The cost of an asset, including the cost to put it in
place. When used with equipment (capital expenditure), the term means the net
invoice price of property or supplies including cost of modifications,
attachments, accessories, or auxiliary apparatus necessary to make the
property usable for the purpose for which it was acquired. Other charges,
such as the cost of installation, transportation, taxes, duty, or protective
in-transit insurance, are included or excluded from the unit acquisition cost
in accordance with the recipient's regular accounting practices. It does not
include costs for rental of property or alteration and rental of real
A 3-character code used to identify a specific category of
extramural research activity, applied to various funding mechanisms. NIH uses
three funding mechanisms for extramural research awards: grants, cooperative
agreements and contracts. Within each funding mechanism, NIH uses 3-character
activity codes (e.g., F32, K08, P01, R01, T32, etc.) to differentiate the
wide variety of research-related programs NIH supports. A comprehensive list
of activity codes is on the NIH Web site at http://grants.nih.gov/grants/funding/ac_search_results.htm.
A use of program income earned during or after the project
period that permits income that is generated under a grant to be added to
funds committed to the project by the Federal awarding agency and recipient
and used to further eligible project or program objectives. (See definitions
for deductive alternative and cost sharing or matching alternative and Administrative
Requirements—Management Systems and Procedures—Program Income.)
The general business management practices that are common to the administration of all grants, such
as financial accountability, reporting, equipment management, and retention
A request for (or the award of) additional funds during a
current project period to provide for an increase in costs due to unforeseen
circumstances. All additional costs must be within the scope of the peer
reviewed and approved project.
A payment made to a recipient before the
recipient disburses the funds for program purposes.
The process of assigning costs to one or more
cost objectives, in reasonable and realistic proportion to the benefit
provided or other equitable relationship. For additional information, see Cost Considerations—The Cost Principles.
A cost incurred by a recipient that is: (1) reasonable for
the performance of the award; (2) allocable; (3) in conformance with any
limitations or exclusions set forth in the Federal cost principles applicable
to the organization incurring the cost or in the NoA as to the type or amount of cost; (4) consistent with regulations, policies,
and procedures of the recipient that are applied uniformly to both federally
supported and other activities of the organization; (5) accorded consistent
treatment as a direct or indirect cost; (6) determined in accordance with
generally accepted accounting principles; and (7) not included as a cost in
any other federally supported award (unless specifically authorized by
For additional information on each, see Cost Considerations—The Cost Principles.
|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. See also
definitions for Major A&R and Minor A&R.
|applicable clinical trial
Applicable clinical trial is the term used in
Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007
(P.L. 110-85) to designate the scope of trials that may be subject to the
registration and reporting requirements in FDAAA. Applicable clinical trials
generally include interventional studies (with one or more arms) of drugs,
biological products, or devices that are subject to FDA regulation, meaning
that the trial has one or more sites in the U.S., involves a drug, biologic,
or device that is manufactured in the U.S. (or its territories), or is
conducted under an investigational new drug application (IND). For the
complete statutory definition and more detailed information see http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm.
Those receipts that offset or reduce direct
or indirect costs. Typical examples of such transactions include purchase
discounts, rebates, or allowances; recoveries or indemnities on losses,
insurance refunds; and adjustments of overpayments or erroneous charges.
A request for financial support of a project or activity
submitted to NIH on specified forms and in accordance with NIH instructions.
Information and Processes for detailed information
about the application process, including an explanation of the types of
The statute that provides the authority for Federal
agencies to incur obligations to and make payments out of the
U.S. treasury for specified purposes.
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 NoA 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
A certification by an applicant, normally included with
the application or State plan, indicating that the entity is in compliance
with, or that it will abide by, a particular requirement if awarded a Federal
The process of resolving audit findings, including those
related to management and systems deficiencies and monetary findings (that
is, questioned costs).
|authorized organization representative
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 individual is equivalent to the
signing official in the eRA Commons, i.e., holds
the SO Role.
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.
The NIH IC responsible for the award, administration, and
monitoring of grant supported activities.
The intervals of time (usually 12 months each) into which
a project period is divided for budgetary and funding purposes.
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
Unobligated Federal funds remaining at the end of any
budget period that, with the approval of the GMO or under an automatic
authority, may be carried forward to another budget period to cover allowable
costs of that budget period (whether as an offset or additional
authorization). Obligated, but unliquidated, funds
are not considered carryover.
|change in scope
An activity whereby the objectives or specific aims
identified in the approved grant application are significantly changed by the
grantee after award. GMO prior approval is required for a change in scope to
be allowable under an award. See Administrative
Requirements—Changes in Project and Budget—Prior Approval Requirements—Change
of Scope for additional information.
|change of grantee organization
Transfer of the legal and administrative responsibility
for a grant-supported project or activity from one legal entity to another
before the expiration of the approved project period (competitive segment).
|change of PD/PI
A process, usually initiated by the grantee, whereby the
federally approved PD/PI is replaced by another individual, with the approval
of the GMO.
|Chief Grants Management Officer
The Grants Management Officer within an awarding agency
who is the principal Grants Officer in the agency. The Chief Grants
Management Officer provides leadership to an organizational component that is
responsible for the business and fiscal management of an IC's grant
portfolio. Generally, the CGMO will have the authority to appoint and
exercise line authority over one or more GMOs. At NIH each awarding component
has a CGMO.
Research with human subjects that is:
- Patient-oriented research. Research conducted with
human subjects (or on material of human origin such as tissues, specimens,
and cognitive phenomena) for which an investigator (or colleague) directly
interacts with human subjects. Excluded from this definition are in vitro
studies that utilize human tissues that cannot be linked to a living
individual. It includes:
- mechanisms of human disease
- clinical trials
- development of new technologies
- Epidemiological and behavioral studies.
- Outcomes research and health services research.
Studies falling under 45 CFR part 46.101(b) (4) (Exemption 4)
are not considered clinical research by this definition.
A prospective 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. Behavioral human subjects research
involving an intervention to modify behavior (diet, physical activity,
cognitive therapy, etc.) fits this definition of a clinical trial. Human
subjects research to develop or evaluate clinical laboratory tests (e.g.,
imaging or molecular diagnostic tests) might be considered to be a clinical
trial if the test itself imposes more than minimal risk for the subjects.
Biomedical clinical trials of an experimental drug,
treatment, device, or behavioral intervention may proceed through four
Phase I. Tests a new biomedical intervention in a
small group of people (e.g. 20-80) for the first time to determine efficacy
and evaluate safety (e.g., determine a safe dosage range and identify side
Phase II. Study the biomedical or behavioral intervention
in a larger group of people (several hundred) to determine efficacy and
further evaluate safety.
Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of
people (from several hundred to several thousand) by comparing the intervention
to other standard or experimental interventions as well as to monitor adverse
effects, and to collect information that will allow the interventions to be
Phase IV. Studies conducted 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.
The process by which a Federal awarding agency determines that
all applicable administrative actions and all required work under an award
have been completed by the grantee and the Federal awarding agency.
|Code of Federal Regulations
The codified regulations of the Federal government based
on the final agency regulations published in the Federal Register.
The Federal agency which, on behalf of all Federal
agencies, is responsible for: reviewing, negotiating, and approving cost
allocation plans, indirect cost rate and similar rates; monitoring non-Federal
audit reports; conducting Federal audits as necessary; and resolving
cross-cutting audit findings. The cognizant agency
under the applicable cost principles and under OMB Circular A-133 may be
different for a given recipient.
An individual involved with the PD/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 senior/key
personnel. The designation of a co-investigator, if applicable,
does not affect the PD/PI's roles and responsibilities as specified in the
NIHGPS, nor is it a role implying multiple PD/PI.
A request for (or the award of) additional funds during a
current project period to support new or additional activities which are not
identified in the current award that reflect an expansion of the scope of the
grant-approved activities. Competitive revisions require peer review.
The initial project period recommended for support (up to
5 years) or each extension of a project period resulting from a renewal
|conference (domestic or international)
A symposium, seminar, workshop, or any other organized and
formal meeting, whether conducted face-to-face or via the Internet, where
individuals assemble (or meet virtually) to exchange information and views or
explore or clarify a defined subject, problem, or area of knowledge, whether
or not a published report results from such meeting.
A grant whose purpose is to support activities related to
the conduct of a conference(s) or defined set of conference-related
|conflict of interest
Conflict of Interest is a cross-cutting issue that affects
many policy areas such as peer review, financial conflict of interest, and
responsible conduct of research. There are different uses of this term
throughout this document. It generally means that a competing personal
interest could affect, or could appear to affect, an individual's judgment or
could cause the individual's impartiality to be questioned. Conflicts of
Interest (actual or potential) may arise in the objective review process or
in other activities or phases of the financial assistance process. See also Financial Conflict of Interest for a
specific definition covering that policy area.
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. These agreements typically
involve a specific level of effort from the consortium organization's PD/PI
and a categorical breakdown of costs, such as personnel, supplies, and other
allowable expenses, including F&A costs. The relationship between the
recipient and the collaborating organizations is considered a relationship. (See Consortium Agreements chapter in IIB.)
Construction of new buildings or the modernization of, or
completion of shell space in, existing buildings (including the installation
of fixed equipment, but excluding the cost of land acquisition and off-site
improvements). The construction of shell space is not allowable as a
construction activity since shell space does not provide usable space for
research activities. Expansion, new construction, or activities that would
change the "footprint" of an existing facility (e.g., relocation of existing
exterior walls, roofs, or floors, attachment of fire escapes) is considered
construction. See Construction chapter in IIB.
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. To prevent apparent or actual conflicts of
interest, grantees and consultants must establish written guidelines
indicating the conditions of payment of consulting fees. Consultants also
include firms that provide professional advice or services. (See Cost Considerations—Allowability of Costs/Activities—Selected Items of
When multiple PD/PIs are designated, NIH requires that the
applicant organization identify one of the PD/PIs as the Contact PD/PI to
serve as a primary point of contact. Serving as Contact PD/PI confers no
special authorities or responsibilities within the project team. The Contact
PD/PI must meet all eligibility requirements for PD/PI status. However, as
with the single PD/PI model, if the Contact PD/PI is not an employee, the
applicant organization must have a formal written agreement with the Contact
PD/PI that specifies an official relationship between the parties. See Multiple PI chapter
in IIB for additional information.
An award instrument used to acquire from a non-federal
party, by purchase, lease, or barter, property or services for the direct
benefit or use of the Federal government. The same term may be used to
describe a vendor relationship between a recipient and another party under a
grant (to acquire routine goods and services); however, the recipient may use subaward to describe the contract under a grant
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.
Any amount charged in excess of the Federal share of costs
for the project period (competitive segment).
The government-wide principles, issued by OMB (or, in the
case of commercial organizations, the Federal Acquisition Regulation [48 CFR
part 21], or, in the case of hospitals, 45 CFR part 74, Appendix E,
"Principles For Determining Costs Applicable to Research and Development
Under Grants and Contracts with Hospitals"), on allowability and unallowability of costs under federally
sponsored agreements. See Cost
Considerations—The Cost Principles for additional details.
See matching or cost sharing definition.
cost sharing or matching alternative
An alternative use of program income whereby income
accrued during the period of grant support may be used to satisfy a cost
sharing or matching requirement. (See also definitions for additive alternative and deductive alternative and Administrative Requirements—Management Systems and
|data and safety monitoring plan
For each NIH-supported clinical trial, NIH requires a data
and safety monitoring plan that will provide oversight and monitoring to
ensure the safety of participants and the validity and integrity of the data.
The level of monitoring should be commensurate with the risks and the size
and complexity of the clinical trial. A detailed data and safety monitoring
plan must be submitted to the applicant's IRB and subsequently to the
awarding IC for approval prior to the accrual of human subjects.
|debarment and suspension
The actions taken by a debarring official in accordance
with OMB guidance at 2 CFR part 180, "Non-procurement Debarment and
Suspension," as implemented by HHS in 2 CFR part 376, to exclude a person or
organization from participating in grants and other non-procurement awards
government-wide. If debarred or suspended, the person or organization may not
receive financial assistance (under a grant, cooperative agreement, or subaward, or contract under a grant) for a specified
period of time. Debarments and suspensions carried out pursuant to 2 CFR part
376 are distinct from post-award suspension action by an awarding agency.
(See also Public Policy Requirements and
Objectives—Debarment and Suspension.)
The process of collecting funds owed by recipients to the
Federal government, which, under grants, generally are owed as a result of
formal cost disallowances.
A document used to record a legal obligation of one party
to pay a financial obligation to another in accordance with predetermined
terms and conditions.
An alternative for the use of program income earned during
the period of grant support under which allowable costs of the project or
program to be paid by the Federal government are offset by the amount of the
program income. (See also definitions for additive
alternative and cost sharing or matching
alternative and Administrative
Requirements—Management Systems and Procedures—Program Income.)
A departure on a single-case or class basis from a
regulatory or policy requirement. A single-case deviation represents a
request for waiver or exception sought for one grant only that arises on a
case-by-case basis. A class deviation involves more than one grant for which
the same type of deviation action is being requested.
Costs that can be identified specifically with a
particular sponsored project, an instructional activity, or any other
institutional activity, or that can be directly assigned to such activities
relatively easily with a high degree of accuracy.
A charge to a grant that the Federal awarding agency
determines to be unallowable in accordance with the applicable Federal cost
principles or other terms and conditions contained in the award.
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
A nine-digit number established and assigned by Dun and
Bradstreet to uniquely identify a business entity.
|Entity Identification Number
A three-part coding scheme of 12 characters used in PMS to
identify organizations and individuals. The first character identifies the
recipient as an organization or an individual. The next nine characters are
the Employer Identification Number. The last two characters are a suffix to
provide distinction between organizational entities that are assigned a
single EIN and those that have more than one.
An individual who is classified as a New Investigator and
is within 10 years of completing his/her terminal research degree or is
within 10 years of completing medical residency (or the equivalent) is
considered an Early Stage Investigator (ESI). See definition of New Investigator.
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.
|Excluded Parties List System
A public database maintained by the General Services
Administration which is the official government-wide system of record for
debarments, suspensions, and other exclusionary actions. (see also Public Policy Requirements and
Objectives—Debarment and Suspension.)
The Electronic Research Administration (eRA) Commons is a virtual meeting place where NIH
extramural grantee organizations, grantees, and the public can receive and
transmit information about the administration of biomedical and behavioral
research. The eRA Commons is divided into both
unrestricted and restricted portions that provide for public and confidential
Operating authorities provided in Federal Administrative
Regulations (e.g., A-110) to grantees that waive the requirement for prior
approval for specified actions. NIH extended expanded authorities to all NIH
awards except for the provision to automatically carry over unobligated
balances thus these authorities have become the NIH Standard Terms of Award.
Therefore, the term Expanded Authorities is no longer used at NIH (see Administrative Requirements—Changes
in Project and Budget—NIH Standard Terms of Award).
Generally, the date signifying the end of the current
project period, after which the grantee is not authorized to obligate grant
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 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.
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.
When used in conjunction with the acquisition of real
property, equipment, or supplies under an award (whether paid by Federal
funds or satisfying some or all of a matching or cost sharing requirement),
the dollar amount that is the product of the Federal share of project costs
multiplied by the current fair market value of the property.
The amount, generally expressed both in dollars and as a
percentage of the total approved budget for a project or program, whether
provided as funds, property, or direct assistance provided by the Federal
government. The Federal share and any non-Federal share are so noted in the NoA.
The Federalwide Assurance is the
only type of new assurance of compliance accepted and approved by OHRP for
institutions engaged in non-exempt human subjects research conducted or
supported by HHS. Under a FWA, an institution commits to HHS that it will
comply with the requirements set forth in 45 CFR part 46, as well as the terms of assurance.
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.)
Transfer by NIH of money or property to an eligible entity
to support or stimulate a public purpose authorized by statute.
|financial conflict of interest
A financial conflict of interest exists when the grantee's
designated official(s) reasonably determines that an investigator's
significant financial interest could directly and significantly affect the
design, conduct, or reporting of the PHS-funded research. See 42 CFR part 50, Subpart F, Responsibility of Applicants for Promoting
Objectivity in Research for which PHS funding is sought and Public Policy Requirements and
Objectives—Financial Conflict of Interest.
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. A for-profit organization is considered to
be a small business if it is independently owned and operated, if it is not
dominant in the field in which research is proposed, and if it employs no
more than 500 persons. (Also see definition for small
For-profit organizations also are referred to as "commercial organizations."
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 chapter in IIB.)
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 PD/PI.
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.
|funding opportunity announcement
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. Funding opportunity
announcements may be known as program announcements, requests for
applications, notices of funding availability, solicitations, or other names
depending on the Agency and type of program. Funding opportunity
announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts.
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.
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 NoA. The grantee is legally responsible and accountable to NIH for the performance and financial
aspects of the grant-supported project or activity. Also known as awardee or recipient.
has been designated by the Office of Management and Budget as the single
access point for all grant programs offered by 26 Federal grant-making
agencies. It provides a single interface for agencies to announce their grant
opportunities and for all applicants to find and apply for those
|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. See also Chief Grants Management Officer definition. The Chief Grants Management
Officer is the principal Grants Management Officer who provides leadership to
an organizational component that is responsible for the business and fiscal
management of an IC's grant portfolio. Generally, the CGMO will have the
authority to appoint and exercise line authority over one or more GMOs.
|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.
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.
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 Public Policy Requirements and Objectives—Human Subjects Protections.)
The impact/priority score is the rating which is assigned
to an individual application by an SRG, and designates the reviewers'
assessment of the likelihood for the project to exert a sustained, powerful
influence on the research field(s) involved, in consideration of established
review criteria. The impact/priority score is one mechanism by which the SRG
makes a recommendation to the funding component concerning the application's
scientific and technical merit. Impact/priority scores may be numeric (10 – 90) or alphabetical (ND, for example).
|investigational new drug
A new drug or biological drug that is used in a clinical investigation.
and administrative costs definition.
Something new or improved, including research for (1)
development of new technologies, (2) refinement of existing technologies, or
(3) development of new applications for existing technologies. For the
purposes of PHS programs, an example of innovation would be new medical or
biological products for improved value, efficiency, or costs.
|Institute or Center
The NIH organizational component responsible for a
particular grant program or set of activities. The terms "NIH IC," or "awarding IC" 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.
|Institutional Animal Care and Use Committee
The PHS Policy on Humane Care and Use of
Laboratory Animals incorporates the U.S. Government Principles for the Utilization and Care of
Vertebrate Animals used in Testing, Research, and Training, and
requires the grantee to maintain an animal care and use program based on the
Guide for the Care and Use of Laboratory Animals. An Institutional Animal
Care and Use Committee (IACUC) appointed by the Chief Executive Officer or
designee, is federally mandated to oversee the institution's animal program,
facilities, and procedures (Public Law 99-158, Sec. 495). IACUC review and
approval is required for all PHS supported activities involving live
vertebrate animals prior to funding.
|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 may be 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 Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost—Salaries and Wages.)
|Institutional Review Board (IRB)
An administrative body established to protect the rights
and welfare of human research subjects recruited to participate in research
activities conducted under the auspices of the organization with which it is
affiliated. The Institutional Review Board has the authority to approve,
require modifications in, or disapprove all research activities that fall
within its jurisdiction.
Property that does not have physical existence. The term
includes copyrights, patents, and other intellectual property generated or
developed under awards. It also includes copyrights for which assignments of
rights are acquired under awards; patents and other intellectual property for
which ownership is acquired under awards; loans, notes, and other debt
instruments (even if considered tangible for some purposes); lease
agreements; and stock and other instruments of property ownership.
|Intergovernmental Personnel Act (IPA)
The Intergovernmental Personnel Act Mobility
Program provides for the temporary assignment of personnel between the
Federal Government and state and local governments, colleges and
universities, Indian tribal governments, federally funded research and
development centers, and other eligible organizations. The goal of the
Intergovernmental Personnel Act mobility program is to facilitate the
movement of employees, for short periods of time, when this movement serves a
sound public purpose.
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
The requirement pursuant to 37 CFR part 401 that
recipients of contracts, grants or cooperative agreements fully disclose any
subject inventions made during the performance of work under a funding
agreement in order to protect the Federal government's rights.
Research funded as a result of an investigator, on his or
her own, submitting a research application. Also known as unsolicited
research. Unsolicited applications are reviewed by chartered CSR review
Institutional Profile File (IPF) number is a unique number
used by NIH for tracking/reporting awards to grantee institutions.
NIH policy allows the submission of certain elements of a
competing application to be deferred until later in the application process,
after review when the application is under consideration for funding. Within
the Status module of the eRA Commons, users will
find a feature to submit Just-In-Time information when requested by the NIH.
Through this module, institutions can electronically submit the information
that is requested after the review, but before award. See Completing
the Pre-Award Process—Just-In-Time Procedures for additional
An amount defined in a contract and chargeable against funds
due to the contractor for each day the contractor fails to complete the
project beyond the contract completion date.
An A&R project under a grant whose primary purpose is
other than construction or modernization, including a project involving
modernization, improvement or remodeling, exceeding $500,000 in direct costs
awarded for the project. Major A&R may include improvement,
conversion, rearrangement, rehabilitation or remodeling. Major A&R does
not apply to minor alterations, renovations or repairs funded under a
research project grant or alterations or renovations funded under an NIH
center grant. Major A&R is an unallowable activity or cost under foreign
grants and foreign components in domestic grants.
|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 statute
or program regulation. Costs used to satisfy matching or cost-sharing
requirements are subject to the same policies governing allowability as other costs under the approved budget.
Extramural research awards are divided into three main
funding mechanisms: grants, cooperative agreements and contracts. A funding mechanism is the type of
funded application or transaction used at the NIH. Within each funding
mechanism NIH includes programs. Programs can be further refined by specific activity codes.
A legal action resulting in the unification of two or more
legal entities. When such an action involves the transfer of NIH grants, the
procedures for the recognizing a successor-in-interest will apply. When the
action does not involve the transfer of NIH grants, the procedures for
recognizing a name change will apply.
An A&R project under a grant whose primary purpose is
other than construction or modernization, including a project involving
improvement or remodeling, which does not exceed $500,000 in direct costs.
Minor A&R is not an allowable activity or cost under grants to
individuals or grants for limited purposes, such as grants in support of
scientific meetings (conference grants). Routine maintenance and repair of
the organization's physical plant or its equipment is not considered A&R;
these types of costs are typically treated as F&A costs.
Alteration, renovation, remodeling, improvement,
expansion, and/or repair of an existing building and the provision of
equipment necessary to make the building suitable for use for the purposes of
a particular program. The entire purpose of the modernization grant is to
modernize biomedical research facilities and not to support the conduct of
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.
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.
An action whereby the name of an organization is changed
without otherwise affecting the rights and obligations of that organization
as a grantee.
A PD/PI who has not previously competed successfully as a
PD/PI for a substantial independent research award is considered a New
Investigator. For example, a PD/PI who has previously received a competing
NIH R01 research grant is no longer considered a New Investigator. However, a
PD/PI who has received a Small Grant (R03) or an Exploratory/Developmental
Research Grant Award (R21) retains his or her status as a New Investigator. A
complete list of NIH grants that do not disqualify a
PD/PI from being considered a New Investigator can be found at http://grants.nih.gov/grants/new_investigators/resources.htm.
See also the definition of Early Stage Investigator.
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
|non-competing continuation application/award
A financial assistance request (in the form of an
application or progress report) or resulting award for a subsequent budget
period within a previously approved project period for which a recipient does
not have to compete with other applicants.
When cost sharing or matching is required as a condition
of an award, the portion of allowable project/program costs not borne by the
Any corporation, trust, association, cooperative, or other
organization that is operated primarily for scientific, educational, service,
charitable, or similar purposes in the public interest; is not organized for
profit; and uses net proceeds to maintain, improve, or expand the operations of
the organization. Non-profit organizations include institutions of higher
education, hospitals, and tribal organizations (that is, Indian entities
other than federally recognized Indian tribal governments).
|Notice of Award
The official, legally binding document, signed (or the
electronic equivalent of signature) by a Grants Management Officer that:
- notifies the recipient of the award of a grant;
- contains or references all the terms and conditions of
the grant and Federal funding limits and obligations; and,
- provides the documentary basis for recording the obligation of Federal funds in the NIH accounting
The amounts for which the recipient has made binding
commitments for orders placed for property and services, contracts and subawards, and similar transactions during a funding
period that will require payment during the same or a future period.
A process that involves the thorough and consistent
examination of applications based on an unbiased evaluation of scientific or
technical merit or other relevant aspects of the proposal. The review is
performed by persons expert in the field of endeavor for which support is
requested, and is intended to provide advice to the individuals responsible
for making award decisions. (See also The
Peer Review Process.)
Government-wide guidance issued to Heads of Federal
agencies by the Director of OMB. OMB Circulars directly pertinent to grants
include the following:
- cost principles (OMB Circular A-21, OMB Circular A-87, and OMB Circular A-122). See Cost Considerations—The Cost Principles for additional information;
- uniform administrative requirements (OMB Circular A-102 and OMB Circular A-110);
- audit requirements for non-profit organizations (OMB Circular A-133). See Monitoring—Audit for additional information.
Some (but not all) of these OMB Circulars have been
reissued in Title 2 of the Code of Federal Regulations.
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.
Individuals who have committed to contribute to the
scientific development or execution of the project, but are not committing
any specified measurable effort (i.e., person months) to the project. These
individuals are typically presented at "effort of zero person months" or
"as needed." Individuals with measurable effort may not be listed
as Other Significant Contributors (OSCs). Consultants should be included if
they meet this definition.
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.
NIH-wide FOA enabling applicants to electronically submit an investigator-initiated grant application for a specific activity code, e.g., Research Project Grant (Parent R01).
Requirement that the recipient of a NRSA postdoctoral
fellowship engage in qualified research or teaching activities for a length
of time equal to the period of NRSA support received. Only the first year of
training incurs a payback obligation. In general, payback activity must
involve at least 20 hours per week and be conducted over 12 consecutive
months; special exceptions may be considered on a case-by-case basis. See Ruth L. Kirschstein National Research Service Awards—Payback for additional information.
|Payment Management System
The HHS centralized grants payment system operated by the
Division of Payment Management, Program Support Center.
Most HHS (and some other Federal government agencies') recipients receive
grant payments through this system.
A form of objective review required by statute. It is an
assessment of scientific or technical merit of applications by individuals
with knowledge and expertise equivalent (peer) to that of the individuals
whose applications for support they are reviewing, that is, reviewers who are
the professional equals of the PD/PI for the proposed project and who often
are engaged or were previously engaged in comparable activities. See The Peer Review Process for additional
The metric for expressing the effort (amount of time)
PD/PI(s), faculty and other senior/key personnel devote to a specific
project. The effort is based on the type of appointment of the individual
with the organization; e.g., calendar year, academic year, and/or summer
term; and the organization's definition of such. For instance, some
institutions define the academic year as a 9-month appointment while others
define it as a 10-month appointment.
|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 also clinical trial definition.)
Any cost incurred prior to the beginning date of the
project period or the initial budget period of a competitive segment (under a
multi-year award), in anticipation of the award and at the applicant's own
risk, for otherwise allowable costs.
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
See definition for fee.
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 Director/ Principal Investigator
The individual(s) designated by the applicant organization
to have the appropriate level of authority and responsibility to direct the
project or program to be supported by the award. The applicant organization
may designate multiple individuals as program directors/principal
investigators (PD/PIs) who share the authority and responsibility for leading
and directing the project, intellectually and logistically. When multiple PD/PIs
are named, each is responsible and accountable to the applicant organization,
or as appropriate, to a collaborating organization for the proper conduct of
the project or program including the submission of all required reports. The
presence of more than one PD/PI on an application or award diminishes neither
the responsibility nor the accountability of any individual PD/PI.
Gross income earned by the grantee organization 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
The NIH official responsible for the programmatic,
scientific, and/or technical aspects of a grant.
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. This report may also be
called the non-competing continuation progress report.
Location(s) of where the work described in the research
plan will be conducted.
The total time for which Federal support of a project has
been programmatically approved as shown in the NoA;
however, it does not constitute a commitment by the Federal government to
fund the entire period. The total project period comprises the initial
competitive segment, any subsequent competitive segments resulting from a
renewal award(s), and extensions.
Land, including land improvements, structures, and
appurtenances, but not movable machinery and equipment.
The organizational entity or individual receiving a grant
or cooperative agreement. See also definition for grantee.
A request for assistance to extend for one or more
additional budget periods a project period that would otherwise expire.
Renewal applications compete for funds with other renewal applications,
revised (supplemental) and new applications. The previous NIH term was
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."
The Research Administrator acts as a local agent of the
SOR and/or PD/PIs providing day-to-day grant-related support. See also Roles and Responsibilities—Grantee Staff.
Fabrication, falsification, or plagiarism in proposing,
performing, or reviewing 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.
Responsible party is the term used in Title VIII of the
Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to
refer to the entity or individual who is responsible for registering a
clinical investigation and submitting clinical trial information to the
Clinical Trial Registry Data Bank. Responsible party is defined by the law as
the sponsor of the clinical trial or the PD/PI of such clinical trial if so
designated by a sponsor, contractor, grantee, or awardee,
so long as the PD/PI is responsible for conducting the trial and has
sufficient data rights. For the complete statutory definition and more
detailed information see http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm.
An application that has been previously submitted, but was
not funded, and is being resubmitted for new consideration. Applicants must
make significant changes to the application and can only resubmit once the
summary statement is available. Additional policies on resubmissions can be
found in the applicable Application Instruction Guide. The previous NIH term
was "revision." A resubmission has a suffix in its application
identification number, e.g., A1.
As defined in the Federalwide SF424 (R&R): An application that proposes a change in 1) the Federal
Government's financial obligations or contingent liability from an existing
obligation, or 2) any other change in the terms and conditions of the
existing award. Note in general for NIH applicants, #2 would not require the
submission of another application. NIH grantees use revision applications to request
an increase in support in a current budget period for expansion of the
project's approved scope or research protocol. Applicants must apply and
undergo peer review. The previous NIH term was "competing
supplemental." NOTE: The former NIH term "revision," is now
"resubmission". A revision has a suffix in its application identification
number; e.g., S1.
|scientific review group (SRG)
A scientific review group (SRG) is a peer review committee
group of primarily non-government experts (peer reviewers), qualified by
training or experience in particular scientific or technical fields, or as
authorities knowledgeable in the various disciplines and fields related to
the applications under review, to evaluate and give expert advice on the
scientific and technical merit of the applications. No more than one-fourth
of the members of any SRG may be Federal employees, as noted in 42 CFR part
|scientific review officer (SRO)
A scientific review officer (SRO) is the NIH official who
serves as the designated Federal official having legal responsibility for
managing the peer review meeting, the procedures for evaluating the
applications assigned to the SRG and the determinations and management of
conflicts of interest, as noted in 42 CFR part 52(h).
|scope of work
The aims, objectives, and purposes of a grant; as well as
the methodology, approach, analyses or other activities; and the tools,
technologies, and timeframes needed to meet the grant's objectives. This
includes the research or training plan included with the original grant
application, along with any approved modifications.
The PD/PI and other individuals who contribute to the
scientific development or execution of a project in a substantive, measurable
way, whether or not they receive salaries or compensation under the grant.
Typically these individuals have doctoral or other professional degrees,
although individuals at the masters or baccalaureate level may be considered
senior/key personnel if their involvement meets this definition. Consultants
and those with a postdoctoral role also may be considered senior/key
personnel if they meet this definition. "Zero percent" effort or "as needed"
is not an acceptable level of involvement for senior/key personnel.
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 part 121.
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.
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.
A legal instrument by which a recipient provides funds (or
property in lieu of funds) to an eligible subrecipient (or a lower-tier transaction) to perform a substantive portion of the
grant-supported program or project. The term includes such financial
assistance when provided by any legal agreement (even if the agreement is
called a contract) but does not include any form of assistance which is
excluded from the definition of grant, including the
recipient's procurement of property or services needed to carry out the
project or program. The term includes consortium agreements.
A party that receives a subaward from a recipient or another subrecipient under a
Federal financial assistance award and is accountable to the recipient or subrecipient for the use of the Federal funds provided by
Process whereby the rights to and obligations under an NIH
grant(s) are acquired incidental to the transfer of all of the assets of the
grantee or the transfer of that part of the assets involved in the
performance of the grant(s). A SII may result from legislative or other legal
action, such as a merger or other corporate change.
All personal property excluding equipment, intangible
property, debt instruments, and inventions of a contractor conceived or first
actually reduced to practice in the performance of work under a funding
agreement ("subject inventions"), as defined in 37 CFR part 401,
"Rights to Inventions Made by Non-profit Organizations and Small
Business Firms Under Government Grants, Contracts, and Cooperative
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—Debarment and Suspension and Administrative
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 NoA 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.
- For reports prepared on a cash basis, the amount of
obligations incurred by the recipient that has not been paid; or
- For reports prepared on an accrued expenditure basis,
the amount of obligations incurred by the recipient for which an outlay has
not been recorded.
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.
The portion of the funds authorized by the Federal agency
for expenditure by the recipient that has not been obligated by the
|withholding of support
A decision by NIH not to make a non-competing continuation
award within the current competitive segment.