Informed Consent Document

The informed consent document is an extremely important aspect of the study design and the IRB application. A good informed consent will not only explain the study procedures and what is to be expected, but also minimize unrealistic expectations if a potential “cure” or treatment is expected. A well-written informed consent document will protect subjects and allow them to make an informed decision about whether to participate in the research. Poorly written documents and procedures may dissuade potential subjects.

Forms should be simple, clear and easy to read. The average reading level for an informed consent document should be at the 6th grade level and not contain unnecessary medical jargon or technical terms.

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