Office of Research Administration

Institutional Review Board

Policies:

  1. SUNY Downstate Medical Center - Human Research Protections Program (DRAFT POLICY IRB-01)
  2. SUNY Downstate Office of Compliance and Audit Services
  3. SUNY Downstate HIPAA - Health Insurance Portability and Accountability Act
  4. SUNY Downstate Medical Center - Language Services to Patients with Limited English Proficiency
  5. NYC H+H Kings County Clinical Research Office Memo
  6. NYC H+H Kings County Human Subject Research Protections Program
  7. NYC H+H Kings County System to Track and Approve Research (STAR)
  8. BRANY IRB
  9. NCI Central IRB

Note: The above referenced IRB-01 policy was approved by the Executive Performance Improvement Council on March 8, 2017; however, it is pending approval by the Medical Executive Committee.  It represents the current thinking of the IRB

Guidance Materials:

  1. Acronyms and Definitions
  2. Approval Requirements
  3. Ancillary Reviews
  4. Data Security
  5. Fees for Industry Sponsored Studies
  6. ICH GCP (E6-R2) 2016
  7. IRBNet (IRB Application and Reporting System)
  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, or Volunteers as Research Participants
  16. Training and Conflict of Interest Disclosure

Educational Presentations:

  1. Top 12 IRB Tips
  2. 50 Shades of Gray - Why and When is IRB Approval Required?
  3. IRBNet - Visual Snap Shot of Submission Process (IRBNet Training Energizer)

Compliance Documents:

  1. Statement of Compliance
  2. Federal Wide Assurance

IRB Updates:

  1. December 2016 Update