Glossary

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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)

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

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.
Includes: (1) projects relating to the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS; (2) various sequelae specifically associated with the syndrome; and (3) preparation and screening of anti-AIDS agents as well as vaccine development, including both preclinical and clinical studies. Not all applications examining various influences on T-lymphocytes or retroviruses will be appropriate for the expedited AIDS review process. Applications only indirectly related to AIDS will be evaluated by established Scientific Review Groups (SRGs) appropriate to the scientific discipline during regular NIH review cycles and should not be submitted in response to the expedited AIDS receipt dates. Applicants are urged to take note of the yearly NIH Plan for HIV-Related Research and indicate how their application addresses the NIH priorities set forth in that Plan. The Plan can be found on the NIH Office of AIDS Research homepage

Ancillary Study

An ancillary study is an adjunctive or supplemental study to an ongoing study. An ancillary study may or may not be a clinical trial. Determine whether an ancillary study is a clinical trial by answering the four questions that define NIH clinical trials based on the information about the ancillary study alone, regardless of the clinical trial status of the parent trial. An ancillary clinical trial is a trial for which the answer to the four questions is "Yes".

An ancillary clinical trial to a larger clinical trial may be considered an independent clinical trial if it includes an additional intervention to patients or a sub-population of patients within the larger clinical trial. An example of an ancillary study that is not a clinical trial could be research which involves analyses of stored samples collected in an ongoing clinical trial but no additional intervention to the human subjects/patients.

Animal Welfare Assurance

Document an institution and all performance sites involving animals in research must have on file with the Office of Laboratory Animal Welfare before a PHS Agency may award a grant or contract.

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.

Application Submission System & Interface for Submission Tracking (ASSIST)

The Application Submission System & Interface for Submission Tracking (ASSIST) is a web-based system used to prepare grant applications using the SF424 Research & Related form set and to submit electronically through Grants.gov to NIH and other participating agencies. See Preparing Your Application Using ASSIST.

AREA

Academic Research Enhancement Award

B

Basic Experimental Studies with Humans

Studies that prospectively assign human participants to conditions and that assess biomedical or behavioral outcomes in humans to better understand aspects of phenomena without specific application towards processes or products in mind.

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)

Bioengineering Consortium

The focus of bioengineering issues at the NIH which consists of senior-level representatives from each of the NIH Institutes, Centers, and Divisions plus representatives of other Federal Agencies concerned with biomedical research and development. Go to Bioengineering Consortium (BECON).

C

Center Grants

Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.

Clinical Research

Research with human subjects that is:

1) 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: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

2) Epidemiological and behavioral studies.

3) Outcomes research and health services research

Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.

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.

Clinical Trial Research Experience

The involvement of a student, postdoctorate, or early career faculty member in a clinical trial led by their mentor or other investigator, with the goal of obtaining clinical trial experience relevant to their research interests and career goals. A clinical trial research experience is one in which the participant is supervised by a more experienced investigator and is intended to prepare the participant to potentially lead an independent clinical trial in the future. The applicant can be part of the clinical trial team and can use the data generated during the clinical trial research experience in his/her proposed research project. NIH expects the mentor to assume overall responsibility of the trial including registering and reporting in clinicaltrials.gov and obtaining IRB approval.

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.

Commitment Base

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

Competing Research Project Grant

An application for a Research Project Grant requiring peer review, as opposed to a non-competing continuation.

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.

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).

Continuous Submission

As a way of recognizing their service to NIH, reviewers with substantial review service are permitted to submit their research grant applications (R01, R21, or R34) on a continuous basis and to have those applications undergo initial peer review in a timely manner. Read more about Continuous Submission.

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.

Cost Principles

The government-wide principles, issued by OMB (or, in the case of commercial organizations, the Federal Acquisition Regulation [48 CFR 21], or, in the case of hospitals, 45 CFR 75, Appendix IX, "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 NIH Grants Policy Statement: 7 Cost Considerations 7.2 The Cost Principles for additional details.

D

Delayed Onset Study

Research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

Delayed Start

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

E

Early Established Investigator (EEI)

A Program Director / Principal Investigator (PD/PI) who is within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an Early Stage Investigator (ESI).

Early Stage Investigator (ESI)

A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.

Electronic Research Administration (eRA)

The NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. Registration is required. Go to eRA.

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.

Existing dataset

An existing dataset may be constructed of different types of data including but not limited to survey data, demographic information, health information, genomic information, etc. Also included would be data to be derived from existing samples of cells, tissues, or other types of materials that may have been previously collected for a different purpose or research question but will now be used to answer a new research question. In general, these will be studies meeting the NIH definition for clinical research with a prospective plan to analyze existing data and/or derive data from an existing resource and where no ongoing or future contact with participants is anticipated.

Exploratory/Development Research

Research studies in the early and conceptual stages of development. Exploratory studies may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data.

Extramural Awards

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

Extramural Research

Research supported by NIH through a grant, contract, or cooperative agreement.

F

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.

Federal Laboratory

As defined in 15 U.S.C. §3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

Federal Program

(1) All Federal awards which are assigned a single number in the CFDA.

(2) When no CFDA number is assigned, all Federal awards to non- Federal entities from the same agency made for the same purpose should be combined and considered one program.

(3) Notwithstanding paragraphs (1) and (2) of this definition, a cluster of programs.

The types of clusters of programs are:

(i) Research and development (R&D);

(ii) Student financial aid (SFA); and

(iii) "Other clusters,'' as described in the definition of Cluster of Programs.

Federal-Wide Assurance (FWA)

The Federal-Wide 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 46, as well as the terms of assurance.

Financial Conflict of Interest

A financial conflict of interest exists when the recipient'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 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS funding is sought and NIH Grants Policy Statement: 4.1 Public Policy Requirements and Objectives 4.1.10 Financial Conflict of Interest.

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. 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 business concern.)

Foreign Component

The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient 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 recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are:

  • collaborations with investigators at a foreign site anticipated to result in co-authorship;
  • use of facilities or instrumentation at a foreign site; or
  • receipt of financial support or resources from a foreign entity.
Foreign travel for consultation is not considered a foreign component. (See NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components).

Foreign Organization

An entity that is:

(1) A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance;

(2) A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public;

(3) A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree-granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or

(4) An organization located in a country other than the United States not recognized as a Foreign Public Entity.

G

Gender

Human subject term indicating a classification of research subjects into women and men.

General Purpose Equipment

Equipment which is not limited to research, medical, scientific or other technical activities. Examples include office equipment and furnishings, modular offices, telephone networks, information technology equipment and systems, air conditioning equipment, reproduction and printing equipment, and motor vehicles. See also "Equipment" and "Special Purpose Equipment."
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021