The goal of pre-review is to ensure that materials reviewed by the full board are “review ready.” For a submission to be “review ready,” IRB analysts focus on:

• Completeness: Ensuring that all items in HRP-308, HRP-309, elements of HRP-314, and other applicable checklists have been addressed.
• Consistency: Ensuring that the documents submitted are broadly consistent with one another and with ARROW.
• Clarity: Ensuring that content in application materials address the questions in the ARROW application and protocol/consent/template sections, for example, and that there are no major gaps that would create difficulty for IRB members during review. 

In addition to Completeness, Consistency, and Clarity, IRB analysts will rely on the regulations and good judgment to resolve issues they encounter.

Review ready examples

Example #1 -- Recruitment: “Patients will be identified by the medical oncologists, surgical oncologists, radiation oncologists, and research staff.”
This information is not review ready. To evaluate this recruitment approach, information on whether medical records need to be accessed and when/how subjects will be approached will be needed. 
Example #2 – Data storage and retention: “Data will be stored on departmental computers.”
This information is not review ready. To assess data security and compliance with institutional policy, information on the identifiability of the data, the departmental server, who will have access to the data, and the length of storage will be needed.

Using worksheets and checklists

IRB analysts use HRP-308 (Pre-Review), HRP-309 (Ancillary Review Matrix), and HRP-314 (Criteria for Approval) worksheets to guide pre-review. Analysts will be directed to relevant worksheets, checklists, and SOPs depending on the nature of the study. Worksheets are used to guide review and are not saved, whereas checklists, except for the HIPAA authorization checklist (HRP-441), are prepared in ARROW by the IRB analyst prior to IRB and completed after the IRB meeting. Note that the Word versions of worksheets and checklists in Box contain footnotes which may provide additional useful information. Analysts are encouraged to consult Word versions during their review.

Consider both the need for specific reviewer expertise and any internally or externally imposed time constraints when scheduling a submission for full board review.

Unless specific reviewer expertise is required, analysts should schedule items for the next possible meeting date. Consult the calendar for meeting dates and scheduling deadlines. Scheduling deadlines are generally one week prior to the meeting. Contact the panel administrator if you have an item that will need to be scheduled but will be past the posted deadline.

IRB member attendance spreadsheets can be found here for HS panels and here for MRR panels. Contact the office administrator if members are listed but have not yet confirmed their attendance.

In the event that a submission must be scheduled for a meeting where a reviewer with specific expertise is not available, analysts should invite a consultant to review.

In some instances, it may be necessary to reschedule items to balance agendas. Analysts will be informed of this by a panel administrator.

Preparing an item for scheduling

Consider the readability of the application materials (consent, assent, protocol, and recruitment materials, as applicable) resolving comments and accepting changes, if necessary, to minimize burden on IRBM reviewers. Leave comments on any unresolved issues intact and clearly indicate where IRBM review is needed.

Complete all relevant checklists.

Scheduling

• When all checklists have been prepared, select “Schedule for an IRB Meeting.”
• Select the item type (e.g., change, initial review) and meeting date. If specific reviewer expertise is needed, enter a comment in the text box.
• Email the panel administrators if there are specific issues that would facilitate assignment or their preparation for the meeting.

If the agenda item type needs to be fixed, send an email to AskARROW to get the issue resolved. Please include a detailed description of what you need to happen. For example, “I selected "Changes To Previously Approved Research Studies” and need it to be “Expedited: Approval of Minor Changes to Previously Approved Protocols.”

See Post Meeting Processing for more information, including:

• Completing Checklists for Full Board
• Preparing Minutes
• Recording Meeting Decisions
• Issuing Correspondence
• Reviewing Modification Responses
• Reviewing Deferral Responses
• Approved with Administrative Hold
• Finalizing Documents

See Minutes Instructions for reminders and instructions on completing each section.

See Reviewing Reading Center/Analysis Center Studies for information on reviewing SDACs.

Staff are asked to prospectively capture full board decisions on controversial or otherwise complex issues when they occur. This may help inform future decision-making processes for related issues that arise in the future. See the synced spreadsheet for examples of issues that have been previously documented. Please consult with your supervisor before making an entry.

Collect Responses Link - record responses here

Synced Spreadsheet Link – searchable spreadsheet