IRB COVID-19 FAQs

Last updated: September 2, 2022

UPDATED September 7, 2022

COVID-19: Cornell IRB COVID-19 guidance and FAQs have been updated (Sept. 7, 2022). Face masks are still required for in-person, on-campus human participant research activities similar to clinical exams or procedures. Review the revised guidance in its entirety here.

TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols will be required to complete CITI training in human participant research ethics. See details here. For more information about Cornell IRB training requirements, visit the IRB Training webpage.

IRB PROTOCOLS: As of February 1, 2022, we are using the RASS-IRB system for new protocol submissions, continuing reviews, amendments, and adverse event and protocol deviation reporting. See more details about the transition to RASS-IRB here. Find how-to documentation and recordings of Zoom training sessions on the RASS Guide Site. For help or feedback about the system, contact the RASS team at: rass@research.cornell.edu. For content-related questions about your IRB protocol or other human participant research topics, email irbhp@cornell.edu per usual. You can also schedule a Zoom meeting with members of the RASS or IRB teams via Microsoft Bookings.

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 have a hybrid work arrangement and are available 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, which can be done via Microsoft Bookings.

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 utilize Microsoft Bookings or 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. IRB-approved (or exempted) human participant research can be conducted on campus without special 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, students, or visitors. Please check the Cornell COVID-19 Dashboard to see the current campus Alert Level.

Mask policy update, September 2, 2022: Masking and other public health requirements on campus change periodically and are communicated on the Cornell COVID-19 Response website. Campus face mask requirements, specifically, are described on their own webpage here.

Human participant research activities similar to clinical exams or procedures should follow masking requirements used in Cornell healthcare facilities. As of August 2022, face masks are required in campus healthcare settings. Examples of such research activities include venipuncture, MRI, ECG/EKG, and use of any other devices that research staff have to place on a participant’s body.

For all other indoor human participant research activities, the IRB strongly encourages use of face masks for participants and research staff, particularly in higher density situations or when participants are at higher risk of severe illness from COVID-19 (as indicated by the CDC).

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 or a self-screening attestation.

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 an amendment request in RASS-IRB 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: 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 please submit an amendment request in RASS-IRB 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.