Investigator Forms

In order to protect against financial conflicts of interest or perceived conflicts of interest, all investigators must complete a Conflict Of Interest Form at the time of initial protocol submission and with each reapproval request. Disclosures must also be made at any time conflicts related to the specific protocol are added or increased.

If the IRB determines that a conflict exists that could influence the research or jeopardize the well being of subjects, the IRB may require additional information about the conflict or may require that the conflict be resolved before the research is approved. In addition, it may require that the conflict be disclosed to the subject in the Informed Consent Statement.

Anyone receiving honoraria from a sponsoring institution exceeding $5,000 annually will be considered to have a conflict of interest.

Continuing Review

Requests for continuing reviews must be completed and submitted for IRB approval prior to the expiration date. Please remember to allow sufficient time for approval at a convened IRB meeting (or expedited approval process if applicable) prior to the expiration date. If the investigator fails to provide continuing review information and the IRB has not provided reapproval by the expiration date, the research must stop, unless the IRB finds that it is in the best interest of individual subjects to continue participating in the research interventions or interactions. However, enrollment of new subjects cannot take place after the expiration date.

The following information must be included:

1. A completed Continuing Review of Research Involving Human Subjects Form
2. Copy of most recent consent document
3. Updated Conflict of Interest Form from the investigator(s)

Termination

The following information must be included for a termination/closure request

1. A completed Continuing Review of Research Involving Human Subjects Form
2. A protocol progress report/summary, if applicable

HIPAA is the Health Insurance Portability and Accountability Act of 1996. HIPAA requires many things, including the standardization of electronic patient health, administrative and financial data. It also establishes security and privacy standards for the use and disclosure of "protected health information" (PHI).

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The informed consent process involves an interactive and multifaceted process, not just “signing a form.” A subject’s consent must always be given freely, without coercion, and must be based on a clear comprehension of what participation involves.

The informed consent process begins during initial contact with a potential subject and continues for the duration of the subject’s participation.

The informed consent form and all materials given to subjects (including advertisements, contact letters, questionnaires, telephone scripts, and study summary sheets) should be written in “lay language” at an 8th grade reading level or lower, and should not contain technical and medical terminology. It must also be in a typewritten format with a font of at least 12 points. Bridgeport Hospital requires that investigators use the informed consent form template and assent form template for minors.

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.

Keep all signature information on last page of consent form.

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The Outline of Research Study should include enough information in the 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.

The Proposal for Research Involving Human Subjects (Face Sheet) should be typewritten. 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 to which investigators in the protocol belong as well as any other departments involved in the protocol.