Description of Procedures

In this section of the consent form, all study procedures need to be described, preferably in sequential order and in lay terms, avoiding the use of medical jargon and technical terms. Investigators should compare the research plan of the protocol to this section. All of the procedures in the protocol should match exactly those in the consent form. Subjects should also be informed regarding any procedures that are experimental. If standard of care or clinical procedures are also included, these should be differentiated from the research procedures. The duration of time for completing these procedures and/or the protocol should also be estimated, and this information should be included. For example, if there are three visits spaced four weeks apart, the participant needs to be told that the duration of the study is 12 weeks, or three months. The subject will also want to know the names of the personnel with whom they will interact and the setting of the research. Investigators may find it helpful to consult information written for patients or consumers. Examples of such references are Getz & Borfitz, Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials, CenterWatch, 2002; and Zaret & Katz, The Yale University School of Medicine Patient’s Guide to Medical Tests, Houghton Mifflin, 1997. For controlled trials, the researcher should explain the features of the research design (e.g., randomization-“like the toss of a coin”; and double-blinding—“neither you nor the investigator will know which drug or research intervention you are receiving until the study has been completed and the blind has been broken”). For protocols with questionnaires, it is routine to tell the subject that he or she may refuse to answer any questions that he or she finds embarrassing or offensive.