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National Advisory Eye Council Operating Procedures

January 2012

Review of Grant and Cooperative Agreement Applications

The Council shall review all pending applications which have undergone initial peer review. Summary Statements for all applications will be made available to Council Members in advance of the meeting. Individual applications will be made available upon request of a Council Member. Applications not identified for special consideration are acted upon as a group, without any conflict of interest implications, and approved en bloc.

Special Consideration

Ordinarily, only applications that have been scored and are within the funding range are presented to Council for special consideration. However, a member of Council or NEI staff may request that any individual application be discussed. No application requiring special consideration will be funded without Council review.

Applications are routinely presented to the Council for special consideration when:

The research proposed has been identified by either Council or staff as being of particular interest (e.g., consideration of program relevance) or concern. This includes but is not limited to concerns raised by the Scientific Review Group (SRG) related to the protection of human subjects; representation of women, minorities, and or children in clinical research; ethical questions or potential biohazards. Routine administrative issues such as missing IACUC or IRB documentation, incorrect coding by scientific review staff, or other minor issues that are easily resolved prior to the NAEC meeting will not routinely be presented.
The application is for a Phase III clinical trial within the funding range.
The application is from a foreign institution and is within the funding range;
The adequacy of the initial review or some other aspect of the recommendation from the SRG has been questioned by either Council or staff.
The application has been identified by either Council or staff as having High Program Relevance (HPR).
An applicant has submitted a grievance letter.

Options for Council Action

The following options generally are available to Council:

Concurrence with the recommendations of the SRG;
Deferral for SRG reconsideration of the scientific and technical merit of an application. Council may include in its deferral action the recommendation that the re-review be carried out by either the same or by a different SRG and/or that a site visit be made in the re-review of the application. If the second SRG review results in a recommendation with which the Council does not agree, the Council may nonconcur with the SRG recommendation without deferral for additional review. Awards may only be made when both an SRG and the Council have recommended that an application has significant and substantial merit;
Deferral so that NEI staff can obtain additional information for Council consideration at a subsequent meeting;
Non-concurrence with the recommendations of the SRG.

Appeals

Grantees have the right to submit letters of appeal to the NAEC and will be brought to the Councils attention for action.

An appeal letter will be accepted only if the letter 1) describes a flaw(s) or perceived flaw(s) 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 "Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects", on the part of one or more non-federal peer reviewers, or conflict of interest statutes and ethical conduct regulations applicable to federal employees serving as 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 Authorized Organization Representative (AOR) will not be considered an appeal, but rather a grievance. The NEI will handle grievances according to NEI-specific procedures.

The NEI will make available to Council, at a minimum, a list of the appeal letters received for that meeting and the relevant summary statements. The NEI cannot deny the PD/PI and/or the applicant institution the opportunity to have an appeal letter made available to Council, regardless of the NEI's assessment of its merit. The Scientific Review Officer's and Program Officer's responses, and additional items may be included, and access to the application image may be provided, as deemed necessary by the Appeals Officer. However, the NEI may determine which appeal letters warrant discussion by the Council members, and Council members may raise certain ones for discussion if they so choose.

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 application may be re-reviewed by the same or a different SRG, depending on the flaw(s) in the original review process that led to the appeal.

The re-review will consider only the original application, without additional materials or modifications. If the application is deferred for re-review in the SRG that reviewed the application originally, the Scientific Review Officer may explain to the SRG that the application was deferred administratively for re-review, but not that the re-review resulted from an appeal of their original review.

At the subsequent Council meeting, only the results of the re-review, and not of the first review, will be made available to Council. No information regarding the appeal is made available to Council. The reviewers involved in the re-review will not have access to the summary statement that resulted from the disputed review or the appeal letter. The outcome of the re-review is final and may not be appealed.

In most cases, the re-review will entail re-assignment to a subsequent review round and delay in the final funding decision.

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. If no action is taken by Council, the outcome is equivalent to concurrence with the SRG's recommendation and denial of the appeal.

The Council must vote on the final decision to request re-review or deny the appeal, and the result of this vote is documented in the official grant file. 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 result of an appeal does not represent a reversal or overturning of the recommendations of an SRG.

Guidelines for Staff Negotiations and Interim Administrative Actions

Each Institute has guidelines for staff to use in making adjustments in funds or duration of grants and cooperative agreements recommended by its Council, as well as in other terms and conditions. The Council reviews the guidelines annually and recommends necessary modifications.

It is generally agreed that NEI staff may use administrative discretion to:

Approve the appointment of a new Principal Investigator or Program Director to continue an active research or training project at the same institution.
Approve the transfer of a project grant when the Principal Investigator moves to another institution.
Provide funds for the orderly termination of an ongoing project when the competing continuation application will not be awarded and sudden termination of the grant would cause a serious loss of important scientific material or impose a severe hardship to already employed personnel. In such cases: (a) the award will usually be made for a three month period but will in no case exceed twelve months; (b) careful review will be given to needs for salaries and consumable supplies; and (c) no funds will be provided for additional animals, equipment, or travel, except under the most unusual circumstances.
Provide limited interim funding when a recommendation of deferral on a competing continuation application would result in a loss of continuity of the project.
Provide additional funds to a noncompeting application when well justified and when NEI resources allow; for example, institution-wide salary and fringe benefit increases, and increased costs of supplies. These and other increases of an administrative nature may be provided, if not related to an expansion of the scope of the project or to a significant change in scientific direction.
Adjust competitive applications in project period and/or amounts to meet the needs of the project and the priorities of the Institute. Council recommendations, program relevance, policy, research effort, and NEI resources will serve as a guide in making such adjustments.