Invitation to Participate/description of the Study

The first paragraph of the consent form should include an overview of the study in lay terms. Included in this description is a clear invitation for the individual subject to participate in the research: “You are invited to participate because …”  This section should state clearly why prospective subjects have been selected. (If there is more than one subject population included in the research, it is preferable to have a consent form for each group. The information to be provided for an adult with diabetes may be very different from that which is provided for a “healthy control” subject.) In addition, this section must note that the study involves research, as well as the purposes of the research (both immediate and long-term), and the expected duration of the subject’s participation (although the later information may also be included in the next section, “Description of procedures”. If the protocol involves innovative therapy, the investigator must make it clear that these research procedures are not standard of care. Some IRBs, such as the School of Nursing Committee on Research Involving Human Subjects, prefer a question-and-answer format for this section of the consent form.