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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.
I (patient name) give permission for [practice name] to give me medical treatment. I allow [practice name] to file for insurance benefits to pay for the care I receive. I understand that: [practice name] will have to send my medical record information to my insurance company.
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.
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.
Examples include: (1) if patients are capable of or willing to engage in decision making (2) if providers feel it provides more or less medico-legal protection, (3) if the Emergency Department is overwhelmed and time is of the essence to make decisions, and (4) if the facility lacks well-validated risk prediction tools ...