Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge, or a clinical investigation. Under FDA regulations research is defined as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration.
Research Misconduct: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing 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 the 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 differences of opinion.
Research Participant: A living individual about whom an investigator conducting a systematic investigation, designed to develop or contribute to generalized knowledge obtains data through intervention or interaction with the individual, or identifiable private information.
- An individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient; or in the case of a medical device, a human who participates in a clinical investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A participant may be in the normal health or may have a medical condition or disease.
Risk: The possibility of suffering harm or loss. A risk may be known or unknown.