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What Is Informed Consent? There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.
Drafting tips for preparing consent forms: If possible, keep words to 3 syllables or fewer. Write short, simple, and direct sentences. Divide sentences into two when necessary. Keep paragraphs short and limited to one idea.
For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject's participation; a detailed description of ...
Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.
Write the name of the research project here I have received, read and kept a copy of the information letter/plain language statement. I have had the opportunity to ask questions about this research and I have received satisfactory answers. I understand the general purposes, risks and methods of this research.