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

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.

For more information, go to these resources:

• NIH's Research Using Human Specimens, Cell Lines, or Data FAQs
• NIAID Human Subjects Application and Grant Handbook
• NIAID Human Subjects Resources portal

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

For more information, go to these resources:

• NIH's iEdison
• NIAID's Invention Reporting Has Four Parts (for grants)
• NIAID's Invention Reporting for Contracts SOP

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.

For more information, go to ITN and Juvenile Diabetes Research Foundation International.

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

For more information, go to IMPAC and NIAID's IMPAC and RePORTER SOP.

See overall impact/priority score.

Form in a Grant Application Package 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. Also see Targeted/Planned Enrollment Table.

For more information, go to these resources:

• NIAID's Send NIAID the Inclusion Enrollment Form in NIAID Human Subjects Application and Grant Handbook
• NIAID Human Subjects Application and Grant Handbook
• NIAID Human Subjects Resources portal
• For electronic grant applications: the Grant Application Guide for your Grant Application Package.
• For paper applications: the PHS 398 instructions.

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

For more information, go to NIAID's Small Business Awards portal and Office of Technology Development.

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

For more information, go to NIAID's Contracts portal.

Contract that provides an unspecified quantity of supplies or services during a fixed period. The government schedules deliverables by placing orders with a contractor.

For more information, go to FAR 16.504 and NIAID's Contracts portal.

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.

For more information, go to these resources:

• HHS's Electronic Federalwide Assurance and IRB/IEC Registrations
• NIAID's Human Subjects Certifications: IRB or IEC SOP
• NIAID Human Subjects Resources portal

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

For more information, go to NIAID's Independent Government Cost Estimate SOP and Contracts portal.

Small group of independent investigators and biostatisticians who review data.

For more information, go to NIAID's Clinical Trial Monitoring SOP and NIAID Human Subjects Resources portal.

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.

For more information, go to NIAID's Clinical Trial Monitoring 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. For institutions, see Federalwide Assurance

For more information, go to these resources:

• HHS's Extension of an FWA to Cover Collaborating Individual Investigators and the IIA
• HHS's Individual Investigator Agreement sample form
• 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.

For more information, go to these resources:

• Definitions in 45 CFR 46.102(f) and full 45 CFR 46
• HHS's Guidance on Research Involving Coded Private Information or Biological Specimens
• NIH's Research Using Human Specimens, Cell Lines, or Data FAQs
• NIAID's Private Information or Biological Specimens in Human Subjects Research questions and answers
• NIAID Human Subjects Application and Grant Handbook
• 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.

For more information, go to 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.

For more information, go to these resources:

• 45 CFR 46.116 general requirements for informed consent
• 21 CFR 50.20
• NIAID Human Subjects Resources portal

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 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.

For more information, go to NIH's Center for Scientific Review and these NIAID resources:

• Initial Peer Review Assesses Scientific Merit in the NIH Grant Cycle: Application to Renewal
• Peer Review portal

initial peer review criteria

Basis for assessing the scientific and technical merit of NIH research grant applications for initial peer review.

For more information, go to these NIAID resources:

• How NIH Review Criteria Affect Your Score in the NIH Grant Cycle: Application to Renewal
• Review Criteria SOP
• Peer Review portal

Request for applications, program announcement, 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.

Initiatives are published in the NIH Guide. RFAs and PAs are also published in Grants.gov as funding opportunity announcements, and contract solicitations are in FedBizOpps.gov.

See targeted research and the converse investigator-initiated.

For more information, go to these NIAID resources:

• Opportunities and Announcements portal
• Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal; Targeted Research SOPs
• RFAs, PAs, and Solicitations questions and answers
• High-Priority Topics: Concepts and Initiatives questions and answers

Go to the NIH Guide and NIH's Research Project Grant Parent R01 Guide notice.

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.

For more information, go to NIAID's Grant Application portal.

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

For more information, go to Fogarty International Center and NIH ICs.

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.

For more information, go to these resources:

• NIH's IACUC Guidebook
• NIAID's Working With Your IACUC in How to Write an Application Involving Research Animals
• 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 Office of Laboratory Animal Welfare.

For more information, go to these resources:

• NIH's IACUC Guidebook
• NIAID's Working With Your IACUC in How to Write an Application Involving Research Animals
• NIAID's 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 institutional official for human subjects.

For more information, go to 45 CFR 46.103 and the NIAID Human Subjects Resources portal.

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.

For more information, go to these resources:

• NIH Guidelines for Research Involving Recombinant DNA Molecules
• NIH Office of Biotechnology Activities
• Biodefense and Biosecurity portal

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.

National Center for Research Resources program that NIAID participates in, which funds research at institutions in states with historically low rates of NIH support.

For more information, go to National Center for Research Resources and IDeA.

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.

For more information, go to these resources:

• PHS Policy on Humane Care and Use of Laboratory Animals
• 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.

For more information, go to the 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. Different laws may define IRB requirements differently. See definitions below.

See institutional review board certification of approval and independent ethics committee.

For more information, go to these resources:

• NIH's Electronic Federalwide Assurance and IRB/IEC Registrations
• Definitions in 45 CFR 46, 21 CFR 50.3, and 21 CFR 56
• NIAID's Human Subjects Certifications: IRB or IEC SOP
• NIAID Human Subjects Resources portal

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.

For more information, go to these resources:

• Definitions in 45 CFR 46.102
• HHS's Electronic Federalwide Assurance and IRB/IEC Registrations
• NIAID's Human Subjects Certifications: IRB or IEC SOP
• NIAID Human Subjects Resources portal

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

For more information, go to the NIAID Human Subjects Resources portal.

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.

For more information, go to CSR Study Section Roster Index at CSR.

Grade of adverse events or side-effects of interventions.

For more information, go to the NIAID Human Subjects Resources portal.

Communication or other interpersonal contact between an investigator and a human subject.

For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.

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.

For more information, go to these NIAID resources:

• Inter- and Intra-Agency Agreements SOP
• Other Grant Types portal

Temporary, administrative measure used to fund topscoring 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.

For more information, go to these NIAID resources:

• NIAID Funding News newsletter
• NIAID Funding News and Email Alerts Subscription Center

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.

For more information, go to NIAID's Change of Principal Investigator SOP.

U.S. federal tax collection agency. For more information, 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.

For more information, go to NIAID's Foreign SOPs and NIAID International Awards portal.

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

For more information, go to these resources:

• Definitions in 45 CFR 46.102 and 45 CFR 46
• NIAID Human Subjects Resources portal

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

For more information, go to NIAID's Extramural and Intramural Research questions and answers and the Division of Intramural Research.

Similar to an IND, allows an unapproved medical device to be used for investigational purposes.

For more information, go to 21 CFR 812.1 and 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.

For more information, go to the 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.

For more information, go to the NIAID Human Subjects Resources portal.

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

For more information, go to definitions in 21 CFR 312.3 and the NIAID Human Subjects Resources portal.

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.

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

For more information, go to these resources:

• 21 CFR 312
• 21 CFR 312.23 IND content and format
• NIAID Human Subjects Resources portal

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.

For more information, go to these resources:

• Investigator Responsibilities in Human Research questions and answers of the Office for Human Research Protections
• HHS's Guidance on Research Involving Coded Private Information or Biological Specimens
• NIAID's Are You Conducting Human Subjects Research? in NIAID Human Subjects Application and Grant Handbook
• NIAID Human Subjects Resources portal

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 or solicitation are not. See parent program announcement and the converse, targeted research.

For more information, go to NIH's Parent Announcements and these NIAID resources:

• Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal
• How does NIH define investigator-initiated applications? question and answer
• NIH Funding Opportunities Relevant to NIAID
• Grant Application portal

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).

For more information, go to these NIAID resources:

• Investigator-Initiated Clinical Trials Resources
• 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 the 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 Program identified in NIH's just-in-time notification letter.

For more information, go to these NIAID resources:

• Research Conduct Training Sample Letter
• Just-in-Time SOP
• Just-in-Time questions and answers

Action that allows the government to expand a contract beyond its original scope and terms without undergoing an open competition. It is used in various circumstances, such as to protect national security.

For more information, go to these resources:

• FAR Parts 5, 6, 7 and 13
• HHSAR Parts 305, 306 and 307
• NIAID's Justification for Other than Full and Open Competition SOP
• NIAID's Contracts portal

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.

See Research and Related Senior/Key Person Profile form and other support.

For more information, go to NIAID's Senior/Key Person Profile Form: Prepare the Biographical Sketches in the NIH Grant Cycle: Application to Renewal.

Written preliminary contractual instrument that authorizes a contractor to begin immediately manufacturing supplies or performing services.

For more information, go to FAR 16.603-1 and NIAID's Contracts portal.

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.

For more information, go to NIAID's Office of Technology Development.

Costs to an agency for recurring operations and supporting and disposing of items acquired during a contract.

They include the amortized annual costs associated with capital, installation, operations, maintenance, and disposal, discounted over the lifetime of a product.

For more information, go to NIAID's Contracts portal.

See Bibliography and References Cited.

marketing application

Application submitted to FDA for a new drug or a product license application for a biological product.

For more information, go to definitions in 21 CFR 312.3 and full 21 CFR 312.

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.

For more information, 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.

For more information, go to these NIAID resources:

• Grants portals
• Selection of Appropriate Funding Mechanisms SOP
• Award Types questions and answers

One of the National Library of Medicine's databases of scientific publications. Go to NLM Databases & Electronic Resources.

For more information, go to the National Library of Medicine and NLM Databases & Electronic Resources.

Five-year grant that NIAID awards investigators with stellar records of research accomplishment.

For more information, go to NIAID's MERIT Awards and Extensions SOP.

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 risk.

For more information, go to 45 CFR 46.102 and 21 CFR 50.3.

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.

Policy stating that an investigator must submit plans for sharing mammalian and non-mammalian eukaryotic models to comply with NIH policy.

For more information, go to these resources:

• NIH Policy on Sharing Model Organisms
• NIH's Model Organism for Biomedical Research
• NIAID's Sharing Model Organisms SOP
• NIAID's 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.

For more information, go to NIH's Modular Research Grant Applications and NIAID's Modular Grants SOP.

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.

For more information, go to these resources:

• Definitions in 21 CFR 812.3 and 21 CFR 812
• NIAID's Clinical Trial Monitoring SOP
• NIAID Human Subjects Resources portal

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.

For more information, go to these resources:

• NIH's Multiple Principal Investigators
• NIAID's Take Heed -- You Might Want to Avoid a Multiple PI Application in the NIH Grant Cycle: Application to Renewal

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.

For more information, 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 must respond to a request for applications or program announcement.

For more information, go to these NIAID resources:

• Instructions for Preparing a Multiproject Research Application and Multiproject Awards SOP
• Other Grant Types portal