Just-In-Time (JIT) notifications with awards from the federal government often come with a request to provide a rough time table for IRB review. Please read your JIT notice letter carefully to see what is required, or send your JIT notice letter to Sharon Ellison, Joe (SJ) Austin, or Dara Barnard in the DUHS IRB for assistance. JITs still require CRU review prior to IRB review. Unless there are extenuating circumstances, JITs will be scheduled for review at the next available IRB meeting. They do not warrant review immediately (jumping to the head of the queue); instead, the investigator must communicate with the funding agency to tell them the study’s expected IRB review date.
Often, the following language will be sufficient to satisfy a JIT notification:
“The Duke University Health System (DUHS) IRB will be reviewing the study protocol and documents for the study entitled “[study title]” at the convened IRB meeting on [date]. The IRB will ensure that the study complies with all Revised Common Rule requirements before beginning any human subject research activities.”
As of January 21, 2019, studies initiated on or after that date are expected to comply with all Revised Common Rule requirements, with certain exceptions for FDA-regulated studies. Also as of January 21, 2019, OHRP eliminated the requirement that IRBs review grant applications or other funding proposals related to the research, to assess concordance between the scope of work described in the grant vs the activities described in the protocol and the IRB application.
The Revised Common Rule does not have any requirement for IRB review for concordance, so the IRB ended this practice as of January 21, 2019, for studies initiated on or after that date.