Institutional Review Regarding Human Subjects Research
Columbia University maintains a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP) that regulates our ability to conduct research involving human subjects. Compliance with this Assurance requires the university to ensure that all human subjects research conducted under the auspices of the institution is reviewed and approved by the Institutional Review Board (IRB) prior to the conduct of the research. In addition, the university is expected to provide a comprehensive, ongoing training program in basic human subjects protections and to verify that all applicants submitting protocols for IRB approval have undergone this training.
The Columbia Human Research Protection Office (HRPO) at Morningside oversees human subjects research for faculty, staff, and students on the Morningside and Lamont campuses. Students from Teachers College or Barnard should seek approval from the IRB at their respective institution. Staff at any of these IRBs can provide guidance on research that may require review from multiple institutions, if needed.
All Columbia faculty, employees, and students who propose to conduct research involving human subjects, whether funded or non-funded, are required to:
- Complete the appropriate web-based training program(s) on the protection of human research participants prior to submitting their research application to the IRB via the Rascal electronic submission system. The training can be found on Columbia’s Rascal website.
- The required basic training for all researchers is TC0087 - Human Subjects Protection Training.
- Additional training is required if the research involves minors (Research with Minors, an option in TC0087).
- TC0019 - HIPAA: Health Insurance Portability Accountability Act Research Training Course is required if protected health information (PHI) is collected or created during the study.
- Submit their research to the IRB for review and approval. Protocols that constitute research with human subjects but fall into federally-designated exempt categories also need to be reviewed by the IRB for an exempt determination. The term “exempt” reflects exemption from the requirements of the regulations, not exemption from IRB review. All IRB applications must be submitted electronically through Rascal.
The Graduate School of Arts and Sciences requires all faculty advisors and graduate students to determine whether or not their current or prospective research involves the use of human subjects and, if so, to complete the applicable web-based training program(s) immediately and apply for review and approval by the Morningside IRB. Failure to do so may result in serious penalties to the university and individual researchers, such as the discarding of research findings and the prevention of the publication of results. The Columbia Students as Researchers Policy also requires submission of some projects that may not meet the regulatory definitions of “research” but involve humans or data about them. The IRB has also developed guidance that provides practical information to facilitate the submission of student research proposals.
Note that the Principal Investigator (PI) must be a full time member of the faculty (Officer of Instruction), or an Officer of Research, at specific ranks as described in the Faculty Handbook. See “Obligations and Responsibilities of Officers of Instruction and Research, Principal Investigators” section.
For student research, the faculty advisor, or other appropriate faculty member, should be listed as PI on the student’s IRB application. Students may be co-investigators. Faculty sponsors/PIs are ultimately responsible for the conduct of all student research and should familiarize themselves with IRB policies.
If you need guidance to determine whether or not you are conducting research involving human subjects, you may consult the following charts provided by the US Office of Human Research Protections (OHRP); and you may contact the CU HRPO at Morningside at (212) 851-7040 or by email at [email protected].
Human Subjects Research conducted without CU IRB approval is considered serious non-compliance with CU Policy and Federal Regulations and is subject to sanctions.
For information on the web-based training program and information on submitting a protocol, see the Columbia HRPO/IRB website. A short web-based Rascal training module (not required) that illustrates how to create and submit a protocol in Rascal is available via the Rascal Testing Center link: TC0017 - Rascal Training: How to do Human Subjects Protocols.
Please contact the HRPO at Morningside by phone at (212) 851-7040 or by email to [email protected] if you have any questions relating to research with human subjects.