Some new questions have been added to the CLARA new submission form to allow us to better track the types of research being done on campus.
First, some questions related to foreign involvement in research have been added to the Contracts section. These questions will help ensure any studies being done outside the US, or involving data sent across national borders, receive any needed import/export control reviews. Also, the Association for the Accreditation of Human Research Protection Programs (AAHRPP, our accrediting body), needs us to report annually how many studies are being done outside the US. We are starting to see more of this type of study, so we need to capture these data in CLARA (because hand-counting these studies is really tedious, experience has shown).
Also, if you are entering a study that will be reviewed by an external IRB (xIRB), CLARA will now ask you the review status (full board, expedited, exempt) the xIRB is using. AAHRPP also wants to know this information, and hand-counting these is making us cry.
Last but not least, don’t forget the new data storage questions in the form’s Risks section, which are intended to help us meet institutional policies and federal regulations regarding the safeguarding of data.