Research Guidance | COVID-19
Last Updated April 3, 2020 - 6:00 PM
RESEARCH ACTIVITIES - state of ohio stay at home order
Updated April 8, 2020 - 6:00 PM
The University is restricting on-campus research activity to critical research and essential functions until further notice.
Gov. Michael DeWine issued a "Stay at Home" order on March 23, which has been extended to May 1.
Please make every effort to work from home. However, part of this executive order permits critical research and essential functions to continue at the University. All UToledo research is restricted to critical research activities as defined below.
Only essential personnel that have been approved by their college dean and the Office of Research are to access research laboratories to maintain "critical" research laboratories and provide essential research laboratory support functions. PIs/Laboratory leads must submit the Critical Personnel form (COVID-19 Forms Page) to their department chair and dean for approval of all essential personnel.
Critical Research and Essential Research-Related Activities Include:
- Activity that if discontinued would generate significant data and sample loss.
- Activity that if discontinued would pose a safety hazard.
- Activity that maintains critical equipment in facilities and laboratories.
- Activity that maintains critical samples, reagents, and materials.
- Activity that maintains animal populations
- Activity that maintains critically needed plant populations, tissue cultures, bacteria, archaea, and other living organisms
- COVID-19 related activity that has a timeline for deployment that could address the crisis.
- Activity in support of essential human subject research.
- Clinical trial activity that if discontinued would negatively impact the patient’s care.
As a reminder, faculty members cannot and should not require graduate students to come to campus. Graduate students need to have approval from their department chair to be designated as essential personnel.
Essential personnel should be limited to one to two individuals in each research group, with exceptions clearly justified.
Identify alternative essential research personnel in case individuals have health issues or other reasons why they cannot fulfill the responsibility to the laboratories. Please continue to adhere to the university guidelines for social distancing while protecting health and safety of those working in the laboratories.
For general UToledo information and recommendations related to COVID-19, please see the 2019 Novel Coronavirus website.
Temperature Check and Reporting for those Working On Campus:
All UToledo employees authorized to work on campus must self-check and submit their body temperature before reporting to work. Employees who have a temperature reading at or above 100.0 degrees Fahrenheit should not report to work. While presence of a fever does not necessarily mean an individual has COVID-19, individuals with an elevated temperature should monitor themselves for respiratory symptoms, such as cough and shortness of breath, and call their primary care provider if their condition worsens.
UToledo Human Resources has developed a webform through which employees can submit their temperatures.
Employees who are working remotely are not required to monitor their temperatures.
The following are specific recommendations to researchers in planning for potential impacts of COVID-19 in our region.
Research Facilities and Laboratory Safety
See additional guidance on lab safety and disinfection through this link.
Updated April 2, 2020 - 5:00 PM
Update your Research/laboratory group contact list. Keep both hard and electronic copies in a remotely accessible drive.
Please establish a system by which lab members can and will check the status of each other. We must look after not only our physical health, but also consider the mental health impact that current events can have on our research community.
Will there be interruptions in laboratory experiments, due to coronavirus?
Research laboratories are required to reduce on-site activities to critical research and essential functions effective midnight March 23, 2020 by order of the Ohio governor. A Laboratory Ramp Down Checklist has been sent in prior communications. All group meeting should be held remotely.
Core facilities may not be available (the Histology Core on the Health Science Campus is not accepting new samples).
All researchers should observe the 6' social distancing in any shared usage space when conducting critical research. Consider staggered work schedules keeping safety protocols in mind and communicate the need to avoid performing high-risk procedures alone. Proper personal hygiene is critical to mitigating the spread of the disease.
Should Researchers Expect Shortages of Personal protective Equipment (PPE), Such as N95s and Gloves That Are Often Used In Laboratory Spaces? If So, How Should They Prepare?
It would be prudent for PIs and research laboratory supervisors to anticipate a PPE shortage, and limit the number of personnel entering lab spaces that require donning and doffing of PPE (masks, gowns, face shields, etc.) for critical lab functions. This is especially important for users of N95 masks because these items are being prioritized for the healthcare industry. Please contact EHRS to discuss options available if shortages do occur.
What can I plan to Take Out of my lab or office?
Researchers are not allowed to set up an off-campus laboratory site. Under no circumstances is it appropriate to remove animals or other materials from UToledo-approved housing or research spaces.
Researchers may arrange with their PI or lab manager to take copies of notebooks, data storage devices, or laptop computers for remote work.* No other materials, equipment or laboratory supplies are allowed offsite.
*Transfer and/or transport of Controlled Unclassified Information (CUI) or other data that requires a controlled environment requires prior approval from the Export Control Officer (Gary Rafe. Gary.Rafe@UToledo.edu ) and must be in accordance with UToledo Data Security Policies.
What additional recommendations do you have to prepare my laboratory research area?
Only engage in critical experiments at this time. Assess and prioritize critical laboratory activities (e.g. cell culture maintenance, etc.) and identify essential personnel. Secure access to laboratory notebooks and records. Ensure that you have access to contact information for your staff. Finally, work with your staff to ensure that they have the ability to work remotely on items such as monitoring experiments (if possible), data analysis, writing, literature review, and proposal editing. Also, see the information posted on Research Lab Safety Procedures.
Will there be interruptions in Institutional Biosafety Committee (IBC) activities, including review of protocols and amendments, due to coronavirus?
The IBC and support staff will continue to review submissions (i.e., protocols and amendments) during this time. If you have any questions, please email IBCommittee@utoledo.edu .
Will the Department of Environmental Health & Radiation Safety be available during time?
EHRS will maintain all essential functions, such as emergency spill and fire response, hazardous waste collection and supplies, radioactive package delivery, and public health activities. Depending on staffing, non-essential operations may need to be suspended.
Proposal Submission and Award Management
Updated March 18, 2020
Will the Office of Research and Sponsored Programs be available to process submissions and awards during this time period?
Although the Office of Research and Sponsored Programs (ORSP) staff may be working remotely, submissions and processing of awards will continue according to the normal operations and posted sponsor proposal deadlines. Employees who are working remotely will respond to emails and monitor phone messages during normal business hours.
Will my proposal still be submitted to the federal government on time if the federal agency to which I intend to apply is closed due to a COVID-19 outbreak?
Currently, federal agencies are accepting proposal submissions as usual. If a COVID-19 outbreak closes a federal agency that is currently accepting proposals, we expect that the agency will continue to accept proposals with the proposals remaining in a queue pending resumption of agency operations. The Council On Governmental Relations webpage features comprehensive links to key federal agencies' COVID-19 operations.
Will I be able to get an extension on a proposal deadline in the event of a COVID-19 outbreak?
Most sponsors, including NIH and NSF, do not grant prior approval for late submission; however, there are existing sponsor polices that address extenuating circumstances. Please do not count on receiving extensions and plan your time accordingly. Current NIH guidance can be located at NOT-OD-15-039 and Special Exceptions to NSF's Deadline Date Policy (PAPPG 19-1).
Also see
- NIH LATE APPLICATION POLICY Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19) - issued 3/9/2020
- Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 (link is external) - issued 3/12/2020
- NSF FAQs #16 and #17 - issued 3/4/2020
Allowable Costs, Charges, Effort on Sponsored Projects
Updated March 24, 2020 - 5:00 PM
I'm the principal investigator on a sponsored project with non-essential research. can my effort and that of my research team still be charged to the grant during a "Stay-At-Home" order?
In general, yes, provided that you and you team remain engaged in your sponsored project. ORSP is updating Sponsor Information frequently.
It is the PI’s responsibility to ensure that all paid participants and key personnel remain engaged in the sponsored project. If the project scope requires adjustment due to remote working conditions, the PI should contact their sponsor project manager requesting a change in scope – keep the Office of Research & Sponsored Programs (and your Grants Accounting Analyst or Director of Grants Accounting, Laura Hallauer) informed of changes in project scope.
I’m a Principal Investigator, Post-doctoral researcher, research assistant or other funded project personnel working remotely from home during self-quarantine. Can my effort still be charged to the grant?
In general, yes, provided you remain engaged in your sponsored project. Current NIH and NSF approval requirements remain in effect if you become disengaged or reduce effort on your projects.
What if I’m sick and can’t work on my project? Can my salary still be charged to the grant?
Yes. Sick leave and other paid absences permitted under university policy may be charged to the grant pursuant to the University’s indirect cost rate agreement with the government.
I'm A Principal Investigator or researcher and I am required to work from home due to the coronavirus. Would I be able to charge supplies related to telework (printer and office supplies, laptop, etc.) to the grant?
These types of expenses are considered administrative costs (indirect costs) and generally cannot be charged to a grant.
Human Subjects Research – Pause of Selected Studies
Updated April 8, 2020
The following FAQs pertain to the human subjects research pause memo sent to IRB protocol principal investigators on March 16, 2020. This pause does NOT apply to research on COVID-19. Please contact the Human Research Protection Program (HRPP) for additional guidance.
| March 16, 2020 Notice of Pause in Face-to-Face Studies from Dr. Frank Calzonetti |
Which human subject studies elements must be paused?
All face-to-face interactions with participants, unless the interaction is essential to the health and well-being of the participant. Essential studies with direct face-to-face interactions may continue. To the extent possible, study activities that can be done electronically or remotely, should be done this way.
Non-essential studies that require direct face-to-face interactions must immediately pause new enrollment and discontinue face-to-face interactions unless study procedures can be modified to use alternative methods of gathering study data (e.g., on-line technologies, telephone interviews, email).
Studies involving no direct face-to-face interactions with participants may continue (e.g., tissue collection for subjects undergoing standard care, secondary data analysis, remote or online contact).
Which human subject studies are considered essential?
Generally, essential studies are therapeutic studies critical to the treatment of a significant life-threatening condition. Examples of non-essential studies include interventions intended to improve health but not for the treatment of a specific disease and therapeutic studies for conditions that are not life-threatening in the near-term.
What should I do if I think my study is considered essential?
Notify the HRPP via email to irb.biomed@utoledo.edu indicating why the you believe that study is essential and what additional precautions are in place for the safety of participants.
May new subjects be enrolled on existing studies not subject to the pause?
This should be decided on study-by-study basis. The risk/benefit ratio may have changed from the time at which the protocol was reviewed and approved. For biomedical studies, in particular, study teams should evaluate how illness and absences, drug shortages, facility closures, or lack of required personal protective equipment may impact treatment, delivery or monitoring.
What additional precautions should I take when conducting direct face-to-face interactions?
Follow UTMC related guidance as issued. For example, visitors will be screened for fever and respiratory symptoms upon entering the hospital.
Call participants in advance of their appointment to determine if they have traveled recently or have a fever. If necessary, researchers may determine that the appointment should be canceled and give a recommendation to contact their healthcare provider.
Should observation studies be paused?
Yes, if they have face-to-face contact.
Does this pause apply to studies being conducted at other locations?
Yes, this applies to all UToledo faculty, staff and students conducting research with human subjects.
Do we need approval from the IRB for communications to study subjects explaining the pause in activities?
No. It is not necessary to submit a modification.
If I am pausing study procedures on a project reviewed by an external IRB of Record, must I notify that IRB?
Yes, as soon as feasible. The IRB of Record may require review/approval prior to resumption of study procedures.
I am conducting FDA-regulated research and I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?
Yes. The FDA will need to be notified. Contact the HRPP via email at irb.biomed@utoledo.edu for specific guidance on the notification process.
Should NIH or other sponsors (federal, industry or non-profit) be notified that select protocols or face-to-face activities of a funded research study will be paused?
Yes. The PI should notify the Sponsor and send a copy of the correspondence to the HRPP via email at irb.biomed@utoledo.edu.
May IRB-approved screening of potential subjects continue by phone or email?
Yes
Can I submit a new study for IRB review that includes direct face-to-face interactions?
Yes, but you cannot begin the face-to-face components of your study until after UToledo lifts the pause on select studies.
Must the IRB approve amendments to the study protocol before implementing changes?
Yes, except where necessary to eliminate immediate hazards to human subjects. If a change is made to eliminate immediate hazards to participants, please notify the IRB following the the Deviation Procedure.
Is an amendment necessary if I wish to change the mode of data collection for my exempt study?
Yes, UToledo IRBs review amendments to exempt studies.
How will the pause in my research impact my grant expenditures?
All study-related activities that are not affected by a pause can continue to be charged as normal. Additionally, there should not be a significant disengagement of the PI or other senior key personnel from affected projects.
My study may be impacted by the pause, which could lead to delays in completion. What should I do?
Most federal sponsors, including NIH, allow for a one-time no cost extension for 12 months at the end of the project. Contact ORSP to discuss options prior to your project end date.
Research involving animals
Updated March 19, 2020
| March 18 Notice - DLAR/IACUC Steps to Mitigate COVID-19 Impact on Animal Research from Dr. Frank Calzonetti |
What plans are in place to ensure that animals continue to receive husbandry and veterinary
care?
Our veterinarian and DLAR staff are considered to be essential personnel and will continue to provide veterinary medical care; assessment of animal health and wellbeing; provision of food, water, and clean cages; and maintenance of proper environmental conditions for animals located in DLAR facilities. PI's are responsible for the care of animals outside of DLAR facilities. Identify essential personnel and limit animal access to only those personnel to manage current experiments.
In-person DLAR training courses have been cancelled and will be scheduled at a later date.
Will there be interruptions in animal experiments, Due to Coronavirus?
Current studies may continue to completion, if they may be monitored according to the animal protocol and humane endpoints. However, no new animal studies will be approved to start until further notice. Breeding must cease and no new breeding pairs may be established.
Can orders Still be Placed for New Animals and Are Exports of Animals Permitted?
Until further notice, to minimize the number of animals requiring daily care, orders for additional animals are no longer being accepted. Imports and exports of animals are halted until further notice. At this time, we recommend that study teams with pending orders or transfers consider canceling or postponing these unless animal welfare will be compromised.
Will there be interruptions in institutional Animal care and use committee activities, including review of protocols and amendments, due to coronavirus?
The Institutional Animal Care and Use Committee (IACUC) and support staff will continue to review submissions (I.e., protocols and amendments) during this time. If you have any questions, please contact the IACUC office at IACUC@UToledo.edu.