Can leftover specimens be used in IVD studies without informed consent?
The document entitled, “Guidance for Industry, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies using Leftover Human Specimens that are not Individually Identifiable”, describes the limited circumstances in which FDA intends to exercise enforcement discretion regarding requirements for informed consent. (See Glossary for definition of “leftover specimens”.
Related Questions
- Why are the "reliability" fields no longer used in the full coin record pages for individual Celtic coin specimens, as they were in the Epaticcus prototype?
- Why cant the 300-1D, 300-2D, 700-1D and 700-2D calibration specimens be used in STM?
- Can leftover specimens be used in IVD studies without informed consent?
