informed consent
a way to protect people entering a drug trial. Each participant in a clinical trial in the U.S. must sign a consent form that explains the purpose of the trial, the results expected, the mechanics of the trial, potential risks, a list of other treatments that are available. There is also a statement telling the participant that (s)he can leave the clinical trial at any time.
The permission granted by a participant in a research study (including medical research) after he/she has received comprehensive information about the study. This is a statement of trust between the institution performing the research procedure and the person (e.g., a patient) on whom the research procedures are to be performed. This includes, for example, the type of protection available to people considering entering a drug trial. Before entering the trial, participants must sign a consent form that contains an explanation of: (a) why the research is being done, (b) what the researchers want to accomplish, (c) what will be done during the trial and for how long, (d) what the risks associated with the trial are, (e) what benefits can be expected from the trial, (f) what other treatments are available, and (g) the participant's right to leave the trial at any time. Informed consent also pertains to situations where certain tests need to be performed. See Clinical Trial.
an agreement signed by prospective volunteers for a clinical research trial that indicates their understanding of (1) why the research is being done, (2) what researchers want to accomplish, (3) what will be done during the trial and for how long, (4) what risks are involved, (5) what, if any, benefits can be expected from the trial, (6) what other interventions are available, and (7) the participant’s right to leave the trial at any time.
A process in which a person learns key facts about a clinical trial, including potential risks and benefits, before deciding whether or not to participate in a study. Informed consent continues throughout the trial.
A process of reaching an agreement based on full disclosure. Informed consent has components of disclosure, comprehension, competence and voluntary response. Informed consent often refers to the process by which one decides to donate the organs of a loved one.
