Home For Research Subjects About the HRPP / IRB Contact Us Submitting a Protocol Maintaining IRB Approval




Columbia University IRB




State Law

Ethical Principles
Policies & Guidance

Selected University Research Policies


Institutional Review Board (IRB)




International Standards


Related Information

Education & Training

Required Training:


Additional Training Opportunities:

Frequently Asked Questions
Related Links
- CUMC IRB (Medical Center Campus)


- Sponsored Projects Administration


- Finance Gateway - Global Support





Have questions, suggestions, or concerns about research that involves human subjects? Use the IRB Staff Directory or

Office email address ("Ask the IRB" link) to contact us!



News & Announcements


Visit the Morningside IRB Office on Wednesday’s

from 1:00-3:00 without an appointment*

When: Any Wednesday

Where: Studebaker Building

615 West 131st Street, 3rd Floor

(Building entrance is on W. 132nd Street due to construction)

Time: 1:00 pm – 3:00 pm


*Alternatively an appointment may be scheduled

by calling 212-851-7040.


Current list of CUMC IT certified systems:



HRPO Process Updates





Policy & Guidance Refresher


July/August 2014


Protocol Deviations and Violations

All deviations from and violations of Columbia IRB policies or IRB determinations, including departures from the requirement for adherence to the approved protocol, must be reported to the IRB.

• A protocol deviation is defined as a variation from the approved protocol for one subject or to address a temporary situation that is identified by the research team and approved by the IRB before implementation.

• A protocol violation is defined as a variation from the approved protocol that was implemented without prospective approval by the IRB (and was not implemented to avoid or minimize imminent harm*). Protocol violations may be considered as noncompliance with the federal regulations and institutional policies for the protection of human subjects. If the violation is noncompliance, the provisions of the IRB Noncompliance Policy will apply.



PGR Archive


Information for Research Subjects
  • Research at Columbia University
  • What is the IRB?
  • Should I Participate in Research?
About the HRPP / IRB
  • Purpose / Scope / Responsibilities
  • IRB Roster and Meeting Schedule
  • Quality Improvement Program
  • Compliance Oversight
  • Federalwide Assurance
Contact Us
 Submitting a Protocol
  • RASCAL Tutorial
  • Tips for Efficient Protocol Review
  • Resubmitting
  • Creating Consent Forms

Maintaining IRB Approval

  • Modifying a Protocol
  • Renewing a Protocol
  • Other Reporting Requirements

     -Adverse Events                                     

     -Protocol Deviations & Violations  
     -Interim Analysis / Safety Reports

  • Closing out a Project

CUMC Home | At Columbia University | Affiliated with New York-Presbyterian Hospital | Comments | Text-Only Version