Appeals of NIH Initial Peer Review

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Notice Number: NOT-OD-11-064

Key Dates
Release Date: April 15, 2011

Related Announcements

• October 20, 2011 - See Notice NOT-OD-12-003. Publication of the Revised NIH Grants Policy Statement (Rev. 10/1/2011): Policy Changes, Clarifications and Document Enhancements.
• July 29, 2011 - See Notice NOT-OD-11-101. This Notice clarifies NIH policy for handling the resubmission (A1 version) of a New, Renewal, or Revision application (A0) to the NIH for which an appeal of NIH initial peer review is pending resolution.
• NOT-OD-16-129 :New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017
• NOT-OD-10-080: Enhancing Peer Review: Clarification of Resubmission Policy and Determination of New Application Status
• Appeals of Initial Scientific Peer Review; NIH Guide Volume 26, Number 38, November 21, 1997
• NOT-OD-09-054: Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process

National Institutes of Health (NIH)

The purpose of this Notice is to inform the extramural research community of recent revisions to the NIH policy concerning appeals of the initial peer review process. These revisions will become effective for all competing applications ( applications below) received for the January 25, 2011 due date (October 2011 Council round) and thereafter.

Background

NIH Peer Review

The dual peer review system for the National Institutes of Health is mandated by statute in accordance with section 492 of the Public Health Service Act and federal regulations governing "Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects" (42 CFR Part 52h). The first level of review is carried out by a Scientific Review Group (SRG), a committee of scientists who have expertise in relevant scientific disciplines and current research areas, and who make recommendations concerning the scientific and technical merit of the applications. The second level of review is performed by Institute and Center (IC) National Advisory Councils or Boards (Councils). Councils are composed of both scientific and lay members chosen for their expertise, interest, or activity in matters related to health and disease. The official outcome of the initial level of review is made available to investigators, Council members and NIH staff via a written report, the NIH summary statement.

Definitions

Appeal: 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).

Grievance: A grievance is a written communication from a PD/PI and/or applicant organization that presents concerns about the peer review process for a particular application and does not meet the criteria for an appeal.

Policy

Applicability

The revised policy applies to appeal letters received with respect to the initial peer review of all competing applications submitted to the NIH for support, for the January 25, 2011 due date and thereafter, including: 1) reviews conducted by the NIH Center for Scientific Review (CSR) and reviews conducted by NIH Institutes and other NIH Centers; and 2) applications such as fellowship applications that typically do not require Council review. This policy 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.

Appeal Letters

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) (see contact information in the upper left-hand corner of the first page of the summary statement). The PO can answer questions about the summary statement and review outcome, and provide advice to the applicant. For example, the PO may recommend modifying the application according to NIH policies for resubmission applications (NOT-OD-10-080) and the issues that were raised in the review and communicated in the summary statement, or may recommend reconsidering the basic intent of the project and submitting a new application that has substantial differences in aims and approach (NOT-OD-10-080). At no time should the PD/PI or an official of the applicant organization attempt to contact individual members of the SRG to discuss the review of an application, as doing so could jeopardize the confidentiality of the review process.

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.

The ICs may establish deadlines by which appeal letters must be received in order to be made available at the Council meeting. However, in no circumstance will an appeal letter be accepted before the summary statement has been transmitted to the PD/PI or later than 30 calendar days after the relevant Council meeting.

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:

• 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 SRG.
• Factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.

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. Appeals involving potential COI or violation of ethical conduct rules on the part of an NIH staff member or other federal employee will be referred to the appropriate Deputy Ethics Counselor for consideration and resolution before any further review of, or action on, the appeal is taken.

NIH Staff

NIH staff will consider the basis for the appeal letter, and evaluate the merit of the appeal. If both review staff and program staff support an appeal, then the original application, without additional materials or modifications, will be re-reviewed by the same or a different SRG. In this case, only the results of the re-review, and not the first review, are made available to Council, and information about the appeal is not made available to Council.

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.

Consideration by Council

Only two outcomes are possible following consideration of an appeal letter by Council:

• The Council may concur with the appeal, and recommend that the application be re-reviewed.
• The Council may concur with the SRG's recommendation and deny the appeal. Although factual errors or other issues may be evident, the Council may determine that these factors were unlikely to alter the final outcome of the SRG and deny the appeal. No action by the Council is equivalent to concurrence with the SRG’s recommendation and denial of the appeal.

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. At no time should the PD/PI or an official of the applicant organization attempt to contact individual members of the Council to discuss their consideration of an application or appeal, as doing so could jeopardize the confidentiality of the review process.

Resolution

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.

Temporary Suspension

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.

Please direct all inquiries to:

NIH Review Policy Officer
[email protected]