What is an Informed Consent Form?

An informed consent form is a legal document used to provide information in situations where informed consent is required for legal or ethical reasons. It is reviewed and signed to indicate that the contents were understood. The informed consent form is kept on file to provide proof that informed consent was obtained. In the event that there is a dispute, the form can be referenced to resolve the matter.

The idea behind informed consent is that if a situation or activity could potentially be dangerous, there is an ethical obligation to inform people about the danger so they can decide if they want to participate. After reviewing the risks and benefits of the situation, along with steps being taken for protection, people can make an informed choice about proceeding or not. If people are not provided with information, they do not have the ability to consider the risks of their choices, and thus may agree to do something risky without being aware of what they are committing to.

All research studies that use human participants require informed consent. Likewise, before people undergo medical procedures, they must sign informed consent forms. Such forms may also be required for activities that are dangerous, like sky diving or snorkeling. In addition, people may be required to sign a liability release for recreational activities, indicating that they know the risks and do not hold the person or persons in charge responsible for any injuries or damages incurred.

In an informed consent form, the procedure or activity must be clearly explained in language that the person can understand. The risks and potential benefits should be listed, along with explanations of steps taken to mitigate them to make the situation safer. Informed consent forms also contain a clause explaining that people are entitled to ask for a more complete explanation and that they can ask questions about the procedure. Before signing an informed consent form, people should make sure that they fully understand what they are agreeing to and that they have no questions.

Another aspect of an informed consent form is a disclosure stating that people have the right to refuse to participate at any time. People can withdraw from studies, procedures, and treatments if they no longer feel comfortable and will not be subjected to any penalty. By signing the form, people indicate that they understand the information being disclosed and that they are making an informed choice about their participation. Informed consent forms also have a box people can check to indicate that they are declining to participate, should someone read the form and decide that the risks are too high.