Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) were expected to go into effect on January 19, 2018; however, last-minute government action has delayed the implementation.
HSO staff and investigators were looking forward to taking advantage of the revisions, many of which reduce administrative burden. The HSO is planning to implement some of the changes for non-federally funded research in the near future, in order to offer more flexibility to the research community. Since the HSO was prepared to implement the Common Rule as written, several policy and KC IRB changes need to be reworked before we can do so. Until additional changes are announced:
- New studies should still plan to utilize the revised informed consent document template currently available on the HSO website. The new template includes a summary section of important information and additional elements of informed consent, both of which provide value to human subjects.
- The new exempt categories for chart reviews and benign behavioral interventions will not be available to researchers. Investigators should continue to submit these studies under the current level of review.
- All expedited and full Board research will continue to require renewal as scheduled. Please submit your renewal when requested.
Stay tuned for more information on changes to the IRB process coming in late February.