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 firstname.lastname@example.org. 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; however, all in-person office hours are currently paused. 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 email@example.com to schedule a time to speak with one of our IRB staff members.
Conducting Research during the COVID-19 Pandemic
A: As of July 1, on-campus, in-person research with human participants is allowed to begin restarting. Projects must be approved by college/unit leadership via the research reactivation process outlined in this guide from the Cornell Research and Operations Reactivation Committee. A committee on Human Subjects Research Reactivation has also published guidelines, which should be used by college/unit leadership in reviewing research reactivation plans that involve in-person, on-campus human subjects research. Any changes to IRB protocols must also be reviewed by the IRB. Contact the IRB office if you have questions.
On July 28, the IRB published additional guidance for investigators on conducting in-person research during the COVID-19 pandemic. The guidance includes sample documents for researchers to use with study participants, 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 still consider whether it is feasible to modify to use remote interaction such as telephone or Zoom. Amendments to currently approved protocols will be required: please email firstname.lastname@example.org with a description of the modification and any resulting changes to your consent process and data security plans.
A: Cornell recommends that any off-campus, in-person interactions with study participants be done sparingly, and with appropriate physical distancing procedures in place. While aimed at on-campus research, these guidelines developed by the Committee on Human Subjects Research Reactivation can be used as guidance for developing protocols for off-campus, in-person human subjects research interactions, as well. The same is true for the IRB guidance on in-person research during the COVID-19 pandemic.
Please also consider whether it is feasible to modify your protocol 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.
If your current IRB-approved study involves in-person activities, consider whether it is feasible to modify to use remote interaction. Amendments to currently approved protocols will be required: please send an email to email@example.com with a description of the modification and any resulting changes to your consent process and data security plans.
A: If you would like to modify your study procedures to replace in-person study visits with virtual/remote or phone options, these changes must be approved in advance by the IRB as an amendment to the approved study.
For the following types of modifications, the Cornell IRB is streamlining the amendment process: please send an email to firstname.lastname@example.org with a description of the modification and any resulting changes to your consent process and data security plans.
- Physical/Social Distancing (move from in-person to remote data collection)
- Recruitment process change (move from in-person to remote)
- Consent process change (move from in-person to remote, written to oral, etc.)
- 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)
- Other: send us an email describing the change, and we'll let you know if we need more information.
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 come in close contact with someone with COVID-19, then no amendment is 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.