Part I: NIH Grants—General Information

This glossary defines terms commonly used throughout this policy statement. These definitions may be amplified and additional definitions may be found in other sections of this document and in source documents such as applicable statutes, grants administration regulations, and OMB Circulars.

This glossary also includes a list of commonly used acronyms and other abbreviations.

Definitions

Application: A request for financial support of a project/activity submitted to NIH on specified forms and in accordance with NIH instructions. (See "Application and Review Processes" for detailed information about the application process, including an explanation of the types of applications.)

Approved Budget: The financial expenditure plan for the grant-supported project or activity, including revisions approved by NIH as well as permissible revisions made by the grantee. The approved budget consists of Federal (grant) funds and, if required by the terms and conditions of the award, non-Federal participation in the form of matching or cost sharing. The approved budget specified in the Notice of Grant Award may be shown in detailed budget categories or as total costs without a categorical breakout. Expenditures charged to an approved budget that consists of both Federal and non-Federal shares are deemed to be borne by the grantee in the same proportion as the percentage of Federal/non-Federal participation in the overall budget.

Authorized Organizational Official: The individual, named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards.

Award: The provision of funds by NIH, based on an approved application and budget, to an organizational entity or an individual to carry out an activity or project.

Awarding Office: The NIH Institute or Center responsible for the award, administration, and monitoring of grant-supported activities.

Budget Period: The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.

Competitive Segment: The initial project period recommended for support (up to 5 years) or each extension of a project period resulting from a competing continuation award that establishes a new competitive segment for the project.

Consortium Agreement: A collaborative arrangement in support of a research project in which some portion of the programmatic activity is carried out through a formalized agreement between the grantee and one or more other organizations that are separate legal entities administratively independent of the grantee.

Contract Under a Grant: A written agreement between a grantee and a third party to acquire routine goods or services.

Consultant: An individual that provides professional advice or services on the basis of a written agreement for a fee. These individuals are not normally employees of the organization receiving the services. Consultants also include firms that provide professional advice or services.

Cooperative Agreement: A financial assistance mechanism used when substantial Federal programmatic involvement with the recipient during performance is anticipated by the NIH Institute or Center.

Co-Investigator: An individual involved with the principal investigator in the scientific development or execution of a project. The co-investigator may be employed by, or be affiliated with, the applicant/grantee organization or another organization participating in the project under a consortium agreement. A co-investigator typically devotes a specified percentage of time to the project and is considered "key personnel." The designation of a co-investigator, if applicable, does not affect the principal investigator's roles and responsibilities as specified in this policy statement.

Cost Sharing: See "Matching or Cost Sharing."

Direct Costs: Costs that can be specifically identified with a particular project(s) or activity.

Domestic Organization: A public or private non-profit institution (including Federal, State, and other agencies) or for-profit organization that is located in the United States or its territories, is subject to U.S. laws, and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.

Equipment: An article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds the lesser of the capitalization threshold established by the organization or $5,000.

Expanded Authorities: The operating authorities provided to grantees under certain research grant mechanisms that waive the requirement for NIH prior approval for specified actions.

Expiration Date: The date signifying the end of the current budget period, after which the grantee is not authorized to obligate grant funds regardless of the ending date of the project period or "completion date."

Facilities and Administrative Costs: Costs that are incurred by a grantee for common or joint objectives and that, therefore, cannot be identified specifically with a particular project or program. These costs were previously known as "indirect costs," and, in most instances, will be referred to in this document as "F&A costs."

Federal Demonstration Partnership: A cooperative initiative among some Federal agencies, including NIH, select organizations that receive Federal funding for research, and certain professional associations. Its efforts include a variety of demonstration projects intended to simplify and standardize Federal requirements in order to increase research productivity and reduce administrative costs.

Federal Institution: A Cabinet-level department or independent agency of the executive branch of the Federal Government or any component organization of such a department or agency.

Fee: An amount in addition to actual, allowable costs incurred that is normally paid to a for-profit organization under a contractual arrangement. This increment above cost also is referred to as "profit." (Also see "Grants to For-Profit Organizations—Small Business Innovation Research and Small Business Technology Transfer Programs—Allowability of Costs and Fee—Profit or Fee.")

Financial Assistance: Transfer by NIH of money or property to an eligible entity to support or stimulate a public purpose authorized by statute.

Foreign Component: Under a grant to a domestic organization, the performance of any significant element or segment of the project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, with or without grant funds.

Foreign Organization: An organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed principal investigator.

For-Profit Organization: An organization, institution, corporation, or other legal entity that is organized or operated for the profit or financial benefit of its shareholders or other owners. Such organizations also are referred to as "commercial organizations."

Full-Time Appointment: The number of days per week and/or months per year representing full-time effort at the applicant/grantee organization, as specified in organizational policy. The organization's policy must be applied consistently regardless of the source of support.

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

Grant-Supported Project/Activities: Those programmatic activities specified or described in a grant application or in a subsequent submission(s) that are approved by an NIH Institute or Center for funding, regardless of whether Federal funding constitutes all or only a portion of the financial support necessary to carry them out.

Grantee: The organization or individual awarded a grant or cooperative agreement by NIH that is responsible and accountable for the use of the funds provided and for the performance of the grant-supported project or activities. The grantee is the entire legal entity even if a particular component is designated in the award document. The grantee is legally responsible and accountable to NIH for the performance and financial aspects of the grant-supported project or activity.

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. Only GMOs are authorized to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH Institute and Center that awards grants has one or more GMOs with responsibility for particular programs or awards.

Hospital: A non-profit or for-profit hospital or medical care provider component of a non-profit organization (for example, a foundation). The term includes all types of medical, psychiatric and dental facilities, such as clinics, infirmaries, and sanatoria.

Indirect Costs: See "Facilities and Administrative Costs."

Institute/Center (IC): The NIH organizational component responsible for a particular grant program(s) or set of activities. The terms "NIH IC" or "awarding office" 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. In the latter case, the terms refer specifically to the designated Grants Management Officer.

Institutional Base Salary: The annual compensation paid by an applicant/grantee organization for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. The base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds.

International Organization: An organization that identifies itself as international or intergovernmental, and has membership from, and represents the interests of, more than one country, without regard to whether the headquarters of the organization and location of the activity are inside or outside of the United States.

Key Personnel: Individuals who contribute in a substantive way to the scientific development or execution of a project, whether or not they receive compensation from the grant supporting that project. The principal investigator and collaborators are included in this category.

Matching or Cost Sharing: The value of third-party in-kind contributions and the portion of the costs of a federally assisted project or program not borne by the Federal Government. Matching or cost sharing may be required by law, regulation, or administrative decision of an NIH Institute or Center. Costs used to satisfy matching or cost sharing requirements are subject to the same policies governing allowability as other costs under the approved budget.

Modular Application: A type of grant application in which support is requested in specified increments without the need for detailed supporting information related to separate budget categories. When modular procedures apply, they affect not only application preparation but also review, award, and administration of the application/award.

Monitoring: A process whereby the programmatic and business management performance aspects of a grant are reviewed by assessing information gathered from various required reports, audits, site visits, and other sources.

New Investigator: An individual that has not previously served as a principal investigator on any Public Health Service-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory development grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research careers ((K01, K08, and K12). Current or past recipients of Independent Scientist and other non-mentored career awards (K02 and K04) are not considered "new investigators."

Notice of Grant Award: The legally binding document that notifies the grantee and others that an award has been made, contains or references all terms and conditions of the award, and documents the obligation of Federal funds. The award notice may be in letter format and may be issued electronically.

Organization: A generic term used to refer to an educational institution or other entity, including an individual, which receives and/or applies for an NIH grant or cooperative agreement.

Principal Investigator/Program Director/Project Director: An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible and accountable to the grantee for the proper conduct of the project or activity.

Prior Approval: Written approval from the designated Grants Management Officer required for specified postaward changes in the approved project or budget. Such approval must be obtained prior to undertaking the proposed activity or spending NIH funds.

Program: A coherent assembly of plans, project activities, and supporting resources contained within an administrative framework, the purpose of which is to implement an organization's mission or some specific program-related aspect of that mission. For purposes of this policy statement, "program" refers to those NIH programs that carry out their mission through the award of grants or cooperative agreements to other organizations.

Program Income: Gross income earned by a grantee that is directly generated by the grant-supported project or activity or earned as a result of the award.

Program Official: The NIH official responsible for the programmatic, scientific and/or technical aspects of a grant.

Project Period: The total time for which support of a project has been programmatically approved. The total project period is comprised of the initial competitive segment, any subsequent competitive segment(s) resulting from a competing continuation award(s), and noncompeting extensions.

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

Recipient: The organizational entity or individual receiving a grant or cooperative agreement. See "Grantee."

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. The term does not include honest error or honest differences of opinion.

Significant Rebudgeting: A threshold that is reached when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded. Significant rebudgeting is one indicator of change in scope.

Small Business Concern: A business that is independently owned and operated and not dominant in its field of operation; has its principal place of business in the United States and is organized for profit; is at least 51 percent owned, or in the case of a publicly owned business, at least 51 percent of its voting stock is owned by U.S. citizens or lawfully admitted permanent resident aliens; has, including its affiliates, not more than 500 employees; and meets other regulatory requirements established by the Small Business Administration at 13 Code of Federal Regulations (CFR) Part 121.

State Government: The government of any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, any U.S. territory or possession, or any agency or instrumentality of a State exclusive of local governments. For purposes of NIH grants, federally recognized Indian tribal governments generally are considered State governments. State institutions of higher education and State hospitals are not considered State governments for purposes of the Department of Health and Human Services' general administrative requirements for grants and this policy statement.

Stipend: A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.

Suspension: Temporary withdrawal of a grantee's authority to obligate grant funds, pending either corrective action by the grantee, as specified by NIH, or a decision by NIH to terminate the award.

Termination: Permanent withdrawal by NIH of a grantee's authority to obligate previously awarded grant funds before that authority would otherwise expire, including the voluntary relinquishment of that authority by the grantee.

Terms and Conditions of Award: All legal requirements imposed on a grant by NIH, whether based on statute, regulation, policy, or other document referenced in the grant award, or specified by the grant award document itself. The Notice of Grant Award may include both standard and special conditions that are considered necessary to attain the grant's objectives, facilitate postaward administration of the grant, conserve grant funds, or otherwise protect the Federal Government's interests.

Total Project Costs: The total allowable costs (both direct costs and facilities and administrative costs) incurred by the grantee to carry out a grant-supported project or activity. Total project costs include costs charged to the NIH grant and costs borne by the grantee to satisfy a matching or cost-sharing requirement.

Withholding of Support: A decision by NIH not to make a noncompeting continuation award within the current competitive segment.

This section provides information about how NIH is organized to award and administer grants and describes its relationship to other organizations both within the Department of Health and Human Services (hereafter referred to as "HHS" or the "Department") and external to HHS.

NIH is an organizational component of HHS, the mission of which is to improve human health by increasing scientific knowledge related to disease and health. NIH operates under the general policy guidance of the Department in carrying out its mission, which is accomplished through the conduct and support of biomedical and behavioral research, research training, research infrastructure, and communications. These efforts take place intramurally (primarily at NIH) and extramurally (through grants, cooperative agreements, and contracts awarded to institutions of higher education, governmental organizations, non-profit research organizations, for-profit organizations, and individuals). NIH also works closely with other HHS components^[1] and other Federal departments and agencies.

NIH is organized into Institutes and Centers (ICs), each with its own mission and functions, separate appropriations, and statutory authorities. The ICs that award grants are listed in Part III. Although these ICs operate under the same general grant process and requirements, there may be differences of which applicants and grantees need to be aware. This information may be obtained from NIH staff. The policies and procedures generally applicable to NIH grants are set forth in this NIH-wide policy statement.

At the Departmental level, HHS develops, issues, and maintains regulations that govern the HHS grants process. Among these are the regulations that implement the OMB Circular A-102 common rule (applicable to grants to State, local, and Indian tribal governments) and OMB Circular A-110 (applicable to grants to institutions of higher education, hospitals, and other non-profit organizations). These regulations are codified at 45 Code of Federal Regulations (CFR) Part 92 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 45 CFR Part 74 (Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments, and Indian Tribal Governments)^[2]. They provide the standard framework for the terms and conditions of NIH awards as specified in Part II.

Roles and Responsibilities

The relationship between NIH and its grantees involves those engaged in the scientific or technical aspects of the work as well as those responsible for a variety of support functions. NIH, as a Federal grantor agency, is responsible to Congress and the U.S. taxpayer for carrying out its mission in a manner that not only facilitates research but also does so cost-effectively and in compliance with applicable rules and regulations. NIH seeks to ensure integrity and accountability in its grant award and administration processes by relying on a system of checks and balances and separation of responsibilities within its own staff and by establishing a similar set of expectations for grantee organizations. The grantee's roles and responsibilities assume increasing importance as NIH shifts to a greater reliance on systems compliance and provides greater decision-making authority to grantees.

The following subsections highlight the major functions and areas of responsibility of Federal and grantee staff. NIH recognizes that additional staff members in a number of different organizations may be involved in grant-related activities; however, this section details only the major participants representing the Government and the grantee. The responsibilities of those NIH staff members in the Center for Scientific Review (CSR) involved only in the initial peer review process are described in the "Application and Review Processes" section. The responsibilities of other offices, such as the Office for Human Research Protections (OHRP), are described in Part II.

NIH and HHS Staff

Grants Management Officer: The Grants Management Officer (GMO) whose name appears on the Notice of Grant Award is the NIH official responsible for the business management and other non-programmatic aspects of the award. 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 applicants and grantees, including interpretation of grants administration policies and provisions; and administering and closing out grants. The GMO works closely with his or her counterparts in other NIH ICs and with the designated Program Official. The GMO is the focal point for receiving and acting on requests for NIH prior approval or for changes in the terms and conditions of award and is the only NIH official authorized to obligate NIH to the expenditure of funds or to change the funding, duration, or other terms and conditions of award.

Grants Management Specialist: The Grants Management Specialist is an agent of the GMO and is assigned responsibility for the day-to-day management of a portfolio of grants.

Program Official: The Program Official is responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The Program Official's responsibilities include, but are not limited to, development of research and research training programs to meet the IC's mission; coordination with CSR/IC Scientific Review Administrators; and postaward administration, including review of progress reports, participating in site visits, and other activities complementary to those of the GMO. The Program Official and the GMO work as a team in many of these activities.

Scientific Review Administrator: The Scientific Review Administrator (SRA) is a health science administrator who manages the activities of a scientific review group, including CSR study sections. The SRA performs an initial review of applications for completeness and conformity to requirements, ensures that adequate numbers of reviewers with appropriate expertise are available for application review, assigns applications to individual reviewers as discussion leaders and for preparation of written critiques, and serves as the overall point of contact with applicants during the initial phase of the peer review process, i.e., until the conclusion of the scientific review group meeting.

Other NIH and HHS Staff: The grantee may be required to interact with other NIH or HHS staff/offices, in addition to the GMO and Program Official, with respect to its organization-wide systems and/or individual transaction(s). These include the office responsible for negotiation of F&A costs and research patient care rates, typically the cognizant (based on geographical location) HHS Division of Cost Allocation office or the Office of Acquisition Management and Policy, NIH^[3]; the Division of Payment Management; the Office of the Inspector General; OHRP; the Office of Laboratory Animal Welfare, (OLAW); and the Office of Research Integrity. Staff in these offices generally coordinate with the GMO, but they are responsible for discrete areas of specialization and are not required to channel their communications with the grantee through the GMO. Part III includes a list of these organizations and their addresses and telephone numbers.

Grantee Staff

Authorized Organizational Official: This official is the designated representative of the grantee organization in matters related to the award and administration of its NIH grants, including those that require NIH approval. In signing a grant application, this individual certifies that the applicant organization will comply with all applicable assurances and certifications referenced in the application. This individual's signature on the grant application further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application. (Also see "Legal Implication of Application.") This individual also is responsible to NIH for ensuring that the organization complies with applicable Federal laws and regulations, its application, and the terms and conditions of individual awards. NIH does not specify the organizational location or full set of responsibilities for such an official; however, it requires the designation of such an official as the focal point for the organization's responsibilities as the grantee.

Principal Investigator: The principal investigator (PI) (also may be known as "program director" or "project director") is the individual, designated by the grantee, responsible for the scientific or technical aspects of the grant and for day-to-day management of the project or program. The PI is not required to be an employee of the grantee. However, since the grant, if awarded, is made to the organization, the applicant organization must have a formal written agreement with the PI that specifies an official relationship between the parties, but need not involve a salary or other form of remuneration. If the PI is not an employee of the applicant organization, NIH will assess whether the arrangement will result in the organization being able to fulfill its responsibilities under the grant, if awarded.

The PI is a member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. He or she works closely with designated officials within the grantee organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; ensure that Federal support of research findings is appropriately acknowledged in publications, announcements, news programs, etc. (see "Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources"); and comply with organizational as well as Federal requirements. NIH encourages the PI to maintain contact with the NIH Program Official with respect to the scientific aspects of the project and the designated GMO concerning the business and administrative aspects of the award.

NOTE: NIH staff conduct official business only with the designated PI and authorized organizational officials.