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informed consent formEBM
The document used in a clinical trial that explains to potential participants the risks and potential benefits of a study, and the rights and responsibilities of the parties involved. The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. It is designed to begin the informed consent process, which consists of a dialogue between the subject and the research team; if the individual then decides to enter the trial, he or she gives his or her official consent by signing the document.
The document should specify the nature of the care and its proposed merits and hazards. If the care involves an invasive procedure, the document should provide enough detail about the procedure so that a reasonable person can decide whether it is in his or her interest to proceed. The material risks of the procedure, and consequences of not undergoing the procedure, should be listed. Alternatives to the procedure should be enumerated. Any special terms or conditions should be explicitly stated in the document. The form should include the name and title of the practitioner who provides the information to the patient. The document becomes valid when it is dated and signed by all parties.