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

 

 

Regulations

  -   Federal
  -   State Law
Ethical Principles
Policies & Guidance
  -   Selected University Research Policies
  -   IRB Policies/Procedures/Guidance
   -   General: OHRP & FDA
   - International Standards
   -   Related Information
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

Coming May 31, 2015

Click here for more details

Schedule of Informational and Support Sessions

 

Current list of CUMC IT certified systems:

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

4/16/2015

IRB 101

 

Date:April 20, 2015

Time: 10:00am - 2:00pm

Location: Alumni Auditorium

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=78108

4/15/2015

Monthly HRPO/Researcher Meeting:

 

Rascal IRB 2.0 Demo

 

Date: April 16, 2015

Time: 3:30 - 4:30pm

Location: P&S Amphitheatre 7

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=78086

3/26/2015 Revised Incidental Findings Policy Released

                                                        more...

Policy & Guidance Refresher

March/April 2015

Human Subjects Protection Training

Before a protocol will be approved by a CU IRB, the PI must review the Human Subjects Protection Training course and receive a passing score of 80 or greater on the relevant exams.  Research personnel other than the PI who have contact with subjects, contact with confidential study data, or are otherwise engaged in the research (i.e., key personnel) must also complete training in the protection of human subjects prior to participation in the research. 

Effective October 20, 2010, there is a requirement for refresher training to be completed every 3 years.  In addition, all research personnel who have previously completed the CUMC Good Clinical Practices Courses or the Morningside Human Subjects Training Course must complete the CITI Human Subjects Protection Training Program no later than March 31, 2011. 

For more information on the Human Subjects Protection training requirements, please see our FAQs

 

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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