Extramural Glossary

An individual, investigator-initiated research project application or grant.

The Academic Research Enhancement Award (R15 or AREA) funding mechanism is designed to enhance the research environment of educational institutions that have not been traditional recipients of NIH research funds, this award provides limited funds to those institutions’ faculty members to develop new research projects or expand ongoing research activities in health sciences and to encourage students to participate in the research activity. As funds are anticipated to continue to be available each year, the NIH is now inviting applications for AREA grants through a standing, ongoing Program Announcement.

In the instances when these applications are reviewed by CSR study sections, they are processed in the same manner as the other applications. DHHS policies concerning assurances of protection of human subjects involved in research also apply to R84s. Pertinent background information may be obtained from the Fogarty International Center.

Human subjects terms that are defined by the Office of Management and Budget Directive No. 15 and used by NIH to allow comparisons to national databases.

A method used to prevent bias in research. People are assigned by chance to receive experimental treatment(s), standard treatment(s), or no treatment/placebo.

A study in which participants are randomly (i.e., by chance) assigned to one or two or more treatment arms or regimen of a clinical trial. Occasionally placebos are utilized. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms.

The Rapid Access to Intervention Development (RAID) program facilitates translation to the clinic of novel, scientifically meritorious therapeutic interventions originating in the academic community. See http://dtp.nci.nih.gov/docs/raid/raid_index.html

This program assists academic and nonprofit investigators in the discovery stage of anticancer drug research. R·A·N·D can assist in the discovery of small molecules, biologics, or natural products through such mechanisms as the development of high-throughput screening assays, computer modeling, recombinant target protein production and characterization, and chemical library generation.

The goal of this program is the expeditious movement of novel molecules and concepts from the laboratory to the clinic for clinical trials of efficacy. RAPID will assist investigators who submit successful requests by providing any (or all) of the preclinical and phase 1 clinical developmental requirements for phase 2 clinical efficacy trials. These include, for example, preclinical pharmacology, toxicology, and efficacy studies; bulk supply, GMP manufacturing and formulation; and regulatory and IND support and phase 1 clinical studies. Suitable types of agents for RAPID may range from single chemical or biological entities to defined complex mixtures with the potential to prevent, reverse, or delay carcinogenesis.

Peer reviewer who serves as a backup for a primary peer reviewer and secondary peer reviewer. A reader reads a grant application thoroughly before an initial peer review meeting, but does not necessarily prepare a written critique.

Land, including land improvements, structures, and appurtenances, but not movable machinery and equipment.

Also called "Grant Rebudgeting." With the advent of modular grants, grantees no longer have to request permission from NIH for rebudgeting (formerly moving money from one budget category to another). For nonmodular grants, permission is still required for some items.

A procedure for contesting the peer review of a grant application. Synonymous with "Appeal."

The date that grant applications are due for submission (to any NIH Institute or Center) at the NIH Center for Scientific Review (CSR). Investigator-initiated applications have three receipt dates, which for the majority of applications are February 1, June 1, and October 1; see the CSR Web site for the standard receipt dates according to the type of funding mechanism (i.e., grant application). Grant applications and contract proposals that are submitted in response to an initiative (e.g., a Request for Applications or a Requests for Proposals, respectively) from an NIH Institute or Center are listed as an initiative announcement in the NIH Guide for Grants and Contracts [check] and FedBizOpps, respectively.

The routing of applications arriving at NIH. The referral section of CSR is the central receipt point for competing applications. CSR referral officers assign each application to an institute and refer it to a scientific review group, notifying applicants of these assignments by mail. Alternatively, NIH encourages applicants to self assign. For more information, scroll down after clicking on Requesting Assignment for Your Application.

The entity receiving financial assistance directly, in the form of a grant or cooperative agreement, from a Federal agency to carry out a project or program. Although grant funding and benefits may be limited to a particular site or component of a larger entity, the entire legal entity that received the award is legally responsible for carrying out a program or project, even if the grant award document refers only to the particular site or component.

A designation given by a study section advising that an application be funded. The application gets a priority score and summary statement. Roughly the top half of applications being reviewed are recommended for funding.

Funding level recommended for each future year approved by the scientific review group, subject to availability of funds and scientific progress.

A grant whose term (e.g., four years) is over and for which the applicant is again seeking NIH support. Such applications are designated to be type 2 applications. The designation of such grant applications as renewal or competing continuation applications has been discontinued and has been replaced by renewal applications.

Supports full-time or part-time work for individuals with high potential to reenter an active research career after taking time off to care for children or parents or to attend to other family responsibilities.

A contract extension of six months or more which also increases the estimated cost of the contract and is intended as a continuation of work with the incumbent contractor.

Competing continuation application.

The official statement that invites grant or cooperative agreement applications to accomplish a specific program purpose. RFAs indicate the amount of funds set aside for the competition and generally identify a single application receipt date.

When it is issued, a computer-generated letter is sent to the principal investigator with information on the change.

A document used to initiate an acquisition action which provides the background information necessary for the preparation of the Request for Proposal. (See Section IV, D, of the Research Contracts Branch's Orange Book).

A document used to initiate new actions (modifications) taken after the initial contract award. (See Section VII, A, of the Research Contracts Branch's Orange Book).

The Government’s invitation to prospective offerors to submit a proposal based on the terms and conditions set forth in the RFP. The RFP is also called the Solicitation. An RFP is also considered to be an Initiative sponsored by an NIH IC that requests proposals for a contract to meet a specific need, such as the development of an animal model. RFPs have a single proposal receipt date and are published in the FedBizOpps and NIH Guide for Grants and Contracts.

Contract that provides for purchasing supplies or services during the contract period, with deliveries scheduled by placing orders with the contractor. (FAR 16.503)

A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.

This branch within the NCI's Division of Extramural Activities serves as the Institute's officially designated centralized source of scientific information and science-based budget information on NCI-supported research projects. This branch analyzes and classifies the science content of all Institute-supported projects as well as that of unfunded applications submitted to the Institute. RAEB also prepares analyses comparing the distribution of funds among research areas, which serve as a basis for budget projections.

All research activities, both basic and applied, and all development activities that are supported at universities and other institutions. "Research" is the 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.

A funding mechanism by which the NIH procures specific services. These are negotiated contracts which may be funded from intramural or extramural accounts. Excluded are inter/intra-agency agreements (Y01 and Y02), resource and support contracts (N02), and station support contracts (N03).

NIH Programs occasionally identify requirements for certain types of resources or services integral to the conduct of current research and development activities. When ICD program specific requirements can well be defined in advance, contracts may be awarded for research services, e.g., data processing, drug testing, or toxicology screening and research resources, e.g., collection and distribution of materials needed to conduct biomedical research and development, or maintaining and operating special equipment or facilities for access by a number of investigators.

Activity supporting shared resources for a multidisciplinary research group of investigators focused on a common research topic;

Grants that support multidisciplinary, long-term research and development programs at research centers. Research centers usually have a clinical orientation and include all P activities (excluding NLM for all years and NINR for FY 1986) that are not included in research projects (R); M01 activities; selected U activities (U41, U42, U54); R07 and G12.

The Research Contracts Branch (RCB) participates in the planning, review, award and management of all National Cancer Institute (NCI) contracts and simplified acquisitions. In addition, RCB acts as a service center for contract actions and purchasing required by the National Institute of Neurological Disorders and Strokes (NINDS) and the National Center for Complementary and Alternative Medicine (NCCAM).

To provide support designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge for the control of categorical diseases.

Items such as tuition, fees, books, research expenses, travel, statistical and computational services, etc.

To provide matching Federal funds, up to 75%, for construction or major remodeling to create new research facilities. In addition to basic research laboratories, this may include, under certain circumstances, animal facilities and/or limited clinical facilities where they are an integral part of an overall research effort.

Extramural awards made for Other Research Grants, Research Centers, Research Projects, and SBIR/STTRs.

A United States research organization that is:

• A nonprofit college or university OR
• A nonprofit research institution, including nonprofit medical and surgical hospitals. (A "nonprofit institution" is defined as an organization that is owned and operated exclusively for scientific or educational purposes, no part of the net earnings of which inures to the benefit of any private shareholder or individual.) OR
• A contractor-operated, federally funded research and development center, as identified by the National Science Foundation in accordance with the Government-wide Federal Acquisition Regulation issued in accordance with section 35(c)(1) of the Office of Federal Procurement Policy Act (or any successor legislation thereto). (Laboratories staffed by Federal employees do not meet the definition of "research institution" for purposes of the STTR program.)

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, results, processes, or words without giving appropriate credit. The term does not include honest error or honest differences of opinion.

The cohort of grants supported by a given NIH organization and administered by an Institute or Center Program Officer (or Program Official or Program Director).

To support a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach.

For the support of broadly based, multidisciplinary, often long-term, research program which has a specific major objective or a basic theme. A program project generally involves the organized efforts of relatively large groups, members of which are conducting research projects designed to elucidate the various aspects or components of their objectives. Each research project is usually under the leadership of an established investigator. The grant can provide support for certain basic resources used by the groups in the program, including clinical components, the sharing of which facilitates the total research effort. A program project is directed toward a range of problems having a central focus, in contrast to the usually narrower thrust of the traditional research project. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort.

To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his specific interest and competencies.

Awards given in response to investigator-initiated applications for research funds. Most grants issued by NCI are RPGs. Expenditures for these grants constitute 45-50% of the NCI budget. Examples: Traditional (R01), New Investigator (*R01), Program Projects (P01), MERIT Awards (R37), RFAs (R01, U01), Cooperative Agreements (U01 not responsive to RFA), Shannon Awards (R55), Small Grants (R03), Explatory/Developmental Grants (R21/R33), SBIR/STTR Grants (R43/R44 & R41/R42)

For support of a scientist, committed to research, in need of both advanced research training and additional experience.

Monies adding funds to an existing grant to support and promote diversity, people with disabilities, and people returning to work from family responsibilities.

Monies that add funds to an existing grant to support graduate students, postdoctoral fellows, and faculty with disabilities.

Monies that add funds to an existing grant to support scientists who have taken time off to care for children or parents, or to attend to other family responsibilities.

Monies that add funds to an existing grant to support underrepresented minority investigators and students.

Shortening a grant's budget period by giving it a new anniversary date, generally to avoid having too many awards start at the end of a fiscal year. Resetting a grant's start date may affect when a grantee would submit a recompeting application.

These grants are used by the NIH and the extramural community to support research projects that will enhance the capability of resources to serve biomedical research.

These grants are used by the NIH and the extramural community to support research projects contributing to improvement of the capability of resources to serve biomedical research.

Sending NIH an application for initial peer review after is has been reviewed by a study section, but not funded and then revised and resubmitted by the applicant one or more times. Each resubmission is given a code, e.g., A1. NIH limits applicants to one resubmission of a particular application.

The summary of the assessment of the scientific merit of an application for research or other funding from the NIH; the Resume appears at the front of an NIH summary statement. Also, in a different context, a summary of a person's background, education, experience, and achievements that is submitted with a job application.

Time span for one Center for Scientific Review peer review round from the receipt of applications to the date of the initial peer review meeting. There are three cycles a year for investigator-initiated grants.

NIH committee of senior peer review administrative staff that advises NIH on extramural review issues. It has one voting member from each Institute or Center (including several from the NIH Center for Scientific Review).

The correct term at the NIH is "Amended Application." An amended or revised application is one that has been officially resubmitted to the NIH after having been revised in response to prior review(s) of its scientific merit by an NIH peer review group as summarized in a summary statement.

Grants.gov term for money added to a grant to expand its scope or meet needs of a research protocol. Applicants must apply and undergo peer review. The NIH term has been "competing supplement?.

Awards to both individuals and institutions to provide research training in specified healthrelated areas.