Institutional Review Board Submission Requirements | NYU Langone Health

Skip to Main Content
Getting Started with the Institutional Review Board Submission Process Institutional Review Board Submission Requirements

Institutional Review Board Submission Requirements

When submitting to the institutional review board (IRB) at NYU Grossman School of Medicine, investigators need to be aware of the review process for different types of submissions as well as our IRB policies and procedures.

All new studies must be submitted through Research Navigator. See instructions for using Research Navigator (Kerberos ID and password required). Investigators must complete certain courses and follow specific submission processes in order to obtain and maintain IRB approval.

Required Human Subjects Research Training

The Collaborative IRB Training Initiative (CITI) program prepares research investigators to conduct studies that involve human participants. All NYU Grossman School of Medicine researchers conducting human subjects research are required to complete the course.

Learn more about required courses.

Initial Submission

For information on submitting a new study (initial submission) to the NYU Grossman School of Medicine IRB, consult the guidance document appropriate to your project. If you still have questions, contact IRB education and training to schedule a meeting with one of our scientific managers who can assist with your submission.

After receiving your submission, the IRB Operations team will review your study documentation. In the event that additional information is required, a “Request for Clarification” will be sent to the principal investigator and the primary study contact. After clarification requests are addressed, the submission is forwarded to a designated reviewer or placed on the next available agenda for full board review.

Maintaining IRB Approval

Any changes to the study must be reported to the IRB through Research Navigator, whether the change is after approval (modification) or during an annual renewal period (continuation).

Modifications

Any modifications to the study must be approved by the IRB before implementation. Investigators must submit documentation to the IRB regarding the proposed changes. The following documents are required:

  • a detailed outline of all changes and a rationale for each change, which may be a separate document or a letter from the principal investigator and should be titled “Summary of Modifications”
  • a marked-up copy for each revised document, as applicable; each copy must show all changes highlighted using track changes in Microsoft Word
  • any other relevant documents

The IRB may also request additional information to complete the review and approval process.

If the principal investigator of a study changes, the IRB requires a modification that includes a confirmation signature from the appropriate department chair. For any other change in study staff, such as sub-investigators or study coordinators, a chair’s signature is not required. For new staff additions, an accompanying CV and financial disclosure form are required.

Continuations

Renewed approval is required at least annually for all non-exempt research, unless a shorter approval period was determined by the IRB.

For initial studies approved after January 21, 2019, the requirement for continuing review may be eliminated for the following:

  • non–FDA (U.S. Food and Drug Administration)-regulated studies approved via expedited review
  • non–FDA-regulated full board studies that remain open for data analysis and/or long-term follow-up

What to Submit for a Continuing Review

The following documents are required when submitting for a continuing review, as applicable:

  • data safety monitoring reports
  • publications relevant to risks or potential benefits
  • interim findings
  • multicenter trial reports

The IRB may request additional information to complete the review and approval process.

Continuing reviews submitted without these documents may render your submission incomplete, and it will be returned to the principal investigator for clarification.

For studies that do not require continuing review, investigators are required to keep the IRB up to date on any modifications to the research, new information indicating a change to the risks or potential benefits of the research, and protocol violations. Investigators must report when all study activities are complete by submitting a closure.

Closures

Completion or termination of your study is a change in activity that must be reported to the IRB. Closure of a study means that no further research, follow-up, or data analysis may be performed. The study cannot be closed if any subjects are still participating in your study or research results are still being reviewed. A study is not deemed closed because no additional subjects are to be enrolled.

The IRB requires a final report to allow closure of all study files and to collect information that the IRB may use in the evaluation and approval of related studies. If your study has closed, you must submit a final study closure via Research Navigator.

Reportable New Information

The principal investigator must promptly notify the IRB of any unanticipated problems involving risks to subjects or others that occurs during the course of a study within five working days of learning about the event. Use Research Navigator to report such new information.

Unanticipated Problems Involving Risks to Participants or Others

Unanticipated problems are events—including internal or external events, deaths, life-threatening experiences, injuries, breaches of confidentiality, or other problems—that occur any time during or after the research study. The monitoring entity or principal investigator determines that the events include all of the following:

  • They are unanticipated—that is, not in the consent form, investigator brochure, protocol, package insert, or label or they are unanticipated in frequency, severity, or specificity.
  • They are related to the research procedures—that is, caused by or probably caused by research activity, or if a device is involved, probably caused by or associated with the device.
  • They are harmful—that is, they caused harm to participants or others or placed them at increased risk for harm.

In other words, to qualify as an unanticipated problem, an event must be unanticipated and related and harmful.

Unanticipated deaths or life-threatening experiences related to the research (at NYU Langone or when NYU Langone is the coordinating institution in a multisite study) must be reported immediately when the research team learns of the event.

Reportable Events and Information Other Than Unanticipated Problems

Reportable events and information other than unanticipated problems include the following:

  • new information indicating a change to the risks or potential benefits of the research, in terms of severity or frequency (such as analysis indicating lower-than-expected response rate or a more severe or frequent side effect, other research finding that an arm of study has no therapeutic value, or an FDA labeling change or withdrawal from market)
  • protocol deviation or violation, only if one or more of the following criteria is met:
    • it was intended to eliminate apparent immediate hazard to a research participant
    • it was harmful (caused harm to participants or others or placed them at increased risk of harm)
    • it represented possibly serious or continued noncompliance
  • a complaint unresolved by the research team or that indicates increased or unexpected risks
  • incarceration of a participant, when the principal investigator believes it is in the best interest of the participant to remain in the study
  • an unanticipated adverse device effect
  • new information about the effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects
  • a protocol exception request (include the protocol exception request appendix)