Continuing Research

Renewal Form

The UCSC IRB is responsible for reviewing projects involving human subjects at least once each year. The Committee makes every effort to distribute continuation/renewal forms to facilitate the process, however, it is the investigator’s responsibility to ensure that the research is reviewed annually.

The UCSC IRB limits all project approvals to an initial approval period of 12 months, and upon continuing review to an additional approval period not to exceed 12 months. After 5 years all projects must be resubmitted in full for Initial Review. Investigators are required to submit a Renewal Form not later than 14 days prior to the continuing review deadline. The continuing review form is used as 1) a request for reapproval of ongoing research where annual (or more frequent) review is required, 2) a final report to be used when research has been completed or terminated, or 3) an interim report (an IRB-required report of study progress that is not required for reapproval). Continuing review actions will be carried out at a convened IRB meeting, except in those cases where expedited review is permitted.

Reapprovals

Investigators may not continue to conduct their investigations beyond the continuing review deadline. Studies that have expired before the form has been reviewed will be suspended until the IRB review has been conducted. However, if the investigator is in communication with the IRB, the information regarding conduct of the study is forthcoming, and, in the opinion of the Chair, the subjects participating is such a study would suffer a hardship if medical care were discontinued, appropriate medical care may continue beyond the expiration date for a reasonable amount of time. However, new subjects cannot be enrolled.