National Advisory Eye Council Operating Procedures

January 2008

Review of Grant and Cooperative Agreement Applications

The Council shall review all applications having undergone initial review. Applications not identified for special consideration are reviewed en bloc. Summary Statements for applications will be made available to Council Members. Applications will be available upon request of a Council Member.

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 about the protection of human subjects, representation of women, minorities, and or children in clinical research, ethical questions or potential biohazards. IRG flagged concerns related to 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 collaborative clinical research project within the funding range; an NEI-initiated program; or conference grant 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 initial review group (IRG) has been questioned by either Council or staff.

Options for Council Action

The following options generally are available to Council:

1. Concurrence with the initial review group (IRG) recommendations;
2. Deferral for IRG 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 a different IRG and/or that a site visit be made in the re-review of the application. If the second IRG review results in a recommendation with which the Council does not agree, the Council may nonconcur with the IRG recommendation without deferral for additional review. Awards may be made, however, only when both an IRG and Council have recommended that an application has significant and substantial merit;
3. Deferral so that NEI staff can obtain additional information for Council consideration at a subsequent meeting;
4. Non-concurrence with IRG recommendations based on other than scientific/technical merit considerations (this applies only to policy, procedural or administrative matters).

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.