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What is an Informed Consent?

informed consent
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What is an Informed Consent?

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Informed consent refers to the process by which the study doctor and/or staff provide potential patients with key facts about the clinical study. This process allows participants an opportunity to review a brief written description of study procedures (including risks and benefits) in consideration of their participation in the study. After patient understands study procedures, they are asked to sign an Informed Consent form. Back to top…

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An informed consent is a document that describes all study procedures, possible risks, side effects, benefits, and alternative treatments. Before volunteers sign the informed consent, they are given the opportunity to have their questions answered by a trained member of the ECIR staff. Even after signing the informed consent, volunteers may leave the trial at any time and are given the opportunity to discuss alternative treatments with the ECIR medical staff.

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Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to discussing a clinical trial with a doctor or nurse, people are asked to sign a written consent form explaining the study. However, signing the form does not mean people must stay in the study. People can leave the study at any time-either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.

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An informed consent is a document that describes all study procedures, possible risks, side effects, benefits, and alternative treatments. Before volunteers sign the informed consent, they are given the opportunity to have their questions answered by a trained member of the EIR staff. Even after signing the informed consent, volunteers may leave the trial at any time and are given the opportunity to discuss alternative treatments with the EIR medical staff.

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Informed consent is a FDA requirement that says you must be given complete information about the study before you agree to take part.

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