We are in Phase 3* of the Resumption of Research Phased Plan
* For principal investigators who have had a plan approved for resumption.
Email research-covid@uky.edu with questions concerning research and COVID-19 policies.
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Phase 3: Resumption of Research Phased Plan
A university-wide announcement went out September 22, 2020, announcing that PIs with approved plans could move to Phase 3 on September 28. See Lisa Cassis' email with full details here.
Even if you have been approved for research resumption during Phase 2 of the plan, please read the updated plan.
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.
- 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).
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New FAQs
If I submitted my Phase 3 and Phase 4 plans with my Phase 2 plan and had them all approved, do I need to resubmit these plans to move to Phase 3?
If you originally completed, and had approved, your individualized plan/Excel template to include details for conducting research during Phase 3 AND your plan does not involve undergraduates or human participants research, then you may move to Phase 3 on September 28, 2020.
If your plan DID include undergraduates or human participants research, you will need to submit a revised plan that takes into account the updated guidance in the revised version of the University of Kentucky Resumption of Research Phased Plan. Once your revised plan is approved, you may move to Phase 3 on September 28, 2020.
Are undergraduate or high school students allowed in our research labs this fall?
Trainee participation in research is outlined according to Phase and is focused on working safely while advancing the research mission, minimizing risk to all personnel. Additional information can be found on page 10 of the updated University of Kentucky Resumption of Research Phased Plan.
Phase 2: Undergraduates and high school students are not allowed in research laboratories during Phase 2, with the exception of undergraduates who are staff on grants or contracts, with special permission.
Phase 3: High school students or other volunteers are not allowed during Phase 3. Justification is required for specific undergraduates to participate in research during Phase 3, so that health and safety is maximized and the research mission is protected. Prioritization should be given to undergraduates taking research course credits for degree completion. Including undergraduates in the research plan should take into consideration training needs that would place personnel in close proximity for extended periods of time. However, PIs may choose not to include undergraduates in their research plans due to increased risk to research personnel in the workspace. If students feel unsafe, they should be allowed to opt out of on-site research activities and will be provided alternative learning opportunities.
Undergraduates involved in research are required to be re-tested prior to initiation of work.
Special considerations: Undergraduates can participate in human participants research if safety concerns are addressed adequately in the PI’s plan. However, undergraduate participation in COVID-related research in general should be excluded, but exceptions will be considered if risk is adequately mitigated.
PIs who are willing to have undergraduate students in their research spaces must include them in their approved Resumption of Research Plan and justify their selection (course/graduation requirement).
There are undergraduates who would like to work in my lab, how do I verify they have been re-tested for COVID-19 prior to starting work in order to comply with the resumption plan?
Because in Phase 3, undergraduate students are required to be re-tested for COVID-19 before coming into research workspaces, PIs and/or supervisors should require proof that the student completed the test. This could be in the form of a copy of the scheduled appointment, a verification note from the testing site if provided upon request, or being shown the email transmission that the test result is ready. This verification should not include the test result, because this is protected information. If the student tests positive, then UK Health Corps will inform the student who will be moved to isolation. The student is responsible for interfacing with the PI as to next steps. Students working in labs should be tested no more than 7-days prior to the start of the work in the lab. For more information related to student testing visit: https://www.uky.edu/coronavirus/students/testing-screening-and-tracing
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Biological Safety
The Department of Biological Safety and Division of Environmental Health & Safety encourage all personnel to continue to mask up, wash your hands, complete daily health screenings, and physically distance. We remind all research staff that lab safety practices and procedures in place prior to COVID-19 should continue to be followed. Additional COVID-19 information and resources are available on our website, https://ehs.uky.edu.
Monthly meetings of the UK Institutional Biosafety Committee (IBC) will continue to be held via videoconference for the remainder of 2020. Per the NIH Guidelines these meetings are open to members of the community and individuals interested in attending can email brandy.nelson@uky.edu to request access.
The UK Department of Biological Safety has been reorganizing. Holley Trucks, who has served as the Assistant Biological Safety Officer for more than 10 years, has started a new role as the Animal Research Compliance Manager. Delena (Dee) Mazzetti, who has served as a Sr. Biosafety Specialist and IBC administrator for more than 10 years, has taken on the role of Assistant Biological Safety Officer. If you’ve ever been interested in a career in Biosafety, now may be your opportunity. We will be posting new positions soon. Check in at https://ukjobs.uky.edu for future job postings. |
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Russell Sage Foundation: Request for Articles on the Social and Political Impact of COVID-19 in the US
Learn more / Nov 3, 2020
This recognizes theoretical and empirical papers which enhance initial understanding of the social and political impacts of the COVID-19 outbreak in the US by publishing them in the foundation's journal. Papers should demonstrate early research on the following:
- how social and political dynamics shape responses to the pandemic
- how the pandemic itself alters social and political dynamics for individuals, communities and institutions.
This includes research exemplifying the interplay among politics and policy; information exchange; economics; psychology; social structures, including networks and institutions; power and status; and public behavior in the US. Authors of each published paper will receive an honorarium worth $1,000. They will also receive support to present and finalize their draft paper.
Christopher and Dana Reeve Foundation: Quality of Life Grants Program COVID-19 Grant
Learn more / LOI Oct 13, application Nov 20, 2020
The aim of the Reeve Foundation’s new Quality of Life (QOL) grants program is to address social isolation during the COVID-19 pandemic with the goal of enhancing connectedness of people living with paralysis and their caregivers to their communities and preventing adverse health outcomes. Six to 10 grants will be awarded within the range of $25,000-$50,000.
Though we are looking to the field for innovative ways to address the program’s aim and goals, funds may support programs and projects to:
- Connect isolated individuals and remotely foster engagement and connection through
- Virtual support groups
- Online activities to help support self-care and stress management
- Virtual and online adaptive physical activity and health promotion programs
- Art sessions
- Gaming
- Adapt services or create new services to continue to support and engage family caregivers
- Facilitate connection through the use of technology, including increasing access to internet, broadband service, and tablets (via loan closets)
- Provide programs with online opportunities for volunteering
- Create strategies to strengthen and/or build social networks
- Provide access to tools and resources to help people remain connected and engaged
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FDA-Regulated Clinical Trials COVID-19 Guidance
September 21, 2020, the FDA issued guidance for investigators and sponsors regarding the measurement and analysis of COVID-19-related symptoms in clinical trials evaluating drugs to prevent or treat COVID-19 in outpatient adult and adolescent subjects. Since daily assessment of all COVID-19 related symptoms may not be feasible or may be burdensome for subjects, the guidance provides a set of common COVID-19 related symptoms and approach to measurement. The guidance also provides recommendations on endpoint selection and efforts to minimize missing data. It recommends including information in the consent document and process to educate participants on the importance of providing follow-up data even if they choose to discontinue investigational treatment.
The agency also updated the FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, originally issued in March. The September update includes question and answers on a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol and considerations for electronic signatures on clinical trial records, including consent documents, during the public health emergency. |
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There are three COVID-19 Unified Research Experts (CURE) Alliance teams.
PURPOSE:
- To facilitate and coordinate COVID-19 research within a given area at UK
- To align COVID-19 research in given area to funding opportunities
- To serve as a liaison both within and external to UK in area COVID-19 related research
TEAMS:
INTERNAL PILOT FUNDING:
July 13, 2020: Due to current commitments to many excellent applications, we are not accepting new applications for the UK CURE Alliance COVID Pilot Program. Availability of funds will be reevaluated in four to six weeks. Please contact Joel Thompson ( joel.thompson@uky.edu) if you have any questions.
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If you have general questions related to research operations during the COVID-19 pandemic or would like to report non-compliance of a laboratory or PI as it relates to the UK Resumption of Research Plan please email research-covid@uky.edu.
Below are specific contacts that provide specialized services to support our research community:
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undefinedBiological Safetyundefined
Brandy Nelson, undefinedbrandy.nelson@uky.edu, (859) 257-1049undefined
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undefinedOffice of Sponsored Projects Administration (OSPA)undefined
Contact your college RA or CGO, call (859) 257-9420, or visit undefinedwww.research.uky.edu/office-sponsored-projects-administrationundefined
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undefinedOffice of Research Integrity (ORI)undefined
undefinedrs_ori@uky.edu, (859) 257-9428undefined
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undefinedProposal Development Office (PDO)undefined
undefinedpdo@uky.eduundefined
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undefinedOffice of Technology Commercialization (OTC)undefined
undefinedotcinfo@uky.edu, (859) 323-1054undefined
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undefinedOffice of the Attending Veterinarianundefined
Mark Suckow, undefinedmsuckow@uky.edu, (859) 257-1117undefined |
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