Continuing Review Procedures
A continuing review of research is required at intervals appropriate to the degree of risk, but not less than once per year. [cfr46.109(e)]
For each approved study that has been reviewed under expedited or full committee status, Northeastern University’s Office of Human Subject Research Protection or the IRB assigns a continuing review interval and expiration date. The office sends notification to investigators 4-6 weeks prior to the impending expiration of the study approval. The investigator must complete the accompanying continuing review/study completion form (CRF) and return it at least two weeks before the designated date. The PI is required to complete the CRF whether the study is ongoing, has concluded or never started. Directions for completing the CRF are on the form.
If the study is ongoing or never started, the PI may request renewed approval. Studies that were originally approved under expedited procedures can be renewed by the same means. Studies that received initial approval by the full committee must be reviewed at the next scheduled IRB meeting if they are still open to enrollment. The investigator must allow sufficient time for the review to be completed before the expiration date. If the study procedures have been followed as approved, the documentation is in order, and the IRB finds that there are no problems or new information that would change the approval status, the study will be renewed.
Projects that do not receive written notice of renewed approval from HSRP may not continue past the expiration date.