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NIH Grants Policy Statement (12/03) Part I: NIH Grants—General Information -- File 2 of 2
THE NATIONAL
INSTITUTES OF HEALTH
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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
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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.
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.
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.
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 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.
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.
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.
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 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.
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/funding/funding.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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