Coronavirus and Your Research Program

 

Campus-wide messages related to research:

On this page:

If you have any questions, please contact Stephanie Endy at sne16@case.edu.

 

Research Restrictions as of March 17, 2020

Restriction 1: Human Subjects Research

During this period of remote work, there should be minimal contact with human subjects involved in research. Contact with human subjects should be limited to remote methods (e.g. email, phone, Zoom, RedCap, Qualtrics) to the extent possible. Please contact the IRB Office if you need to revise or amend your IRB protocol to conduct remote interviews or surveys. 
 
In those instances in which human subjects research cannot be performed remotely, and are not essential to a participant's health, researchers should work with their teams to develop revised/alternative plans to enable continued progress on research or should delay projects. 
 
Researchers who need to have physical interactions with human subjects in clinical trials should follow the guidance of the hospital or clinic in which those studies are taking place.

Restriction 2: Students

Undergraduate Researchers

Undergraduate students are not permitted to be on campus to carry out any research activities.

Graduate Student Researchers

Graduate students conducting research for their thesis/dissertation or as part of a research assistantship may continue their research activities, if possible to do safely while using social distancing, staggering of time in labs, etc. However, research groups should implement mechanisms and/or shift activities to conduct research remotely wherever possible (e.g., computational work, research of online resources and databases, data analysis, etc.). Where research activities on campus and in associated research facilities are necessary, additional practices should be adopted to keep health and safety a priority (see section on Planning below).

 

Preparing Your Research Program

Now is a good time to make sure that we are prepared for the impact of the Novel Coronavirus on our research. In addition to the guidance published on this page, please also consider the guidance for investigators from Vice President for Research Dr. Suzanne M. Rivera on March 13, 2020.

Here are a few simple scenarios in which to consider these impacts:

  • What would the impact be to my research and sponsored programs if I had to self-isolate for two weeks?
  • What would the impact be to my research and sponsored programs if more than one of my research staff had to self-isolate for two weeks?
  • What would the impact be to my research and sponsored programs if CWRU advised all faculty and staff to work remotely?
  • What would the impact be to my research and sponsored programs if CWRU partially reduced campus operations?
  • What would the impact be to my research and sponsored programs if the event duration were two, four, or six weeks?

Here are a few ways to begin assessing the potential impact of the coronavirus on your research in any of the above scenarios:

  • Are there any studies involving participants, animals, ingredients, or experiments that would be adversely affected?  If so, what plans should be put in place to allow for them to continue or allow for them to be stopped and later resumed in the least impactful way?
  • What standing purchasing orders or human resource issues might be impacted?
  • Would data collection/analysis/storage be impacted?
  • What costs would be associated with these impacts?
  • What regulatory approvals will expire soon and might be impacted if they are not renewed? Can they be renewed early?
  • Are there any collaborators that need to be notified?
  • What sponsor reports or deadlines might be due during this time period? 
  • Would the impact of these actions warrant a for-cost or no-cost extension request for any of my sponsored projects?
  • What notice might I need to give sponsors or regulators if the research is going to be paused or significantly delayed beyond a couple of weeks?

Once you have considered the impact for each of these scenarios, please take appropriate steps to make sure your research program is prepared. 

If you have any questions, please contact Stephanie Endy at sne16@case.edu.

 

Additional Considerations for Human Subjects Research

  • Is the location of the study remaining open and available for participants to be present?  Has the location implemented any procedures to slow the spread of the coronavirus that will affect participation in your study or the ability of your study to proceed?  
  • Does your protocol require in-person participation or treatment?  Can it be modified for remote participation?
  • Does your protocol require in-person monitoring?  Can it be modified for remote monitoring?
  • Should your participants be screened for coronavirus as part of your inclusion/exclusion criteria?
  • Would your data or results be affected if your participants had to self-quarantine or if they contracted coronavirus?
  • Do any modifications made to your protocol and approved by the IRB due to the coronavirus also need to be reflected in ClinicalTrials.gov?

Remember, any modifications you make to your protocols as a result of preparation for the coronavirus need to be submitted to the IRB and approved before implementation.

Additional Resources

 

Additional Considerations for Environmental Health and Safety

Most considerations for environmental health and safety would only come into play should critical lab staff with unique knowledge be unavailable.

  • Do you have a limited number of critical lab staff with unique knowledge?  Are there others in your lab who can be cross-trained?
  • Does your lab operate machines that use active cooling through liquid gasses, dry boxes, or inert boxes using gas blankets?  What would happen if materials like liquid gasses, CO2, nitrogen, or dry ice become unavailable?
  • How frequently are you saving or freezing samples of your cell cultures?
  • Do you have long-term experiments that might benefit from more frequent preservation?
  • Do you have the requisite local knowledge to do controlled shutdowns of complex machines or devices such as NMRs without on-site help from the company?
  • Have you shared with EHS the locations and amounts of materials that are air, water, or otherwise unstable for observation in case of lab closure?

Please note: 

There is no need to order more gasses or cryogenic liquid gases then your research currently requires or can safely store. Case Western Reserve University has taken proactive steps to secure materials of strategic importance to the continuity of research.  One such class of materials is the continued supply of air gases and cryogenic liquid gases.  CWRU is working with our main vendor, Airgas, to assure the continued supply of these materials. We have verified continuation of service with Airgas and their supply chain.  We are confident that we will continue to receive the required resources and to continue to receive liquefaction and compression capabilities necessary to see CWRU safely through any disruption caused by COVID19.  In addition, Airgas is working with the university to site additional strategic materials on campus so that we have a buffer supply in the case of a service disruption to the Airgas supply chain.  These gasses include but are not limited to: Carbon Dioxide and 3% Hydrogen Balance Nitrogen.  Airgas has assured us that there is continued local supply of liquid nitrogen and liquid helium available. Finally, CWRU is working with Airgas to look into additional onsite placement and delivery of air gasses should there be a pronounced stop in supply chain availability.

 

For questions about EHS, or to report locations of unstable materials, please contact Marc Rubin at mdr6@case.edu.

 

A more complete listing of agency guidance is available on the COGR website at https://www.cogr.edu/institutional-and-agency-responses-covid-19-and-additional-resources.

 

 

Other Guidance

Council on Governmental Relations FAQs Regarding COVID-19's Impact on Federal Awards

 

If you have any questions, please contact Stephanie Endy at sne16@case.edu.