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External Review/Single IRB

Submitting a Protocol for External Review with Yale HRPP IRES – Requesting Single IRB

External Review, or Single IRB, use can only be granted by Yale HRPP/IRB. All protocols must go through Yale HRPP/IRB in order to request use of an external IRB. There is a separate, expedited submission pathway along with unique documents. Please note the Yale HRPP/IRB specific documents below. Complete the forms and follow the procedures outlined below.

Documents you'll need

  1. ☐ Yale HRPP specific documents
    1. — Financial disclosure
      1. Put PI’s name in upper right corner along with Yale IRB#
    2. — Request to use External IRB
      1. Select chosen by sponsor on document (question 2) should it be true.
  2. ☐ Study Protocol
    1. — You can use sponsor protocol for industry sponsored projects
  3. ☐ Informed Consent Forms (ICFs)
    1. — Use track changes for consent form modifications
  4. ☐ Recruitment
    1. — Centralize all recruitment materials into one folder for IRES upload
  5. ☐ Patient Facing Materials
    1. — Centralize all recruitment materials into one folder for IRES upload
  6. ☐ Sponsor Contract

Create an initial submission in IRES

  1. ☐ Basic Study Information Section
    1. — Completed question 5 for external IRB (yes)
    2. — Leave question 6 blank for Lead Principal Investigator
    3. — Load only the most recent protocol to last question
  2. ☐ External IRB Page
    1. — Question 3: write "non-responsive"
  3. ☐ Drugs
    1. — Load the Investigator Brochures to question 3 “attach files”
  4. ☐ Local Site Documents
    1. — Consent forms
      1. Include only ICFs with track changes
    2. — "Other Attachments" 
      1. Load:
        - Request to use external IRB doc
         
      2. - Financial disclosure 
      3. - Sponsor contract

Maintenance:

  1. ☐ Submit annual approval Continuing Review letter from central IRB to IRES for record keeping.

Intranet access

Some links in this section require access to the YNHHS intranet or Teams platforms.