Archived Human Subject Research COVID-19 Alerts

March 12, 2020

Considerations on how research may be conducted

Human Subjects Research Considerations for Activities Involving Direct Physical Contact with Study Participants

At this time, research protocols that involve being in the physical presence of research participants (e.g., medical procedures, study drug administration, in-person interviews, in-person focus groups, in-person cognitive/behavioral therapeutic services) may continue their research activities.

Please consider whether any research activities can be conducted remotely by telephone or electronically. If such remote procedures are already approved by the IRB, investigators are encouraged to implement them. Until further notice, if remote procedures are not currently approved by the IRB and an investigator would like to utilize them, a Modification Request should be submitted to the IRB prior to such implementation.

Human Subjects Research Considerations for Activities Not Involving Direct Physical Contact with Study Participants

Research activities may continue as planned.

UK Healthcare

If UK Healthcare implements mandatory COVID-19 screening of staff, visitors, and students, it may impact research participants traveling to campus for planned study visits. Incorporating mandatory UK Healthcare COVID-19 research participant screening before any direct interaction takes place or conducting mandatory telephone screening prior to coming to campus for planned study visits does not require the submission of a Modification Request.

Eliminating Apparent Hazards to Research Participants

Per federal regulations, an investigator can make changes to a protocol to eliminate apparent hazards to research participants without first obtaining IRB approval. Note that this option is only available for changes impacting participants already enrolled in the research; not for enrolling new participants. If a change is made to the protocol to eliminate apparent hazards without IRB approval, the investigator must submit a Protocol Violation to the IRB within 14 calendar days of the change. The change may apply to a single participant or all participants enrolled in the research study. A description of the change and the rationale for making the change should be included in the Protocol Violation.

Please contact the UK Office of Research Integrity via irbsubmission@uky.edu or (859)257-9428 with questions about this notice or for consultation about whether your research protocol should be revised via a Modification Request as indicated in this notice.

We will update this notice as the ORI receives updates affecting UK research.

March 17, 2020 (Update 2 - 12:00 pm)

Direct physical contact with study participants/Whether to create a Modification Request

Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research.

ORI will continue to update the COVID-19 Human Subject Website with available information. However, events are occurring rapidly, some of which require leadership consultation and deliberation on how to operationalize.

Our guiding principle is maintaining the safety of the research subjects and the research team members. We are implementing changes based on University-wide initiatives communicated from President Capilouto. In addition, any protocol operating within UK Healthcare must abide by specific mandates which apply to healthcare facilities and operations.

Researchers should also consider directives or mandates from research sponsors and individual colleges or departments designed to mitigate risks or limit exposure.

Lastly, researchers are advised to operate at their discretion to protect the health, safety, and well-being of everyone in our community.

This notice concerns UK research activities involving direct physical contact with study participants.

Given the current concerns about the COVID-19 coronavirus outbreak and the real or perceived risk of exposure, the risk/benefit ratio of research participation must be taken into careful consideration for each IRB-approved protocol at UK. Ethical principles of research and the federal regulations for protecting human research participants all require an acceptable risk/benefit ratio.

Studies for which there is little-to-no direct benefit to research participants

Research activities that involve direct contact with/being in the presence of participants and offer little-to-no benefit to the participant may be delayed/paused, effective immediately (or as soon as can reasonably be implemented) at the PI’s discretion (and after communicating with the sponsor as applicable). This delay/pause would remain in place until official notice is issued by UK indicating all research activities can resume. Procedures such as telephone contact, remote monitoring, and/or remote data collection may continue for these studies as planned.

Studies for which there is direct benefit to research participants

Research activities that provide direct benefit to the participants may continue, uninterrupted. However, investigators should use discretion and universal precautions. Any activities that can be conducted remotely by telephone or electronically should be implemented in such a manner to the fullest extent possible.

Examples of research protocols providing direct benefit and not providing direct benefit

Providing direct benefit = therapeutic interventions involving study drugs, some medical devices, or cognitive/behavioral treatments
Not providing direct benefit = observational activities (public or otherwise), in-person interviews, focus groups, in-person surveys/questionnaires

Research protocols or any single component of a research protocol may be delayed/paused or temporarily modified for COVID-19 concerns without submitting a Modification Request to the IRB.

Per federal regulations, an investigator can make changes to a protocol to eliminate apparent hazards to research participants without first obtaining IRB approval. The change may apply to a single participant or all participants enrolled in the research study.

However, if changes to research procedures are permanent and not currently approved by the IRB, a Modification Request should be submitted prior to implementing the changes.

UK Healthcare

Please contact the UK Office of Research Integrity via irbsubmission@uky.edu or (859)257-9428 with questions about this notice or for consultation about whether your research should be delayed/paused as indicated in this notice.

March 18, 2020 (Update 3 - 4:00 pm)

Updated Direct physical contact with study participants/Whether to create a Modification Request

Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research. For answers to questions regarding clinical research management during COVID-19, please see the frequently asked questions page.

Researchers should also consider directives or mandates from research sponsors and individual colleges or departments designed to mitigate risks or limit exposure.

Lastly, researchers are advised to operate at their discretion to protect the health, safety, and well-being of everyone in our community.

This notice concerns UK research activities involving direct physical contact with study participants.

Studies for which there is little-to-no direct benefit to research participants

Research activities that involve direct contact with/being in the presence of participants and offer little-to-no benefit to the participant should be delayed/paused, effective immediately (or as soon as can reasonably be implemented without causing harm by stopping therapy) at the PI’s discretion (and after communicating with the sponsor as applicable). This delay/pause would remain in place until official notice is issued by UK indicating all research activities can resume. Procedures such as telephone contact, remote monitoring, and/or remote data collection may continue for these studies as planned.

Studies for which there is direct benefit to research participants

Research activities that provide direct benefit to the participants may continue, uninterrupted. New accruals can occur if studies offer options that are of direct benefit beyond standard of care options, if a study is available. However, investigators should use discretion and universal precautions. Any activities that can be conducted remotely by telephone or electronically should be implemented in such a manner to the fullest extent possible.

Examples of research protocols providing direct benefit and not providing direct benefit

Providing direct benefit = therapeutic interventions involving study drugs, some medical devices, or cognitive/behavioral treatments
Not providing direct benefit = observational activities (public or otherwise), in-person interviews, focus groups, in-person surveys/questionnaires


Type of Treatment/Trial	Suggested Actions
Treatment Interventional Trials (Studies that include a therapy such as a drug or procedure)	Continue subjects on studies with therapeutic benefit or where stopping procedures would cause harm. Open to new accrual for studies with therapies that could have benefit over standard options.
Non-treatment Intervention (Studies that include supportive care, prevention, diagnostic, behavioral, or other types of non-treatment interventions)	Continue subjects on studies with clear benefit or where stopping intervention would cause harm. Open to new accrual for studies with benefit over standard options.
Observational Studies (Studies with No direct therapeutic benefit or where stopping procedures would NOT cause harm)	Pause, except for remote contact

COVID-19 related IRB Modification Request NOT required to delay, pause, or temporarily modify research activities

Research protocols or any single component of a research protocol may be delayed/paused or temporarily modified for COVID-19 concerns without submitting a Modification Request to the IRB. Per federal regulations, an investigator can make changes to a protocol to eliminate apparent hazards to research participants without first obtaining IRB approval. The change may apply to a single participant or all participants enrolled in the research study.

However, if changes to research procedures are permanent and not currently approved by the IRB, a Modification Request should be submitted prior to implementing the changes.

UK Healthcare (UKHC)

These guidelines will continue to change in alignment with UKHC policies and procedures related to COVID-19 and individual studies, or specific patients being enrolled in studies are subject to change by the Executive Vice President for Health Affairs (EVPHA) and/or the VPR. If UKHC implements mandatory COVID-19 screening of staff, visitors, and students, it may impact research participants traveling to campus for planned study visits. Incorporating mandatory UKHC COVID-19 research participant screening before any direct interaction takes place or conducting mandatory telephone screening prior to coming to campus for planned study visits does not require the submission of a Modification Request.

Please contact the UK Office of Research Integrity via irbsubmission@uky.edu or (859) 257-9428 with questions about this notice or for consultation about whether your research should be delayed/paused as indicated in this notice.

March 19, 2020 (Update 4 - 4:00 pm)

Regulatory and Operational Questions

Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research.

The ORI’s COVID-19 Human Subject Website has been created to share information on adjusting human research to maintaining the safety of the subjects and staff, while complying with directives and mandates from the institution, research sponsors, and individual colleges or departments.

It will be updated frequently with most recent announcements visible on the ORI home page. We are including the date and time with version number to make clear, newly posted or urgent information.

Since many concerns revolve around clinical research, the website includes a Clinical Research Covide-19 FAQ.

Please know that UK ORI and IRB are operational and will continue to review submissions and communicate with research through E-IRB. While some ORI staff are working remotely, we are monitoring email addresses with the same or greater frequency and are available by phone as well. See the complete list of all ORI Contacts.

March 26, 2020 (Update 5 - 1:00 pm)

Clinical Research COVID-19 FAQ now COVID-19 Research FAQs

The Clinical Research COVID-19 FAQ webpage is now COVID-19 Research FAQs and includes FAQs regarding all human research studies.

Please refer to the COVID-19 Research FAQs for added or updated questions/answers. The new FAQs have the date that they were added and an alert icon next to them.

The ORI homepage and ORI COVID-19 Alerts page will post new announcements related to the conduct of human studies as they are made available.

April 7, 2020 (Update 6 - 10:30am)

Notice regarding ORI Quality Assurance Wellness Checks

The ORI Quality Improvement/Quality Assurance (QA/QI) Program is not scheduling or conducting any visits at this time due to COVID-19 concerns. We will resume our visits once the university returns to regular business function and the conduct of in-person events.

Investigators who had Wellness Check visits scheduled for late March and all of April 2020 have been contacted and informed their visit will be delayed until after the current COVID-19 restrictions have been lifted and staff/students return to campus. We will work with investigators to reschedule their visit as soon as possible.

Please contact Pam Stafford (pastaf3@uky.edu) if you have questions or concerns.

April 7, 2020 (Update 7 - 11:45 am)

IRB Meetings

Due to current COVID-19 concerns, IRB meetings are being conducted electronically through Zoom. Investigators will receive an invite containing a Zoom link prior to the meeting.

Investigators should inform ORI staff if they have other study personnel to whom they need a meeting invitation sent. Investigators should not forward the meeting link to their study personnel. It’s important for ORI staff to know everyone who will be attending so they are aware of who is and is not supposed to be admitted into the virtual meeting during each scheduled appointment time.

In addition, the number of attendees for each protocol needs to be limited in order to keep attendance tracking manageable for documentation purposes, so we ask that investigators have no more than two (2) individuals from the list of study personnel join them for the meeting.

April 7, 2020 (Update 8 - 1:30 pm)

Remote Informed Consent

Remote informed consent may be proposed for new COVID-19 research or implemented for an existing protocol in response to the pandemic. See ORI guidance for best practice in obtaining remote informed consent.

April 16, 2020 (Update 9 - 8:10 am)

COVID-19 Related Studies

***Effective April 16, 2020: If your research involves investigating any aspect of COVID-19, please enter “COVID-19” at the start of your Project Title in your IRB protocol application.***

Please add COVID-19 to “Title of Project” and “Short Title Description” of your current IRB protocol.

For protocols being reviewed by an external IRB, please enter “Non-UK COVID-19” before the PROJECT and SHORT titles.

For the latest UK COVID-19 human research updates please go to the Office of Research Integrity (ORI) website, ORI COVID-19 Alerts for all past and present updates, or for specific information on how COVID-19 may effect your research project, please see COVID-19 Research FAQs.

April 27, 2020

All human research activities remain paused

As previously announced, all on-campus research activities remain paused except for the following:

Research with direct participant benefit
Research where stopping intervention would cause harm
Covid-19 research
Studies with no in-person contact

The current pause will remain in place until further notice. Please see the COVID-19 Research FAQs for important frequently asked research questions related to human research.

May 29, 2020 (Update 10 - 5:00 pm)

UK Resumption of Research Phased Plan; Phases for Resumption of Human Subjects Research

The Vice President for Research (VPR) has released UK’s Resumption of Research Phased Plan. Please read the VPR’s plan, which outlines specific institutional resumption requirements and instructions (click here for a PDF version).

ORI has developed Human Subjects Research FAQs for applying the plan and safeguards in human subject research including a Human Subjects Research Phases Table with examples of the type of study appropriate to resume with each phase.

June 12, 2020 (Update 11 - 8:00 am)

**COVID-19 related announcements from the June IRB Review Newsletter**

Applying the UK Resumption of Research Phase Plan to Human Subject Research

ORI has developed Human Subjects Research FAQs for applying UK’s Resumption of Research Phased Plan released by the Vice President for Research (VPR). The FAQs include a Human Subjects Research Phases Table with examples of the type of study appropriate to resume with each phase.

Consolidated Guide for Submitting and Conducting COVID-19 Human Research

This guidance combines questions and answers for newly initiated COVID-19 protocols or modifications to add COVID-19 objectives to existing research. Click to view guidance.

Revised "UK ORI Best Practice for Remote Informed Consent Guide

This guide outlines requirements and best practices for remote consent of subjects unable to travel to the research site and those isolated for infection control reasons. Additional guidance and tools are provided for FDA-regulated research which has the extra requirements for electronic records and signatures (FDA 21 CFR part 11). Click to view guidance.

July 10, 2020 (Update 12 - 8:15 am)

Clarification regarding resumption of in-person research

Please note: you must meet the requirements of the VPR Resumption of Research Phased Plan (training & individualized plan submission for Phases 2-4) before conducting any in-person human subjects research. Both the researcher training completion and the individualized plan for research work space/personnel are automatically routed by the VPR’s office to the respective department chair for evaluation. Unless otherwise indicated, protocol-specific IRB approval to resume research that has been paused due to COVID-19 concerns is not required.

July 27, 2020 (Update 13 - 12:23 pm)

UK CITI COVID-19: Back to Campus course

The "COVID-19: Back to Campus" optional course is now available in the UK Collaborative Institutional Training Initiative (CITI) curriculum. This course is designed to educate staff, student, and faculty on topics such as background of the disease, how it likely spreads, recommendations by the CDC, NIH, and OSHA, prevention methods, laboratory and research hygiene, mental health and well-being tips, among others.

The course also includes supplemental modules on specific areas such as research with human subjects and safe lab reactivation involving animal research.

If interested in this course, refer to the UK Office of Research Integrity's Human Subject Protection Training FAQs for information on accessing the course.

**NOTE: This course does not replace the training modules under the UK Resumption of Research Phased Plan and you will not receive credit for this course.

April 2, 2021 (Update 14 - 10:30 am)

Message from the VPR - Phase 4 of Resumption to Research Phased Plan

We are pleased to announce that we are moving forward to Phase 4 of the University of Kentucky Resumption of Research Phased Plan. Phase 4 places us at research activity up to 100% of pre-pandemic levels while continuing to follow CDC and institutional guidelines of 6-ft physical distancing, mask wearing requirements in research workspaces, washing hands and disinfecting workspaces. We understand that the requirement of 6-ft physical distancing may not allow 100% research capacity within your workspace depending on the number of research personnel and space considerations. We encourage you to continue to use staggered work schedules and other measures to stay within our policies and procedures. We will inform you if requirements for physical distancing change.

As you will see in the revised 13-page Resumption of Research Phased Plan, if you have already submitted and received approval for a PI plan through Phase 4 you do not need to submit additional materials. However, some changes to the revised Resumption of Research Phased Plan may require you to submit revised PI plans. These include changes in human participants research on page 8 within the Human Subjects Research Phases Table (see row 9). If you perform in-person research in which transmission risks cannot be fully controlled by the research teams, please submit a revised plan to receive pre-approval for such research. The revised plan should describe how you will work to reduce risks for your in-person studies. This revised plan will go through the standard approval process: Chairs and/or unit Directors, Associate Deans for Research, and Deans will review and approve your plan, then it will be filed with the Office of the Vice President for Research.

Please note that even though we are moving to Phase 4 of our resumed research, until further notified, high school students or other volunteers are not permitted in research and creative workspaces. If you wish to include high school students or other volunteers in your research and creative work, you must request pre-approval in your revised PI plan. Pre-approval requests should be sent to the Office of the Vice President for Research at research-covid@uky.edu. Following pre-approval, your plan will go to the Associate Dean for Research for final approval.

We encourage all research personnel to be vaccinated. However, we remind you that it is not permissible to ask researchers or participants if they have been vaccinated with emergency use authorized vaccines.

Upon receipt of this email, please move forward with Phase 4 research, and as always, be safe and well as your important research and creative work resume.

The Phased Resumption Working Group

Lisa A. Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research
University of Kentucky