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COVID-19 and Human Subjects Research

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The UMKC Institutional Review Board (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 (PDF)

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 umkcirb@umkc.edu. 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 and call volume. Please follow the instructions below to help us address all questions efficiently and not overload individual inboxes.

For UMKC IRB questions:

COVID-19 and IRB FAQs

Priority 1:  Any research related to COVID-19 and SARS-CoV-2

Priority 2:  Amendments to research directly related to COVID-19 response in order to enhance participant safety

Priority 3:  Reports of New Information (RNI) directly related to COVID-19 

Priority 4:  Continuing Reviews (CR) of studies based on upcoming expiration dates

Priority 5:  All other submissions

To assist us in identifying priority submissions:

  • New studies = Include COVID-19 in the “Title” in your eCompliance application
  • Amendments = Include COVID-19 in your eCompliance application
  • Reports of New Information (RNI) = Include COVID-19 in your eCompliance application

No. This is not a research activity and does not need IRB review.

Yes. Prior IRB approval must be obtained before initiating any change to previously approved research, except when necessary to eliminate apparent immediate hazards to participants. If prior approval is not obtained due to immediate hazards, you must notify the IRB within five days using the event report in eCompliance.

Implement the change. Within five days, submit an event report in eCompliance detailing the change implemented and the PI’s rationale for implementing the change prior to IRB approval. If necessary, submit an amendment to update your study documents accordingly.

Investigators are encouraged to modify their studies to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening and consenting. These changes still require IRB review and approval prior to implementation, unless they are necessary to eliminate immediate hazards to participants (see previous FAQ).

To modify your study to allow for remote visits, submit an amendment in eCompliance.

  • Be sure to include “COVID19” in the amendment so staff can triage and prioritize review accordingly.
  • In your amendment, clearly explain which visits/procedures you are proposing to replace and with what methods.

Maybe. Any study previously approved for the consent process to occur in person with signed documentation of consent must have an amendment submitted in order to get an approved waiver of documentation. Such a waiver would allow you to consent remotely.

If you have an IRB approval that includes a waiver of documentation (signed consent) and previously collected consent in person (just without obtaining participant signatures) you would be able to consent over the phone in lieu of in person.

Investigators are encouraged to modify their studies to replace written informed permission/assent/consent with verbal permission/assent/consent if their study meets one of the regulatory criteria for a waiver of documentation [45 CFR 46.117(c)(1)] below.

  • The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality; OR
  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; OR
  • The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

To modify your study to allow for verbal permission/assent/consent, submit an amendment in eCompliance.

  • Be sure to include “COVID19” in the amendment so staff can triage and prioritize review accordingly.
  • In your amendment, clearly explain your proposed new method for obtaining permission/assent/consent verbally.
  • Don’t forget to make the corresponding changes to your informed permission/assent/consent form(s) (e.g., removing signature lines).

If temporarily halting research activities will have NO effect on the safety or welfare of participants you do not need to report this to the IRB. 

If temporarily halting research activities could result in increased risk of harm or affect the welfare of subjects, you must submit an event report for IRB review and approval prior to halting research activities.

  • Be sure to include “COVID19” in the event report so staff may triage and prioritize review accordingly.
  • Be sure to address how this stoppage in research activities could affect research participants (in the short and long term).

Ultimately this is a decision that should be made by the Principal Investigator. At this time UMKC has not restricted research related interactions with subjects. The UMKC IRB does not have specific recommendations or requirements about postponing or canceling study visits, but we believe it would be prudent for investigators to follow University, Truman Medical Centers and CDC recommendations.  Researchers should, however, prioritize the health and safety of project personnel, collaborators and human subjects when deciding how to move forward with research activities.
Research involving vulnerable populations, individuals over age 70 or individuals with underlying health conditions should take special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html). In general, Principal Investigators\Research Teams should begin to prepare how to temporarily postpone, limit or adapt research-related activities in a manner that protects safety of researchers, participants, facilities and equipment, should research activities which need to be restricted in the near future (https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-ihe-response.html).

Principal Investigators\Research Teams should begin to plan now on ways to avoid or minimize bringing groups of people together for data collection activities (e.g., focus groups, whole group interventions) to telephone or online (e.g., Zoom) formats; follow recommended guidelines for reducing exposure and, if prudent, pause study activities; determine whether it is necessary to completely suspend research activities and, if so, pause recruitment until the situation changes. Changes in research activities require review and approval by the IRB of record for the project prior to implementation. If you do choose to submit a modification, please add “COVID” in the application title. The UMKC IRB will prioritize these modifications.

Ultimately this is a decision that should be made by the Principal Investigator. At this time, UMKC has not restricted research-related interactions with subjects. The UMKC IRB does not have specific recommendations or requirements about postponing or canceling study visits, but we believe it would be prudent for investigators to follow University, Truman Medical Centers and CDC recommendations.  Researchers should prioritize the health and safety of project personnel, collaborators, students and human subjects when deciding how to move forward with research activities. Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html). In general, Principal Investigators\Research Teams should begin to prepare how to temporarily postpone, limit or adapt research-related activities in a manner that protects safety of researchers, participants, facilities and equipment, should research activities need to be restricted in the near future (https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-ihe-response.html).

Interacting with Research Participants

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

Clinical Trials: 

There 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 (PDF) 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?