Review and update, if necessary, the checklists prepared for the meeting based on board decisions and discussion. In most instances, the notes in section 6 of HRP-401 should be deleted. If no revisions are needed, or after any needed revisions have been made, select “Complete checklist.” Do not complete checklists if the item was deferred or the board did not find the study team’s request to enroll children (HRP-416) or waive consent (HRP-410), for example, approvable. 

Complete the HIPAA waiver/alteration checklist, if applicable. Staff should sign the checklist by typing their first and last name into the "Reviewer Signature" box.

Prepare minutes using the “Create Meeting Minutes” activity in ARROW.  

• Minutes can be created in advance of the IRB meeting and then updated by selecting “Create Meeting Minutes” again. See the Minutes Instructions when preparing minutes.  
• Select all relevant checklists or choose “Not Applicable”. NOTE: Choose “Not Applicable” for studies that have been deferred OR if you are drafting the minutes in advance of the meeting. 
• Select “OK”. 

Note that questions will differ slightly if the submission is an Initial Review, Change, Continuing Review (CR), or Reportable Event. For example, responses for changes should indicate whether continuing review status has changed as a result of the submission. 

• Select “Record Meeting Decision”. 
  • For changes of protocol, if the study is moving from Approved No CR to CR required, select "Approved- Continuing Review Required."
• Enter the motion. 
• Enter the vote count. Vote counts can be found in the annotated agenda located in the appropriate Committee Management folder.  
• For changes, enter the meeting date as the approval date.
• Enter the risk level or changes to the risk level. (HS Only) 
• Enter the FDA status or changes to the FDA status. (HS Only) ** This action will not update the FDA status in the “More Details” section of the main study space. After recording the decision, use “Update Regulatory Status” feature to update the FDA status of the study.
• Note whether the expiration date of the study is changing. If the study was previously excused from CR and CR will now be required, or the CR period is changing, answer “yes” and enter the new expiration date. For a change reviewed that will now have a 12-month CR period, the expiration date is the COP approval date plus 12 months, minus one day. (E.g., change approved 4/24/2023, expiration date is 4/23/2024.)
• For initial reviews, enter the Continuing Review status and the approval period if continuing review is required. This will generally be 12 months unless the board has determined otherwise. For changes, indicate if the CR status is being updated. If the CR status is changing, identify the reasoning for the change.  
• Indicate the need for administrative hold, if applicable. 

Decisions 

Modifications Requested 

• • Enter the board’s requested modifications into the appropriate sections of the application using the “IRB Request” comment type.    
  • Add any requested modifications into the appropriate documents (e.g., protocol, consent). Use “Upload Revision”, when applicable, to upload documents with IRB requests. 

Deferred 

• • Enter the board’s concerns and requests for modification or more information using the “IRB Request” comment type. 
  • Add any requested modifications into the appropriate documents (e.g., protocol, consent). Use “Upload Revision”, when applicable, to upload documents with IRB comments. 

Disapproved 

• • Enter the board’s rationale for disapproval into the appropriate sections of the application. Use the “IRB Request” type reviewer note to describe each issue. 
  • Add any requested modifications into the appropriate documents (e.g., protocol, consent). Use “Upload Revision”, when applicable, to upload any documents with comments.   

Approved or Approved with Administrative Hold 

• • Proceed to “Prepare and issue correspondence then “Finalize documents” for unconditionally approved studies. Documents for studies approved with administrative hold should not be stamped until the administrative hold has been lifted. See the “Approved with Administrative Hold” section below for applicable studies. 

• Select “Edit letter to the study team” and use the pull-down menu to select the appropriate letter. 
  • In some instances, it may be necessary to add funding listed in “other funding” in the ARROW application manually. This is typically due to a sponsor request. 
• Use the “Send Correspondence to the Study Team” action to send the letter.

Review the modification response to determine if the board’s requests have been addressed.   

• If the response does not adequately address the board’s requests, enter additional “IRB Request” notes in the application and comments in the application materials, as necessary, and return the application to the study team.  
  
  
• If it is unclear whether the response adequately addresses the board’s requests or the study team disagrees with requests, consult with a supervisor to determine if the response should be returned to the study team, reviewed by the primary reviewers, or sent for full board review. 
  
  
• If all concerns have been addressed and the board determined that modifications could be approved under simple concurrence, complete HRP-402 and finalize documents.
  
  
• If the board determined that modifications must be reviewed under expedited review procedures, use the “Send to IRB member” activity to send the response to the reviewing IRB members and/or any other board members who may have requested review of the study team’s response. 
  • Include an explanation of the modifications requested, response received, and a link to the process for completing IRB Member review. 
  • When the IRBM reviewers have submitted their response, confirm that reviewers agree the study can be approved and complete HRP-402 and finalize documents. 
    
    
• If the study team has not adequately addressed the board’s requests, or if the investigators have included additional, non-editorial changes to application materials, the submission should be scheduled for full board review.  Unless there are special considerations, the item should be scheduled for the panel that performed the initial review.  Select “Responses to Requests for Modifications” as the agenda item. 

Completing HRP-402 Non-committee Review for an acceptable modification response 

1. 1. Check the box noting you do not have a Conflicting Interest. 
      1. Indicate the level of review (simple concurrence or expedited review). 
   2. Under “Determination” indicate if with the modifications, the study meets approval criteria. 
   3. Under “Additional Information”, note whether the study was Approved, Approved with Administrative Hold, or Approved with No Continuing Review. 
   4. If continuing review will be required, note the approval period and the rationale for continuing review (e.g., The study is FDA regulated.) 
   5. If the modification response was reviewed under expedited procedures, the approval must appear in IRB minutes. Select “Expedited Approval of Convened Board Requests” when completing 402. Report the approval on the agenda, selecting the earliest meeting date for which an agenda has not yet been prepared. Modification responses approved by simple concurrence do not need to be displayed on an agenda. Select “Not Displayed on the Meeting Agenda.”

A deferral response will return the study to the IRB Pre-Review state. Review the deferral response to determine if all the board concerns have been addressed.  

• If there are outstanding concerns, enter reviewer notes (using the “IRB Request” note type) in ARROW and return the application to the study team.   
• Once all outstanding concerns have been addressed, or when the outstanding concerns cannot be addressed in Pre-Review, schedule the item for board review. 
  • Update the 401 notes field to include a summary of the reasons for deferral and the study team’s response.   
  • Schedule the deferral response for the panel that deferred the original submission whenever possible. Select “Previously Deferred Submissions” as the agenda type. 

• VA Studies
  • Use the “Send to Ancillary Committee” activity to send the application to the VA Research and Development Committee (RDC).  
  • If the VA requests modifications at this point in their process, the study team should submit a change of protocol to address the requested changes. This should occur infrequently for initial reviews as those studies are endorsed by the VA prior to IRB review. 
  • After the VA’s approval, the application will return to “IRB Review of Administrative Hold Response” state. Complete HRP-402 using “Review Level” of “Simple Concurrence” to lift the administrative hold.   
  • Prepare and issue correspondence as above and finalize the consent and assent documents, if applicable. 

Finalize consent and assent documents, and study information sheets, as applicable, using the “Finalize Documents” activity. Standalone HIPAA authorization forms are not stamped. The consent stamp will appear in the bottom right corner of the consent and assent documents.  Ensure the document does not include text in this location.  Do not stamp consent documents for other sites included on sIRB applications.