Glossary

A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.

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.

An oversight organization reporting to Congress.

Any historically black college or university established prior to 1964 whose principal mission was and is the education of black Americans, and is accredited by a nationally recognized accrediting Agency or Association determined by the Secretary [of Education] to be a reliable authority as to the quality of training offered or is, according to such an Agency or Association, making reasonable progress toward accreditation.

A financial assistance request (in the form of an application or progress report) or resulting award for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.

A financial assistance request (in the form of an application or progress report) or resulting award for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.

Office of Research Information Systems - Provides IT systems, data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans' Administration).

The Planned Enrollment Report is used when you are planning to conduct a study that meets the NIH definition for clinical research. It provides a breakdown of the planned sample by sex/gender, race, and ethnicity.

Periodic, report submitted by the grantee and used by NIH to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report.

Patient-Reported Outcomes Measurement Information Systems

Research Portfolio Online Reporting Tools

Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.

• Fabrication is making up data or results and recording or reporting them.
• Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
• Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
• Research misconduct does not include honest error or honest differences of opinion.

Research Performance Progress Report - Progress reports are required annually to document grantee accomplishments and compliance with terms of award.

The strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results.

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).

Extramural Trainee Reporting and Career Tracking System