Glossary

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

Research and Development Contract

A funding mechanism by which the NIH procures specific services.

I

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.

Investigator-Initiated Research

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

K

Key Personnel

Key Personnel include PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant

M

Mechanistic Study

A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

MOU

Memorandum of Understanding

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

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

NCCAM

National Center for Complementary and Alternative Medicine (dissolved 12/2014)

NCCIH

National Center for Complementary and Integrative Health

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.

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

NICHD

National Institute of Child Health and Human Development

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

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.

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.

Notice of Funding Opportunity (NOFO)

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. Notices of funding opportunity may be known as funding opportunity announcements, program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Notices of funding opportunity can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts.

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.

OLAW

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

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).

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 .

PECASE

Presidential Early Career Award for Scientists and Engineers - The Presidential Award is the highest honor bestowed by the U.S. Government on outstanding scientists and engineers beginning their independent careers.

Peer Review

The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of applications based on an evaluation of scientific or technical merit or other relevant aspects of the application. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support is requested. Peer review is intended to provide guidance and recommendations to the NIH individuals responsible for making award decisions.

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.

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.

Phase IIB Competing Renewal

An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.

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.

Postdoctoral Scholar

An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training.

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.

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.

Public Access Policy

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