Transfer of IRB Oversight for Studies

SponsorsTo request transfer of IRB oversight for an ongoing Single Site or Multisite Study, the following items are required in addition to the standard study submission requirements:

  • Completed appropriate Transfer of IRB Addendum:
  • Informed Consent Document(s) currently approved for use (if applicable), in Word and unlocked.
  • Request for Alteration or Waiver of IC and/or Request for Alteration or Waiver of Authorization (if applicable), even if previously approved by another IRB
  • Recruitment Materials and Study-Related Materials (diaries etc.) in use or to be used in the future. (When enrollment is closed, recruitment items are not required).
  • Summary of the amendments and administrative changes to the original protocol since its initial approval AND a revised protocol incorporating all amendments to date.
  • If the study is funded by a grant, confirm that the protocol has been previously checked against the grant application by either another IRB or your organization’s research department. If this has not occurred, please submit a copy of the grant application so it can be done by our Board.
  • Additional requirements for Single Site Study:
    • Most current version(s) of the approved Informed Consent(s) (if applicable) signed by a subject with all personal information redacted.
    • Research Oversight Jurisdiction Form for research conducted at an institution (e.g., hospital, academic medical center, etc.).

Expired IRB Approval

If prior IRB approval has expired a signed, dated letter on site/institution letter head addressing the following information is required:

  • Rationale for the lapse in IRB approval and corrective measures to prevent future IRB lapses.
  • Statement indicating why a re-opening is needed and is in the best interest of study subjects.
  • Summary of procedures that were conducted during lapse of IRB approval and investigator determination that these procedures were conducted because they were in the best interest of the subjects.

The Board may require revisions to materials even if they are currently in use.

If you have question regarding your transfer study or site, please contact Submissions.

For site transfer requirements, see Transfer of IRB Oversight for Sites.