Human Research Policy Guide

The Human Research Protection Office / IRBs provides policies and guidelines for researchers at the University. Below is a list of policies and procedures relevant to human research. In addition, the Clinical Research Handbook provides a comprehensive overview of all policies and guidelines for clinical research at the University.

IRB Standard Operating Procedures 

Version 5.2: Effective February 12, 2019

 

Audio/Video/Photographic Recording of Human Subjects Policy

Template Consent Form Addendum

 

The Case Report Policy clarifies whether case reports require IRB and/or Privacy Office/HIPAA Compliance review and approval.

The Clinical Coordinating Centers Guidance provides guidance regarding the information that should be submitted to the IRB for review of a clinical coordinating center proposal.

When a Columbia University (CU) Investigator is collaborating with a non-CU affiliate investigator who is engaged in CU non-exempt human subject research but is not covered by another IRB, an Individual Investigator Agreement (IIA) may need to be executed.   

Through the agreement created on a protocol-specific basis, the non-affiliate collaborator will agree to abide by specific ethical principles and regulatory requirements while engaged in the Columbia research.  

The request for an IIA checklist should be completed to provide information about the collaborator and role in the research and attached to the Rascal protocol for review. 

Note: For exempt research involving collaboration with a non-CU affiliate, the IIA checklist still must be completed and attached in Rascal. However, a formal agreement may not be required.

 

  • Informed Consent Policy
  • Electronic Informed Consent guidance
  • Same Day Consent Policy
    • The IRB aims to avoid seeking consent for research on the same day as elective procedures when possible, and provide adequate protections when such consent is necessary. (Updated Nov/Dec 2015)
  • Surrogate Consent
    • Obtaining consent for research purposes from a representative of an adult subject rather than directly from the subject (“surrogate consent”) requires the prior approval of the IRB. The IRB may allow use of surrogate consent in accordance with Columbia’s policy only for subjects who lack the capacity to provide their own consent. More details on surrogate consent can be found in the Informed Consent Policy. (Updated May/June 2015)
  • Consent Form Template for Minimal Risk Research
    • The minimal risk consent form template was developed as a tool to facilitate the development of consent forms that include elements required by federal regulation. It is a guide but the language that is provided can and should be customized to apply to your study. You are not required to use this template or consent format, however readability and health literacy factors have been considered and incorporated into this template. Visit the IRB Protocol Resources page for the templates. (Updated Jan/Feb 2014)
  • Radiation Risk Calculator and Consent Form Language for Radiation Risk
  • Model MRI Risk Information for IRB Consent Forms
  • Data Security Plans Involving the Use, Storage or Transmission of Electronic Research Data Constituting Sensitive Data (effective 10.10. 2022) 
    • This Policy provides standards for IRB review and approval of data security plans involving the storage of electronic research data constituting Sensitive Data in human subjects research conducted at Columbia University, including Columbia University Medical Center (“CUMC”), or by Columbia University researchers. The intent of this Policy is to ensure that the protection of the privacy of research subjects and the confidentiality of identifiable research data is in accord with the requirements of HHS, NIH and FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA).  

Superceded Policies: 

  • Additional Requirements for Protocols Funded by Specific Federal Agencies or Subject to Specific Federal Policies
    • During the review of research that is supported or conducted by specific federal agencies, and/or is subject to the requirements of those agencies, or is subject to specific federal policies, the Columbia IRBs consider the respective requirements as they relate to the protection of human subjects and must make specific determinations, e.g., consent, reporting, monitoring. These requirements are in addition to the requirements for approval of research that the IRB considers for all research involving human subjects. (Updated April 2018)

Genetic Testing Policy, effective 2/16/16, superseded 12/10/19

Guidance on Research Involving Genetic Testing; effective 12/23/10, superseded 2/16/16.

Archived Policies & Procedures

Policy on the Conduct of Research with Human Embryos and Human Pluripotent Stem Cells

CU IRB Policy, effective 5/16/24:  Incidental Findings from Imaging Procedures Conducted For Research Studies

Archived Document, Superseded by 5/16/2024:  Incidental Findings from Imaging Procedures Conducted For Research Studies (8/7/2012 - 10/1/2018)

CU IRB Guidance for International Research: Information and documents to be provided for IRB review

Columbia University IRB Fee Schedule Effective 1/1/2022

Initial Review for Industry-Supported Research: $3,000.

(Protocol, Principal Investigator, Consent Forms, Recruitment Materials & other Applicable Materials)

Renewal Review for Industry-Supported Research: $1,500.

Modification Review for Industry-Supported Research: $750.

(Protocol amendment and other modifications requiring convened review)

Administrative Review Fee for Studies Reviewed by Commercial IRBs: $1500.00.

There is no charge for review of unanticipated problems involving risks to subjects.

 

IRB Fee Schedule Effective 2008 - 2021

IRB Policy on Resolution of Queries After Study Closure dated 08/20/2024

The NIH Data Management and Sharing (DMS) Policy is effective with grant applications submitted on or after January 25, 2023. It applies to all research funded or conducted in whole or in part by NIH that results in the generation of scientific data. The policy requires submission of a DMS plan with new or competitive renewal applications, and compliance with the plan.  

-      Guidance and Sample Language for Informed Consent to Address Requirements of the NIH Data Management and Sharing Policy

An important part of the plan is to clearly communicate information about data management and future sharing of scientific data, including limitations on future use, to research participants when prospective consent is obtained.

-       Please review the Research Data at Columbia University webpage for additional resources that have been developed to assist Columbia researchers with meeting policy requirements.

 

: Policy on IRB Review of Oral History Projects

Additional Requirements for Research Involving Pregnant Women

Pregnant women, fetuses, and neonates are a vulnerable population and, as such, require additional protections when they are research subjects. It is recognized, however, that pregnant women, fetuses, and neonates should not be denied the benefits of participating in research. Distinction must be made between studies for which the reproductive status of the pregnant woman or the unique characteristics of fetuses and neonates are criteria for inclusion in the research, and studies for which the pregnancy status of the woman is incidental. (Updated April 2013)

  • Principal Investigator Eligibility
    • The principal investigator normally must be an officer of instruction with a full-time appointment in the rank of professor, associate professor, assistant professor, or instructor or an officer of research with a full-time appointment as a senior research scientist/scholar or a research scientist/scholar, with certain exceptions described in the Faculty Handbook. Persons with appointments carrying other instructional or research titles, including those in a visiting or adjunct grade, may act as co-principal investigators with officers in one of the instructional or research grades cited above. However, they may not serve as the sole principal investigator without the approval of their department chair, director, dean or vice president, and the Provost. (Updated Sep/Oct 2014)
  • Guidance on Changes in Principal Investigator
  • 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. (Updated July/Aug 2014)

     

     

     

    Reliance Request Form

    Single IRB review for Multi-site Research subject to NIH sIRB Policy

    Columbia as a Reviewing IRB

    Columbia as a Relying Site

    Resubmission of Protocols After 60/90 Days

    • 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 Columbia University Faculty Handbook. (Updated June 2013)

    When research involves skin biopsies, sufficient information such as: description of the procedure, number of biopsies to be performed, the site and size of biopsies, the collection method, and the subject’s underlying condition, should be included in the protocol so that the IRB can evaluate its risk for the targeted population. The consent form should provide enough details about the procedures, its risks, discomforts and post-biopsy care instructions.

    Students as Study Subjects in Research Guidance

    • 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 the Human Subjects Protection Training Program page. (Updated Mar/Apr 2015)

     Use of Publicly Available Datasets

    This guidance identifies a specific set of conditions under which research involving the analysis of de-identified data in publicly available datasets is considered to not qualify as "research" with "human subjects" (per applicable federal regulation) and therefore does not need to be submitted to the IRB for review.

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