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

 

seal

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

4/12/2016

IRB 101

 

Date: May 5, 2016

Time: 10:00am - 2:00pm

Location: P&S Amphitheater 1

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=82858

4/5/2016 Revised Genetic Testing Policy (March 31, 2016) released

                                                        more...

Policy & Guidance Refresher

January/February 2016

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.

 

PGR Archive

 

 

Current list of CUMC IT certified systems:

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

 
 

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

 


 
Receive News & Announcements via E-Mail: Click Here to Join Our Listserve
 
CUMC Home | At Columbia University | Affiliated with New York-Presbyterian Hospital | Comments | Text-Only Version