Can investigational IVD studies receive expedited review (see Glossary for definition) by an IRB?
Yes, in many cases an investigational IVD study is eligible for IRB expedited review (see 21 CFR 56.110), for both initial approval and continuing review. The categories of research that may be reviewed by the IRB through an expedited review procedure are described in the Federal Register notice on expedited review. As stated in that notice, however, sponsors and investigators may not use the expedited review procedure where identification of the subjects and/or their responses would reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
