This SOP describes the process for protocols requiring expedited IRB review and approval. The categories for research that the IRB may review through an expedited review procedure include research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the specific categories listed in the regulations at Federal Register (FR) Volume 63, No. 216, and (3) the research is not classified. The criteria for approval using the expedited procedure are the same as those for review by a convened IRB. (See SOP 007: Criteria for Approval.)
Unless the IRB determines otherwise, continuing review of research (following approval period of 5 years) is not required for research eligible for expedited review if:
The IRB chair may designate an IRB member(s) to review Expedited submissions. Reviewers are selected based on their expertise in the application content and knowledge of applicable regulations. If a designated reviewer is not available, the IRB Chair will review the submission.
The IRB Chair or designee may use the expedited review procedure to review minor modifications to previously approved research during the period for which approval is authorized if the following conditions are met:
The full IRB must review any modification that possibly entails more than minimal risk to the participants at a convened meeting.
Expedited studies are communicated to the IRB at the next convened meeting after approval of the project.
*Please note: Some expedited review categories described below could qualify for WVU’s Flex Review mechanism. Please see SOP 020: Flex Review for additional information on Flex review.
3.1. Clinical studies of drugs and medical devices, only when condition (a) or (b) is met:
3.2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
3.3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples include the following:
3.4. Data collection through noninvasive procedures (not involving general anesthesia or sedation) is routinely employed in clinical practice, excluding procedures involving x- rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Examples include the following:
3.5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
3.6. Data collected from voice, video, digital, or image recordings made for research purposes.
3.7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, or cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
3.8. Continuing review of research previously approved by the convened IRB as follows:
This category (Category 8) identifies three situations in which research that is greater than minimal risk and was initially reviewed by a convened IRB, may undergo subsequent continuing review by the expedited review procedure. For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site when the conditions of this category are satisfied for that site. However, with respect to category 8(b), while the criterion that “no participants have been enrolled” is interpreted to mean that no participants have ever been enrolled at a particular site, the criterion that “no additional risks have been identified” is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.
3.9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories two (2) through eight (8) do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. The determination that “no additional risks have been identified” does not need to be made by the convened IRB.
4.1. The IO and WVU OHRP Director authorize WVU OHRP staff to complete a preliminary review of the submitted protocol materials to determine completeness and accuracy. WVU OHRP staff assign protocols to IRB members (primary reviewers) for review paying close attention to the protocol’s scientific discipline, the potential reviewer’s area of expertise, and representation for vulnerable populations involved in the research.
The IRB Chair or designee is assigned as an expedited reviewer. The assigned expedited reviewers perform an in-depth review of pertinent documentation and materials submitted by the investigator and WVU OHRP staff.
4.2.1. For new protocol submissions and continuing review applications, the assigned expedited reviewer and WVU OHPR staff ensure that it is documented within the WVU electronic IRB system application that the research meets the criteria for expedited review and approval. The WVU OHRP staff and IRB reviewer ensure that the applicable expedited category (or categories) is selected.
4.2.2. For amendment applications, the assigned expedited reviewer and WVU OHRP staff ensure that it is documented within the WVU electronic IRB system whether the amendment to the previously approved research is eligible for expedited review and the modification involves no more than minimal risk to participants.
4.3. If the expedited reviewer determines the application does not qualify for an expedited review, the reviewer notifies the WVU OHRP staff, who will assign the protocol submission for the next available convened IRB meeting.
If the expedited reviewer recommends that the protocol submission be tabled or disapproved, the reviewer notifies the WVU OHRP staff, who will move the item to the agenda for discussion at a convened IRB meeting. In accordance with SOP 008: IRB Determinations, the research may only be tabled or disapproved by the convened IRB.
If the expedited reviewer determines that the criteria for approval of the application have been met, the reviewer may approve the application.
21 CFR 312
21 CFR 812
45 CFR 46.402(a)