Glossary

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Common Fund

The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund.

A

Account Administrator (AA)

An individual typically in the grantee organization's central research administration office designated by a SO to facilitate the administration of NIH eRA Commons accounts. The AA can create, modify and/or remove the necessary accounts for these types: AO, AA, FSR, PI or ASST. Although the AA can create additional accounts, the AA cannot modify institutional profile (IPF) information.

Activity Code

A 3-character code used to identify a specific category of extramural research activity, applied to financial assistance 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. Comprehensive List of Activity Codes

Additive Alternative

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 the NIH Grants Policy Statement: 8. Administrative Requirements 8.3 Management Systems and Procedures-Program Income

Administrative IC

The NIH Institute or Center (IC) to which the Center for Scientific Review (CSR) routes NIH grant applications for a funding decision. An IC may request to change this assignment if the application is more suited to another IC. Also referred to as primary assignment.

Administrative Official

In the eRA Commons, reviews the grant application for accuracy before the signing official submits the final application to the NIH.
  • May be the same person as the signing official.
  • Resides in either the central research administration office or academic departments.
  • Create additional AO and PI accounts
  • Not authorized to transmit applications to the NIH.
Has authority to review electronically submitted application before it moves on to CSR.

Administrative Requirements

The general business management practices that are common to the administration of all grants, such as financial accountability, reporting, equipment management, and retention of records. Uniform administrative requirements for grants are found in OMB Circular A-102 and OMB Circular A-110 (now found at 2 CFR Part 215).

Administrative Supplement

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.

Advance Payment

A payment that a Federal awarding agency or pass-through entity makes by any appropriate payment mechanism, including a predetermined payment schedule, before the non-Federal entity disburses the funds for program purposes.

Alien Registration - Card

Status as a permanent resident with a right to live and work permanently in the U.S. Commonly known as Green Card.

Animals in Research

Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. The generation of custom antibodies and animals obtained or euthanized for tissue harvest constitute activities involving vertebrate animals. To learn more about policies and guidance on the use of animals in PHS funded research, training, and testing, see the NIH Office of Laboratory Animal Welfare.

Applicable Credit

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.

Application Cycle

NIH accepts applications for most programs in three cycles. The applications received within a cycle are typically reviewed within the same council round. Many NIH Funding Opportunity Announcements are open for up to three years with standard due dates falling in each cycle.

Application Viewing Window

Once an error-free application is submitted through Grants.gov to eRA, the eRA system assembles an application image and posts it in the PD/PI's eRA Commons account. The PD/PI, delegated Assistants, Administrative Officials (AOs) and Signing Officials (SOs) have 2 business days to view the assembled application in eRA Commons - just as a reviewer would see it. The application viewing window is linked to the time of submission, not the due date. It begins the day after the assembled application image is posted in eRA Commons and excludes weekends and Federal holidays.
Within the viewing window, an SO can Reject the application and stop it from moving further in the process. After the viewing window, the application automatically moves forward for further consideration and the submission process is complete.

Approved Budget

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

Assistant Role (ASST)

In the NIH Commons the role designed to allow PIs to delegate certain responsibilities for data entry of grant information and upkeep of their personal profiles. The ASST does not have any other functions in the system.

Authorized Organization Representative (AOR)

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.

B

Basic Research

Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (CFR 272.3)

Bayh-Dole Act

The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212), implemented by 37 CFR 401, affords grantees the right to elect title and retain ownership to inventions they develop with funding under an NIH grant award. Under the regulations, grantees are required to report all subject inventions to the awarding agency, as well as include an acknowledgement of federal support in any patents.

Bilateral Agreement

A general science agreement between the U.S. and a foreign country. Grant applications from institutions in these countries that have been recommended for approval by the scientific review group are given special funding consideration by Council.

Bridge Awards

Bridge awards provide continued but limited interim support (bridge funding) for meritorious investigators who just miss the funding cutoff and have minimal support from other sources. The continued funding will permit the PD/PI additional time to strengthen a resubmission application. A Bridge award recipient usually will receive an R56 award for a single year. Investigators may not apply for R56 grants. Applications for conversion to an R56 will be selected by IC staff from reviewed applications that fall at or near the payline margins.

Budget Period

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

C

Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

See Common Rule definition of research at 45 CFR 46.102(d)

See Common Rule definition of human subject at 45 CFR 46.102(f)

The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.

A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life

Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:

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 effects).

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 used safely.

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.

Close Date or Closing Date

The Close Date of a funding opportunity announcement is the date the funding agency lists in Grants.gov as the last submission due date for the announcement.

Cluster of Programs

A grouping of closely related programs that share common compliance requirements. The types of clusters of programs are research and development (R&D), student financial aid (SFA), and other clusters. "Other clusters" are as defined by OMB in the compliance supplement or as designated by a state for Federal awards the state provides to its sub-recipients that meet the definition of a cluster of programs. When designating an "other cluster," a state must identify the Federal awards included in the cluster and advise the sub-recipients of compliance requirements applicable to the cluster, consistent with 45 CFR § 75.352(a). A cluster of programs must be considered as one program for determining major programs, as described in 45 CFR § 75.518, and, with the exception of R&D as described in 45 CFR § 75.501(c), whether a program-specific audit may be elected.

Co-funding

Funding arrangement through which two or more Institutes or Centers share in the funding of a grant.

Commitment Base

Funds used for non-competing (type 5 or ongoing awards), typically 70-80 percent of the dollars spent for research project grants.

Common Fund

The NIH Common Fund supports cross-cutting, trans-NIH programs, including those referred to as NIH Roadmap programs. See The NIH Common Fund.

Competitive Revision

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.

Consortium Agreement

A formalized agreement whereby a research project is carried out by the recipient and one or more other organizations that are separate legal entities. Under the agreement, the recipient 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 subaward relationship. (See the NIH Grants Policy Statement: 15 Consortium Agreements).

Contract Transaction Types

Type 1 New contract
Type 2 Renewal
Type 3 Modification
Type 4 Letter contract
Type 5 Continuation of an incrementally (typically, in one year increments) funded contract
Type 6 Task orders and subsequent modifications relating to existing ordering agreements
Type 7 Exercise of option

Cooperative Research and Development Agreement

Any agreement between one or more NIH laboratories and one or more non-Federal parties under which the PHS, through its laboratories, provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-Federal parties) and the non-Federal parties provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory.

Covered Small Business Concern

For purposes of the SBIR/STTR programs, a small business concern that:
  1. Was not majority-owned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms on the date on which it submitted an application in response to a solicitation under the SBIR program; and
  2. Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.

Credential Field

Credential is a field on Grants.gov's R&R Senior/Key Person Profile form which is part of every competing grant application submitted through Grants.gov to NIH. Including the eRA Commons ID for the PD/PI, any multi-PD/PIs and Project Leads (for multi-project application components) is an NIH requirement and is critical to our ability to post errors, warnings and the assembled application image in eRA Commons. The credential field is not marked required on the federal-wide form since not all agencies that use the form need this field. NIH uses the Health and Human Services logo within the application guide to flag agency-specific instructions and clarifications for fields on federal-wide forms. Pay special attention to the HHS logo or you may miss key NIH requirements.

Cumulative Inclusion Enrollment Report

The Cumulative Inclusion Enrollment Report is used to report the sex/gender, race, and ethnicity of the actual participants that have been enrolled in the study or if an applicant is proposing a new study using an existing dataset/resource where the participants have already been enrolled.For more details about completing these forms, please see the Supplemental Instruction Guide

D

Data and Safety Monitoring Plan

Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

Debt Collection

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.

Delayed Start

Research plans can be described at time of application, but research will not immediately begin (will occur later in the funding period)

Departmental Grants Appeals Board

The independent office established in the Office of the Secretary with delegated authority from the Secretary to review and decide certain disputes between recipients of HHS funds and HHS awarding agencies under 45 CFR Part 16 and to perform other review, adjudication and mediation services as assigned.

Disaggregated Application

An application with a portion (or subproject) funded as a separate grant.

Domestic Organization

A public (including a State or other Governmental Agency) or private non-profit or for-profit organization located in the United States or its territories which is subject to U.S. laws and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.

Dual Assignments

Applications simultaneously assigned to two Institutes, Centers, or Divisions. The primary Institute has complete responsibility for administering and funding the application; the secondary assumes this responsibility only if the primary is unable or unwilling to support it.

Dual Review System

Peer review process used by NIH. The first level of review provides a judgment of scientific merit. The second level of review (usually conducted by an ICD's advisory Council) assesses the quality of the first review, sets program priorities, and makes funding recommendations.

E

Electronic Streamlined Non-Competing Award Process (eSNAP)

Electronic submission of a Non-Competing continuation progress report, through the eRA Commons, for an award subject to the SNAP (Streamlined Non-Competing Award Process) provisions. Use of eSNAP is mandatory for SNAP awards (see NOT OD-10-093).

Enrollment Data

Provides race and ethnicity data for the cumulative number of human subjects enrolled in an NIH-funded clinical research study since the protocol began. This data is provided in competing continuation applications and annual progress reports.

eRA Commons

The Electronic Research Administration (eRA) Commons is a virtual meeting place where NIH extramural recipient organizations, recipients, 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 information, respectively.

Expiration Date

In context of awarded grant:
The date signifying the end of the current project period, after which the grantee is not authorized to obligate grant funds.

In context of funding opportunity announcement key dates:
The day after the last submission due date for the announcement. As of the Expiration Date, the announcement is no longer active and applications will not be accepted unless either the late policy or system issue policy apply.

Extramural Awards

Funds provided by the NIH to researchers and organizations outside the NIH.

F

Facilities and Administrative (F&A) Costs (or indirect costs)

Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)

Fast Track

The simultaneous submission and concurrent review of a combined Phase I/Phase II SBIR or STTR grant application. This option is intended to reduce/eliminate the funding gap between SBIR/STTR Phase I and Phase II projects.

Federal Demonstration Partnership (FDP)

A cooperative initiative among some Federal agencies, including NIH, selected organizations receiving Federal funding for research, and certain professional organizations. Its efforts include demonstration projects intended to simplify and standardize Federal requirements in order to increase research productivity and reduce administrative costs.
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021