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CU Denver | Anschutz 3/27/2020 Coronavirus Research Guidance |University of Colorado Anschutz Medical Campus CU Denver | Anschutz Photo provided by the National Institute of Allergy and Infectious Diseases’s Rocky Mountain Laboratories. CORONAVIRUS RESEARCH GUIDANCE The University of Colorado Denver | Anschutz Medical Campus continues to closely monitor the outbreak of coronavirus disease, known as COVID-19. With the ongoing concern about the spread of this disease, laboratories and research facilities should begin to plan for the possibility of a disruption to normal operations. The purpose of this communication is to help your planning and preparation activities with a focus on research endeavors. There are different considerations for bench, animal and clinical research and so each research team or laboratory is best positioned to create a continuity plan that will meet their unique needs. The guidance below is provided to facilitate the development of that plan. Please remember that unit Continuity of Operations Plans (COOPs) are also required to be completed, which will help with this process. Please contact [email protected] with questions. MOST RECENT UPDATES Additional Research Access Information March 23, 2020 First, we want to thank everyone in the research community for your flexibility and partnership in working through the changes of the last few days... Volunteer and Donation Opportunities March 20, 2020 With the rapidly changing landscape during the COVID-19 outbreak, many of us are reflecting on ways in which we can help. Many have already done so, through donation of supplies... Approval process to access the CU Anschutz or CU Denver Campus and/or conduct face-to-face clinical research activities March 18, 2020 As the campus continues to balance the risk to participants and employees related to COVID-19, acknowledging the potential therapeutic benefit of certain clinical research studies... Initial Review Process for COVID-19 Clinical Research Protocols Seeking Approval During the Pandemic March 16, 2020 Given limited access to the hospital, this committee will evaluate COVID-19 clinical research protocols that are seeking approval during the coronavirus outbreak... Previous Updates Assumptions that you can use for planning, based on a scenario with widespread COVID-19 communal transmission Steps you can take now to ensure continuity of critical functions Vivarium Considerations for the Denver | Anschutz campuses OLAR has sufficient food, water, and supplies and cross training of staff to cover basic vivarium operations (health monitoring, basic husbandry, and facility maintenance). In the event of quarantine or significant staff shortages, only essential functions required to maintain the health and well-being of the animals will be performed, including maintenance of unique genetic lines. All biosecurity measures and PPE requirements will remain in effect to protect colony health. Any changes or modifications in standard procedures will be communicated with research staff. Research essential functions such as breeding and administration of experimental agents that are not able to be completed by lab staff due to illness or quarantine should be communicated with OLAR as early as possible. OLAR will assist with these as staff time permits. Research personnel are asked to plan for potential phased reductions of research activities with animals. If these reductions are necessary, OLAR will communicate with research staff prior to asking the research community to implement any of these phases. Phases should include: Delaying the ordering of new research animals Delaying the start of new animal studies Decreasing colony size to minimum maintenance levels, including separating most breeding animals to the minimum required to maintain unique lines Ending research studies early in the vivarium https://www.cuanschutz.edu/coronavirus/research-guidance 1/3 3/27/2020 Coronavirus Research Guidance |University of Colorado Anschutz Medical Campus Research personnel that are willing to assist OLAR with basic husbandry and colony maintenance are asked to contact OLAR. OLAR will maintain a list in case OLAR staff levels are significantly reduced. Screening for COVID-19 Risk in Clinical Research Participants Measures you can take to prevent the spread of illness among your group if the risk of COVID-19 increases within the CU Denver | Anschutz Medical Campus community Sponsored project guidance IRB Information for our researchers in response to COVID-19 Laboratory Housekeeping: Expectations for Cleaning and Disinfection FREQUENTLY ASKED QUESTIONS FOR SPONSORED PROJECT ADMINISTRATION How does COVID-19 affect the University’s travel policy? I was planning grant-related travel, but the conference was cancelled due to precautions regarding COVID-19. May I still charge the travel-related costs to the grant? What guidance does the Procurement Service Center (PSC) provide regarding travel? I need to purchase travel soon. What should I do? I have a conference or travel award, but the conference has been canceled. What should I do? Who should I contact if I do not know what to do? Can an employee in self-isolation still charge time and effort to an award? Can an employee’s sick leave be charged to an award? Can charges related to telework, such as a laptop, be charged to an award if I am required to work from home? Can I charge salaries and benefits to an award if an employee cannot work on an award? One of my subrecipients is at an organization that is closed. What impact will this have on my research? Will federal agencies provide an extension to proposal deadlines? What reagents and supplies are needed, and how can I donate? What is the latest guidance on HIPAA and working remotely? I have an award from a non-federal sponsor (industry, association, state government, etc.). What should I do? https://www.cuanschutz.edu/coronavirus/research-guidance 2/3 3/27/2020 Coronavirus Research Guidance |University of Colorado Anschutz Medical Campus What is FDA guidance on Conduct of Clinical Trials of Medical Products? What is NIH's guidance on Clinical Trials? What is NIH’s guidance on costs at this time? What is NIH’s guidance on Financial, RPPR and other reports? What is NIH’s guidance on Prior Approval Requirement Waivers? What is NIH’s guidance on Extension of Closeout? What is NIH’s guidance on LATE APPLICATIONS for institutions impacted by COVID-19? NEXT STEPS The university is following guidance from the Colorado Department of Public Health & Environment (CDPHE), CDC and other agencies. The individuals involved in planning the university’s response are working in consultation with experts from UCHealth, EHS (Environmental Health and Safety), University Emergency Management, the School of Medicine and others on campus to update the university’s existing pandemic response plan in the event of widespread U.S. community transmission of COVID-19 or announcement of a COVID-19 pandemic. Expect to see additional updates, including research specific FAQs via email, as well as updates to the university’s COVID-19 webpages. CU Anschutz COVID-19 Updates CU Denver COVID-19 Updates https://www.cuanschutz.edu/coronavirus/research-guidance 3/3.
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