Informed Consent

All medical care requires the patient’s consent. In some cases, patients approve a care plan by getting a prescription filled or seeing a specialist. This is called simple consent.

In other cases, patients are asked to agree to the doctor's plan for their care in writing. This is called informed consent; and it recognizes a patient’s need to know about a procedure, surgery or treatment before he or she decides to have it.

Clinical trials require informed consent, which consists of a document and a conversation.

Informed Consent Document

The informed consent document provides a summary of the clinical trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternative treatments. It also describes the rights of clinical trial volunteers. The document is designed to begin the informed consent process, which consists of conversations between the patient and the research team.

Clinical trial volunteers give official consent by signing the document. However, the document is not a contract, and volunteers may withdraw from the trial at any time.

According to regulations in the United States, no informed consent document may say anything that asks – or seems to ask – a patient to give up his or her 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.

Informed Consent Process

The informed consent process provides volunteers with ongoing explanations that will help them make educated decisions about whether to begin or continue their participation in a trial. Before volunteers make the decision to participate in a clinical trial, they can discuss the study with the research team. If they decide to participate, the researchers will continue to update them on any new information that may affect them. Volunteers 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.”