Extramural Glossary

Information linking specimens or data to individually identifiable living people or their medical information. Examples include names, social security numbers, medical record numbers, and pathology accession numbers.

NIH's electronic invention reporting system. Sometimes called "Edison" instead of "iEdison."

IMPAC is the second generation computer database system developed and maintained by the Office of Extramural Research for information concerning PHS extramural programs.

Information for Management, Planning, Analysis and Coordiination (IMPAC) II is the second generation computer database system developed and maintained by the Office of Extramural Research for information concerning PHS extramural programs..

Focuses on the long-range results of the program and subsequent changes in health status. Impact evaluations are rarely possible because they are costly, involve extended commitment, and may depend upon other strategies in addition to the recruitment and retention component of the research project.

The rate of occurrence of new cases of a particular disease in a population being studied -- compare with "prevalence."

A mechanism in which the total work effort under a contract is to be performed over multiple time periods and funds are allotted, as they become available, to cover discernible phases or increments of performance. (See Section VII, D, of the NCI Research Contracts Branch's Orange Book).

A contract used to acquire supplies and/or services when the exact times and/or exact quantities of future deliveries are not known at the time of contract award. This type of contract is generally reserved for Non-R&D requirements. There are three types of indefinite - delivery contracts: definite quantity, requirements, and indefinite quantity.

U.S. Department of Health and Human Services agency providing healthcare to Native American and Alaskan Native peoples.

Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program.

Provides funds to recruit and support scientists and students with disabilities. This program will also provide support for NIH investigators who become disabled, such as assistants or special equipment.

IMPAC was a computer database system developed and maintained by the Office of Extramural Research for information concerning PHS extramural programs. This internal NIH database contained confidential information on applications, awards, awardees, and peer reviewers. It has been replaced by IMPAC II.

The permission given by a person before surgery or other medical procedures. The patient, or parent or guardian, must understand the potential risks and benefits of the procedure and legally agree to accept those risks.

Individuals that travel less than two times per year.

First level of peer review by non-NIH scientific experts, called peer reviewers, who assess the scientific and technical merit of grant applications and contract proposals.

Significance - Is the topic important? Will it advance scientific knowledge? Approach - Are the hypothesis, design, and methods well developed and appropriate? Are potential problems addressed? Innovation - Does the proposal involve new ideas or methods; does it challenge existing paradigms? Investigator - Does the investigator and collaborators have the training and experience to do the work? Environment - Will the scientific environment contribute to success? Is there institutional support for the project? Does the work take advantage of existing opportunities including collaborations?

The first level of a two-stage peer review system. Legislatively mandated panels of subject matter experts are established according to scientific discipline or medical specialty. Their primary function is the review and rating of research grant applications for scientific and technical merit. They make recommendations for the appropriate level of support and duration of award.

A request for applications (RFA), request for proposals (RFP), or program announcement (PA) stating the Institute's interest in receiving research applications in a given area because of a programmatic need or scientific opportunity. RFAs and RFPs generally have monies set aside to fund the applications responding to them; program announcements generally do not.

In the review of a grant application submitted to the NIH, this term refers to a required peer review criterion. In thiis context, "innovation" means the degree to which a project or program applies novel concepts and innovative approaches.

Major NIH organizations; Institutes, such as NIAID and Centers, such as the Fogarty International Center.

A not-for-profit, non-governmental American organization that provides national advice on issues relating to biomedical science, medicine, and health, and its mission to serve as adviser to the nation to improve health. It works outside the framework of the U.S. federal government to provide independent guidance and analysis and relies on a volunteer workforce of scientists and other experts, operating under a rigorous, formal peer-review system. The Institute provides unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.

The NIH organizational component responsible for a particular grant program or set of activities. NIH is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems.

IACUCs derive their authority from the law. IACUCs are mandated by the Health Research Extension Act (HREA and the Animal Welfare Act (AWA) of 1985. The laws require that each institute that receives PHS support for activities involving vertebrate animals or is subject to the authority of the AWA must operate an animal care and use program with clear lines of authority and responsibility. The program must include a properly constituted and functioning IACUC with procedures for self monitoring, training, veterinary care and appropriately maintained facilities.

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 grant.

A document filed with the HHS Office for Human Research Protections (OHRP) formalizing the research institution's commitment to protect human subjects in its federally supported research. The OHRP has developed a new, simplified process for obtaining a Federal wide Assurance (FWA) of Protection for Human Subjects, applicable to all federal agencies. In the future, only the FWA will be accepted, although the deadline when it will replace other more limited assurances (e.g., the special project assurance for a specific research project) has been indefinitely extended.

The annual compensation paid by an applicant/grantee organization for an employee's appointment whether that individual's time is spent on research, teaching, patient care, or other activities. The base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds.

Person working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the Commons' Signing Official (SO).

Person working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the eRA Commons' Signing Official (SO).

To support a newly trained clinician appointed by an institution for development of independent research skills and experience in a fundamental science within the framework of an interdisciplinary research and development program.

The cooperative agreement counterpart to the T32, this award enables institutions to provide research-training experiences for graduate students and postdoctoral scientists in specified shortage areas. In addition, these awards involve identified NIH Intramural Staff who serve as a part of the training faculty and participate in the operation of the training program.

A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the United States must be approved by an IRB before they begin. Every institution that conducts or supports biomedical or behavioral research involving human subjects must, by Federal regulation, have an IRB that initially approves and periodically reviews the research so as to protect the rights of human subjects.

Documentation from your Institutional Review Board that it has approved your research protocol, consent form (if applicable), monitoring and reporting procedures, and plans for analyzing intervention differences among different types of human subjects, for example women and minorities, ethnic or racial subgroups, and children. The IRD also approves your research annually with the noncompeting grant application and any time there are major changes in the research protocol or other procedures. The IRB must also certify its approval of the results of subset analyses in renewal applications and contract proposals.

Also called "Integration of Effort" or "Program as an Integrated Effort," which are a characteristic evaluated in the review of program project (P01) grant applications. When evaluating this review criterion, the following aspects of the research program are assessed by the peer reviewers: 1) evidence of coordination, inter-relationships, and synergy among the meritorious research projects and core components as related to the common theme of the program project; 2) the advantages or value added that could be realized by conducting the proposed research as a P01 rather than through separate research efforts; 3) the presence and quality of mechanisms for regular communication and coordination among investigators; 4) the mechanisms for quality control of the research (e.g., internal or external advisory boards; and 5) for competing renewal applications, evidence of productive collaborations, such as joint publications, that have resulted from the P01 award.

A cluster of study sections in the Center for Scientific Review that are responsible for the review of grant applications in scientifically related areas. These study sections share common intellectual and human resources.

The separate and distinct types of intangible property that are referred to collectively as "intellectual property," including but not limited to: patents, trademarks, copyrights, trade secrets, SBIR technical data (as defined in this section), ideas, designs, know-how, business, technical and research methods, and other types of intangible business assets, and including all types of intangible assets either proposed or generated by an SBC as a result of its participation in the SBIR Program.

A formal agreement among government agencies to collaborate on and fund research. In the context of the NCI, an Interagency Agreement is a written arrangement between NCI and one or more Federal Agencies outside the Department of Health and Human Services (DHHS). (See Section II, C, of the Research Contracts Branch's Orange Book).

NIH's electronic invention reporting system.

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.

This support is intended to provide minimal funding to maintain continuity in research enterprises or to obtain additional data that would allow the investigator to re-complete for renewal of a current grant.

Allows peer reviewer to submit critiques and preliminary scores for the applications that they are reviewing. Allows Peer Reviewers, scientific review officers (SROs), and extramural support assistants (ESAs) to view all critiques in preparation for a review meeting. IAR creates a preliminary summary statement body containing submitted critiques for the SRO(s) and ESA(s).

A formal agreement among distinct components of a government agency to collaborate on and fund research. In the context of the NCI, an Intra-agency Agreement is a written arrangement between the NCI and one or more other component(s) of DHHS. (See Section II, C, of the Research Contracts Branch's Orange Book).

Research conducted by, or in support of, employees of the NIH.

Research conducted by government-run NIH laboratories.

Any discovery which is or may be patentable or otherwise protectable.

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.

Adequate research facilities and educational opportunities for pursuing cancer-related research - commitment to scientific development of applicant, and commitment to provide protected time.

Status given by the U.S. Food and Drug Administration (FDA) to a new drug or biogical product to be used in a clinical investigation. FDA approval to experimentally test a new drug in people under controlled circumstances. However, an investigational new drug cannot be legally marketed and sold in the United States until the FDA grants approval after concluding that it is safe and effective for appropriate use in humans.

Under regulation 21 CFR 312, application filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all trial phases, protocols, Institutional Review Board (IRB) members, and investigators. Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug. Often used interchangeably with "IND."

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 committees.

In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of the investigator.