Informing Subjects About Research Results
When possible, after the completion of a study, subjects should be informed of the findings of the research. Individual subjects should also be informed of any findings that relate to their particular health status. Depending on the specific laboratory tests performed, and the type laboratory used, there may be further stipulations for reporting results to subjects. If the results are from specific laboratory tests performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratories, they may be reported to the subject and/or the subject’s physician. These laboratory tests may be utilized for diagnosis and treatment. If the same laboratory results were obtained from a research, non-CLIA-approved laboratory, then these results should not be used to diagnose and treat. Therefore, if these laboratory results are abnormal, the participant should be advised to see his or her primary health care provider and have the laboratory tests repeated at a CLIA-approved laboratory.
Generally, subjects have the right to access their data on demand, even if these data lack immediate clinical utility. In cases where the IRB has approved temporary or permanent nondisclosure of data, the subject should be informed of the reasons for such nondisclosure. The consent form should include information about whether or not subjects will have access to their research results. In some studies a subject may not wish to be informed about his or her test results (e.g., when disclosure of the data is of questionable benefit to the subject). In these cases, subjects may be asked whether or not her or she wants the research results after being informed about the nature of the data.