Frequently Asked Questions
The informed consent regulations require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?
No. FDA does not require any subject to "waive" a legal right. Rather, FDA requires that subjects be informed that complete privacy does not apply in the context of research involving FDA regulated products. Under the authority of the FD&C Act, FDA may inspect and copy clinical records to verify information submitted by a sponsor. FDA generally will not copy a subject's name during the inspection unless a more detailed study of the case is required or there is reason to believe that the records do not represent the actual cases studied or results obtained.
The consent document should not state or imply that FDA needs clearance or permission from the clinical investigator, the subject or the IRB for such access. When clinical investigators conduct studies for submission to FDA, they agree to allow FDA access to the study records. Informed consent documents should make it clear that, by participating in research, the subject's records automatically become part of the research database. Subjects do not have the option to keep their records from being audited/reviewed by FDA.
When an individually identifiable medical record (usually kept by the clinical investigator, not by the IRB) is copied and reviewed by the FDA, proper confidentiality procedures are followed within FDA. Consistent with laws relating to public disclosure of information and the law enforcement responsibilities of the FDA, however, absolute confidentiality cannot be guaranteed.