Getting Started with the Institutional Review Board Submission Process
There are several steps researchers need to take before submitting a new study request to an institutional review board (IRB), whether the IRB is within NYU Grossman School of Medicine or is one of the external IRBs we have contracted with. IRB Operations can assist researchers in learning how to do the following:
- Determine If Your Project Is Human Subjects Research
- Determine the Type of Initial Review Your Study Requires
- Use Research Navigator to Submit Your Study for Review
- Disclose Financial Conflicts
Before you begin a study, you should first determine whether your project meets the definition of human subjects research. The U.S. Department of Health and Human Services (HHS) Oﬃce for Human Research Protections provides graphic aids and guides that can help you determine whether a project involving human subjects must be reviewed by an IRB according to HHS regulations.
Federal regulations stipulate that an IRB does not need to review research if it does not involve human subjects. If your study does not qualify as human subjects research, your sponsor or a publication may require certification confirming this. In this instance, you complete our self-certification form or the quality improvement self-certification form.
If your research does involve human subjects, the IRB will determine the type of initial review required. There are three types of review: exempt, expedited, and full board. To learn more, see our policy and procedures manual.
To submit a study to the IRB, faculty, staff, and partnering researchers use their Kerberos ID to log into Research Navigator. This program allows you to create a new study profile and manage the documents and data related to your study.
Through Research Navigator, you may need to submit additional forms, including the IRB addenda for vulnerable populations and requests for a waiver of authorization of informed consent, depending on the nature of your research.
In Research Navigator, you will also find online training videos for how to use the program.
Disclosure of financial conflict is required for all personnel listed on your IRB application at the time of a study’s new submission, a continuing review request, and any modification or amendment involving a change to your study staff.
If a conflict is indicated on any of your electronic financial disclosure forms, Research Navigator routes it to the Conflicts of Interest Management Unit for review. IRB approval can be issued without conflict of interest determination. However, the individual or individuals missing conflict of interest determination cannot participate in research activities until the determination has been issued.
See more details about the Conflicts of Interest Management Unit’s requirements and guidance in completing an electronic financial disclosure form (access requires a Kerberos ID and password).