What is “informed consent”?
Anyone entering a clinical trial in the United States is required to sign an informed consent, a form indicating that they understand what will happen to them during the study. It is a continuing process throughout the study to provide updated information for participants. To help you decide whether or not to participate, the doctor will help to explain the details of the study. Then you will be given the informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. Then you decide whether or not to sign the document. Informed consent is not a contract, but an agreement that you understand the study. You may withdraw from the trial at any time.
Informed consent is the permission given by a patient to perform a medical treatment or surgical procedure after the patient has been advised of the risks or hazards that could influence a reasonable person in deciding whether or not to consent. In order for the patient to make an informed decision about whether to consent, the patient needs information about the treatment or procedure and the risks associated with it. Informed consent deals with the information provided to the patient and how it is provided when obtaining the patient’s permission to perform the treatment or procedure.
In short, a person’s written consent to a surgical or medical procedure, other course of treatment (e.g. mental health) or participation in a research study, which occurs after the person demonstrates sufficient understanding of the potential risks, complications and consequences of the treatment (or non-treatment). While state laws may vary, the elements of informed consent must include: -the nature of the decision/procedure -reasonable alternatives to the proposed intervention -the relevant risks, benefits, and uncertainties related to each alternative -assessment of patient understanding -the acceptance of the intervention by the patient, voluntarily without coercion or duress Some studies take their recommendations further: “A detailed informed consent should be obtained from high-risk living kidney donor transplant recipients as well as donors and family members after the high perioperative risk potential has been explained to them.” (74) And “Living Kidney Donors must be informed
