Extramural Glossary

NIH-wide funding opportunity announcement enabling applicants to submit an electronic investigator-initiated grant application for a single grant mechanism, e.g., Research Project Grant (Parent R01). In the NIH Guide, view Parent Announcements for Unsolicited or Investigator-Initiated Applications.

A property right awarded by the Government whereby the Government grants the right to exclude others from making, using or selling the invention for a period of years.

Competing and noncompeting research grant applications require information regarding the development of intellectual property resulting from Federal Government (NIH) funding.

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 and/or obtains readily identifiable private information. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease; (b) therapeutic interventions; (c) clinical trials; and (d) development of new technologies.

Time and effort that T32 trainees and fellows must repay the government. During the first year, trainees owe one month of payback for every month of support; then they start paying back one month for every month worked.

A percentile-based funding cutoff point determined at the beginning of the fiscal year by balancing the projected number of applications coming to an Institute with the amount of funds available.

The Division of Payment Management operates the Payment Management System (PMS). PMS was developed to establish a central point with the capability of paying most Federal Assistance grants, contracts, and block grants. The main purpose of this system is to serve as a fiscal intermediary between awarding agencies and the recipients of grants and contracts, with particular emphasis on: (1) expediting the flow of cash between the Federal Government and recipients; (2) transmitting recipient disbursement data back to the awarding agencies; and (3) managing cash advances to recipients.

A system for evaluating grant applications, cooperative agreements, and contract proposals that uses reviewers who are the professional equals of the applicant. For contracts, peer review is a Federal legislative requirement (42 USC 289) for all research and development projects funded by the NIH. All biomedical and behavioral R&D contract projects require technical peer review and approval of both project concepts and proposals before contracts may be awarded, regardless of whether they originate from extramural or intramural program requirements. Technical peer review of R&D contract project concepts identifies the basic purpose, scope, and objectives of the projects and establishes relevance, priority, and need of projects to accomplish NIH program objectives. Technical peer review of R&D contract proposals provides objective evaluation of technical aspects and acceptability or nonacceptability of specific proposals based on the requirements stated in the Request for Proposal, and helps to achieve program goals by identifying the best technically qualified offerors. For peer review of grant applications.

The criteria for review of a grant application or contract proposal. The standard five NIH peer review criteria are; Significance, Approach, Innovation, Investigators, and Environment; these criteria are not pre-weighted. Different or additional criteria can be used depending on the grant or contract mechanism or announcement.

A scientist, usually from academia but increasingly from industry and other places of research, who comes to NIH to review grant applications or contract proposals. This includes the scientific review group chairperson, who leads the other peer reviewers in discussions of the scientific merit of the applications or proposals.

The amount of money that will be allowed and paid to cover the food and lodging expenses of an employee or consultant working on official business for the United States Federal Government at a distance of at least 50 miles away from his/her home; specific amounts are set annually for specific locations throughout the United States and the world.

Represents the relative position or rank of each priority score (along a 100.0 percentile band, with a range of 0.1 to 99.9) among the scores assigned by a particular study section.

A ranking that represents the relative position of each priority score among the scores assigned by a scientific review group at its last three meetings. The range is from .1 to 99.9; the lower the numerical value of the percentile score, the better.

A score that represents the relative position or rank of each priority score among the scores assigned by that particular study section at its last three meetings. The range is from .1 to 99.9; the lower the numerical value of the percentile score, the better.

A recipient report which contains for each grant information on the comparison of actual accomplishments to objectives established for the period. In addition, where the output of the project can be quantified, a computation of the cost per unit of output may be required.

The NIH/NCI-recognized institution at which NIH/NCI-funded research has occured, is occuring, or will occur.

Performance-based service contracting (PBSC) emphasizes that all aspects of an acquisition be structured around the purpose of the work to be performed as opposed to the manner in which the work is to be performed or broad, imprecise statements of work which preclude an objective assessment of contractor performance. It is designed to ensure that contractors are given freedom to determine how to meet the Government's performance objectives, that appropriate performance quality levels are achieved, and that payment is made only for services that meet these levels.

The time interval required to complete work defined in a statement of work (SOW). A period of performance can be revised only through an agreement between a contractor and a contracting officer, who must issue a formal modification to a contract.

An individual who has been appointed to serve on a chartered review committee (e.g., a study section managed by the Center for Scientific Review or a parent subcommittee managed by the NCI Division of Extramural Activities) for a defined tour of duty (typically, 4 years).

Measurement of a person's effort in academic, summer, or calendar months a year. Used on NIH applications and other forms instead of percent effort.

A Phase 0 (zero) clinical trial is designed to study the pharmacodynamic and pharmacokinetic properties of a drug. In a Phase 0 trial, a limited number of doses, and much lower doses of the drug are administered, therefore there is less risk to the participant.

These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase 1 trial usually enrolls only a small number of patients, sometimes as few as a dozen.

These studies continue to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.

These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

This is a broadly based, prospective investigation, including community and other population-based trials, usually involving several hundred or more people, to evaluate an experimental intervention in comparison with a standard or control or compare two or more existing treatments. Often the aim is to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy.

Postmarketing studies, carried out after licensure of the drug. Generally, a Phase IV trial is a randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Phase IV trials are important in evaluating AIDS drugs because many drugs for HIV infection have been given accelerated approval with small amounts of clinical data about the drug's effectiveness.

Such support may be provided to grantee(s) and their institution(s) following a recommendation by Institute program staff and approval from the NCI Executive Committee for grants and cooperative agreements that will not be renewed.

NCI staff developed these award to foster the translation of emerging technologies from pilot research-to-research development, speeding the adoption of near-term technological opportunities. The R21 award is an initial short-term award that allows the grantee(s) to test and prove the feasibility and validity of a new/innovative technologic approach to a problem in cancer research and the R33 award is a larger, longer-term award that is approved (or disapproved) by Institute staff after assessing how well the R21 grantee(s) or new R33 applicants have achieved specific milestones. Notices about the availability of these awards are published in the NIH Guide.

Clinical research that involves the testing of a new drug in an orderly series of steps.

PHS noncompeting application to continue a grant, used to report progress. Also see SNAP and go to the 2590 on the Web.

Standard Public Health Service application for all competing research grants and cooperative agreements.

Term and condition of all PHS awards involving live, vertebrate animals.

This is NCI's comprehensive cancer database. It contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, and supportive care; a registry of approximately 1,800 open and 12,000 closed cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care.

This term is a common (but historic) term that continues to be used by the applicant community to refer to the summary statement, which is the official NIH record of the peer review of a grant application.

A tablet, capsule, or injection that looks like the drug or other substance being tested but contains no drug or active agent.

A method of investigation of drugs in which an inactive substance (placebo) is given to one group of patients, while the drug being tested is given to another group.

Grants to support the planning and development of cancer research-focused program that are awarded for the purpose of assisting institutions and associated investigators to better compete for NCI cancer center support (P30) grants.

It is the Policy of the Public Health Service (PHS) to require institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities (hereinafter referred to as activities) conducted or supported by the PHS. The PHS endorses the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" developed by the Interagency Research Animal Committee. This Policy is intended to implement and supplement those Principles. No PHS support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with this Policy.

Provides support to minority post-baccalaureate and post masters degree graduates who intend to engage in health-related research while applying for graduate or medical school.

When processing these fellowship applications at least three reference letters must be included. None of these letters can be from the sponsors. The original letters are sent to the appropriate Institutes(s), and the copies are destroyed after the study section meeting. These letters are found in the back of the duplicated copies. The important point is that in these cases reviewers should get a duplicated copy and not an original.

A statement in summary form of the intent of the applicant to request funds. It is used to determine the applicant's eligibility and how well the project can compete with other applications and eliminate proposals for which there is little or no chance for funding.

To provide predoctoral minority students with supervised research training in specified health and health-related areas leading toward the research degree (e.g., Ph.D.).

To provide predoctoral students with disabilities with supervised research training in specified health and health-related areas leading toward the research degree (e.g., Ph.D.).

To provide predoctoral individuals with supervised research training in specified health and health-related areas leading toward the research degree (e.g., Ph.D.).

The annual budget request submitted to Congress by the U.S. President. The process begins with NCI's budget request, which, as part of the NIH budget request, is modified by the Office of Management and Budget. Since enactment of the National Cancer Act of 1971, the NCI submits a separate Bypass Budget document directly to the President.

Monitors the development and execution of the activities of the National Cancer Program.

The Presidential Award established by former President Bill Clinton in 1996 is the highest honor given by the U.S. government to scientists and engineers early in their independent research careers. Eight federal departments and agencies which fund scientific and engineering research nominate investigators for the award from among their research grant recipients who are considered most meritorious and who have no more than five years of independent research experience.

Test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer.

A peer reviewer who reads a grant application thoroughly, writes a critique of it before an initial peer review meeting, and then presents it to the scientific (initial) review group for discussion.

The one person designated by, and responsible to, the applicant/awardee institution or contractor organization for the scientific and administrative direction and proper conduct of all aspects of the grant application, grant award, or contract award. Also known as Program Director or Project Director.

The written permission provided by the authorized granting official from the DHHS awarding office before the recipient may undertake certain activities (such as performance or modification of an activity), expend funds, or exceed a certain dollar level.

Written approval that a contractor must obtain from a contracting officer to change a project or budget after an award is made.

Written approval that a principal investigator must get from an NIH institute's grants management officer to change a project or budget after an award is made.

An average of the individual ratings given by voting members of the scientific review group. Ratings range from 1.0 (outstanding) to 5.0 (acceptable), reflecting a judgment of scientific merit.

A Federal law that protects against needless collection or release of personal data.

A privately-owned automobile, aircraft, or motorcycle used by the traveler other than on a "for hire" or rental basis.

Documents the degree of implementation of the recruitment and retention activities. It describes how many items, of what materials, are provided to whom, by whom, and when and whether they responded. This type of evaluation may look at the origin of the research project, the methods used, the target population, program personnel/staff, and cost.

The acquisition of property or services for the direct benefit or use of the government, generally via a contract.

The acquisition of property or services for the direct benefit or use

A coherent assembly of plans, project activities, and supporting resources contained within an administrative framework, whose purpose is to implement an organization's mission or some specific program-related aspect of that mission. For purpose of this policy statement, "program" refers to those NIH programs that carry out their mission through the award of grants or cooperative agreements to other organizations.

An announcement by an NIH institute or center requesting applications in the stated scientific areas. Generally, money is not set aside to pay for them. The announcement invites applications and provides such information as eligibility and evaluation criteria, funding preferences/priorities, how to obtain application kits, and the submission deadline.

A PAR specifies that applications will automatically be referred to an NIH Institute or Center (IC) for review; in the NCI, this means the NCI Division of Extramural Activities (DEA). In issuing the PAR, members of the program staff may want to consider establishing a single receipt date and convening a special panel to review applications submitted in response to this kind of request for applications. As with other aspects of the initiative, these features must be approved by the relevant NCI official. Specific funds are not set-aside by the ICs for PARs.

A PAS indicates that funds will be set aside to support research proposed in response to the announcement. The availability of a special fund to support the initiative signals NCI's interest in the research area to the scientific community.

The coordination, interrelationships and synergy among the meritorious research projects and core components as related to the common theme of the program project. Also called Integrated Effort" or "Integration of 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.

The need to balance an institute's support of research in all its programmatic areas with its high-quality applications eligible for funding.

IMPAC II designator signifying a scientific program and program officer.

The PCRB is a branch within the Office of Referral, Review, and Program Coordination of the NCI Division of Extramural Activities. The staff of this branch coordinate the development and publication of NCI program concepts (e.g., Requests for Applications and Program Announcements) and the receipt, referral, and assignment of all grant applications.

The NCI Health Scientist Administrator (HSA) responsible for the development of initiatives and for the scientific management of research programs sponsored by the NCI. This person serves as the focal point for all science-related activities associated with the negotiation, award, and administration of grants. Program Directors work closely with scientific review administrators and grants management staff to resolve issues.

Gross income earned by a grantee that is directly generated by the grant supported project or activity or earned as a result of the award.

Exactly equivalent to Program Director (which is the term used in the NCI) or Program Official; Program Officer and Program Official are used in some other NIH Institutes and Centers. This person is an Institute staff member who is responsible for overseeing and monitoring a scientific program and progress of grants in his or her portfolio. Program Officers work closely with grants management staff to resolve issues.

Documentation in the official grant file of a program director's (or officer's or official's) evaluation of the scientific aspects of a research project, other support to identify possible overlap, and other factors that may affect a grant's funding level.

NIH cmmittee of program staff that discusses extramural program and policy issues. It has at least one voting member from each NIH institute.

Exactly equivalent to Program Director (which is the term used in the NCI) or Program Officer; the term Program Officer is used in some NIH Institutes and Centers. This person is an Institute staff member who is responsible for overseeing and monitoring a scientific program and progress of grants in his or her portfolio. Program officials work closely with grants management staff to resolve issues.

An award activity for the support of a research program that has a well-defined central theme, research focus, or objective. Program projects must have at least three interrelated, well thought-out subprojects along with (but not required) core resources necessary to support these projects at all times. It is expected that interrelationship and synergism among component research projects will often be multidisciplinary in nature, and will result in greater scientific contributions than if each subproject were supported individually

An assistance grant or award used by the NIH and by the recipient grantee(s) or awardee(s) and institution(s) for the support of broadly based, multidisciplinary, often long-term, research program which has a specific major objective or a basic theme. A program project generally involves the organized efforts of relatively large groups, members of which are conducting research projects designed to elucidate the various aspects or components of their objectives. Awarded on behalf of a principal investigator, a P01 grant can support projects and shared resources. A program project funded by the NCI must contain at least three related projects, and can contain one or more cores (i.e., support facilities), each of which must support at least two projects. Each research project is usually under the leadership of an established investigator. The grant can provide support for certain basic resources used by the groups in the program, including clinical components, the sharing of which facilitates the total research effort. A program project is directed toward a range of problems having a central focus, in contrast to the usually narrower thrust of the traditional research project. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort.

Also called Grants Technical Assistant. This person generally works with one or more Scientific Review Administrators to support the NIH peer review process.

The dollar amount a grant award is reduced from the amount recommended by the study section (scientific review group). This is done so institutes can maintain a sufficient number of grants in their portfolio and to combat inflation of grant costs.

A report which contains for each grant or contract information on the comparison of actual accomplishments to objectives established for the period. In addition, where the output of the project can be quantified, a computation of the cost per unit of output may be required.

Panels consisting of 20 to 30 prominent members of the scientific, medical, and advocacy communities that assess the state of the science for a single type of cancer or a group of closely related cancers and make recommendations for future research.

A research component of a larger multicomponent application (e.g., P01), with a separate detailed budget.

Notifies the applicant organization of the application number and the assigned study section, study section address, and SRA name and phone number.

The total allowable cost incurred by a recipient (and the value of the in-kind contributions made by third parties) in accomplishing the objectives of the award during the project period.

A qualified individual designated by the contractor’s organization to direct the project or program being supported by the contract. This individual has primary responsibility for guiding and/or performing the work as described in the contract work statement.

The person responsible for the scientific direction and conduct of an individual research project within a multi-component application.

Commonly referred to as the application number or grant number, depending upon its processing status. This unique identification number for the grant is composed of the type code, activity code, Institute code, serial number, support year, and/or suffix code.

The individual representing the Government for the purpose of technical monitoring of the contract. The Project Officer may also be considered to be the Institute staff member who coordinates the substantive aspects of a contract from planning the request for proposal to oversight. However, the project officer has no authority to obligate the Government or change the terms of the contract. This authority resides with the Contracting Officer.

The total time for which support of a project has been recommended (usually no more than 5 years), consisting of one or more budget periods.

Law that ensures companies transacting business with the government are paid on time. Government must pay within 30 days from the date a contractor submits an invoice or must pay interest. (FAR 32.9)

A feasibility study demonstrating the viability of an idea.

Written offer by an individual or non-Federal organization to enter into a contract, usually in response to a request for proposals (RFP). It consists of a technical and a business proposal, including a description of the project and its costs, and the methods, personnel, and facilities to carry it out.

The Pro-Children Act of 1994 requires the prohibition of smoking in indoor facilities (or in some cases portions of facilities) used routinely or regularly for the provision of health care, day care, early childhood development, education, or library services to persons under 18, if the services are funded by applicable Federal funds, either directly or through State or local governments. [check this out!!!]

Required of all research activities in which human subjects are involved.

Interested party's written objection to an agency's contract solicitation, proposed award, or award. See FAR 33.101.

The detailed plan for conducting a clinical trial. It states the trial's rationale, purpose, drug or vaccine dosages, length of study, routes of administration, who may participate, and other aspects of trial design (including a description of research and data analysis methods).

A process used at cancer centers for performing in-house review and monitoring of the scientific merit of clinical protocols prior to their activation and use with patients.

A model of something to be further developed, which includes designs, protocols, questionnaires, software, and devices.

The NIH policy designed to ensure that the public has access to the published results of NIH-funded research (go to http://publicaccess.nih.gov/ for more information).

A component of the United States Department of Health and Human Services (DHHS). The NIH is the largest agency within the DHHS and within the Public Health Service.

A searchable database of reports of research published in scientific and biomedical journals that is maintained by the National Library of Medicine at the NIH.

PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal papers. These papers are indexed with a PMCID, a series of numbers preceded by ?PMC?. PMC content is publicly accessible and integrated with other databases (go to http://www.pubmedcentral.nih.gov/).

The reference number assigned to an article or manuscript archived in PubMed Central. The PMCID is the number that must be cited on applications, proposals or reports as part of compliance with the Public Access Policy. See also ?Citation ID.?

The unique number assigned to a PubMed citation for an article published in a journal. This number does NOT indicate compliance with the Public Access Policy.