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The requirements of an informed consent for a medical or surgical procedure, or for research, are that the patient or subject (i) must be competent to understand and decide, (ii) receives a full disclosure, (iii) comprehends the disclosure, (iv) acts voluntarily, and (v) consents to the proposed action.
Most consent includes general risks, risks specific to the procedure, risks of no treatment and alternatives to treatment. Additionally, many consent forms express that there are no guarantees that the proposed procedure will provide a cure to the problem being addressed.
A statement that the study involves research. An explanation of the purposes of the research. The expected duration of the individuals participation. A description of the procedures to be followed. Identification of any procedures which are experimental.
The Elements of Informed Consent. Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. Presidents Commission, 1982; Meisel and Roth, 1981).
Informed consent is required for many aspects of health care.[16][17][1] These include consent for: Treatment, dissemination of patient information, discussion of HIPPA laws, specific procedures, surgery, blood transfusions, and. anesthesia.
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Defining consent informed the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.
It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care, for a person. This principle reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice.
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.

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