COVID-19 Alerts

 

COVID-19 Alerts


 

 

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

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 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 6 - 10:30 am)

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) or Kasandra Lambert (kasandra.lambert@uky.edu) if you have questions or concerns.


 

 

March 26, 2020 (Update 5 - 2:00 pm)

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.  


 

 

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

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 COVID-19 FAQ

See also the Vice President for Research (VPR) COVID-19 Guidance for Researchers website. 

Please know that UK ORI and IRB are operational and will continue to review submissions and communicate with researchers 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 18, 2020 (Update 3 - 4:00 pm)

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

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 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
Treatment Type

 

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

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 should 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

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)

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 12, 2020

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.