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.
Any institution engaged in human subject research (not otherwise exempt) that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects.

Bridgeport Hospital FWA: 00002819
Bridgeport Hospital IRB Registration: 00002079
The IRB has a federally mandated responsibility to protect human subjects involved in research. The efforts and expertise required to achieve this are substantial.

Below is the Fee Schedule for Protocol Submission and subsequent IRB action.

Initial Review: A $3,000 fee covers the cost of reviewing the protocol, informed consent document, investigator's brochure, any advertisements and translations, as well as amendments, administrative letters, and serious adverse events. 

Annual Review: A $700 fee per year covers any action required following the initial review, i.e., annual review, reporting of adverse events and all other communication. 

Payment is expected independent of the IRB decision and is due within 30 days of receipt of invoice. This fee may be waived for non-commercially sponsored studies at the discretion of the IRB office.

IRB meetings for 2017 will continue to be held on the first Thursday of every month (except for the months of July and August) from 11 am. to 1 pm in the DuPont Board Room. All submissions must be received by the Wednesday of the previous week at 4 pm.

Meeting Submission Deadline
(4 pm Wednesday)
Jan 5, 2017 Dec. 28, 2016
Feb 2, 2017 Jan. 25, 2017
March 2, 2017  Feb. 22, 2017
April 6, 2017 March 29, 2017
May 4, 2017 April 26, 2017
June 1, 2017 May 24, 2017
July 20, 2017 July 12, 2017
Sept 7, 2017 Aug. 30, 2017
Oct 5, 2017 Sept. 27, 2017
Nov 2, 2017 Oct. 25, 2017
Dec 7, 2017 Nov. 29, 2017