IRB Policy: Guidance on In-Person Research During the COVID-19 Pandemic

Last Updated: March 22, 2022

UPDATED April 29, 2022

Cornell's IRB is 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, questions, or feedback about the RASS-IRB 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.

Face masks are still required for in-person, on-campus human participant research. Please regularly check the Cornell IRB COVID-19 FAQs and guidance materials for research on campus during the pandemic, as well as the Cornell COVID Dashboard and the Research Continuity Guidance webpage for information about how the pandemic is impacting Cornell research. Contact irbhp@cornell.edu with any questions or concerns.

The Cornell Office of Research Integrity and Assurance (ORIA) has developed guidance relevant to researchers planning for on-campus[1] human participant research operations. This guidance is updated periodically as New York State and Cornell University public health restrictions change.

Note: While this document is focused on in-person human participant research taking place on the Cornell Ithaca campuses (Ithaca, Geneva and Cornell Tech[2]), many of the requirements and considerations listed below are also relevant to researchers interacting with study participants off-campus in Ithaca or elsewhere in the field. For off-campus research, other restrictions may also apply, depending on local, state, national or international policies.
 
 

Requirements for On-Campus Human Participant Research

  • Refer to the Coronavirus Research Continuity Guidance webpage for the most up-to-date guidelines for Cornell researchers.
  • As of June 1, 2021, research reactivation plans approved by your college or equivalent academic unit are no longer required, nor is IRB approval of those reactivation plans.
  • The guidelines for study participants are generally the same as for other visitors to campus. As of mid-fall 2021, there are vaccination and COVID-19 testing requirements for all invited guests and visitors to the Cornell Ithaca campus who are 12 years of age or older. See the Cornell COVID-19 Visitors Information page for details on implementing this requirement. The Cornell Tech campus has its own visitor policy, which you can review on this webpage. If you believe your participant enrollment or retention will be severely negatively impacted by this visitor requirement, please contact your IRB Administrator for assistance.
  • Face mask requirements: Masking and other public health requirements on campus generally depend on which COVID-19 Alert Level the Cornell Ithaca Campus is operating under at any given point in time. Campus face mask requirements, specifically, are described on their own webpage here. Requirements for on-campus, indoor human participant research will match those of Cornell healthcare facilities. As of March 14, 2022, masking is still required for all on-campus, indoor research interactions between researchers and participants.
  • Any human participant research on campus that involves procedures that do not meet the current IRB masking requirements will need to be reviewed by Cornell Environment, Health and Safety. IRB staff can help facilitate that contact as part of your IRB protocol review. Please call or email the IRB office if you have any questions about how the mask requirements may impact your research.
  • If your research requires study participants to be within six feet of a researcher or other participant, then they should be screened for COVID-19 symptoms or exposure prior to arrival on campus. The IRB still recommends a self-screening procedure. Researchers should not collect or record the answers to participants’ screening questions. Instead, participants can sign and submit an attestation, confirming they have self screened. (See Appendix B of this document for a sample attestation.)
    • Note: COVID-19 screening procedures do not require IRB approval as long as they are done for safety purposes and not for research data collection. No amendment is needed to add a COVID-19 screening procedure to an IRB-approved study.
  • You may require that study participants be vaccinated in order to participate in your research; however, you should not record proof of vaccination (e.g., photographing a vaccination card, writing down exact vaccination details, etc.). Instead, simply make a note that the participant was “cleared” to participate in the study.
    • Note 1: As of fall 2021, study participants 12 and older who are visitors to the Cornell Ithaca campus are required to show proof of vaccination or a recent negative COVID-19 test. Visit the Cornell COVID-19 Visitors Information page to see current requirements. The Cornell Tech campus has its own visitor policy, which you can review on this webpage. If you believe your participant enrollment or retention will be severely negatively impacted by this visitor requirement, please contact your IRB Administrator for assistance.
    • Note 2: If students in a specific class or academic program are the focus of your research, you cannot require that they be vaccinated. The university is implementing its own vaccination requirements—and exemptions—for students.
  • Keep a daily log of study participants who come to campus and any research team members with whom they come in contact, in case needed for contact tracing purposes by local public health officials. To protect confidentiality, logs should not be stored with study data nor linked to a specific study, and they should be destroyed after 30 days. See Appendix C of this document for a sample contact tracing log.
  • Keep abreast of New York State COVID-19 guidelines that might impact movements or actions of researchers or study participants.
  • Keep abreast of current guidelines for research and other activities on campus via the Cornell COVID-19 and Reactivation Planning website, as well as the Cornell Environment, Health and Safety COVID-19 website.

Additional IRB Considerations

  • Decisions about bringing volunteers to campus for in-person study visits should be more conservative for people at higher risk for severe illness from COVID-19 per public health guidance. Researchers should take this into consideration as they develop plans for in-person human participant research protocols. For research involving participant populations at higher risk for severe illness, study consent forms may need to include information about this added risk.
  • If your study procedures involve use of any shared objects or devices (e.g., pen, computer keyboard, blood pressure cuff), please follow the IRB/EHS Guidance on Cleaning Devices/Objects that Contact Intact Skin.
  • If your study involves a significant risk of viral transmission, (e.g., respiratory function testing, prolonged close contact between study participants and researchers without effective PPE, etc.), then you must include details in your protocol application about mitigation of risk of SARS-CoV-2 infection, and also include information in the study consent form about this risk and how it will be mitigated. One example of a mitigation strategy could be that participants are required to be vaccinated in order to take part in the study.
  • Any modifications to IRB protocols (beyond simply adding COVID-19-related screening procedures) will require an amendment request to be submitted to the IRB (irbhp@cornell.edu). If you previously amended your protocol to change all in-person activities to remote/virtual platforms and you would now like to shift back to in-person activities, an amendment request will be needed.
  • The Cornell IRB recommends that researchers consider whether any in-person activities can be modified to use remote interaction (e.g., online surveys, interviews using Zoom), thereby reducing risk of exposure to both researchers and participants. Such a change to study procedures would also require an amendment request.
  • Regularly visit the Cornell IRB COVID-19 FAQs webpage to stay abreast of new and revised guidance.

Appendices

[1] This guidance applies to researchers on the Ithaca, Geneva, and Cornell Tech campuses.

[2] For researchers based at the Cornell Tech campus, please refer to Cornell Tech’s Novel Coronavirus (COVID-19) Updates website for information about campus restrictions.