Glossary

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

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.

M

Model Organism

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

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

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.

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.

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.

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

Racial Categories

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.
 
Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)
 
Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian or “Negro can be used in addition to “Black or African American.
 
Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
 
White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

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.

Research Centers

Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.

Research Grants

Major extramural research grants awarded to institutions, hospitals, and other research organizations, including small businesses, to support circumscribed research led by investigators, create developmental opportunities, and to provide research related resources under programs such as Research Careers, Research Centers, Research Projects, SBIR/STTRs, and Other Research.

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.

Research Patient Care Costs

Costs of routine and ancillary services provided by hospitals to participants in research protocols.

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.

Review Cycle

Refers to the Center for Scientific Review's thrice yearly initial peer review cycle, from the receipt of applications to the date of the review. See Standard Receipt Dates