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If you agree to receive all or some of the treatment options, you give your consent (agree) by signing a consent form. The completed and signed form is a legal document that lets your doctor go ahead with the treatment plan.
The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.
Elements of Informed Consent Title of the Study. Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the students information first. Purpose of the Study. Subject Selection Criteria. Study Procedures. Potential Risks and Discomforts. Potential Benefits. Cost and Compensation.
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information (i.e., the elements) that must be included as part of the consent process.
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patients role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patients
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The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patients understanding of elements 1 through 4.

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