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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.
I consent voluntarily to be a participant in this study and understand that I can refuse to answer questions and I can withdraw from the study at any time, without having to give a reason.
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.
If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.
The consent form must include: A statement that the study involves research. Purpose of the research. Procedures. Risks or discomforts to the subject. Benefits of the research to the subject. Treatment Alternatives. Costs of Participation. Confidentiality.
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The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.
If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.
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.

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