Dysport consent form 2025

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Key components of informed consent include: Clear communication of information in simple, understandable language. Comprehensive disclosure of risks, benefits, and alternatives. Verification of the individuals decision-making capacity. Assurance of voluntariness without coercion. Proper documentation of the consent.
The maximum recommended total dose of DYSPORT administered for treatment of upper limb spasticity must not exceed 16 Units/kg or 640 Units, whichever is lower. Repeat DYSPORT treatment should be administered when the effect of a previous injection has diminished but no sooner than 16 weeks after the previous injection.
Consent must be freely given, informed, specific, unambiguous, and verifiable.
Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patients role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patients preference,
If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.
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Informed consent language should be written in the second person (you), not in the first person (I). Minimize passive voice to the extent possible. Example of passive voice: A summary of results will be sent to all study participants. Example of active voice: We will send you a summary of the results.
Function The nature of the procedure or intervention. The risks and benefits of the procedure or intervention. Reasonable alternatives. The risks and benefits of alternatives. An assessment of the patients understanding of these elements [10][11]
The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subjects voluntary agreement

dysport consent form