Human participant definition

Human participant means an individual who is or becomes a participant in research, either as a recipient of a test article or as a control or an individual on whose specimen a medical device is used. A participant may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e) and 21 CFR 812.3(p)]
Human participant or "participant" means any individual, customer, volunteer, or employee who is the subject of research conducted or authorized by the department, facility, local agency, or contractor.
Human participant means a living individual about whom an investigator (whether professional or student) conducting research (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the participant or the participant’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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). Identifiable private information is information for which the identity of the participant 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 participant is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102]

Examples of Human participant in a sentence

  • Human participant research means research involving a living individual about whom an investigator obtains, through either primary or secondary sources: (1) information or data through intervention or interaction with the individual, or (2) identifiable private information.

  • INFORMED CONSENT Human participant research/data collection may begin only after the participants have been provided complete information about the risks and benefits associated with participation in the research.

  • Human participant research can proceed only with the consent of the individual or his/her LAR, unless waived in accordance with Federal regulations.

  • Human participant research must be reviewed if it is conducted by any faculty member, staff person, student, or any individual who is under the auspices of ASMS or a collaborating entity.

  • Type of Study: (Tick the appropriate boxes)Observational Interventional Prospective Retrospective Cross-sectional Human participant No human participation In-vitro Drug Devices Surgical procedure Life-style modification Single center Multi-centric Any other ………………………………………………………………………….If multicentric, how many centers: India ……….


More Definitions of Human participant

Human participant means a living individual about whom an investigator obtains
Human participant means a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual, or (ii) identifiable private information. Intervention includes both physical procedures by which data are gathered and manipulations of the participant or the participant’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 reasonablyexpect 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. Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)]
Human participant means a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
Human participant means any living person who consents to participate in a health research activity or a body of a deceased person or part of a body of a deceased person as provided in the Human Tissue Act;
Human participant means a living individual about whom a researcher (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention may include both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
Human participant means a living or non-living individual, including human remains, about whom a researcher, whether professional or student, conducting research obtains private information or data through intervention or interaction with the individual, involving physical procedures by which data are gathered, for example, blood draws, and/or manipulations of the
Human participant means a living individual from whom a researcher obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.