Retention of Signed Informed Consent Forms

As described in the UF Research Records Retention page of this website, and under HHS regulations at 45 CFR 46.115(b), an investigator must maintain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution for a minimum of 3 years after completion of the research for those studies not requiring a HIPAA authorization and 6 years after completion of the research for those studies requiring a HIPAA authorization Consent forms for FDA-regulated studies should be retained in accordance with the sponsor agreement.

Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by authorized representatives of the University, HHS, or appropriate study sponsor at reasonable times and in a reasonable manner (45 CFR 46.115(b)). Scanned consent forms for FDA-regulated clinical and device trials must be maintained in a 21 CFR Part 11 compliant environment. Retention of multiple copies of each record is not required, thus if you scan the entire consent form, you do not need to maintain the original copy.