Office of Research Administration

Institutional Review Board




  1. IRB-01: SUNY Downstate Medical Center Human Research Protections Program (WORD)  (PDF)
  2. RFDMC-01: Research Conflict of Interest Policy
  3. PHA-11: Investigational Drug/Dispensing and Utilization
  4. SUNY Downstate Office of Compliance and Audit Services
  5. SUNY Downstate HIPAA (Health Insurance Portability and Accountability Act) Policies and Forms

    Select HIPAA policies and forms:

    Research Certification for Reviews Preparatory to Research

    BAA Template Policy (HIPAA-3)

    BAA Template Form

    HIPAA De-Identification of Information (HIPAA-6)

    Minimum Necessary Guidelines (HIPAA-15)

    Use of Limited Data Sets (HIPAA-27)

    Uses and Disclosures for Research Purposes (HIPAA-28)

  6. SUNY Downstate Medical Center - Language Services to Patients with Limited English Proficiency
  7. NYC H+H Kings County Clinical Research Office Memo
  8. NYC H+H Kings County Human Subject Research Protections Program
  9. NYC H+H Kings County System to Track and Approve Research (STAR)
  11. NCI Central IRB


IRB Updates:

  1. January 2018
  2. October 2017
  3. May 2017
  4. December 2016

Investigator Guidance Materials:

  1. Acronyms and Definitions
  2. Ancillary Reviews
  3. Data Security
  4. Fees for Industry Sponsored Studies
  5. ICH GCP (E6-R2) 2016
  6. IRBNet (IRB Application and Reporting System)
  7. Lay-Person Summary
  8. Local Research Context for External IRB
  9. Material Transfer Agreements
  10. Obtaining Legally Effective Informed Consent and HIPAA Research Authorization
  11. Recruitment, Referral, Screening, Advertising, and Incentives
  12. Responsibilities
  13. Reportable Events
  14. Submission Requirements For IRB Review
  15. Students, Residents, Fellows, Volunteers, or Employees as Research Participants
  16. Training and Conflict of Interest Disclosure
  17. Applicable Clinical Trial (ACT) Checklist

IRB Member Reviewer Guidance:

  1. IRB Member Roles and Goals
  2. IRB Member Checklist for Full or Expedited Review
  3. IRB Member Training Energizer for IRBNet

IRB Office Guidance:

  1. IRB Records and Destruction
  2. Records Management Certificate of Destruction

  3. Records Management Certificate of Destruction – Supplement Form A

Educational Presentations:

For educational presentation materials, please click on "Training" Tab on the IRB Menu.

Compliance Documents:

  1. Statement of Compliance
  2. Federal Wide Assurance