About the HRPO/IRBs

The mission of the CU IRB is to enhance and facilitate the ethical conduct of human subjects research conducted by Columbia, and by Columbia faculty, regardless of location. The CU IRB will perform this mission through its review of human subjects research, its educational and training initiatives, and its compliance oversight and quality improvement programs. For more information, please see the Columbia University Human Research Protection Program Executive Summary 2013.

Internal IRBs

There are six IRBs in the Columbia HRPP. Five IRBs (four full-board, one expedited review) are responsible for review of human subjects research conducted by faculty, employees, staff, and students at CUMC and NYP and one IRB is responsible for human research conducted by faculty, employees, staff, and students at CU-MS. Additional IRBs may be added as necessary to ensure adequate and timely review of research proposals submitted for consideration.

External IRBs

CUMC and NYP have IRB Authorization Agreements with the New York State Psychiatric Institute (NYSPI), the Weill Medical Center of Cornell University, the National Cancer Institute Central IRB (CIRB), CU-MS, Massachusetts General Hospital/Partners (central IRB for the NeuroNEXT trials), and the Fred Hutchinson Cancer Center (central IRB for the HVTN studies) to rely on reviews by their IRBs for certain types of research projects. Details regarding each agreement are provided in the IRB Standard Operating Procedures (SOPs).

The IRB conducts quality improvement initiatives to evaluate and strengthen the quality of our human research protection program. The primary purpose of these initiatives is to increase the efficiency of our performance and ensure compliance with federal regulations for the protection of human subjects in research.

The IRB has the responsibility to oversee the conduct of research that it approves. Consistent with this responsibility, the IRB may audit research studies conducted at Columbia University or Columbia University Medical Center as well as research in which faculty and/or staff of Columbia University are engaged outside the institution. The Compliance Oversight Manager is responsible conducting audits at both campuses and reports to the Executive Director of the IRB.

When, as a result of an audit, or in the course of routine IRB business, incidents of noncompliance by investigators with federal regulations or Columbia University Medical Center IRB policies are identified, they are brought to the attention of the Executive Director of the IRB and the Chair of the Board to which the protocol is assigned. The incidents of non-compliance are then reviewed and managed in one of several ways depending on the severity of the non-compliance. A plan of corrective action is documented for each incident of non-compliance.

The Federalwide Assurance (FWA) is the institution's commitment to comply with federal regulations for the protection of human subjects in research.

Terms of Assurance US Department of Health & Human Services (DHHS) Federalwide Assurance (FWA)

Additional FWA information can be obtained from The Office for Human Research Protections (OHRP)
Assurance page: http://www.hhs.gov/ohrp/assurances/assurances_index.html