These regulations require the institution’s IRB to ensure that each research protocol contains adequate provisions to protect a subject during the course of the study. In addition, each investigator is required to describe during the consent process the provisions put in place to maintain the confidentiality of the subject’s participation and of the data collected from the subject during the course of the research. The regulations also require that subjects be informed of all persons who may have access to a subject’s confidential information as part of their oversight of clinical trials. These persons would include members of the FDA, study monitors for industrial sponsored trials, and staff from the IRBs.
The following links provide access to the specific federal regulations: