Glossary

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

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)

A

AREA

Academic Research Enhancement Award

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)

BRAIN

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.

C

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.

Competing Applications

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

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.

Extramural Awards

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

Extramural Research

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

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

IDeA

Institutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas.

IDeA

Institutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas.

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 – 90) or alphabetical (ND, for example).

Independent Clinical Trial

An independent clinical trial is one for which the researcher proposing the study has primary or lead responsibility for conducting and executing the trial. NIH policy permits individual career development awardees and individuals appointed to institutional career development awards to be involved in a range of clinical trial activities, including leading independent clinical trials. For NRSA trainees or fellows, however, NIH policy precludes leading an independent clinical trial as part of their training experience. Instead, NRSA trainees and fellows interested in clinical trials may gain clinical trial research experience by working on a trial led by their mentor or another investigator.

Person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research or undergo a medical procedure.

In giving informed consent, people may not waive legal rights or release or appear to release an investigator or sponsor from liability for negligence. Go to 21 CFR 50.20 and 50.25

Institute or Center (IC)

The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC" or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.

Acronym Full Name Organizational Code
CC Clinical Center CC
CSR Center for Scientific Review RG
CIT Center for Information Technology CIT
FIC John E. Fogarty International Center TW
NCATS National Center for Advancing Translational Sciences (NCATS) TR
NCCIH National Center for Complementary and Integrative Health AT
NCI National Cancer Institute CA
NCRR National Center for Research Resources (dissolved 12/2011) RR
NEI National Eye Institute EY
NHGRI National Human Genome Research Institute HG
NHLBI National Heart, Lung, and Blood Institute HL
NIA National Institute on Aging AG
NIAAA National Institute on Alcohol Abuse and Alcoholism AA
NIAID National Institute of Allergy and Infectious Diseases AI
NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases AR
NIBIB National Institute of Biomedical Imaging and Bioengineering EB
NICHD Eunice Kennedy Shriver National Institute of Child Health and Human Development HD
NIDA National Institute on Drug Abuse DA
NIDCD National Institute on Deafness and Other Communication Disorders DC
NIDCR National Institute of Dental and Craniofacial Research DE
NIDDK National Institute of Diabetes and Digestive and Kidney Diseases DK
NIEHS National Institute of Environmental Health Sciences ES
NIGMS National Institute of General Medical Sciences GM
NIMH National Institute of Mental Health MH
NIMHD National Institute on Minority Health and Health Disparities MD
NINDS National Institute of Neurological Disorders and Stroke NS
NINR National Institute of Nursing Research NR
NLM National Library of Medicine LM
OD Office of the Director OD

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.

Intramural Research

Research conducted by, or in support of, employees of the NIH.

Investigator-Initiated Research

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

M

Model Organism

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

MSTP

Medical Scientist Training Program - MTSP supports the integrated medical (or equivalent professional clinical) degree and graduate research training required for the investigation of human diseases

N

NCRR

NIH National Center for Research Resources (dissolved 12/2011)

New Investigator

A PD/PI who has not previously competed successfully as a PD/PI for a substantial independent research award is considered a New Investigator.

NIDCR

NIH National Institute of Dental and Craniofacial Research

NIH Guide for Grants and Contracts

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

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

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.

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.

NRSA

National Research Service Award - Ruth L. Kirschstein National Research Service Award (NRSA)

O

Office of Research Integrity

(ORI) - HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research.

OHRP

Office for Human Research Protections - HHS office overseeing human subject protection for HHS-supported research.

ORIS

Office of Research Information Systems - Provides IT systems, data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans' Administration).

ORIS

Office of Research Information Systems - Provides data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans’ Administration).

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 .

Peer Review Criteria

The reviewers judge the overall impact for the project to exert a sustained, powerful influence on the research field(s) based on five criteria: Significance, Investigator(s), Innovation, Approach, and Environment.

Planned Enrollment Report

The Planned Enrollment Report is used when you are planning to conduct a study that meets the NIH definition for clinical research. It provides a breakdown of the planned sample by sex/gender, race, and ethnicity.

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.

Public Access Policy

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

R

REAP

Research Enhancement Award Programs

RePORT

Research Portfolio Online Reporting Tools

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 and Development Contract

A funding mechanism by which the NIH procures specific services.
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021