In cases where subject accrual occurs elsewhere, signed consent documents are retained according to the policies of the institution where the research is conducted. Nevertheless, to enhance comprehension and readability, investigators are strongly urged to use a format in the body of the consent form that presents information in sections, introduced by headings, and that clearly and simply identifies and describes each of the elements to be discussed, even if the sections repeat information that appears on the printed form. Monetary compensation is not a benefit. For more information, see the NIH Multiple Project Assurance G.3. The use of headings in informed consent documents helps to ensure that all the basic elements of informed consent are conveyed to the prospective research subject in a simple, efficient way.
Headings promote comprehension and readability.
For each procedure, test, treatment or drug, explain the risks, discomforts and inconveniences and provide an estimate of their likelihood. Describe the steps that will be taken to prevent, lessen or treat them. However, depending on the nature of the study, the PI may want to add additional information in the body of the consent document concerning these and other issues. How long this study will last and how many people will be enrolled.