Human Research Protection Office and IRBs

Frequently Used Services

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Single IRB Review Process

NIH policy requires multi-site research studies to rely on single IRB (sIRB) review.  Check here HRPO guidance, resources, FAQs and the required form to submit for initiating an IRB reliance request 

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Human Research Policy Guide

HRPO/IRB Policies and guidelines, including the IRB Standard Operating Procedures, and a link to the Clinical Research Handbook provide a comprehensive overview of the policies and guidelines for conducting human subjects research at the University

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The Revised Common Rule

NEW! Find out about the revised federal regulations for human subjects research protection and how they affect you

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IRB Consultation Service

IRB consultations are offered at the Morningside, Manhattanville and Medical Center campuses. Check here for times and locations for walk-in consults - no appointment necessary

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Human Subjects Research Regulations & Ethical Principles

NEW! The recently revised federal regulations for human subjects research are now listed here, along with other relevant federal and state regulations, and ethical principles of human subjects research

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Protocol and Consent Form Resources

IRB reviews, creating and submitting a protocol, Consent Form templates and suggested language

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Maintain IRB Approval

All changes to the research protocol must be submitted for prospective IRB approval unless a change needs to be implemented immediately to remove or minimize an imminent harm to subjects

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Human Subjects Protection Training Program & Educational Resources

As a prerequisite for IRB approval, all human subjects researchers must complete CITI Human Subjects Protection and HIPAA Privacy training. Access training programs here.

IRB 101s and Monthly Investigator meetings (MIMs) are regularly scheduled information sessions. Slidedecks and materials from the meetings are posted here.

 

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Information for Research Participants

Find information about participating in research at the University

Recent Announcements

Important Policies and Resources for the Columbia Research Community

Dear fellow members of the Columbia community,

Columbia University is deeply committed to integrity in scholarly research, and we write to remind you of key policies and resources to support your research endeavors. If you conduct research or support people who do, please be sure to read the information below.

Conflict of Interest and Conflict of Commitment Policies

  • The University’s conflict of interest and conflict of commitment policies set out disclosure requirements while affirming that a researcher’s outside activities may stimulate and nurture scholarship. These policies address how real or perceived conflicts may cause bias in research, or affect an individual’s ability to carry out their University responsibilities because of time commitments or competing priorities. All Columbia researchers must comply with these policies.
  • CUIMC affiliates must also follow CUIMC’s policies on conflict of interest in clinical care and education which address some of the additional complexities of biomedical research. 
  • Disclosure of potential conflicts to the University must be completed at least annually through Rascal. Protocol-specific disclosures must be filed with human subject research protocols
  • New resources this fall include an addendum that individuals may append to consulting agreements. The addendum contains important provisions that help ensure the consulting is aligned with University policy. All conflict of commitment requirements must be followed in relation to such engagements.

Research Security Resources and Guidance

  • Research security remains a priority at the federal and University levels. To safeguard our research, the University’s Research Security webpage contains resources and guidance in this area.
  • FAQsaddress considerations for common international engagements and collaborations.
  •  Researchers must pay particular attention to making all disclosures required by federal funding agencies. The U.S. government recently published revised disclosure requirements that are being implemented this year.   Please review the updates to make sure your current and pending (other) support and biographical sketch disclosures are complete.
    • Federal law and Columbia policy prohibit senior and key personnel on federally-funded sponsored projects from participating in malign foreign talent recruitment programs (MFTRPs).  Please review the definition of MFTRP. Starting in 2024, federal funding agencies are requiring researchers to certify that they are not participating in MFTRPs. NASA- and DoD-funded researchers must complete a standalone certification to this effect. If you have questions about whether a possible engagement might be considered an MFTRP, please contact [email protected].

Policies and Resources on Misconduct in Research and Data Management and Retention

  • The University’s Policy on Misconduct in Research ensures that issues of plagiarism, falsification, or fabrication of research are addressed with rigor, care, and confidentiality. 
  • The University’s Guidelines on Retention of Research Data reiterate that research data acquired under the auspices of the University must be stewarded, managed, and shared in accordance with scholarly practice and funding agency requirements. 
  • This Fall, we launched Version 2.0 of “Handling Scientific Images Do’s and Don’ts,” an asynchronous training in Rascal regarding proper handling of digital scientific. This new version is highly interactive and available to all in Rascal.  It is strongly recommended for all postdoctoral researchers and associate research scientists at CUIMC and in other relevant departments, as well as for Principal Investigators and other team members.

Human Research Protection

  • Conducting research involving human research participants is a privilege that comes with significant responsibility. Prospective IRB approval is required for all research involving human subjects.
  • Respect for participants in human subjects research is a fundamental principle underlying all Columbia human subject research.
  • Researchers must follow all requirements that help ensure the safety of human research participants. We highlight here the importance of obtaining and documenting informed consent to participate in research. 

Additional Resources

  • The Office of the EVP for Research publishes 6 research handbooks containing key research policies and procedures in many areas; a Quick Guide to Research, highlighting the many offices that support research at Columbia; and a Quick Guide for Principal Investigators, which summarizes key information for PIs. This office also offers many resources to help researchers find funding and collaborate on major proposals.  Visit the Find Funding webpage for more information.

If you have questions about research compliance issues, please contact the applicable EVPR office or the Office of Research Compliance and Training at [email protected].

Wishing you a productive rest of the year.

 

Jeannette M. Wing

Executive Vice President for Research

Professor of Computer Science

 

Angela V. Olinto

Provost

Professor of Astronomy and of Physics