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The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3)
Statement of Your Consent:I have been informed of the risks and benefits involved, and all my questions have been answered to my satisfaction. Furthermore, I have been assured that any future questions I may have will also be answered by a member of the research team. I voluntarily agree to take part in this study.
Informed Consent Checklist (1998)A statement that the study involves research.An explanation of the purposes of the research.The expected duration of the subject's participation.A description of the procedures to be followed.Identification of any procedures which are experimental.More items...
Following are a few guidelines for writing an effective consent letter:Ensure that the formal letter/ email has a clear heading regarding the consent.Explain the requirements (if any) from the respondents.Mention the duration of the program or participation.More items...?02-Mar-2021
The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.