Renewal/extension of IRB approval

A protocol approved by the IRB either through expedited or full board review is only approved for up to a one-year period from the date of IRB approval.  Research cannot continue beyond the one-year period without IRB approval. It is the principal investigator’s responsibility to submit a continuing review application before expiration of IRB approval and in ample time for IRB review.

CHS-IRB, SOP makes no provision for any refinement period allowing the research to continue beyond the expiration date of the IRB approval. Therefore, continuing the review and re-approval of research must occur on or before the date when the IRB approval date expires. Investigators are asked to submit the request for renewal of IRB approval together with all appropriate documents no later than a month before the expiration of the protocol’s approval date in order to allow for review and approval of a study continuation request.

Failure to obtain renewal of previous approval date not only will cause project delays but could lead to suspension of the study, delay or loss of funding, delay or loss of publication possibilities, or may even include reporting of non-compliance to respective officials. According to the SOP of the CHS IRB, all research related activities on any study involving human participants may not continue until the IRB has reviewed and approved the study to continue by issuing a new approval letter.

Documents required for request of IRB approval extension:

• Covering letter: Clearly stating that renewal of the approval date of a previously approved study is being requested.
• Progress report: A short report which includes how many participants have been enrolled thus far in the study, how many have yet to be recruited, expected time of close out of the study, summary of SAE (where applicable), reason for delays (if applicable) and any other relevant information related to the study.
• A copy of previous IRB approval