Standards and Procedures

OPRS SOP 307: Approval Period and Determination of Expiration

Approved Date

Revised Date

Full Details


Continuing review must occur at intervals appropriate to the degree of risk. The determination of the length of the approval period is made by the IRB considering the degree of risk, according to the standards outlined in SOP 404: Initial Review – Criteria for IRB Approval.

The determination of the length of the approval period, if applicable, is documented in the board member checklist and if reviewed by the convened board, in the minutes. The expiration date is the last day of approval and the date by which continuing review must occur.

Review of a change in a protocol (i.e. modification or amendment) does not alter the date by which continuing review must occur because continuing review is review of the full protocol, not simply a change to it.


1. Procedures for Assignment of Determined Expiration Date

The approval period of a study, whether during initial or continuing review is determined by the IRB. The assignment of the expiration date is based on the type of review and the determination of approval period.

1.1. For research reviewed by a convened board, the expiration date is one day earlier in the following year than the date the convened board approves the research. The meeting facilitator is responsible for verifying the correct expiration date. If the IRB determines the study requires continuing review more or less frequently than annually, the meeting facilitator enters the expiration date manually in the records according to the IRB determination.

1.2. For research which is expired and is reviewed after the expiration date, the new expiration date will be set as described above. The lapse in approval due to the expiration of the study and the dates of the lapsed approval must be documented in the study file and meeting minutes, as appropriate. If required by the IRB, the investigator will provide the IRB with an action plan to prevent any future lapses in approval.

1.3. For research that is approved with changes by the convened board, the expiration date will be set as described above. The approval period does not begin until the changes are accepted by the IRB Chair and the approval letter is sent. The approval effective date is the date the approval letter is sent.

2. Expiration of Approved Studies

2.1. The IRB sends the Principal Investigator one email notification regarding the need to apply for continuing review prior to the expiration date. There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. Extensions beyond the expiration date will not be granted.

2.2. A continuing review form must be submitted to be reviewed by the IRB even if the continuing review cannot be conducted before the expiration date. If the Principal Investigator fails to apply for re-approval by the expiration date, the study will be administratively closed by an IRB staff member. Once the study is closed, the Principal Investigator must submit a new study application for initial review and approval if he/she wishes to continue with the study.

2.3. Once IRB approval for a study expires, an expiration notice is generated and sent via email to the Principal Investigator. The expiration notice informs the investigator the research is expired. No research activity may continue until the application for continuing review is approved by the convened IRB. The notice also informs the investigator that no new participants may be enrolled.

2.4. Conducting any study-related procedures after IRB approval expires must be requested in writing to the IRB Chair for review and approval. If the IRB Chair determines that subjects participating in an expired study would suffer a hardship because research procedures/medication must be discontinued, appropriate research procedures may continue beyond the expiration date for a reasonable amount of time. The IRB Chair will address on a case-by-case basis those rare instances where failure to enroll new subjects would seriously jeopardize the safety or well-being of an individual. Prospective research data cannot be collected until a continuing review application or other progress report is reviewed and approved. The IRB Chair will notify the Investigator of the decision by way of written documentation and this documentation will be attached permanently to the continuing review report form, accessible by all IRB members. Documentation will be retained in the OPRS study file.

2.5. Expiration of IRB approval does not require a report according to SOPs 904 and 905 as a suspension or termination of IRB approval.