HRP-313 - Expedited Review describes the criteria to be used within the IRBs Office in identifying new initial applications that qualify for expedited review. In order for a study to qualify for expedited review, it must be minimal risk. 

Studies that involve certain subject populations, activities and/or require additional regulatory oversight will not qualify for expedited review. Specifically:

• Studies involving interactions with prisoners will be excluded.
• Studies involving MRIs will be excluded. These should be assigned to the HS IRB.
• Studies that involve the use of drugs will be excluded.
• Studies intended to evaluate the safety and effectiveness of a medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

The assigned IRBS has the discretion to refer any IR for review by the full IRB. Situations that may require full IRB review include:

• The IR does not appear to qualify for expedited review.
• The ST does not wish to comply with the reviewer's requests.
• The IR raises issues that cannot be resolved by the IRBS and the ST without additional input from the full IRB.
• The IR requires assessment by a clinical reviewer or reviewers with certain expertise (e.g. international research), NOTE: Generally, if an IR requires clinical assessment, it may need to be scheduled for full board review. However, in some instances, the IR may only require consultation from a medical reviewer. In this case, the IR can undergo expedited review. Consult with team manager if unsure.
• The expedited reviewer determines that the IR cannot be approved (only the convened IRB can disapprove an initial review).

As part of pre-review, the reviewer may request consultation in order to obtain additional expertise as needed. (See HRP-051 – Consultation) Contact the IRBM to confirm availability and no COI. Then, send the submission to the IRBM using the Send to IRB Member activity.

1. If the assigned IRBS/IRBD determines that the expedited IR requires review by the full IRB, they will proceed as follows:
   1. The assigned analyst may retain ownership of the IR. In such cases the assigned IRBS should follow the Convened Board Reviews process.
   2. If the reviewing IRB and IRBS needs to be re-assigned, the assigned IRBS will consult with the team manager or IRBD for reassignment instructions. The originally assigned IRBS will email the IRBS to whom the IR has been reassigned to alert the IRBS of the change in both ownership and review type. The newly assigned IRBS may consult with the originally assigned IRBS as needed when reviewing the IR.
2. If the IR appears to qualify for expedited review, the assigned IRBS will conduct a pre-review of the IR.
3. When  all outstanding issues have been resolved, the assigned IRBS will complete checklists in ARROW. NOTE: If the IR falls under VA purview, the assigned IRBS/IRBD must follow the steps outlined in the VA IRX Approval Process section [Link to section below].
   1. See Completing HRP-401.
      1. For expedited studies, Section 6: Notes, does not apply.
      2. Select “Complete” NOT “Pre-Review Prepared (Convened Board)” and select “Ok”.
   2. When completing 402:
      1. The Comments section can be used to include any important or unique aspects of the IR review for purposes of documentation in the history tab for the initial application. Any consultations with others (e.g., FDARROP) should be described here and any documentation uploaded in the related documents section of the activity form.
4. Once 402 is complete, Edit Letter to Study Team activity and select the appropriate letter type from the drop-down menu.
5. Use the Send Correspondence to Study Team activity to send the approval notice to the study team and answer 'yes' to 'Are the minutes completed' in this activity form.
6. If any consent forms require approval with the IR, the assigned IRBS should use the Finalize Documents activity to finalize and stamp the new consent forms. NOTE: If an administrative hold has been placed on the study, the consent form(s) cannot be released until the hold is lifted. The approval date for the consent documents should be the date the initial review is approved. In the case of an administrative hold, the approval date of the documents will be the date the hold is removed.

1. When all outstanding issues have been resolved, the assigned IRBS will complete checklists.
   1. When completing 402:
      1. The analyst will identify the applicable expedited review category(ies).
      2. Select Approved with Administrative Hold as the expedited review determination.
      3. Under Administrative hold requirement, select Other and include the following in the comment box: “VA approval is required before the administrative hold can be lifted.” Note: this comment will appear on the determination letter.
      4. Select the appropriate Agenda Item Type and meeting date.
2. Next, draft the letter using the Edit Letter to Study Team activity. Select the Expedited Approved with Admin Hold letter template. Edit expiration date.
3. Use the Send Correspondence to Study Team activity to send the approval notice to the study team.
4. Send to the VA using the Send to Ancillary Committee activity. In the comment box, add: “The IRB approved the study with an administrative hold via expedited procedures. The hold can be released on provision of the VA RDC's final approval.”
5. NOTE: The consent form(s) cannot be stamped until the hold is lifted. The approval date of the documents will be the date the hold is removed.
6. Once the VA issues approval, complete 402 to lift the hold. Select Simple Concurrence.
7. Stamp any consent forms.