Important Updates to IRB Forms, Policies, and Submission Requirements

By Office of Communications & Marketing | Aug 4, 2026

The SUNY Downstate Institutional Review Board (IRB) has updated several forms, policies, and submission requirements. Investigators should review the changes outlined below before preparing or submitting a new IRB application.

Recent updates include:

• Forms 11-A4 and 11-A4Q are now discontinued
  These forms are no longer in use. Requests for "Not Research" or "Not Human Research" determinations should now be submitted using Form 11-4C.
• TriNetX Data Reminder
  A new reminder has been added to Step 11. TriNetX data is confidential and may not be shared with outside institutions, external collaborators, or anyone not authorized by SUNY Downstate and terms of the TriNetX license. All users are expected to follow institutional policies governing data privacy, security, and appropriate use. Each new project involving TriNetX data requires a separate IRB acknowledgment. Please submit Form 11-4C to the IRB for every subsequent project. TriNetX has proven to be an asset to Downstate researchers.  For more information about TriNetX, visit the Clinical Trials/For Investigators webpage here.

Additional recent updates include:

• Revised informed consent and HIPAA waiver request forms (Forms 8-19A and 8-19B)
• Updates to Policy IRB-01
• Enhanced Form 11-4C with digital signatures
• New Conflict of Interest (COI) guidance
• Updated requirements for Kings County research
• New guidance for research involving artificial intelligence (AI)
• Revised ancillary review requirements for certain clinical research
  Please review the latest information before submitting your next IRB application.

For complete details, forms, and submission instructions, visit the IRB Electronic Application Process webpage.