Continuing review refers to a periodic IRB review of ongoing research activities to ensure that the rights and welfare of participants are protected. The review includes an analysis of the risk/benefit ratio, with special attention to whether new information or unanticipated risks have been discovered since the previous IRB review, and whether any new information regarding the risks and benefits should be provided to participants.
Continuing Review Process
Studies that present greater that minimal risk to participants, or that received initial full board review, generally require review at the monthly convened committee meeting. Studies deemed minimal risk, or that have reached data analysis only, do not require full board continuing review. Studies approved under the 2018 Common Rule that are minimal risk do not require annual continuing review and are eligible for administrative check-in if deemed appropriate by the IRB. Continuing review submissions must be submitted to the IRB at least 30 days prior to the expiration date to ensure adequate time for IRB review. Failure to submit on time may result in study expiration causing all research activity to halt. For more information, refer to the IRB Policy 11: Continuing Review or Procedure 11a: Continuing Review Procedure.
What You Need to Know
- Exempt studies (which have an "e" at the end of the IRB number) do not require continuing review.
- For studies that require continuing review, it must occur not less than once per year.
- Courtesy emails are sent as reminders when continuing review is due, beginning 90 days prior to the expiration of the current IRB approval. Submissions are required at least 30 days prior to expiration.
- There is NO grace period that allows the conduct of research beyond the expiration date of study approval. Therefore, continuing review and re-approval of research must occur on or before the date when the IRB approval expires.
- To assure that continuing review applications are submitted in a timely manner to avoid expiration of the study
- Providing the IRB with sufficient information and documentation to facilitate a substantive continuing review of the study progress
- To review and approve IRB continuing review applications as documented by signature on the xForm
- To notify the IRB of a completed study by submitting a "Continuing Review or Study Closure - ETSU" xForm
- Ensuring that all research activities halt immediately if the IRB approval expires and for notifying all appropriate parties (i.e., study staff, lab coordinators, research subjects, project directors, sponsors/funders, etc.)
When is continuing review required?Research approved by the IRB may continue only for the time period set by the IRB. The time period for some studies is limited by the DHHS and FDA regulations to at least once per year (i.e., 365 days). The IRB can determine a short time period such as six (6) months but not a longer time period. If continuing review is required for your study, an expiration date is documented in the approval letter, and continuing review must receive IRB approval by that date.
When is continuing review not required?
Studies approved under the 2018 Common Rule does not require annual continuing review when:
- The research is determined minimal risk by the IRB
- The study has reached the point of data analysis or long-term clinical follow-up only
Exempt research also does not require continuing review.
Can the IRB require continuing review when not required by regulation?Yes, the IRB has the authority to determine the appropriate review period and subsequent review requirements. If the IRB determines that continuing review is required for a study, the rationale for the determination is documented during the IRB review process.
How and when should a continuing review application be submitted?The continuing review application should be submitted at least 30 days prior to expiration to allow sufficient time for IRB review. The "Continuing Review or Study Closure xform" should be submitted in IRBManager by the PI or study staff. The form asks questions about the study progress, changes to the study, enrollment numbers, and summary of study events (i.e., complaints, deviations, adverse events). If the study is still enrolling and involves a consent process, the consent form will need to be attached for stamping.
How and when can I close the study?Once the researchers have completed all study procedures and the data have been stripped of identifiers, the study may be closed with the IRB. The study does not have to be active with the IRB for the duration of data analysis of de-identified data. If the study was approved to retain identifiers indefinitely, please contact our office to discuss the appropriate time for study close out. Study closures requires formal submission to the IRB using the same form as continuing review.
What are the requirements for reporting on study progress if continuing review is not required?For active studies where continuing review is not required by regulation or the IRB, the study requires submission of an Administrative Check-in xform at least annually. At the time of initial approval, the IRB will determine what type of reporting is required and how frequently. The approval notice will state either an expiration date with continuing review requirement or a requirement for annual administrative check-in. The Administrative Check-in xform is to be submitted in IRBManager and asks brief questions about the study's progress. The IRB staff will review the submission to ensure that no issues have occurred and will issue a new check-in date for the following year. See the Administrative Check-in webpage for more information.