Language in ICD

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The consent form is, in essence, a teaching tool-a nontechnical, understandable document, written at an eighth-grade reading level.

Surveys have shown that the average IC document is written at a 10th grade reading level, even though the reading level of the average subject is 6th to 8th grade level. ( Paasche-Orlow & Frederick Brancati, Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for Research-Related Injury, 118 AM. J. MED. 175 (2005)

Study participants need to read (or have read to them) and comprehend the IC document (ICD).

The coordinator of the study should use whatever resources are available to promote participant understanding of the study such as, graphics, video, or even the device to be used, if possible. Care must be taken to avoid medical jargon that participants could not possibly understand.

One must explain terms that a common man may find difficult to understand. For example, such words as “placeboâ€, “double blind†and “randomization†must be explained. A reader who is not associated with the study is often the best person to help identify difficult or confusing areas in the document.

Avoid presenting an overly positive (or negative) picture of the clinical trial for which consent is being obtained.

Emphasis must be placed on the risks as well as the benefits. Participants should understand the distinction between what is research and what is routine medical therapy OR the distinction between clinical care and clinical trial .

Remember: A study participant may wish to know more about the risks than a patient.

The idea is not to coerce but to provide the participant with the facts.