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Regulations

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Education & Training
 Required Training:
  -   Human Subjects Protection
  - FDA Regulated Research
  -   HIPAA (for Research)
  -   Research with Minors
  - Clinical Research Coordinators
 Additional Training Opportunities:
  -   Monthly Investigator Meetings
  -   IRB 101
  -  

Annual Educational Conference

  - RASCAL Workshops
   -  

Other Web-Based Training

Frequently Asked Questions
Related Links
  -   CU IRB (Morningside Campus)
  - Columbia University - Research
  -   RASCAL
  -   Sponsored Projects Administration
   -   Clinical Trials Office
   

–  Research Pharmacy

   -   CTSA
  - Finance Gateway- Global Support
   -   HIPAA Home Page
  -

Radiation Safety Office

External Links
   -   AAHRPP
   -   FDA Guidance
   -   NYSPI IRB
   -   OHRP
  - PRIM&R
   -   WIRB

 

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Have questions, suggestions, or concerns about research that involves human subjects? Use the IRB Staff Directory, Phone Tree, Office email address ("Ask the IRB" link), or suggestion box to contact us!

 

News & Announcements

 

Rascal IRB 2.0

 

Enhanced Module is now live!

IRB 2.0 Site Map

Updated Schedule of Informational and Support Sessions

 

Current list of CUMC IT certified systems:

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

6/1/2015 Rascal IRB 2.0 enhanced module is now live!

                                                        more...

Policy & Guidance Refresher

May/June 2015

Surrogate Consent

Obtaining consent for research purposes from a representative of an adult subject rather than directly from the subject (“surrogate consent”) requires the prior approval of the IRB. The IRB may allow use of surrogate consent in accordance with Columbia’s policy only for subjects who lack the capacity to provide their own consent.

More details on surrogate consent can be found in the Informed Consent Policy

PGR Archive

 
 

Information for Research Subjects
  • Research at Columbia University
  • What is the IRB?
  • Should I Participate in Research?
  • Studies Seeking Participants
About the HRPP / IRB
  • Purpose / Scope / Responsibilities
  • IRB Rosters and Meeting Schedule
  • Quality Improvement Program
  • Compliance Oversight
  • Federalwide Assurance
Contact Us
 Submitting a Protocol Maintaining IRB Approval
  • Reporting Adverse Events
  • Modifying Your Protocol
  • Renewing Your Protocol
  • Other Reporting Requirements
    - Protocol Deviations & Violations
    - Interim Analysis / DSMB Reports
    - Suspension
  • Closing out a project

 


 
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