Informed consent is the name for the process of learning about surgical procedures and their associated risks. A signed and witnessed consent form (informed consent) is required by law before any surgical procedure. The consent process involves much more than signing a form. Proper consent should include clear explanation of the following:
- what procedure is to be done and why
- risks and benefits of the procedure and the likelihood of each (risk and benefit) occurring
- other treatment options – instead of the proposed procedure, and associated risks and benefits of other options
- how your information will be kept confidential
In addition you should be given:
- an opportunity to ask questions and time to consider your options
- adequate time to review the informed consent form prior to surgery
Difficulty understanding unfamiliar medical terms is common, so consent forms should be written as simply as possible. According to a report in Critical Care Medicine (2005; 33(4): 867-882), consents should be written for a person at a fifth to eighth grade reading level, in order to ensure understanding.
Once the procedure, risks, and potential benefits have been explained, it is the patient’s (or family member’s) responsibility to ask if the procedures are not clear.
Two simple tips can help if more time is needed before making a decision:
- Ask that the consent form be left to read and think about prior to signing.
- Repeat what you heard back to the person who is obtaining your consent.