Glossary

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

Basic Experimental Studies with Humans

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.

A

A1 application

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.

B

Basic Experimental Studies with Humans

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.

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)

C

Chartered Advisory Committee

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

Clinical Research

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.

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.

Contact PD/PI

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)

Cooperative Agreement

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.

Council Round

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.

Current Dollars

Actual dollars awarded, without adjustment for inflation.

D

Data and Safety Monitoring Board (DSMB)

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.

Direct Costs

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)

E

Early Established Investigator (EEI)

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).

Early Stage Investigator (ESI)

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. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.

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.

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. 

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.

G

Grant or Grant Agreement

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, 6304:
(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 awarding agency or pass-through entity's direct benefit or use;
(2) Is distinguished from a cooperative agreement in that it does not provide 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) Does not include an agreement that provides only:


(i) Direct United States Government cash assistance to an individual;
(ii) A subsidy;
(iii) A loan;
(iv) A loan guarantee; or
(v) Insurance.

See NIH Grants Policy Statement: 1.2 Definition of Terms Cooperative Agreement.

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.

Grants Management Specialist (GMS)

A NIH staff member who oversees the business and other non-programmatic aspects of one or more grants and/or cooperative agreements. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with statutes, regulations, and guidelines; negotiating grants; providing consultation and technical assistance to grantees; and administering grants after award.

H

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues, and body fluids from identifiable individuals as human subjects and to graphic, written, or recorded information derived from such individuals. (See Public Policy Requirements and Objectives-Human Subjects Protections).

I

Institutional Review Board

An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated.

Investigational New Drug Application

Under regulation 21 CFR 312, application filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all phases, protocols, IRB members, and investigators.

M

Model Organism

Animal, plant, or other organism used to study basic biologic processes to provide insight into other organisms. See Model Organism Sharing.

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.

N

NIH-Defined Phase III Clinical Trial

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.

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.

Non-Competing Continuation Application/Award

A financial assistance request (in the form of an application or progress report) or resulting award for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.

Non-competing Continuation Awards

A financial assistance request (in the form of an application or progress report) or resulting award for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.

O

OLAW

Office of Laboratory Animal Welfare - NIH office overseeing compliance with the PHS Policy on Humane Care and Use of Laboratory Animals

P

Personally Identifiable Information

Information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Some information that is considered to be PII is available in public sources such as telephone books, public Web sites, and university listings. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. Non-PII can become PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual.

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.

Protected Personally Identifiable Information

PII - An individual's first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, etc.

PubMed

PubMed provides access to citations from biomedical literature. It includes over 17 million citations from MEDLINE and other life science journals for biomedical articles back to the 1950s, along with links to full text articles and other resources.

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 & Development

All research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.

Research Misconduct

Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.

  • Fabrication is making up data or results and recording or reporting them.
  • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
  • Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
  • Research misconduct does not include honest error or honest differences of opinion.

Review Committee

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.

RPPR

Research Performance Progress Report - Progress reports are required annually to document grantee accomplishments and compliance with terms of award.

S

Scientific Rigor

The strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results.

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.

STTR

Small Business Technology Transfer: A program designed to support cooperative research/research and development with potential for commercialization, through a formal cooperative effort between a small business and a U.S. research institution.

T

Translational Research

Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.

U

Underrepresented Group

Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.

Used as an eligibility requirement for diversity supplements, fellowships (F31), and other NIH programs.

X

xTrain

xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.