Definitions of Special Issues Presented to Council

Related Extramural SOP: Special Issues Requiring Council Review SOP

Program staff must prepare the following types of special issues to present to Council.

1. Reinstatement of Research Aims. Applications for which the division is requesting to reinstate specific aims or research not recommended for support by the study section.

   Council does not review restorations of budget or years cut by the study section; but because of the budgetary impact, NIAID OD approval is required through the submission of an administrative supplement. See the Administrative Supplements to Grants and Cooperative Agreements SOP.

2. Unscored Applications. Unscored applications a division proposes to award. Center for Scientific Review and IC study sections are rating as many as 50 percent of the applications as "unscored," meaning unlikely to be competitive. These applications may be awarded as NIAID R56-Bridge awards or selective pay grants or under an RFA or PA, if a division makes a persuasive case both to the Institute and Council. Unscored applications should receive R56-Bridge awards only in extraordinary circumstances.
3. Non-Peer-Reviewed Applications. Used in some circumstances. Council performs both initial peer review and second-level review functions. Renewal MERIT awards are the most common example. See MERIT Awards and Extensions SOP.
4. Deferred Applications. All Council-deferred applications independent of review results.
5. Unresolved Appeals. Formerly called rebuttals. When program staff working with a scientific review officer have been unable to resolve the applicant's concerns, the DEA director reviews the appeal, and staff present it to Council. For policy, see the Appeals of Scientific Review of Grant Applications SOP.
6. Foreign Applications. Foreign applications a division proposes to award. (Foreign applicants may NOT receive R56-Bridge awards.) See Foreign and International Grants and Components SOP.
7. Council Member Applications. Applications proposed for award where a Council member is PI. A subcommittee other than the one on which the Council member serves reviews these applications.
8. Human Subjects. Applications proposed for award with unresolved concerns about a lack of assurance of protection of human subjects. See Human Subjects SOPs.
9. Biohazards. Applications proposed for award with unresolved concerns about biohazards.
10. Use of Animals in Research. Applications proposed for award with unresolved concerns about a lack of assurance of protection of animals in research. See Animals in Research for Grants SOP.
11. Minority Recruitment Plans in Institutional Training Grant Applications. Fundable, meritorious NRSA applications with inadequate plans for minority recruitment. When the study section deems a plan inadequate, options are (1) no special action, pay by overall impact/priority score; (2) defer payment pending submission and staff approval of a recruitment plan; or (3) defer for study section rereview pending receipt of an acceptable plan.
12. Inclusion of Women and Minorities as Subjects in Clinical Research. Applications a division plans to award with an unresolved inclusion issue ("U" code). See Human Subjects Inclusion Codes.
13. Inclusion of Children as Subjects in Clinical Research. Applications a division plans to award with an unresolved inclusion issue ("U" code). See Human Subjects Inclusion Codes.
14. Renewal Applications With a Greater than 20 Percent Increase. Renewal applications a program division wishes to award with an increase in direct costs of more than 20 percent over the final noncompeting year. Program staff must prepare a special issue worksheet for Council review; Council must approve the increase. See Renewal Funding SOP.
15. Discretionary. Applications program staff present to Council for items such as the addition of substantial funds or years when important to obtain Council's advice for public health or political or scientific reasons. Because of a potential budgetary impact, these issues require pre-Council clearance through NIAID DAIDSFunding, NIAID DAITFunding, and NIAID DMIDFunding. See MERIT Awards and Extensions SOP.