Federal RegulationsThe Public Health Service Act (P.L. 93-348) as implemented by HHS regulation Sec. 45 CFR 46 - Protection of Human Subjects, sets forth a common federal policy for the protection of human subjects. The regulations stipulate the composition and duties of an IRB, establish standards for informed consent, provide for sanctions against institutions and individuals who violate the regulations, and require more intensive scrutiny of research involving fetuses, in vitro fertilization, pregnant women, prisoners and children. These regulations do not supersede other state and federal laws; they create additional duties for individuals involved in research involving human subjects.
Research means a systematic investigation designed to develop or contribute to knowledge in a particular discipline. Activities that meet this definition constitute “research” for purposes of these regulations whether or not they are supported or funded under a program considered research for other purposes. For example, some “demonstration” and “service” programs may include “research activities.”
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.
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 participant.
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 which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (for example, 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.
Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (Sec. 46.102)