October 16 Email Update

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.

UK INFECTIOUS DISEASES RESEARCH DAY 2020
The COVID-19 pandemic - What have we learned?

November 5, 2020
1 pm - 3:45 pm
Register

When in public, wear a cloth face covering over your nose and mouth. Wash your hands often with soap and water, for at least twenty seconds.

New FAQs

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

See more FAQs

Biological Safety Updates

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.

It is a good time to check the certification expiration date on your biosafety cabinet. Biosafety cabinets must be certified annually to ensure their performance maintains safe operations for personnel, research materials, and the environment. Certification may be scheduled by contacting one of UK's approved vendors. See approved vendor pdf.

PPE at UK Supply Center

The UK Supply Center currently has a significant supply of the following items available for departmental ordering: Lysol, ear loop face masks, nitrile gloves and hand sanitizer.

Departments can order needed items through the UK Supply Center online catalog available via their website. Departments should consider utilizing the Supply Center for these items prior to sourcing similar items from external suppliers. Questions can be directed to the Supply Center through the Contact information page on their website.

Salaries Charged to Federal Sponsored Projects

The Office of Management and Budget (OMB) initially provided flexibilities allowing Federal agencies to grant administrative, financial and audit requirement flexibilities to recipients of Federal awards. Most of those flexibilities expired in June and July (for M-20-17 and M-20-20). The flexibility and allowability of salary and other project activities (in M-20-26), which were originally extended through September 30, 2020, have also expired. As a result, charges for salaries and benefits for project personnel during low operational activity (as defined in HR Policy 70 as Administrative No-Pay) are no longer allowable charges to sponsored projects. As a result, personnel in Admin No-Pay status can no longer be charged to a sponsored project. This restriction will remain in place until the Federal government takes action to extend or reinstate the administrative and financial flexibilities. The Council on Governmental Relations (COGR), Association of American Universities (AAU), Association of American Medical Colleges (AAMC), American Council on Education (ACE) and American Association for the Advancement of Science (AAAS) submitted a letter, dated September 2, 2020, to OMB requesting extension and reinstatement of M-20-17 and M-20-26. Further information will be provided if the status of these flexibilities change.

CURE Alliance Core 1 Health & Biomedical Sciences:

One of the more interesting questions many of us have been asking ourselves about COVID-19 is why do some people hardly know they are sick while others have more severe symptoms, are hospitalized, or even die? We have heard that being older and having underlying diseases increases the risk for a severe infection, but this does not account for all the variability we have seen in the population. So, is there something else, maybe a genetic difference? Two recent papers published in the journal Science by an international collaboration of investigators provide some evidence that our genetics may make a difference in how severe the infection may be. Type I Interferon (IFN) is a protein that is known to be important in defending infected cells against viruses. Using what is known about IFN during infection with influenza virus, in the paper by Zhang, et al., the authors identified a group of genes that when mutated result in loss of function and reduced production of IFN. Interestingly, they found that a cohort of 23 of 659 patients with life-threatening COVID-19 had these mutations and concluded that these mutations and others like them contribute to the severity of disease in some patients. An accompanying paper by the same group ( Bastard, et al.) reported that about 13% of 987 patients with life-threatening COVID-19 had auto-antibodies specific for varying types of IFNs whereas none of the 663 patients examined with mild symptoms or who were asymptomatic had auto-antibodies to IFN. Together, these two papers confirm the importance of type I IFN in host defense against SARS-CoV-2 and indicate that severity of disease can be due to inborn errors of immunity.

CURE Alliance Core 2 Materials & Methods:

Single chain antibodies have the potential to safely neutralize coronaviruses by binding and blocking the virus’s characteristic spike protein. The recent paper by Wrapp, et al. describes the structural characteristics of the single chain antibodies and the spike protein that are central to this novel pathway to slowing the spread of this disease.

CURE Alliance Core 3 Social Sciences:

A new article ( Simon, et al.) out this week summarizes research showing that almost half of American results reported symptoms of mental health difficulties in June 2020 with more than 10% reporting thoughts of suicide. It raises the issue of prolonged grief being a concern given the increased numbers of deaths due to COVID-19. The authors describe specific concern about the mental health of health care workers and other essential workers and advocate for funding of research and additional training for primary care and mental health personnel. The article concludes: “In summary, a second wave of devastation is imminent, attributable to mental health consequences of COVID-19. The magnitude of this second wave is likely to overwhelm the already frayed mental health system, leading to access problems, particularly for the most vulnerable persons. The solution will require increased funding for mental health; widespread screening to identify individuals at highest risk including suicide risk; availability of primary care clinicians and mental health professionals trained to treat those with prolonged grief, depression, traumatic stress, and substance abuse; and a diligent focus on families and communities to creatively restore the approaches by which they have managed tragedy and loss over generations.”

Research on Rehabilitation Needs Associated with the COVID-19 Pandemic
NOT-HD-20-031 / First Due Date: February 5, 2021

The purpose of this Notice of Special Interest is to encourage applications in three areas related to the intersection of COVID-19, the associated mitigation actions, and rehabilitation:

Encourage research to address the rehabilitation needs of survivors of COVID-19
Understand the impact of disruptions to rehabilitation services caused by the COVID-19 pandemic and associated mitigation actions
Understand the social, behavioral, economic, and health impact of the COVID-19 pandemic and the associated mitigation actions on people with physical disabilities

Research applications addressing these topics are considered responsive; not all topics are expected within the same application. Applications will be directed to the National Center for Medical Rehabilitation Research (NCMRR) at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

See Additional COVID-19 Funding Opportunities

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.

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:

Health CURE Alliance: Becky Dutch, College of Medicine
Materials/Methods CURE Alliance: Brad Berron, College of Engineering
Social Sciences CURE Alliance: Julie Cerel, College of Social Work

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.

Learn More

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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:

Biological Safety
Brandy Nelson, brandy.nelson@uky.edu, (859) 257-1049

Office of Sponsored Projects Administration (OSPA)
Contact your college RA or CGO, call (859) 257-9420, or visit www.research.uky.edu/office-sponsored-projects-administration

Office of Research Integrity (ORI)
rs_ori@uky.edu, (859) 257-9428

Proposal Development Office (PDO)
pdo@uky.edu

Office of Technology Commercialization (OTC)
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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