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  Columbia University Human Research Protection Program (HRPP)

 

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
   -   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

IRB OFFICE ADMINISTRATIVE HOURS ANNOUNCED!

The IRB Office has implemented "Administrative Quiet Time" every day from 11:00am to 1:00pm.  The IRB Staff will not be responding to email or phone calls during that time.  If you have an emergency during these hours, please call the IRB Office Main Line at (212) 305-5883. 

Current list of CUMC IT certified systems:

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

6/5/2013

 

Mix and Mingle - Meet the IRB staff

 

Monthly IRB- Researcher Meeting

Date: June 18, 2013

Time: 3:00 - 5:00 pm

Location: Hammer LL103

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=63235

 

We have designed this session to provide an informal setting for researcher and IRB staff to meet and discuss questions, concerns, and/or suggestions.

Bring your questions and comments! There will be a suggestion box so that ideas and questions can be submitted anonymously, though in person queries are certainly welcome.

Light refreshments will be provided and IRB staff will be present for discussion of human subject issues both general and specific.

 

5/6/2013

Email Update - Review of April 19 MIM

4/3/2013

IRB 101

Date: April 22, 2013

Time: 10:00am - 2:00pm

Location: Alumni Auditorium (Black Building)

 

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=63176

1/15/2013 2013 Spring Educational Events Schedule Released

                                                        more...

Policy & Guidance Refresher

June 2013

GUIDELINES FOR SHORT-TERM VISITORS IN RESEARCH-RELATED ACTIVITIES

Columbia University benefits from the presence of many visitors who come to the University for limited periods of time to participate in its research and, at the Columbia University Medical Center, its clinical programs. In many cases, such visitors are appointed as officers of research or instruction or designated as visiting scholars or visiting scientists, as set forth in the Columba University Faculty Handbook.  In a few exceptions, short-term visitors have no appointment, formal affiliation, or designation with the University (“Non-Affiliated Visitors”). Non-Affiliated Visitors may include high school students, visiting undergraduates, post-baccalaureates, and other observers (who observe, but do not practice, research or clinical techniques or processes) or trainees (who receive training in research or clinical techniques or processes, including practice with appropriate supervision).

While the presence of visitors promotes the mission of the University, we have an obligation to ensure that their activities are conducted in a safe, professional and responsible manner.  All visitors are subject to University policies and procedures, as well as applicable federal, state and local laws that may apply to their activities.  These Guidelines are designed to facilitate adherence to these policies and procedures. 

 

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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