Informed Consent Process And Documentation

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.