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I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.
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.
Write directly to the reader, as though you are explaining the facts in person. Informed consent language should be written in the second person (?you?), not in the first person (?I?). Minimize passive voice to the extent possible.
Consent to Participate I have been encouraged to ask questions and all of my questions have been answered to my satisfaction. I have also been informed that I can withdraw from the study at any time. By signing this form, I voluntarily agree to participate in this study.