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<HEAD>
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<TITLE>NOT-OD-11-064: Appeals of NIH Initial Peer Review
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Appeals of NIH Initial Peer Review
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NOT-OD-11-064. NIH">
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<META NAME="Keywords" CONTENT="NOT-OD-11-064: Appeals of NIH Initial Peer Review
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<div class=WordSection1>
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<span class="title">Appeals of NIH Initial Peer Review</span>
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<hr noshade>
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<p><span class="heading3">Notice Number:</span>
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<span class="title">NOT-OD-11-064 </span></p>
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<p><span class="heading3">Key Dates</span><br>
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<strong>Release Date:</strong> April 15, 2011</p>
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<span class="heading3">Related Announcements</span><br>
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<ul>
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<li>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.</li>
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<li> 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.
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</li><li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html">NOT-OD-16-129 </a>:New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017 </li>
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<li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-080.html">NOT-OD-10-080</a>: Enhancing Peer Review: Clarification of Resubmission Policy and Determination of New Application Status</li>
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<li><a href="https://grants.nih.gov/grants/guide/notice-files/not97-232.html">Appeals of Initial Scientific Peer Review</a>; NIH Guide Volume 26, Number 38, November 21, 1997 </li>
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<li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-054.html">NOT-OD-09-054</a>: Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process</li>
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</ul>
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<div class="heading3">Issued by</div>
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<p class=regulartext>National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)</p>
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<div class="heading2">Purpose</div>
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<p class=regulartext>The purpose of this Notice is to inform the extramural
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research community of recent revisions to the NIH policy concerning appeals of
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the initial peer review process. These revisions will become effective for all
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competing applications ( applications below) received for the January 25, 2011
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due date (October 2011 Council round) and thereafter.</p>
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<p class=MsoTitle> Background</p>
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<p class=regulartext><strong>NIH
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Peer Review</strong></p>
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<p class=regulartext>The dual peer review system for the National Institutes of
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Health is mandated by statute in accordance with section 492 of the Public
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Health Service Act and federal regulations governing "Scientific Peer
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Review of Research Grant Applications and Research and Development Contract
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Projects" (<a
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href="http://www.access.gpo.gov/nara/cfr/waisidx_07/42cfr52h_07.html">42 CFR
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Part 52h</a>). The first level of review is carried out by a Scientific Review
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Group (SRG), a committee of scientists who have expertise in relevant
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scientific disciplines and current research areas, and who make recommendations
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concerning the scientific and technical merit of the applications. The second
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level of review is performed by Institute and Center (IC) National Advisory
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Councils or Boards (Councils). Councils are composed of both scientific and lay
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members chosen for their expertise, interest, or activity in matters related to
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health and disease. The official outcome of the initial level of review is
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made available to investigators, Council members and NIH staff via a written
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report, the NIH summary statement.</p>
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<p class=regulartext><strong>Definitions</strong></p>
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<p class=regulartext>Appeal: An appeal is a written communication from a Program
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Director/Principal Investigator (PD/PI) and/or applicant institution that meets
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the following four criteria: 1) is received after issuance of the summary
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statement and up to 30 calendar days after the second level of peer review, 2)
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describes a flaw or perceived flaw in the review process for a particular
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application, 3) is based on one or more of four allowable issues (described
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below), and 4) displays concurrence from the Authorized Organization
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Representative (AOR). </p>
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<p class=regulartext>Grievance: A grievance is a written communication from a
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PD/PI and/or applicant organization that presents concerns about the peer
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review process for a particular application and does not meet the criteria for
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an appeal.</p>
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<p class=MsoTitle>Policy</p>
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<p class=regulartext><strong>Applicability</strong></p>
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<p class=regulartext>The revised policy applies to appeal letters received with
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respect to the initial peer review of all competing applications submitted to
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the NIH for support, for the January 25, 2011 due date and thereafter, including:
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1) reviews conducted by the NIH Center for Scientific Review (CSR) and reviews
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conducted by NIH Institutes and other NIH Centers; and 2) applications such as
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fellowship applications that typically do not require Council review. This
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policy does not apply to appeals of the technical evaluation of Research and
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Development contract projects through the NIH peer review process, appeals of
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NIH funding decisions, or appeals of decisions concerning extensions of MERIT
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awards. </p>
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<p class=regulartext><strong>Appeal
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Letters</strong></p>
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<p class=regulartext>An applicant who is concerned about procedural aspects
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related to the completed initial peer review of his or her application first
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should consider the comments in the summary statement, and then should contact
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the appropriate NIH Program Official (PO) (see contact information in the upper
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left-hand corner of the first page of the summary statement). The PO can
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answer questions about the summary statement and review outcome, and provide
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advice to the applicant. For example, the PO may recommend modifying the
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application according to NIH policies for resubmission applications (<a
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href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-080.html">NOT-OD-10-080</a>)
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and the issues that were raised in the review and communicated in the summary
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statement, or may recommend reconsidering the basic intent of the project and
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submitting a new application that has substantial differences in aims and
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approach (<a
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href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-080.html">NOT-OD-10-080</a>).
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At no time should the PD/PI or an official of the applicant organization
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attempt to contact individual members of the SRG to discuss the review of an
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application, as doing so could jeopardize the confidentiality of the review
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process. </p>
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<p class=regulartext>Following discussion of concerns with the PO, if the PD/PI
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and/or an official of the applicant organization wishes to appeal the outcome
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of the initial peer review process, an appeal letter must be submitted, either
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in hard copy or electronically, to the PO. The appeal letter must display concurrence
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from the AOR of the applicant organization for the application. Although
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the content of the appeal letter may originate from the PD/PI, Contact PD/PI
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for multiple PD/PI applications, or an organizational official(s) (not
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necessarily the AOR), the AOR must send the letter directly to the PO, or must
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send his/her concurrence to the PD/PI who will forward the materials and AOR concurrence
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to the PO. A communication from the PD/PI or official of the applicant
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organization (other than the AOR) only or with a cc to the AOR will not be
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accepted. The PO will send the PD/PI and/or institutional official, and AOR,
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an acknowledgement letter within 10 days of receipt of the appeal letter. </p>
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<p class=regulartext>The ICs may establish deadlines by which appeal letters must
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be received in order to be made available at the Council meeting. However, in
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no circumstance will an appeal letter be accepted before the summary statement
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has been transmitted to the PD/PI or later than 30 calendar days after the
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relevant Council meeting. </p>
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<p class=regulartext>An appeal letter will be accepted only if the letter 1)
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describes the flaws in the review process for the application in question, 2)
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explains the reasons for the appeal, and 3) is based on one or more of the
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following issues related to the process of the initial peer review:</p>
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<ul>
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<li>Evidence of bias on the part of one or more peer reviewers.</li>
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<li>
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Conflict of interest, as specified in regulation at <a
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href="http://search2.google.cit.nih.gov/search?site=NIH_Master&client=NIHNEW_frontend&proxystylesheet=NIHNEW_frontend&output=xml_no_dtd&filter=0&getfields=*&q=42+CFR+52h.5">42
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CFR 52h.5</a>. Scientific Peer Review of Research Grant Applications and
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Research and Development Contract Projects , on the part of one or more peer
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reviewers.</li>
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<li>Lack of appropriate expertise within the SRG.</li>
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<li>
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Factual error(s) made by one or more reviewers that could have
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altered the outcome of review substantially.</li>
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</ul>
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<p class=regulartext>Appeal letters based solely on differences of scientific
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opinion will not be accepted. A letter that does not meet these criteria
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and/or does not include the concurrence of the AOR will not be considered an
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appeal letter, but rather a grievance. The IC will handle grievances according
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to IC- specific procedures. Appeals involving potential COI or violation of
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ethical conduct rules on the part of an NIH staff member or other federal
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employee will be referred to the appropriate Deputy Ethics Counselor for
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consideration and resolution before any further review of, or action on, the
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appeal is taken.</p>
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<p class=regulartext><strong>NIH
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Staff </strong></p>
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<p class=regulartext>NIH staff will consider the basis for the appeal letter, and
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evaluate the merit of the appeal. If both review staff and program staff
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support an appeal, then the original application, without additional materials
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or modifications, will be re-reviewed by the same or a different SRG. In this
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case, only the results of the re-review, and not the first review, are made
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available to Council, and information about the appeal is not made available to
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Council.</p>
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<p class=regulartext>If review staff and program staff do not support the appeal,
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or do not agree on its merit, the PD/PI and/or an institutional official (not
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necessarily the AOR) may elect to withdraw the appeal letter. The request to
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withdraw an appeal letter must be submitted either in hard copy or
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electronically to the PO, and must display concurrence from the AOR of the
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applicant organization for the application. Although the content of the
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request may originate from the PD/PI, Contact PD/PI for multiple PD/PI
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applications, or an organizational official(s) (not necessarily the AOR), the
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AOR must send the request directly to the PO, or must send his/her concurrence
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to the PD/PI who will forward the materials and his/her concurrence to the PO.
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A communication from the PD/PI or institutional official (other than the AOR) only
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or with a cc to the AOR will not be accepted. </p>
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<p class=regulartext>If review staff and program staff do not support the appeal,
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or do not agree on its merit, and the appeal letter is not withdrawn, the
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appeal letter will be made available to Council. The IC may not deny the PD/PI
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or applicant organization the opportunity to have an appeal letter made
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available to Council. </p>
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<p class=regulartext><strong>Consideration
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by Council</strong></p>
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<p class=regulartext>Only two outcomes are possible following consideration of an
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appeal letter by Council:</p>
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<ul>
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<li>The Council may concur with the appeal, and recommend that the
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application be re-reviewed. </li>
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<li>The Council may concur with the SRG's recommendation and deny the
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appeal. Although factual errors or other issues may be evident, the Council
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may determine that these factors were unlikely to alter the final outcome of
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the SRG and deny the appeal. No action by the Council is equivalent to
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concurrence with the SRG’s recommendation and denial of the appeal.</li>
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</ul>
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<p class=regulartext>The recommendation of Council concerning resolution of an
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appeal is final and will not be considered again by the NIH through this or
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another process. At no time should the PD/PI or an official of the applicant
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organization attempt to contact individual members of the Council to discuss
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their consideration of an application or appeal, as doing so could jeopardize
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the confidentiality of the review process. </p>
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<p class=regulartext><strong>Resolution</strong></p>
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<p class=regulartext>The Executive Secretary for the Council will communicate the
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Council recommendation concerning an appeal to the PD/PI, AOR, and NIH staff
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with a need to know. If the appeal letter was received by the IC deadline, the
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PD/PI and AOR will receive a written explanation of the resolution no later
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than 30 calendar days after the Council meeting. If the appeal letter was
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received after the IC deadline, the Executive Secretary will provide, no more
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than 30 calendar days after the date when the appeal letter was received, a
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written explanation of the IC’s plan for making the appeal available to
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Council. </p>
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<p class=regulartext>If the Council recommended that the application be
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re-reviewed, the original application will be re-reviewed without additional
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materials or modifications. The application may be re-reviewed by the same or
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a different SRG, depending on the flaws in the original review process that led
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to the appeal. In most cases, the re-review will entail re-assignment to a
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subsequent review round and delay in the final funding decision. The outcome
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of the re-review is final and cannot be appealed again.</p>
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<p class=regulartext><strong>Temporary
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Suspension</strong></p>
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<p class=regulartext>On occasion, and for specific circumstances, the NIH may
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suspend temporarily the policy and process for handling appeals of NIH initial
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peer review. Such decisions will be announced in NIH Guide Notices and/or the
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relevant Funding Opportunity Announcements when they are issued in the NIH
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Guide for Grants and Contracts.</p>
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<div class="heading2">Inquiries</div>
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<p class=regulartext>Please direct all inquiries to:<br>
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<br>
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NIH Review Policy Officer<br>
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<a href="/cdn-cgi/l/email-protection#c290a7b4aba7b592adaeaba1bb8da4a4aba1a7b082afa3abaeecacabaaeca5adb4"><span class="__cf_email__" data-cfemail="ecbe899a85899bbc8380858f95a38a8a858f899eac818d8580c2828584c28b839a">[email protected]</span></a></p>
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<HR>
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<A HREF="/grants/guide/WeeklyIndex.cfm?04-15-11">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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