Institutional Review Board Special Submission Requirements | NYU Langone Health

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Getting Started with the Institutional Review Board Submission Process Institutional Review Board Special Submission Requirements

Institutional Review Board Special Submission Requirements

In addition to the requirements all investigators must meet in order to submit a new study to NYU Grossman School of Medicine’s institutional review board (IRB), some studies must also meet special submission requirements, such as studies involving expanded access for the use of drugs or devices, the emergency use of a drug, biologic, or device, or research on decedents.

NYU Grossman School of Medicine’s Institutional Review Board Serving as a Single Institutional Review Board

Effective January 25, 2018, all National Institutes of Health (NIH)–sponsored studies that are multisite and have at least one domestic site are required to use one IRB as the single IRB (sIRB) of their study for studies submitted after the effective date. For more details regarding the policy, please see the NIH’s Single IRB policy.

Learn more about using the NYU Grossman School of Medicine IRB as the sIRB of your study (Kerberos ID and password required). Please contact NYU Grossman School of Medicine’s IRB at irb-single@nyulangone.org before you submit a grant to the NIH that includes our IRB serving as an sIRB.

Expanded Access for the Use of Drugs or Devices

Investigators must apply for IRB approval to use U.S. Food and Drug Administration (FDA)–regulated drugs or devices outside of an established clinical trial to treat study participants with serious diseases for which there are no comparable or satisfactory FDA-approved therapy options available. In these instances, you must include an appendix for expanded access with your study submission.

Emergency Use

Federal regulations in the protection of human subjects do not permit research activities to begin without prior IRB review and approval. These regulations, however, do not limit or interfere with the authority of a physician to provide emergency medical treatment for patients, subject to FDA requirements for release and emergency use of an unapproved drug, biologic, or device on a single patient.

Principal investigators are required to submit a written report on the emergency use to the IRB within five working days. You should notify the IRB of the emergency use of the device or the drug by submitting a notification of emergency use of investigational drug or device and emergency use consent form with your new study submission.

Research on Decedents

The application for research on decedents should be used when creating a study focusing exclusively on identifiable information from deceased individuals. The IRB needs to determine that your study is allowable under the Health Insurance Portability and Accountability Act (HIPAA). This form should be uploaded to your Research Navigator study profile.