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Competing applications for NIH grants and cooperative agreements, including renewals and revisions, are subject to peer review as required by sections 406 and 492 of the PHS Act, as amended by the NIH Reform Act of 2006. NIH policy is intended to ensure that applications for funding submitted to the NIH are evaluated on the basis of a process that is fair, equitable, timely, and conducted in a manner that strives to eliminate bias. 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 by an IRG or SRG, and a second level of review by the IC National Advisory Council/Board.
The NIH peer review process has evolved over the years to accommodate increasingly collaborative and multi-disciplinary research, 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 http://grants.nih.gov/grants/peer/peer.htm. Information also is available from GrantsInfo, or from OEP (see Part III).
The DRR in the 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 announcement 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 and center 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 staff in the soliciting IC review the application for responsiveness to the RFA, and the scientific review office in that IC 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 IRG or 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 SROs. Generally, study sections are chartered groups composed of formally appointed members serving multiyear terms, to which the SRO 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 non-federal scientists who have expertise in relevant scientific disciplines and are actively engaged in research. NIH's conflict-of-interest and confidentiality of information requirements for reviewers are intended to promote an unbiased review process by minimizing even the appearance of a conflict of interest and by restricting the use of privileged application information.
Applicants are notified by e-mail that the application has been received and that they may have access to the SRO, SRG, and IC assignments for the application in the eRA Commons. At this time, applicants may request reconsideration of the SRG and IC assignment. Applicants also are notified by e-mail to check eRA Commons for any change in the application's SRG or IC assignment, as well as a change in Council date. Once the assignment process is completed, the SRO is the primary contact for communication with the applicant until the conclusion of the SRG meeting. An applicant organization may withdraw an application from consideration at any time during the review process. A request to withdraw an application must be signed by the PD/PI and an AOR.
In preparation for the initial review, SROs review applications to determine whether they are complete and conform to administrative requirements. For each reviewable application, they then assign (from among the standing and temporary members) at least three reviewers to write a critique of the application and to be prepared to discuss the application in detail.
Following the initial review, the SRO prepares a summary statement for most applications 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 an impact score. Summary statements are then provided to the IC's program staff and the PD(s)/PI(s).
The SRG assesses overall impact in the determination of scientific and technical merit; overall impact is defined differently for different types of applications. When considering applications for research grants and cooperative agreements, reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the five scored review criteria, and additional review criteria (as applicable for the project proposed). All of the criteria, weighted as appropriate for each application or as described in the FOA, will be considered when assigning the overall impact score.
The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria.
Reviewers will consider each of the five criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
The FOA should be consulted for additional information describing each of the scored review criteria.
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
The FOA should be consulted for additional information describing each of the relevant additional review criteria.
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
The FOA should be consulted for additional information describing each of the relevant additional review considerations.
Although the review criteria are intended for use primarily with investigator-initiated 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 other pertinent factors as stated in FOAs.
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 consideration of the summary statement, they believe the review process was procedurally flawed. The NIH policy for appeals of initial peer review does not apply to appeals of the technical evaluation of Research and Development contract projects through the NIH peer review process, appeals of NIH funding decisions, or appeals of decisions concerning extensions of MERIT awards. In addition, NIH will not review a resubmission application when an appeal of initial peer review is pending on the original application. Appeals of initial peer review outcome will not be accepted for applications in response to an RFA.
An appeal is a written communication from a Program Director/Principal Investigator (PD/PI) and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues (described below), and 4) displays concurrence from the Authorized Organization Representative (AOR).
An applicant who is concerned about procedural aspects related to the completed initial peer review of his or her application first should consider the comments in the summary statement, and then should contact the appropriate NIH Program Official (PO). Following discussion of concerns with the PO, if the PD/PI and/or an official of the applicant organization wishes to appeal the outcome of the initial peer review process, an appeal letter must be submitted, either in hard copy or electronically, to the PO. The appeal letter must display concurrence from the AOR of the applicant organization for the application. Although the content of the appeal letter may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the letter directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and AOR concurrence to the PO. A communication from the PD/PI or official of the applicant organization (other than the AOR) only or with a "cc" to the AOR will not be accepted. The PO will send the PD/PI and/or institutional official, and AOR, an acknowledgement letter within 10 days of receipt of the appeal letter.
An appeal letter will be accepted only if the letter 1) describes the flaws in the review process for the application in question, 2) explains the reasons for the appeal, and 3) is based on one or more of the following issues related to the process of the initial peer review:
Appeal letters based solely on differences of scientific opinion will not be accepted. A letter that does not meet these criteria and/or does not include the concurrence of the AOR will not be considered an appeal letter, but rather a grievance. The IC will handle grievances according to IC-specific procedures.
If review staff and program staff do not support the appeal, or do not agree on its merit, the PD/PI and/or an institutional official (not necessarily the AOR) may elect to withdraw the appeal letter. The request to withdraw an appeal letter must be submitted either in hard copy or electronically to the PO, and must display concurrence from the AOR of the applicant organization for the application. Although the content of the request may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the request directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and his/her concurrence to the PO. A communication from the PD/PI or institutional official (other than the AOR) only or with a "cc" to the AOR will not be accepted.
If review staff and program staff do not support the appeal, or do not agree on its merit, and the appeal letter is not withdrawn, the appeal letter will be made available to Council. The IC may not deny the PD/PI or applicant organization the opportunity to have an appeal letter made available to Council. Only two outcomes are possible following consideration of an appeal letter by Council:
The recommendation of Council concerning resolution of an appeal is final and will not be considered again by the NIH through this or another process.
The Executive Secretary for the Council will communicate the Council recommendation concerning an appeal to the PD/PI, AOR, and NIH staff with a need to know. If the appeal letter was received by the IC deadline, the PD/PI and AOR will receive a written explanation of the resolution no later than 30 calendar days after the Council meeting. If the appeal letter was received after the IC deadline, the Executive Secretary will provide, no more than 30 calendar days after the date when the appeal letter was received, a written explanation of the IC's plan for making the appeal available to Council.
If the Council recommended that the application be re-reviewed, the original application will be re-reviewed without additional materials or modifications. The application may be re-reviewed by the same or a different SRG, depending on the flaws in the original review process that led to the appeal. In most cases, the re-review will entail re-assignment to a subsequent review round and delay in the final funding decision. The outcome of the re-review is final and cannot be appealed again.
On occasion, and for specific circumstances, the NIH may suspend temporarily the policy and process for handling appeals of NIH initial peer review. Such decisions will be announced in NIH Guide Notices and/or the relevant Funding Opportunity Announcements when they are issued in the NIH Guide for Grants and Contracts.
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, as judged by the SRG, 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.
In addition, Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants. Council members will be asked to recommend consideration of funding for applications that afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH funding.
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. For some applications (e.g., Kirschstein NRSA Fellowship applications) the second level of review is conducted by senior level IC staff.
All incomplete applications, non-compliant modular applications, and applications determined to be nonresponsive to FOA requirements will not be reviewed. If the FOA remains open with subsequent submission dates, the applicant may resubmit a corrected or complete version of an investigator-initiated application for consideration in the next review cycle. One resubmission application may be submitted for an appropriate due date up to 37 months after the application due date of the initial application. Any application on the same topic proposed as a resubmission more than 37 months from the initial receipt date will not be accepted; it must be formatted and submitted as a new application.
Following the initial review, the summary statement will be available to the PD/PI in the eRA Commons. If an application does not result in funding, there may be an opportunity to respond to the reviewers' comments and resubmit the application. Applicants just receiving their summary statements should consult the NIH Next Steps page for detailed guidance. Applicants seeking advice beyond that available online may want to contact the NIH Program Officer listed at the top of the summary statement.
The IC Director or designee is the official who 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 one revised version of the application for review in a future cycle.
Some of the ICs publish paylines as part of their funding strategies to guide applicants on their likelihood of receiving funding. Application scores can only be compared against the payline for the fiscal year when the application will be considered for funding, which is not necessarily the year when it was submitted. At the beginning of fiscal years when the agency awaits an actual budget, there may be a delay of several months to determine paylines. If the application is assigned to an IC that does not announce a payline, the Program Officer listed at the top of the summary statement may be able to provide guidance on the likelihood of funding.
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 Completing the Pre-Award Process below. 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.