||See institutional animal care and use committee.
||International AIDS Vaccine Initiative. Go to
||See institutional biosafety committee.
||Introduction to Biomedical Research Program.
||See institutes and centers.
||See Investigational Device Exemption.
||See Institutional Development Award Program.
|Identification number, application
||See application identification number.
Information 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
Go to NIH's FAQs about Research Using Human Specimens, Cell
Lines or Data.
||See Indefinite Delivery Indefinite Quantity contract.
||See independent ethics committee.
||NIH's electronic invention reporting system. See Employee invention report. Go to iEdison and NIAID's Invention
Reporting Has Four Parts (for grants) and Invention Reporting for Contracts SOP.
||See individual investigator agreement.
||Internal monitoring board.
| Immune Tolerance Network
|| 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.
||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 CRISP SOP.
| Inclusion Enrollment Report Table
Form for reporting human
subject research participation
as part of a grant
progress report or revision (competing
Go to NIAID's Send the Inclusion
Enrollment Form With Your Progress Report tutorial page. Also see Targeted/Planned
For electronic applications, go to the Grant
Application Guide for your Grant
Application Package. For paper applications, go to the PHS
398 for instructions. Go to NIAID's How to Write a Human Subjects Grant Application tutorial and Human Subjects, Clinical Research.
|| Organization that fosters the growth of new ideas or companies by providing resources such as financing, management expertise, office services, and possibly office space. Go to NIAID's Small Business Awards and Office of Technology Development.
||See investigational new drug.
| Indefinite delivery indefinite quantity contract
||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 NIAID's R&D Contracts.
| Indefinite quantity contract
||Contract that provides an unspecified quantity of supplies or services during a fixed period. The government schedules deliverables by placing orders with a contractor. Go to FAR 16.504 and NIAID's R&D Contracts.
| Independent ethics committee
Body used by an international research organization that performs the functions of an institutional review board. It also must file a Federalwide Assurance with the HHS Office for Human Research Protections.
Go to NIAID's Human Subjects Certifications: IRB or IEC SOP and Human Subjects, Clinical Research.
| Independent government cost estimate
||Estimate by the 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 and R&D Contracts.
|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 and Human Subjects, Clinical Research.
|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 on Human Subjects, Clinical Research.
||Formerly used term -- see facilities and administrative costs.
Single Project Assurance for human
subjects from the Office for Human Research Protections that
replaces other types of individual investigator agreements.
Go to the Office for Human Research Protections' Extension of an FWA to Cover Collaborating Individual Investigators
and the IIA and an online Individual
Investigator Agreement. For institutions, see Federalwide Assurance.
Go to NIAID's Human Subjects, Clinical Research.
the identity of a human subject that an investigator may ascertain
or through a coding system.
Go to definition 45
CFR 46.102(f) and full 45 CFR 46. If identity
is knowable, the study is considered to be human
Go to the Office
for Human Research Protections Guidance on Research Involving Coded Private Information or Biological Specimens. Go to NIAID's Private Information or Biological Specimens in Human Subjects Research questions and answers and Human Subjects, Clinical Research.
|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 the Final Information Quality Bulletin for Peer Review in the Federal Register.
|Information for Management, Planning, Analysis, and Coordination
|Information Quality Bulletin for Peer Review
||See OMB Information Quality Bulletin for Peer Review.
| Informed consent
Person's voluntary agreement, based upon 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 45
CFR 46.116 general requirements for informed consent. See NIAID's Human Subjects,
Clinical Research. Also see 21
CFR 50.20. Informed consent requirements may vary by law.
| Initial peer review
First level of peer review by non-NIH scientific experts, called peer reviewers, who assess the scientific merit of grant applications and contract proposals. NIH's Center for Scientific Review conducts peer review of investigator-initiated applications.
ICs 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 requests for proposals.
Go to NIAID's Peer Review portal, Initial Peer Review Assesses Scientific Merit tutorial page and Peer Review of R&D Contract Technical Proposals SOP.
Also see dual peer review, study section, scientific review group, and integrated review group.
| Initial peer review criteria for grants
Basis for assessing the scientific merit of NIH research grant applications for initial peer review. Go to NIAID's How NIH Review Criteria Affect Your Score tutorial page and Review
|Initial review group
||Formerly used term -- see integrated review group and study section.
for applications, request
for proposals, or program
announcement (PA) to stimulate research in a scientific topic. Parent program announcements are PAs that are not initiatives; the converse is an institute-specific initiative.
Publication of an initiative follows approval of the concept by NIAID's main advisory Council.
Initiatives are published in the NIH Guide. Also find RFAs and PAs in Grants.gov as funding opportunity announcements, and contract requests
for proposals in FedBizOpps.
Go to NIAID's Opportunities and Announcements and R&D Contracts. Go to NIAID's How Funding Opportunities Work and subsequent tutorial pages, Targeted Research SOPs, RFAs, RFPs, and PAs questions and answers, and High-Priority Topics: Concepts and Initiatives questions and answers.
| Institute-specific initiative
Initiative that states the interest of one or more ICs to receive applications or proposals in an area of scientific need or opportunity. Also see its converse, parent program announcement.
| Institutes and centers
||Major NIH organizations: institutes, such as NIAID, and centers, such as the Fogarty International Center. Go to NIH ICs.
| Institutional animal care and use committee
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 to ensure humane care and use of animals and is complying with regulations. They also review and approve protocols.
Go to the Office of Laboratory Animal Welfare's IACUC Guidebook and NIAID's Working With Your IACUC and subsequent tutorial pages, Animals in Research SOP, and Research Animals.
| Institutional animal care and use committee certification
Approval by an IACUC of a project involving animals in research. Grant applications and contract proposals must include verification of IACUC certification before award.
See institutional official for animal welfare. Go to the Office of Laboratory Animal Welfare's IACUC Guidebook and NIAID's Working With Your IACUC and subsequent tutorial pages, Animals in Research SOP, and Research Animals.
| 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 can use an online Federalwide Assurance.
See 45 CFR 46.103. See institutional official for human subjects. Go to NIAID's Human Subjects, Clinical Research.
| Institutional biosafety committee
Committee set up by an institution under NIH Guidelines for Research Involving Recombinant DNA Molecules to review recombinant DNA research and ensure its appropriate use.
IBCs may also review other biohazardous research, including biodefense select agents. Go to NIH Office of Biotechnology Activities.
| Institutional business official
Person working in a research organization's business office who has signature or other authority. For Grants.gov that person is called an authorized
organizational representative; for the Commons it is a signing official.
| Institutional Development Award Program
||National Center for Research Resources program that NIAID participates in, which funds research at institutions in states with historically low rates of NIH support. Go to IDeA.
| 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 Research Animals.
| Institutional official for human subjects
Senior 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 NIAID's Human Subjects, Clinical Research.
| Institutional review board
set up or 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. Frequently, foreign entities that conduct IRB functions are called independent ethics committees.
See full 45 CFR 46, definition 21 CFR 50.3, and full 21 CFR 56. Different laws may define IRB requirements differently.
IRBs must register with the Office
for Human Research Protections, HHS. Go to NIAID's Human Subjects Certifications: IRB or IEC SOP and Human Subjects, Clinical Research. See institutional review board certification of approval and independent ethics committee.
| Institutional review board certification of approval
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 (IRB) or independent ethics committee (IEC) in accordance with an approved assurance.
Includes IRB or IEC 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 institutional review board approval annually
in a noncompeting grant
application and when major changes in a
protocol or other procedures occur. IRBs must also certify approval of results
of subset analyses
in renewal grant
applications and contract
See definition 45 CFR 46.102. Go to Electronic
Federalwide Assurance and IRB/IEC Registrations and NIAID's Human Subjects Certifications: IRB or IEC SOP and Human Subjects, Clinical Research.
|Institutional review board documentation
||Method of documenting an IRB's assessment of proposed or active research. Go to NIAID's Human Subjects, Clinical Research.
| Integrated review group
||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.
| Intensity or severity of adverse events
||Grade of adverse events or side-effects of interventions. Go to NIAID's Human Subjects, Clinical Research.
||Communication or other interpersonal contact between an investigator and a human subject.
Go to definition 45 CFR
46.102 and full 45
| Interagency agreement
Written arrangement between two or more federal agencies. See Y series activity code.
| Interim PI
Principal investigator appointed by a grantee institution with NIAID approval to temporarily replace a permanent PI who will be absent from a project for three or more consecutive months. Go to the Change of Principal Investigator SOP.
| Internal Revenue Service
U.S. federal tax collection agency. Go to IRS.
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.
||Physical procedures and other manipulations of human subjects or their environment for gathering research data. Go to definition 45 CFR 46.102 and
CFR 46. Go to NIAID's Human Subjects, Clinical Research.
| Intramural research
||Research conducted in government laboratories headed by NIH-employed scientists. See also NIAID Division of Intramural Research and extramural research. Go to NIAID's Extramural and Intramural Research questions and answers.
||Written arrangement between two or more ICs. Approval authority is the same as for interagency agreements.
| Investigational device
including a transitional device, under investigation. Go to definition 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. Go to NIAID's Human Subjects, Clinical Research.
| 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 drugs that are proposed for a new use, contain a new component, have a new dosage or mode of administration, or are in a new combination or combined in new proportions.
See investigational new drug application, clinical trials, and human subjects. Go to NIAID's Human Subjects, Clinical Research.
| 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 NIAID's Human Subjects, Clinical Research.
| Investigational new drug
Status given by the FDA to a new drug or biological product to be used in a clinical investigation. See definition 21 CFR 312.3. See investigational new drug application and clinical research.
| Investigational new drug application
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 IRBs.
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.
Go to 21 CFR 312.23 IND content and format. See clinical research, clinical trials, treatment investigational new drug, and human subjects. Go to NIAID's Human Subjects, Clinical Research.
|Investigational new drug, treatment
|| See treatment
investigational new drug.
for human subjects research
Person involved in human
subjects research, excluding those
who only provide 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
See the Investigator
Responsibilities section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
Go to NIAID's Are You Conducting Human Subjects Research? tutorial page on Human Subjects, Clinical Research. Go to the Office for Human Research Protections's Guidance on Research Involving Coded Private Information or Biological Specimens.
| Investigator-Initiated Clinical Trial Planning and Implementation Grant
NIAID's mandatory two-stage process for investigator-initiated clinical trials. First, applicants apply for an R34, Clinical Trial Planning grant, which provides funds to prepare materials NIAID needs to determine a project's feasibility as well as documentation for applying for the next step, a clinical trial cooperative agreement (U01).
Go to NIAID's Investigator-Initiated Clinical Trials Resources for links to Questions and Answers, NIH Guide notices, and other resources. Go to NIAID's Human Subjects, Clinical Research.
| Investigator-initiated research
as a result of an investigator's submitting a research grant
application to NIH on a topic of his or her choice (also known as unsolicited
Applications responding to program announcements are investigator initiated; those responding to requests for application are not. See the converse, targeted research, and parent program announcement.
Go to NIAID's How to Choose an Application Topic tutorial page and How does NIH
define investigator-initiated applications? question and answer.
||Institute of Medicine. Go to IOM.
||See institutional review board.
||See integrated review group.
|See Internal Revenue Service.
||See Immune Tolerance Network.
||See Justification for other than full and open competition.
Timeframe that requires applicants to
send some information to NIH after
a grant application has been peer
reviewed and is in the range of possible
Just-in-time is used for other
support information and other items, including certification of IRB
certification, and Research
Conduct Training Sample Letter.
Business officials should submit information using the JIT feature of the eRA
Commons or fax the information to the NIH grants management office identified in NIH's just-in-time notification letter.
Go to NIAID's Just-in-Time SOP and Just-in-Time questions and answers.
| Justification for other than full and open competition
||Action that allows the government to expand a contract beyond its original scope and terms without undergoing an open competition. This is used for various circumstances, such as national security issues. Go to FAR Parts 5, 6, 7 and 13 and HHSAR Parts 305, 306 and 307. Go to NIAID's Justification for Other than Full and Open Competition SOP and R&D Contracts.
||See career development awards.
| Key personnel -- grants
Participants in a grant or application who
contribute substantively to the scientific development
or execution of a project. Key personnel contribute a specified level of time (contrast with other significant contributor) whether or not earning a salary.
include the principal
investigator as well as any consultants who meet the definition above.
Go to NIAID's Senior/Key
Person Profile Form: Prepare the Biographical Sketches in Part 6. Other Application Sections of the NIH Grant Cycle: Application to Renewal. See Research and Related Senior/Key Person Profile form and other support.
PI leadership plan.
| Letter contract
Written preliminary contractual instrument that authorizes a contractor to begin immediately manufacturing supplies or performing services. Go to FAR 16.603-1 and NIAID's R&D Contracts.
| Letter of interest
||Letter NIAID may require or request from an applicant or offeror before the Institute issues an RFA or RFP or before it accepts grant applications or contract proposals.
||Legally binding agreement that gives certain rights to a licensee, e.g., patent rights or use of materials, such as in a biological material license or material transfer agreement. Go to NIAID's Office of Technology Development.
Cost to an agency for recurring operations and supporting
and disposing of items acquired during a contract. Go to NIAID's R&D Contracts.
Amortized annual cost of a product, including costs associated with capital, installation, operations, maintenance, and disposal, discounted over the lifetime of the product.
For electronic applications, Bibliography
and References Cited in the Research and Related Other Project Information component of
For paper grant applications, Part G. of PHS
Plan. Go to Other Project
Information Form: Bibliography and References Cited in the NIH Grant Cycle: Application to Renewal.
| Majority group
||Human subjects term indicating a white person, not Hispanic, having origins in the original peoples of Europe, North Africa, or the Middle East.
| Marketing application
||Application submitted to FDA for
a new drug or a product license application for
a biological product.
Go to definition 21 CFR 312.3 or
full 21 CFR
||Process congressional committees and subcommittees use to debate, amend, and rewrite proposed legislation.
| Matching or cost sharing
||Value of third-party contributions; the portion of costs of a federally funded project not paid for by the federal government.
| Material transfer agreement
Legal document defining the conditions under which materials can be transferred and used among research laboratories, usually for unpatented biological materials transferring to non-profit entities or for-profit entities for research purposes only.
Go to NIAID's Office of Technology Development.
||See Minority Biomedical Research Support.
||Materials Cooperative Research and Development
Budget activity or grouping of
related activities that may vary for budgetary or reporting purposes.
usually combine activity
codes; for example, the training mechanism includes career (K), fellowship (F),
and training (T)
activity codes. Other frequently used mechanisms are research
project grants, small business awards, and contracts.
Often used interchangeably with activity code. Go to NIAID's Grants portals, the Selection
of Appropriate Funding Mechanisms SOP, and Award Types questions and answers.
| Medical device
||Diagnostic or therapeutic article that does not work through chemical action, such as a diagnostic test kit.
||One of the National Library of Medicine's databases of scientific publications. Go to NLM Databases & Electronic Resources.
||See method to extend research in time award.
| Method to extend research in time award
||Five-year grant that NIAID awards investigators with stellar records of research accomplishment. Go to NIAID's MERIT Awards and Extensions SOP.
| Microbiology and Infectious Diseases Research Committee
||NIAID scientific review group for grant applications in microbiology and infectious diseases. Go to MIDRC roster.
||See Microbiology and Infectious Diseases Research Committee.
||Multilateral Initiative on Malaria. Go to MIM.
| Minimal risk
||Human subjects term indicating that the probability and magnitude of harm or discomfort anticipated in research are not greater than those encountered in daily life or routine tests. See definition 45 CFR 46.102 and 21 CFR 50.3.
| Minority group
Human subjects term indicating a subset of the U.S. population distinguished by racial, ethnic, or cultural heritage.
Categories are: American Indian or Alaskan Native, Asian, black or African American, Hispanic or Latino, and Native Hawaiian and other Pacific Islander.
Inclusion of a group should be determined by the scientific questions under examination and their relevance. Not every study will include all minority groups or subpopulations. Also see underrepresented group.
| Minority Biomedical Research Support
|| Program to increase the number of researchers who are members of minority groups underrepresented in the biomedical sciences. Go to MBRS.
||See underrepresented minorities.
| Misconduct in science
See research misconduct.
| Model organism
Animal, plant, or other organism used to
study basic biologic processes to provide insight into other organisms.
Go to NIH's Model Organism for Biomedical Research and NIAID's Sharing Model Organisms SOP and Sharing Model Organisms questions and answers.
| Model organism sharing
Policy stating that an investigator must submit plans for sharing mammalian and non-mammalian eukaryotic models to comply with the NIH Policy on Sharing Model Organisms.
Go to NIH's Model Organism for Biomedical Research and NIAID's Sharing Model Organisms SOP and Sharing Model Organisms questions and answers.
||See contract modification.
| Modified summary statement
||Former term for a summary statement containing reviewer critiques; now standard practice.
Modular budget justification page
For paper grant applications, form for a modular budget justification in the PHS 398 grant application. For non-modular budgets, see detailed budget page. Go to NIAID's Strategy
for Planning a Budget in the NIH Grant Cycle: Application to Renewal.
Modular Budget, PHS 398
See PHS 398 Modular Budget (for electronic applications).
| Modular budget
grant budget type that eliminates the need for details by requiring applicants to request budgets in modules of $25,000.
Used for grant applications requesting $250,000 or
less in annual direct
costs for R01, R03, R15, R21, R34, and some requests for applications and program announcements.
Go to NIAID's Modular
Grants SOP and NIH's Modular Research Grant Applications.
Person designated by a sponsor or contract
research organization to oversee an investigation. A monitor may
be an employee or a consultant to
a sponsor or a contractor.
Monitor also means to oversee an investigation. See clinical
trial monitoring. Go to definition 21 CFR 812.3 or
full 21 CFR 812.
Go to NIAID's Clinical Trial Monitoring SOP, Human Subjects, Clinical Research and R&D Contracts.
|Monitoring, clinical trial
||See clinical trial monitoring.
||Multiple project assurance.
||See material transfer agreement.
||Describes a grant application or award that has more than one principal
investigator at one
or more institutions. Go to NIAID's Take Heed -- You Might Want to Avoid a Multiple PI Application in the NIH Grant Cycle: Application to Renewal and NIH's Multiple
|Multiple PI Leadership Plan
Part of a multiple
PI grant application that describes how the PIs
will manage the project, including
making decisions on scientific direction, allocating resources,
and resolving conflicts. Go to NIAID's Take Heed -- You Might Want to Avoid a Multiple PI Application in the NIH Grant Cycle: Application to Renewal.
| Multipotent stem cell
||Stem cell usually derived from an early embryo or embryonic germ cell that can differentiate into many types of cells of the endoderm, ectoderm, and mesoderm. Compare with totipotent, pluripotent, oligopotent, and unipotent stem cells.
| Multiproject grant
Single grant that funds at least two related research projects. For some grant types, multiproject applications may be investigator-initiated or responding to an RFA or PA. Go to NIAID's Instructions for Preparing a Multiproject Grant Application and Multiproject Awards SOP.