# |
|
2590 |
See PHS 2590. |
398 |
See PHS 398. |
424 |
See SF 424. |
45 CFR Part 46 |
Code
of Federal Regulations covering protection of human
subjects. 45 CFR 46 is divided into four subparts: A, B, C, and D.
Subpart A, known as the Common
Rule, governs human subjects research for
virtually all relevant federal agencies; Subparts B, C, and D address
special areas.
For more information, go to definitions in 45 CFR
46.102, full 45
CFR 46, and NIAID Human Subjects Resources portal.
Go to the laws underlying
45 CFR 46:
|
A |
|
AAALAC |
See Association for Assessment and Accreditation of Laboratory Animal Care.
|
abstract |
For electronic applications, see Project Summary/Abstract and Project Narrative. For paper PHS 398 Grant Applications, see Description.
For more information, go to NIAID's Project
Summary/Abstract and Project Narrative in the NIH Grant Cycle: Application to Renewal. |
Academic Research Enhancement Award (AREA, R15) |
Grant that stimulates research at health professional academic institutions with less than $3 million of NIH support in total costs in four or more of the last seven years.
For more information, go NIH Academic Research Enhancement
Award (AREA) Grants and NIAID's Academic Research Enhancement Awards SOP. |
accelerated approval |
Regulation FDA instituted to allow quicker approval of drugs that treat serious diseases and fill an unmet medical need based on a surrogate endpoint -- a marker used as an indirect or substitute measurement that represents a clinically meaningful outcome. FDA uses accelerated approval for drugs designated as fast track.
Accelerated approval, along with fast track and priority review, is part of FDA's approach to making therapeutically important drugs available at an earlier time.
For more information, go to FDA's Fast Track, Accelerated Approval and Priority Review. |
acceptable proposal |
Contract proposal judged by the majority of a technical evaluation group to be eligible for inclusion in a competitive range or award.
For more information, go to NIAID's Contracts portal. |
Accounting Act, Budget |
See Budget and Accounting Act. |
acquisition |
Obtaining of supplies or services by the federal government with appropriated funds through purchase or lease. For more information, go to NIAID's Contracts portal.
|
acquisition plan |
Document a contracting officer uses to begin preparing a request for proposals following concept clearance for a new acquisition or major change in an existing project.
For more information, go to NIAID's Acquisition Planning Resources on the Contracts portal. |
activity code |
Three digit identifier of an award type,
e.g., R01 is
a standard research
grant. For budget purposes, activity codes are grouped into funding
mechanisms, and the terms are often used interchangeably. Major series of activity codes are:
For descriptions, go to NIAID's Grants portals and Award Types questions and answers.
For staff, go to NIAID's Selection
of Appropriate Funding Mechanisms SOP. |
administrative change |
Unilateral, written change that does not affect rights of the contracting parties. For more information, go to NIAID's Contracts portal.
|
administrative standard |
See OMB circulars. |
administrative supplement |
Monies added to a grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted.
For more information, go to NIAID's Administrative Supplements to Grants and Cooperative Agreements SOP. |
adult stem cell |
Stem cell from a developed organism, including multipotent, oligopotent, and unipotent but not pluripotent or totipotent stem cells. |
advance agreement |
Agreement negotiated before a contractor incurs a cost, specifying whether it is allowable. An advance agreement may be negotiated before or during a contract and must be in writing. It may apply to a contract, group of contracts, or all contracts of a contracting office, agency, or several agencies.
For more information, go to NIAID's Contracts portal. |
adverse device effect |
Serious adverse effect on health and safety of human subjects from an investigational medical device. See also unanticipated adverse device effect.
For more information, go to NIAID Human Subjects Resources portal. |
adverse effect |
Unanticipated problem or unfavorable symptom or disease occurring during clinical research. Though not necessarily caused by the study treatment, it can harm human subjects or others, for example, a loss of research records,
drug overdose, serious symptom, or death.
For more information, go to 45
CFR part 46, subpart A and the NIAID Human Subjects Resources portal. |
adverse event |
Occurrence of an adverse effect occurring during a clinical study. Also see serious adverse event.
For more information, go to definitions in 45 CFR part 46, subpart A and NIAID Human Subjects Resources portal. |
advisory Council |
See Council, advisory and National Advisory Allergy and Infectious Diseases Council. |
AERIO |
See agency extramural research integrity officer. |
agency extramural research integrity officer |
NIH extramural officer who evaluates the merit of research misconduct allegations and reports findings to appropriate executives. Also see RIO.
For more information, go to NIAID's Research Misconduct Cases SOP. |
AIDSInfo |
HHS AIDS information site. For more information, go to AIDSinfo and HHS.
|
AIDS-related research |
Research of the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS and its sequelae; does not include all studies of T lymphocytes or retroviruses.
For more information, call a program officer in NIAID's Division of AIDS. |
AIDS Research Advisory Committee (ARAC) |
Chartered committee that makes recommendations about all aspects of HIV and AIDS research relating to the mission of the NIAID Division of AIDS, including goals, priorities, information dissemination, and the evaluation of therapies.
For more information, go to the ARAC roster. |
AIDS Research Review Committee (AIDSRRC) |
NIAID scientific review group for AIDS grant applications. For more information, go to the AIDSRRC roster. |
AIDSRRC |
See AIDS Research Review Committee. |
AITRC |
See Allergy, Immunology, and Transplantation Research Committee. |
ALERT System, PHS |
Department of Health and Human Services system for making public the names of organizations and people accused or found guilty of research misconduct.
For more information, go to PHS Administrative Action Bulletin Board of the Office of Research Integrity and NIAID's Research Misconduct Cases SOP. |
Alien Registration Receipt Card |
Commonly known as "Green Card," shows a person's status as a permanent resident with a right to live and work permanently in the U.S. Also called Form I-551.
For more information, go to U.S. Citizenship and Immigration Services and NIAID's Foreign Workers on NIH Awards SOP. |
Allergy, Immunology, and Transplantation Research Committee (AITRC) |
NIAID scientific review group for grant applications in allergy, immunology, and transplantation. For more information, go to the AITRC roster.
|
allowable cost |
Cost in a contract that is reasonable, meets accepted accounting principles, is defined in the Federal Acquisition Regulations, or is agreed to by contracting parties.
For more information, go to FAR 31 and NIAID's Contracts portal. |
alterations and renovations |
Grant budget category for work to change the physical characteristics of an existing facility or installed equipment. |
amendment |
Alternative term for an application resubmission. For contracts, see contract modification. |
American Recovery and Reinvestment Act (ARRA) |
Law to stimulate the growth and recovery of the U. S. economy. ARRA gives $1.12 billion to NIAID above its regular appropriation for biomedical research in fiscal years 2009 and 2010. Funds come with additional requirements for grantees.
For more information, go to NIAID and the Economic Recovery Act. |
American Indian or Alaska Native |
Human subjects term indicating a person having origins in the original peoples
of North, Central, or South America who maintains an affiliation with a tribe or
community.
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. |
analysis |
Human subjects term indicating NIH requirements for human subjects analysis plans. Plans depend on the research proposed and may include monitoring to detect and address adverse effects and intervention differences among groups and subgroups, for example, women, minorities, ethnic or racial groups and subgroups, and children.
Requirements differ depending on risk, complexity, and the probability of finding intervention differences. New and renewal applications and contract proposals must include the results of group and subgroup analyses. See valid analysis.
For more information, go to the NIAID Human Subjects Resources portal. |
Animal and Plant Health Inspection Service (APHIS) |
Agency of the U.S. Department of Agriculture that ensures the health and care of animals and plants through the Animal Welfare Act.
Investigators who possess or use a select agent must register with and get approval from either the APHIS Agricultural Select Agent Program or CDC National Select Agent Registry, depending on the agent.
For more information, go to these resources:
|
Animal Welfare Assurance |
Document an institution and all performance sites involving animals in research must have on file with NIH's Office of Laboratory Animal Welfare before a PHS agency may award a grant or contract.
For more information, go to NIAID's Animals in Research portal.
|
animals in research |
Live, vertebrate animal used for research, research training, biological testing, or related purposes. See animal welfare assurance.
For information and links to legislation, go to PHS Policy on Humane Care and Use of Laboratory Animals and the Animal Welfare Regulations tutorial of the Office of Laboratory Animal Welfare.
For more information, go to these NIAID resources: How to Write an Application Involving Research Animals tutorial and the Animals in Research portal.
|
animals in research code |
Number a scientific review group places on a summary statement during initial peer review reflecting the application of regulations for research animals to a project; some codes can result in a bar to award.
For more information, go to NIAID's Research Animals Involvement Codes on the Animals in Research portal. |
anniversary
date |
See grant
anniversary date. |
AOR |
See authorized
organizational representative. |
APHIS |
See Animal and Plant Health Inspection Service. |
appeal, grant |
See grant appeal. |
appeal of peer review |
Procedure for contesting an initial peer review outcome, which NIAID advises against. Synonymous with rebuttal.
For more information, go to these NIAID resources:
|
Appendix |
Supplemental information an investigator may include with a grant application.
For more information, go to NIAID's If You Need an
Appendix in the NIH Grant Cycle: Application to Renewal. |
applicable clinical trial |
Designation for defining the requirement to register on clinicaltrials.gov.
Applicable drug clinical trial. Controlled clinical investigation, other than a phase I clinical investigation, of an investigational
drug subject to FDA regulation.
Applicable device clinical trial. Clinical study of health outcomes (not including small feasibility studies) that compares an intervention with an investigational medical device against a control in human subjects, or pediatric postmarket surveillance.
For more information, go to these resources:
|
applicant |
Institution applying for a grant. Informally, applicant may refer to a principal investigator writing a grant application, though the institution is the official applicant. |
application |
See grant application. |
Application Guide |
See Grant Application Guide. |
application identification number |
Application type |
Activity code |
Institute |
Serial no. |
Suffix year |
Amendment |
Supplement |
1 |
R01 |
AI |
183723 |
01 |
A1 |
S1 |
Number on a grant application identifying the following:
|
application package |
See Grant Application Package. |
application type |
Broad category of grant application, noted as the first digit on an application identification number.
- Type 1 -- New -- provides PHS support for a new grant.
- Type 2 -- Renewal -- extends a project period that would otherwise expire for one or more grant budget periods; applications are peer reviewed and compete for funding.
- Type 3 -- Supplement -- provides additional funds to a grant as an administrative supplement or revision (aka competing supplement)
- Type 4 -- Extension -- provides time and funds beyond the recommended level. Used only for a few award types.
- Type 5 -- Noncompeting continuation -- continues support in the out years of a grant; does not compete for funds.
- Type 6 -- Change of grantee -- transfers a grant only when one organization buys out another, also called successor of interest.
- Type 7 -- Change of grantee -- transfers a grant from one institution to another (other than Type 6).
- Type 8 -- Change of NIH institute -- transfers a grant from one institute to another.
- Type 9 -- Change of institute -- continues support for grant transferred from one institute to another.
|
appropriation |
Law that authorizes federal agencies to obligate funds and make payments from the treasury for specified purposes as well as the amount of money NIH receives. Appropriations are in annual acts and permanent law.
For more information, go to these NIAID resources:
|
appropriations, continuing |
See continuing resolution. |
ARAC |
See NIAID AIDS Research Advisory Committee. |
archive
date |
Grants.gov term
for the date a funding
opportunity announcement expires and moves to the Grants.gov archive.
Archive date differs from closing
date. See the equivalent NIH Guide term expiration
date. |
AREA grant |
See Academic Research Enhancement Award. |
ARRA |
See American Recovery and Reinvestment Act. |
Asian |
Human subjects term indicating a person having origins in the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, or Vietnam.
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. |
assent |
Child's agreement
to participate in research,
which is not just a failure to object. See human subjects.
For more information, go to 45
CFR 46 and definitions in 45 CFR
46.402 and 45
CFR 46.116 General requirements for informed consent. |
assignment |
See receipt, referral, and assignment of grant applications. |
assistance |
Award of money, property, or services to accomplish a public purpose. Authorized by federal law, assistance mechanisms such as grants and cooperative agreements are awarded in less detail than are acquisitions (contracts). Responsibility for performance is the recipient's or may be shared with the government. |
assistant role for eRA Commons |
Commons role
delegated by a principal investigator to view the status of electronic applications; abbreviated ASST. An assistant can view the same information as a signing official: errors and warnings and application images but not summary statements. |
Association for Assessment and Accreditation of Laboratory Animal Care |
Private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. For more information, go to AAALAC. |
ASST |
See assistant role for eRA Commons. |
assurance |
Written, binding commitment an institution submits to a federal agency promising to comply with human subjects or animals in research regulations and stating procedures for achieving compliance.
For more information, go to these NIAID resources:
|
assurance, animal welfare |
See Animal Welfare Assurance. |
assurance, human subjects |
See institutional assurance of protection for human subjects and Federal-wide assurance. |
assurance, Institutional assurance of protection for human subjects |
See institutional assurance of protection for human subjects. |
assurance, principal investigator signature |
See principal investigator signature assurance. |
authorization |
Legislation enacted by Congress that
sets up or continues the legal operation of a federal program or agency
either indefinitely or for a specified time or that sanctions an
expenditure. An authorization is normally a prerequisite for an appropriation or
other budget authority.
For more information, go to these NIAID resources:
|
authorizations act |
Law that establishes or continues federal agencies or programs, establishes terms and conditions under which they operate, authorizes appropriations, and specifies how funds are to be used. Authorizations acts sometimes provide permanent appropriations. |
authorized
organizational representative (AOR) |
Grants.gov term
for an official
designated by an organization
applying for an NIH grant.
He or she ensures that the organization complies with terms
and conditions and
other administrative requirements and is accountable for the use of
NIH funds and performance of the research.
An AOR may sign an institutional
assurance of protection for human subjects and Animal
Welfare Assurance, making a commitment on behalf of the institution to
meet policy requirements. NIH may
use the term institutional
business official instead.
For more information, go to these NIAID resources:
|
average programmatic reduction |
Dollar amount a grant is reduced from the amount recommended by a scientific review group in initial peer review. NIAID may make such a reduction in some fiscal years so it can maintain a sufficient number of grants in its portfolio and combat inflation of grant costs. See financial management plan and biomedical research and development price index.
For more information, go to these NIAID resources:
|
award |
Legally binding document that includes compliance terms
and conditions and states that the government has obligated funds as direct costs and facilities and administrative costs. See grant and contract. |
award type |
See activity code. |
B |
|
BAA |
See Broad Agency Announcement. |
Background and Significance |
Section of an NIH grant application's Research Plan describing the background, existing state of knowledge, gaps the project is intended to fill, and health relevance of the research.
For more information, go to NIAID's Background
and Significance in the NIH Grant Cycle: Application to Renewal. |
bar to award |
Block to the award of a grant application until problems are resolved. For example, if a scientific review group has concerns about insufficient protection of human subjects or research animals, it enters a code 44 in the summary statement.
NIAID can also bar an award for unacceptable inclusion of children, women, or minorities. See restriction.
For more information, go to these NIAID resources:
|
Bayh-Dole Act |
Law encouraging universities and researchers to develop their inventions into marketable products.
See Small Business Innovation Research, Small Business Technology Transfer, technology transfer, and Federal Technology Transfer Act.
For more information, go to these resources:
|
Belmont Report |
Statement of ethical principles for human subjects research issued by the National Commission for the Protection of Human Subjects in 1978. Also see Nuremberg Code.
For more information, go to the Belmont Report. |
beneficence |
Ethical principle in the Belmont Report stating an obligation to protect people by not doing harm, maximizing benefits, and minimizing risks.
For more information, go to the Belmont Report. |
Bibliography
and References Cited |
For electronic grant applications, a field and attachment in the Research and Related Other Project Information component
of the Grant Application Package.
For more information, go to NIAID's Other Project
Information Form: Bibliography and References Cited in the NIH Grant Cycle: Application to Renewal. |
bilateral agreement |
General science agreement between the U.S.
and a foreign country. |
Biographical Sketch |
For electronic grant applications, attachment in the Research and Related Senior/Key Person Profile component
of the Grant Application Package that highlights the scientific accomplishments of key personnel listed in an application.
For paper applications, form in the PHS 398 application that highlights the scientific accomplishments of key personnel.
For more information, go to these resources:
|
biologic or biological |
Therapeutic serum, toxin, antitoxin, or analogous product for preventing, treating, or curing disease or injury. For more information, go to the definition in 21 CFR 600.
|
Biological Material License |
License agreement used when NIH seeks to transfer unpatented biological materials to a for-profit entity for commercial use.
For more information, go to NIAID's Office of Technology Development. |
Biomedical Research and Development Price Index (BRDPI) |
Index that enables NIH to measure annual changes in prices of research and development items and services. See also constant dollars and current dollars.
For more information, go to these resources:
|
biosafety level |
Guidelines for microbiological and medical laboratories that provide levels of protection for workers based on risks of manipulating transmissible agents, using engineering controls, management policies, work practices, and occasionally, medical intervention.
For more information, go to CDC's The 1, 2, 3's of Biosafety Levels. |
biosketch |
See Biographical Sketch. |
black or African American |
Human subjects term indicating a person having origins in
the black racial groups of Africa.
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.
For more information, go to the NIAID Human Subjects Resources portal. |
BML |
See biological material license. |
Board of Scientific Counselors (BSC) |
Body that advises the NIAID Division of Intramural Research and NIAID directors on the Institute's intramural research programs, basing its recommendations on periodic reviews of staff and laboratories.
For more information, go to BSC Roster. |
BRDPI |
See Biomedical Research and Development Price Index. |
Bridge award |
See R56-Bridge
award. |
broad agency announcement (BAA) |
General solicitation that identifies areas of scientific interest or aims to advance science. It differs from a request for proposals, which specifies a service or product the government wishes to acquire.
Broad agency announcements include criteria for selecting proposals and attracting offerors, who develop a statement of work and performance specifications.
For more information, go to these NIAID resources:
|
BSC |
See Board of Scientific Counselors. |
BSL |
See biosafety levels. |
Budget and Accounting Act |
Law requiring the president to send a comprehensive budget for all government agencies to Congress. It mandates the Office
of Management and Budget (OMB) to help the president prepare the budget. |
budget appropriation |
See appropriation. |
budget authority |
Legal authority to spend monies for programs, projects, or activities. Budget authority may be classified by the period (one-year, multiyear, no-year), timing of congressional action (current or permanent), or manner of determining the amount available (definite or indefinite).
For more information, go to these NIAID resources:
|
budget authorization |
See authorization. |
Budget Components, Research and Related |
See Research and Related Budget component form. |
budget, federal |
See federal budget. |
budget, NIAID |
NIAID's annual allotment of funds and plans for spending them. For more information, go to NIAID's Paylines and Funding portal. |
budget pages |
For electronic grant applications, see the Research and Related Budget components of the Grant Application Package. For paper grant applications, see modular budget justification page and detailed budget page.
For more information, go to NIAID's Strategy
for Planning a Budget in the NIH Grant Cycle: Application to Renewal. |
budget period |
See grant budget period. |
budget resolution |
Legislation in the form of a concurrent resolution proposing a budget for the federal government. It establishes budget totals, divides spending into functional categories (e.g., transportation), and may include reconciliation instructions to House or Senate committees.
For more information, go to these NIAID resources:
|
budgetary overlap |
Overlap of support that occurs when budgetary items requested in a grant application are already provided by another source.
For more information, go to NIAID's Prepare Your Other Support Submission in the NIH Grant Cycle: Application to Renewal. |
business official, institutional |
See institutional business official. |