Institutional Review Entity

Regulatory & Compliance Resources Institutional Review Entity
Purple hero (default)
Regulatory & Compliance Resources Institutional Review Entity

In compliance with the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, NYU established the Institutional Review Entity, a committee of biosafety experts that oversees a strict dual use research of concern review process for research conducted at NYU School of Medicine and NYU’s downtown campus. The committee’s review of proposed life sciences research projects minimizes the risk such research may pose if the knowledge, information, products, or technologies it provides are misused. If a research project is identified as dual use research of concern, the committee creates and implements a risk mitigation plan specific to the experiment.

Institutional Guidelines for Dual Use Research of Concern

At NYU, life sciences research is conducted to further biomedical knowledge and to develop new treatments and interventions that improve healthcare. However, the nature of such research—for example, analysis of the mechanism of contagion of a deadly virus—allows for it to be potentially misused to cause harm. 

Known as “dual use research of concern,” such research is defined by the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”

Dual Use Research of Concern Experimental Criteria

Guidelines set forth by the U.S. government’s dual use research of concern policy may apply to experiments using the following agents and toxins:

  • avian influenza virus (highly pathogenic)
  • Bacillus anthracis
  • botulinum neurotoxin (in any quantity)
  • Burkholderia mallei or pseudomallei
  • Ebola virus
  • foot-and-mouth disease virus
  • Francisella tularensis
  • Marburg virus
  • reconstructed 1918 influenza virus
  • rinderpest virus
  • toxin-producing strains of Clostridium botulinum
  • variola major or variola minor virus
  • Yersinia pestis

A research project may be considered dual use research of concern if it involves one of the above select agents or toxins and the experiment could result in one or more of the following experimental outcomes:

  • The experiment enhances the harmful consequences of the agent or toxin.
  • The experiment disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification.
  • The experiment confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates its ability to evade detection methodologies.
  • The experiment alters properties of the agent or toxin in a manner that would enhance its stability, transmissibility, or ability to be disseminated.
  • The experiment alters the host range or tropism of the agent or toxin.
  • The experiment enhances the susceptibility of a host population to the agent or toxin.
  • The experiment generates or reconstitutes an eradicated or extinct agent or toxin listed above.

Dual Use Research of Concern Review Process

As a principal investigator proposing research at NYU, you should notify the Institutional Review Entity as soon as you anticipate that your experiment will involve one or more of the select agents or toxins listed above.

To submit an application describing the proposed experimental use of listed agents or toxins to the Institutional Review Entity, use Research Navigator (login with a Kerberos ID is required). As part of the application, attach a completed dual use research of concern registration form as a "supporting document."

In your application, include the identity of the listed agents or toxins that will be used and an assessment of whether your proposed research produces, aims to produce, or can reasonably be anticipated to produce one or more of the experimental outcomes that meet the criteria of dual use research of concern.

Upon receipt of application of potential dual use research of concern, the Institutional Review Entity staff disseminates the notification to its members for review. We meet monthly immediately after Institutional Biosafety Committee meetings.

Review includes verification that the proposed research uses one of the listed agents or toxins and a review of the principal investigator’s assessment of whether the proposed research will or is anticipated to achieve any of the listed categories of effects. Our experts may review additional documents related to your project proposal; project reports; and examples of similar research that has already been published if these documents will assist us in making a determination.

If we conclude that your proposed research meets one or more of the criteria set by U.S. government policy, we then conduct a detailed risk assessment to determine whether the research meets the definition for dual use research of concern.

If we determine that the research in question does not involve one or more of the categories of experiments detailed above, the research project is not subject to additional review or oversight, but you should continue to assess the potential for it to meet the criteria of dual use research of concern going forward.

If we determine that the research falls within the scope of dual use research, we notify the U.S. government funding agency within 30 days of review. If we further determine that the research meets the definition of dual use research of concern, we work with you to develop a draft risk mitigation plan and submit it to the U.S. government funding agency within 90 days for review and approval.

Once a risk mitigation plan is approved, you can proceed to implement the plan. Throughout the duration of the research project, we review the plan and the research project at least once per year. Any change in the status of a dual use research of concern project or risk mitigation plan must be communicated as soon as possible, and we notify the U.S. government funding agency within 30 calendar days.

Dual Use Research of Concern Risk Mitigation Plan

If NYU’s Institutional Review Entity determines that a proposed experiment meets the definition for dual use research of concern, we assist investigators in creating and submitting a risk mitigation plan. The plan must be developed and submitted to the governmental funding agency within 90 days.

The plan denotes the specific measures an investigator intends to take to reduce the identified risks of the proposed research. In addition, planned actions are detailed to assess whether the following components are adequate to mitigate risk:

  • existing biosafety and biosecurity measures
  • the applicability of existing countermeasures
  • educational and training measures for research staff
  • the plan for monitoring the conduct of the research
  • the plan for responsible communication of the research findings

No research activities may begin until approval is granted or until further review, if needed, is conducted by committees such as the Institutional Biosafety Committee, Institutional Animal Care and Use Committee, or Institutional Review Board.

Our Institutional Review Entity evaluates all active dual use research of concern protocols and risk mitigation plans annually and modifies plans as needed to ensure continued compliance with federal guidelines.

Principal investigators must notify the Institutional Review Entity immediately if ongoing research produces a previously unanticipated experimental outcome listed in the U.S. government policy or if it otherwise meets the definition of dual use research of concern.

Dual Use Research of Concern Policies and Training

Investigators working with any of the agents or toxins listed in the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern are required to read and understand the NYU Policy on Identification and Oversight of Dual Use Research of Concern.

Additionally, you must complete dual use research of concern training before submitting a research application and be retrained annually if an experiment lasts longer than one year. The training module is available later this spring for NYU School of Medicine faculty and staff by logging into iDevelop, which requires a Kerberos ID. Those based in NYU’s downtown campus can request training materials from NYU’s Environmental Health and Safety office by emailing ehs@nyu.edu.

After completing training, you receive a certificate that must be attached to the research application in Research Navigator.

If you have questions or requests for additional information about the NYU dual use research of concern policies or training, contact Natalie L. Mays, institutional contact for dual use research, at natalie.mays@nyumc.org or 646-754-5258. You can also email our Institutional Review Entity at ire@nyumc.org.

Dual Use Research of Concern Resources 

Researchers may find the following resources useful.