Informed Consent Informed consent is a process in which the facts, such as the potential risks and benefits, the intervention, and required tests, are explained. The research doctor or nurse will give the patient written information called a consent form that explains these facts. If a patient agrees to take part in the study, he or she will be asked to sign the consent form. Patients can discuss the informed consent with their doctors, nurses, family, or friends before agreeing to participate and can continue to ask questions throughout the study. Anyone considering a clinical trial should feel free to ask any questions or bring up any issues concerning the trial at any time.
Informed consent is an ongoing process as long as a person is in the study.
A patient can leave the study at any time either before the study starts or at any time during the study or follow-up period. Privacy and Confidentiality Clinical trials recruit patients to help uncover the causes of cancer and the pattern of disease so better prevention, diagnostic, and treatment methods can be developed. In these studies, issues of privacy and confidentiality are extremely important because it is often necessary for researchers to gather behavior information, medical histories, and tissue samples from patients. To protect a patient's confidentiality, this data may be stored or preserved in data banks or tissue registries where only authorized individuals will have access to them. In most studies, data and samples are assigned numbers for identification purposes.