All IRB studies are approved for one year or less, depending on the level of risk. The approval period ends on the expiration date. Investigators must submit a Continuing Review submission in eRA to request continuation of research activities beyond the expiration date. Continuing review is also called "renewal" and "re-approval".
The study expiration date is included in approval letters from the IRB. The IRB Office sends out reminders 90, 60, and 30 days before the expiration date. It is the investigator's responsibility to submit a Continuing Review submission, allowing sufficient time for the review and re-approval process to be completed before the current approval expires.
If all study activities are complete, then a Study Closure should be submitted. This should only be done once all uses of identifiable private information for research purposes have ceased, including data analysis, data transmission, preparation of a study publication, internal or external audit, and any other activity involving the use of identifiable private information for research purposes.
Investigators must submit the following documentation to request continuing review:
A study will usually undergo the same level of review for initial and continuing review. For example, a study that was originally reviewed using the expedited review procedure will usually undergo its continuing review on an expedited basis. The most common exception to this rule is a study that was originally reviewed by the full board but that had no accrual during the previous period, or that remains open only to data analysis. This class of study may be reviewed using an expedited review. Studies certified as exempt are not required to undergo Continuing Review.
Continuing review provides an opportunity to reassess the totality of the study and assure that, among other things, risks to subjects are being minimized and are still reasonable in relation to anticipated benefits. Reviewers will evaluate whether the research meets the criteria for IRB approval.
Research activities can continue while the IRB reviews the Continuing Review submission, as long as the expiration date has not passed. However, the Continuing Review submission must be approved by the IRB by the end of the expiration date. For example, if the expiration date is 01-Jan-2011, the Continuing Review must be approved by 11:59 pm 01-Jan-2011. If it is not approved, the study would be expired at 12:00 am 02-Jan-2011.
There is no grace period extending the conduct of the research past the expiration date. Extensions will not be granted. The continuation of research after the expiration date is a violation of the regulations. Therefore, if approval of the Continuing Review submission is not obtained before expiration, all research activities pertinent to the study must stop. Approval must be given by the IRB before the research activities can resume.
If a study is expired for more than 90 days, the study will be closed permanently. A new application may be submitted for the continuation of the project, which will go through IRB review.
In rare cases, the IRB may find that failure to continue research activities after the expiration would seriously jeopardize the safety or well-being of an individual. The IRB will consider these situations on a case-by-case basis. Please contact the IRB Office with any questions about this process.