NYU IRB Coronavirus Information for Human Subjects Research Investigators
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.
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.
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 firstname.lastname@example.org.
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.
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 email@example.com.
FAQs Regarding the NYU IRB During the COVID-19 Pandemic
On Office Functions
Is the IRB Office closed, or is it open during the COVID-19 pandemic?
For the safety of the NYU community, University personnel are working remotely as much as possible. The IRB Committee and the IRB Office are functioning remotely.
How can I contact the IRB Office?
You can contact the IRB via phone by calling 212-998-4808 and leaving a message. You can also send emails to firstname.lastname@example.org. IRB Office staff are responding to both phone mail and email during regular business hours.
What hours will the IRB staff be available to talk via phone and answer emails?
Staff will be available remotely during regular business hours, from 9 am until 5 pm Monday through Friday.
Will the IRB Office still have seminars and drop-in consultations?
Yes! The IRB Office is offering consultations and seminars remotely via Zoom.
Drop-in consultations: To ensure the privacy of the participants in our drop-in sessions, we will now need to send out the Zoom link via email. To get on the list for these drop-in Consultations, please email dropinIRB@nyu.edu. Please provide your name and NYU Net ID. Please use your NYU email account for all correspondence.
Seminars for spring 2020: Seminars are by request. Please request a seminar for your class or group by completing the IRB Training Request Form. Currently, available seminars are “IRB (Human Subjects) Overview,” “Cayuse IRB System Overview,” and “Human Research during the COVID-19 Pandemic.”
On Submitting human research studies to the IRB
Is the IRB still reviewing submissions?
Yes, the IRB is still reviewing submissions. Studies involving in-person interactions will be approved with the condition that no in-person interactions may occur until the suspension is lifted. Investigators are encouraged to design protocols that include either only remote interactions or include the option to conduct both remote and in-person interactions. In-person activities included in approved protocols may be conducted once the suspension is lifted without requiring a modification.
Will review turn-around times be affected by office closure?
All IRB Office staff and IRB reviewers are prepared to work remotely. As the Cayuse IRB system is internet based there should be little change to the current review and submission process.
Is the IRB prioritizing certain types of submissions?
Yes. We are prioritizing:
- modifications which add procedures to conduct remote interactions,
- time-sensitive submissions related to the COVID-19 pandemic,
- modifications requesting exceptions to the suspension of in-person interactions,
- time-sensitive research on remote teaching and learning.
My study requires in-person contact with study subjects. Can it be approved for immediate use?
Since the advent of the COVID-19 pandemic, the IRB has been reviewing and approving studies that propose in-person research with a delayed start. 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 form, 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 to follow.