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Columbia University IRB

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State Law

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Selected University Research Policies

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Institutional Review Board (IRB)

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General

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International Standards

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Related Information

Education & Training
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Required Training:

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Additional Training Opportunities:

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

- Sponsored Projects Administration
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AAHRPP

- Finance Gateway - Global Support
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OHRP

- PRIM&R
 

 

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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

 

 

Current list of CUMC IT certified systems:

https://rsam.cumc.columbia.edu/RSAM_DEFAULT.aspx

3/1/2016 Revised Policy on Noncompliance in Human Subjects Research released
2/22/2016 New Genetic Testing Policy & Decision Tree released, effective February 12, 2016

Visit the Morningside IRB Office on Tuesdays

from 10:00-11:00 am without an appointment*

When: Any Tuesday

Where: Studebaker Building

615 West 131st Street, 3rd Floor

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

Time: 10:00 – 11:00 am

 

*Alternatively an appointment may be scheduled

 

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Policy & Guidance Refresher

Sponsor-Investigator Responsibilities

When a Principal Investigator (PI) is acting as a Sponsor-Investigator, additional consideration must be given as to how compliance with FDA requirements will be maintained. The Columbia University FDA Compliance Program for FDA-regulated Human Subjects Research outlines the institutional oversight of S-I research.

 

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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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