17-PI-20 Informed Consent-Updated Process and Documents.pdf 2025

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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.
Generally, the IRB requires consent to be documented by a written consent form that includes all the required elements, and all appropriate optional elements, approved by the IRB prior to use. An IRB approved consent document will contain the date of IRB approval.
The informed consent document, which should include an information sheet for the participant to retain, confirms that people understand exactly what is involved in the study, and what they are to do, and provides protection from liability.
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.
Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subjects legally authorized representative at the time of consent. 2. A copy of the signed and dated consent form must be given to the person signing the form.
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Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patients role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patients preference,

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