This SOP describes the process for the approval period and determinations of expiration for human subject research within the auspices of the WVU IRB.
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, and according to the standards outlined in SOP 030: Continuing Review of Approved Research.
The determination of the length of the approval period, if applicable, is documented by the reviewer within the WVU electronic protocol submission system, and if reviewed by the convened board, in the meeting 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 because continuing review is review of the full protocol, not simply a change to it.
3.1. The approval period of a protocol, 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.
3.1.1. For research reviewed by a convened board, WVU’s electronic protocol submission system automatically assigns the expiration date as one day earlier in the following year than the date the convened board approves the research. The OHRP staff is responsible for verifying the correct expiration date. If the IRB determines the study requires continuing review more or less frequently than annually, the OHRP staff enters the expiration date manually in the WVU electronic protocol submission system according to the IRB determination.
3.1.2. For protocols approved for five years (if eligible), the WVU electronic protocol submission system automatically assigns the expiration date as one day earlier than five years from the date the IRB approves the research. The OHRP staff is responsible for verifying the correct expiration date.
3.1.3. For research that is expired and is reviewed after the expiration date, the investigator must submit a new protocol for review and the new expiration date will be set as described above. The WVU electronic protocol submission system automatically closes the expired protocol, and the investigator submits a new protocol for review and approval.
3.1.4. For research that is approved with changes by the convened IRB, the expiration date will be set as described above. The approval period does not begin until the changes are accepted by the IRB Chair (or designee) and the approval letter is sent.
4.1. The IRB sends the investigator/research team multiple automatic notifications from the WVU electronic protocol submission system 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.
4.2. A continuing review submission must be completed and submitted within the WVU electronic protocol submission system to be reviewed by the IRB even if the continuing review cannot be conducted before the expiration date. If the investigator/research team fails to apply for re-approval within the allotted time based on the review type of their research (45 days for Full Review, and 30 days for Expedited Review, per SOP 030: Continuing Review of Approved Research), the protocol will be automatically closed. Once the protocol is closed, the Principal Investigator (PI) must submit a new protocol application for initial review and approval before he or she can continue with the research.
4.3. Once IRB approval for a protocol expires, an expiration notice is automatically generated and sent from the WVU electronic protocol submission system. The expiration notice informs the PI the research is expired. No research activity may continue until the new study application is reviewed and approved by the IRB. The notice also informs the PI that no new participants may be enrolled until the new protocolapplication is reviewed and approved by the IRB.
4.4. Conducting any protocol-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 participants s enrolled in the project with an expired protocol 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 participantss would seriously jeopardize the safety or well-being of an individual. Prospective research data cannot be collected until a new protocol application or other progress report is reviewed and approved. The IRB Chair will notify the PI of the decision by way of written documentation (e-mail is appropriate) and this documentation will be attached permanently to the new study application in the WVU electronic protocol submission system, accessible by all IRB members and OHRP staff.
Expiration of IRB approval does not require a report according to SOP 034: Reporting to External Agencies.
WVU Policies:
SOP 030: Continuing Review of Approved Research
SOP 034: Reporting to External Agencies
Federal Regulations:
21 CFR 56.109
45 CFR 46.109
AAHRPP:
Element II.2.E
