justified on VA Form 10-1313-4.
Equipment consists of relatively permanent, fixed assets that are
essential to the completion of the proposed research.

\(a\) When feasible, equipment is to be purchased in the first year of
the project. Under unusual circumstances, and if properly justified,
BLR&D and CSR&D services will consider equipment requests in years 2-5.
***NOTE:** Terminology such as 'miscellaneous small pieces of equipment'
is not be used.*

\(b\) Expendable items are to be requested as supplies.

\(c\) Approval must be received in advance to request equipment totaling
more than \$50,000 (see App. F for deadlines and instructions).

\(8\) [Supplies]{.underline}. Itemize expendable supplies in separate
categories, such as: glassware, chemicals, radioisotopes, etc.
Categories totaling less than \$1,000 do not need to be itemized. If
animals are to be purchased, state the species, cost per animal, and
number to be purchased in the first year.

\(9\) [All Other Expenses]{.underline}. List all other expenses by major
category, including costs for publications, rental and contractual fees.
Include the daily and total charges for Animal Research Facility
maintenance of all animal subjects required in the research. ***NOTE:**
Check Table 3 for a list of unauthorized items.* List service contracts
for equipment utilized only for the proposed research. If the equipment
is used by multiple research projects, request a proportionate amount of
the service contract. Travel costs are permitted for project staff if
the travel is directly related to the proposed research, but travel
costs for scientific meetings as well as registration fees and expenses
for books and journals are not permitted.

+-----------------------------------------------------------------------+
| ### TABLE 3. Unauthorized Budget Items                                |
+-----------------------------------------------------------------------+
| ## Personnel                                                          |
+-----------------------------------------------------------------------+
| Increases over years to account for inflation or salary increases     |
+-----------------------------------------------------------------------+
| Dishwashing aide                                                      |
+-----------------------------------------------------------------------+
| Summer students                                                       |
+-----------------------------------------------------------------------+
| Graduate Students                                                     |
+-----------------------------------------------------------------------+
| ## Equipment                                                          |
+-----------------------------------------------------------------------+
| Office Furniture                                                      |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| ######### SUPPLIES                                                    |
+-----------------------------------------------------------------------+
| Office supplies                                                       |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| OTHER (Usually supplied by local facility)                            |
+-----------------------------------------------------------------------+
| Books and journals                                                    |
+-----------------------------------------------------------------------+
| "charge-back costs'                                                   |
+-----------------------------------------------------------------------+
| Registration and travel to scientific meetings                        |
+-----------------------------------------------------------------------+
| Medical media and/or slide preparation and/or photography             |
+-----------------------------------------------------------------------+
| Photocopying charges                                                  |
+-----------------------------------------------------------------------+
| Maintenance costs which are unjustified                               |
+-----------------------------------------------------------------------+
| Maintenance costs for core or shared equipment                        |
+-----------------------------------------------------------------------+
| Library computer searches                                             |
+-----------------------------------------------------------------------+
| Word processing                                                       |
+-----------------------------------------------------------------------+
| Long distance phone charges                                           |
+-----------------------------------------------------------------------+
| Cylinder demurrage charges                                            |
+-----------------------------------------------------------------------+
| Communication costs                                                   |
+-----------------------------------------------------------------------+
| Radioisotope waste disposal                                           |
+-----------------------------------------------------------------------+
| Biohazard waste disposal                                              |
+-----------------------------------------------------------------------+

e\. **[VA Form 10-1313-4, Estimated Expenses For the
Project]{.underline}.**

> \(1\) Enter the totals for each budget category for all additional
> years of support requested. The total operating expenses for the first
> year must be identical to the total indicated on VA Form 10-1313-1 and
> VA Form 10-1313-3. Cost-of-living adjustments are not allowed.

\(2\) All differences in the operating expenses between years needs to
be fully justified.

\(3\) [Justification]{.underline}. All items in the budget must be
clearly justified. Use continuation pages if necessary.

\(a\) [Personnel.]{.underline} Fully explain the role and percent effort
of the PI and all personnel listed in the Personnel section of form
10-1313-3. If the PI is a non-clinician scientist, paid by the research
appropriation CC103, fully describe the basis for any difference in the
% effort for the work proposed and total VA effort (salary support). The
signature of the ACOS for R&D on VA Form 10-1313-1 signifies agreement
to have the non-clinician PI perform the work described to justify
salary. Salary compensation may not be requested for a clinician if the
person is licensed to practice medicine in the U.S. A clear statement to
this effect must be included in the justification.

\(b\) [Consultants.]{.underline} Clearly explain the expertise of each
consultant with regard to the proposed research. State the frequency of
consultations. M.D. consultants may not receive salary compensation.

> ( c) [Equipment.]{.underline} For each item, justification should
> include a discussion of why the equipment is needed and why similar
> existing equipment (if any), whether in the laboratory, common
> resource equipment, borrowed, or on loan, cannot be used. Describe the
> equipment used in the generation of the data in the "Work
> Accomplished" section and its availability for the proposed research.
> The equipment budget is capped at \$50,000. Requests for exceeding the
> equipment budget cap must be included in the letter of intent (see
> Appendix D for instructions).

\(d\) [Supplies.]{.underline} Explain how the costs for each category of
supplies were derived (e.g., based on the PI's expense history in
performing similar research).

\(e\) [All Other Expenses.]{.underline} Items in this category should be
explained in the same manner as those in the supplies category.
Personnel contracts or IPAs should be fully explained including the
basis for the individual's salary.

\(4\) The budget totals on VA Form 10-1313-3 and VA Form 10-1313-4 must
match each other as well as the totals in block 11 of VA Form 10-1313-1.
The accuracy of these items needs to be checked before sending the
proposal.

f\. **[Investigator Information (VA Form 10-1313-5/6, VA Form
10-1313-8)]{.underline}**. The two forms (VA Form 10-1313-5/6, and VA
Form 10-1313-8) must be completed for the PI and for each scientist who
will participate in the design, performance or scientific direction of
the proposed research. For those investigators devoting 5 percent effort
or less, include only biographical information (see VA Form
10-1313-5/6). Do not include any of the above forms for consultants or
technical staff. ***NOTE**: VA Form 10-1313-7 is no longer required.*

\(1\) [Investigator's Biographic Sketch (VA Form
10-1313-5/6)]{.underline}. Follow the instructions on the form. If
requesting more than a 3-year duration, include all appropriate prior
funding history.

\(2\) [Investigator's Total Research/Development Support (VA Form
10-1313-8)]{.underline}. Read these instructions carefully as they are
different from previous instructions for this form. Total research
support is defined as all financial resources, whether Federal,
non-Federal, commercial or institutional available in direct support of
the individual's research. Examples are current Merit Review awards,
research grants, cooperative agreements, contracts, institutional
awards, and awards from VA research programs such as EPID, CLIN, HSR&D,
RR&D, CSP and REAPs or Centers. Include all currently funded and pending
support. Do [not]{.underline} include the current application as pending
support.

\(a\) [Copy VA Form 10-1313-8 as needed.]{.underline} If the
investigator has no active or pending support, write "None" in the first
description box. Otherwise, starting with active awards, follow the
instructions on the form for "Status." In the "Grant/Project No" box
write the name of the awarding agency and the project number, if
assigned. In the Grant/Project Title box, write the full title and the
sub-project number, if appropriate.

\(b\) In the box provided for description, use the following format:

[1]{.underline}. Role. State the investigator's role in the project (PI,
co-investigator, PI of sub-project, etc.)

[2]{.underline}. Dates of Approved/Pending Project. Indicate the
inclusive dates of the project as funded or proposed.

[3]{.underline}. Annual Direct Costs. For active awards, provide the
current year's direct cost budget and for pending applications provide
the proposed initial budget period.

[4]{.underline}. Percent Effort. For an active award, provide the level
of effort (whether salaried or unsalaried) as approved for the current
budget period. For pending projects list the level of effort proposed
for the initial budget period.

[5]{.underline}. Major Goals. Provide a brief statement of the overall
objectives of the project. If it is a sub-project on a center grant or
contract, provide the objectives for the sub-project only.

\(c\) Using this format, continue to list all active and pending funding
for the investigator.

\(d\) [Overlap.]{.underline} After listing all of an investigator's
support, in a paragraph headed "Overlap," summarize any potential
overlap between the research in the proposal and any active or pending
research with respect to the science, budget, or the investigator's
total effort. Statements such as "there are no budgetary, scientific or
administrative overlaps" without any discussion of the science are not
acceptable.

[1]{.underline}. Budget overlap occurs when duplicate or equivalent
budget items, such as equipment or salary, requested in the application
are already funded, requested in a pending application, or provided from
another source.

[2]{.underline}. Commitment overlap occurs when any personnel listed on
the project has time or effort commitments (whether salaried or
unsalaried) that exceed 100 percent. No individual listed on the project
budget form may have more than 100 percent effort.

[3]{.underline}. Scientific overlap occurs when substantially the same
research is proposed in more than one application, is submitted to two
or more funding sources, or when the research objectives and the
research designs are the same or grossly similar in two or more
applications, regardless of funding sources.

g\. **[General Instructions for Response and Narrative.]{.underline}**
Observe the page number limitations specified in Table 4. Proposals
exceeding page limitations will not be reviewed.

+----------------------------+-----+-----------------------------------+
| # **                       |     |                                   |
| TABLE 4: Page Limitations  |     |                                   |
| and Content Requirements** |     |                                   |
+----------------------------+-----+-----------------------------------+
| **Section**                | **L | **Content**                       |
|                            | imi |                                   |
|                            | t** |                                   |
+----------------------------+-----+-----------------------------------+
| Response (Revised          | 3   | See instructions, paragraph 2h    |
| applications)              |     |                                   |
+----------------------------+-----+-----------------------------------+
| List of abbreviations and  |     |                                   |
| acronyms                   |     |                                   |
+----------------------------+-----+-----------------------------------+
| Research Narrative         | 25  | All text, figures, charts, tables |
| (sections 1-4)             |     | and diagrams                      |
+----------------------------+-----+-----------------------------------+
| Human Subjects (as needed) |     | See instructions, paragraph 2k    |
+----------------------------+-----+-----------------------------------+
| Animal Subjects (as        |     | See Instructions, paragraph 2l    |
| needed)                    |     |                                   |
+----------------------------+-----+-----------------------------------+
| Resources                  | 1   | See instructions, paragraph 2m    |
+----------------------------+-----+-----------------------------------+
| Publications from last     |     | See instructions, paragraph 2o    |
| funding period             |     |                                   |
+----------------------------+-----+-----------------------------------+
| Literature citations       | 4   | Complete citations including      |
|                            |     | titles and **all** authors        |
+----------------------------+-----+-----------------------------------+
| Appendix (Supplemental     |     | No more than five publications    |
| methodology may **not** be |     | including accepted or submitted   |
| included)                  |     | manuscripts.                      |
|                            |     |                                   |
|                            |     | Photographs that do not copy well |
|                            |     | (include photocopies in           |
|                            |     | Narrative).                       |
|                            |     |                                   |
|                            |     | Questionnaires                    |
|                            |     |                                   |
|                            |     | Other materials that do not copy  |
|                            |     | well (include photocopies in      |
|                            |     | Narrative)                        |
+----------------------------+-----+-----------------------------------+

\(1\) Avoid delays and misunderstandings by carefully reading and
following the instructions. Use proper English and avoid jargon. For
terms that are not universally known, spell out the term for the first
time followed by an abbreviation enclosed in parentheses; thereafter the
abbreviation may be used. Also, include these terms in the List of
Abbreviations and Acronyms.

\(2\) Observe type size specifications and margin requirements
throughout the application, or it will not be reviewed. Prepare the
original application on standard 8.5" X 11" white paper, single-sided
and single-spaced. Except for margin requirements of specific forms,
allow a 1" margin at all edges and use a single column. Multiple columns
may not be used. Use standard type fonts with black letters that can be
clearly copied. Do not use photo reductions. All tables, diagrams,
graphs, and charts, must be clear and legible.

\(3\) The height of the letters must be at least 11 points, the type
density must be no more than 15 characters per inch (CPI) and have no
more than 6 lines of type within a vertical inch. For proportional
spacing, any representative section of text must not exceed a density of
15 CPI. Smaller type sizes are difficult to read and give the applicant
an unfair advantage by allowing more text in the proposal. Rather than
relying on font selections by word processor or printer combinations,
correct type size needs to be verified with a standard type-measuring
device. At least the minimum type size must be used throughout the
application.

\(4\) All figures and tables must be included in the text. As long as it
is clearly legible, type size for figures, charts, tables, footnotes,
and figure legends, may be smaller.

\(5\) Proposals that are difficult to read will be administratively
withdrawn.

\(6\) Originals of photographs that do not copy well need to be included
in the appendix. Photocopies of these photographs also are to be placed
in the text of the proposal and are included in the 25-page limit.
Unpublished questionnaires may also be placed in the appendix. Methods
and/or procedures, even if unpublished, are to be incorporated into the
Narrative and are not to be placed in the appendix. The Narrative must
be comprehensible without references to any other document, including
the appendix.

h\. **[Response (resubmitted applications only, three-page
limit)]{.underline}**. A revised application will not be reviewed if it
fails to comply with all of the requirements for resubmission. Prior to
submitting a revised application, the PI should have received the
summary statement and critiques from the previous review.

\(1\) The resubmission must contain substantial revision to the content
of the proposal. The revised application must start with a Response of
not more than 3 pages, which summarizes the substantial additions,
deletions, and changes based on the comments and suggestions in the
summary statement. If suggested changes are not made, the reasons need
to be explicitly stated. The three-page response does not count toward
the 25-page narrative limit.

\(2\) The changes in the Narrative must be clearly marked by a vertical
bar in the margin, bracketing, indenting, or a change in typography,
unless the changes are so extensive that it includes the majority of the
text. In that case, indicate it in the Response. Do not use underline or
shading. The Work Accomplished section needs to include any new work
accomplished since the prior submission. Acceptance by BLR&D and CSR&D
services to review a revised application automatically terminates the
prior version.

i\. **[List of Abbreviations and Acronyms Used.]{.underline}** Provide a
list of the abbreviations and acronyms used in the Narrative and define
the term the first time it is used in the Narrative text. The exception
is for those terms that are commonly understood (e.g., known by
undergraduate biology students, such as DNA, ATP, etc.).

j\. **[Narrative (25 page limit including all text, figures, charts,
graphs, and diagrams).]{.underline}** The Narrative is organized into
four major sections: Rationale, Background and Significance, Work
Accomplished, and Work Proposed. Use the Narrative to explain (1) what
the P.I. proposes to do; (2) why the proposed work is important; (3)
what similar work has been done; and (4) how the proposed work will be
done. All tables, graphs, charts, diagrams, and photographs must be
included in the 25-page limit; items that do not photocopy well may also
be included in an appendix. The 25-page limit for the Narrative will be
strictly enforced. Applications that exceed this limit or fail to comply
with type size or margin specifications will not be reviewed. Within the
Narrative, BLR&D and CSR&D services recommend the following outline and
page restrictions.

\(1\) **Rationale (1-2 pages recommended)**

\(a\) [Statement of the Problem.]{.underline} Briefly state the problem
to be investigated.

\(b\) [Hypotheses or Key Question.]{.underline} State the hypotheses or
key questions to be answered by the proposed research.

\(c\) [Specific Objectives.]{.underline} Briefly and concisely list the
long-term and more immediate objectives of the proposed research. For
long-term objectives, identify expected intermediate goals.

\(2\) **Background and Significance (2-3 pages recommended)**

\(a\) [Background.]{.underline} Briefly describe the current status of
research relevant to the present application and how it relates to the
hypotheses or key questions. Critically evaluate existing, relevant
knowledge and explicitly state the gaps that the proposed research will
fill. Cite only relevant and recent literature. The Background section
needs to be sufficiently complete to demonstrate that the PI is aware of
the critical issues related to the proposal. It need not be exhaustive.

\(b\) [Significance.]{.underline} Explain the potential importance of
the proposed work and identify any unique ideas or potential
contributions that might result from this study.

\(c\) [Relevance to Veterans Health.]{.underline} Describe the relevance
of the proposed work to the VA patient care mission specifically and
health issues in general.

\(3\) Work Accomplished (6-8 pages recommended)

\(a\) [New applications (including revisions to new
applications).]{.underline} Describe the preliminary or previous studies
conducted by the PI that are pertinent to the application. The
information should help reviewers evaluate the experience and competence
of the investigator to pursue the research. The experience and/or
competence of key collaborators may be briefly described. Up to five
publications and/or submitted or accepted manuscripts by the PI may be
placed in the appendix.

\(b\) [Renewal Applications.]{.underline} In addition to describing
relevant preliminary studies, a progress report is required for all
renewal applications. Provide the beginning and ending dates for the
last period of funding. Summarize the previous program's specific aims
and/or objectives, as well as changes to the specific aims due to budget
reductions. Discuss the progress made toward achieving the specific aims
by providing a succinct account of relevant published and unpublished
results of work funded by the previous application. In the section
entitled "Publications From Previous Funding Period," provide complete
references for all publications, manuscripts submitted or accepted for
publication, patents or other printed materials that have resulted from
this project during its last funding period. Up to five publications,
submitted or accepted manuscripts may be placed in the appendix.

\(4\) **Work Proposed**

\(a\) Provide a timetable describing the sequence of the proposed
research.

\(b\) It is useful to specifically relate each experiment to particular
hypotheses and/or key questions. Describe the research design, methods,
and procedures to be used to accomplish the specific aims of the
application.

\(c\) Describe the experimental design and/or approach and how the data
will be collected, analyzed and interpreted. Describe new methodologies
to be used and why they are preferred over existing methods.

\(d\) Discuss potential problems and limitations of the proposed methods
and/or procedures and possible alternative procedures to achieve the
specific aims.

\(e\) If humans or animals are to be studied, power analysis needs to be
used to justify the number to be studied. Justify the species of animal
to be used. If cell lines or tissue specimens are used, discuss the
source of the material.

\(f\) The Narrative section must be comprehensible without reference to
any other document.

k\. **[Human Studies Section (no limit, be succinct - not included in
25-page limit for narrative).]{.underline}** If form 10-1313-1, Block
19, Human Subjects is checked "Yes," create a section heading titled
"Human Subjects." Applicants must address the involvement of human
subjects and protections from research risk relating to their
participation in the proposed research plan. In this section, provide
information to [address all of the following four evaluation
criteria]{.underline} as they apply to the research proposed. ***NOTE:**
Applications that fail to comply will be withdrawn without review.*

\(1\) **[Risk to Subjects]{.underline}**

\(a\) [Human Subjects Involvement and Characteristics.]{.underline}
Describe the proposed involvement of human subjects in the work outlined
in the Research Design and Methods section. Describe the characteristics
of the subject population, including their anticipated number, age
range, and health status. Identify the criteria for inclusion or
exclusion of any subpopulation. Explain the rationale for the
involvement of special classes of subjects, such as pregnant women,
prisoners, institutionalized individuals, or others who may be
considered vulnerable populations.

\(b\) [Sources of Materials.]{.underline} Identify the sources of
research material obtained from individually identifiable living human
subjects in the form of specimens, records, or data. Indicate whether
the material or data will be obtained specifically for research
purposes, or whether use will be made of existing specimens, records, or
data.

\(c\) [Potential Risks.]{.underline} Describe the potential risks to
subjects (physical, psychological, social, legal, or other) and assess
their likelihood and seriousness to the subjects. Differentiate the
therapeutic risk from research risk.

[1]{.underline}. Therapeutic risk is the risk or potential risks
associated with an intervention that is required for medical care, but
occurs as part of the research. An example is an endoscopy that was
required for medical follow-up of a specific illness.

[2]{.underline}. Research risk is associated with an intervention that
is done only for research purposes regardless if it is an experimental
intervention or a commonly used intervention, for example, an extra
endoscopy. Where appropriate, describe alternative treatments and
procedures, including the risks and benefits of the alternative
treatments and procedures to participants in the proposed research.

\(2\) **Adequacy of Protection from Risks**

\(a\) [Recruitment and Informed Consent.]{.underline} Describe plans for
the recruitment of subjects and the process for obtaining informed
consent. Include a description of the circumstances under which consent
will be sought and obtained, who will seek it, the nature of the
information to be provided to prospective subjects, and the method of
documenting consent. ***NOTE:** The informed consent document may not be
submitted at this time.*

\(b\) [Protection Against Risk.]{.underline} Describe the planned
procedures for protecting against or minimizing potential risks,
including risks to confidentiality, and assess their likely
effectiveness. Where appropriate, discuss plans for ensuring necessary
medical or professional intervention in the event of adverse effects to
the subjects. In studies that involve interventions, describe the plan
for data and safety monitoring of the research to ensure the safety of
subjects.

\(3\) **Potential Benefit of the Proposed Research to the Subject and
Others.** Discuss the potential benefits of the research to the subjects
and others. Discuss why the risks to subjects are reasonable in relation
to the anticipated benefits to subjects and others.

\(4\) **Importance of the Knowledge to be Gained.** Discuss the
importance of the knowledge to be gained as a result of the proposed
research. Discuss why the risks to subjects are reasonable in relation
to the importance of the knowledge that reasonably may be expected to
result.

l\. **[Animal Subjects (no page limit, be succinct \-- not included in
25-page limit for narrative)]{.underline}**. In this section, provide
information to [address all of the following five evaluation
criteria]{.underline} as they apply to the animal subjects research
proposed. ***NOTE:** Applications that fail to comply and to address the
following elements will result in the application being withdrawn
without review.*

\(1\) Provide a detailed description of the proposed use of the animals
in the work outlined in the Research Design and Methods section.
Identify the species, strains, ages, sex, and numbers of animals to be
used in the proposed work.

\(2\) Justify the use of animals, the choice of species, and the numbers
to be used. If animals are in short supply, costly, or to be used in
large numbers, provide an additional rationale for their selection and
numbers.

\(3\) Provide information on the veterinary care of the animals
involved.

\(4\) Describe the procedures for ensuring that discomfort, distress,
pain, and injury will be limited to that which is unavoidable in the
conduct of scientifically sound research. Describe the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining
devices, where appropriate, to minimize discomfort, distress, pain, and
injury.

\(5\) Describe any method of euthanasia to be used and the reason(s) for
its selection. State whether this method is consistent with the
recommendations of the Panel on Euthanasia of the American Veterinary
Medical Association. If not, present a justification for not following
the recommendations.

m\. **[Resources (1 page limit -- not included in 25-page limit for
narrative)]{.underline}**

\(1\) Describe the facilities to be used to conduct the proposed
research. Specifically indicate the performance sites (location with
specific room numbers and indicate VA space or off-site). In addition,
specify if any portion of the proposed study will be conducted in a
collaborator's laboratory or in an off-site common/core facility.

\(2\) Describe the equipment, capabilities and capacities, their
relative proximity and the extent of availability to the project.
Include a description of common resource space and equipment available
to the proposed research.

\(3\) If clinical space will be used, describe the location,
availability, and purpose.

\(4\) Do not describe resources that are available, but will not be used
for the proposed research.

\(5\) If a VA investigator (PI or VA co-investigator) will perform any
portion of the proposed research in assigned off-site space, a copy of
an approved off-site waiver must be included in the application. If any
of the proposed work will be done in VA leased space, a copy of the
approval for the use of the lease must be included. If a non-VA
co-investigator (a person neither paid by nor on a without compensation
(WOC) appointment with the VA) will complete specific portions of the
proposed work in their off-site laboratory, no waiver is needed.

n\. **[Publications from Last Funding Period.]{.underline}** List the
complete references of all publications, manuscripts that are accepted
or submitted, patents, or other printed material from the PI and/or
collaborators that are based on work accomplished toward the specific
aims and/or objectives of the previous funding period.

o\. **[Literature Citations (four-page limit).]{.underline}** Include a
complete citation for all references (all authors, year, title, journal,
volume number, and inclusive pages). Start each citation on a new line.
List citations by number in the order they first appear in the
application. For renewals, the list may include, but does not replace,
the citations in "Publications from Last Funding Period."

p\. **[Endorsements]{.underline}**

\(1\) **Just-in-Time Submission of Compliance** **and/or** **Assurance
Documents.** Do [not]{.underline} submit any human subjects, animal
subjects, or biosafety forms and/or approvals with this application.
When a local facility conducts compliance assurance reviews is a local
decision. Whether the review(s) is done prior to submission of the
application or at a later date, BLR&D and CSR&D services require just in
time submission of compliance and/or approval documentation for human
studies, animal studies, and biosafety.

\(2\) Include a memorandum signed by the Chair, R&D Committee stating
the application was reviewed and approved for submission to VA Central
Office (include the date of approval) by the R&D Committee.

\(3\) If the appropriate compliance and/or assurance subcommittees [have
not]{.underline} approved the application, following review by
compliance and/or assurance subcommittees, the R&D Committee must review
and approve the proposal before any studies contained in the application
may be conducted.

\(a\) The R&D approval letter must contain the following statement:

"This application has not yet been reviewed by the necessary
subcommittees for approval. The PI has been reminded that only fully
approved procedures may be conducted."

\(b\) If the research proposes using humans or animals as subjects, the
R&D Committee must document discussion of the adequacy of the
applications section(s) on "Human Studies" and/or "Animal Subjects."

\(4\) Include a memorandum signed by the facility Director stating that
the Director understands the impact of the proposed research on the
facility's organization, that the Director endorses the project, and
that the space described in the application and necessary support of the
VA facility will be available. If the PI's appointment is to start at
the time of funding, the medical center Director's letter
[must]{.underline} contain a statement indicating that the Director
agrees to employee the PI at least 5/8ths time. The R&D Committee and
facility Director endorsements may be combined as long as all requested
items are addressed and the R&D Chair and the facility Director sign the
memorandum.

\(5\) Provide letters from each collaborator indicating a willingness to
fulfill the duties described in the application.

q\. **[Revised Proposals.]{.underline}** Revised proposals must include
the final Summary Statement (including VA Form 10-1313A, Merit Review
Board Summary Statement) and reviews from the most recent review cycle.
These materials shall be the very last items in the application with the
summary statement placed last.

r\. **[Page Numbering.]{.underline}** Type the last name of the PI in
the lower right corner of each page and number each page consecutively,
starting with the VA Form 10-1313-1 (e.g., Smith-1 to Smith‑37).

**3. TRANSMITTING THE APPLICATION**

a\. **[Intent to Submit]{.underline}**. By the deadline listed in Table
1, staff of the ACOS for R&D enters the appropriate information in
PROMISE and transmits it electronically to the RDCC.

b\. **[Submitting the application]{.underline}**. Proposal submission
involves the electronic transmission of VA Form 10-1313-1 and VA Form
10-1313-2 (including the abstract) and sending hard copies (paper) of
the entire proposal. The receipt deadlines are March 15 for the spring
round and September 15 for the fall round. If the due date is on a
weekend, the following Monday is the due date.

\(1\) ACOS for R&D staff complete and electronically transmit VA Form
10-1313-1 (Face Page) and VA Form 10-1313-2 (Summary Description) using
the PROMISE system to the RDCC.

\(2\) The paper copies of these forms must be printed from the PROMISE
system. The information on the paper copies must be identical to the
electronically submitted information.

\(3\) For the paper submission of the entire proposal, the ACOS for R&D
and PI sign the printed copy of VA Form 10-1313-1. "Per," "by," or "for"
signatures are not acceptable.

\(4\) Use of the PROMISE system is confined to staff of the ACOS for
R&D.

> c\. **[Submit the following in one package]{.underline}**

\(1\) The original single-sided application with the signatures of the
PI and ACOS for R&D on page 1 (VA Form 10-1313-1), assembled in the
order specified in the table of contents.

\(2\) ***NOTE:** Prior to making copies, redact the PI's social security
number*. Twenty-five exact, clearly legible copies reproduced back to
back. Each copy is to be bound with a binder (paper) clip. Do not staple
copies or use rubber bands or colored paper separators.

\(3\) Seven collated sets of appendix material, such as reprints and
manuscripts, may be stapled and each item is to be marked with the PI's
name. Videotapes and books are not acceptable as 'reprints.' ***NOTE:**
A summary sheet listing all the items in the appendix is useful.*

\(4\) Twenty copies of VA Form 10-1313-1 with VA Form 10-1313-2
duplicated back-to-back.

d\. Carefully check the proposal and copies before submitting them to VA
Central Office.

e\. Either United States (U.S.) mail or courier service may be used to
send the application (original, twenty-five exact copies, seven collated
copies of the appendix). Applications should be mailed to the following
address:

Department of Veterans Affairs

BLR&D/CSR&D

Merit Review Application (121F)

810 Vermont Avenue, NW

Washington, DC 20420

Telephone Number for Courier Delivery: (202) 254-0183/84

f\. **[Under Separate Cover.]{.underline}** The ACOS for R&D may send a
list of suggested external reviewers and those reviewers believed to
have a bias against the proposed research to Department of Veterans
Affairs, 121F, 810 Vermont Avenue, Washington, DC 20420. Include the
address, telephone number and e-mail address, if available, for each
suggested reviewer. A separate letter may request that the proposal be
referred to a specific Merit Review Subcommittee. ***NOTE:** The request
must be justified and consistent with the purview of the requested
Subcommittee; see Appendix H.* Final decision on reviewers and referrals
are the responsibility of the Program Review Division. The deadline for
these letters is one day after the deadline for receipt of applications.

**4. DEFICIENCIES.** Deficiencies may be corrected only at the direction
of the Program Review Division. No late material (e.g., reprints,
approval letters, endorsement letters, proposal corrections, etc.) will
be accepted unless specifically requested by the portfolio manager for
the Merit Review Subcommittee. The only exception is official letters of
acceptance for publication for submitted manuscripts, which may be sent
to the Program Review Division at any time.

**5. PROPOSAL WITHDRAWAL.** A proposal may be withdrawn by the ACOS for
R&D by contacting the Chief, Program Review Division.

**6. SITE CHANGE DURING REVIEW CYCLE.** All information given to
reviewers must reflect the PI's circumstances and research site. If a PI
transfers to another VA, or the facilities available to the project
change, the portfolio manager for the Merit Review subcommittee must be
notified and updated information supplied, if requested.

**7. POST SUBMISSION COMMUNICATION.** The originating VA medical center
is notified of receipt and tentative acceptance to review the proposal
along with the name of the Merit Review subcommittee or other review
entity to which the proposal was assigned.

a\. Questions or concerns about the assignment may be directed to the
Chief, Program Review.

b\. Shortly after review by the Merit Review subcommittee, the
originating VA medical center will receive an early notification letter
and preliminary and/or draft copy of the Summary Statement and
individual reviews. Subcommittee review dates are posted on the VA R&D
website.

**8. JUST-IN-TIME RECEIPT OF COMPLIANCE AND ASSURANCE**

**DOCUMENTATION**

a\. The following paragraph is limited to the [receipt]{.underline} of
compliance and assurance documentation. It is a local facility decision
whether subcommittee review for human subjects, animal subjects, and/or
biosafety is conducted prior to the submission of the application, after
the submission, or after notification of possible funding.

\(1\) Research offices will be notified of proposals that are in
consideration for funding and the specific just-in-time documentation
needed to complete the review process. If a proposal is being considered
for funding, the office of the ACOS for R&D must submit, to BLR&D or
CSR&D, all required forms and approvals of appropriate R&D subcommittees
or their equivalents. These documents will [not]{.underline} be accepted
prior to this notification. Secondary review, by BLR&D and CSR&D, of
human, animal, or biosafety protocols will be conducted and may delay
funding the proposal. **No proposal will be funded until these forms and
approvals are received and accepted by BLR&D and CSR&D.**

\(2\) If the proposal was submitted prior to review by R&D
[subcommittees]{.underline}, the R&D Committee must re-review the
proposal and all supporting compliance and/or assurance documentation
and approvals. Compliance/assurance documentation, including proposal
title and principal investigator name, must exactly correspond to the
work proposed in the application. A letter from the R&D Committee
Chairman must accompany these documents and state that the R&D Committee
has given full approval to the proposal.

b\. **[Approval Dates.]{.underline}** Approval of all forms pertaining
to human studies, animal subjects or biosafety must be current at the
time the forms are submitted to VACO. Be especially mindful of this
requirement when submitting revised applications. The committee
Chairperson must sign all committee forms. If the Chairperson is also
the PI, another member of the committee must be delegated the
responsibility for signing the forms. Under no circumstance may a member
of the Research Service administrative staff or the ACOS for R&D sign
committee forms.

c\. **[Human Subjects.]{.underline}** The Human Studies Subcommittee or
its equivalent IRB must evaluate all proposals involving human subjects
or human tissue. Send a copy of the "Report of Subcommittee on Human
Studies" (VA Form 10-1223). If the [IRB]{.underline} approved the
protocol by expedited review, exempted the protocol from
[IRB]{.underline} review, or granted a waiver from obtaining informed
consent, it must be explicitly stated in section 8 "Comments" of VA Form
10-1223 form. The chair of the IRB must sign the form. ***NOTE:** In
lieu of VA Form 10-1223, BLR&D and CSR&D will accept an equivalent IRB
form as long as it contains all of the elements of VA Form 10-1223.*

\(1\) Unless the proposed research was granted a waiver from obtaining
informed consent, one or more approved consent forms, filled out using
VA form 10-1086, must be included after VA Form 10-1223.

\(2\) The title on the informed consent form must be the same as the
title of the application (VA Form 10-1313-1, box 10). If multiple
informed consents are needed, the consent form title may be the
application title with a project title appended to it.

\(3\) Each page of each consent form must be date stamped and the dates
on the consent form and Report of the Human Subjects Subcommittee form
must be current. Forms from a previous submission of the application may
be used, if the dates of approval have not expired and if changes to the
proposed research did not necessitate re-review by the IRB.

\(4\) The VA informed consent form (VA form 10-1086) must be used, even
if the affiliated university's IRB is the IRB of record.

\(5\) For research involving human subjects or human tissue, all
investigators, research coordinators, and research assistants involved
in that research must document training in the ethical principals and
accepted practices on which human studies research should be conducted.
Documentation of successful training on both the protection of human
research subjects and Good Clinical Practice is required and must be
dated within one year of submission of the just-in-time materials.
Documentation may be in the form of a certificate from the training
program(s) or equivalent documentation from ORD. One letter detailing
the training for multiple investigators is acceptable. Documentation of
the training requirement must follow VA Form 10-1223 and VA Form
10-1086.

\(6\) If the research involves banking of human specimens, gene testing,
gene transfer, and/or stem cells, it must comply with all VA policies
and guidelines regulating the conduct of such types of research.

\(7\) Recombinant DNA: Research involving recombinant deoxyribonucleic
acid (DNA) must comply with all VA regulations regarding human subject
protection in genetic research, biohazards, and other related
guidelines. Recombinant DNA is defined according to VA guidelines as:

\(a\) Molecules that are manufactured outside living cells by joining
natural or synthetic DNA segments to DNA molecules that can replicate in
a living cell, or

\(b\) Molecules that result from the replication of those described in
the first part of this definition.

d\. **[Animal subjects.]{.underline}** An approved, current VA ACORP
must be submitted for any proposal using animals or animal tissues using
the criteria in items (1) and (2) below. Note: These criteria do not
serve as a basis for determining if local IACUC approval is required;
they should be used only for the purposes of determining if an ACORP
must be submitted as a prerequisite for receiving VA funding for a Merit
Review application.

 

> \(1\) An ACORP must be submitted when requested if any of the
> following conditions apply (the \"Yes\" box for animal subjects should
> be checked in item 19 on form 10-1313-1):

 

> \(a\) Animals are requested in the application budget for use in
> proposed experiments.
>
> \(b\) Animals purchased with other VA funds or with non-VA funds would
> be used primarily or exclusively for experiments proposed in the
> application.
>
> \(c\) Animal tissues or primary cell lines purchased with other VA
> funds or with non-VA funds would be derived from animals sacrificed
> primarily or exclusively for use in the experiments proposed in the VA
> application.

 

> \(2\) An ACORP is not required for submission if none of the criteria
> in item (1) apply, and the proposed animal use meets one of the
> following criteria (the \"No\" box for animal subjects should be
> checked in item 19 on form 10-1313-1):

 

> \(a\) Immortal animal cell lines or explants would be used in the
> proposed experiments such that no additional animals would need to be
> euthanatized to meet application objectives.
>
> \(b\) Animals on other IACUC-approved projects would be used, but
> these animals would be utilized for other projects even if the need
> for the animals by the proposed VA project did not exist.
>
> \(c\) Animal tissues, blood and other body fluids, or primary cell
> lines would be obtained from live animals on other IACUC-approved
> protocols, but samples from these animals would be collected even if
> the need for the tissues or cell lines by the proposed VA project did
> not exist.

\(d\) Animal tissues, blood and other body fluids, or primary cell lines
would be obtained from animals euthanatized while on other
IACUC-approved protocols, but samples from these animals would be
collected even if the need for the tissues or cell lines by the proposed
VA project did not exist.

> \(e\) Animal-derived reagents or products such as serum, antibodies
> and mediators required in the application are limited to those that
> would be purchased from a USDA-licensed commercial vendor.

 

> \(3\) If guidance is needed on applying the criteria in paragraphs (1)
> and (2), the CVMO should be contacted.

e\. **[Investigational Drugs and Devices.]{.underline}** Federal Drug
Administration (FDA) approval for use of an investigational drug (IND)
or device must be on file at the VA medical center. The R&D concurrence
memorandum, signed by the Chair, R&D Committee, certifies that the
appropriate approvals are on file. VA Form 10-9012, Investigational Drug
Information Record, must be used for this purpose, but need not be
submitted.

f\. **[Biohazards.]{.underline}** Whether or not the Biohazards box in
VA Form 10-1313-1 is checked, the biohazards form, VA Form 10-0398, must
be submitted, have the proper signatures, and be dated.

g\. **[R&D Approval.]{.underline}** Following review and approval by all
required subcommittees, the R&D committee must review and give final
approval to the application. A letter of approval, signed by the Chair,
R&D Committee, must be sent through the medical center Director with the
other compliance and/or assurance documentation.

h\. **[Submission of Documents.]{.underline}** Send the original and
seven exact copies of all compliance and/or assurance documentation via
regular mail or courier to:

Department of Veterans Affairs

BLR&D/CSR&D

JIT Documents (121E)

810 Vermont Avenue, NW

Washington, DC 20420

Telephone Number for Courier Delivery: (202) 254-0183/84

**9. QUESTIONS AND INQUIRIES**: Inquiries related to Merit Review
submission or review should be directed to the Chief of Program Review,
BLR&D and CSR&D services. The PI may contact the BLR&D and CSR&D
Portfolio Managers (121E) with questions specifically related to
scientific issues raised in the Summary Statement for a reviewed
proposal or the scientific content of a proposal to be submitted. The
Associate Chief of Staff (ACOS) for Research and Development (R&D) is to
make all other contacts with BLR&D and CSR&D staff, including questions
relating to Summary Statements and budgets.

## Supplemental Instructions for Submitting 

## an Epidemiology Research (EPID) Proposal

1\. Applications must be complete at the time of submission and must
comply with all the guidelines for submitting BLR&D and CSR&D Merit
Review Award Program (Merit Review) proposals with the following
modifications:

a\. Block 15 on VA form 10-1313-1 (Merit Review Application). Under
"Program" enter "821" for BLR&D and CSR&D Services and under "Cost
Center" enter CC106, which is the cost center designation for Special
Research Programs.

b\. If an Epidemiologist and/or a Statistician are required for the
project, they should be identified in the personnel section of the
budget, and their role clearly delineated in the budget justification
section.

c\. The budget section should detail the cost of enrolling subject
groups for the project.

d\. The Narrative section of the proposal should address the following
issues:

\(1\) In the Background section, the significance of the problem
investigated to veterans' health and the Department of Veterans Affairs
(VA) research priority areas should be clearly described.

\(2\) In the Work Accomplished section, the proposal should provide:

\(a\) Pilot data demonstrating cooperation between investigators in
attaining various samples needed for the project, if applicable. This is
particularly important if more than one investigator is involved in the
project.

\(b\) Data demonstrating the feasibility of interaction between
investigators at the various study sites, if applicable.

\(3\) In the Work Proposed section, the narrative should describe:

\(a\) The experimental design of the project including various
comparison groups.

\(b\) Subjects recruitment strategies, if applicable, including control
groups. The criteria to be used for subject selection; the criteria for
assignments to various study groups; and the number of subjects expected
to be recruited each year until the conclusion of the study [should be
clearly detailed.]{.underline}

\(c\) The statistical analysis including the statistical approach to the
questions being investigated, calculations of sample size and other
comparative measurements should be described. The proposal also needs to
detail how various data measures will be categorized and assessed.

## Supplemental Instructions for submitting 

## a CLINICAL RESEARCH (CLIN) Proposal

Applications must be complete at the time of submission and shall comply
with all of the guidelines for submitting Merit Review Award Program
(Merit Review) proposals with the following modifications:

1\. Block 15 on VA form 10-1313-1 (Merit Review Application). Under
"Program" enter "821" CSR&D Service and under "Cost Center" enter CC106,
which is the cost center designation for Special Research Programs.

2\. In the personnel section, a statistician to be associated with the
project is to be identified and the statistician's role needs to be
clearly delineated. A letter from the statistician, describing the
statistician's role in the study design and analysis is to be included
in the Administrative Issues section, following the letters of
endorsement.

3\. The budget must contain a line item for costs of study safety
monitoring.

4\. The Narrative must address the following issues:

a\. In the Background section, include references to meta-analysis
studies, if appropriate. If the study involves the use of drugs,
pertinent pharmacological and toxicological data needs to be summarized
with appropriate documentation.

b\. As appropriate, the following items must be included in the Work
Proposed section:

\(1\) An experimental design of the study, including descriptions of
comparison groups and control measures;

\(2\) A flowchart of basic study design.

\(3\) Subject (patient) recruitment, selection criteria, and method of
assignment to comparison groups.

\(4\) Intervention and/or methods of treatment including, if
appropriate, the method of randomization, provision for double-blinding,
and breaking the blind.

\(5\) Methods of follow-up and methods of ensuring uniformity of the
intervention.

\(6\) Outcome measurements including any specialized rating scales.

\(7\) A schedule of observations and laboratory tests.

\(8\) Sample size issues including the assumptions used to determine
number of subjects required, expected drop out rates and procedures for
analyzing the data with respect to the drop outs, duration of subject
intake period, number of participating medical centers, and description
of other studies that could compete for subjects; and

\(9\) A statistical analysis section describing how the major hypothesis
or research questions will be tested, including the specification of
major endpoints. Studies need to be powered to achieve clinically
meaningful outcomes, not just statistically significant outcomes.

\(10\) Immediately following the Narrative, in a section titled "Safety
and Monitoring," the plans for monitoring the safety of participants and
the accuracy and integrity of the data must be detailed.

\(a\) For multi-site projects, describe any quality assurance procedures
including plans for auditing or monitoring clinical site practices.

\(b\) An appropriate data and safety monitoring plan, including a
description of risks and safety measures must be included in the
proposal at the time of submission. For single site studies with a high
risk intervention and all multiple site studies, a Data and Safety
Monitoring Board (DSMB) or its equivalent (which may consist of one
individual) must be proposed. The responsibility of the DSMB is to
review the progress of the study for safety and efficacy at least every
6 months with a recommendation to the local IRB to continue, amend or
terminate the trial. Consideration for use of DSMB should be given if
the study involves vulnerable populations, is blinded or involves
placebo controls. For information on requirements for the protection of
human subjects in research, refer to VHA Handbook 1200.5. *NOTE:
Personnel involved in any aspect of the study may not serve on the
DSMB.*

## Instructions for PREPARATION AND SUBMISSION OF A LETTER OF INTENT FOR THE MERIT REVIEW PROGRAM INCLUDING EPIDEMIOLOGY RESEARCH PROGRAM (EPID) AND CLINICAL RESEARCH PROGRAM (clin)

1\. The Letter of Intent (LOI) should consist of single-spaced typed
pages. Use only letter-quality print. All text must be prepared with at
least 11-point font, with no more than 15 characters per inch and no
more than 6 lines per inch. Page margins must be a minimum of 1 inch at
each edge. LOIs failing to follow these requirements and/or exceeding
the page limitations will be administratively withdrawn.

2\. A standard Merit Review LOI consists of the following:

a)  **VHA Research & Development Letter Of Intent Cover Page (VA Form
    10-1313-13)**

> VA Form 10-1313-13 has been revised (Revised May 2004). **DO NOT USE
> PREVIOUS VERSIONS.**
>
> Instructions for VA Form 10-1313-13 (Boxes 1-5):
>
> **[Box 1]{.underline}**. Select the appropriate service (BLR&D or
> CSR&D) based on the nature of your proposed study. Use the following
> guidelines for BLR&D and CSR&D purviews:
>
> The BLR&D purview includes laboratory studies, both *in vitro* and *in
> vivo*, including tissue culture and animal models; and studies on
> human biological samples. The CSR&D purview includes studies on whole
> human subjects involving interventional or exploratory procedures
> (with the exception of procedures for obtaining biological samples
> such as drawing blood, buccal swabs etc.)
>
> **Next, select a portfolio from the drop-down list for BLR&D or CSR&D
> service**. For a description of the portfolios, refer to the purview
> of BLR&D/CSR&D Merit Review Subcommittees. This selection is a
> recommendation only. Program Review will make all final assignments.
>
> **[Box 2]{.underline}**. Select "New", if the LOI is for [the first
> submission of the proposed research]{.underline} or the first LOI
> submission for a competitive renewal of an ongoing project. *Note:
> This definition of "new" is valid only for an LOI submission and may
> differ for a full proposal submission*. [If this is not a new LOI, you
> should select either "Revision" or "Resubmission."]{.underline} Select
> "Revision," if the there are [any substantive changes]{.underline} in
> the scientific component of the study (e.g., number and scope of
> specific aims or methodology proposed) since the previous LOI
> submission. Select "Resubmission," if there are [no substantive
> changes]{.underline} in the scientific component of the study since
> the previous LOI submission.
>
> **[Box 3]{.underline}.** Select Merit Review, and indicate whether it
> is a Standard Merit Review or one of the special Merit Review
> programs. If you select Clinical Research Program in Box 3, your
> portfolio selection in Box 1 should be CLIN, and if you select
> Epidemiology Research Program in Box 3, your portfolio selection in
> Box 1 should be EPID. If you are applying to the MREP, select MREP
> under Training Programs in Box 3 [AND]{.underline} select a portfolio
> in Box 1. If you are responding to the Deployment Health Research RFA,
> select response to specific announcement under "Other Programs" in Box
> 3, type in "Deployment Health Research" for the RFA title
> [AND]{.underline} select a portfolio in Box 1.
>
> **[Box 4.]{.underline}** Limit the title to a total of 72 characters,
> including spaces.
>
> **[Box 5.]{.underline}** A proposal may have only one principal
> investigator. As per current policy, BLR&D and CSR&D Services do not
> allow co-PIs (see Handbook 1202.1).

b)  **Study Description** (2-page limit). Succinctly addresses each of
    the following:

    a.  Hypothesis(es)/Research Questions

    b.  Discrete Study Objectives

    c.  Description of Relevance to VA

    d.  Overview of Design/Methods

> *Note: This section should include a clear statement of the model(s)
> of choice for the study, i.e., human, animal, cell culture etc.*

e.  Description of Intervention(s)/Treatment(s) - *if applicable*

f.  Total Budget and Study Duration

> *Note: The annual Merit Review budget is capped at \$150,000,
> excluding non-clinician PI salary and equipment. The equipment budget
> is capped at \$50,000. In rare instances, permission may be granted to
> exceed the budget caps. If you are requesting permission to exceed the
> budget cap(s) (annual budget and/or equipment budget), clearly state
> the request and provide justification.*
>
> *Excessive budgets based on research that is too broad, is unfocused,
> or has too*
>
> *many hypotheses or specific objectives are inappropriate for special
> funding*
>
> *consideration. In such cases, the PI needs to consider limiting the
> scope of the*
>
> *proposal.*

c)  **Statement of Disclosure**. 1-2 sentence statement from the PI
    indicating that no financial or contractual relationship exists
    between any organization involved in the proposed study that could
    constitute a real or apparent conflict of interest (including all
    investigators and collaborators who plan to devote 5 percent or more
    effort to the proposed project). If such a relationship or contract
    does exist, full disclosure must be provided.

d)  **Acknowledgment of the VA policy to include women and minorities in
    research** (if applicable).

e)  **References**: Up to five reference citations relevant to the
    proposed study.

**(3) If you are submitting an LOI for the Clinical Research program
(CLIN), use the standard LOI format, but be sure to address the
following under the study description:**

a)  **Overview of Design/Methods**- clarify the following aspects of the
    study:

-   Phase of the clinical trial (I, II, III or IV) (*Note: LOIs for
    Phase I studies must have prior approval from the CRADO*)

-   Open label, randomized, blinded, or double blinded

-   Single site or multi-site *(Note: If the study involves more than
    one site, provide justification)*

-   Study population(s) and sample size

-   Study endpoints

b)  **Description of Intervention(s)/Treatment(s)**

c)  **Total Budget and Study Duration**

> *Note: In rare instances, permission may be granted to exceed the
> budget cap and study duration limit. If you are requesting permission
> to exceed the budget cap(s) (annual budget and/or equipment budget)
> and/or the study duration limit of 3 years, include a clear statement
> of the request(s) and provide justification.*

**(4) If you are submitting an LOI for the Epidemiology Research Program
(EPID), use the Standard LOI format, but be sure to address the
following in the study description:**

# Overview of Design/Methods should include

-   Description of study population(s), if applicable

-   Subject recruitment procedures, if applicable

-   Description of sampling methods

-   Description of experimental measures to be evaluated, methods of
    procedure and links between data and proposed measures

-   Data analysis plan

**(5) The deadline for LOI submission to BLR&D/CSR&D is two months
before the Merit Review application deadline. Early submission of LOIs
is encouraged.**

> Submit the original and 3 copies, reproduced back-to-back, to the
> following address via courier:
>
> Department of Veterans Affairs
>
> BLR&D/CSR&D Letter Of Intent
>
> Program Management Division (121E)
>
> 810 Vermont Avenue NW
>
> Washington DC 20420
>
> Telephone Number for Courier Delivery: 202-254-0183/84

## Requesting Acceptance inTo THE INTRAMURAL RESEARCH program FOR NON-CLINICAN SCiENTISTS

**1. [New Non-clinician]{.underline}.** All new non-clinician Principal
Investigators (PIs) to be paid by the medical research and prosthetics
appropriation must be accepted into the (BLR&D or CSR&D) intramural
research program prior to submitting a Merit Review, CLIN, or EPID
application, or responding to a request for proposals.

a\. A "new" PI is one who has not been an independent PI on a BLR&D
and/or CSR&D-funded Merit Review project within the last 5 years.
Acceptance into the BLR&D and CSR&D program is in addition to meeting
the eligibility requirement (refer to Veterans Health Administration
(VHA) Handbook 1200.15) and the requirement to conduct research at a
Department of Veterans Affairs (VA) medical center or VA-approved site
(refer to VHA Handbook 1200.16). ***NOTE:** MREP awardees are not
considered to be independent PIs and must request acceptance into the
BLR&D and CSR&D intramural research program.*

b\. A scientist whose application for acceptance is denied or revoked
may not be a PI on any BLR&D and CSR&D-funded project.

**2. [Changes.]{.underline}** BLR&D and CSR&D must be informed of any
change in laboratory location, geographic commitment, paid 8^ths^, or VA
employment status. Non-clinician PIs wishing to transfer their research
projects to a new VA facility must submit an acceptance request through
the new facility.

**3. [Commitment.]{.underline}** Acceptance into the BLR&D and CSR&D
intramural research program is based upon the applicant's record of
prior commitment and service to the VA medical center and local
intramural research program. Commitment and service may include working
in another VA investigator's laboratory, collaborating or interacting
with other VA investigators, helping train and/or mentor VA junior
scientists, functioning as a resource for the research community, and
serving on local VA research committees.

**4. [Information to be Submitted.]{.underline}** The following
information must be submitted:

a\. **Letter Requesting Acceptance.** The letter requesting acceptance
into the BLR&D and CSR&D program must be endorsed by Associate Chief of
Staff (ACOS) for Research and Development (R&D), Chief of Staff, and
medical center Director. Requests for more than one investigator at a
medical center may not be combined in a single request. A separate
request must be submitted for every investigator. Requests for
acceptance into the program or waiver from the requirement for a 5/8^th^
clinical appointment may NOT be combined with a request for an off-site
waiver. (refer to VHA Handbook 1200.15 for VA requirements for clinical
appointments, and VHA Handbook 1200.16 for off-site waivers). Requests
for acceptance into the program may be submitted throughout the year but
must be received at least two months prior to the proposal receipt
deadlines. Requests may not be appended to proposals. ***NOTE:** Be sure
to include the applicant's social security number only on the original;
the social security number should be redacted from all submitted
copies.*

b\. **Employment Status.** Description of current VA and/or affiliated
university employment status including title, source of salary support,
and current number of VA eighths employed. Include a statement of how an
applicant's appointment will change if the proposal is funded.
***NOTE**: A PI may not be placed on an Intergovernmental Personnel Act
(IPA) assignment.*

c\. **Location.** Specific location of office and laboratory.

d\. **Activities.** Description of applicant's activities at the VA
medical center, including research, teaching, mentoring, administration,
and any clinical care activities.

e\. **Funding History**. Applicant's research funding history.

f\. **Ratio.** Medical center ratio of the number of funded clinicians,
including without compensation (WOC) employees doing research at the
medical center to funded non-clinicians (include all sources of funding
(government, private, industry, etc.).

g\. **Curriculum Vitae.** Must include current VA appointment (VA-Paid
or WOC) and previous service to a VA medical center.

**5. [Evaluation.]{.underline}** Applicants will be evaluated to
determine if they meet the intent of the intramural program by
contributing to the research service over and above the requirements of
their personal research program. Over the course of their VA careers,
non-clinician PIs are re-evaluated for their VA career track advancement
in the intramural program (e.g., Merit Review resubmissions and the
Research Career Scientist Program (refer to VHA Handbook 1202.4).

**6. [Due Dates.]{.underline}** BLR&D and CSR&D accepts requests
throughout the year. Submission of the request as early as possible is
encouraged. The last date for submitting a request is January 15 for the
March 15 application receipt deadline and July 15 for the September 15
application receipt deadline respectively. Requests received after these
deadlines will be reviewed for the subsequent round.

**7. [Submission.]{.underline}** Submit the original application package
plus three exact copies, reproduced back-to-back to the following
address:

Department of Veterans Affairs

BLR&D/CSR&D

Permission to Submit (121E)

VA Central Office

810 Vermont Avenue, NW

Washington DC 20420

Telephone Number for Courier Delivery: (202) 254-0183/84

## 

## PURVIEW OF BLR&D and CSR&D MERIT REVIEW SUBCOMMITTEES

###### 

###### 1. ACRONYMS for SUBCOMMITTEES

> a\. AGCG = Aging and Clinical Geriatrics
>
> b\. CARD = Cardiovascular Studies
>
> c\. CLIN = Clinical Research Program
>
> d\. ENDO = Endocrinology
>
> e\. EPID = Epidemiology Research Program
>
> f\. GAST = Gastroenterology
>
> g\. GMED = General Medical Science
>
> h\. HEMA = Hematology
>
> i\. IMMU = Immunology and Dermatology
>
> j\. INDI = Infectious Diseases

k\. MHBS = Mental Health and Behavioral Sciences

l\. NEUA = Neurobiology A

m.  NEUB = Neurobiology B

n.  NEUC = Neurobiology C

o.  NEUD/E = Neurobiology D/E

> p\. NEPH = Nephrology
>
> q\. ONCO = Oncology
>
> r\. RESP = Respiration
>
> s\. SURG = Surgery

**2. SUBCOMMITTEES**

In any given review cycle, a Subcommittee may be further divided into
panels depending upon the total number and scope of proposals received.

a\. **[Aging And Clinical Geriatrics (AGCG)]{.underline}.** The AGCG
Subcommittee reviews proposals on the physiologic aspects of the aging
process and on the management and clinical aspects of diseases highly
prevalent in the elderly. Studies on disease prevention in the elderly
including vaccination, nutrition, exercise physiology, and behavioral
modification are also reviewed. Specific geriatric syndromes that are
reviewed include incontinence, constipation, falls, gait and balance
disorders, and frailty. Other areas include pharmacology and
pharmacokinetics in the elderly, osteoarthritis in the elderly,
management of dementia and depression, and sleep disorders unique to the
elderly.

b\. **[Cardiovascular Studies (CARD)]{.underline}.** The CARD
Subcommittee reviews proposals on the etiology, pathogenesis, diagnosis,
and treatment of diseases and disorders of the heart and vascular
system. This Subcommittee reviews studies on the etiology and
pathogenesis of idiopathic hypertension while the NEPH Subcommittee
reviews nephrogenic hypertension and ENDO reviews endocrine
hypertension. Neurobiology Subcommittees review studies of innervation
and neural control of the heart. The PSBD Subcommittee reviews
behavioral control of hemodynamics and cardiac performance.

c\. **[Clinical Research Program (CLIN)]{.underline}.** The CLIN
Subcommittee reviews single-site or small multi-site clinical trials
designed to assess the potential effects of therapeutic interventions on
intermediate physiological measures or studies aimed at definitive
clinical outcomes. Proposals reviewed in CLIN are focused on clinical
outcomes in human subjects and require special attention to human
studies concerns including safety issues, appropriate populations, and
adequate statistical power to obtain meaningful results.

d\. **[Endocrinology (ENDO)]{.underline}.** The ENDO Subcommittee
reviews applications on the biology, physiology, molecular biology, and
genetics of regulation of all endocrine organs and their products (e.g.,
insulin, glucagon, corticosteroids, and sex hormones). The etiology,
pathogenesis, diagnosis, and treatment of diseases associated with
endocrine abnormalities (e.g., diabetes, Cushing's syndrome,
hyperthyroidism, and obesity) and bone and mineral metabolism (cell
biology of bone formation and resorption, osteoporosis, vitamin D and
calcium studies) are also reviewed.

e\. **[Epidemiology Research Program (EPID)]{.underline}.** The EPID
Subcommittee reviews applications that employ a population based
approach in design and methodology, and investigate the prevalence,
etiology, and risk factors of diseases and disorders affecting veterans.
This Subcommittee also reviews applications that assess the efficacy of
modern diagnostic, treatment, and preventive strategies.

f\. **[Gastroenterology (GAST)]{.underline}.** The GAST Subcommittee
reviews applications on the biology and physiology of the
gastrointestinal (GI) system and associated organs such as liver,
spleen, gallbladder, and pancreas. Studies on GI motility, regulation of
GI secretion, digestion, nutrition, and absorption are examples. This
Subcommittee also reviews studies focusing on the etiology,
pathophysiology, diagnosis, and treatment of diseases of the GI system
and on target organ damage. Also reviewed are studies assessing the
effects on GI function produced by immunologic, infectious, toxic, or
carcinogenic agents.

g\. **[General Medical Science (GMED)]{.underline}.** The GMED
Subcommittee reviews proposals on cellular or molecular biology,
biochemistry, biophysics, or genetics that are not restricted to a
particular disease process or organ system. ***NOTE:** Basic science
approaches that relate to a particular organ system may be reviewed by
the appropriate organ system Subcommittee.*

h\. **[Hematology (HEMA]{.underline}).** The HEMA Subcommittee reviews
proposals on the physiology of the cellular and non-cellular
constituents of blood. The processes of hemostasis, thrombosis, blood
coagulation, cell adhesion, hemocompatibility, hematopoiesis, and
fibrinolysis are examples. Studies on the etiology, pathogenesis,
diagnosis, and treatment of blood diseases such as leukemia, lymphoma,
anemia, and thrombocytopenia are reviewed. Studies on normal and
abnormal macrophage, platelet, and neutrophil functions are also
reviewed.

i\. **[Immunology and Dermatology (IMMU]{.underline}**). The IMMU
Subcommittee reviews proposals on the basic immunologic mechanisms
involved in functions of the immune system. Studies on the etiology,
pathogenesis, diagnosis, and treatment of autoimmune disease,
immunodeficiency, immune-complex disorders, and diseases related to
allergic or delayed hypersensitivity reactions are also reviewed. This
Subcommittee reviews proposals on immunopharmacology, immunogenetics,
and dermatological disorders of immunologic or unknown etiology, and
immunology of organ transplantation. The ONCO Subcommittee reviews
immunotherapy of cancer and tumor immunology. The INDI Subcommittee
reviews the immune response to specific infectious agents and vaccine
development.

j\. **[Infectious Diseases (INDI)]{.underline}.** The INDI Subcommittee
reviews proposals on the etiology, pathogenesis, diagnosis, and
treatment of infectious diseases of man and relevant animal infection
models. Areas of investigation include pathogenic mechanisms,
host-defense mechanisms, immune responses to specific infectious agents,
life cycles of the infectious agent, anti-microbial drug therapies, and
vaccine development. The IMMU Subcommittee reviews studies on basic
immunologic mechanisms that relate to all classes of infectious agents.
The appropriate organ or system Subcommittee reviews studies on organ
pathology associated with an infectious agent.

k\. **[Mental Health and Behavioral Sciences (MHBS).]{.underline}** MHBS
reviews studies of the etiology, pathobiology, diagnosis and treatment
of psychiatric, behavioral (including addictive and craving) disorders
in humans including the psychoses, mood disorders, anxiety, panic and
post-traumatic stress disorder, alcoholism and drug abuse. Sleep
disorders as they relate to mood or cognitive function are reviewed by
this panel while respiratory aspects are reviewed by the RESP
subcommittee. Treatment trials are currently reviewed by the clinical
studies program. The aging and clinical geriatrics subcommittee may
review studies on management of dementia.

**[Neurobiology.]{.underline}** The Neurobiology Subcommittee reviews
proposals on the etiology, pathogenesis, diagnosis, and treatment of
diseases of the central and peripheral nervous systems utilizing *in
vitro* and non-human *in vivo* models. This subcommittee will be
subdivided into Neurobiology A (NEUA), Neurobiology B (NEUB),
Neurobiology C (NEUC), Neurobiology D (NEUD) and/or Neurobiology E
(NEUE), depending on the number and scope of proposals received in any
given review cycle. The Neurobiology Subcommittees will review proposals
utilizing *in vitro* and non-human *in vivo* models.

Topics reviewed by the Neurobiology Subcommittees **[may]{.underline}**
be divided as follows:

**l. NEUA** reviews studies involving in vitro and in vivo nonhuman
models of psychiatric, behavioral and addictive disorders, analgesia and
anesthesia. This subcommittee reviews studies of postmortem tissue from
psychiatric patients, behavioral chronobiology, neurobiology and
neuropharmacology of psychoactive or neurotoxicological agents.

**m. NEUB** reviews studies involving sleep, epilepsy, and/or neuronal
plasticity.

**n. NEUC** reviews studies of injury and trauma to the central nervous
system, including spinal cord injury, traumatic brain injury, stroke,
intracerebral and subarachnoid hemorrhage, and the effects of ablation
or pressure on neuronal function caused by CNS tumors. This subcommittee
also reviews studies of injury and trauma to the peripheral nervous
system, such as peripheral or diabetic neuropathies. NEUC reviews
studies on demyelinating disorders such as multiple sclerosis, as well
as neuromuscular disorders that are primarily neurologic or muscular, or
involve the neuromuscular junction. Studies on the anatomical,
biochemical, and/or molecular basis of pain may also be reviewed. NEUC
may also review studies involving sensory disorders of vision, taste,
hearing, and smell.

**o. NEUD** and **NEUE** review studies of neurodegeneration including
Parkinson's Disease, Alzheimer's Disease, upper and lower motor neuron
disease, amyotrophic lateral sclerosis (ALS) and Huntington's Disease.

Neuroendocrinological studies focusing on hypothalamic releasing
factors, anterior or posterior pituitary hormones, or peripheral
hormones such as cortisol will be reviewed by ENDO. Studies on neoplasms
occurring in the nervous system will be reviewed by ONCO, whereas
studies on surgical approaches to resecting CNS tumors will be reviewed
by SURG. Functional imaging will be reviewed by MHBS.

p\. **[Nephrology (NEPH)]{.underline}.** The NEPH Subcommittee reviews
proposals on the etiology, pathogenesis, diagnosis, and treatment of
diseases and disorders of the kidney. This Subcommittee reviews studies
on end stage renal disease including peritoneal dialysis and renal
function following transplantation. The ONCO Subcommittee reviews
studies on carcinomas in the kidney. The SURG Subcommittee reviews
studies on the surgical approaches to disorders of the kidney and
genitourinary tract.

q\. [**Oncology (ONCO**)]{.underline}**.** The ONCO Subcommittee reviews
proposals on the etiology, pathogenesis, diagnosis, and treatment of
various malignant conditions. Studies focusing on aspects of the
oncologic process including cancer initiation, promotion, progression,
and metastasis are reviewed, as are aspects of therapy including
chemotherapy, radiation therapy, immunotherapy, and gene therapy. The
Subcommittee also reviews proposals focusing on premalignant conditions.
The effects of solid tumors on specific organ or system function is
reviewed by the appropriate organ Subcommittee. SURG reviews surgical
management of solid tumors

r\. **[Respiration (RESP)]{.underline}.** The RESP Subcommittee reviews
proposals on the etiology, pathogenesis, diagnosis, and treatment of
diseases and disorders of the lung. Respiratory aspects of sleep
disorders (sleep apnea), the effects of immunologic, infectious,
carcinogenic, or toxic insults on the lung, and the effects of
transplantation on pulmonary function are also reviewed.

s\. **[Surgery (SURG)]{.underline}.** The SURG Subcommittee reviews
proposals on the surgical aspects of cardiac, thoracic, orthopedic,
vascular, pulmonary, gastrointestinal, renal, and genitourinary tract
disorders. Complications of major surgery such as hemostasis, altered
immunity, secondary infection, sepsis, multi-organ failure, and
reperfusion injury are reviewed. The SURG Subcommittee reviews all
aspects of physical trauma, wound healing, surgical nutrition, and burn
treatment. This Subcommittee reviews studies on surgical aspects of
organ transplantation, organ transplant survival, and immuno-suppressive
therapy. Surgical approaches to peripheral and central nervous system
lesions, and reconstructive surgery, ophthalmological, head and neck,
ear, nose, and throat disorders are also reviewed. This Subcommittee
also reviews studies of impotence, dental studies including dental
trauma and prostheses, and structural and neoplastic disorders of the
oral cavity. The INDI Subcommittee reviews microbiological aspects of
dental and periodontal disease. The IMMU Subcommittee reviews
immunologic aspects of organ transplantation.

## 

## MERIT REVIEW APPEAL PROCESS

**1. PURPOSE OF THE APPEAL PROCESS**. 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 appeal process is designed to uncover
factual errors through reexamination by individuals not involved in the
initial decision. The appeal process is entirely separate from the MERIT
review process. The appeal must be regarding a decision that precluded
funding. It is not intended as a means to resolve differences of
scientific opinion between the applicant and the original reviewers, to
adjust funding decisions, or to circumvent the peer review process.

**2. BASIS FOR APPEAL.** The Merit Review Subcommittee consensus as
presented in the [final]{.underline} Summary Statement is the only basis
for an appeal.

a\. An appeal may be made if the PI believes it can be demonstrated that
the Subcommittee showed any of the following:

\(1\) Clear bias in the review process, or

\(2\) That it missed relevant points, or

\(3\) That it seriously misunderstood or misinterpreted critical
elements of the research proposal.

b\. Issue(s) upon which the appeal is based must appear in the Summary
Statement. If the same issue is raised in individual reviews, the
individual review may also be included in the appeal.

c\. Issues raised [only]{.underline} in individual reviews may not form
the basis of, or be part of, an appeal.

d\. All information forming the basis of the appeal must have been part
of the original proposal. Data obtained since the original submission of
the proposal, additional information not included in the original
proposal, explanations of material not clearly presented in the original
proposal, and letters of support may not be included. If the
investigator believes that the Subcommittee consensus was biased, such
claim may be corroborated by evidence other than the Summary Statement.

e\. The appeal process is completely separate from the Merit Review
application process. The investigator's decision to submit a revised
application needs to be made separately from the decision to appeal.

**3. REVIEW OF AN APPEAL.** The appeal letter, Summary Statement, and
original proposal are considered in the review of an appeal. The
individual critiques of the proposal will only be considered if
pertinent to the appeal.

a\. The review of an appeal will focus on the validity of the issues in
the appeal letter. Reviewers, who were not part of the original
scientific review, will be instructed to consider only the appeal
issues. The PI receives copies of the written reviews.

b\. In considering the appeal review, BLR&D and CSR&D Services have the
following options:

\(1\) **Sustain the investigator's appeal.** The proposed Merit Review
program will then be administratively reviewed for funding based on
scientific merit and programmatic priorities. A sustained appeal may or
may not be funded.

\(2\) **Deny the appeal.**

**4. APPEAL DOCUMENTATION**

a\. The appeal must be reviewed and approved by the local Research and
Development (R&D) Committee, the Associate Chief of staff (ACOS) for
R&D, and the medical center Director.

b\. Appeal documentation must include:

\(1\) A letter of approval from the medical center Director.

\(2\) A letter of approval from the R&D Committee. The Director's and
R&D's letters may be combined as long as the Director and Chair, R&D
sign the letter.

\(3\) The appeal letter signed by the PI and the ACOS for R&D. The
appeal letter can be no longer than five single-spaced pages, using only
letter-quality print. All text must be prepared with at least 11-point
font, with no more than 15 characters per inch and no more than six
lines per inch. Page margins must be a minimum of one inch at each edge.
Submissions failing to comply with these instructions will be withdrawn
without review.

\(4\) The proposal Summary Statement.

\(5\) The individual reviews of the proposal.

\(6\) The complete proposal as originally submitted.

\(7\) If necessary, documentation to support a claim of bias, e.g.,
reprints of published work, if referenced.

**5. SUBMISSION OF AN APPEAL**

a\. Deadlines for receipt of appeals in are September 15 following the
spring cycle of Merit Review and March 15 following the fall cycle.

b\. Submit the original and ten copies of the appeal package, reproduced
back-to-back, to the following address:

Department of Veterans Affairs

BLR&D/CSR&D

Merit Review Appeal (121E)

810 Vermont Ave, NW

Washington, DC 20420

Telephone Number for Courier Delivery: (202) 254-0183/84