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NIAID Glossary of Funding and Policy Terms and Acronyms: E-H

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

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Early-stage investigator

Applicant who has completed one of the following within the past 10 years, whichever was later:

  • A final research degree.
  • Discipline-specific training required to become a researcher.

ESI is a subset of new investigator status, so ESIs must meet those criteria as well. See Are You "New"? Status affects initial peer review and funding decisions.

Go to NIAID's New Investigator Guide to NIH Funding and NIH's New Investigators Program.


Congressional requirement that a federal agency set aside funds within an appropriation for a stated recipient or purpose, for example, to establish a research center grant program or conduct a clinical trial.

E-Biz POC See e-business point of contact.
E-business point of contact Person who manages an organization's grant activities and gives other staff privileges to submit grant applications through
ECB See Electronic Council Book.
eCMS See Electronic Contract Management System.
Edison See iEdison.
EIN See employer identification number.
EIR See employee invention report.
Electronic Contract Management System Contracting database that allows potential contractors to prepare and submit contract proposals electronically and enables NIAID staff to administer contracts. Go to NIAID's R&D Contracts.
Electronic Council Book

NIH database system showing a grant application's summary statement, percentile or priority score or both, scientific review group, program class code, application type, activity code, application identity number, principal investigator, and project title downloaded from IMPAC.

ECB also lets members of NIAID's main advisory Council recommend awards early for fundable applications with no special concerns; see human subjects concern, human subjects codes, and animals in research codes. Go to ECB and NIAID's Electronic Council Book SOP.

Electronic grant file File containing all official documentation for a grant.
Electronic Research Administration Infrastructure to allow NIH to electronically receive, review, and administer grant awards. When completed, it will create an online dialogue between NIH and its grantees covering the entire life cycle of a grant. Go to eRA.
Electronic streamlined noncompeting award progress report

System that allows PIs and grantee institutions with awards that have automatic carry over authority to electronically submit a streamlined noncompeting award process progress report. eSNAPs are due 45 days before a noncompeting award's start date.

See expanded authorities and PHS 2590. Go to NIAID's Send Us an Annual Progress Report, eSNAP SOP, and Progress Reports and eSNAP questions and answers.

Embryo Organism in the early stages of development, which in humans is the first six weeks.
Embryonic germ cell Pluripotent stem cell from a fetal gonad cell; precursor to egg or sperm.
Embryonic stem cell Pluripotent stem cell derived from the inner cell mass of a blastocyst-stage embryo.
Employee invention report Invention report due to NIAID within two months after an investigator gives written disclosure to an organizational official. For grants, go to NIAID's Invention Reporting Has Four Parts; for contracts, Invention Reporting for Contracts SOP. Go to iEdison.
Employer identification number Identification of a business to the U.S. Internal Revenue Service; also known as a federal tax identification number. Entered on the SF 424 form of a grant application.
En bloc approval Concurrence by a full advisory Council or a subset of Council members (or occasionally another group) with initial peer review group recommendations for funding approval. Go to NIAID's Council.
Enrollment report table See Inclusion Enrollment Report table.
Entire Proposed Project Period Budget

For paper grant applications only, Form page 5 in the PHS 398 grant application, used to request a budget over $250,000 for a full project period. Also see Detailed Budget for Initial Budget Period. For electronic applications, see Research and Related Budget components.

Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

EPMC See Extramural Program Management Committee.
Equitable Characterizes a state in which investigators fairly distribute research benefits and burdens when selecting human subjects.
eRA See electronic Research Administration.
eRA Commons Web site where NIH grantees, staff, and the public access and share administrative information about research awards; includes both restricted and public sites. Go to Commons.
eRA Commons signing official See signing official.

For electronic grant applications, result of or eRA Commons validation that stops an application from becoming final -- moving to the Center for Scientific Review.

Errors reflect significant inaccuracies, inconsistencies, omissions, or incorrect formatting. Go to NIAID's About Validations in the NIH Grant Cycle: Application to Renewal and Corrected or Late Electronic Applications questions and answers.

Escalation Price adjustments based on increases or decreases to indexes identified in a contract.
Escalation factor

Percentage of increase applicants can request in a competing non-modular grant application to cover annual changes in the price of items and services. It covers personnel costs but not equipment. Also referred to as inflationary factor.

The awarded escalation factor is linked to the Biomedical Research and Development Price Index. See financial management plan and recommended levels of future support and go to NIAID's Budget and Funding.


See early-stage investigator.

eSNAP See Electronic streamlined noncompeting award progress report.
Ethnic and racial subgroup See racial and ethnic categories and subpopulations.
Eunice Kennedy Shriver National Institute of Child Health and Human Development Eunice Kennedy Shriver National Institute of Child Health and Human Development. Go to NICHD.
Evaluation criteria Standards in contracting used to evaluate an offeror's technical and operational effectiveness. Go to NIAID's R&D Contracts and Technical Review SOPs.
Executive Committee, NIAID

NIAID management committee comprising staff from the NIAID Office of the Director, division directors, and other managers.

Executive Committee makes scientific and management policy decisions, allocates resources, establishes grant paylines, approves grant funding plans, and reviews concepts for presentation to NIAID's main advisory Council.

Exemption categories for human subjects research Human subjects term indicating six research categories exempt from human subjects regulations. The six exemptions rarely apply to NIAID-supported researchers. Go to human subjects regulations 45 CFR 46.101 and NIAID's Human Subjects, Clinical Research. Also see exemption for human subjects research.
Exemption for human subjects research

Research excluded from human subjects regulations 45 CFR 46.101. The six human subjects exemptions rarely apply to NIAID-supported researchers because their research is either "human subjects" or "not human subjects."

Go to NIAID's Is Your Research Exempt? tutorial page on Human Subjects, Clinical Research. Also see exemption categories for human subjects research.

Exemption for IND application

FDA term for an IND application filed with FDA, usually by a sponsor. It includes a detailed description of the planned investigation including phase I, II, and III clinical trials and names of investigators and IRB members. FDA has 30 days to review an IND.

Go to definition 21 CFR 312.3 and full 21 CFR 312.

Existing specimen Specimen or data that have been and are no longer collected. Go to NIH's Human Subjects: FAQs About Research Using Human Specimens, Cell Lines, or Data and NIAID's Human Subjects, Clinical Research.
Expanded authorities Legislation providing greater autonomy to grantees, based on regulation 45 CFR Part 74. With the exception of automatic carry over of funds from one budget period to the next, expanded authorities apply to all grants. Go to NIAID's Grantees Can Take Many Actions Independently in the NIH Grant Cycle and Expanded Authorities or Federal Demonstration Partnership SOP.
Expanded availability FDA process that gives people with life-threatening illnesses access to investigational drugs and devices, including treatment investigational new drugs and open study protocols. Go to 21 CFR 312.34 and 21 CFR 312.36.
Expected adverse events Adverse events described in package labels, brochures, protocols, and consent forms. Go to NIH's Adverse Event Reports and NIAID's Human Subjects, Clinical Research.
Expedited IRB review

Review of a research project by a designated voting member or members rather than an entire IRB, allowed for some low-risk research and minor changes in approved research. See 45 CFR 46.110. Go to NIAID's Human Subjects Certifications: IRB or IEC SOP on Human Subjects, Clinical Research.

Expedited second-level review

Second-level review of qualifying grant applications by a subset of members of our advisory Council a few weeks after initial peer review to potentially enable NIAID to make awards earlier than usual.

To qualify, an application must be within the payline and have no concerns identified by the study section or Council. Go to NIAID's Advisory Council, NIAID R01 Application to Award Timeline, Expedited Council Review and Award SOP, and Second-Level Review Is Faster for Some Applications tutorial page.

Experimental Therapy unproved or not yet scientifically validated for safety and efficacy. A procedure may be considered "experimental" without necessarily being part of formal research.
Expiration date NIH Guide term for the date a funding opportunity announcement expires and moves to the archive. The expiration date is different from the closing date. See the equivalent term archive date.
Extramural Program Management Committee NIH committee that helps define extramural policy, composed of heads of institute extramural administrative organizations, such as NIAID's Division of Extramural Activities.
Extramural research

Research supported by NIH through a grant, contract, cooperative agreement, or other funding mechanism to an organization external to NIH. NIAID has three extramural research divisions: Division of AIDS, Division of Allergy, Immunology, and Transplantation; and Division of Microbiology and Infectious Diseases.

See also intramural research. Go to NIAID Research Funding and Extramural and Intramural Research questions and answers.

F&A cost See facilities and administrative cost.
F awards See fellowship awards.
FACA See Federal Advisory Committee Act.
Face Page

For electronic applications, see SF 424 (Cover Page) and PHS 398 Cover Page Supplement. Go to NIAID's SF 424 (Cover Page) in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, Form page 1 in the PHS 398 grant application or Form page 1 in a PHS 2590 progress report.

Facilities and administrative cost

Costs associated with the general operation of an institution and the conduct of its research activities. Formerly indirect costs. HHS supports full reimbursement for F&A costs for most grant programs. Allowable F&A costs include:

  • Depreciation use allowance.
  • Facilities operations and maintenance.
  • General administration and expenses.
  • Departmental administration.
  • Sponsored project administration.
  • Libraries.

See direct cost and go to NIAID's Make Sure Your Institution Has Negotiated F&A Rates in the NIH Grant Cycle: Application to Renewal.

Facilities contract

Contract for the procurement, construction, and installation of facilities or their use, maintenance, or management. Go to NIAID's R&D Contracts.
Facilities and Other Resources

For electronic grant applications, attachment on the Research and Related Budget Other Project Information form.

FAR See Federal Acquisition Regulation.
FDA See Food and Drug Administration.
FDP See Federal Demonstration Partnership. Web site that publicizes federal government procurement opportunities over $25,000. Go to Federal Business Opportunities SOP and Go to NIAID's R&D Contracts.
Federal Acquisition Regulation Primary authority for government procurement. FAR is published as 48 CFR Chapter 1. Its provisions are implemented and augmented by agency supplements -- see HHSAR. Go to HHS Acquisition Regulations and the FAR.
Federal Advisory Committee Act Law regulating federal advisory committees to ensure a balance of scientists, lay persons, races, and geographical areas. Go to the FACA.
Federal budget General roadmap for federal spending, outlining the categories and amounts. Also see authorization and appropriation. Go to NIAID's tutorial pages starting with Planning and Budget Cycle: NIAID Budget and Planning and to Budget and Funding.
Federal Demonstration Partnership Cooperative initiative among federal agencies, including NIH, and outside organizations that receive federal research funding. It conducts demonstration projects to simplify and standardize requirements to increase research productivity and reduce administrative costs. Go to FDP and NIAID's Expanded Authorities or Federal Demonstration Partnership SOP.
Federal Register Official, daily government publication communicating proposed and final regulations and legal notices issued by federal agencies, including announcements of the availability of research funds. Go to Federal Register.
Federal Technology Transfer Act Law authorizing government agencies to enter into cooperative research and development agreements with private companies. See technology transfer. Go to 15 USC 63 Sec. 3710 and NIAID's Office of Technology Development.
Federalwide Assurance

Online form every institution and collaborating institution conducting human subjects research must file with the Office for Human Research Protections, HHS, to establish policies and procedures to protect human subjects as required by 45 CFR 46. See institutional assurance of protection for human subjects.

For individuals, see Individual investigator agreement. Go to Electronic Federalwide Assurance and IRB/IEC Registrations. Go to NIAID's Human Subjects, Clinical Research.


Agreed-to amount beyond an initial cost estimate in cost-reimbursement arrangements. A fee may be fixed at the outset of performance, as in a cost-plus-fixed-fee contract, or may vary within a specified range, as in a cost-plus-incentive-fee contract. Go to NIAID's R&D Contracts.


Individual award to students and scientists at predoctoral, postdoctoral, or senior levels; underrepresented groups and the disabled; and postdoctoral trainees in the NIAID Division of Intramural Research to develop careers in biomedical research.

Activity codes are as follows:

  • F31, National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research
  • F32, Postdoctoral Individual National Research Service Award
  • F33, National Research Service Awards for Senior Fellows
  • F35, Intramural NRSA Individual Postdoctoral Program Appointee

Go to NIAID's Fellowship Grants SOP, Fellowships questions and answers, Fellowships tutorial page, and Training and Career Awards.

Fetus Product of conception from the time of implantation until delivery. See definition 45 CFR 46.201.
FIC NIH Fogarty International Center. Go to FIC.
Final proposal revision Final contract proposal revision that NIAID asks offerors to submit after negotiations have ended. It documents cost and technical agreements reached during negotiations. Go to NIAID's Negotiation, Source Selection, and Award SOPs and R&D Contracts.
Final research data Recorded factual material commonly accepted by the scientific community as necessary to document, support, and validate research findings. Go to NIAID's Data Sharing for Grants: Final Research Data SOP.
Financial conflict of interest Significant financial interests that would likely bias NIAID grantees or contractors. By law, institutions must manage, reduce, or eliminate them. Go to OER's Conflict of Interest Web site.
Financial management plan Policy establishing consistency in funding that specifies budget levels for items such as paylines, programmatic reductions, R56-Bridge award levels, and caps for renewal grants. Go to NIAID's Funding Decisions questions and answers, Financial Management Plan SOP, NIAID Funding Policy and Process SOP, and Budget and Funding.
Financial status report

Report showing the status of funds for a grant or cooperative agreement, mandatory for continued funding.

FSRs are due in the Commons at the end of a competitive segment for grants awarded under the streamlined non-competing application process, and 90 days after the end of a budget period for grants not awarded under SNAP. Go to NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal.

Firm-fixed-price contract Fixed-price contract that cannot be adjusted for a contractor's costs. It provides maximum incentive for a contractor to control costs and perform efficiently and imposes a minimum administrative burden on the contracting parties. Go to FAR 16.202-1 and NIAID's R&D Contracts.
Fiscal year Federal budget year: October 1 to September 30.
Fixed-price contract

Contract type that provides for a firm or, in some cases, an adjustable price. Fixed-price contracts with an adjustable price may include a ceiling price, target price, or both.

Unless otherwise specified, these prices can be adjusted only by clauses in a contract. Go to FAR 16.206-1 and NIAID's R&D Contracts.


See funding opportunity announcement.

FOIA See Freedom of Information Act.
Food and Drug Administration HHS agency that reviews clinical research to regulate the marketing of foods, drugs, devices, and cosmetics. Go to FDA.
Foreign component Significant part of a grant performed outside the U.S. either by a grantee or researcher employed by a foreign institution that includes:
  • Involvement of human subjects or animals in research.
  • Extensive foreign travel by grantee project staff for collecting data, surveying, sampling, and similar activities.
  • Grant activities that may involve the population, environment, resources, or affairs of a foreign country.

Go to NIAID's Foreign and International Grants and Components SOP and other Foreign SOPs, and International Awards questions and answers.

Foreign institution Private or public nonprofit institution or for-profit organization in a country other than the U.S. and its territories. Go to NIAID International Grants and Contracts and International Awards questions and answers and Foreign and International Grants and Components SOP.
FPR See final proposal revision.
Freedom of Information Act Law requiring wide dissemination of government documents on public request, while safeguarding proprietary information. Go to FOIA and NIH FOIA.
FSR See financial status report.
FTE Full-time equivalent.
FTTA See Federal Technology Transfer Act.
FTTP Full-time training position.
Full and open competition Process that permits all sources to compete for a contract. See justification for other than full and open competition. Go to FAR 6.003 and FAR 16.206-1 and NIAID's R&D Contracts.
Full board review Review meeting of a majority of IRB members, including at least one nonscientific member. To gain IRB approval, a majority of members present at a meeting must agree. Go to NIAID's Plan for Registering an IRB or IEC and Obtaining an FWA tutorial page and Human Subjects Certifications: IRB or IEC SOP.
Fundable score

Percentile or priority score for a grant application that falls within an NIH institute's payline. Go to How NIAID Determines Which Applications to Fund tutorial page, Funding Decisions questions and answers, and Budget and Funding.

Funded carryover Competing grant application that was unfunded at the end of a fiscal year and funded in a future fiscal year.
Funding mechanism See mechanism and activity code.
Funding opportunity announcement notice of a federal grant funding opportunity. NIH FOAs can be RFAs or PAs. Each FOA includes instructions -- a Grant Application Guide, and forms -- a Grant Application Package.

For each FOA, NIH publishes announcements with additional information and instructions in the Guide. Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Funding Opportunity Announcements questions and answers, and Grant Application, Electronic SOP. Also see parent program announcement.

Funding plan Budget outline that NIAID develops according to the budget allocation for a fiscal year. It specifies standard items, such as paylines, selective payment amounts, R56-Bridge award pools, and caps for renewal grants. See appropriation and go to NIAID's Financial Management Plan.
FWA See Federalwide Assurance.
FY See fiscal year.
GAO See Government Accountability Office.
GAVI Global Alliance for Vaccines and Immunization. Go to GAVI.
Gender Human subjects term indicating a classification of research subjects into women and men. In some cases, gender cannot be determined, e.g., for pooled blood samples. Go to NIAID's Human Subjects, Clinical Research.
Gene therapy Treatment of genetic disease by altering the genetic structure of either somatic or germline cells.
General Accounting Office See Government Accountability Office.
Genome Organism's chromosomes containing genes and other DNA.
Genome-wide association study Research to study variation across the entire human genome to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. See the Data Sharing for Grants: Genome-Wide Association Studies SOP.
Germline cell Cell that becomes egg or sperm.
GLP Good laboratory practice. Go to GLP.
GMP See Grants Management Program.
GMP Good manufacturing practice.
Government Accountability Office

Legislative Branch office that examines the use of public funds to help Congress ensure federal government accountability. GAO performs financial audits, program evaluations, analyses, investigations, and other services.

GAO was formerly known as the General Accounting Office. Go to GAO and GAO Reports.

Government-furnished property Items the government possesses or acquires and makes available to a contractor. Go to FAR 45.101 and NIAID's R&D Contracts.

Financial assistance award from NIAID for peer reviewed research. The grantee is responsible for the research with little or no direct government involvement. NIH generally awards grants to institutions, which must comply with all terms and conditions of award and meet requirements outlined in How to Manage Your Grant Award.

Term covers grants and cooperative agreements. See Notice of Award and go to NIAID's Grants and Contracts, Grant Awards questions and answers, and Application and Awards SOPs.

Grant anniversary date

Based on a grant's start date, basis for funding noncompeting and renewal awards. NIAID cannot fund these awards before their anniversary date. See grant start date.

Grant appeal

HHS provision for a grantee institution to address an administrative decision on a grant made by an NIH institute.

There are two levels: an informal NIH procedure and a formal HHS procedure. A grantee must first exhaust informal procedures before appealing to the HHS Appeals Board. Go to NIAID's Appeals of Scientific Review of Grant Applications SOP and Should You Appeal? in the NIH Grant Cycle: Application to Renewal.

Grant application

Application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper PHS 398 or electronic SF 424 forms and instructions.

For help in preparing an NIH grant application, go to NIAID's All About Grants tutorials and NIAID R01 Application to Award Timeline.

Grant Application Guide

Instructions for completing an electronic Grant Application Package. Each funding opportunity announcement has its own package and guide. Go to NIH's Application Guides.

Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Applying for a Grant questions and answers, and Grant Application, Electronic SOP.

Grant Application Package

Electronic forms applicants complete in response to a funding opportunity announcement that uses electronic application. Each opportunity has its own package, which includes SF 424 R&R forms as well as those called PHS 398, and a Grant Application Guide.

Go to NIAID's NIH Funding Opportunities Relevant to NIAID, Get Ready Now to Apply Electronically tutorial page, Grant Application, Electronic SOP, and Applying for a Grant questions and answers.

Grant budget period Interval into which a grant project period is divided for funding and reporting purposes, usually 12 months. See grant anniversary date.
Grant closeout

Procedure to officially conclude a grant within 90 days after the end of an award. NIAID staff determine whether administrative actions and required work are complete.

A grantee uploads a final financial status report in the eRA Commons and sends the grants management specialist a status of federal cash -- PSC 272, final progress report, and final invention statement -- HHS 568, including any inventions reported previously for that award.

Go to iEdison for invention reporting and NIAID's File Final Reports at Award End in the NIH Grant Cycle: Application to Renewal.

Grant compliance review Evaluation by a grants management specialist to assess an institution's business and financial management systems to ensure that grantees follow grant regulations and policies.
Grant out year Year following a first year of funding of a grant's competitive segment, during which a principal investigator applies for a noncompeting continuation award. See streamlined noncompeting award process. Go to Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.
Grant project period Total period a project has been recommended for support, which may include more than one competitive segment. For example, a project period for a grant begun in 1990 can be divided into competitive segments 1990 to 1994, 1994 to 1998, etc.
Grant rebudgeting

Ability of grantees to move funds from one budget category to another without prior approval from NIH when there is no change of scope. For nonmodular grants, permission is required for some items. Go to NIAID's Grantees Can Take Many Actions Independently and What Constitutes a Change in Scope? in the NIH Grant Cycle: Application to Renewal.

Grant start date Official date a grant award begins; same as the first day of the first budget period. Also see grant anniversary date and go to NIAID's Early Grant Awards questions and answers.
Grant type See application type and activity code.
Grantee Institution receiving a grant or cooperative agreement, which assumes legal, financial, and scientific responsibility for the funds and research. In rare cases, a grantee may be an individual. See principal investigator and applicant.
Grants Management Program NIAID organization in the Division of Extramural Activities that oversees the business aspects of grants. Go to GMP Contacts.
Grants management officer NIAID staff member who ensures that both the granting agency and grantees meet all requirements of laws, regulations, and policies. Go to GMP Contacts.
Grants management specialist

NIAID staff member who interprets and applies grant policies and is the focal point for all business and policy activities, including negotiation, award, and administration of grants and cooperative agreements.

Go to NIH Grants Policy Statement. For Grants Management Program staff, go to GMP Contacts.

Site through which applicants find and apply for grants from many federal agencies. Go to

Gray zone

Priority score or percentile that falls just outside a payline. NIAID holds applications that fall in the gray zone until the end of the fiscal year for potential funding. Also see deferred.

Go to the How NIAID Determines Which Applications to Fund tutorial page, NIAID's Budget and Funding, and Funding Decisions questions and answers.

Green Card See Alien Registration Receipt Card.
GWAS See Genome-wide association study.
Guide for Grants and Contracts See NIH Guide for Grants and Contracts.
Health Care Financing Administration See Centers for Medicare and Medicaid Services.
Health Insurance Portability and Accountability Act Law from 1996 that amends the Internal Revenue Code to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance. Go to HIPAA.
Health Research Extension Act of 1985 Law that provides legislative basis for guidelines for the care and treatment of research animals and oversight by institutional animal care and use committees. Go to the Health Research Extension Act of 1985 Public Law 99-158. Go to NIAID's Research Animals.
HHS See Department of Health and Human Services.
HHSAR Department of Health and Human Services codification of uniform acquisition policies and procedures that implements and supplements the Federal Acquisition Regulation. Go to HHSAR.
High-priority area Area of research NIAID emphasizes to prompt grant applications and contract proposals from the extramural research community. Go to NIAID's Funding Opportunities and Announcements.
Highly influential scientific information

Information that NIH or OMB determines could have an impact of more than $500 million in one year on the public or private sector; is novel, controversial, or precedent-setting; or has significant interagency interest.

See influential scientific information and OMB Information Quality Bulletin for Peer Review. Go to the Final Information Quality Bulletin for Peer Review in the Federal Register.

Highly pathogenic agent

NIAID term for a an infectious agent or toxin that may warrant biosafety level 3 biocontainment or higher according to either the Biosafety in Microbiological and Biomedical Laboratories manual, an investigator's institutional biosafety committee, or a designated institutional biosafety official.

If there is a conflict, the highest level applies. Compare with select agent.

HIPAA See Health Insurance Portability and Accountability Act.
HISI See highly influential scientific information.
Hispanic or Latino Human subjects term indicating a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.
HOPE Health Omnibus Programs Extension Legislation. Go to HOPE.
Human subject

Legally defined term indicating a living person about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information.

Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Go to 45 CFR 46, NIAID's Human Subjects, Clinical Research, Human Subjects questions and answers, How to Write a Human Subjects Application tutorial, and NIH's FAQs about Research Using Human Specimens, Cell Lines or Data.

Defined differently by FDA. See definition 21 CFR 50.3 (g) and subject.

Human subjects assurance See Institutional assurance of protection for human subjects.
Human subjects code

Number a scientific review group places on a summary statement during initial peer review reflecting the application of human subjects regulations to a project as well as the inclusion of women, children, and racial and ethnic populations.

Some codes indicate a human subjects concern that would result in a bar to award. Go to NIAID's Human Subjects Involvement Codes, Human Subjects Inclusion Codes, and Human Subjects SOPs on Human Subjects, Clinical Research.

Human subjects concern Human subjects term indicating actual or potential unacceptable risk or inadequate protection against risk to human subjects. See human subjects code. Go to Human Subjects SOPs on NIAID's Human Subjects, Clinical Research.
Human subjects exemption categories See exemption categories, human subjects.
Human subjects research See research using human specimens or data.

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