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

Last Updated: September 7, 2022

UPDATED October 10, 2022

TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols are now required to complete CITI training in human participant research ethics. This is the same training required of study personnel named on Expedited and Full Board IRB protocols. See details here. For more information about Cornell IRB training requirements, visit the IRB Training webpage.

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.

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.

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.
  • The guidelines for study participants are generally the same as for other visitors to campus. The Cornell Tech campus has its own visitor policy, which you can review on this webpage.
  • Face mask requirements: 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).
  • Any proposed human participant research on campus that will not meet current 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 the IRB recommends participants self-screen for COVID-19 symptoms or exposure prior to arrival on campus. 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: 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.
  • Keeping a daily log of study participants is not required, given that Cornell University and the local public health department are no longer conducting contact tracing. If your research group decides to continue keeping a log of participants for your own contact tracing purposes, 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.
  • Keep abreast of Tompkins County Health Department and 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 Response 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. Examples of mitigation strategies could include requiring a negative COVID-19 antigen test and/or vaccinations 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 (via RASS-IRB). 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.