Office of Research Administration

Institutional Review Board

Policies:

  1. IRB-01: SUNY Downstate Medical Center Human Research Protections Program
  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
  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)
  10. BRANY IRB
  11. NCI Central IRB

Note: The above referenced IRB-01 policy was approved by the Executive Performance Improvement Council and the Medical Executive Committee in March 2017 and has an effective date of June 30, 2017.

IRB Updates:

  1. May 2017 IRB Update
  2. December 2016 IRB Update

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, or Volunteers as Research Participants
  16. Training and Conflict of Interest Disclosure

IRB Member Reviewer Guidance:

  1. IRB Member Roles and Goals
  2. Approval Requirements
  3. Criteria For IRB Approval: Full or Expedited Review Process (Memory Jogger)
  4. Informed Consent Checklist
  5. Full or Expedited Review Checklist

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