NIH Grants Policy Statement
Part I: NIH Grants—General Information -- File 2 of 2
INSTITUTES OF HEALTH
AS A GRANT-MAKING ORGANIZATION
This section provides information about how NIH is organized
to award and administer grants and describes its relationship to other
organizations within HHS (or the Department) and external to HHS.
NIH, whose mission is to improve human health by increasing
scientific knowledge related to disease and health, is an organizational
component of HHS. NIH operates under the general policy guidance of the
Department in carrying out its mission, which is accomplished through the
conduct and support of biomedical and behavioral research, research training,
research infrastructure, and communications. These efforts take place
intramurally (primarily at NIH) and extramurally (through grants, cooperative
agreements, and contracts awarded to institutions of higher education,
governmental organizations, non-profit research organizations, for-profit
organizations, and individuals). NIH also works closely with other HHS components
and other Federal departments and agencies.
HHS develops, issues, and maintains regulations that govern
the Department’s grants process. Among these are the regulations that implement
the OMB Circular A-102 common rule (applicable to grants to State, local, and
Indian tribal governments) and OMB Circular A-110 (applicable to grants to
institutions of higher education, hospitals, and other non-profit
organizations). These regulations are codified at 45 CFR Part 74 (Uniform
Administrative Requirements for Awards and Subawards to Institutions of Higher
Education, Hospitals, Other Non-Profit Organizations, and Commercial
Organizations; and Certain Grants and Agreements with States, Local
Governments, and Indian Tribal Governments) and 45 CFR Part 92 (Uniform Administrative
Requirements for Grants and Cooperative Agreements to State and Local
They provide the framework for the terms and conditions of NIH awards as
specified in Part II of the NIHGPS.
NIH is organized into ICs, each with its own mission and
functions, separate appropriations, and statutory authorities. The ICs that
award grants are listed in Part III.
Although the ICs operate under the same general grant process and requirements,
applicants and grantees need to be aware of differences that may exist. This
information may be obtained from NIH staff. The policies and procedures
generally applicable to NIH grants are set forth in the NIHGPS.
NIH, as a Federal grantor agency, is responsible to Congress
and the U.S. taxpayer for carrying out its mission in a manner that not only
facilitates research but does so cost-effectively and in compliance with
applicable rules and regulations. NIH seeks to ensure integrity and
accountability in its grant award and administration processes by relying on a
system of checks and balances and separation of responsibilities within its own
staff and by establishing a similar set of expectations for grantee
organizations. The grantee’s roles and responsibilities have assumed greater
importance as NIH has shifted to increased reliance on systems compliance and
provided greater decision-making authority to grantees.
The following subsections highlight the major functions and
areas of responsibility of Federal and grantee staffs. NIH recognizes that
additional staff members in a number of different organizations may be involved
in grant-related activities; however, this section details only the major
participants representing the Federal government and the grantee. The
responsibilities of CSR staff members, who are involved only in the initial
review phase of the peer review process, are described in the “Application and Review Processes” section in
this Part. The responsibilities of other offices, such as OHRP, are described
in Part II.
The roles and
responsibilities of NIH and HHS participants are as follows:
Management Officer. The GMO whose name appears on the NGA is the NIH
official responsible for the business management and other non-programmatic
aspects of the award. These activities include, but are not limited to,
evaluating grant applications for administrative content and compliance with
statutes, regulations, and guidelines; negotiating grants; providing
consultation and technical assistance to applicants and grantees, including
interpretation of grants administration policies and provisions; and
administering and closing out grants. The GMO works closely with his or her
counterparts in other NIH ICs and with the designated PO. The GMO is the focal
point for receiving and acting on requests for NIH prior approval or for
changes in the terms and conditions of award and is the only NIH official
authorized to obligate NIH to the expenditure of Federal funds or to change the
funding, duration, or other terms and conditions of award.
Management Specialist. The GMS is an agent of the GMO and is assigned
responsibility for the day-to-day management of a portfolio of grants.
Official. The PO is responsible for the programmatic, scientific, and/or
technical aspects of assigned applications and grants. The PO’s
responsibilities include, but are not limited to, development of research and
research training programs to meet the IC’s mission; coordination with CSR/IC
SRAs; and post-award administration, including review of progress reports,
participation in site visits, and other activities complementary to those of
the GMO. The PO and the GMO work as a team in many of these activities.
Review Administrator. SRAs are health science administrators who manage the
activities of SRGs, including CSR study sections. For the SRG for which he or
she is responsible, the SRA reviews applications for completeness and
conformity to requirements, ensures that adequate numbers of reviewers with
appropriate expertise are available for application review, assigns
applications to individual reviewers as discussion leaders and for preparation
of written critiques, and serves as the overall point of contact with
applicants during the initial phase of the peer review process, i.e., until the
conclusion of the SRG meeting.
NIH and HHS Staffs. In addition to the GMO and PO, the grantee may be
required to interact with other NIH or HHS staff members or offices with
respect to its organization-wide systems and/or individual transactions. These
include the office responsible for negotiating F&A costs and research
patient care rates, typically the cognizant (based on geographical location)
DCA office or DFAS;
OIG; OHRP; OLAW; and ORI. Staff members in these offices generally coordinate
with the GMO, but they are responsible for discrete areas of specialization and
are not required to channel their communications with the grantee through the
GMO. Part III includes a list of these organizations and their addresses and
The roles and
responsibilities of grantee participants are as follows:
Organizational Official. The AOO is the designated representative of the
grantee organization in matters related to the award and administration of its
NIH grants, including those that require NIH approval. In signing a grant
application, this individual certifies that the applicant organization will comply
with all applicable assurances and certifications referenced in the
application. This individual’s signature on the grant application further
certifies that the applicant organization will be accountable both for the
appropriate use of funds awarded and for the performance of the grant-supported
project or activities resulting from the application. (Also see “Legal Implication of Application.”) This
individual also is responsible to NIH for ensuring that the organization
complies with applicable Federal laws and regulations, including required
certifications and assurances, its application, and the terms and conditions of
individual awards. Under NIH’s eRA Commons, this individual is the SO. Although
NIH requires that the grantee organization designate such an official, NIH does
not specify the organizational location or full set of responsibilities for
Investigator. The PI (who also may be known as the PD) is the individual,
designated by the grantee, responsible for the scientific or technical aspects
of the grant and for day-to-day management of the project or program. The PI is
not required to be an employee of the grantee. However, because the grant, if
awarded, is made to the organization, the applicant organization must have a
formal written agreement with the PI that specifies an official relationship
between the parties even if the relationship does not involve a salary or other
form of remuneration. If the PI is not an employee of the applicant
organization, NIH will assess whether the arrangement will result in the
organization being able to fulfill its responsibilities under the grant, if
The PI is a member of the grantee team
responsible for ensuring compliance with the financial and administrative
aspects of the award. This individual works closely with designated officials
within the grantee organization to create and maintain necessary documentation,
including both technical and administrative reports; prepare justifications;
appropriately acknowledge Federal support of research findings in publications,
announcements, news programs, and other media; and ensure compliance with other
Federal and organizational requirements. NIH encourages the PI to maintain
contact with the NIH PO with respect to the scientific aspects of the project
and the GMO concerning the business and administrative aspects of the award.
NOTE: NIH staff members conduct official business only with
the designated PI and AOOs.
This subsection provides an overview of NIH’s grant support
mechanisms, types of entities eligible to receive grants, types of
applications, types of funding opportunities, application submission (including
application forms, application receipt points and deadlines, legal implication,
and proprietary information), and the peer review process. It includes
publications and NIH websites that can be accessed for additional information
concerning the NIH grants process and programs.
NIH ICs award grants under multiple programs and subprogram
initiatives and use a variety of support mechanisms. NIH grants may be
distinguished by purpose, type of recipient, amount, or other characteristics.
One method NIH uses to differentiate the various support mechanisms is activity
coding that indicates the category and specific form of support (e.g., R01,
F32). The applicability of requirements may vary for different activity codes.
Therefore, applicants should consult one or more of the information sources
described in “Sources of Information about
NIH’s Grants Process and Programs” at the end of this section. Some of the
distinctions also are significant for purposes of applying Part II of the
In general, NIH grants may be awarded to organizations that
are domestic or foreign, public or private, or non-profit or for-profit.
Eligible organizations include governments, including Federal institutions,
institutions of higher education, hospitals, and, in this usage, also include
individuals. Any special criteria for applicant eligibility or requirements
concerning the qualifications of the PI or other staff or participants will be
specified in the program solicitation, program guidelines, or other publicly
available documents. Part II includes information on fellow and trainee
NIH uses several different extramural award instruments in
support of its mission. NIH grants and cooperative agreements are financial
assistance instruments. Under a cooperative agreement, NIH expects to be
substantially involved in carrying out the project. Grants are used both for
investigator-initiated research and for more targeted research. Cooperative
agreements generally do not result from investigator-initiated applications.
The NIHGPS pertains to grants and cooperative agreements; however, NIH may
apply terms and conditions that differ from those in the NIHGPS consistent with
the nature of its involvement under cooperative agreements.
In the NIH grants process, five types of applications are
used most frequently. Each of the first four application types is considered
“competing” because, through the peer review process, the application must
compete for available funding with other applications.
Application (Type 1)—a request for financial assistance for a project or
activity that is not currently receiving NIH support and must compete for
Continuation Application (Type 2)—a request for funding to renew, by one or
more additional budget periods, a project period that would otherwise expire.
Supplemental Application (Type 3)—a request for an increase in support in a
current budget period for expansion of the project’s approved scope or research
protocol. The request may specify budgetary changes required for the remainder
of the project period as well as for the current budget period. (A Type 3
prefix also refers to a request/award for a non-competing administrative
supplement [see “Administrative
Requirements—Changes in Project and Budget—Prior-Approval Requirements—Need for
Additional NIH Funding without Extension of Budget and Project Period.”]).
(Amended) Application—an unfunded application that the applicant has
modified following initial review and resubmitted for consideration. NIH allows
a maximum of two revised applications. An amended application may be submitted
for any of the three preceding types of applications. However, NIH generally
treats unfunded applications resubmitted under a different process or research
grant mechanism than the original application (e.g., an application originally
submitted as investigator-initiated and, subsequently, resubmitted in response
to an RFA, or an application originally submitted as an R01 and, subsequently,
resubmitted as an R21) as new applications rather than as amended applications.
Grant Progress Report (Type 5)—a progress report and request for funding of
a non-competing continuation award for the second or subsequent budget period
within an approved competitive segment (see “Administrative
Requirements—Monitoring—Reporting—Non-Competing Grant Progress Reports”).
NIH uses the numbers shown in parentheses as prefixes to
distinguish the application types and any resulting awards.
The preponderance of applications submitted to NIH under the
categories of research and research training (including fellowships) are for
investigator-initiated research and are considered “unsolicited” applications.
NIH reviews such applications in three review cycles per year. The schedules for submission,
review, and award of unsolicited applications are included in the application
instructions and on the NIH home page.
All applicants are encouraged to contact the IC from which
they plan to seek funding. See Part III
for a list of the IC contact points. However, any applicant requesting $500,000
or more in direct costs in any year in an unsolicited application is required
to contact the IC PO, in writing or by telephone, as early as possible during
development of the application but no later than 6 weeks before submission.
This requirement applies to a single application, whether a new, competing
continuation, competing supplemental, or revised (amended) grant application,
under any NIH support mechanism; it also applies to a group of applications,
such as those for clinical trial networks, meeting that threshold in the
aggregate even if no single application in the group requests that much.
Applicants that are uncertain about which IC to contact should contact the
Division of Receipt and Referral, CSR (see Part III). CSR
will accept such applications for review only if an IC has agreed to accept the
application for consideration and the applicant submits with its application a
letter to that effect with the name of the authorizing program staff member and
IC affiliation (see “The Peer Review Process”).
An application subject to this policy that does not include the required
information in the cover letter accompanying the application will be returned
to the applicant without review. This policy does not apply to applications
submitted in response to RFAs or other announcements that include specific
budgetary limits. However, such applications must be responsive to any
budgetary limits specified or NIH will return them to applicants without
NIH may develop areas of high priority or special research
interest and use a special solicitation to stimulate submission of applications
in those areas. These solicitations are published in the NIH Guide for
Grants and Contracts, which is electronically linked to Grants.gov, a
government-wide site for locating grant and cooperative agreement funding
NIH solicitations take one of two forms: PAs and RFAs. NIH
uses PAs to describe new, continuing, or expanded program interests of an IC or
to announce the availability of a new mechanism of support. PAs may be used for
any support mechanism other than construction awards. Unless otherwise
specified in the PA, new applications (and associated competing continuation
and competing supplemental applications) submitted in response to PAs are
treated as unsolicited, are subject to the common receipt dates, compete for
funding with all other unsolicited applications, and are subject to the
standard peer review process. PAs also are used to annually solicit
applications for the SBIR and STTR programs. Those applications must be
received by the dates specified in the PA.
An RFA is a more targeted
solicitation; it may be used to solicit the following:
applications in a well-defined scientific area
grant applications for a one-time competition
for cooperative agreements.
RFAs are stand-alone solicitations, and each will provide
sufficient information to allow prospective applicants to determine whether to
apply. That information includes the amount of funding available, the number of
awards anticipated, whether cost sharing is required, the deadline date for
receipt of applications, and other information describing the nature of the
effort desired and the obligations of recipients. For cooperative agreements,
the RFA will describe the responsibilities and obligations of NIH and awardees
as well as joint responsibilities and obligations.
To be considered for support, an applicant must be an
eligible entity and must submit a complete application in accordance with
established receipt (deadline) dates. Information to be submitted typically
includes a project description, budget and budget justification, biographical
sketches of key personnel, and other information specified in the application
instructions, in the solicitation, and/or in program guidelines, if any.
Applicants should consult the cost principles and general administrative
requirements for grants pertaining to their organizational type in order to
prepare the budget and complete other parts of the application. Applicants may
be required to provide proof of organizational eligibility (such as proof of
non-profit status), trainee or fellow eligibility and citizenship, or other
eligibility information. Applications also must demonstrate compliance (or
intent to comply), through certification or other means, with a number of
public policy requirements. The more significant of the public policy
requirements for the purpose of peer review are those concerning research
involving human subjects; inclusion of both genders, members of minority
groups, and children in clinical research; and research involving live
vertebrate animals. Part II details public policy requirements and cost and
Exhibit 1 lists the required application forms, which vary
by support mechanism. These forms and associated instructions are available
electronically on the NIH home page (http://grants.nih.gov/grants/forms.htm). Questions about
application forms and instructions may be directed to DEOIR, OER, NIH by
telephone at 301-435-0714 or by e-mail at GrantsInfo@nih.gov (see Part
III). Certain forms (rather than a complete application kit) are available
electronically on the NIH home page (http://grants.nih.gov/grants/forms.htm).
Exhibit 1. Required Forms for Competing Applications
Application for a Public
Health Service Grant
Research project grants and
cooperative agreements, program projects, centers, K awards, Kirschstein-NRSA
institutional research training grants, conference grants, and SBIR and STTR
grants (see Section VI of the instructions)
Application for Ruth L. Kirschstein
National Research Service Award Individual Fellowship
Public Health Service Grant Application for Use by: State
and Local Government Applicants and Nongovernmental Applicants for Health
PHS 5161-1, with budget and assurances applicable to
nonconstruction (424-A and 424-B) or construction (424-C and 424-D)
State, local, and Indian tribal governmental applicants
for all types of grants, and nongovernmental applicants for construction
Application Receipt Points and
All competing applications,
whether solicited or unsolicited, are required to be sent or delivered via the
USPS or a courier delivery service, in the number of copies specified in the
application instructions or solicitation, to the central NIH receipt point:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC-7710
Bethesda, MD 20892-7710 (zip code for applications sent by USPS regular or
Bethesda, MD 20817 (zip code for applications sent using a courier service)
Preaddressed mailing labels are included with the
CSR will not accept applications delivered by individuals.
Applicants responding to RFAs should submit copies of their
application concurrently to CSR and the soliciting IC.
An unsolicited application will be considered to be on time
for a particular review cycle if it is received by or mailed on or before the
published receipt date for that cycle and a proof of mailing is provided. If
the receipt date falls on a weekend or a Federal holiday, the date for
receipt/mailing is extended to the next business day.
An application submitted in response to an RFA or a PA but
received after the deadline date (if one is specified in the RFA or PA) may be
accepted only if it carries a legible proof-of-mailing date assigned by the
carrier and that date is no later than 1 week prior to the deadline date. This
applies only to PAs with specific, published receipt dates, i.e., dates other
than the standard ones used for unsolicited applications. For PAs using the
standard receipt dates, the rules for unsolicited applications apply as
The established receipt or deadline date will be waived only
in extenuating circumstances. A request for a waiver must accompany the
application and must explain the basis for requesting a waiver. A waiver will
not be considered before the application is received. Only CSR has the
authority to waive an established receipt date.
Legal Implication of Application
The signature of an AOO on the application certifies that
the organization will comply with all applicable assurances and certifications
referenced in the application. The applicant organization is responsible for
verifying the accuracy, validity, and conformity with the most current
organizational guidelines of all the administrative, fiscal, and scientific
information in the application, including the F&A cost (indirect cost)
rate. The AOO’s signature further certifies that the applicant organization will
be accountable for the appropriate use of any funds awarded and for the
performance of the grant-supported project or activities resulting from the
Applicants for and recipients of NIH grant funds, whether
such funds are received directly from NIH, indirectly under a contract or
consortium agreement, or as student assistance under a training grant, are
responsible for and must adhere to all applicable Federal statutes,
regulations, and policies, including income tax regulations. Questions concerning
the applicability of income tax regulations to grant funds should be directed
to the IRS. The applicant also is expected to be in compliance with applicable
State and local laws and ordinances.
The HHS OIG maintains a post office box and a toll-free hot
line for receiving information from individuals concerning fraud, waste, or
abuse under HHS grants and cooperative agreements. The identity of the caller
is kept confidential, and callers are not required to give their names. The
address and telephone number of the OIG and the OIG hot line are included in
Part III. Anyone who becomes aware of the existence (or apparent existence) of
fraud, waste, or abuse related to NIH grants or grant funds is encouraged to
report this information to the OIG in writing or to the OIG hot line. Examples
of fraud, waste, and abuse that should be reported include, but are not limited
to, embezzlement, misuse, or misappropriation of grant funds or property, and
false statements, whether by organizations or individuals. This includes theft
of grant funds for personal use; using funds for non-grant-related purposes;
theft of federally owned property or property acquired or leased under a grant;
charging the Federal government for the services of “ghost” individuals; charging
inflated building rental fees for a building owned by the grantee; submitting
false financial reports; and submitting false financial data in bids submitted
to the grantee (for eventual payment under the grant).
Part II of the NIHGPS includes administrative and other
remedies the Federal government may use if a grantee deliberately withholds
information or submits fraudulent information or does not comply with
applicable requirements. Even if a grant is not awarded, the applicant may be
subject to penalties if the information contained in or submitted as part of an
application, including its certifications and assurances, is found to be false,
fictitious, or fraudulent. The Federal government may pursue civil or criminal
action under a variety of statutes and regulations.
The Program Fraud and Civil Remedies Act of 1986, 31 U.S.C.
3801 et seq., provides for the administrative imposition by HHS of civil
penalties and assessments against persons who knowingly make false, fictitious,
or misleading claims to the Federal government for money, including money
representing grants, loans, or benefits. A civil penalty of not more than
$5,000 may be assessed for each such claim. If a grant is awarded and payment
is made on a false or fraudulent claim, an assessment of not more than twice
the amount of the claim, up to $150,000, may be made in lieu of damages.
Regulations at 45 CFR Part 79 specify the process for imposing civil
penalties and assessments, including hearing and appeal rights.
The Criminal False Claims Act, 18 U.S.C. 287 and 1001,
provides for criminal prosecution of a person who knowingly makes or presents
any false, fictitious, or fraudulent statements or representations or claims
against the United States. Violations carry a maximum sentence of 5 years imprisonment
and a fine of $250,000.
The Civil False Claims Act, 31 U.S.C. 3729(a), provides for
imposition of penalties and damages by the United States, through civil
litigation, against any person who knowingly makes a false or fraudulent claim
for payment, makes or uses a false record or false statement to get a false
claim paid or approved, or conspires to defraud the Federal government to get a
false claim paid. A “false claim” is any request or demand for money or
property made to the United States or to a contractor, grantee, or other
recipient, if the Federal government provides or will reimburse any portion of
the funds claimed. Civil penalties of $5,500 to $11,000 may be imposed for each
false claim, plus damages of up to three times the amount of the false claim.
NIH also may administratively recover misspent grant funds
pursuant to the authorities contained in 45 CFR Parts 74 and 92.
Applicants are discouraged from submitting information considered
proprietary unless it is deemed essential for proper evaluation of the
application. However, if the application contains information that the
applicant organization considers to be trade secrets, information that is
commercial or financial, or information that is privileged or confidential, the
pages containing that information should be identified as specified in the PHS
When such information is included in the application, it is
furnished to the Federal government in confidence, with the understanding that
the information will be used or disclosed only for evaluation of the
application. The information contained in an application will be protected by
NIH from unauthorized disclosure, consistent with the need for peer review of the
application and the requirements of the FOI and Privacy
Acts, which are discussed in “Public
Policy Requirements and Objectives” in Part II. However, if a grant is
awarded as a result of or in connection with an application, the Federal
government shall have the right to use or disclose the information to the
extent authorized by law. This restriction does not limit the Federal
government’s right to use the information if it is obtained without restriction
from another source.
The Peer Review Process
Competing applications for NIH grants and cooperative
agreements, including those for competing continuations and competing
supplements, are subject to peer review as required by sections 406 and 492 of
the PHS Act or by NIH policy. The peer review system used by NIH, often
referred to as the “dual review system,” is based on two sequential levels of
review for each application—initial review and National Advisory Council/Board
review. The NIH peer review process has evolved over the years to accommodate
changes in workload, resource constraints, and recommendations of various
groups that have studied it. However, the underlying basis for the system—to
provide a fair and objective review process in the overall interest of
science—has not changed. Information concerning NIH’s peer review process may
be found at the following websites: http://www.csr.nih.gov and http://grants.nih.gov/grants/peer/peer.htm. Information also
is available by e-mail at GrantsInfo@nih.gov, or by calling,
writing, or faxing a request to CSR (see Part III).
CSR is the receipt point for all competing grant
applications submitted to NIH, whether the peer review will be conducted by CSR
or by an IC. The primary determining factors in whether CSR or an IC will be
responsible for the peer review are the solicitation type, the support
mechanism, and/or the program. In general, CSR is responsible for the initial
review of research project grant applications (including AREA applications),
Kirschstein-NRSA individual fellowship applications, and SBIR/STTR
applications, while the ICs handle the initial review of conference grant
applications, applications resulting from RFAs, and program project grant
CSR also may review other types of applications at IC
request. When the IC is responsible for the initial review, CSR reviews the
application for completeness, and the scientific review office of the
soliciting IC reviews the application for responsiveness to the RFA,
coordinates the initial technical review, and prepares the summary statements.
CSR Referral Officers, who are senior health science
administrators with both research and scientific review experience, assign each
application to one or more ICs for potential funding and to an SRG for initial
review of the scientific merit of the application. These determinations are
made on the basis of the application’s contents, the referral guidelines, and
any written request by the applicant organization (accompanying the
application) for a specific study section or IC assignment.
SRGs, including CSR study sections, are organized by
scientific discipline or current research areas and are managed by health
scientist administrators functioning as SRAs. Generally, study sections are
chartered groups composed of formally appointed members serving multiyear
terms, to which the SRA often adds temporary members or other additional
reviewers. Ad hoc SEPs are formed to review applications that cannot be
reviewed by a standing review group or study section because they require
special expertise or involve other special circumstances.
SRGs, whether study sections or SEPs, are primarily composed
of scientists actively engaged in research. NIH’s conflict-of-interest and
confidentiality of information policies for reviewers are intended to ensure an
unbiased review process by minimizing even the appearance of a conflict of
interest and by restricting the use of privileged application information.
Within 6 to 8 weeks following the established application
receipt date, applicants are notified that the application has been received
and are advised of the SRA, SRG, and IC assignments. At this time, applicants
may request reconsideration of the SRG and IC assignment. Once the assignment process
is completed, the SRA is the contact for all communication with the applicant
until the conclusion of the SRG meeting. An applicant may withdraw an
application from consideration at any time during the review process. A request
to withdraw an application must be signed by the PI and an AOO. If an
application is withdrawn before it enters the review process, CSR will return
the application to the applicant. Applications withdrawn by the applicant after
the beginning of the formal review may be destroyed by NIH or returned to the
applicant at NIH’s discretion.
In preparation for the initial review, SRAs review
applications to determine whether they are complete, conform to administrative
requirements, and contain the information necessary for a detailed review. For
each reviewable application, they then assign (from among the standing and
temporary members) reviewers to write a critique of the application and readers
to be prepared to discuss the application in detail.
Following the initial review, the SRA prepares a summary
statement for each application reviewed. The summary statement includes the
reviewers’ written comments, and, for scored applications, a summary of
strengths and weaknesses, other summary highlights of the discussion, and a
priority score. Summary statements are then provided to the IC’s program staff
and the PI.
The goals of NIH-supported research are to advance the
understanding of biological systems, improve the control of disease, and
enhance health. Reviewers judge the likelihood that the proposed research will
have a substantial impact on the pursuit of NIH’s research goals by addressing,
in their written comments about the application, the following criteria:
Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge be advanced? What will be the
effect of these studies on the concepts or methods that drive this field?
Are the conceptual framework, design, methods, and analyses adequately
developed, well integrated, and appropriate to the aims of the project? Does
the applicant acknowledge potential problem areas and consider alternative
Does the project employ novel concepts, approaches or methods? Are the aims original
and innovative? Does the project challenge existing models or develop new
methodologies or technologies?
Is the investigator appropriately trained and well suited to carry out this
work? Is the work proposed appropriate to the experience level of the PI and
other researchers (if any)?
Does the scientific environment in which the work will be done contribute to
the probability of success? Do the proposed experiments take advantage of
unique features of the scientific environment or employ useful collaborative
arrangements? Is there evidence of organizational support?
All of the criteria, weighted as appropriate for each
application, will be considered when assigning the overall score. An
application does not need to be strong in all categories to be judged likely to
have a major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out work that, by its nature, is
not innovative but is essential to move a field forward.
Although the review criteria are intended for use primarily
with unsolicited research project grant applications (e.g., R01 and P01),
including those in response to PAs, to the extent reasonable, the criteria also
will form the basis of the review of solicited applications and non-research
activities. However, for some activities (e.g., construction grants), the use
of these criteria may not be feasible. Applications also may be reviewed
against specific criteria as stated in RFAs or PAs.
In addition to the above criteria, in accordance with NIH
policy, all applications will be reviewed with respect to the following:
of plans to include both genders, members of minority groups, children, and
their subgroups, as appropriate for the scientific goals of the research. Plans
for the recruitment and retention of subjects also will be evaluated.
of the proposed budget and duration in relation to the proposed research.
of the proposed protection for humans, animals, or the environment to the
extent they may be adversely affected by the project proposed in the
To preserve and underscore the fairness of the NIH peer
review process, NIH has established a peer review appeal system to provide
applicants the opportunity to seek reconsideration of the initial review
results if, after review of the summary statement, they believe the review
process was procedurally flawed. This appeal process is not intended to deal
with differences of scientific opinion between or among PIs and reviewers.
The applicant should discuss concerns about the conduct of
the review, whether the initial review was conducted by CSR or by the IC, with
the PO responsible for the application; the PO who will attempt to resolve the
applicant’s concerns. If, after discussion with the PO, the applicant still has
concerns, the AOO may submit a formal letter of appeal to the PO, who will
handle it in accordance with the appeal procedures outlined below.
The PO will consult with the SRA or staff of the IC
scientific review office. This consultation may result in a decision to
re-review the application. A re-review consists of a review of the same
application, not a revised version, by the same or another review group without
access to the summary statement of the disputed review. If the NIH staff and
the PI cannot agree on a course of action, the appeal will be reviewed by the
designated IC Appeals Officer. That official will make the appeal letter
available to the Council along with the IC recommendation on the appeal and any
written comments from the SRA or review group. The Council may reject the
appeal and let the initial review results stand or recommend that the
application be re-reviewed. The Council’s decision may not be further appealed.
National Advisory Council or Board
Summary statements for those applications recommended for
further consideration are presented to the assigned IC National Advisory
Council or Board (hereafter “Council”) for use in the second level of review.
Council members include senior scientists with broad experience and members of
the public with general knowledge of, and interest in, the IC’s mission. The
Council reviews applications not only for scientific and technical merit but
also for relevance to the IC’s programs and priorities. The Council may concur
with the SRG’s recommendation, may decide not to recommend an application on
the basis of program or policy considerations, or may recommend deferral of an
application and refer it back to the SRG for re-review. With very limited
exception, an application may not be considered for funding unless it has
received a favorable recommendation by both the SRG and the Council.
All incomplete applications, non-compliant modular
applications, and applications determined to be nonresponsive to solicitation
requirements will be returned to the applicant by CSR or by the IC referral
office without further action. The applicant may resubmit a changed or complete
version of an unsolicited application for consideration in the next review
Following the initial review, the PI will receive a copy of
the summary statement and will be advised by letter from the responsible IC
whether the application has been recommended for further consideration by the
The IC Director or designee is the official that has the
authority to make final award decisions from among those applications receiving
a favorable initial review and Council recommendation. If an application has
been recommended for further consideration but is not expected to be funded in
the current cycle, the application may be held by NIH for one or more
additional cycles and will compete with other applications submitted for that
cycle. If an application is unsuccessful, the applicant may subsequently submit
up to two revised versions of the application for review in a future cycle(s).
Successful applicants will be notified of additional
information that may be required or other actions leading to an award. The
process leading to an award, including the business management review performed
by the GMO, is described in Part II. The decision not to award a grant, or to
award a grant at a particular funding level, is discretionary and is not
subject to appeal to any NIH or HHS official or board.
Information about NIH’s Grants Process and Programs
NIH maintains a number of information resources about its
grant programs and activities that can be accessed through OER’s home page.
Some are descriptive materials that enable interested parties to learn about
NIH grant initiatives, funding opportunities, and proposed and actual policy
changes. Others provide historical data. This information is updated annually
or as needed. The NIH website address for these materials and other
grant-related materials is http://grants.nih.gov/grants/oer.htm (a
more specific address may be provided below). In addition, these materials may
be requested by e-mail from GrantsInfo@nih.gov or by telephone at
301-435-0714 (see Part III).
The information resources
include the following:
Extramural Programs. A compendium of the scientific programs of the NIH
components that award grants, cooperative agreements, and contracts. It
indicates current areas of research emphasis, highlights special interests of
each IC, and identifies specific NIH offices to be contacted for further
information about particular programs, policies, and procedures. The website
address is http://grants.nih.gov/grants/oer.htm.
Guide for Grants and Contracts. A publication that announces new programs
and policies, including program announcements, RFAs, and RFPs. The website
address for the NIH Guide for Grants and Contracts is http://grants.nih.gov/grants/guide/index.htm. The NIH Guide
also is available on a subscription basis. For subscription instructions, see http://grants.nih.gov/grants/guide/listserv.htm.
Electronic Research Administration Commons. The NIH eRA Commons facilitates
research administration between, NIH, grantee organizations, and the public by
providing the capability for an electronic exchange of information. The eRA
Commons is divided into both unrestricted and restricted portions that provide
for public and confidential information, respectively. For additional
information, see https://commons.era.nih.gov/commons/.
An Internet site that will provide a simple, unified “storefront” for all
customers of Federal grants to electronically find opportunities, apply, and
manage grants. It will facilitate the quality, coordination, effectiveness, and
efficiency of operations for grant-makers and grantees. For additional
information, see http://www.fedgrants.gov.
Grants. A compendium of information that includes data on NIH research
grant awards organized in a variety of ways. The website address is
Retrieval of Information on Scientific Projects. CRISP is an online system
available to the public that is updated quarterly and provides a brief
description of and administrative data on each NIH-funded research project.
Guidelines. Publications that include detailed policy and procedural
information applicable to specific programs/activities. NIH-wide program
guidelines are published initially in the NIH Guide for Grants and Contracts
(see above) and also are accessible by title at http://grants.nih.gov/grants/documentindex.htm. The SBIR/STTR
Phase I grant guidelines are available at NIH’s “Small Business Funding
Opportunities” site (http://grants.nih.gov/grants/funding/sbir.htm).
IC home pages also should be consulted for IC-specific guidelines (see Part III).
Each IC also maintains its own home page accessible through
the NIH home page “Institutes and Offices”
submenu (also see Part III for website addresses).
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