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.

Effective Jan. 1, 2021 the fee schedule for the Bridgeport Hospital Institutional Review Board protocol submission and subsequent action is as follows:

Initial Review: A $4,000 fee will be billed with the fully executed Clinical Trial Agreement. This 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. Payment is expected within 30 days of submission. Subject enrollment will not be permitted until receipt of payment.

Annual Review: A $750 fee per year will be billed with the annual review reminder. This fee covers any action required following the initial review, i.e., annual review, reporting of adverse events and all other communication. 

Amendments: A $500 fee will be billed for major amendments (full IRB review).

Amendments: A $250 fee will be billed for minor amendments (expedited review).

Payment is expected within 30 days of IRB action, independent of the IRB decision Non-payment will result in temporary/ permanent cessation of subject enrollment at Bridgeport Hospital.  

Checks should be made payable to the Bridgeport Hospital Foundation, Institutional Review Board Account #1210.

Any questions regarding this policy should be directed to Evelyn Colon, IRB Administrator, at 203-384-4549.

IRB meetings in 2021 will continue to be held on the first Thursday of every month (except for the months of July and August) from 11 am – 1 pm. All submissions must be received by the Wednesday of the previous week at 4 pm.


Meeting Submission Deadline
(4 pm Wednesday)
January 7, 2021

December 28, 2020

February 4, 2021 January 27, 2021
March 4, 2021 February 24, 2021
April 1, 2021  March 24, 2021
May 6, 2021 April 28, 2021
June 3, 2021 May 26, 2021
July 15, 2021* July 7, 2021*
September 2, 2021    August 25, 2021
November 4, 202 October 27, 2021
December 2, 2021 November 24, 2021
   
* Summer Meeting