Risk-specific consent forms are most helpful in defending an allegation of failure to inform. However, obtaining a patient's signature is an important part of securing consent for treatment and the overall process of sharing risk and benefit information. Personalizing the consent form through the addition of specific issues discussed with the patient is an excellent practice and demonstrates that the form completion was not just a perfunctory task. The form serves as the objective evidence of the informed consent process.
The discussion should address the most serious risks, less serious risks with a high likelihood of occurring, and any other risks to which the patient attaches significance. The documentation of the discussion of risks can be entered on either the form or in the patient's medical record.
Documentation of patient-specific and/or procedure-specific risks has been helpful in the successful defense of numerous CRICO consent-related claims. For example, more than one claim arising from a pregnancy subsequent to a sterilization procedure has been successfully denied when the defense demonstrated that the procedure was correctly performed and the procedure-specific consent form listed failure of the procedure to prevent pregnancy as a risk.