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NIAID Glossary of Funding and Policy Terms and Acronyms—I

For Institute program-specific acronyms, go to NIAID Profile and Fact Book.

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Term Definition
I2 See IMPAC.
IACUC See institutional animal care and use committee.
IAVI International AIDS Vaccine Initiative. Go to the IAVI.
IBC See institutional biosafety committee.
IBRP Introduction to Biomedical Research Program.
IC See institutes and centers.
IDE See investigational device exemption.
IDeA Program See Institutional Development Award Program.
identification number, application See application identification number.
identifier

Information on human subjects that links 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. See coded private information.

Go to these resources:

IDIQ See indefinite delivery indefinite quantity contract.
IEC See independent ethics committee.
iEdison

NIH's electronic invention reporting system. See Employee Invention Report.

Go to these resources:

IIA See Individual Investigator Agreement.
IMB Internal monitoring board.
Immune Tolerance Network (ITN)

Organization that funds research of immune tolerance in humans for kidney, liver, and islet transplantation; autoimmune diseases; and allergy and asthma. Supported by NIAID, NIDDK, and Juvenile Diabetes Research Foundation International.

Go to ITN and Juvenile Diabetes Research Foundation International.

IMPAC

Internal NIH database with confidential information on grant applications and awards. IMPAC stands for Information for Management, Planning, Analysis, and Coordination.

Go to IMPAC and NIAID's IMPAC and RePORTER SOP.

impact score

See overall impact/priority score.

improper conduct

NIH term denoting a person's performance of assigned duties in a manner that:

  • Purposely contributes to the abuse or waste of money.
  • Is injurious to the integrity of HHS or NIH.
  • Is contrary to the standards of conduct established by HHS, the Office of Government Ethics, or established personnel practices and policies.

Improper conduct does not include criminal offenses.

The term is also used for policies for fraud, waste, and abuse in NIH programs by NIH employees, grantees, contractors, or others doing business with NIH.

Go to the Office of Government Ethics and NIAID's Reporting Fraud, Waste, and Abuse SOP.

Inclusion Enrollment Report

Form in a grant application package for human subjects research to report participation of special populations—such as African Americans, Asians, or Native Hawaiians. See Inclusion Enrollment Report (PHS 2590 forms). Also see Targeted/Planned Enrollment Report.

Go to these NIH resources:

Other NIH resources:

NIAID resources:

incubator

Organization that fosters the growth of new ideas or companies by providing resources such as financing, management expertise, office services, and possibly office space.

IND See investigational new drug.
indefinite delivery indefinite quantity contract (IDIQ)

Contract that provides an indefinite quantity of supplies or services during an unspecified period. The government schedules deliverables by placing orders with a contractor. Go to FAR 16.504.

indefinite quantity contract

Contract that provides an indefinite quantity of supplies or services during a fixed period. The government schedules deliverables by placing orders with a contractor. Go to FAR 16.504.

independent ethics committee (IEC)

Body used by an international research organization that performs the functions of an institutional review board: ensure the protection of human subjects by independently approving, modifying, or disapproving research protocols.

For an HHS-supported award, an IEC must register with the Office for Human Research Protections.

Go to these resources:

independent government cost estimate

Estimate by an NIAID contracting officer and program staff of the cost for goods and services purchased by a contract.

Go to NIAID's Independent Government Cost Estimate SOP.

independent monitoring committee or safety monitoring committee

Small group of independent investigators and biostatisticians who review data. Go to NIAID's Clinical Trial Monitoring SOP.

independent safety monitor

Physician or other expert who is independent of a study and readily available to review and recommend actions on adverse events and other safety issues.

Go to NIAID's Clinical Trial Monitoring SOP.

indirect costs Formerly used term—see facilities and administrative costs.
Individual Investigator Agreement

Assurance for human subjects from the Office for Human Research Protections that replaces other types of individual investigator agreements. For institutions, see Federalwide Assurance

Go to these resources:

individually identifiable

Describes private information regarding the identity of human subjects that an investigator may ascertain directly or through a coding system. If identity is knowable, the study is considered to be human subjects research.

Go to these resources:

inflationary factor See escalation factor.
influential scientific information

Scientific information an agency can reasonably determine will have a substantial impact on important public policies or private sector decisions.

See highly influential scientific information and OMB Information Quality Bulletin for Peer Review.

Go to Final Information Quality Bulletin for Peer Review in the Federal Register.

Information for Management, Planning, Analysis, and Coordination See IMPAC.
Information Quality Bulletin for Peer Review See OMB Information Quality Bulletin for Peer Review.
informed consent

Person's voluntary agreement based on adequate knowledge and understanding to participate in human subjects research or undergo a medical procedure.

In giving informed consent, people may not waive legal rights or release or appear to release an investigator, sponsor, or institution from liability for negligence.

Go to these resources:

initial peer review

First level of peer review by non-NIH scientific experts, called peer reviewers, who assess the merit of grant applications and contract proposal. For grants, merit is based on the reviewers' judgment of the likelihood that the topic will make a high impact on its field.

NIH's Center for Scientific Review conducts initial peer review of investigator-initiated applications.

Institutes and centers review applications and proposals with their own review requirements: program projects (P), cooperative agreements (U), training (T) and career development (K) grants, contracts (N), and responses to requests for applications and solicitations.

Also see dual peer review, study section, scientific review group, and integrated review group.

Go to NIH's Center for Scientific Review and these NIAID resources:

initial peer review criteria

Basis for assessing the merit of NIH research grant applications for initial peer review. Standard NIH review criteria are:

Other criteria include human subjects and vertebrate animals. Also see overall impact/priority score.

Go to these NIAID resources:

initial review group Formerly used term—see integrated review group and the related term study section
initiative

Request for applications (RFA), program announcement (PA), or solicitation to stimulate research in a scientific topic. (Parent program announcements, e.g., the Parent R01, are not initiatives.)

Publication of an initiative follows review and approval of a concept by NIAID's main advisory Council, called concept clearance.

RFAs and PAs are published in the NIH Guide and in Grants.gov as funding opportunity announcements. Contract solicitations are in FedBizOpps.gov.

See targeted research and the converse investigator-initiated.

Go to these NIAID resources:

Innovation

1. One of the standard NIH initial peer review criteria used to assess how much a project can shift the current research paradigm or refine, improve, or propose a new application of an existing concept, method, instrumentation, or clinical intervention.

Also see Approach, Significance, and overall impact/priority score.

2. Section of the Research Strategy in the grant application.

Go to these NIAID resources:

institute-specific program announcement

Program announcement that states the interest of one or more institutes and centers to receive applications in an area of scientific need or opportunity. Applicants must follow the instructions in the funding opportunity announcement.

Applications are considered to be investigator-initiated. Also see its converse parent program announcement.

Go to NIAID's Application portal.

institutes and centers (IC)

Major NIH organizations: institutes, such as NIAID, and centers, such as the Fogarty International Center. Go to NIH ICs.

institution, foreign See foreign institution.
institutional animal care and use committee (IACUC)

Committee established by a research institution to ensure appropriate and humane care and use of animals in research.

IACUCs independently determine that an institution is meeting requirements and complying with regulations. They also review and approve protocols. See Office of Laboratory Animal Welfare.

Go to these resources:

institutional animal care and use committee certification

Statement by a grantee that its institutional animal care and use committee approved a project involving animals in research. Grant applications and contract proposals must include certification of IACUC approval before award. See Office of Laboratory Animal Welfare.

Go to these resources:

institutional assurance of protection for human subjects

Human subjects term indicating a document filed with the Office for Human Research Protections, HHS, formalizing a research institution's commitment to protect human subjects. Institutions file an online Federalwide Assurance.

See institutional official for human subjects and risk.

Go to 45 CFR 46.103 and the NIAID Human Subjects Application and Grant Handbook.

institutional biosafety committee (IBC)

Committee set up by an institution under NIH guidelines to review recombinant DNA research and ensure its appropriate use.

IBCs may also review other biohazardous research, including select agents.

Go to these resources:

institutional business official

Person working in a research organization's business office who has signature and possibly other authorities.

For Grants.gov that person is called an authorized organizational representative; for the Commons it is called a signing official.

Institutional Development Award Program

National Institute of General Medical Sciences program that NIAID participates in, which funds research at institutions in states with historically low rates of NIH support.

Go to NIGMS's Institutional Development Award.

institutional official for animal welfare

Senior official who signs an institution's animal welfare assurance, making a commitment on behalf of the institution to comply with the PHS Policy on Humane Care and Use of Laboratory Animals. Also see Grants.gov term, authorized organizational representative.

Go to NIAID's Animals in Research portal.

institutional official for human subjects

Official who signs an institution's human subjects assurance, making a commitment on behalf of the institution to comply with 45 CFR Part 46. Also see Grants.gov term, authorized organizational representative.

Go to the NIAID Human Subjects Application and Grant Handbook.

institutional review board (IRB)

Committee used by an institution to ensure the protection of human subjects by independently approving, modifying, or disapproving research protocols.

IRBs can be domestic or foreign and must follow federal regulations and local institutional policy. Foreign entities that conduct IRB functions may be called independent ethics committees.

IRBs must register with the Office for Human Research Protections, HHS. Different laws may define IRB requirements differently. See institutional review board certification of approval.

Go to these resources:

institutional review board certification of approval

Human subjects term indicating that an institution has officially notified the supporting agency that proposed research has been reviewed and approved by an institutional review board or independent ethics committee following an approved assurance.

This includes approval of a clinical research protocol, consent form (if applicable), monitoring and reporting procedures, and plans for analyzing intervention differences among groups of human subjects, e.g., women, minorities, ethnic or racial subgroups, and children.

Institutions must indicate IRB or IEC approval annually in a noncompeting grant application and when major changes in a protocol or other procedures occur. IRBs or IECs must also approve results of subset analyses in renewal applications and contract proposals.

Go to these resources:

institutional review board documentation

Method of documenting an institutional review board's assessment of proposed or active research.

integrated review group (IRG)

Group of study sections organized around an area of science that perform initial peer review in the NIH Center for Scientific Review. Also see peer review, dual peer review, study section, and scientific review group.

Go to CSR Study Section Roster Index at CSR. For advice, read Ensure You Get the Right Assignments in the Strategy for NIH Funding.

intensity or severity of adverse events

Grade of adverse events or side-effects of interventions.

interaction

Communication or other interpersonal contact between an investigator and a human subject. Go to definitions in 45 CFR 46.102 and full 45 CFR 46.

interagency agreement, intra-agency agreement (Y)

Written arrangement between two or more federal agencies. An interagency agreement is between federal agencies; an intra-agency agreement is between NIH institutes or centers.

Go to these NIAID resources:

interim payline

Temporary, administrative measure used to fund top-scoring applications early in the fiscal year.

NIAID uses interim paylines before receiving its annual appropriation and immediately afterwards while our budget office is crunching the numbers to create actual paylines. Some fiscal years require a longer period of interim paylines for reasons other than the lack of budget data.

Interim paylines are set conservatively so NIAID has the funds to pay the best quality applications throughout the fiscal year. Because interim paylines are not true paylines, we do not announce them through NIAID Funding Newsletter and Email Alerts.

Go to these NIAID resources:

interim PI

Principal investigator appointed by a grantee institution with NIAID's approval to temporarily replace a permanent PI who will be absent from a project for three or more consecutive months.

Go to NIAID's Change of Principal Investigator SOP.

Internal Revenue Service

U.S. federal tax collection agency. Go to IRS.

international organization

Organization that identifies itself as international or intergovernmental and has members from and represents the interests of one or more countries outside the U.S.

Go to NIAID's Foreign SOPs and NIAID International Awards portal.

intervention

Physical procedures and other manipulations of human subjects or their environment for gathering research data.

Go to these resources:

intervention difference See analysis.
intramural

Research conducted in government laboratories headed by NIH-employed scientists. See NIAID's Division of Intramural Research and the converse extramural.

Go to NIAID's Extramural and Intramural Research questions and answers and the Division of Intramural Research.

intra-agency agreement (Y)

Written arrangement between two or more institutes and centers. Approval authority is the same as for interagency agreements.

Go to these NIAID resources:

investigational device Device, including a transitional device, under investigation. Go to definitions in 21 CFR 812.3 and full 21 CFR 812.
investigational device exemption

Similar to an IND, allows an unapproved medical device to be used for investigational purposes. Go to 21 CFR 812.1.

investigational drug

1. Substance in a clinical stage of evaluation not released by FDA for general use or for sale in interstate commerce.

2. Commercial drug that is proposed for a new use, contains a new component, has a new dosage or mode of administration, or is in a new combination or combined in new proportions with another drug.

See investigational new drug application, clinical trials, and human subjects.

investigational medical device

Healthcare product that does not work by chemical action or by being metabolized and is not yet approved for marketing by FDA. See clinical trials and human subjects.

Go to the NIAID Human Subjects Resources portal.

investigational new drug (IND)

Status given by FDA to a new drug or biological product to be used in a clinical investigation. See investigational new drug application and clinical research.

Go to definitions in 21 CFR 312.3 and the NIAID Human Subjects Resources portal.

investigational new drug application (INDA)

Under regulation 21 CFR 312, application filed by a drug sponsor with FDA to conduct clinical trials, submitted with Form FDA 1571. Application includes detailed descriptions of all phases, protocols, and lists of investigators and reviewing institutional review boards.

Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug. May be used interchangeably with IND.

See clinical research, clinical trial, human subjects, and treatment investigational new drug,

Go to these resources:

investigational new drug, treatment See treatment investigational new drug.
investigator for human subjects research

Person involved in human subjects research, excluding one who provides only coded private information or specimens, e.g., through a tissue repository, unless also a consultant or collaborator. Investigators who do not have access to identifiers are exempt from human subjects requirements.

Go to these resources:

investigator, new

See new investigator.

investigator-initiated

Research funded after an investigator submits a grant application to NIH on a topic of his or her choice that is within an institute's mission (also known as unsolicited research).

Applications responding to program announcements are investigator-initiated; those responding to requests for applications or solicitations are targeted research. See parent program announcement.

Go to NIH's Parent Announcements and these NIAID resources:

Investigator-Initiated Clinical Trial Planning and Implementation Award (R34, R01, or U01)

NIAID's mandatory process for investigator-initiated clinical trials:

  • A planning grant (R34) is an option for investigators who need funds for planning a clinical trial.
  • Clinical trials we define as high risk require a cooperative agreement (U01).
  • For clinical trials that are not high risk, applicants submit a milestone-driven R01 application.
  • R01 and U01 applicants must show they are ready to start the clinical trial. Criteria for readiness depend on the level of risk to participants.
  • For all three grants, applicants are strongly encouraged to request prior consultation from program staff before application.

Go to these NIAID resources:

IOM Institute of Medicine. Go to IOM.
IRB See institutional review board.
IRG See integrated review group.

IRS

See Internal Revenue Service.
ISI See influential scientific information.
ITN See Immune Tolerance Network.

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Last Updated February 03, 2014

Last Reviewed April 08, 2013