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Columbia University IRB

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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:

https://secure.cumc.columbia.edu/cumcit/secure/security/scp_systems.html

9/17/2014

IRB 101: Human Subjects Research Protections & How to Submit a Protocol to the CU IRB- Morningside

Date: Friday, October 24, 2014

Time:   12:00 – 2:00 pm

Location:  Hamilton 413

Register at:

https://calendar.columbia.edu/sundial/webapi/register.php?eventID=73963

9/17/2014

How to submit a Modification and/or Renewal for your Protocol to the CU IRB-Morningside

Date: Friday, September 26, 2014

Time:   1:00 – 2:00 pm

Location:  Hamilton 413

Register at: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=73972

 

9/17/2014

IRB 101: Human Subjects Research Protections & How to Submit a Protocol to the CU IRB- Morningside

Date: Friday, September 26, 2014

Time:   11:00am – 1:00 pm

Location:  Hamilton 413

Register at:

https://calendar.columbia.edu/sundial/webapi/register.php?eventID=73957

8/27/2014

HRPO Process Updates

 

More...

 

 

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
     -Suspension

  • Closing out a Project
     
 

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