OPRS SOP 403: Expedited Review
Approved Date
Revised Date
Full Details
DEFINITIONS
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a) Minimal Risk |
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. |
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b) Minor modification |
In this policy, a modification is minor if it does not involve greater than minimal risk to the participant and it does not have a significant impact on the (1) risk level of the study, (2) risk:benefit ratio of the study, or (3) a participant’s willingness to participate in the study. |
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c) Substantive modification |
A modification is substantive if it cannot be considered a minor modification as defined in this policy. |
POLICY
Expedited review procedures consist of a review of research involving human subjects by the IRB Chair, IRB Vice-Chair or by an experienced reviewer designated by the IRB Chair from among IRB members (see SOP 202 for a full description of the procedure used to designate expedited reviewers). In this policy, the IRB Chair’s designee refers to an IRB Vice-Chair or a designated expedited reviewer.
The IRB Chair or designee may exercise all of the authorities of the IRB, except that he/she may not table or disapprove the research. A research proposal may be tabled or disapproved only after review by the convened IRB.
The categories of research that may be reviewed by the IRB 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.
OPRS staff and IRB members follow OHRP guidance concerning expedited review procedures of a continuing review application. The IRB is permitted to use expedited review for initial and continuing review of research that involves solely one or more of the activities published at 63 FR 60364-60367. If research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review except in limited circumstances as described in expedited categories (8) and (9) of 63 FR 60364-60367.
Unless the IRB determines otherwise, continuing review of research is not required for research eligible for expedited review if:
- The study was approved on or after the implementation of the Final Rule (January 21, 2019).
- The study was transitioned to the Final Rule.
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 FR categories 1-7 and/or 9, and the proposed modifications do not change the study’s expedited determination; or
- The research was previously determined to be exempt and the proposed modifications do not change the study’s exempt status.
Any modification that possibly entails more than a minimal risk to the participants must be reviewed by the full IRB at a convened meeting.
The IRB Chair or designee may use the expedited review procedure to review amendments proposing changes which have been requested by a convened board. In such cases, changes must be stipulated by the convened board and no additional changes may be added to the amendment that would require convened board review.
When the expedited review procedure is used, all IRB members shall be informed of actions taken by the IRB at least monthly. A report is generated and made available to all voting members of the IRB for their review. This report is sent via e-mail or made available within the electronic submission system by OPRS staff.
PROCEDURES
- Procedures for Expedited Review
- The OPRS staff member conducts an administrative review of the new study, continuing review or amendment application using the IRB internal checklist. If the OPRS staff member determines the application may qualify for expedited review using the Internal Checklist the Internal Checklist also serves as documentation of the determination. Please see SOP 302 – Administrative Review and Distribution of Materials for the full description of the procedure for administrative review.
- The IRB Chair or designee is assigned as an expedited reviewer. Assigned expedited reviewers perform an in depth review of pertinent documentation and materials submitted by the Investigator (SOP 301) and OPRS staff.
- For new study and continuing review applications, the assigned expedited reviewer completes a Board Reviewer checklist documenting whether the application meets one or more of the expedited categories and whether the study meets the criteria for IRB approval. The reviewer documents the applicable expedited category.
- For amendment applications, the assigned expedited reviewer completes a Board Reviewer checklist documenting whether the amendment to the previously approved research is eligible for expedited review and the modification involves no more than minimal risk to participants.
- If the expedited reviewer determines the application does not qualify for an expedited review, the reviewer notifies the OPRS staff member who will assign the study for the next available convened IRB meeting.
- If the expedited reviewer recommends that the study be tabled or disapproved, the reviewer notifies the OPRS staff member who will move the item to the agenda for discussion at a convened IRB meeting. 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.