Human Research Policy Guide

The Human Research Protection Office / IRBs provides policy overviews and research guidelines for researchers at the University. Below is a list of policies 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.

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  • Audio/Video/Photographic Recording of Human Subjects
    • Recording the voice and/or image of an individual creates a type of record that requires unique handling and storage, particularly if the content may be considered sensitive.  As with all research procedures, the dignity of human subjects should be respected.  Therefore, only what is necessary for the purpose of the study should be recorded.  Research subjects must be informed prospectively that such recording will occur, and be provided with information about the storage, confidentiality, and future use of the resulting tape. (Updated Jan/Feb 2015)
  • 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 Exposure Calculator and Risk Statements (Duke University) 
  • Data Security Plans Involving the Use, Storage or Transmission of Electronic Research Data Constituting Sensitive Data
    • 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). (Updated May/June 2014)
  • 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 March 2013)
  • 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)
  • 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)

    Reimbursement/Compensation to Study Participants

    • This policy applies to all human research studies that will provide payments to participants or subjects for either: a) expenses that will incur as a result of participation (e.g., travel related costs); or b) payments to compensate subjects for their willingness to participate in the research study

     

     

    Reliance Request Form

    Columbia as a Reviewing IRB

    • Standard Operating Procedures- Reliance
    • Standard Operating Procedures- Reporting
    • Standard Operating Procedures- Financial Conflicts of Interest

    Columbia as a Relying Site

    • 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)
    • 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)