All medical care requires the patient’s consent. In some cases, you approve a care plan by getting a prescription filled or allowing blood to be drawn. This is called simple consent.
In other instances, clinical trial participants are asked to agree to the care plan in writing. This is called informed consent.
The main purpose of the informed consent process is to communicate to you, the patient, the requirements of the study. You have the right to make decisions about your own health and medical conditions.
Informed consent for a clinical trial involves two parts: a document and a process.
The clinical trial informed consent document provides a summary of the trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternative treatments. It also explains your rights as a clinical trial participant. If you decide to enter the trial, you give your official consent by signing the document.
According to regulations in the United States, no informed consent document may say anything that asks – or seems to ask – you to give up your legal rights. It also may not include anything that releases – or appears to release – the investigator, doctor, sponsor or facility from liability if they are negligent or careless.
The clinical trial informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Before you make your decision, the research team will discuss the trial with you. If you decide to participate in a clinical trial, the researchers will continue to update you on any new information that may affect you. You will also have the opportunity to ask questions before, during and after the trial.
Some information on this page is based on the National Cancer Institute’s “A Guide to Understanding Informed Consent.”