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Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French).
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: ... I understand: I have the right to refuse any procedure or treatment.
What is the Consent Form? Informed consent is documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy of the signed and dated consent form must be given to the person signing the form.
A medical consent form needs to include a few things. These include the patient or their representative's name and signature, the date, the procedure or test for which they are consenting, and any other important details like the practitioner's name or the relevant hospital department.
Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as "you" and the clinical investigator as "I/we." This second person writing style also helps to communicate that there is a choice to be made ...