SOP 018: Expedited Review

1. Purpose

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.)

2. Overview

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 protocol was approved on or after the implementation of the Final Rule (January 21, 2019).
• The protocol was transitioned to the Final Rule.

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 proposed modifications are administrative changes or similar minor changes; or
• The research was previously determined to be eligible for expedited review under Federal Regulation categories 1-7 and/or 9 (see below), and the proposed modifications do not change the protocol’s expedited determination

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. Expedited Review Categories

3.1. Clinical studies of drugs and medical devices, only when condition (a) or (b) is met:

• Research on drugs for which an investigational new drug application (21 CFR 312) is not required.
• Research on medical devices for which:

1. An investigational device exemption application (21 CFR 812) is not required; or
2. The medical device is cleared/approved for marketing, and the device is being used in accordance with its cleared/approved labeling.

3.2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

1. From healthy, non-pregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an eight (8) week period, and collection may not occur more frequently than two (2) times per week; or
2. From other adults and children, considering the age, weight, and health of the participants, the collection procedure, amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml, or 3 ml per kilogram in an eight (8) week period, and collection may not occur more than two (2) times per week.
1. Children are defined in the DHHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. [45 CFR 46.402(a)]

3.3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples include the following:

1. Hair and nail clippings in a non-disfiguring manner
2. Deciduous or permanent teeth at the time of extraction or if routine patient care indicates a need for extraction
3. Excreta and external secretions, including sweat
4. Uncannulated saliva, collected either in an unstimulated fashion or stimulated by chewing gum base, wax, or
   applying a dilute citric solution to the tongue
5. Placenta removed at delivery
   
6. Amniotic fluid obtained at the time of rupture of the membrane before, or during labor
7. Supra- and sub-lingual dental plaque and calculus, provided the collection procedure
   procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accomplished
   in accordance with accepted prophylactic techniques
8. Sputum collected after saline mist nebulization

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:

1. Physical sensors that are applied either to the surface of the body or at a distance and do not involve the input of significant amounts of energy into the participant or an invasion of the participant’s privacy
2. Weighing or testing sensory acuity
3. Magnetic resonance imaging (MRI) and Functional MRI (fMRI)
4. Electrocardiography, electroencephalography, thermography, detection of naturally occuring radioactivity,
   electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography
5. Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where
   appropriate given the age, weight, and health of the individual

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:

1. The research is permanently closed to the enrollment of new participants for longer than a year;
2. All participants have completed all research-related interventions; AND
1. The research remains active only for long-term follow-up; OR
2. No participants have been enrolled, and no additional risks have been
   identified; OR
3. The remaining research activities are limited to data analysis.

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. Procedures

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.

5. References

WVU Policies:
SOP 008: IRB Determinations
SOP 017: Exempt Review
SOP 019: Full Review

Federal Regulations:
21 CFR 312
21 CFR 812
45 CFR 46.402(a)