COMIRB will conduct a continuing review of ongoing Full Board and Expedited research studies at intervals that are appropriate to the level of risk for each research protocol, generally once per year. Continuing review must occur as long as the research remains active for long-term follow-up of participants, even when the research is permanently closed to the enrollment of new participants and all participants have completed all research-related interventions. Continuing review of research must occur even when the remaining research activities are limited to the analysis of private identifiable information.
Failure to meet a continuing review deadline will result in immediate suspension of all study activities. Continuing review packets must be submitted 45 days prior to their deadline. Research may not continue past its expiration date until the investigator has received documentation of COMIRB approval. If the research involves the VA, research may not continue past its expiration date until it is approved by COMIRB and then the VA R&D Committee.
If there is an overriding ethical reason why research activities must continue, even though the study has expired (i.e. subjects are taking a study drug), please contact the Dr. Meredith Mealer, the COMIRB Director, at 303-724-1055. Click here for additional guidance for continuing reviews.
Click here for a Continuing Review Submission Checklist and Submission Instructions.