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The consent form should cover the following areas: The participant's understanding of the research. Consent to the way in which research will be carries out. Privacy and confidentiality of information (the ethical basis of research) Right to withdraw participation and/ or data in the study.
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.
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.
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 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.