IRB Online Training - Definitions Human Subject Definitions as defined by the Code of Federal Regualtion 45 CFR 46.102 Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Interaction includes communication or interpersonal contact between investigator and subject.
IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. For further information, please see the Code of Federal Regulation 45 CFR 46.102 .