Informed consent to treatment in clinical trials

Special characteristics of clinical trials place unique demands on the concept and practice of informed consent to treatment. We focus on the practical problem that consent to treatment forms are not typically able to be understood by patients in clinical trials research. Informed consent forms are significantly less comprehensible than popular press written material and may be as difficult to read as medical journals. Several guidelines for improving informed consent to treatment documents such as the use of non-professionals and patients to critique drafts of consent to treatment forms are proposed and discussed. The use of these guidelines can insure that patients have the opportunity to understand more clearly what their treatment will involve within a clinical trial before they give an informed consent.