Table 2.

Examples of key points for informed consent about incidental findings

The project is for research purposes and is not directed toward, nor designed for, clinical diagnosis, and the scans performed in this study are not optimized to find abnormalities. The investigators for the project are not trained to perform radiologic diagnosis, and the scans to be performed in the study are not optimized to find abnormalities. On occasion, a member of the research team may notice a finding on a scan that seems abnormal. At the present time, variability in the incidence of confirmed findings is very large, with reports varying from a fraction to a small percent in different populations of subjects. (Selected sources should be cited.) Being told about a finding may cause anxiety as well as suggest the need for additional tests and financial costs. Medical insurance may be affected whether or not the finding is ultimately proved to be of clinical significance. When a finding is noticed, the investigator or designate may consult a physician specialist, such as a radiologist or neurologist, as to whether the finding merits further investigation. If this is done, the investigator, consulting physician, or another designate will contact the subject. The decision as to whether to proceed with further examination or treatment lies with the subject. Costs for clinical follow-up are not budgeted in the cost of research. Further information is available from the research team to answer any additional questions about incidental findings.

Final construction of the language for consent will depend on the option selected for handling findings described in the text and in table 1.