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

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.

See overall impact/priority score.

Form for human subjects research to report participation of special populations -- such as African Americans, children, and women -- as part of a grant progress report or revision application.

Go to NIAID's Send the Inclusion Enrollment Form With Your Progress Report in the NIH Grant Cycle: Application to Renewal.

For electronic grant 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 and NIAID Human Subjects Resources portal. See Targeted/Planned Enrollment Table.

Body used by an international research organization that performs the functions of an institutional review board. For an HHS-supported award, an IEC must register with the Office for Human Research Protections, HHS. Go to Electronic Federalwide Assurance and IRB/IEC Registrations.

Go to NIAID's Human Subjects Certifications: IRB or IEC SOP and NIAID Human Subjects Resources portal.

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 Human Subjects Resources portal.

Describes private information regarding the identity of human subjects that an investigator may ascertain directly or through a coding system. Go to definitions in 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 NIAID Human Subjects Resources portal.

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 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 45 CFR 46.116 general requirements for informed consent. Go to NIAID Human Subjects Resources portal. Also go to 21 CFR 50.20 since informed consent requirements may vary by law.

First level of peer review by non-NIH scientific experts, called peer reviewers, who assess the scientific and technical merit of grant applications and contract proposals. NIH's Center for Scientific Review conducts 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 requests for proposals.

Go to NIAID's Peer Review portal, Initial Peer Review Assesses Scientific Merit in the NIH Grant Cycle: Application to Renewal and Peer Review of R&D Contract Technical Proposals SOP. Go to NIAID's Peer Review portal.

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

initial peer review criteria

Basis for assessing the scientific and technical merit of NIH research grant applications for initial peer review. Go to NIAID's How NIH Review Criteria Affect Your Score in the NIH Grant Cycle: Application to Renewal and Review Criteria SOP. Go to NIAID's Peer Review portal.

Request for applications, request for proposals, or program announcement to stimulate research in a scientific topic. (Parent program announcements, e.g., Research Project Grant 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.

Initiatives are published in the NIH Guide. RFAs and PAs are also published in Grants.gov as funding opportunity announcements, and contract requests for proposals are in FedBizOpps. Go to NIAID's list of NIH Funding Opportunities Relevant to NIAID and Contracts.

Go to NIAID's Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal; Targeted Research SOPs; RFAs, RFPs, and PAs questions and answers; and High-Priority Topics: Concepts and Initiatives questions and answers.

See targeted research and the converse investigator-initiated.

Initiative that states the interest of one or more institutes and centers 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 and 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 in How to Write an Application Involving Research Animals, and Animals in Research portal.

Approval by an institutional animal care and use committee 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 in How to Write an Application Involving Research Animals, and Animals in Research portal.

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 45 CFR 46.103. See institutional official for human subjects. Go to NIAID Human Subjects Resources portal.

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 authorities. 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 Animals in Research portal.

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 Human Subjects Resources portal.

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. Frequently, foreign entities that conduct IRB functions are called independent ethics committees.

IRBs must register with the Office for Human Research Protections, HHS. Go to Electronic Federalwide Assurance and IRB/IEC Registrations. Go to full 45 CFR 46, definitions in 21 CFR 50.3, and full 21 CFR 56. Different laws may define IRB requirements differently.

Go to NIAID's Human Subjects Certifications: IRB or IEC SOP and NIAID Human Subjects Resources portal. 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 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 IEC must also certify approval of results of subset analyses in renewal applications and contract proposals.

Go to definitions in 45 CFR 46.102. Go to Electronic Federalwide Assurance and IRB/IEC Registrations and NIAID's Human Subjects Certifications: IRB or IEC SOP and NIAID Human Subjects Resources portal.

Written arrangement between two or more federal agencies.

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

NIAID uses interim paylines before receiving its annual appropriation and immediately afterwards while the budget office is crunching the numbers to create actual paylines.

Interim paylines are conservative so NIAID does not inadvertently exceed its budget early in the fiscal year. Because interim paylines are not true paylines, we do not announce them through NIAID Funding News and Email Alerts.

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.

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.

Similar to an IND, allows an unapproved medical device to be used for investigational purposes. Go to 21 CFR 812.1. Go to NIAID Human Subjects Resources portal.

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. Go to NIAID Human Subjects Resources portal.

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 Human Subjects Resources portal.

Status given by the FDA to a new drug or biological product to be used in a clinical investigation. Go to definitions in 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 institutional review boards.

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 Human Subjects Resources portal.

Person involved in human subjects research, excluding those who provide 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 Investigator Responsibilities in Human Research questions and answers of the Office for Human Research Protections.

Go to NIAID's Are You Conducting Human Subjects Research? in How to Write a Human Subjects Grant Application on NIAID Human Subjects Resources portal.

Go to Guidance on Research Involving Coded Private Information or Biological Specimens of the Office for Human Research Protections.

See new investigator.

Research funded after an investigator submits a 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 applications are not. See parent program announcement and the converse, targeted research.

Go to NIAID's Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal and How does NIH define investigator-initiated applications? question and answer.

NIAID's mandatory two-stage process for investigator-initiated clinical trials. First, applicants apply for a Clinical Trial Planning grant (R34), 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 Human Subjects Resources portal.

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 institutional review board certification of approval, Federalwide Assurance, IACUC certification, and Research Conduct Training Sample Letter.

Business officials should submit information using the just-in-time feature of the eRA Commons or fax the information to the 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 (in contrast to other significant contributors) whether or not earning a salary.

Key personnel 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.

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 Contracts.

Amortized annual cost of a product, including costs associated with capital, installation, operations, maintenance, and disposal, discounted over the lifetime of the product.

See Bibliography and References Cited.

marketing application

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.

Budget activity or grouping of related activities that may vary for budgetary or reporting purposes.

Mechanisms 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.

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.

NIH policy requires members of a minority group be included in clinical research barring a compelling rationale not to do so. See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

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, 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, contractor, or consultant to a sponsor.

Monitor also means to oversee an investigation. See clinical trial monitoring. Go to definitions in 21 CFR 812.3 or full 21 CFR 812.

Go to NIAID's Clinical Trial Monitoring SOP, NIAID Human Subjects Resources portal. and Contracts.

Describes a grant application or grant that has more than one principal investigator at one or more institutions. Each is a full-fledged PI who has responsibilities appropriate to that role.

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 Principal Investigators.

Part of a multiple PI grant application that describes how the principal investigators 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 a request for applications or program announcements. Go to NIAID's Instructions for Preparing a Multiproject Research Application and Multiproject Awards SOP.