Definitions of Special Issues Presented to Council

Related Extramural SOP: Special Issues Requiring Council Review SOP

Present the following special issues 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. Not Discussed Applications. Not discussed applications a division proposes to award.
   • Center for Scientific Review and IC scientific review groups are rating as many as 50 percent of the applications as "not discussed," meaning unlikely to be competitive.
   • NIAID may award these applications as selective pay grants or (very rarely) as NIAID R56-Bridge awards or may fund applications that responded to a request for applications or program announcement if a division makes a persuasive case to:
     • NIAID director and deputy directors
     • DEA director
     • Council
3. Non-Peer-Reviewed Applications. Used in some circumstances.
   • Council performs both initial peer review and second-level review functions.
   • Renewal MERIT awards and clinical trial extensions are the most common examples.
   • See the MERIT Awards and Extensions and Investigator-Initiated Clinical Trial Administrative Extensions SOPs.
4. Deferred Applications. All applications deferred from the previous Council, independent of review results.
5. Appeals. Formerly called rebuttals.
   • DEA director reviews the appeal, and staff present it to Council.
   • See the Appeals of Scientific Review of Grant Applications SOP.
6. Foreign Applications and Grants. Foreign applications a division proposes to award and transfer of a grant or application to or between a foreign institution or international organization.
   • Foreign applicants may NOT receive R56-Bridge awards.
   • See the 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 protection of human subjects. See the 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 protection of animals in research. See the Animals in Research for Grants SOP.
11. Minority Recruitment Plans in Institutional Training Grant Applications. Fundable, NRSA applications with inadequate plans for minority recruitment. When the study section deems a plan inadequate, options are (1) take no special action, pay by overall impact 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. See the Renewal Funding SOP.
15. Discretionary. Applications program staff present to Council for items such as adding substantial funds or years when obtaining Council's advice for public health, political, or scientific reasons is important.
    • Because of a potential budgetary impact, these issues require pre-Council clearance through NIAID DAIDSFunding, NIAID DAITFunding, and NIAID DMIDFunding.
    • See the MERIT Awards and Extensions SOP.