About the Human Research Protection Program (HRPP) / Institutional Review Board (IRB)
Purpose / Scope / Responsibilities
Columbia University has implemented a comprehensive Human Research Protection Program (HRPP), which is under the leadership of the Executive Vice President for Research. The
program is charged with the responsibility of ensuring that all human research studies conducted by
Columbia faculty, employees, and staff are conducted ethically and in a manner that promotes the
protection of participants in research. In accordance with institutional policy, all such research
must not only be in compliance with state and federal regulations, but must also meet or exceed the
standards of accreditation as set forth by the Association for Accreditation of Human Research Protection
The Columbia HRPP is composed of all entities, offices, and individuals engaged in and/or responsible
for the review and conduct of human research at Columbia University (CU), and New York Presbyterian Hospital
(NYPH). CU has two Federalwide Assurances (FWAs): one for Columbia University Medical Center (CUMC) and one
for the main campus at Morningside. NYPH has its own FWA and is a separate legal entity from CU. Although
these are three separate legal entities, one HRPP is responsible for all human research conducted at any of
these three locations, or by their faculty, employees, or staff regardless of location.
For more information, follow this link to the Executive Summary of the Human Research Protection Program.
IRB Rosters and Meeting Schedule
Quality Improvement Program
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.
More information regarding Compliance Oversight is provided at the following link: Columbia University IRB Noncompliance Policy.
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
All of the Columbia University IRBs have been registered with the Office for Human Research Protection (OHRP). The IRB registration number for each IRB is provided below:
IRB00006882 CUMC IRB#5: IRB0010414
CUMC IRB Expedited: IRB00008612
CU IRB Morningside: IRB00006799