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

NIH

National Institutes of Health - A Federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services.

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.

A

Awarding IC

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

C

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.

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

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)

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.

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.

Data and Safety Monitoring Plan

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.

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.

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.

F

Freedom of Information Act (FOIA)

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

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

Grant Number

Sample Grant Number 1 R01 AI 183723 -01 A1 S1

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.

Grants Process

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.

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

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.

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

Intramural Research

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

N

NCI

NIH National Cancer Institute

NCRR

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

NED

NIH Enterprise Directory

NEI

NIH National Eye Institute

NIA

NIH National Institute on Aging

NIAAA

NIH National Institute on Alcohol Abuse and Alcoholism

NIAID

NIH National Institute of Allergy and Infectious Diseases

NIAMS

NIH National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIBIB

NIH National Institute of Biomedical Imaging and Bioengineering

NIDA

NIH National Institute on Drug Abuse

NIDCD

NIH National Institute on Deafness and Other Communication Disorders

NIDCR

NIH National Institute of Dental and Craniofacial Research

NIDDK

NIH National Institute of Diabetes and Digestive and Kidney Diseases

NIEHS

NIH National Institute of Environmental Health Sciences

NIGMS

NIH National Institute of General Medical Sciences

NIH

National Institutes of Health - A Federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services.

NIH Guide for Grants and Contracts

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

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.

NIH/OD

National Institutes of Health, Office of the Director

NIMH

NIH National Institute of Mental Health
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