Informed consent, in a medical setting, means that a patient or his or her representative has been given all the information necessary regarding a medical procedure or treatment. He or she must understand the potential risks and complications. Typically, an informed consent is a piece of paperwork that you must sign before an operation or treatment plan can begin.
Informed consent is also necessary in situations where a person is part of a research study. For instance, if you are a patient participating in a new research study on a trial medication, you should receive an informed consent document detailing the risks of the medication. You must grant the researcher and medical provider access to your documents and sign off on the use of the medication.
Any good informed consent document will include any foreseeable risks or discomforts the subject may face. It will include a description of benefits that could be expected as well as alternative treatments or procedures if any exist. Since the operation or treatment is being studied, an informed consent needs to include information on confidentiality and what the patient can expect when documentation about the research is released to the medical community or public. Additionally, the research’s purpose, duration and description needs to be included alongside information about who to contact for questions about the research, your rights or what to do in the event of an injury related to the medication or treatment program.
Our website has more about what you can do if you have suffered injuries because of not understanding the true impact of a trial drug or test therapy.