Glossary

An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

NIH National Institute of Nursing Research

Notices posted in the NIH Guide for Grants and Contracts that succinctly highlight a specific topic of interest, for example a specific area of research or program. These notices direct applicants to one or more active funding opportunity announcements (often parent announcements) for submission of applications for the initiative described. Many program announcements will be issued as Notices of Special Interest going forward.

Notices posted in the NIH Guide for Grants and Contracts that succinctly highlight a specific topic of interest, for example a specific area of research or program. These notices direct applicants to one or more active funding opportunity announcements (often parent announcements) for submission of applications for the initiative described. Many program announcements will be issued as Notices of Special Interest going forward.

For an application to be considered on-time, all registrations must be completed and an error free application must be submitted to and accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of submitting organization on submission deadline date.

NOTE

• For both paper and electronic submissions, when these dates fall on a weekend or holiday, they are extended to the next business day.
• Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates always must be received (by Grants.gov for electronic applications and the Center for Scientific Review for paper applications) on the dates designated in the announcement to be on time.

NIH-wide FOA enabling applicants to electronically submit investigator-initiated grant application for a specific activity code, e.g., Research Project Grant (Parent R01).

Learn more about types of funding opportunity announcements .

Direct costs for items such as stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with conferences, or training projects. For the purposes of Kirschstein-NRSA programs, this term does not apply. NIH will continue to use the terms trainees, trainee-related expenses, and trainee travel in accordance with NRSA Regulations.

Requirement that the recipient of a NRSA postdoctoral fellowship engage in qualified research or teaching activities for a length of time equal to the period of NRSA support received. Only the first year of training incurs a payback obligation. In general, payback activity must involve at least 20 hours per week and be conducted over 12 consecutive months; special exceptions may be considered on a case-by-case basis. See Ruth L. Kirschstein National Research Service Awards-Payback for additional information.

The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of applications based on an evaluation of scientific or technical merit or other relevant aspects of the application. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support is requested. Peer review is intended to provide guidance and recommendations to the NIH individuals responsible for making award decisions.

The metric for expressing the effort (amount of time) PD/PI(s), faculty and other senior/key personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. See also Frequently Asked Questions Regarding the Usage of Person Months.

A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).

PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.

Program Announcements (PA) are published in the NIH Guide for Grants and Contracts. Go to Program Announcements. Learn more about types of funding opportunity announcements.

The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.

A Signing Official (SO) has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the grantee organization. The label, "Signing Official," is used in conjunction with the NIH eRA Commons. The SO can register the institution, and create and modify the institutional profile and user accounts. The SO also can view all grants within the institution, including status and award information. An SO can create additional SO accounts as well as accounts with any other role or combination of roles. For most institutions, the Signing Official (SO) is located in its Office of Sponsored Research or equivalent.

Streamlined process that includes a number of provisions that modify annual progress reports, NoAs, and financial reports. Funds are automatically carried over and are available for expenditure during the entire project period. All NIH award notices identify whether the grant is subject to or excluded from SNAP.

Routinely applied to:

all 'K' awards and 'R; awards, except R35s. Awards excluded from SNAP are those that do not having the authority to automatically carry over un-obligated balances (centers, cooperative agreements, Kirschstein-NRSA institutional training grants, non-Fast Track Phase I SBIR and STTR awards, clinical trials (regardless of activity code),

Program Project Grants (P01s), R35s and awards to individuals. See section 8.4.1.2 Streamlined Non-Competing Award Process in the NIHGPS for additional information.

SNAP instructions for submitting the progress report appear in the PHS 2590 Non-Competing Continuation Progress Report. When SNAP applies, the progress report must be submitted electronically using the eSNAP module in eRA Commons.

Equipment which is used only for research, medical, scientific, or other technical activities. Examples of special purpose equipment include microscopes, x-ray machines, surgical instruments, and spectrometers. See also Equipment and General purpose equipment.

A set of data elements about a research investigation involving human subjects that describes a proposed or on-going study, most commonly used in the context of the PHS Human Subjects and Clinical Trials Information form.

Note that for the purposes of initial application, NIH supports grouping studies that use the same human subjects population and same research protocols , the same research procedures, and the same human subjects population into a single study record, to the extent that the information provided is accurate and understandable to NIH staff and reviewers.

An action by the NIH awarding IC requiring the recipient to cease all activities on the award pending corrective action by the recipient. It is a separate action from suspension under HHS regulations (2 CFR 376) implementing Executive Orders 12549 and 12689. (See Public Policy Requirements and Objectives-Debarment and Suspension and Administrative Requirements-Enforcement Actions).