Add/Update IRB Documents


How to Add or Update IRB/ARC Documents in the Database 

 

This document will instruct you on how to add a new IRB/ARC approvals, consents and applications OR update an existing IRB/ARC that has a Continuing Review component in the BMC Database.

 

New IRB Approval and Consent
  1. Log into the BMC database at research.bmap.ucla.edu
    1. You must be logged in under the PI’s name OR you must be given “permission” by your PI in the database so that you can log in and manage the project.
  2. Once logged in, click on the “IRB Approvals” or "ARC Approvals" link listed under “Regulatory” at the left side of the screen.
  3. Click “Add New IRB/ARC Approval”
  4. Fill out the required fields (example below) 
    IRB/ARC Number:  
    IRB/ARC Number Suffix:  
    IRB/ARC Principal Investigator:  
    Full IRB/ARC Project Title:  
    Short Title:  
    Approval Date:
    Expiration Date:  
  5. Click “Submit IRB/ARC Approval…” and then click “Add” to complete this step.

NOTE: Steps 5-7 are for IRB ONLY.  ARC continue to step #8.  

  1. The 2nd part of this process for IRB only is to click on the "Consent Forms" link listed under “Regulatory” at the left side of the screen.  This will take you to the “Add a Consent Form to Your Account” page.
  2. “IRB Number and Title” – click on the arrow for a drop down menu of IRB’s listed and select the proper IRB #.
  3. Fill out the required fields.
    1. Fill out “Full Consent Title”, “Short Title” and “Expiration Date” with the proper information.
    2. Select “MRI” under “Acquisition modalities covered by this consent form” and make sure you select the boxes for each “proper personnel covered”.
    3. Click “Submit Consent Form…” then click “Add” to complete this step.
  4. You may notice that on both the “IRB/ARC Approvals” and “Consent Forms” sections that your approval/consent is NOT verified.
    1. To have these verified you will need to email Trent Thixton a digital copy of:
      1. For IRB: both the “IRB Approval Notice” and the actual Consent(s) with the proper IRB # and expiration dates on it
      2. For ARC: the ARC Approval Notice and ARC Application
    2. Requirements for BMC verification of your IRB approved consent include describing proper screening of subjects for metal implants (including some dental work) AND screening female subjects of child-bearing potential for pregnancy.

i. Click here to view a “Potential Risks” example document

 

Renewed IRB/ARC Approval and Consent
  1. Log into the BMC database at research.bmap.ucla.edu
    1. You must be logged in under the PI’s name OR you must be given “permission” by your PI in the database so that you can log in and manage the project.
  2. Once logged in, click on the “IRB Approvals” or "ARC Approvals" link listed under “Regulatory” at the left side of the screen.
  3. Locate the IRB/ARC Number you want to renew and click “Use as a template for new Approval” under “Options”.
  4. Update the fields as required.
  5. Click “Submit IRB/ARC Approval…” and then click “Add” to complete this step.

NOTE: Steps 6-8 are for IRB ONLY.  ARC continue to step #9.

  1. The 2nd part of this process is to click on the “Consent Forms” link listed under “Regulatory” at the left side of the screen.  This will take you to the “Consent Forms” page.
  2. Find the Consent you want to update and click “Use as a template for new Consent Form” under “Options”.
  3. Update the fields as required.
    1. “IRB Number and Title” – click on the arrow for a drop down menu of IRB’s listed and select the updated IRB # that you want to update.
    2. “Full Consent Title”, “Short Title” should stay the same but the “Expiration Date” will need to be updated.
    3. Update the “Personnel covered by this consent form” if needed.
    4. Click “Submit Consent Form…” then click “Add” to complete this step.
  4. You may notice that on both the “IRB/ARC Approvals” and “Consent Forms” sections that your approval/consent is NOT verified.
  5. To have these verified you will need to email Trent Thixton a digital copy of:
    1. For IRB: both the “IRB Approval Notice” and the actual Consent(s) with the proper IRB # and expiration dates on it
    2. For ARC: the ARC Approval Notice and ARC Application
  6. Requirements for BMC verification of your IRB approved consent include describing proper screening of subjects for metal implants (including some dental work) AND screening female subjects of child-bearing potential for pregnancy.

i. Click here to view a “Potential Risks” example document