IRB COVID-19 FAQs

Last updated: November 10, 2021

UPDATED November 10, 2021:

At this time, invited guests and visitors to the Cornell Ithaca campus--including research participants*--who are 12 years old or older must show proof of vaccination for COVID-19 or the results of a recent negative COVID-19 test. Principal Investigators are responsible for enforcing this requirement if it applies to their participant population. See the Cornell COVID-19 Visitors Webpage for more details. The Cornell Tech campus has its own visitor policy requiring proof of vaccination, which you can review on the Cornell Tech COVID-19 Visitors Webpage.

No IRB protocol amendment submission is needed to implement these participant eligibility and screening requirements, unless you are revising recruitment or informed consent materials. Please contact irbhp@cornell.edu with any questions or concerns. The IRB COVID-19 FAQs and guidance materials have been updated to reflect this university policy change.

*If you believe your participant enrollment or retention will be severely negatively impacted by this visitor requirement, please contact IRB Manager Myles Gideon at mbg223@cornell.edu.

All individuals on Cornell's campus--regardless of vaccination status--are required to wear a mask outside (when physical distancing cannot be maintained) and inside campus buildings (except in private, non-shared spaces, or when eating/drinking). As COVID-19 pandemic-related requirements on the Cornell Ithaca campuses are reevaluated and updated, the IRB and ORIA will continue to revise our human participant research-specific FAQs and guidance documents to reflect current guidelines. Thank you for your patience and cooperation, and please contact the IRB if you have any questions.

The IRB office published a newsletter on October 28, 2021. Click to read more.

On this page you will find answers to commonly asked questions pertaining to Cornell IRB office functions and human participant research during the COVID-19 pandemic.

IRB Office Hours and Information during the COVID-19 Pandemic

A:  Yes.  The IRB Committee and staff are functioning remotely during regular business hours.  

A: The easiest way to contact the IRB is by emailing irbhp@cornell.edu. You can also find contact information for specific IRB staff on our website. IRB staff are responding to both email and phone messages during regular business hours, with email being the fastest way to get in touch. Staff are also happy to arrange phone calls or Zoom meetings, as needed.

A: Yes. IRB staff are available bi-weekly on the 2nd and 4th Tuesday of each month from 1-4pm remotely (e.g., phone, Zoom, email).  We encourage you to email irbhp@cornell.edu to schedule a time to speak with one of our IRB staff members.

Conducting Research during the COVID-19 Pandemic

A: Yes, the IRB is still reviewing and approving IRB submissions. Please note, these approvals do NOT supersede guidance posted on the Research Continuity Webpage.

A: Yes. As of June 1, 2021, IRB-approved (or exempted) human participant research can be conducted on campus without additional "reactivation approval" by college/unit leadership. Investigators and study participants must still follow Research Continuity Guidance, as well as current public health requirements for Cornell employees (for researchers) or visitors (for study participants). 

Cornell IRB guidance for investigators on conducting in-person research during the COVID-19 pandemic is regularly updated to reflect changes in campus public health requirements.  Investigators should refer to this IRB-specific guidance as you develop or amend protocol procedures, and utilize sample documents such as a COVID-19 information sheet, a self-screening attestation, and a contact tracing form.

If your existing or new study involves on-campus, in-person activities, please consider whether it is feasible to modify to use remote interaction such as telephone or Zoom.

Please Note: Any changes to IRB protocols must be reviewed by the IRB. For non-exempt research, please submit a completed amendment form with a description of the modification and any resulting changes to your consent process, data security plans, and supporting documents. For research with an exemption determination, please send an email to irbhp@cornell.edu with the same information (no amendment form required). Contact the IRB office if you have questions.

A: IRB approved research may be conducted off campus in Ithaca and other domestic locations without any special approvals; however, investigators should refer to Faculty and Staff Travel guidelines, as additional steps are required for international travel for university business. Investigators should also refer to Research Continuity Guidance, as well as current public health requirements for Cornell employees.

Research conducted in off-campus locations must also comply with all applicable laws and regulations (see Tompkins County DOH, NYS DOHCDCWHO, and any other relevant health agencies for updates).

If your existing or new study involves off campus, in-person research activities, please consider whether it is feasible to modify your protocol or continue to use remote interaction such as telephone or Zoom.

A: Yes, you can continue to engage in any research-related activities (e.g., recruitment, consent, data collection) that do not require in-person interaction. If you already have IRB approval to conduct these types of activities, then there is no need for any further action.

A. Yes, undergraduate students are allowed to conduct research without any additional restrictions. Please refer to Research Continuity Guidance for more details.

A: If you would like to modify your study procedures to replace in-person study activities with virtual/remote or phone options--or replace virtual/remote with in-person options--these changes must be approved in advance by the IRB as an amendment to the approved study. 

For non-exempt protocols, please submit a completed amendment form with a description of the modification and any resulting changes to your consent process, data security plans, and supporting documents. For research with an exemption determination, please send an email to irbhp@cornell.edu with the same information (no amendment form required). Contact the IRB office if you have questions.

Examples of modifications requiring this type of amendment include:

  • Physical/Social Distancing (move from in-person to remote data collection or vice versa)
  • Recruitment process change (move from in-person to remote or vice versa)
  • Consent process change (move from in-person to remote, written to oral, or vice versa)
  • Enrollment (changes in the number of participants being recruited/enrolled)
  • Study site/location changes
  • Study population change (e.g., change in age range, location of participants)
  • Personnel (add or remove study team members)

A: Yes, the PI may decide to voluntarily pause, delay, or reschedule interactions with participants because of COVID-19; in such cases, there is no need to inform the IRB, regardless of the review level.  However, you must:

  • ensure the voluntary pause does not increase any risk to the study participants if your study is a greater-than-minimal risk study that involves some type of patient care.
  • contact study participants who will be affected by this pause (e.g., a study visit will be cancelled, etc.).

Investigators should notify the study sponsor and any other necessary individuals or agencies, as required.

Investigators should document the voluntary pause in their research records.

A: No, if the intention is only to screen out potential participants who may have COVID-19, or to ensure they meet Cornell campus visitor requirements (e.g., fully vaccinated, recent negative COVID-19 test), then no amendment is needed to add screening procedures to your protocol. If, however, you need to revise recruitment or informed consent materials, then an amendment will be needed.

Please consider using this sample self-screening attestation provided by the Cornell IRB.

A: Yes. Even if the research is paused for the time being, the PI must still submit the request for Continuing Review to ensure that the study's IRB approval remains active. This will allow the research to begin immediately when appropriate and/or permitted.