About Our Program The Institutional Review Board (IRB) is an administrative committee of Bridgeport Hospital, whose purpose is to ensure that the rights and welfare of human subjects of research conducted at or sponsored by Bridgeport Hospital regardless of the source of funding are protected pursuant to Federal Regulations (45 CFR part 46 and 21 CFR part 56). In taking on this responsibility, the IRB ensures that the human subject research is conducted ethically and in compliance with the Belmont Report, applicable federal, state, local and institutional requirements by performing prospective and continuing review of the protocol, the informed consent process and the procedures utilized to enroll subjects. The IRB uses the following definitions of human subjects research set forth in 45 CFR 46.102: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator conducting research obtains identifiable private information. Human subjects research includes, but is not limited to, studies with tissues, fluids, or other material removed from a living human, as well as a wide range of medical, behavioral, biological and epidemiology studies. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’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 which 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 (i.e., the identity of the subject 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.