What is meant by “Coexisting” data or specimens?
Exemption 4 applies to retrospective studies of specimens and/or data that have already been collected. The materials must be “on the shelf” (or in the freezer) at the time the protocol is submitted to the IRB or other designated officials at your institution to determine whether the research is indeed exempt. Research that involves the ongoing collection of specimens and/or data does not meet the criteria for Exemption 4, even if they were destined to be discarded.
