Office of Research Administration

Institutional Review Board

 

Policies and Guidance:

IMPORTANT ANNOUNCEMENT:

Please review this important IRB Update (click link for most recent update made on 12.28.2018) to keep informed of the transition to new forms, templates, guidance, and Policy IRB-01 to be in compliance with the revised Common Rule and IRB Policy, effective for new submissions that are approved by the IRB on or after January 21, 2019.

Policies:

  1. Select SUNY Downstate Medical Center Policies:
  2. Select SUNY RF Policies:
  3. Select NYC H+H, Kings County Policies:
  4. BRANY IRB
  5. NCI Central IRB

 

IRB Updates:

  1. December 2018 (Updated 12.28.2018)
  2. October 2018
  3. May 2018
  4. January 2018
  5. October 2017
  6. May 2017
  7. December 2016

Investigator Guidance:

  1. Applicable Clinical Trial (ACT) Checklist
  2. Belmont Report
  3. Conflict of Interests (COI) Disclosure Requirements (updated 12.27.2018)
  4. DRAFT Data Security (draft posted on 12.28.2018 for public comment)
  5. FDA Guidance
  6. Fee Schedule for Industry Sponsored Research
  7. Genome-Wide Association Studies (GWAS- NIH)
  8. GWAS FAQs (NIH)
  9. ICH GCP (E6-R2) 2016
  10. IRBNet (IRB Application and Reporting System)
  11. Lay-Person Summary
  12. Local Research Context for External IRB (updated 12.21.2018)
  13. Material Transfer Agreements
  14. Military Health System Research Regulatory Oversight Office
  15. DRAFT Obtaining Legally Effective Informed Consent and HIPAA Research Authorization (draft posted on 12.28.2018 for public comment)
  16. Office for Human Research Guidance (Alphabetical List)
  17. Qualtrics Tip Sheet
  18. Recruitment, Referral, Screening, Advertising, and Incentives
  19. REDCap: Research Data Capture and Analysis System
  20. Students, Residents, Fellows, Volunteers, or Employees as Research Participants
  21. Training Requirements (updated 12.27.2018)
  22. Veterans Affairs Office of Research and Development

IRB Member Reviewer Guidance:

  1. Common Rule (45 CFR 46) (2009 Version)
  2. Common Rule (45 CFR 46) (2018 requirements, effective 1/21/2019)
  3. Expedited Review Categories
  4. Guidance Full or Expedited Review (updated 12.28.2018)
  5. Checklist for Full or Expedited Review (updated 12.28.2018)
  6. IRB Member Roles and Goals
  7. 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