Human Subjects Research
All research that involves human subjects must be reviewed before initiation of the study by one of the Institutional Review Boards (“IRB”) designated on the University’s Federalwide Assurances, except as noted below. This is true whether the research is being funded by a government agency or by any other source. Faculty and other investigators may consult with the appropriate IRB well in advance of submitting a project for review to discuss IRB-related issues that may affect the design or conduct of their study.
Certain research projects, in particular those conducted at affiliate institutions, may be reviewed by an IRB other than one of the Columbia IRBs. Information regarding which IRB is appropriate for the review of such research projects is available by contacting the CUMC IRB.
The University has several IRBs, including one dedicated to reviewing research conducted on the Morningside and Lamont campuses. Information on the policies governing human subjects research, and the process for approval of this research is available on line:
Conflicts of InterestPersonnel who plan to participate in the design, conduct or reporting of human subjects research must submit individual, protocol-specific conflict of interest disclosure forms. The Institutional Review Board (IRB) will not give final approval to any protocol until all conflicts of interest have been reviewed by the appropriate conflict of interest committee and addressed to the satisfaction of both that committee and the IRB.
Human Subjects Protection Training
Before a protocol will be approved by a CU IRB, the PI must complete the Human Subjects Protection Training course. 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 continuing education 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 requirement, click here.
To access the course: https://www.rascal.columbia.edu/login/tc0087/
Privacy and Information Security
Anyone eligible to participate in human subjects research at CUMC, as well as Morningside personnel whose research includes access to subjects’ protected health information, must complete a one-time HIPAA training on privacy and security of health information: https://www.rascal.columbia.edu/login/tc0019/
Research with Minors
If the study population includes children, completion of the CITI
Research with Minors training module is required. The module is
accessible within the CITI Human Subjects Protection Training Program,
and should be accessed through the RASCAL Training Center: https://www.rascal.columbia.edu/login/tc0087/
Clinical Research Coordinators
All Clinical Research Coordinators (CRCs) must complete the Clinical Research Coordinator Training Program. For more information about the CRC Training Program, click here. The Rascal training course is available at https://www.rascal.columbia.edu/login/tc0098/.
For questions, contact the Clinical Trials Office at email@example.com or (212)342-2763.