External Institutional Review Boards | NYU Langone Health

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Institutional Review Board Operations External Institutional Review Boards

External Institutional Review Boards

With few exceptions, all human subjects research taking place at NYU Langone Health must be reviewed by an Institutional Review Board (IRB).

NYU Langone’s IRB Operations Unit can cede review to an external IRB under the following circumstances:

  • Your study is industry initiated and using one of the following external IRBs:
    • Biomedical Research Alliance of New York Institutional Review Board (BRANY IRB)
    • Western Institutional Review Board (WIRB)
    • Central Institutional Review Board for the National Cancer Institute (NCI CIRB)

OR

  • Your study is a federally sponsored, multicenter trial that requires the use of a single IRB (sIRB).

Exceptions are considered on a case-by-case basis.

Use of external IRBs is only permitted after NYU Langone’s External Review Unit confirms your eligibility. Research activities can only begin after the External Review Unit grants institutional clearance upon confirming you have met all institution-specific requirements.

If you’re interested in enlisting the services of an external IRB, whether commercial or academic, review this page, including the videos, to learn about the requirements and processes.

Watch a video that introduces the use of an external IRB (Kerberos ID and password required for access).

Note that if you are receiving federal funding for a multisite study that requires the use of an sIRB, and if NYU Langone is the main site, please contact irb-single@nyulangone.org for information about using NYU Grossman School of Medicine IRB as the sIRB of your study (Kerberos ID and password required).

Using an External IRB

Learn more about the process of using an external IRB.

Determining Eligibility to Use an External IRB

To cede review to an external IRB, the External Review Unit must first determine your study is eligible for review and oversight by an external IRB.

Watch a video explaining how to obtain eligibility confirmation and institutional clearance for your submission (Kerberos ID and password required for access).

To request permission to use an external IRB, you must complete the Request for Use of an External IRB form. Email the completed form to the External Review Unit at irb-external@nyulangone.org.

Note that we participate in SMART IRB, an initiative that streamlines the IRB reliance process for multisite studies.

Initial Study Submission Requirements and Principal Investigator Responsibilities for Institutional Clearance

Once you have received a response from the External Review Unit indicating that your study meets the eligibility criteria for use of an external IRB, you will need to follow several procedural steps to obtain institutional clearance. Institutional clearance is granted by the External Review Unit and is required before you can begin any research activities at this institution.

Watch a video regarding external IRB-specific submission requirements for institutional clearance to ensure you complete every step of the process (Kerberos ID and password required for access).

Continuing Review, Study Modifications, and Study Closures

The study team submits study modifications, continuing reviews, and study closures directly to the external IRB for review. After the external IRB has approved them, they must be submitted in Research Navigator for institutional tracking and documentation purposes. Note that modifications including changes in personnel are an exception to this and must be cleared by the External Review Unit before submission to the external IRB.

Read more about the process of documenting continuations and modifications for externally reviewed studies.

If you have questions or concerns about the use of an external IRB, please email NYU Langone’s External Review Unit at irb-external@nyulangone.org.