Appeals Policy and Procedures for Applicants

The appeals process is designed to resolve procedural issues surrounding the initial peer review of an application. The appeals process is used when the issue cannot be resolved administratively. Additional information on the appeals of initial review can be found in the NIH Guide Notices NOT-97-232: Appeals of Initial Scientific Peer Review, NOT-OD-11-064: Appeals of NIH Peer Review, and NOT-OD-11-101: Resubmission of Applications with Pending Appeals of NIH Initial Peer Review.

An applicant who is concerned about any procedural aspect of the completed initial peer review of an application should first consider the comments in the summary statement and then contact the appropriate NHLBI Program Official (PO). The PO may answer questions about the summary statement and review outcome as well as provide guidance to the applicant.

If the applicant alleges that procedural flaws affected the outcome of initial peer review, Program Officials may provide guidance to applicants about timing considerations related to appealing the initial peer review and other administrative considerations, in light of the NIH submission policy. In most cases, it is advantageous to revise and submit a new or resubmission application rather than appeal the initial peer review.

In situations when misunderstandings or disagreements related to initial peer review cannot be resolved by discussion, it may be possible to appeal the initial peer review to the National Heart, Lung, and Blood Advisory Council. The first step in the appeals process is the submission of a formal appeal letter. The four types of procedural flaws related to initial peer review that can form the basis of an appeal are:

Evidence of bias on the part of one or more peer reviewers.
Conflict of interest, as specified in regulation at 42 CFR 52h.5. “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects”, on the part of one or more peer reviewers.
Lack of appropriate expertise within the initial peer review committee.
Factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.

Appeal Letters

A valid appeal letter is a clear and succinct written communication (generally three to five pages long) from an institution Authorized Organization Representative (AOR) and the Program Director/Principal Investigator (PD/PI) that meets both of the following conditions:

describes or explains the reason(s) for the appeal on the basis of a flaw or perceived flaw in the initial peer review of a specific application as specified in one or more of the four allowable issues (described above)
is submitted after the summary statement is issued and received at the NHLBI at least 30 calendar days prior to the closed session of the Council meeting to which the application is assigned, in order for NIH staff and Council members to give careful and full consideration to an appeal. Please consider the possibility that a revision of the letter may be necessary to make the appeal valid and allow sufficient time for revisions in order to meet the deadline.

If extenuating circumstances prevent a valid appeal letter from arriving 30 calendar days prior to the closed session of the Council meeting to which the application is assigned, such letters may be submitted up to 30 calendar days after the closed session of the Council meeting for deliberation at the next Council closed session meeting date.

A typical valid appeal letter does not:

cite material that was not in the original application (see NIH Notice 97-232)
refer to the review of a prior version of the application
use the locus of review as the basis of an appeal
refer to the cover letter as a basis for appeal (a cover letter is not formally a part of an application)
cite concerns or complaints about those policies or procedures regulating initial peer review
cite differences in scientific opinion
appeal the initial peer review of applications submitted in response to Requests for Applications (RFAs) (see section 2.4.2 (Appeals of Initial Scientific Review) of the NIH Grants Policy Statement)
appeal the peer review that follows a Council decision to re-review (i.e. only one appeal is granted per application)
include discussions, communications, or both with NIH staff unless it is directly applicable to the procedural flaw related to peer review
respond to the reviewer’s critiques in a manner that is consistent with the introduction section of a resubmission application (A1)
request Council to fund the application

Letters addressing the peer review of grant applications are carefully evaluated by senior Institute staff to determine whether the issues raised constitute a valid formal appeal, as defined in the NOT-OD-11-064. When presenting information in support of an appeal, applicants are encouraged to identify the page numbers and sections of the application where information is presented. When citing references, the citation number in the application should also be provided.

A letter that does not meet these criteria and/or does not include the concurrence of the AOR will not be considered a valid appeal letter. A letter that is determined to be invalid may be returned for revisions that may make it valid, so long as the timeframe for a valid appeal letter has not passed.

The AOR may elect to withdraw an appeal at any time prior to Council review. In order to withdraw an appeal, an AOR-signed letter indicating the desire for withdrawal must be submitted to the PO. All valid appeal letters that are not officially withdrawn prior to the Council meeting are discussed and considered by Council. Note: If the review staff administratively agree to re-review an application prior to Council consideration, the PO will notify the PI and AOR about the action. If this occurs, the PI will receive an automatic mailer informing him/her that the application has been reassigned and the assignment will be available in the PI’s NIH eRA commons account.

An application is in a pending status until the Council has made a decision on the appeal. NIH-wide policy NOT-OD-11-101 states that the NIH will not accept any application that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. Therefore, while an application is undergoing the appeals process, the applicant may not submit another application with similar science. These applications are considered overlapping applications.

Council Decision

The applicant will be notified about Council’s decision within 30 calendar days after Council’s deliberation of the appeal. Possible outcomes of Council review are:

concurrence with the decision of the initial peer review group as reflected in the summary statement
concurrence with the claims presented in the applicant's appeal letter resulting in the recommendation for the deferral for re-review of the unchanged application

Council’s decision concerning resolution of an appeal is final and will not be considered again by the NIH through this or another process.

Guidance for Applicants to Support Fair and Appropriate Review of Application

Prior to application submission and subsequent to the peer review meeting, applicants should contact the appropriate NHLBI PO (listed in the Funding Opportunity Announcement and in the upper left-hand corner of the first page of the summary statement) regarding their application.

Between the time of application submission and the date of the initial peer review meeting, applicants should contact Scientific Review Officers (SROs), designated federal officials committed to ensuring the fair and appropriate review of grant applications, with any concerns related to the review of their applications. To facilitate the fair and appropriate peer review of their application, applicants are encouraged to take the following proactive steps:

In the cover letter and conversations with the SRO, identify those scientists who may have scientific bias either toward or against the science proposed within the application.
In the cover letter, identify potential reviewers who may have either a positive or negative conflict of interest with the submitted application. Once the application is assigned to a review committee, follow-up with the SRO (especially after the roster is posted) about those reviewers who may have conflicts with the application.
In the cover letter and in follow-up conversations with the SRO, identify specific scientific topic areas (not specific reviewers) of expertise needed to review the application.

References

NIH Grants Policy Statement (Section 2.4.2 (Appeals of Initial Scientific Review)
http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch2.htm

NIH POLICY MANUAL 4204-204B - Peer Review Process
http://oma1.od.nih.gov/manualchapters/grants/4204-204B/

NIH Notice NOT-OD-11-064: Appeals of NIH Initial Peer Review
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html

NIH Notice NOT-97-32: Appeals of Initial Scientific Peer Review
http://grants.nih.gov/grants/guide/notice-files/not97-232.html

NIH Notice NOT-OD-14-074: NIH and AHRQ Announce Updated Policy for Application Submission
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.html

NIH Notice NOT-99-146: Reminder-Policies on Application Submission
http://grants.nih.gov/grants/guide/notice-files/not99-146.html

NIH Notice NOT-OD-09-100: Reminder and Clarification of NIH Policies on Similar, Identical, or Essentially Identical Applications, Submission of Applications Following RFA Review, and Submission of Applications with a Changed Activity Code
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-100.html

NIH Notice NOT-OD-11-101: Resubmission of Applications with Pending Appeals of NIH Initial Peer Review http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-101.html

Last Updated: October 8, 2015