Glossary
Scientific Rigor
2
21st Century Cures
G
Grant Number
- type of application (1)
- activity code (R01)
- organization to which it is assigned (AI)
- serial number assigned by the Center for Scientific Review (183723),
- suffix showing the support year for the grant (-01)
- other information identifying a revision (S1), resubmission (A1), or a fellowship's institutional allowance. For contracts, the suffix is replaced by a modification number.
Sample Grant Number 1 R01 AI 183723 -01 A1 S1
H
HEAL
High Risk/High Impact (HR/HI)
I
Impact Score
Institute or Center (IC)
The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC" or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.
K
Key Personnel
M
MEDLINE
N
NIH-Defined Phase III Clinical Trial
An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
NRFC
An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.
O
Office of Research Integrity
P
Peer Review
The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of applications based on an evaluation of scientific or technical merit or other relevant aspects of the application. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support is requested. Peer review is intended to provide guidance and recommendations to the NIH individuals responsible for making award decisions.
R
Research & Development
All research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.
Review Committee
The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.
Review Cycle
S
Scientific Review Group
A peer review committee group of primarily non-government experts (peer reviewers), qualified by training or experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under review, to evaluate and give expert advice on the scientific and technical merit of the applications. No more than one-fourth of the members of any SRG may be Federal employees, as noted in 42 CFR 52(h).
Scientific Rigor
Scored Review Criteria
Significant Differences
Special Emphasis Panel (SEP)
Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.