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All sections of the consent form, except the Consent section, should be written in second person (You are invited). Headers should include Informed Consent followed by the title of the study (e.g., the header in this document). Footers should include page numbers.
A declaration of consent is a written agreement that covers a wide range of issues and situations. But generally speaking, there is always one party giving permission to another party to perform a particular action. Among other things, the consent form involves: Identifiable descriptions of all parties.
Format and Style of Informed Consent Documents- Key Points Consent forms should be written in lay language, at a level understandable to the participants in the study (6th to 8th grade reading level for adult participants). Researchers may use flowcharts and tables to enhance reading comprehension.
Researchers should strive to write consent forms at a sixth to eighth grade level unless their potential subjects 1 Page 2 are known to read at a much higher or lower reading level. Studies show that even highly literate subjects are not usually offended by simple material (1, 8).
The JHM IRB recommends that the reading level of the informed consent document should be no higher than an 8th grade level. The IRB recognizes that some consent forms are of such a technical nature that it may not be possible to keep to an 8th grade reading level.
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Whether it be express, implied, opt-in, or opt-out consent, it is important to obtain clear and informed consent in all data privacy matters. The power of consent lies in giving individuals control over their personal data and enabling them to make informed decisions.

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