NYU School of Medicine Institutional Review Boards
When submitting to the institutional review boards (IRBs) at NYU School of Medicine, researchers need to be aware of the review process for different types of submissions as well as our IRB policies and procedures. See below for additional information on these topics:
- Institutional Review Board Policies and Structure
- Submitting a New Study to NYU School of Medicine’s Institutional Review Board
- NYU School of Medicine’s Institutional Review Board Serving as a Single Institutional Review Board
- Expanded Access for the Use of Drugs or Devices
- Emergency Use
- Research on Decedents
- Submitting a Study Modification to NYU School of Medicine’s Institutional Review Board
- Submitting a Continuing Study Review to NYU School of Medicine’s Institutional Review Board
- Reportable New Information
- Final Study Closure
The institutional review boards at NYU School of Medicine promote and protect the welfare and rights of all human research participants. Our policies and procedures manual, “NYU School of Medicine Policies and Procedures for Human Subjects Research Protection,” details not only the policies and regulations governing research with human subjects, but also the procedures for submitting research proposals for review. These policies and procedures apply to all research involving human subjects if NYU School of Medicine faculty, staff, students, or facilities are involved, regardless of sponsorship or performance site.
There are five IRBs at NYU School of Medicine, four of which convene monthly. The fifth board, Board E, meets on an ad hoc/emergency basis. Each of these committees is composed of faculty, staff, and community representatives, and includes both scientist and nonscientists.
Submissions that require full board review will be assigned to the next scheduled board meeting. If you have questions about your IRB submission once you know which IRB will review your submission, call or email an IRB coordinator. If your question is not specific to an IRB submission, email us at email@example.com. Do not use this address to send in your IRB submission; you must use Research Navigator. For information regarding submission turnaround time, you may refer to our 2017 metrics (Kerberos ID and password required).
If you are currently participating in a research study and would like to talk to the IRB about a question, concern, or complaint, please call our office at 212-263-4110. You can also visit us at One Park Avenue, 6th floor, in Manhattan, Monday through Friday, from 9:00AM to 5:00PM.
NYU School of Medicine’s Human Research Protections Program was the first institution in New York City to be awarded full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The AAHRPP is a nonprofit organization that works with organizations that conduct human research to raise the level of protection for research participants.
The AAHRPP accredits organizations that provide participant safeguards surpassing the threshold of state and federal requirements, therefore heightening the level of public confidence in the safety and ethical conduct of research.
Accreditation signifies that organizations such as NYU School of Medicine are committed to the most comprehensive protections for research participants and the highest quality research. The high ethical and professional standards required for accreditation enhance the wellbeing of research participants and have significant benefits for the organizations, sponsors, and regulators.
To submit a new study (initial submission) to our IRB, complete the following steps:
- Determine whether your project meets the definition of human subjects research.
- Determine the type of review your project will require from the IRB (exempt, expedited, or full board).
- Use Research Navigator to create a study profile (Kereberos ID and password required).
- Use Research Navigator to submit your initial review request to the IRB (and all other relevant Office of Science and Research administrative offices and ancillary review committees).
- If needed, fill out and attach additional forms to your study profile in Research Navigator. These include the IRB addenda for vulnerable populations and requests for a waiver of authorization of informed consent.
- If you have questions, consult the IRB’s guidance document appropriate to your project. If you still have questions after consulting the guidance, contact our Division of Education and Training to reserve a block of time with one of our scientific managers, who can assist you with your submission.
After we receive your submission, our administrative staff reviews your study documentation. In the event that additional information is required, they send a “Request for Clarification” to the PI and the primary study contact. Once all clarification requests are addressed, the submission is then forwarded to a designated reviewer or placed on the next available agenda for full board review.
If you have questions about your IRB submission, call or email the IRB coordinator assigned to your project. If your question isn’t specific to an IRB submission, email us at firstname.lastname@example.org. Do not send your IRB submission to this email account; you must use Research Navigator.
Effective January 25, 2018, and applicable to multisite studies sponsored by the National Institutes of Health (NIH), the NIH is requiring grants submitted after January 25, 2018, to provide a plan for a single IRB (sIRB) review. See NIH sIRB policy for more details.
Please contact NYU School of Medicine’s IRB at email@example.com before you submit a grant to the NIH that includes our IRB serving as an sIRB.
You must apply for IRB approval to use 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.
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
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, or HIPAA. This form should be uploaded to your Research Navigator study profile.
You must seek IRB approval before making any changes to an approved research study—even if the changes are planned for the period for which IRB approval has already been given. Changes to the study may not be implemented until approved by the IRB. However, when a change is necessary to eliminate immediate hazard to a subject, you may implement a change without IRB approval, notifying the IRB at once.
Modifications are protocol changes that are within the scope of what the IRB has authorized. For example, if a researcher wishes to add a population to an existing study without altering study procedures or purpose, an amendment is usually appropriate.
The degree and significance of the changes affect whether the amendment receives full or expedited review. The IRB may use expedited review to review minor changes in an ongoing, previously approved study during the period for which approval is authorized. For a more significant proposed change, such as the addition of procedures involving increased risk or discomfort to subjects, a full board review is needed before the change can be implemented.
What to Submit for a Modification
Investigators must submit documentation to the IRB regarding proposed changes. The following documents are required, but the IRB may request additional information to complete the review and approval process:
- 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
Changes in Study Staff
When the principal investigator of a study changes, the IRB needs to receive a modification submission that includes a confirmation signature from the appropriate department chair. For any other change in study staff, such as sub-investigators or study coordinators, the chair’s signature is not required. For new staff additions, an accompanying CV and financial disclosure form are required.
For initial studies approved after January 21, 2019, the requirement for continuing review may be eliminated for the following:
- non-FDA-regulated studies approved via expedited review
- non-FDA-regulated full board studies that remain open for data analysis and/or long-term follow-up only
The IRB must conduct a review of ongoing research as long as the research remains active at intervals that are appropriate to the level of risk for each research protocol but not less than once per year.
During the IRB review process, the board determines the level of review necessary for the project. A project that is particularly risky or has an investigator with a protocol recently suspended by the IRB for compliance concerns might be subject to another review of the project within a couple months after receiving IRB approval.
What to Submit for a Continuing Review
The following documents are required, but the IRB may request additional information to complete the review and approval process:
- signed disclosures of financial interest forms for each study team member
- data safety monitoring reports (if applicable)
- publications relevant to risks or potential benefits (if applicable)
- interim findings (if applicable)
- multicenter trial reports (if applicable)
Continuing reviews submitted without these documents may render your submission incomplete; it will be returned to the PI for clarification.
Some minimal risk studies are no longer required to renew their IRB approval on an annual basis (continuing review). However, the 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, protocol violations, and report when all study activities are complete by submitting a closure. Use Research Navigator to make an appropriate submission in timely manner.
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
- 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)
The completion or termination of your study is a change in activity and must be reported to the IRB. A final report to the IRB allows the closure of all files and provides information that the IRB may use in the evaluation and approval of related studies.
Closure of a study means that no further research, follow-up, or data analysis may be performed. If any subjects are still participating in your study or research results are still being reviewed, the study cannot be closed. A study is not closed simply because no additional subjects are to be enrolled.
If your study has closed, you should submit a final study closure via Research Navigator. You must upload a final report with the closure submission.