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ARCHIVED - NIH Grants Policy Statement (10/03)


NIH Grants Policy Statement
(12/03)

Part I: NIH Grants—General Information -- File 1 of 2


Part I: NIH Grants—General Information

This part contains a glossary defining terms and abbreviations commonly used throughout the NIHGPS; describes NIH and its relationship to other organizations within HHS; specifies grantee, NIH, and other HHS staff responsibilities; outlines the grant application and review processes; and explains the various resources available to those interested in the NIH grants process.

GLOSSARY

The glossary lists commonly used acronyms and other abbreviations used in the NIHGPS.[1] The glossary also defines terms commonly used throughout the NIHGPS. The 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.

Abbreviations

A&R

Alteration and Renovation

ACF

Administration for Children and Families

ACH

Automated Clearinghouse

AHRQ

Agency for Healthcare Research and Quality

AIA

American Institute of Architects

AoA

Administration on Aging

AOO

Authorized Organizational Official

APAC

Annual Payback Activities Certification

AREA

Academic Research and Enhancement Award

ASHRAE

American Society of Heating, Refrigeration and Air Conditioning
Engineers

CDC

Centers for Disease Control and Prevention

CFR

Code of Federal Regulations

CGMO

Chief Grants Management Officer

CMS

Centers for Medicare and Medicaid Services

CoC

Certificate of Confidentiality

COR

Career Opportunities in Research Education and Training Program

CRISP

Computer Retrieval of Information on Scientific Projects

CSR

Center for Scientific Review

DAB

Departmental Appeals Board

DCA

Division of Cost Allocation, HHS

DEA

Drug Enforcement Administration

DEOIR

Division of Extramural Outreach and Information Resources, NIH

DES

Department of Engineering Services, NIH

DFAS

Division of Financial Advisory Services, NIH

DoC

Department of Commerce

DoD

Department of Defense

DoL

Department of Labor

DPM

Division of Payment Management, HHS

DSMB

Data and Safety Monitoring Board

EA

Expanded Authorities

EO

Executive Order

eRA

Electronic Research Administration

F&A

Facilities and Administrative (costs)

FAC

Federal Audit Clearinghouse

FAR

Federal Acquisition Regulation

FCTR

Federal Cash Transactions Report (SF 272)

FDA

Food and Drug Administration

FDP

Federal Demonstration Partnership

FEMA

Federal Emergency Management Agency

FIC

Fogarty International Center

FICA

Federal Insurance Contributions Act

FOI

Freedom of Information

FOIA

Freedom of Information Act

FSR

Financial Status Report (SF 269 or 269A)

FTR

Federal Travel Regulation

FWA

Federal-Wide Assurance

GCRC

General Clinical Research Centers

GMO

Grants Management Officer

GMS

Grants Management Specialist

GMP

Guaranteed Maximum Price

GPO

Government Printing Office

GSA

General Services Administration

hESC

Human Embryonic Stem Cells

HHS

Department of Health and Human Services

HRSA

Health Resources and Services Administration

HVAC

Heating, Ventilating, and Air Conditioning

IACUC

Institutional Animal Care and Use Committee

IBC

Institutional Biosafety Committee

IC

Institute or Center

IDE

Investigational Device Exception

IHS

Indian Health Service

IND

Investigational New Drug

IPA

Intergovernmental Personnel Act

IR&D

Independent Research and Development

IRB

Institutional Review Board

IRG

Initial Review Group

IRS

Internal Revenue Service

K award

Career award

Kirschstein-NRSA

Ruth L. Kirschstein National Research Service Award

LWOP

Leave Without Pay

MARC-U*STAR

Minority Access to Research Careers Undergraduate Student Training in Academic Research Program

MOU

Memorandum Of Understanding

MPA

Multiple Project Assurance

NCRR

National Center for Research Resources

NEARC

National External Audit Review Center, OIG

NEI

National Eye Institute

NEPA

National Environmental Policy Act

NFI

Notice of Federal Interest

NFPA

National Fire Protection Association

NGA

Notice of Grant Award

NHSC

National Health Service Corps

NICHD

National Institute for Child Health and Human Development

NIDCR

National Institute of Dental and Craniofacial Research

NIGMS

National Institute of General Medical Sciences

NIH

National Institutes of Health

NIHGPS

National Institutes of Health Grants Policy Statement

NIMH

National Institute of Mental Health

NINR

National Institute on Nursing Research

NLM

National Library of Medicine

NRFA

Notice of Research Fellowship Award

NTIS

National Technical Information Service

OBA

Office of Biotechnology Activities, NIH

OCR

Office for Civil Rights, HHS

OER

Office of Extramural Research, NIH

OFCCP

Office of Federal Contract Compliance Programs, DoL

OFM

Office of Financial Management, NIH

OHRP

Office for Human Research Protections, HHS

OIG

Office of the Inspector General

OLAW

Office of Laboratory Animal Welfare, NIH

OMB

Office of Management and Budget

ONR

Office of Naval Research

OPERA

Office of Policy for Extramural Research Administration, NIH

OPHS

Office of Public Health and Science

ORI

Office of Research Integrity, HHS

PA

Program Announcement

PD

Program Director/Project Director

PHS

Public Health Service

PI

Principal Investigator

P.L.

Public Law

PMS

Payment Management System, HHS

PO

Program Official

PSC

Payback Service Center, NIH

R&D

Research and Development

RFA

Request For Applications

RFP

Request For Proposals

S&W

Salaries and Wages

SAMHSA

Substance Abuse and Mental Health Services Administration

SBA

Small Business Administration

SBC

Small Business Concern

SBIR

Small Business Innovation Research Program

SEP

Special Emphasis Panel

SF

Standard Form

SII

Successor-In-Interest

SNAP

Streamlined Non-competing Award Process

SO

Signing Official

SPOC

State Single Point of Contact

SRA

Scientific Review Administrator

SRG

Scientific Review Group

STTR

Small Business Technology Transfer Program

U.S.C.

United States Code

USDA

United States Department of Agriculture

USPS

United States Postal Service

VA

Department of Veterans Affairs

VAMC

VA Medical Center

VANPC

VA-Affiliated Non-Profit research Corporation

 

 

Definitions of Terms

alteration and renovation

Work that changes the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it can be used more effectively for its currently designated purpose or adapted to an alternative use to meet a programmatic requirement. Major A&R (including modernization, remodeling, or improvement) of an existing building is permitted under an NIH grant only when the authorizing statute for the program specifically allows that activity. (See “Allowability of Costs/Activities—Selected Items of Cost—Alteration and Renovation” and “Allowability of Costs/Activities—Selected Items of Cost—Construction.”)

application

A request for financial support of a project or 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 and 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 NGA 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. This official is equivalent to the SO in NIH’s eRA Commons.

award

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

awarding office

The NIH IC responsible for the award, administration, and monitoring of particular grants.

budget period

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

capital
expenditure

The cost of an asset (land, building, equipment), including the cost to put it in place. A capital expenditure for equipment includes the net invoice price and the cost of any modifications, attachments, accessories, or auxiliary apparatus to make it usable for the purpose for which it was acquired. Other charges, such as taxes, in-transit insurance, freight, and installation, may be included in capital expenditure costs in accordance with the recipient’s regular accounting practices consistently applied regardless of the source of funds. (See “Administrative Requirements—Changes in Project and Budget
—Prior-Approval Requirements—Capital Expenditures
.”)

clinical research

Patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research. Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. It includes research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies, but does not include in vitro studies that use human tissues that cannot be linked to a living individual. Studies falling under 45 CFR 46.101(a) (4) are not considered clinical research for purposes of this definition.

clinical trial

A biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical trials of an experimental drug, treatment, device, or intervention may proceed through four phases:

Phase I. Testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).

Phase II. Study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.

Phase III. Study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.

Phase IV. Studies done after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

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.

consortium agreement

A formalized agreement whereby a research project is carried out by the grantee and one or more other organizations that are separate legal entities. Under the agreement, the grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. (See “Consortium Agreements” in Part II, Subpart B.)

contract under a grant

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

consultant

An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. Consultants also include firms that provide professional advice or services. (See “Allowability of Costs/Activities—Selected Items of Cost—Consultant Services.”)

cooperative agreement

A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

co-investigator

An individual involved with the PI in the scientific development or execution of a project. The co-investigator (collaborator) 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 PI’s roles and responsibilities as specified in the NIHGPS.

cost overrun

Any amount charged in excess of the Federal share of costs for the project period (competitive segment).

cost sharing

See “matching or cost sharing” in this section.

direct costs

Costs that can be specifically identified with a particular project or activity.

domestic
organization

A public (including a State or other governmental agency) or private non-profit 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 $5,000 or the capitalization threshold established by the organization, whichever is less.

expanded
authorities

Operating authorities provided to grantees that waive the requirement for NIH prior approval for specified actions (see “Administrative Requirements—Changes in Project and Budget—Expanded Authorities”).

facilities and administrative costs

Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program. These costs also are known as “indirect costs.”

Federal Demonstration Partnership

A cooperative initiative among some Federal agencies, including NIH, selected organizations receiving Federal funding for research, and certain professional associations. Its efforts include 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, paid to an organization providing goods or services consistent with normal commercial practice. This payment also is referred to as “profit.” (See “Grants to For-Profit Organizations—Small Business Innovation Research and Small Business Technology Transfer Programs—Allowable 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

The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the grantee that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Foreign travel for consultation is not considered a foreign component. (See “Grants to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components.”)

foreign
institution

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 PI.

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 IC anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

grant-supported project or
activity

Those activities specified or described in a grant application or in a subsequent submission that are approved by an NIH IC 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 activity. The grantee is the entire legal entity even if a particular component is designated in NGA. 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

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 IC that awards grants has one or more GMOs with responsibility for particular programs or awards.

Grants
Management Specialist

An 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.

hospital

A non-profit or for-profit hospital or a 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.

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 “Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects.”)

indirect costs

See “facilities and administrative costs.”

Institute or
Center

The NIH organizational component responsible for a particular grant program 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 GMO.

institutional base salary

The annual compensation paid by an organization for an employee’s appointment, whether that individual’s time is spent on research, teaching, patient care, or other activities. 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. (See “Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages.”)

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

The 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. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet this definition. “Zero percent” effort or “as needed” is not an acceptable level of involvement for key personnel.

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 IC. 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 of the application, award, and post-award administration.

monitoring

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

new investigator

An individual who has not previously served as a PI on any PHS-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 applies for or receives an NIH grant or cooperative agreement.

other support

Includes all financial resources, whether Federal, non-Federal, commercial or organizational, available in direct support of an individual’s research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts.

Phase III clinical trial

As defined by NIH, a broadly based prospective Phase III clinical investigation (usually involving several hundred or more human subjects) to evaluate an experimental intervention in comparison with a standard or control intervention or to compare two or more existing treatments. 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 also are included. (See “clinical trial.”)

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 and NIH for the proper conduct of the project or activity.

prior approval

Written approval from the designated GMO required for specified post-award changes in the approved project or budget. Such approval must be obtained before undertaking the proposed activity or spending NIH funds (see “Administrative Requirements—Changes in Project and Budget—Prior-Approval Requirements”).

priority score

A numerical rating of an application that reflects the scientific merit of the proposed research relative to stated evaluation criteria.

profit

See “fee.”

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 the NIHGPS, “program” refers to those NIH programs that carry out their missions 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 (see “Administrative Requirements—Management Systems and Procedures—Program Income”).

Program Official

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

progress report

Periodic, usually annual, 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 period

The total time for which support of a project has been programmatically approved. The total project period comprises the initial competitive segment, any subsequent competitive segments resulting from a competing continuation award, and non-competing 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

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. Also termed “research and development.”

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 SBA at 13 CFR 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 HHS’s general administrative requirements for grants and the NIHGPS.

stipend

A payment made to an individual under a fellowship or training grant in accordance with preestablished 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. This meaning of the term “suspension” differs from that used in conjunction with the debarment and suspension process (see “Public Policy Requirements and Objectives—Ethical and Safe Conduct in Science and Organizational Operations—Debarment and Suspension” and “Administrative Requirements—Enforcement Actions.”)

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 NGA may include both standard and special conditions that are considered necessary to attain the grant’s objectives, facilitate post-award 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 F&A 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.

United States

The 50 States, territories, and possessions of the United States, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the District of Columbia.

withholding of support

A decision by NIH not to make a non-competing continuation award within the current competitive segment.

 


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