What does informed consent mean?
You must be fully informed, and consent to participate in a clinical trial. Informed consent involves a discussion between you and the investigator or research team member about what is involved in the trial, its purpose, risks, procedures, your compensation, and who you should contact if you have questions. You are encouraged to ask questions during the discussion so you understand what you are signing. Informed consent also requires you to sign and date the consent form.
Being fully informed is a basic requirement in all research with human participants. Ethically and legally, consent is not considered to be “informed” unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual’s decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.
Informed consent refers to the process by which volunteer patients discover the details of their clinical trial. Patients must be provided all facts about a trial prior to giving consent to participate, including treatment details and possible risks and benefits. The informed consent form must be signed by patients prior to participation. The informed consent process continues throughout the clinical trial.
An informed consent is a document that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities. Participants must be provided all the facts about a trial before giving consent to participate. This includes treatment details and possible risks and benefits.
