For Institute program-specific acronyms, go to NIAID Profile and Fact Book.
See Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
See Project Summary/Abstract and Project Narrative.
Go to these resources:
Grant that stimulates research at health professional academic institutions with less than $6 million of NIH support in total costs in four or more of the last seven years.
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.
Go to FDA's Fast Track, Accelerated Approval and Priority Review.
Contract proposal judged by the majority of a technical evaluation group to be eligible for inclusion in a competitive range or award.
Go to NIAID's Contracts portal.
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.
Written comprehensive plan for fulfilling the government's need in a timely manner and at a reasonable cost. It includes a strategy for managing the acquisition, coordinating and integrating its planning for all personnel involved.
An acquisition plan is required for all acquisitions to be placed by an HHS contracting office expected to exceed $500,000 (inclusive of options) with certain exceptions detailed in HHSAR 307.7101, Policy.
For a legal description, see FAR Part 7: Acquisition Planning, and HHSAR Part 307: Acquisition Planning. Go to NIAID's Acquisition Planning Resources on the Contracts portal.
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:
Go to NIAID's Grants portals and Award Types questions and answers. Also see NIH's list at Types of Grant Programs.
For staff, go to NIAID's Selection of Appropriate Funding Mechanisms SOP and Activity Codes Used by NIAID.
Unilateral, written contract change that does not affect the substantive rights of the contracting parties (e.g., a change in the paying office or the appropriation data). For a legal description, see FAR Part 43, Contract Modifications.
Money added to an existing grant without peer review to pay for items within the scope of an award but unforeseen when a grant application was submitted. See supplement.
Go to NIAID's Administrative Supplements to Grants and Cooperative Agreements SOP.
adult stem cell
Agreement negotiated before a contractor incurs a cost, specifying whether it is allowable. An advance agreement may be negotiated before or during a contract, must be in writing, and must contain a statement of applicability and duration. It may apply to a contract, group of contracts, or all contracts of a contracting office, agency, or several agencies. For a legal description, see FAR 31.109, Advance Agreements.
adverse device effect
See unanticipated adverse device 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.
Go to 45 CFR part 46, subpart A and the NIAID Human Subjects Resources portal.
Occurrence of an adverse effect occurring during a clinical study. Also see serious adverse event.
Go to definition in 21 CFR 812.3 and full 21 CFR 812 and the NIAID Human Subjects Resources portal.
See Council, advisory and National Advisory Allergy and Infectious Diseases Council.
NIH extramural officer who evaluates the merit of research misconduct allegations and reports findings to appropriate executives. Also see RIO.
Go to NIAID's Allegations of Research Misconduct SOP.
HHS AIDS information site. Go to AIDSinfo and HHS.
Research of the etiology, epidemiology, natural history, diagnosis, treatment, or prevention of AIDS and its sequelae; it does not include all studies of T lymphocytes or retroviruses.
For more information, call a program officer in NIAID's Division of AIDS.
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.
Go to the ARAC roster.
Department of Health and Human Services system for making public the names of organizations and people accused or found guilty of research misconduct.
Go to PHS Administrative Action Bulletin Board of the Office of Research Integrity and NIAID's Allegations of Research Misconduct SOP.
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.
Go to U.S. Citizenship and Immigration Services and NIAID's Foreign Workers on NIH Awards SOP.
NIAID scientific review group for grant applications in allergy, immunology, and transplantation. Go to the AITRC roster.
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.
Go to FAR 31 and NIAID's Contracts portal.
Alternative grant term for an application resubmission. For contracts, see contract modification.
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 Planned Enrollment Report and Cumulative Inclusion Enrollment Report.
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.
Go to the NIAID Human Subjects Resources portal.
Agency of the U.S. Department of Agriculture that ensures the health and care of animals and plants through the Animal Welfare Act.
U.S. investigators who possess, use, or transfer a USDA select agent must register with and get approval from APHIS. For an overlap select agent, U.S. investigators must register with and get approval from either APHIS or CDC. Find forms at Federal Select Agent Program.
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.
Go to these NIAID resources:
Live, vertebrate animal used for research, research training, biological testing, or related purposes. This includes production of custom antibodies and animals obtained for their tissues. See animal welfare assurance.
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.
Go to NIAID's Research Animals Involvement Codes on the Animals in Research portal.
See grant anniversary date.
See authorized organizational representative.
Procedure for contesting an initial peer review outcome due to defects in the review process.
Go to these NIAID resources:
Supplemental information an investigator may include with a grant application.
Go to NIAID's What to Add and Not to Add in an Appendix in the Strategy for NIH Funding.
Designation for defining the requirement to register on ClinicalTrials.gov.
Applicable drug clinical trial. Controlled clinical investigation, other than phase I, 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 post market surveillance.
Institution applying for a grant. Informally, applicant may refer to a principal investigator writing a grant application, though the institution is the official applicant.
Number on a grant application identifying the following:
An NIH online system applicants can use—in lieu of standard downloadable forms—to prepare and submit grant applications. ASSIST is a submission option for many activity codes. For more information, go to NIH's ASSIST website.
Broad category of grant application, noted as the first digit on an application identification number.
1. One of the standard NIH initial peer review criteria used to assess how well a research project's strategy, methods, and analyses can accomplish the Specific Aims. Also see Innovation, Significance, and overall impact score.
2. Section of the Research Strategy in the grant application.
Law that authorizes federal agencies to obligate funds and make payments from the treasury for specified purposes; also refers to the amount of money NIH receives. Appropriations are in annual acts and permanent law. See authorization.
Go to these NIAID resources on the Paylines and Funding portal:
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 Planned Enrollment Report and Cumulative Inclusion Enrollment Report.
Child's agreement to participate in research, which is not just a failure to object. See human subjects.
Go to 45 CFR 46 and definitions in 45 CFR 46.402 and 45 CFR 46.116 General requirements for informed consent.
Commons role delegated by a principal investigator to view the status of applications; abbreviated ASST. An assistant can view the same information as a signing official: errors, warnings, and application images, but not summary statements.
Private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.
Go to AAALAC.
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. See Federalwide Assurance (FWA) and Animal Welfare Assurance.
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.
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. See authorization.
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 uses the term institutional business official instead.
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.
Form used to:
Go to the Awaiting Receipt of Application (ARA) form and Awaiting Receipt of Application (ARA) SOP.
Last Updated July 22, 2015
Last Reviewed March 28, 2012