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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.
Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision.
Writing tips 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. The consent doucment must be consistent with what is described in the IRB application.
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.
I consent to participate in the research project and the following has been explained to me: the research may not be of direct benefit to me. my participation is completely voluntary. my right to withdraw from the study at any time without any implications to me.