Application Process

FDA regulations require that all investigators involved in clinical research receive proper training in the protection of human subjects and in the standards and regulatory requirements governing their research activity. This training must be documented prior to starting a study. For the NIH training use Protecting Human Research Participants.

Effective January 1, 2014, the Bridgeport Hospital Institutional Review Board will be using the Mentor Electronic Protocol Management System.  All items for IRB review must be submitted online. 

Completed proposals submitted one week prior to the monthly IRB meeting (first Thursday of every month) will be reviewed promptly.  See meeting dates and submission deadlines.

Investigators must complete the Bridgeport Hospital standard forms and upload to axiommentor. Study templates are available on the investigator forms page. Incomplete submissions will not be accepted by the IRB.

Use short titles that lay persons can comprehend.

An application consists of the following:

1. Typewritten Proposal for Research Involving Human Subjects (Face Sheet). Be certain to include IND number (for experimental drug/device) and information on reimbursement/remuneration. The face sheet must be signed by the PI and Chairs of all of the departments involved in the protocol.
2. Prepare Outline of Research Study. Include enough information in background and methods sections to permit a physician (perhaps one not in your field) to understand the rationale and conduct of the study. The information in the study outline should be sufficient to support the information provided in the informed consent form. Submitting copies of protocols prepared by study sponsors in lieu of the IRB study outline format is NOT ACCEPTABLE. Please edit Header A & Footer A to conform to your study
3. If applicable, prepare an Informed Consent Form using the IRB templates provided, completing or deleting, as appropriate, all information in bold type. Keep the following points in mind:
   
   1. Use lay language (your parent or spouse should be able to understand what the form says), defining in parentheses all medical terms and procedures the first time the words appear;
   2. Explain the concepts of randomized therapy and placebo (inactive substance) when appropriate;
   3. Explain the purpose/rationale of the study and each of its procedures (i.e. what is a transesophageal echo and why is it a part of this study);
   4. Delineate clearly the tests/treatments/visits that are experimental and/or unique to the study vs. those that are part of routine clinical practice;
   5. Clearly state the risks and benefits of participating in the study. Offer benefits that are reasonable (early phase drug trials and observational studies cannot usually be expected to provide direct benefit to individual subjects).
   6. Give subjects a clear picture of what will be expected of them: where will they have to go, how often, for how long at each visit and for how long will they be in the trial.
   7. Clearly states steps that will be taken to protect patient confidentiality.
   8. Edit Header A & Footer A to conform to your study.
   9. Keep all signature information on last page of consent form.
   10. If a waiver of consent is requested, A waiver of informed consent section should be completed including an explanation of how the study meets each criterion for exemption. The form must be signed by the Principal Investigator.
4. If applicable, a protocol giving a complete description of the proposed research in technical language.
5. An Investigator’s Brochure, if applicable.
6. Copies of all data collection tools, questionnaires, interview/survey forms, assessment materials, and descriptions of materials that subjects will encounter.
7. If applicable, advertisement(s) for subject recruitment.
8. Documentation of training in the protection of human research subjects, and curriculum vitae for each investigator listed on the application.
9. Conflict of Interest Form for each investigator listed on the application.
10. If applicable, complete the required HIPAA Forms – See HIPAA Section for more information
    
    1. Request for Access to Protected Health Information for a Research Purpose
    2. Research Authorization Form