The IRB is responsible for ensuring that informed consent documents include the extent to which the confidentiality of medical records will be maintained. FDA requires sponsors (or research monitors hired by them) to monitor the accuracy of the data submitted to FDA in accordance with regulatory requirements. These data are generally in the possession of the clinical investigator.
Each subject must be advised during the informed consent process of the extent to which confidentiality of records identifying the subject will be maintained and of the possibility that the FDA may inspect the records. The consent document should list all other entities (e.g. the sponsor) who will have access to records identifying the subject. The extent to which confidentiality will be maintained may affect a subject's decision to participate in a clinical investigation.
While FDA access to medical records is a regulatory requirement, subject names are not usually requested by FDA unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual cases studied or actual results obtained.
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