To request transfer of IRB oversight for an ongoing Research Site, the following items are required in in addition to the standard site submission requirements:
- Completed appropriate Transfer of IRB Addendum:
- Transfer of IRB Addendum – Research Site
- Informed Consent Document(s) currently approved for use (if applicable), in Word and unlocked.
- 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.).
- Request for Partial Waiver of Authorization for Recruitment must also be submitted (even if previously approved by another IRB).
- Site specific Recruitment Materials and Study-Related Materials (diaries etc.) in use or to be used in the future (if enrollment is closed, recruitment items are not required).
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 study transfer requirements, see Transfer of IRB Oversight for Studies.