The UAMS Human Research Protection Program Advisory Committee (yes, we have such a thing) recently approved revisions to the UAMS HRPP plan and a revised IRB policy allowing the resumption of so-called “planned emergency” or “exception from informed consent” (EFIC) research. In a nutshell, this type of research allows the participation of subjects without first getting their consent if certain rather stringent requirements are met. For starters, the community from which subjects will be drawn must be consulted and notified before the study begins, and the potential subjects must be in a life-threatening situation for which no good treatments are available.
The change to the HRPP plan is small; it eliminates a line on page 8, under “Scope of Human Subject Research Protection Program,” that indicated we did not allow this type of research to be done here. The new policy, IRB Policy 17.4, describes the local requirements for EFIC research. Note that we have also retired IRB Policy 15.2, Consent Exceptions: Planned Emergency Situations, which had previously indicated we do not do EFIC research here.