ABSTRACT

If your study involved human subjects, you should discuss their relevant features in the Materials and Methods section under the subheading “Human subjects” or “Patients,” or in a separate section, similarly entitled “Human subjects” or “Patients.” Moreover, if the only biological “materials” in your study were human subjects or patients, you can use the heading “Human Subjects and Methods” or “Patients and Methods” instead of “Materials and Methods.” This format is appropriate if the subjects or patients who were included in or who participated in your study formed one or several basically homogeneous groups, such as males between 35 and 45 years of age or patients with specific malignancies at various defined clinical stages. By contrast, if you studied a small number of patients whose clinical picture was non-standard or whose respective conditions led you to pursue a particular line of questioning or hypothesis, you should provide a separate case history for each patient. You should never include any information that might allow someone to identify your human subjects, for example, their names, initials, or hospital identification numbers. Pay attention also to identification numbers on radiologic films and be sure to mask faces in any photographs of human subjects.