Information on human subjects that links specimens or data to individually identifiable living people or their medical information. Examples include names, social security numbers, medical record numbers, and pathology accession numbers. See coded private information.

Go to these resources:

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

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

Go to these resources:

• NIH's iEdison
• NIAID's Invention Reporting Has Four Parts in the Strategy for NIH Funding (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.

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.

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

See overall impact score.

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

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

Improper conduct does not include criminal offenses.

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

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

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.

Go to these resources:

• NIAID's Send NIAID the Inclusion Enrollment Form in NIAID Human Subjects Application and Grant Handbook
• For electronic grant applications: the SF 424 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.

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

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

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

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

Go to these resources:

• HHS's Electronic Federalwide Assurance and IRB/IEC Registrations
• NIAID's Human Subjects Certifications: IRB or IEC SOP
• NIAID Human Subjects Application and Grant Handbook

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

Go to NIAID's Independent Government Cost Estimate SOP.

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

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.

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

Go to these resources:

• NIAID's Human Subjects Application and Grant Handbook
• HHS's
  • Extension of an FWA to Cover Collaborating Individual Investigators and the IIA
  • Individual Investigator Agreement sample form

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

Go to these resources:

• NIAID's
  • Private Information or Biological Specimens in Human Subjects Research questions and answers
  • Human Subjects Application and Grant Handbook
• 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

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

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

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

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

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

Go to these resources:

• 45 CFR 46.116 general requirements for informed consent
• 21 CFR 50.20
• Human Subjects Application and Grant Handbook

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

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

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

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

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

• Strategy for NIH Funding
  • Initial Peer Review
  • Ensure You Get the Right Assignments
• Peer Review portal

initial peer review criteria

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

• Significance
• Investigators
• Innovation
• Approach
• Environment

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

Go to these NIAID resources:

• How NIH Review Criteria Affect Your Score in the Strategy for NIH Funding
• Review Criteria SOP

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

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

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

See targeted research and the converse investigator-initiated.

Go to these NIAID resources:

• Opportunities and Announcements portal
• Choose Approach and Find FOAs in the Strategy for NIH Funding
• RFAs, PAs, and Solicitations questions and answers
• High-Priority Topics: Concepts and Initiatives questions and answers

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

Also see Approach, Significance, and overall impact score.

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

Go to these NIAID resources:

• Strategy for NIH Funding
  • Your Project's Scope: Plot Your Boundaries
  • Highlight Significance and Innovation
  • Write the Research Strategy
  • Flight to Safety for Innovation
  • How NIH Review Criteria Affect Your Score
• Review Criteria SOP

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

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

Go to NIAID's Application portal.

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

Go to these resources:

• NIH's IACUC Guidebook
• NIAID's Working With Your IACUC in How to Write an Application Involving Research Animals

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

Go to these resources:

• NIH's IACUC Guidebook
• NIAID's Working With Your IACUC in How to Write an Application Involving 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 file an online Federalwide Assurance.

See institutional official for human subjects and risk.

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

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

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

Go to these resources:

• NIH Guidelines for Research Involving Recombinant DNA Molecules
• NIH Office of Biotechnology Activities
• NIAID's Biodefense and Select Agents portal

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

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

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

Go to NIGMS's Institutional Development Award.

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.

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

Go to the NIAID Human Subjects Application and Grant Handbook.

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

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

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

Go to these resources:

• 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 Application and Grant Handbook

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

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

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

Go to these resources:

• 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 Application and Grant Handbook

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

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

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

Grade of adverse events or side-effects of interventions.

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

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

Go to these NIAID resources:

• Reviewing and Clearing Inter-Agency Agreements
• Inter and Intra-agency Agreement/Direct CAN Citation (IAA DCC)
• Budget SOPs
• Other Grant Types portal

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

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

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

Go to these NIAID resources:

• Paylines and Funding
• NIAID Funding Newsletter and Blog

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 portal.

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

Go to these resources:

• Definitions in 45 CFR 46.102 and 45 CFR 46
• NIAID Human Subjects Application and Grant Handbook

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

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

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

Go to these NIAID resources:

• Reviewing and Clearing Inter-Agency Agreements
• Inter and Intra-agency Agreement/Direct CAN Citation (IAA DCC)
• Budget SOPs
• Other Grant Types portal

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

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.

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

Go to the NIAID Human Subjects Resources portal.

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

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

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

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

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

Go to these resources:

• 21 CFR 312
• 21 CFR 312.23 IND content and format
• NIAID Human Subjects Application and Grant Handbook

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

Go to these resources:

• Investigator Responsibilities—FAQs from the HHS 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 that is within an institute's mission (also known as unsolicited research).

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

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

• Choose Approach and Find FOAs in the Strategy for NIH Funding
• How does NIH define investigator-initiated applications? question and answer
• NIAID Funding Opportunities List
• Application portal

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

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

Go to these NIAID resources:

• Investigator-Initiated Clinical Trial Resources
• NIAID Human Subjects Resources portal

IRS