Is a subjects study participation and medical information kept confidential?
Subject confidentiality is maintained as much as possible during and after a clinical trial. Outside of the research team, a subject’s name may not be disclosed without the permission of the subject unless required by law. Generally, the sponsor, FDA, and the IRB have access to the study patient’s medical records. To ensure confidentiality, volunteers are assigned a subject number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study. Subject confidentiality is maintained when the results of a clinical trial are reported to government agencies and in scientific meetings and medical journals.
