E |
|
early-stage investigator |
Applicant who is within 10 years of either of the following:
- 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. ESI status affects initial peer review and institute funding decisions.
For more information, go to these resources:
|
earmark |
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 Grants.gov. |
ECB |
See Electronic Council Book. |
Edison |
See iEdison. |
EIN |
See employer identification number. |
EIR |
See Employee Invention Report. |
Electronic Council Book |
NIH database system downloaded from IMPAC that showsthe following information about a grant application:
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.
For more information, go to these resources: ECB and NIAID's Electronic Council Book SOP. |
electronic grant file |
File containing all official documentation for a grant. |
Electronic
Research Administration |
Information technology infrastructure that enables NIH and other federal agencies to
electronically receive, review, and administer grants.
eRA enables NIH and its grantees to have an online dialogue throughout the life cycle of a grant. Go to eRA. Also see eRA Commons. |
electronic
streamlined noncompeting award progress report (eSNAP) |
Process that allows principal investigators and grantee institutions with awards that have automatic carryover 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.
For more information, go to these NIAID resources:
|
embryo |
Organism in the early stages of development, the first six weeks in humans. |
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 (EIR) |
Invention report due to NIAID within two months after an investigator gives written disclosure to an organizational official.
For more information on grants, go to NIAID's Invention
Reporting Has Four Parts in the NIH Grant Cycle.
For more information on contracts, go to NIAID' Invention Reporting for Contracts SOP and NIIH's iEdison. |
Employer Identification Number (EIN) |
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 an initial peer review group to recommend awards for funding. See second-level review.
For more information, go to NIAID's Council. |
enrollment report table |
See Inclusion Enrollment Report table. |
Entire Proposed Project Period Budget |
Form page 5 in the PHS 398 Grant Application for paper applications used when requesting more than $250,000 or applying from a foreign institution. Also see Detailed Budget for Initial Budget Period.
For smaller budgets, see modular budget. For electronic applications, see Research and Related Budget component form.
For more information, go to these resources:
|
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-based interface where NIH grantees,
staff, and the public access and share administrative information about research awards.
Part of Electronic
Research Administration, it includes both restricted and public sites.
For more information, go to this resource: eRA Commons. |
eRA Commons signing official |
See signing official. |
error |
For electronic grant applications, result of Grants.gov or validation in the NIH eRA Commons. An error stops an application from becoming final and moving to the NIH Center for Scientific Review.
Errors reflect significant inaccuracies, inconsistencies, omissions, or incorrect formatting. See warning.
For more information, go to these NIAID resources:
|
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 level of future support.
For more information, go to these NIAID resources:
|
ESI |
See early-stage investigator. |
eSNAP |
See electronic
streamlined noncompeting award progress report. |
ethnic and racial subgroup |
See racial and ethnic categories and subpopulations. |
evaluation criteria |
Standards in contracting used to evaluate an offeror's technical and operational effectiveness.
For more information, go to NIAID's Contracts portal 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.
See exemption
for human subjects research. For more information, go to these resources: 45 CFR 46.101 and NIAID Human Subjects Resources portal. |
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." See exemption
categories for human subjects research.
For more information, go to these NIAID resources: Is Your Research Exempt? in How to Write a Human Subjects Grant Application on NIAID Human Subjects Resources portal. |
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 institutional review board members. FDA has 30 days to review an IND.
For more information, go to these resources: 21 CFR 312.3 and
full 21 CFR
312. |
existing
specimen |
Specimen or data that are no
longer being collected.
For more information, go to these resources:
|
expanded authorities |
Legislation providing greater autonomy to grantees, based on regulation 45 CFR Part 74. With the exception of automatic carryover of funds from one budget period to the next, expanded authorities apply to all grants.
For more information, go to these NIAID resources:
|
expanded access |
FDA process
that gives access to investigational
drugs and investigational medical devices,
including treatment
investigational new drugs and open study protocols, to people with life-threatening illnesses who are not eligible for a clinical trial and when no other effective therapy exists. Also called compassionate use.
For more information, go to these resources: 21
CFR 312.34 and 21
CFR 312.36. |
expected adverse event |
Adverse event described in package labels, brochures, protocols, and consent forms.
For more information, go to this resource: NIAID Human Subjects Resources portal. |
expedited
IRB review |
Review of a research project by a designated voting member or members rather than an entire institutional review board, allowed for some low-risk research and minor changes in approved research.
For more information, go to these resources:
|
expedited second-level review |
Second-level review of qualifying grant applications by a subset of our advisory Council members a few weeks after initial peer review to enable NIAID to make awards earlier. To qualify, an application must be within the payline and have no concerns identified by the study section or Council.
For more information, go to these NIAID resources:
|
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 Grants.gov archive.
Expiration date differs from closing
date. See the equivalent Grants.gov 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 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.
For more information, go to these NIAID resources: NIAID Research Funding and Extramural and Intramural Research questions and answers. |
F |
|
F&A costs |
See facilities and administrative costs. |
F award |
See fellowship award. |
FACA |
See Federal Advisory Committee Act. |
Face Page |
For electronic grant applications, see SF 424 (Cover Page) and PHS 398 Cover Page Supplement.
For paper applications, Form page 1 in either the PHS 398 Grant Application or PHS 2590 Non-Competing Continuation Progress Report.
For more information, go to these resources:
|
facilities and administrative costs (F&A) |
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 costs.
For more information, go to these NIAID resources: Make Sure
Your Institution Has Negotiated F&A Rates in the NIH Grant Cycle: Application to Renewal and Grant Award and Management portal. |
facilities contract |
Contract for the procurement, construction, and installation of facilities or their use, maintenance, or management. Go to NIAID's Contracts portal. |
Facilities and Other Resources |
For electronic grant applications, attachment on the Research and Related Budget Other Project Information form. |
FAR |
See Federal Acquisition Regulation. |
fast track |
Process FDA uses to accelerate development and review of drugs to treat serious diseases and fill an unmet medical need. Drugs designated as fast track are eligible for accelerated approval and possibly priority review.
These three terms describe FDA's approach to making therapeutically important drugs available sooner.
For more information, go to this FDA resource: Fast Track, Accelerated Approval and Priority Review. |
FDA |
See Food and Drug Administration. |
FDP |
See Federal Demonstration Partnership. |
FedBizOpps.gov |
Web site that publicizes federal government procurement opportunities over $25,000.
For more information, go to these resources:
|
Federal Acquisition Regulation (FAR) |
Primary authority for government procurement. FAR is published as 48 CFR Chapter 1. Its provisions are implemented and augmented by agency supplements -- see HHSAR.
For more information, go to these resources: HHS Acquisition Regulations and FAR. |
Federal Advisory Committee Act (FACA) |
Law regulating federal advisory committees to
ensure a balance of scientists, lay persons, races, and geographical areas. For more information, go to this resource: FACA. |
federal budget |
General roadmap for federal spending, outlining the categories and amounts. Also see authorization and appropriation. Go to NIAID Funding Opportunity Planning and the Budget Cycle and Paylines and Funding portal. |
Federal Demonstration Partnership (FDP) |
Cooperative initiative among federal agencies, including NIH, and outside organizations that receive federal research funding. It conducts demonstration projects that simplify and standardize requirements to increase research productivity and reduce administrative costs.
For more information, go to these resources: 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.
For more information, go to Federal Register. |
Federal Technology Transfer Act (FTTA) |
Law authorizing government agencies to enter into cooperative research and development agreements with private companies. See technology transfer.
For more information, go to these resources: 15 USC 63 Sec. 3710 and NIAID's Office of Technology Development. |
Federalwide Assurance (FWA) |
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.
An FWA is an institutional assurance of protection for human subjects. For individuals, see Individual
investigator agreement.
For more information, go to these resources:
|
fee |
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.
For more information, go to NIAID's Contracts portal. |
fellowship |
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 Award for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research
- F32, Postdoctoral Individual NRSA
- F33, NRSAs for Senior Fellows
- F35, Intramural NRSA Individual Postdoctoral Program Appointee
For more information, go to these NIAID resources:
|
fetus |
Product of conception from the time of implantation until delivery. For more information, go to 45 CFR 46.201. |
FIC |
NIH Fogarty International Center. For more information, 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.
For more information, go to NIAID's Negotiation, Source Selection, and Award SOPs and Contracts portal. |
final
research data |
Recorded factual material commonly accepted
by the scientific community as necessary to document, support, and validate research findings.
For more information, 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 these conflicts.
For more information, go to these resources: OER's Conflict of Interest and NIAID's Financial Conflicts of Interest for Awardees SOP. |
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.
For more information, go to these NIAID resources:
|
Financial Status Report (FSR) |
Report showing the status of funds for a grant or cooperative agreement; FSRs are 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.
For more information, go to NIAID's File Final Reports
at Award End in the NIH Grant Cycle: Application to Renewal and Grant Award and Management portal. |
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.
For more information, go to FAR
16.202-1 and NIAID's Contracts portal. |
fiscal year (FY) |
Federal government budget year: October 1 to September 30. |
fixed-price contract |
Contract 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. For more information, go to FAR 16.206-1 and NIAID's Contracts portal. |
FOA |
See funding
opportunity announcement. |
FOIA |
See Freedom of Information Act. |
Food and Drug Administration (FDA) |
HHS agency that reviews clinical research to regulate the marketing of foods, drugs, devices, and cosmetics. For more information, 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.
See domestic.
For more information, go to these NIAID resources:
|
foreign
institution |
Private or public nonprofit institution or
for-profit organization in a country other than the U.S. and its territories. See domestic.
For more information, go to these NIAID resources:
|
FPR |
See final proposal revision. |
Freedom of Information Act (FOIA) |
Law requiring wide dissemination of government documents on public request, while safeguarding proprietary information. For more information, go to the Department of Justice's Freedom of Information Act 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.
For more information, go to these resources:
|
full board review |
Review meeting of a majority of institutional review board members,
including at least one nonscientific member. To gain IRB approval, a majority
of members present at a meeting must agree.
For more information, go to these NIAID resources:
|
fundable
score |
Percentile or overall impact/priority score for a grant
application that falls within an NIH institute's payline.
For more information, go to these NIAID resources:
|
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 (FOA) |
Grants.gov notice
of a federal grant funding
opportunity. NIH FOAs can be requests for applications or program announcements.
Each FOA includes instructions -- a Grant
Application Guide, and forms -- a Grant
Application Package. See parent program announcement.
For each FOA, NIH publishes announcements with additional information and instructions in the Guide.
For more information, go to these NIAID resources:
|
funding plan |
Budget outline that NIAID develops according to the budget allocation for a fiscal year. It specifies standard items, such as paylines, selective pay 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. |
G |
|
GAO |
See Government Accountability Office. |
GAVI |
Global Alliance for Vaccines and Immunization. For more information, 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.
For more information, go to NIAID's NIAID Human Subjects Resources portal. |
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 (GWAS) |
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.
For more information, go to NIAID's Data
Sharing for Grants: Genome-Wide Association Studies SOP. |
germline cell |
Cell that becomes egg or sperm. |
GLP |
Good laboratory practice. |
GMP |
See Grants Management Program. |
GMP |
Good manufacturing practice. |
Government Accountability Office (GAO) |
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. For more information, go to these resources: GAO and GAO Reports. |
government-furnished property |
Items the government possesses or acquires and provides a contractor. For more information, go to these resources: FAR 45.101 and NIAID's Contracts portal. |
grant |
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 in Managing Your Grant in the NIH Grant Cycle: Application to Renewal.
Term also includes cooperative agreements, which have substantial government involvement. See Notice of Award.
For more information, go to these NIAID resources:
|
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 about a grant by an NIH institute. There are two levels: an informal NIH procedure and a formal HHS procedure. A grantee must first exhaust the informal process before appealing to the HHS Appeals Board. Differs from appeal of peer review.
For more information, go to these resources:
|
grant application |
Application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper PHS 398 Grant Applicationor electronic Grant Application Package for most grant types. Grantees use a PHS 2590 to continue a grant. See receipt date.
For more information, go to these resources:
|
Grant Application Guide |
Instructions for completing an electronic Grant Application Package. Each funding opportunity announcement has its own application package and guide.
For more information, go to NIH's SF 424 (R&R) Application Guides and these NIAID resources:
|
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.
For more information, go to these NIAID resources:
|
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 it ends. 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 Federal Cash Transaction Report (PSC 272), final progress report, and final invention statement (HHS 568) , including any inventions reported previously for that award.
For more information, go to these resources:
|
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 the 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.
For more information, go to these NIAID resources:
|
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 2000 can be divided into these competitive segments: 2000 to 2004, 2004 to 2008, and 2008 to 2012. |
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.
For more information, go to these NIAID resources in the NIH Grant Cycle: Application to Renewal:
|
grant start date |
Official date a grant begins; same as the first day of the first grant budget period. Also see grant anniversary date.
For more information, 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 a person. See principal investigator and applicant. |
Grants Management Program (GMP) |
NIAID organization in the Division of Extramural Activities that oversees the business aspects of grants.
For more information, go to NIAID's 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.
For more information, go to NIAID's GMP Contacts. |
grants management specialist |
NIAID staff member working in the Grants Management Program 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.
For more information, go to these resources:
|
Grants.gov |
Site through which applicants find and
apply for grants from many federal agencies.
For more information, go to Grants.gov. |
gray zone |
Overall impact/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.
For more information, go to these NIAID resources:
|
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. |
H |
|
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.
For more information, 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.
For more information, go to these resources: Health Research Extension Act of 1985 and NIAID's Animals in Research portal. |
HHS |
See Department
of Health and Human Services. |
HHSAR |
Department of Health and Human Services codification of uniform acquisition policies
and procedures, which implements and supplements the Federal Acquisition Regulation.
For more information, go to HHSAR. |
high-priority area |
Area of research NIAID emphasizes to prompt grant applications and contract proposals from the extramural research community.
For more information, go to these NIAID Resources:
|
High-Priority, Short-Term Project Award |
See R56-Bridge
award. |
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.
For more information, go to 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 of the Centers for Disease Control and Prevention, 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.
For more information, go to CDC's Biosafety in Microbiological and Biomedical Laboratories.
|
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.
NIH policy requires this minority group to be included in clinical research barring a compelling rationale not to do so. See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table. |
HOPE |
Health Omnibus Programs Extension Legislation. Go to HOPE. |
human embryonic stem cell |
Term defined by NIH policy as a cell that is derived from the inner cell mass of a blastocyst-stage human embryo, is capable of dividing without differentiating for a prolonged period in culture, and is known to develop into cells and tissues of the three primary germ layers. Also see stem cell. |
human subjects |
Legally defined term for living
persons 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.
Term is defined differently by FDA. See subject.
For more information, go to these resources:
|
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.
For more information, go to these NIAID resources:
|
human subjects concern |
Human subjects term indicating actual or potential unacceptable risk or inadequate protection against risk to human subjects. See human subjects code.
For more information, go to NIAID's Human Subjects SOPs on NIAID Human Subjects Resources portal. |
human
subjects exemption categories |
See exemption
categories, human subjects. |
human
subjects research |
See research
using human specimens or data. |