NIAID Glossary of Funding and Policy Terms and Acronyms: I-M

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

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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 accession numbers.

Go to NIH's FAQs about Research Using Human Specimens, Cell Lines or Data.

Form for reporting human subject research participation as part of a grant progress report or revision (competing supplement) application.

Go to NIAID's Send the Inclusion Enrollment Form With Your Progress Report tutorial page. Also see Targeted/Planned Enrollment Table.

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 Application tutorial and Human Subjects, Clinical Research.

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.

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.

Describes private information regarding the identity of a human subject that an investigator may ascertain directly 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 subjects research.

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.

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.

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.

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.

For descriptions of activity codes, go to NIAID's Extramural Activity Codes. Go to NIAID's 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.

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 Criteria SOP.

Request 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 Funding 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.

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.

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.

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.

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.

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.

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.

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.

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.

Committee 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.

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 (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 proposals.

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.

Written arrangement between two or more federal agencies. See Y series activity code. For descriptions of activity codes, go to NIAID's Extramural Activity Codes.

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 Grants and Contracts.

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.

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.

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.

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.

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.

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 requirements.

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.

See new investigator.

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.

Research funded 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 research).

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.

IRS

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 funding.

Just-in-time is used for other support information and other items, including certification of IRB approval, Federalwide Assurance, IACUC 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.

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.

Key personnel include the principal investigator and 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.

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.

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 the SF 424.

For paper grant applications, Part G. of PHS 398 Research Plan. Go to Other Project Information Form: Bibliography and References Cited in the NIH Grant Cycle: Application to Renewal.

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.

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.

See research misconduct.

Animal, plant, or other organism used to study basic biologic processes to provide insight into other organisms. See model organism sharing.

Go to NIH's Model Organism for Biomedical Research and NIAID's Sharing Model Organisms SOP and Sharing Model Organisms questions and answers.

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.

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).

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.

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.

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.