What is defined as human subject involvement?
When human beings are asked to participate physically in an activity (i.e. in a survey, answering a questionnaire) or to donate their tissue, organs, fluids and other bodily materials it is considered human subject involvement. Federal Policy (45 CFR 46) and FDA (21 CFR 50) provide definitions of human subjects. 45 CFR 46: “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) data through intervention or interaction with the individual, or(2) identifiable private information.
