Extramural Glossary

This group establishes biomarkers of disease. Projects specifically related to prostate, lung, and ovarian cancers are among those well under way, with others planned.

An NCI initiative developed to brings together multiple institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk.

Electronic system developed to give NIH institutes and centers (ICs) the opportunity to comment on NIH request for applications (RFAs) or program announcements (PAs) before they are published.

A New Investigator within 10 years of completing his/her terminal research degree or medical residency. A traditional NIH research grant (R01) application from an ESI will be identified and the career stage of the applicant will be considered at the time of review and award.

A requirement by Congress that a federal agency spend a specified amount of money for a stated purpose, for example to establish a centers program or conduct a clinical trial.

A requirement by Congress that a federal agency spend a specified amount of money for a stated purpose, for example to establish a centers program or conduct a clinical trial.

NIH's electronic invention reporting system. Usually called iEdison.

NIH database system showing an application's summary statement, percentile, priority score, study section, program class code, application type, activity code, grant number, PI name, and project title; downloaded from IMPAC II. ECB also lets members of NCI's main advisory Council (NCAB) approve early awards for fundable applications with no special concerns.

NIH's infrastructure for conducting the interactive electronic transactions necessary for the submission, receipt, referral, review, monitoring, and administration of grant applications and awards. Registration is required.

Internet-assisted method by which reviewers of contract proposals submit their critiques

Process allowing an institution to review non-competing grant data and submit a progress report online.

NIH eRA Commons module that allows Principal Investigators (PIs) and grantee institutions to electronically submit their Streamlined Noncompeting Award Process (eSNAP) type 5 progress reports. eSNAPs are due 45 days before a noncompeting award's start date.

Invention report is due to NCI within 2 [?] months after giving written disclosure to an organizational official. Go to the iEdison Web site for invention reporting.

Also known as Taxpayer Identification Number or "TIN". This is the number required by the Internal Revenue Service (IRS) to be used by the offeror in reporting income tax and other returns. The TIN may be either a Social Security Number or an Employer Identification Number issued buy the IRS.

As a body or whole; in one piece; as a unit.

An agreement of opinion or union in action on one item of business (e.g., the collective decision about the Scientific Review Group recommendations for a collection of grant applications).

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.

NCI-based system that provides resources and services to meet NCI needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the Institute and the larger biomedical community.

Scientific, organizational, and administrative environment. The Environment for performance of research proposed in a grant application is a standard Review Criterion that must be addressed by peer reviewers of the application.

Laws, policies and guidelines to ensure equal employment opportunity regardless of race, color, national origin, sex, religion, age, or handicapping condition.

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.

During the process of submitting a grant application electronically, applicants may receive a notification from the eRA Commons regarding errors or warnings that need to be corrected to complete the application process. NIH now allows applicants to only correct errors or warnings up until, but not after, the end of the receipt date deadline. To make any corrections, the original application submission must have been submitted on time with all appropriate registrations in place. Note: Errors stop applications from processing and must be corrected. However, warnings do not stop application submission and are corrected at the discretion of the applicant.

Electronic means of 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).

This term is meant to identify "scientific overlap," which occurs when (1) substantially the same research is proposed for funding in more than one proposal (contract proposal or grant application) submitted to the same Federal agency; OR (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; OR (3) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more proposals or awards, regardless of the funding source.

For the support of a research scientist qualified to pursue independent research which would extend the research program of the sponsoring institution, or to direct an essential part of this research program.

Human subjects terms defined by the Federal government's Office of Management and Budget (OMB) and used by the NIH to allow comparisons to national databases.

Easily identifiable characteristic that implies a common cultural history with others possessing the same characteristic. Based on Federal reporting standards the ethnic categories required by NIH is Hispanic or Latino, which includes a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

An easy death or means of inducing one. Often used by scientists when refering to killing an animal that has been part of a research study.

Applications funded outside an established payline or where no payline exists.

Meeting at which proposed exceptions funding is considered.

Process by which potential exceptions are identified, evaluated, and approved for funding.

Refusal of entry of a patient into a clinical study because he/she exhibits clinical characteristics that match defined Exclusion Critiria and/or he/she does not exhibit clinical characteristics that match defined Inclusion Criteria.

That portion of the Federal Government that serves the President of the United States. The Department of Health and Human Services, of which the National Institutes of Health is one of twelve component agencies, is part of the Executive Branch of our government.

Abolished in late 2010. See Scientific Program Leadership. From the 1980's to 2010 was comprised of the NCI Director, NCI Division Directors, and other scientists/managers (chosen by the Director); this group makes scientific and management policy decisions, allocates resources, establishes grant paylines, approves grant funding plans, and reviews concepts for presentation to NCI's Board of Scientific Advisors

6130 and 6120 Executive Boulevard, Rockville, MD, respectively; the loci of most NCI extramural staff members.

At the NIH, an Executive Secretary generally refers to the federal government employee who organizes and manages review and/or advisory committee meetings (e.g., study section meetings in the Center for Scientific Review [CSR], the Advisory Council of an Institute or Center [e.g., the National Cancer Advisory Board], or a workgroup of experts meeting to develop an initiative or to determine the current state-of-the-science in a particular area of research). In the CSr and in the review operations of the various Institutes and Centers, the Executive Secretary (now simply called a Scientific Review Administrator in most cases), with the approval of his or her supervisor, and in consultation with the Chairman of the Initial Review Group or Study Section and others, is the staff person responsible for judging the need for the specific review process (e.g., by site visit, by teleconference, or study section, etc.), determining finally the scientific disciplines to be represented, compiling names of scientists with qualifications needed for adequate scientific review, and selecting and contacting individual scientists to serve as members of a review committee.

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on instructional strategies, or on instructional techniques, curricula, or classroom management methods.

Research using cognitive, diagnostic, aptitude, and achievement educational tests, surveys, interviews, or observations of public behavior, unless human subjects are identifiable and disclosure of the responses outside the research could reasonably place the subjects at risk of liability or be damaging to their financial standing, employability, or reputation.

Research using cognitive, diagnostic, aptitude, and achievement educational tests, surveys, interviews, or observations of public behavior cognitive, diagnostic, aptitude, and achievement educational tests, surveys, interviews, or observations of public behavior that is not exempt if the subjects are public officials or candidates for public office or federal statutes require that the confidentiality of identifiable information will be maintained.

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if the sources are publicly available or the information is recorded so that subjects cannot be identified.

Research and demonstration projects conducted or approved by agency heads to study public benefit or service programs; procedures for obtaining benefits or services or other changes to those programs.

Taste and food quality evaluation and consumer acceptance studies a) in wholesome foods without additives or b) in food containing a food ingredient at or below the level and use found to be safe, or agricultural chemical or environmental contaminant at or below the level deemed safe by FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Grant regulation 45 CFR Part 74 gives greater autonomy to grantees, including the ability to carry over funds from one budget period to the next. Expanded authorities apply to most R (but not R41 or 43), P, K, and T series grants.

A streamlined (i.e., more rapid and efficient) process for obtaining agreement of opinion or union in action by an Advisory Council (e.g., the National Cancer Advisory Board) on one item of business (e.g., the collective decision about the Scientific Review Group recommendations for a collection of grant applications).

A streamlined (i.e., more rapid and efficient) process for obtaining agreement of opinion or union in action by an Advisory Council (e.g., the National Cancer Advisory Board) on one item of business (e.g., the collective decision about the Scientific Review Group recommendations for a collection of grant applications).

A streamlined (i.e., more rapid and efficient) process for obtaining agreement of opinion or union in action by the National Cancer Advisory Board on one item of business (e.g., the collective decision about the Scientific Review Group recommendations for a collection of grant applications).

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

The processing of these applications is very much like that of R01s, except that this mechanism also has its own set of review guidelines.

To support planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of the NIH. These exploratory studies may lead to specialized or comprehensive centers.

To support planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of the NIH. These exploratory studies may lead to specialized or comprehensive centers. Substantial Federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award.

To encourage the development of new research activities in categorical program areas. (Support generally is restricted in level of support and duration.)

To provide a second phase for support of innovative exploratory and developmental research activities initiated under the R21 mechanism. Although only R21 awardees are generally eligible to apply for R33 support, specific program initiatives may establish eligibility criteria under which applications could be accepted from applicants who demonstrate program competency equivalent to that expected under R33.

The extension of a project period.

A request for a non-competing extension of the project period for a non-SNAP grant should be submitted to the IC GMO, in writing, at least 30 days before the project period will expire.

The NCI Extramural Advisory Board (EAB) provides advice to the Director, NCI, Deputy Director, NCI, and Directors of the NCI Extramural Divisions on issues affecting the extramural program of the NCI from the review, award, and management of extramural grants, contracts, and cooperative agreements, to the broader scientific issues of planning, management, and evaluation of the NCI's extramural programs. The EAB will evaluate existing and proposed policies, procedures, and guidelines for their impact on extramural operations and make recommendations on modifications or development of new policies to improve the effectiveness of extramural operations in meeting the mission of the NCI. The Board will also provide a forum for extramural staff to discuss problems and develop ideas for improving the effectiveness of interactions and communication across programs and with the extramural and intramural scientific community.

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

A branch in the Office of the Director of the NCI that (1) plans, directs and coordinates the financial management of the Institute's grant programs and manages the information systems containing data on grants and grant applications; (2) provides advice, information and policy recommendations concerning grants funding and associated information systems technology to the Office Director and the Institute Director, the NCI Executive Committee, and senior staff of the Institute; (3) participates in the formulation of all major grant budget submissions; (4) administers systems containing data on all Institute grant obligations and makes that information available to Institute and NIH staff; (5) prepares regular and special financial reports on NCI grant and contract programs; and (6) maintains liaison with NIH and NCI offices interested in and responsible for extramural research financial data to assure that the contract and grant databases and systems that are developed and used internally and at NIH are efficient, flexible, user friendly, and allow connectivity for sharing data.

This advisory committee on extramural research policies and practices at the NIH is chaired by the NIH Deputy Director for Extramural Research and it has one member from an extramural division of every NIH Institute and Center. The Director of the NCI Division of Extramural Activities is the NCI representative to this NIH committee.

Research supported by NIH through a grant, contract, cooperative agreement, or other funding mechanism to an external organization.

Research supported by NIH through a grant, contract, or cooperative agreement awarded to an institution outside of NIH.

Includes Health Scientist Administrators, Medical Officers, Program Directors, Scientific Review Administrators, and other professional staff of the NIH and its component institutes and centers.

A staff member who assists scientific review officers (SROs) in peer-review related work. Formerly called Grants Technical Assistant (GTA).

Also called the NIH "Population Tracking Database."