Human Subjects Research
IRB Review
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:
Morningside IRB (including LDEO)
Conflicts of Interest
Personnel 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 Research Training
Before a protocol will be approved by a Columbia University IRB, the PI must review the most pertinent Good Clinical Practice (GCP) or Human Subjects Research course and receive a passing score of 80 or greater on the relevant exam. 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.
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 in Rascal.