Since entering Phase 3 of the gradual re-opening of research activities, the IRB is now considering requests from investigators wishing to conduct in-person research procedures.

All researchers requesting permission to resume in-person research procedures must complete and submit the Reactivation Survey.  Investigators should complete one survey for each research study that they wish to resume in-person procedures. Investigators will receive an email response for each study that they complete the survey for, indicating whether they may resume in-person research activities or whether additional information is necessary to determine if in-person procedures may resume. The email indicating that in-person research procedures may resume will include an information sheet with steps that must be followed in order to proceed.

Please view the Research Reconstitution Plan for guidance on the phased reopening of NYU's research activities, including  Section 4.8  pertaining to human subjects research.

NYU Research Reconstitution Plan

Please view the NYU Research Reconstitution Plan for guidance on the phased reopening of NYU's research activities, including Section 4.8 pertaining to human subjects research.  

Suspension of in-person research

March 18, 2020

To: NYU Researchers Conducting Research Involving Human Subjects

From: NYU Washington Square Institutional Review Board

Effective immediately, all in-person research interactions with human subjects must be suspended if that research is approved under the auspices of the NYU Washington Square IRB. This suspension applies to both domestic and international research.

This policy is being enacted because of the 2020 coronavirus pandemic, which has led both the New York State Department of Health and the New York City Department of Health and Mental Hygiene to strongly recommend that all persons, whether healthy or sick, should stay at home (nyc.gov/coronavirus). The NYU IRB deems person-to-person contact between researchers and their participants to be an unnecessary risk to human subjects.

This suspension does not apply to research activities that are carried out online, over the phone, or through other means that do not require in-person interaction with participants.

NYU investigators whose research employs in-person interaction and who are able to redesign their study designs to include remote interactions are encouraged to do so. If such study designs have not yet been approved by the IRB, investigators should submit an amendment to their IRB approval as soon as possible. Such amendments will be reviewed as quickly as possible. See the NYU IRB guidance on reporting changes due to COVID-19.

If needed, investigators whose research is funded by the National Institutes of Health, the National Science Foundation, or other funding agencies will be provided with assistance in reporting this research disruption to their agencies.

The ban on in-person research activities will be lifted as soon as the NYU IRB, based on guidance from government health agencies, determines it safe for in-person interactions to occur.

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Researchers who believe that risks to the participants would be increased by the disruption of study protocols should contact the University Committee on Activities Involving Human Subjects (UCAIHS), New York University, (212) 998-4808 or ask.humansubjects@nyu.edu.

NYU IRB Guidelines For Reporting Changes Due To COVID-19

The NYU IRB is monitoring the COVID-19 epidemic and is aware that it may impact some Investigators’ ability to carry out study procedures as described in their IRB-approved protocols. We recognize that this might result in protocol deviations and/or protocol amendments.

Our federal-wide assurance with the DHHS requires the institution, researchers, and the Institutional Review Board to follow written procedures to ensure:

  • The prompt reporting of proposed changes in research and
  • Investigators are conducting research activities under the terms and conditions of the IRB-approved study protocol - except when necessary to eliminate apparent immediate harm to the subject.

In the context of the COVID-19 epidemic, such changes to the protocol that do not require prior IRB approval will most likely be for studies in which subjects may receive direct benefits or requires multiple interactions with subjects scheduled to receive the interactions. For instance, a clinical trial evaluating the effects of a mental health intervention may need to alter the method or the timing of the delivery of the intervention, or cease the delivery of the intervention altogether, if a clinic closes or it is in the best interest of the subject(s) to not travel to a clinic.

If you need to make a change to eliminate apparent immediate hazards to subjects, it is permissible to make the change before NYU IRB review and approval. Such safety-related changes may include procedures to minimize potential exposure to COVID-19 through adopting recognized health and safety measures or altering the delivery of study interventions that may directly benefit subjects.

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A modification submitted via Cayuse IRB citing all changes is required within five business days of enacting the change. This modification should note the timing of, the reason for, and the status of the changes. It must contain sufficient detail for the IRB to assess the risk associated with the changes.

To not require prior IRB approval, changes must be necessary to eliminate apparent immediate hazards to the subjects. For instance, moving data collection from in-person to online for a study with one point of data collection would not eliminate immediate risks. Changes to these studies would require prior IRB approval via a Modification submission in Cayuse IRB.

The NYU IRB encourages investigators to prepare for any disruptions or changes to their research by anticipating possible amendments and submitting them to the NYU IRB, even if they ultimately will not be implemented.

We encourage faculty and staff to make plans for possible disruption and to prepare communications to research collaborators and participants. Please contact the NYU IRB office if you are unsure if a change requires IRB approval or have any questions about this guidance at ask.humansubjects@nyu.edu.

FAQs Regarding the NYU IRB During the COVID-19 Pandemic

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On Submitting human research studies to the IRB

For the latest information, please visit the Research and Laboratories page.