Research & Economic Development

Office of the Vice Chancellor

COVID-19 and Human Subjects Research

Updated: March 21, 2020

The UMKC IRB is providing guidance to researchers working with human subjects to provide for contingency planning with respect to study operations and interacting with participants. In addition, our office will work with researchers for study specific questions and any needed amendments or adjustments.

Human Subjects Research Announcement - COVID 19

UMKC IRB Office:
Our offices, like other UMKC offices, are working under normal operations. If there are any adjustments to normal operations per UMKC announcements, our office will continue to be available for researchers through phone, email and our eCompliance system. The main office phone line is 816 235-5927 and our email is Our website also provides contact links to email individuals and obtain policies and other helpful resources.

Contacting the IRB

We anticipate an increase in email/call volume.  Please follow the instructions below to help us address all questions efficiently and not overload individual inboxes.

For UMKC IRB questions:


  • How will the IRB be prioritizing reviews?

  • Should I submit a modification to the IRB before screening my participants for COVID-19?

  • Do I have to submit an amendment to the IRB in order to revise my study to address issues that arise from COVID-19?

  • What if I must implement a change to the research due to an apparent immediate hazard to participants?

  • If my study is currently approved for in person visits, how do I modify my study to allow for remote visits?

  • Do I need to submit an amendment in order to start obtaining consent via telephone/telemedicine?

  • Do I have to get signed consent? Can I switch to a verbal consent process?

  • I’ve decided to temporarily halt research activities all together. Do I need to report this to the IRB?

  • Can I still interact with my research subjects?

  • I have a large focus group scheduled, should I cancel or reschedule it?

  • My research offers extra credit to students or uses a student subject pool to recruit students, can I continue those activities if classes are online?

Interacting with Research Participants:

The primary concern for researchers should always be participant safety and developing contingency plans is encouraged.

Clinical TrialsThere are clinical studies that include safety monitoring in the form of laboratory tests, examinations, or surveys/interviews. Clinical investigators need to work closely with their research team and study sponsor (if applicable) to determine if modifications to safety monitoring are appropriate. Any modifications should be submitted as an amendment to the UMKC IRB and we will work to efficiently review and process approvals. If there are immediate modifications required to eliminate possible hazards to subjects and there is not appropriate time to receive IRB approval, the UMKC IRB should be notified within five days using the event report in eCompliance. If the UMKC IRB is not the IRB of record and you are relying on another IRB, you will need to contact the reviewing IRB.

All Studies Involving Research Participants: Screening for novel coronavirus may be a precaution taken by research units as part of public health surveillance. This type of screening does not need to be reported to or approved by the UMKC IRB and should follow protocols and procedures recommended by the facility where your research is being conducted. In addition, risks related to research participants do not need to be amended to address COVID-19 as these are not related to study procedures but general population health.

Study modifications to allow for remote interaction with subjects are allowable, but require IRB approval through the amendment process in advance to ensure participant safety is not compromised. If there are immediate modifications required to eliminate possible hazards to subjects and there is not appropriate time to receive IRB approval, the UMKC IRB should be notified within five days using the event report in eCompliance.

You do not need to modify your protocol to allow for remote interaction or adjust your study schedule if your study has been determined Exempt or if the UMKC IRB approved protocol does not stipulate how the visit/interaction would occur. In addition, some minimal risk studies may qualify for a waiver of documentation (signed) consent. If you wish to modify your minimal risk study to include this waiver of documentation, please submit an amendment through eCompliance (primarily for Expedited studies). An amendment is not required for Exempt studies.

Suspending Study Enrollment:
If investigators decide to voluntarily suspend participant enrollment or participation for a significant amount of time (more than a month), this should be reported to the UMKC IRB with an amendment to temporarily close a study. Information will need to be provided to ensure participant safety is not adversely impacted by any participation suspension. If the UMKC IRB is not the IRB of record and you are relying on another IRB, you will need to contact the reviewing IRB.

Emergency Use of Test Article:
Processes related to Emergency Use or Compassionate Use of a test article (drug, device or biologic) remain the same with respect to UMKC IRB approval. Our guidance provides information on what is required and how to submit information to the UMKC IRB through eCompliance.

Maintaining Data Security and Confidentiality:
If investigators have the need to work remotely with research data as a result of UMKC approved COVID-19 adjustments, steps should be taken to ensure all research related data will remain secure. Investigators should work directly with their IT professionals to ensure they are working on UMKC encrypted devices and if working remotely with files, are using approved solutions such as VPN client and remote desktop using VPN client and if communicating via email are only using their university email account and minimally necessary information.

Data Results:
If your study is a sponsored study, please communicate with the sponsor to determine if there are any expected changes to data reporting as a result of participants being under self-quarantine or if they contract the novel coronavirus, or to record any study modifications discussed above. If your study is not sponsored, please work with your research team (and reach out to the UMKC IRB if necessary) to determine how your data may potentially be impacted and what additional information and data points you need to capture.

Additional considerations for human subjects research:

  • Is the location of the study remaining open and available for participants to be present? Has the location implemented any procedures to slow the spread of the coronavirus that will affect participation in your study or the ability of your study to proceed?
  • Does your protocol require in-person participation or treatment? Can it be modified for remote participation?
  • Does your protocol require in-person monitoring? Can it be modified for remote monitoring?
  • Should your participants be screened for coronavirus as part of your inclusion/exclusion criteria?
  • Would your data or results be affected if your participants had to self-quarantine or if they contracted coronavirus?
  • Additional considerations for environmental health and safety:
  • Do you have a limited number of critical lab staff with unique knowledge? Are there others in your lab who can be cross-trained?
  • Does your lab operate machines that use active cooling through liquid gasses, dry boxes, or inert boxes using gas blankets? What would happen if materials like liquid gasses, CO2, nitrogen, or dry ice become unavailable?
  • How frequently are you saving or freezing samples of your cell cultures?
  • Do you have long-term experiments that might benefit from more frequent preservation?
  • Do you have the requisite local knowledge to do controlled shutdowns of complex machines or devices such as NMRs without on-site help from the company?
  • Have you shared with EHS the locations and amounts of materials that are air, water, or otherwise unstable for observation in case of lab closure?