Glossary

2 A B C D E F G H I K M N O P R S T U X

Common Fund

The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund.

2

21st Century Cures

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016,provides multiyear funding to four highly innovative scientific initiatives, including the NIH BRAIN Initiative.

B

Basic Research

Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (CFR 272.3)

Bridge Awards

Bridge awards provide continued but limited interim support (bridge funding) for meritorious investigators who just miss the funding cutoff and have minimal support from other sources. The continued funding will permit the PD/PI additional time to strengthen a resubmission application. A Bridge award recipient usually will receive an R56 award for a single year. Investigators may not apply for R56 grants. Applications for conversion to an R56 will be selected by IC staff from reviewed applications that fall at or near the payline margins.

Budget Period

The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.

C

Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

See Common Rule definition of research at 45 CFR 46.102(d)

See Common Rule definition of human subject at 45 CFR 46.102(f)

The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.

A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life

Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:

Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).

Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.

Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.

Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Co-funding

Funding arrangement through which two or more Institutes or Centers share in the funding of a grant.

Common Fund

The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund.

Competitive Revision

A request for (or the award of) additional funds during a current project period to support new or additional activities which are not identified in the current award that reflect an expansion of the scope of the grant-approved activities. Competitive revisions require peer review.

D

Data and Safety Monitoring Plan

Prior to award, this plan must be approved by the applicant‚Äôs IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

E

Extended Payline

NINDS and NIA are paying applications responding to specific AD/ADRD funding opportunities by impact rating rank order (priority, or "overall impact" score) rather than by percentile rank. These institutes are currently paying these applications to an impact rating of 40. Though these pay lines are generally followed, NIA and NINDS may pay a few applications beyond these lines or choose to provide short-term support or require a resubmission from a few applications within these lines, following both peer review comments and published funding priority guidelines.

Extramural Awards

Funds provided by the NIH to researchers and organizations outside the NIH.

F

Fiscal Year

The fiscal year is the accounting period for the federal government which begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2013 begins on October 1, 2012 and ends on September 30, 2013. Congress passes appropriations legislation to fund the government for every fiscal year.

FOA

See Funding Opportunity Announcement

FOIA

See Freedom of Information Act

Funding Opportunity Announcement (FOA)

A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts.

G

Grants Management Officer (GMO)

An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.

H

Health Professional School or College

In the context of NIH's R15 program, health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, DPT, BME, MSEE, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH. Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics & prosthetics, kinesiology, biomedical engineering, occupational therapy and psychology. Accreditation must be provided by a body approved for such purpose by the Secretary of Education.

High Risk/High Impact (HR/HI)

A category of applications identified by a scientific review group as having a high degree of uncertainty in approach but also a high potential for impact. NIH tracks how many of these applications are identified and funded.

I

Impact Score

The impact score is the rating which is assigned to an individual application by an SRG, and designates the reviewers' assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of established review criteria. The impact score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application's scientific and technical merit. Impact scores may be numeric (10 ‚Äì 90) or alphabetical (ND, for example).

Indirect Costs

See Facilities and Administrative Costs (F&A).

Investigator-Initiated Research

Research funded as a result of an investigator, on his or her own, submitting a research application.

M

Multi-project Grant Application

A multi-project application is a single grant application submission with multiple, interrelated components with defined work, personnel, sites and budgets that share a common focus or objective.

MYF

Multi-year funded (MYF) awards are where the project period and budget period are the same and are longer than one year.

N

NIH Guide for Grants and Contracts

The official publication for NIH's medical and behavioral research grants policies, guidelines and funding opportunities.

No-Cost Extension

An extension of time to a project period and/or budget period to complete the work of the grant under that period, without additional Federal funds or competition. See NIH Standard Terms of Award and Prior Approval Requirements.

NOSI

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.

NOSI

NRFC

An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.

P

Parent Announcement

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 .

Payline

The percentile rank is based on a ranking of the impact scores assigned by a peer review committee. The percentile payline is a conservative cutoff point for funding applications.

Program Announcement

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.

Progress Report

Periodic, report submitted by the grantee and used by NIH to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report.

Project Number

Commonly referred to as the application number or grant number, depending upon its processing status. This unique identification number for the grant is composed of the type code, activity code, Institute code, serial number, support year, and/or suffix.

Public Access Policy

The NIH policy designed to ensure that the public has access to the published results of NIH-funded research.

R

Renewal Application

An application requesting additional funding for a period subsequent to that provided by a current award. Renewal applications compete for funds with all other peer reviewed applications.

Research and Development Contract

A funding mechanism by which the NIH procures specific services.

S

Selective Pay

The funding of a small number of programmatically important applications at the margin of the payline as recommended by Council.

Set-Aside

Money taken out of the budget for a specific purpose, for example, to fund a congressionally mandated program.

Significant Differences

For purposes of NIH policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.