TO: Human Subjects Researchers

FROM: Institutional Review Board

DATE: July 31, 2020

Important Updates

Human Subjects Research During COVID-19 Pandemic

Effective March 18, 2020, the NYU IRB suspended all in-person research activities under its jurisdiction. All human subjects research activities that do not include in-person interactions with subjects (e.g., data analysis, remote data collection) may be conducted as approved by the IRB.

Investigators are encouraged to design studies that include remote data collection. 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. The IRB is prioritizing review of such amendments.

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. Complete one survey for each research study that you wish to resume in-person procedures. You will receive an email response for each study that you complete the survey for, indicating whether you may resume in-person research activities or whether additional information is necessary to determine if in-person procedures may resume. The email indicating that you may resume in-person research procedures 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.

IRB Coordination with the Institutional Biosafety Committee (IBC)

The IRB is coordinating with the Institutional Biosafety Committee (IBC) to ensure studies that include human source materials are conducted in full compliance with local, state, and federal regulations and guidelines. When conducting its review, the IRB will require documentation of approval from the IBC for studies involving human source materials (tissues, body fluids, blood, blood byproducts, cell lines, saliva, stool, etc.). This documentation may be asked for when investigators submit Initial, Modification, or Renewal submissions in Cayuse IRB.

For additional information, see the NYU IBC website.

Single IRB Review for Federally Funded Cooperative Research

The revised Common Rule requires that most domestic institutions engaged in federally funded, non-exempt, cooperative human subjects research use a single Institutional Review Board (IRB). If NYU is the lead site, then it will serve as the single IRB in most cases. If NYU is a participating site, then it will rely on the single IRB designated by the lead site.

See the NYU IRB website for additional information, including the process for coordinating single IRB review.

2020 IRB Board Meeting Dates (Deadline Dates)

2nd Tuesday - 11:00 a.m. to 1:00 p.m.

  • August 11 (July 21)
  • September 8 (August 18)
  • October 13 (September 22)
  • November 10 (October 20)
  • December 8 (November 17)

Drop-in Consultation Sessions

Please visit the IRB website for the schedule of drop-in consultation sessions.

Due to the COVID-19 pandemic, IRB drop-in consultation sessions will be conducted via Zoom. To ensure the privacy of the participants in our drop-in sessions, we need to share the Zoom link via e-mail. To get on the list for these drop-in consultations, please use your NYU email account to email ask.humansubjects@nyu.edu with your name, NYU Net ID, date of the drop-in session, and preferred 15-minute time slot between 2:30 and 4:30pm.

Drop-in consultation sessions are meant for general questions that do not require immediate answers. Consultations are only advisory in nature and do not take the place of a formal IRB review. If applicable, you will still need to submit your final application to the NYU IRB for review.

Specific questions that require urgent responses should be asked via phone or email.