Human Subjects Research definition

Human Subjects Research means a systematic investigation through experimentation, testing, evaluation, or observation performed on a living individual or group of individuals, about whom an Investigator obtains 1) data through intervention or interaction with the individual(s), or 2) identifiable private information (45 CFR 46.102).
Human Subjects Research means the systematic scientific evaluation of a living human for the purpose of engaging in clinical or non-clinical research and evaluation.
Human Subjects Research means any activity that meets either the HHS (Office of Human Research Protections) or FDA definitions of "research" and involves "human subjects".

Examples of Human Subjects Research in a sentence

  • The Research Material does not involve specimens or data derived or collected from human subjects and therefore does not need review and approval by the Human Subjects Research Review Official (HSSRO).


More Definitions of Human Subjects Research

Human Subjects Research means research involving an Investigator’s intervention or interaction with a living human individual or with an individual’s identifiable information at or under the auspices of NYU Langone as defined by the IRB under its policies.
Human Subjects Research means “research” involving a “human subject,” as those terms are defined in this Section 2.
Human Subjects Research. 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.
Human Subjects Research means any systematic investigation that (a) is designed to develop or contribute to generalizable knowledge and (b) obtains data through intervention or interaction with living human individuals and/or obtains identifiable private information about living human individuals, including by means of observation or recording of behavior. Intervention includes both physical procedures and manipulations of the human subject or human subject’s environment that are performed for study purposes. Interaction includes communication or interpersonal contact between an investigator and a human subject.
Human Subjects Research means a systematic investigation performed with human subjects (including development, testing, and evaluation) designed to develop or contribute to generalizable knowledge, regardless of the source of funding.
Human Subjects Research means any “research” involving a “human subject” as set forth in applicable Law, and, if not so defined, means any of the following: (i) “research” involving a “human subject” as those terms are defined in 45 C.F.R. § 46.102; or (ii) a “clinical investigation” as defined in 21 C.F.R. § 50.3(c) and similar FDA regulations.
Human Subjects Research means any systematic investigation (a) that is designed to develop or contribute to generalizable knowledge and (b) that obtains data through intervention or interaction with living human individuals and/or obtains identifiable private information about living human individuals, including by means of the observation or recording of behavior. Intervention includes both physical procedures and manipulations of the human subject or human subject’s environment that are performed for study purposes. Interaction includes communication or interpersonal contact between an investigator and a human subject. Private information includes information that individuals can reasonably expect will not be made public. This definition also encompasses any experiment that involves a test article and one or more human subjects (i.e., a "clinical investigation" per FDA regulations).