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 Required Training:
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 Additional Training Opportunities:
  -   Monthly Investigator Meetings
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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

Current list of CUMC IT certified systems:


University Travel Policy to Ebola-affected Countries

Monthly IRB- Researcher Meeting

Topic: NIH Genomic Data Sharing Policy: Proposal and Protocol Requirements


Featured Presenters:

Brenda Ruotolo

Executive Director, HRPO/IRB


Stephanie Scott, M.S., CRA

Communications & Outreach Director

Sponsored Projects Administration (SPA)


Date: October 16, 2014

Time: 3:30 - 4:30pm

Location: Hammer Health Sciences Building, LL204

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=74461


Policy & Guidance Refresher

September/October 2014

Protocol Deviations and Violations

All deviations from and violations of Columbia IRB policies or IRB determinations, including departures from the requirement for adherence to the approved protocol, must be reported to the IRB.

• A protocol deviation is defined as a variation from the approved protocol for one subject or to address a temporary situation that is identified by the research team and approved by the IRB before implementation.

• A protocol violation is defined as a variation from the approved protocol that was implemented without prospective approval by the IRB (and was not implemented to avoid or minimize imminent harm*). Protocol violations may be considered as noncompliance with the federal regulations and institutional policies for the protection of human subjects. If the violation is noncompliance, the provisions of the IRB Noncompliance Policy will apply.

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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