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 6: Effective Date March 6, 2025

 

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 Standard Operating Procedure for reviewing and submitting Requests for Certificate of Confidentiality describes the process for requesting a CoC to the National Institutes of Health (NIH) through the online NIH CoC system.

Standard Operating Procedure; Updated January 7, 2026 to reflect the current CoC Institutional Assurance Statements 

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 (updated 02/01/2026)
  • 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.
  • Consent Form Templates are available under the Consent Form Resources Page.
  • 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).  

 

Emergency Preparedness Plan for the HRPO

  • 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)

 

 

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

 

 

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

Columbia University IRB Fee Schedule Effective 4/1/2025

 

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.

 

Institutional Certifications are expected for the submission of large-scale human genomic data under the NIH Genomic Data Sharing Policy (GDS).  The GDS policy applies to all NIH-funded research that generates large-scale human or non-human genomic data and its use for subsequent research. It also applies when submitting large-scale human genomic datasets from non-NIH funded research to one of the NIH-designated data repositories.

: 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 October 14, 2016)

Guidance for the Classification of Quality Improvement (QI) Activities vs Research 

 https://nyp.acquiadam.com/assets/share/asset/fwniw2svcd 

QI Program Evaluation and Self-Certification Tool
https://nyp.acquiadam.com/assets/share/asset/lo8qswtfmo

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

 

IRB Reliance is when two or more institutions in a multisite or collaborative study rely on one IRB, the “Reviewing IRB”, to review, approve and monitor study procedures conducted by investigators affiliated with the institutions. In such cases, the responsibility for IRB review has been ceded by each Relying Institution.

A reliance agreement must be in place before reliance procedures, such as submission of a protocol for review or review by the Reviewing IRB for a Relying Institution, can commence. The Columbia Reliance Request Form is the primary mechanism by which investigators inform the Columbia Human Research Protection Office (HRPO) about proposed reliance situations, after which relevant decisions can be made, e.g., whether reliance is appropriate and which institution will serve as the Reviewing IRB.

Reliance Request Form

For more information about Columbia reliance processes and forms, please visit the HRPO webpage, Single IRB Review for Multi-site Research.

Columbia Central IRB (cIRB) SOPs

 

This IRB Policy applies to Repositories established at or on behalf of Columbia University (Columbia or the University), including Columbia University Irving Medical Center (CUIMC), for the purpose of storing Materials for current or future research.

  • Columbia University Biobank (CUB)

The Columbia University Biobank (CUB) is a CUIMC-wide effort to enroll all patients of CUIMC-NYP into a unified, longitudinal biobank research protocol with broad future use and data sharing allowances. CUB refers to both the central recruitment initiative and the resulting biobank, and was created to:
· Give all interested participants the opportunity to enroll into the biobank and engage with research programs
· Improve the enrollment and sample collection process for participants, while also creating better safeguards for collected samples and data
· Ensure donated materials have the greatest possible impact on scientific research by facilitating their use by CUIMC researchers across fields
· Accelerate the launch of new projects and efforts to advance research into understudied and rare conditions

To fulfill these aims, CUB has created a number of resources to enable ongoing enrollment of NYP/CUIMC patients and create a comprehensive biobank of samples and clinical data that are available to all Columbia researchers.

CUB can partner with departments, centers, and other groups to perform start-to-finish enrollment, collection, processing, and storage for specific patient groups under the CUB protocol. Participants can be identified based on the location of their clinical care or their clinical diagnosis, and CUB staff will work with clinical care teams to determine the best methods to enrollment (which can take place both remotely and in person).

CUIMC researchers seeking to build out new or unique biobanks should contact CUB staff ([email protected]) to determine how CUB resources can best advance their research efforts.

You may also visit here to find out more about CUB and what services they may provide.

Special federal regulations provide guidance for conducting research with prisoners.  The U.S. Department of Health and Human Services (DHHS) regulations (Subpart A of 45 CFR 46 (Subpart A), also known as the Common Rule), sets out the basic human subject research protections, which include informed consent and review by an Institutional Review Board (IRB).  The Columbia IRB has developed a policy that describes the requirements for any Columbia research that involves prisoners.

Policy on Research with Prisoners (New)

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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