Glossary

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.

The A1 suffix is typically seen as part of an application identification number or grant number and "A1" is often used to refer to a new, renewal, or revision application that is amended and resubmitted after the review of a previous application with the same project number.

Academic Research Enhancement Award

The NIH Institute/Center (IC) responsible for the award, administration, and monitoring of grant supported activities.

Studies that prospectively assign human participants to conditions and that assess biomedical or behavioral outcomes in humans to better understand aspects of phenomena without specific application towards processes or products in mind.

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)

The Brain Research through Advancing Innovative Neurotechnologies Initiative aims to accelerate the development and application of innovate technologies to produce a new, dynamic picture of the brain.

See Biomedical Research and Development Price Index

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.

See Appropriation Act

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

Any committee formed for advisory purposes composed not wholly of Federal officials. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by their parent Agency in collaboration with the U.S. General Services Administration to ensure a properly balanced representation (geographical, women, minorities) and meet other legal requirements

Research with human subjects that is:

1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

2) Epidemiological and behavioral studies.

3) Outcomes research and health services research

Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.

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.

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

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

A set of NOFOs that share a unified theme or initiative. These NOFOs may use different activity codes. They are typically (but not always) published concurrently.

Competing applications are applications for a new, renewal, or resubmission research project grants(RPG), including R01s, R21s, and related mechanisms, that require competitive peer review

See Renewal Application

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.

A grant whose purpose is to support activities related to the conduct of a conference(s) or defined set of conference-related activities.

Dollar amounts adjusted for inflation, based on buying power in a selected base year. The BRDPI is used to determine constant dollars from current dollars.

When multiple PD/PIs are designated, NIH requires that the applicant organization identify one of the PD/PIs as the Contact PD/PI to serve as a primary point of contact. Serving as Contact PD/PI confers no special authorities or responsibilities within the project team. The Contact PD/PI must meet all eligibility requirements for PD/PI status. However, as with the single PD/PI model, if the Contact PD/PI is not an employee, the applicant organization must have a formal written agreement with the Contact PD/PI that specifies an official relationship between the parties. (See NIH Grants Policy Statement: 9 Multiple Program director/Principal Investigator Applications and Awards)

A legal instrument of financial assistance between a Federal awarding agency or pass-through entity and a non-Federal entity that, consistent with 31 U.S.C. 6302-6305: (1) Is used to enter into a relationship the principal purpose of which is to transfer anything of value from the Federal awarding agency or pass through entity to the non-Federal entity to carry out a public purpose authorized by a law of the United States (see 31 U.S.C. 6101(3)); and not to acquire property or services for the Federal government or pass-through entity's direct benefit or use; (2) Is distinguished from a grant in that it provides for substantial involvement between the Federal awarding agency or pass-through entity and the non-Federal entity in carrying out the activity contemplated by the Federal award. (3) The term does not include: (i) development agreement as defined in 15 U.S.C. 3710a; or (ii) An agreement that provides only: (A) Direct United States Government cash assistance to an individual; (B) A subsidy; (C) A loan; (D) A loan guarantee; or (E) Insurance.

At the NIH, there are at least three, and sometimes four, council rounds each fiscal year: October, January, May, and sometimes August. Application receipt dates, initial review dates, and council review dates all fall within one of these council rounds.

See Cooperative Research and Development Agreement

Actual dollars awarded, without adjustment for inflation.

A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.

Prior to award, this plan must be approved by the applicant’s 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.

Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)

A Program Director / Principal Investigator (PD/PI) who is within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an Early Stage Investigator (ESI).

An Early Stage Investigator is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award.  See our list of NIH grants that a PD/PI can hold and still be considered an ESI. For more information, please click here.

See Early Established Investigator

See Early Stage Investigator

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. 

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

Research supported by NIH through a grant, contract, or cooperative agreement.

See Federal Advisory Committee Act

A law enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public.

NIH Fogarty International Center

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.

See Freedom of Information Act

Requires dissemination, upon request, of Government documents while ensuring protection of proprietary and other privacy act information. Go to FOIA.

See Government Accountability Office.

See Grants Management Officer

See Grants Management Specialist

An oversight organization reporting to Congress.

Produces and distributes Federal Government information products.

See Government Printing Office