This SOP describes the process for the continuing review of research under the auspices of WVU IRB that has been previously approved and is ongoing.
The IRB must conduct a continuing review of an approved protocol for the purposes of renewal of the IRB approval period. Continuing review is NOT required for the following: non-FDA Expedited protocols, protocols determined to be Exempt, those protocols that are approved under Flex Review, and NHSR projects.
When considering whether to renew a study, the IRB uses the same criteria used to grant initial approval. The IRB will not approve protocols submitted for continuing review if, because of interim changes in IRB policies and procedures, the IRB would not approve that same protocol as a new proposal.
During continuing review, the IRB determines whether the study can be renewed at the same risk/benefit ratio, or if new information has changed that determination. As an outcome of continuing review, the IRB may require that the research be modified or halted altogether. Additionally, the IRB may need to impose new precautions or revise those it had previously imposed on the research protocol. The IRB will re-assess the approval period for each continuing review application. Determinations are made using the applicable reviewer forms in addition to the reviewer feedback form (as a guide) within the WVU electronic submission system.
Investigators are required to submit a continuing review application to the WVU electronic IRB system at least 45 calendar days prior to the expiration of the study for Full Board protocols, and at least 30 calendar days prior to the expiration of the study for Expedited protocols.
The IRB will conduct a continuing review of ongoing research at intervals that are appropriate to the level of risk for each research protocol. Documentation of the determination of length of the approval period is made in the applicable reviewer forms and, if applicable, the minutes of the convened board meeting.
The determination of the length of approval period is made by the IRB considering the degree of risk, and according to the following standards:
3.1. For studies that are subject to FDA or pre-2018 Common Rule requirements, the following standards of continuing review apply:
3.1.1. For studies reviewed at a convened meeting, continuing review must occur within one (1) year from the date of the convened meeting at which the IRB review and approved the research protocol.
3.1.2. For studies approved using expedited review procedures, continuing review must occur within one (1) year from the date the IRB Chair or designated expedited reviewer gave final approval to the research protocol.
4.1. For studies conducted under the WVU's Federal Wide Assurance (FWA) within the U.S. Department of Health and Human Services (HHS) and subject to the Final Rule, the following standards of continuing review apply:
4.1.1. For studies reviewed at a convened meeting, the continuing review must occur
within one (1) year from the date of the convened meeting at which the IRB reviewed
and approved the research protocol.
4.1.2. Unless the IRB determines otherwise, continuing review of research is not required for research eligible for expedited review (See SOPs 018: Expedited Review and 020: Flex Review). Expedited Studies that fall under FDA Expedited Category 1 will still require annual continuing review.
4.1.3. Unless the IRB determines otherwise, continuing review of research is not required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
5.1. For studies conducted outside of WVU's FWA, the following standards of continuing review apply:
5.1.1. For studies reviewed at a convened meeting, continuing review must occur within one (1) year from the date of the convened meeting at which the IRB reviewed and approved the research protocol.
5.1.2. Unless the IRB determines otherwise, continuing review of research is not required for research eligible for expedited review (See SOPs 018: Expedited Review and 020: Flex Review). Expedited Studies that fall under FDA Expedited Category 1 will still require annual continuing review.
5.1.3. Unless the IRB determines otherwise, continuing review of research is not required for research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
WVU Policies:
SOP 018: Expedited Review
SOP 020: Flex Review
Federal Regulations:
21 CFR 56.109
45 CFR 46.109
45 CFR 46.101 (1)(4)(i)(A)(3)
AAHRPP:
Standard I-9
Element II.2.E.2
