Glossary
Data and Safety Monitoring Plan
Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.
R
RPPR
Research Performance Progress Report - Progress reports are required annually to document grantee accomplishments and compliance with terms of award.
S
Salary Cap
A legislatively-mandated provision limiting the direct salary for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts.
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
The strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results.
Scored Review Criteria
For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account five criteria, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria. Reviewers will consider each of the five criteria in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. See Peer Review Process/Scoring for additional information.
Set-Aside
Money taken out of the budget for a specific purpose, for example, to fund a congressionally mandated program.
Significant Differences
For purposes of NIH policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.
Specific Aims
A component of an application's Research Plan which describes concisely the goals of the proposed research and summarizes the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.. Includes the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).
Streamlined Review
In the peer review process, applications not considered by the Scientific Review Group to be in the more meritorious half are 'streamlined' and designated Not Discussed. Streamlined applications are not discussed at the review meeting and will not be assigned a numerical overall impact/priority score, but the applicants do receive the reviewers' critiques. Streamlined applications will receive criterion scores from the assigned reviewers in addition to the reviewers' critiques to help applicants assess whether or not they should submit a resubmission application.
STTR
Small Business Technology Transfer: A program designed to support cooperative research/research and development with potential for commercialization, through a formal cooperative effort between a small business and a U.S. research institution.
Summary Statement
A combination of the reviewers' written comments and summary of the members' discussion during the study section meeting. It includes the recommendations of the study section, a recommended budget, and administrative notes of special considerations.
T
Training Awards
Awards designed to support the research training of scientists for careers in the biomedical and behavioral sciences, as well as help professional schools to establish, expand, or improve programs of continuing professional education.
Translational Research
Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.
U
Underrepresented Group
Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.
Used as an eligibility requirement for diversity supplements, fellowships (F31), and other NIH programs.
Used as an eligibility requirement for diversity supplements, fellowships (F31), and other NIH programs.
X
XTRACT
Extramural Trainee Reporting and Career Tracking System
xTrain
xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.