September 22, 2020

Dear Colleagues,

As you are aware, the Office of the Vice President for Research (OVPR) in collaboration with the Research Resumption Work Group have developed UK’s Resumption of Research Phased Plan. There are four phases of research resumption and we are currently in Phase 2 of the plan. As we prepare to move to Phase 3 (up to 70% research activity), updates have been made to the Plan that incorporate guidance from the START Team, based on our increased understanding of SARS CoV-2, and based on your feedback regarding undergraduates in research settings. The updated plan has been approved by the Emergency Operations Center (EOC) and vetted through UK senior leadership (https://www.research.uky.edu/resources/uk-resumption-research-plan). Even if you have been approved for research resumption during Phase 2 of the plan, please read the updated plan that is available on our website (click here for a PDF version). 

The major changes to the updated plan are as follows:

  • The local/national conditions for moving from Phase 2 (50%) to Phase 3 (70%) capacity are consistent with START group recommendations and with the underlying factors that the institution uses to monitor the health and well-being of the campus and operational status.
  • The plan has been revised to include all needed information.
  • Language around what is allowed versus not allowed during later phases of the plan for human participant research has been revised. During Phase 3, human participant research is allowed if it is not of direct benefit to the participant but is of benefit to society. In Phase 4, research in which the risk cannot be mitigated is allowed.
  • For undergraduates, Phase 3 allows undergraduates to participate in research with justification (e.g., course/degree requirement). The revised Principal Investigator (PI) plan requires justification for inclusion of undergraduates that focuses on training needs and safety. As per the START committee, undergraduates participating in research must document the completion of their re-test prior to initiating work. If the student tests positive, Health Corps will proceed with their standard communication and the student will not be allowed into research spaces until released by Health Corps.  
  • The online and excel format for submitting PI plans has been expanded to reflect these changes (e.g., undergraduates, human subjects).

I am pleased to inform you that at this time, we have been approved to move on September 28, 2020, to Phase 3 of the Resumption of Research Phased Plan. To move to Phase 3, PIs and/or all faculty who perform research and/or creative work and whom supervise employees and trainees are required to develop an individualized plan for their research workspace or environment. 

If you have previously completed the online training for the basics of the overall plan and the online training module regarding human participants (if your research involves human participants), then you are not required to re-take the training nor re-upload your training certificate.

If you originally completed your individualized plan/Excel template to include details for conducting research during Phase 3, your plan does not involve undergraduates or human participants research (that has changed considering the revised language), and your plan has been approved, then you are approved to move to Phase 3 on September 28, 2020.  

If your plan has been approved for Phase 2, but you have not completed your individualized plan/Excel template for Phase 3 activities or you plan to have undergraduates conduct research, then you will need to develop your plan in discussion with your personnel, using the overall plan to guide you in making decisions. Once you and your group have developed your plan, you will complete and upload  (https://uky.az1.qualtrics.com/jfe/form/SV_0V3V83mWOAzdDzn) your updated PI Plan Submission Form and Excel file taking into consideration the above major changes to the updated Resumption of Research Plan. After submission, the updated plan will be transmitted to your Chair and/or unit Director, who will have initial authority to approve your plan in conjunction with your Associate Dean for Research; your Dean will have final authority over movement to Phase 3 for your program.

If you have not previously completed an individualized plan for approval, you are required to complete online training on the basics of the overall plan, which will assist you in developing your individualized plan. There is an additional required online training module if your research involves human participants. Once you have completed the online training, you should develop your individualized plan using the Excel template that details specifics regarding your research personnel, workspace or space management, activities during the different phases (focusing now on Phase 3), and management of hygiene/disinfecting/PPE. Please discuss these areas with your personnel, using the overall plan to guide you in making decisions during the phases of resumed research. Once you and your group have developed your plan, you will submit it by completing the PI Plan Submission Form and uploading the Excel file and your training certificate(s) at https://uky.az1.qualtrics.com/jfe/form/SV_0V3V83mWOAzdDzn. After submission, the plan will go through the process described above for approval. 

Once approved, you can proceed to Phase 3. However, please understand that your Chair and/or unit Director will be working on your behalf to coordinate your plan with others within your unit or space and may ask you to make changes over time as their overall unit plans evolve. We will inform you when we can move from Phase 3 to Phase 4, or alternatively, if and when we may have to regress in our phases.

We are excited to move to Phase 3 within UK’s Resumption of Research Phased Plan, but we must all remember that we do so with personal health and safety as our number one priority.

Finally, I wish to thank the many people who have worked tirelessly on your behalf to develop the plan (Working group, led by Dr. Linda Dwoskin), provide input on the plan (EOC workstreams, Senate Research Committee, Provost Office, Graduate Student Congress, Associate Deans for Research, Chairs), and implement the plan (CCTS, CRSO, many talented staff within the research administrative units). As you know, we are developing and working through issues such as this that under normal circumstances would have taken several months but are now being developed quickly on your behalf. Please join me in thanking them, and please work with patience and respect towards leadership in your domain who will also work on your behalf to achieve a safe phased resumption of research.

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

May 29, 2020

Dear Colleagues,

We have developed UK’s Resumption of Research Phased Plan. I am pleased to inform you that the plan was approved today through the Emergency Operations Center (EOC) and senior leadership.

Please read the plan that is available on our website and in pdf. As you will see, there are four phases of research resumption, and we are currently in Phase 1. To move to Phase 2, Principal Investigators (PIs) and/or all faculty who perform research and/or creative work and whom supervise others are required to develop an individualized plan for their research workspace or environment. To assist you in developing your individualized plan, you are required to complete online training on the basics of the overall plan, and if your research involves human subjects, there is an additional required online training module. Then you can develop your individualized plan, using the Excel template that details specifics regarding your research personnel, workspace or space management, activities during the different phases (focusing now on Phase 2), and management of hygiene/disinfecting/PPE. Please discuss these areas with your personnel, using the overall plan to guide you in making decisions during the phases of resumed research. Once you and your group have developed your plan, you will submit it by completing the PI Plan Submission Form and uploading the Excel file and your training certificate. After submission, the plan will be transmitted to your Chair and/or unit Director, who will have initial authority to approve your plan in conjunction with your Associate Dean for Research; your Dean will have final authority over movement to Phase 2 for your program.

Once approved, you can proceed to Phase 2. However, please understand that your Chair and/or unit Director will be working on your behalf to coordinate your plan with others within your unit or space and may ask you to make changes over time as their overall unit plans evolve. We will also be adjusting to the institutional guidelines that will be coming forth as we move towards opening of the campus in the fall academic semester. We will inform you when we can move from Phase 2 to Phase 3, or alternatively, if and when we may have to regress in our phases.

We are excited to move to Phase 2 within UK’s Resumption of Research Phased Plan, but we must all remember that we do so with personal health and safety as our number one priority.

Finally, I wish to thank the many people who have worked tirelessly on your behalf to develop the plan (Working group, led by Dr. Linda Dwoskin), provide input on the plan (EOC workstreams, Senate Research Committee, Provost Office, Graduate Student Congress, Associate Deans for Research, Chairs), and implement the plan (CCTS, CRSO, many talented staff within the research administrative units). As you know, we are developing and working through issues such as this that under normal circumstances would have taken several months, but are now being developed in days to weeks by many people working on your behalf. Please join me in thanking them, and please work with patience and respect towards leadership in your domain who will also work on your behalf to achieve a safe phased resumption of research.

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

April 17, 2020

Dear Colleagues,

Recognizing that we are beyond the original anticipated two-week time frame for curtailed on-campus research activities in response to the COVID-19 pandemic, this communication is to guide you by providing further definition of essential research activities that can be performed on campus (all UK owned, leased or managed facilities, properties and research sites). 

Several have asked for more information to guide you in decisions and to assure that social distancing is key to any research that is performed at UK campus facilities. Remember, our first priority is the safety of those participating in our research mission. Toward that goal, we provide the following list of acceptable on-campus essential research activities:  

  • COVID-19 related research
  • Activity that if discontinued would result in irreplaceable data or sample loss;
  • Activity that if discontinued would pose a safety hazard;
  • Activity that maintains critical equipment or core facilities;
  • Activity that maintains critical samples, reagents, and materials;
  • Activity that maintains non-commercial animal populations;
  • Activity that maintains critically needed plant populations, tissue cultures, or other living organisms which cannot be cryopreserved;
  • Activity in support of treatment interventional human subjects research with therapeutic benefit or where stopping procedures would cause harm.

This list sets a base level of on-campus essential research activities that will serve as our starting point for the next step, which is planning to return to normal (or new normal) research operations. You can find more information related to essential on campus research activities on our COVID-19 research website. This includes a lab safety checklist prepared by our experts in Environmental Health and Safety to guide you in appropriate operations if your personnel are on campus performing these essential research activities.  

Until further notified, a waiver is required for laboratories or research groups performing any of these essential research activities at UK’s campus. I ask the cooperation of Principal Investigators of laboratories supervising personnel to complete and submit the waiver (https://uky.az1.qualtrics.com/jfe/form/SV_03AI3VvI3h2Q1Ip) delineating the above essential research activities that will take place within your program on UK’s campus. Once submitted, we will direct your waiver to the appropriate Associate Dean for Research within your College for approval and for information purposes.

We understand that other types of social, behavior, public health or data science research have also been affected by the COVID-19 pandemic. To guide you in decision making regarding research and adaptation or workarounds that facilitate your approach to research in these areas, we have included on our website an FAQ with information provided by UK researchers in these areas. 

We appreciate your cooperation during these challenging times. Stay tuned for information on what we all strive for, namely resuming normal (or the new normal) research operations. 

Lisa Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research

March 27, 2020

Donating PPE

Many of you have asked whether there is a need for any of the personal protective equipment (PPE) that you have in your labs and are willing to loan or donate to UK Healthcare in support of the frontline personnel testing for COVID-19 and treating patients that come into our health care facilities.  The College of Medicine sent the email below that has the list of items they need. There is a Spreadsheet that each lab with excess PPE is requested to submit to Jennifer Rose (contact in the email below). This includes information about the manufacturer and product number because there are specific requirements for the PPE that can be utilized. If UK HealthCare can use your items, they will make arrangements to get them from you.

If the PPE you provide to UK Healthcare was purchased on an NIH grant, the latest NIH guidance is that PIs may re-budget grant funds to repurchase supplies at a later date, use large unobligated balances, or submit an administrative supplement request to the funding IC.  This means that you would need to have evidence of the purchase and track what you are providing in order to request an administrative supplement at a later date. 

However, not all funding agencies have issued similar guidance which means that items may be LOANED, with the expectation that they would be replaced at a later date using non-federal funds. If the PPE you provide to UK Healthcare was purchased on a grant from another funding agency, it is essential that you track these items and the grant on which they were originally purchased. You will be contacted later for this information.

Please share this information with relevant labs and PIs in your areas.    

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

Call to Action: Personal Protective Equipment Request

Over the last few days, I have been blown away by the number of you that have reached out about the supply of personal protective equipment in the UK HealthCare system. So many of you have offered to step up in a huge way and asked what we may need to prepare for the coming months.

We have been working diligently with the UK HealthCare team to identify items that you may have available in your labs. These items include:

  • N95 masks
  • Masks with face shields
  • Any sanitizers
  • Any disinfectant wipes
  • PAPR hoods
  • Isolation masks
  • Surgeon caps/bouffant
  • Gloves
  • Isolation gowns
  • Swabs
  • Viral testing Medium
  • UV Tower
  • Sani-Cloth Wipes, also commonly known as “purple wipes.”

At this point, we are gathering an inventory of items you may have to donate.

If you are interested and able, please fill out your information in this spreadsheet (Excel) so that we may gather a better idea of the available supplies. This is in no way expected, but certainly appreciated.

After you have completed the form, please submit that to Jennifer Rose, UK HealthCare’s Chief Administrative Officer at Jennifer.Rose@uky.edu and someone on her team will follow-up with you and assist in the pick-up coordination.

Thank you as always for your willingness to assist in any way possible.

Jim Geddes, PhD
Vice Dean for Research, College of Medicine

March 20, 2020

Members of our Clinical Research Community, 

Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research. We encourage you to monitor information from the UK Office of Research Integrity (ORI). For answers to questions regarding clinical research management during COVID-19, please see ORI’s Frequently Asked Questions.

Our guiding principle is maintaining the safety of research subjects and 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 health care 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.

The following directives apply to UK clinical research activities involving direct physical contact with study participants.

Given the current concerns about the COVID-19 coronavirus outbreak and the real or potential risk of exposure, the risk/benefit ratio of research participation must be taken into careful consideration for each Institutional Review Board (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.

This Decision Tree (pdf), and the following information can guide you in deciding which studies should be paused. 

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 participants should be delayed/paused, effective immediately (or as soon as can reasonably be implemented without causing harm by stopping therapy) at the Principal Investigator’s (PI’s) discretion (and after communicating with the sponsor as applicable). This delay/pause should 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.

See the ORI site for examples of research protocols providing/not providing direct benefit.

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.

These guidelines will continue to change in alignment with UK HealthCare 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 Vice President for Research.

Please contact the ORI via irbsubmission@uky.edu or 859-257-9428 with questions or for consultation about whether your research should be delayed/paused.

Visit the VPR’s COVID-19 Guidance for Researchers site for updated information. 

Lisa Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research

March 17, 2020

Members of our Research Campus Community,

As communicated this morning by President Capilouto regarding the coronavirus (COVID-19), this unprecedented public health challenge requires that we change and adapt to the situation while working within the guiding principles of ensuring student success and protecting the health and well-being of our students, staff and faculty. 

We understand that our research mission is not one that is easily amenable to pronounced changes in our mode of operations, but we also understand that we need to work together — using our collective knowledge and creativity — to adjust our approach to research during these difficult and rapidly evolving times. While the President’s message communicated the need to move operations from on campus to remote as much as possible, research at UK is not suspended and our research support offices will continue to provide base services. However, please operate in a manner that reduces activities that require researchers to be on campus and that minimizes the possibility that researchers or study subjects experience exposure to the virus. 

We encourage you to move as much of your research as possible, and quickly, to remote operations. Toward this goal, be on the watch for communications from College leadership delineating plans for research operations within your domain, and don’t hesitate to contact your Associate Dean for Research if you have questions once unit plans are disseminated. Consistent with unit-level guidance, we encourage you to develop individualized plans for research program operations.

To help you, we are developing a this website from the Office of the Vice President for Research (VPR) that will contain information such as frequently asked questions regarding research operations (both basic and clinical) and COVID-19, links to federal funding guidelines in relation to COVID-19, helpful hints for how to perform aspects of your research remotely, suggestions for use of remote time for research-related on-line training and development of standard operating procedures, and use of new research-related resources (e.g., electronic laboratory notebook). We suggest that you bookmark this site, https://www.research.uky.edu/resources/covid-19-guidance-researchers, to assist and guide you.

As always, it is important that we work together in the collaborative spirit of UK research, so please feel free to send us your suggestions to help us all as we continue our research mission.

Lisa Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research

March 15, 2020

Dear Colleagues,

As was communicated by President Capilouto regarding the coronavirus (COVID-19), the health, safety and well-being of our campus is a priority, and this includes faculty, staff and trainees engaged in research, as well as research subjects. This communication is to guide you in relation to research operations while the University uses online or other alternative modes of instruction during the period of March 23 through April 3. The Research Enterprise continues to operate as usual, with support offices fully staffed to enable all aspects of research administration.

We are continuing to monitor and evaluate the situation and develop contingency plans related to research operations, if needed, should the situation change. We also encourage principal investigators to develop individual contingency plans for research operations that are consistent with UK’s plan of action. Below we provide a list of items and/or suggestions to consider as they relate to operations of your individual research program should the situation evolve.  

  • Develop a communication plan to assure that you and your laboratory staff are in communication over research operations. Suggestions include creation of an emergency call sheet that has contact information for all laboratory members, designating a point of contact for various research-related activities, delineating modes of interactions for research purposes (e.g. remote meetings). 
  • Identify essential research operations (e.g., special care for animals, cell culture maintenance or on-going experiments), and identify who will be responsible for performing those essential activities (teams identified with back-up plans). This is especially important for ongoing animal experiments to assure investigators are responsible for animal care that is outside of DLAR personnel responsibilities.
  • Delineate research outcomes that can be performed remotely, and what resources are needed to do so (like Zoom https://www.uky.edu/elearning/zoom). Consider using remote work time to draft manuscripts, grant proposals, perform literature reviews, dissertation drafts, etc.
  • Consider resources needed for continued experimentation and whether orders and/or needs should be adjusted, if possible, to ensure on-going operations.
  • If you have regulatory approvals that will be expiring soon, contact offices to request extensions, if needed.
  • Consider cross-training methodologies and/or tasks across laboratory co-workers, to assure that if one essential person is not able to perform their tasks others understand and can perform needed duties. 
  • Consider shutting down non-essential equipment that will not be damaged by shutdown, or that requires reagents (e.g., liquid nitrogen or gases) where supplies may not be readily available. Create plans for equipment maintenance by designated laboratory staff. Devise a plan to clean equipment within your laboratory to protect staff.

Proposal Submissions
Office of Sponsored Projects Administration (OSPA) will continue to submit proposals as usual. If the situation changes and personnel are working remotely, they will continue to support proposal submissions. Federal agencies are flexible about deadlines under difficult circumstances beyond our control.  Any updated information regarding agency policies and communications will be posted on the OSPA website: https://www.research.uky.edu/office-sponsored-projects-administration

Research-Related Travel
Monitor the campus-wide COVID 19 response site to get the latest on university-wide travel guidance and policies: https://www.uky.edu/coronavirus/

Human Subjects Research 
The Office of Research Integrity is fully operational as are the IRBs. Please see their website for the most current guidance on Human Subject Research projects: https://www.research.uky.edu/office-research-integrity

Animal Research 
The Department of Laboratory Animal Research and IACUC will remain fully operational, maintaining safe and compliant animal care. DLAR staff will be on site to provide their standard animal care. Individual investigator’s experiments are solely the responsibility of the laboratory staff. Please be sure to make arrangements with your lab personnel to maintain oversight of your animal research needs in case you are short-staffed due to illness.

Please contact the DLAR supervisor in your area for any questions. See the DLAR website for any COVID-19 impacts that may affect operations: https://www.research.uky.edu/division-laboratory-animal-resources 

See the Office of the Attending Veterinarian website for updated guidance on IACUC services and COVID-19 preparedness guidance for animal care: https://www.research.uky.edu/office-attending-veterinarian

Standard Precautions
Remember all personnel should stay home if they experience any symptoms including fever, cough or difficulty breathing. It is also advisable to encourage limiting physical contact with others, such as hand-shaking and sharing of food. Finally, the most effective prevention measure is frequent, thorough hand-washing. 

Lisa A. Cassis, PhD
Vice President for Research
University of Kentucky

March 12, 2020

UK Researchers,

As was communicated by President Capilouto regarding the coronavirus (COVID-19), the health, safety and well-being of our campus is a priority, and this includes faculty, staff and trainees engaged in research, as well as research subjects.  This communication is to guide you in relation to research operations while the University uses online or other alternative modes of instruction during the period of March 23 through April 3.

The Research Enterprise continues to operate as usual, with support offices fully staffed to enable all aspects of research administration.  Please continue normal research operations, understanding that you may have questions or concerns regarding the specifics of the research and its implementation given the disruptions and challenges that are influenced by COVID-19.  We are continuing to monitor and evaluate the situation and develop contingency plans related to research operations, if needed, should the situation change.  This includes federal funding agency guidance and how this may relate to research operations at UK.  At this time, however, research staff and trainees (graduate student research assistants, postdoctoral fellows) should continue normal research activities under the guidance of principal investigators as the situation evolves.  We also encourage principal investigators to develop individual contingency plans for research operations that are consistent with UK’s plan of action.

Updated information for the Research community, including tips for researchers to consider as they develop their own contingency plans, will be available at research.uky.edu.  For University-level decision making, we have developed a series of workgroups on issues including research, as well as human resources, IT, facilities and others.  If you have specific concerns that might be better addressed there, the leaders of those areas are listed on the website.

For the latest information for the broader university community, see: https://www.uky.edu/coronavirus.

If you have questions related to research operations during this time, please send inquiries to vpr@uky.edu.

Lisa A. Cassis, PhD
Vice President for Research
University of Kentucky