Consent Form Format
Description
How to fill out Confidentiality Agreements Package?
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FAQ
All sections of the consent form, except the "Consent" section, should be written in second person ("You are invited..."). Headers should include ?Informed Consent? followed by the title of the study (e.g., the header in this document). Footers should include page numbers.
Drafting tips for preparing consent forms: Divide sentences into two when necessary. Keep paragraphs short and limited to one idea. Use active verbs. Use the second person (you) not third person (the participant) to increase personal identification.
To achieve truly informed consent, four criteria have been identified: Information disclosure. Competence. Comprehension. Voluntariness.
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.
To achieve truly informed consent, four criteria have been identified: Information disclosure. Competence. Comprehension. Voluntariness.