Clinical investigation is defined as any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
Employees or agents refers to individuals who act on behalf of, exercise authority or responsibility for, or perform activities designated by Boston Medical Center or Boston University.
Human subject is defined as a living individual;
- About whom a researcher obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- About whom a researcher obtains, uses, studies, analyzes, or generates identifiable private information about the individual or identifiable biospecimens; or
- Who is or becomes a subject (either a healthy human or a patient) in research, either as a recipient of the test article or as a control or upon whose specimens, either identified or not identified, an investigational device is used.
Intervention includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. For purposes of this definition, a systematic investigation is the use of a predetermined method to gain information by collecting and analyzing data. Generalizable knowledge is conclusions that can be applied to circumstances outside of the specific instances of the investigation.