Office of Research Administration

Institutional Review Board

 

NOTICE REGARDING NEW IRB-01 POLICY:

 

A new IRB-01 policy (click link to review) is scheduled to go into effect on January 19, 2018, to be in compliance with revised regulations posted by the following entities:

A high level summary of changes to the IRB-01 Policy is provided here (click link to review).

 

The White House and OHRP are in the process of going through a formal rule making process to delay the compliance date for the revised Common Rule.  If the Federal Government implements any new regulations prior to the compliance date of January 19, 2018, we anticipate that we may need to make additional revisions to the IRB-01 policy.

Additional changes to the IRB application forms, informed consent templates, guidance documents, an IRB Update memo, and information sessions are forthcoming.  These materials will be posted on our IRB website and distributed to our research community as appropriate as more information becomes available.

Please be aware that more changes to the FDA and HIPAA regulations are anticipated, but have not been published.  We will amend our policies and documents as needed and educate our research community as things change.

 

Policies:

  1. IRB-01: SUNY Downstate Medical Center Human Research Protections Program (CURRENT POLICY)
  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

 

IRB Updates:

  1. October 2017 IRB Update
  2. May 2017 IRB Update
  3. 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
  17. Applicable Clinical Trial (ACT) Checklist

IRB Member Reviewer Guidance:

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

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