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ARCHIVED - NIH Grants Policy Statement (10/03)


NIH Grants Policy Statement
(12/03)

Part I: NIH Grants—General Information -- File 2 of 2


THE NATIONAL 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.[2]

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 Governments).[3] 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.

Roles and Responsibilities

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:

l      Grants 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.

l      Grants 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.

l      Program 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.

l      Scientific 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.

l      Other 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;[4] 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 telephone numbers.

Grantee Staff

The roles and responsibilities of grantee participants are as follows:

l      Authorized 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 this official.

l      Principal 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 awarded.

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.

Application and Review Processes

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.

Support Mechanisms

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 NIHGPS.

Eligibility

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 eligibility.

Types of Award Instruments

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.

Types of Applications

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.

l      New Application (Type 1)—a request for financial assistance for a project or activity that is not currently receiving NIH support and must compete for support.

l      Competing Continuation Application (Type 2)—a request for funding to renew, by one or more additional budget periods, a project period that would otherwise expire.

l      Competing 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.”]).

l      Revised (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.

l      Non-Competing 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.[5] 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 review.

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 opportunities (http://www.fedgrants.gov).

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:

l      Grant applications in a well-defined scientific area

l      Research grant applications for a one-time competition

l      Construction grant applications

l      Applications 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 administrative policies.

Application Forms

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 title

Form number

Use

Application for a Public Health Service Grant

PHS 398

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

PHS 416-1

Kirschstein-NRSA fellowships

Public Health Service Grant Application for Use by: State and Local Government Applicants and Nongovernmental Applicants for Health Services Projects

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 grants

 

 

Application Receipt Points and Deadlines

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

Suite 1040
6701 Rockledge Drive, MSC-7710
Bethesda, MD 20892-7710 (zip code for applications sent by USPS regular or Express mail)

Bethesda, MD 20817 (zip code for applications sent using a courier service)

Preaddressed mailing labels are included with the application forms.

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 described above.

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 application.

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.

Confidentiality of Information (Proprietary Information)

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 398 instructions.

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).

Initial Review

Responsibilities

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 applications.

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.

Review Criteria

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:

l      Significance. 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?

l      Approach. 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 tactics?

l      Innovation. 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?

l      Investigator. 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)?

l      Environment. 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:

l      Adequacy 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.

l      Reasonableness of the proposed budget and duration in relation to the proposed research.

l      Adequacy of the proposed protection for humans, animals, or the environment to the extent they may be adversely affected by the project proposed in the application.

Appeals of Initial Scientific Review

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 Review

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.

Disposition of Applications

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 cycle.

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 Council.

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.

Sources of 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:

l      NIH 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.

l      NIH 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.

l      NIH 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/.

l      Grants.gov. 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.

l      Research Grants. A compendium of information that includes data on NIH research grant awards organized in a variety of ways. The website address is
http://grants 1.nih.gov/grants/award/award.htm.

l      Computer Retrieval of Information on Scientific Projects. CRISP is an online system (http://www.crisp.cit.nih.gov) available to the public that is updated quarterly and provides a brief description of and administrative data on each NIH-funded research project.

l      Program 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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