Research and Sponsored Programs

Research Guidance | COVID-19


Updated August 5, 2020

ENTERING UNIVERSITY FACILITIES

Access to Health Science Campus (HSC) buildings are restricted to swipe card access only.  For those who do not have swipe card access, you must enter through either the main hospital entrance or Dowling Hall entrance for on-site temperature screening. Buildings are open on Main Campus.  For direct entrance to buildings on Main Campus or HSC, you should monitor for COVID-19 symptoms.

You must not enter buildings if you develop or display symptoms of COVID-19, including but not limited to fever, coughing or trouble breathing. While on campus, individuals are required to wear a face covering, unless eating or alone in an enclosed room or space and to maintain social distancing.  UToledo employees who may qualify for a face covering waiver can submit a request using the current accommodation process.  UToledo students who may qualify for a face covering waiver should contact the Office of Student Disability Services at 419-530-4981 or StudentDisability@utoledo.edu.

If you have been exposed to someone who has tested positive for COVID-19, please see information on the Corona Virus webpage.

If you would like to be tested for COVID-19, UTMC has limited testing opportunities or please visit the Ohio Department of Health site for a list of testing centers in Lucas County.

To voluntarily report a positive COVID-19 case, please contact your designated representative:

  • Faculty - Provost Office at 419-530-8481 or by email.
  • Staff - Human Resources at 419-5830-1481 or by email.
  • Students - Division of Student Affairs at 419-343-9946 or by email.

If you test positive for COVID-19, you cannot enter university buildings or facilities or return to work until ALL of the following criteria have been met:

  • You have gone 24-hours without a fever of 100.0°F or greater.  This must occur without the use of fever-reducing medicines.
  • An improvement in respiratory symptoms, such as cough, shortness of breath; and
  • At least 10 days have passed since symptoms first appeared.

research continuity 

Updated November 23, 2020

Resumption of research activities are allowed to start beyond current "essential" levels on Monday, June 8, 2020 only for researchers with approved Research Operation Plans with associated approved laboratory personnel. 

A Research Operation Plan Cover Sheet document provides a summary of steps and required approvals from chairs and deans.  PIs / Research Group Leaders are responsible for developing and implementing appropriate management plans for their research groups and for training their personnel on appropriate cleaning and disinfecting, hand hygiene, and respiratory etiquette.  All researcher group leaders, including those with research deemed critical, are required to complete steps outlined in the Research Operation Plan Cover Sheet document.

Please be aware that if there is a significant increase in infections, it may be necessary to return quickly to critical research activities and essential functions only, or even to more restricted operations. 

Please continue to adhere to the university guidelines for social distancing while protecting health and safety of those working in university facilities.

For general UToledo information and recommendations related to COVID-19, please see the 2019 Novel Coronavirus website.

Access to and protocols for use of shared resources such as libraries, computing facilities, core facilities, etc. will be determined by the management of each facility.

Any individual who feels that they are being asked to carry out unsafe activities or to work under conditions that are unsafe for themselves and others should discuss their concerns with their immediate supervisor, their department chair or unit head, the College of Graduate Studies or The Environmental Health and Radiation Safety Department.

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.

 For critical and essential research, Principal Investigators/Research Group Leaders must submit the Critical Research and Essential Personnel form to their department chair and dean for approval of all essential personnel.

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. 

Research Facilities and Laboratory Safety

See additional guidance on lab safety and disinfection through this link.

Updated May 12, 2020

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?

The University has extended its remote work directive and is continuing to restrict research activities to critical research and essential functions. A target date  for expanding researcher activities beyond current "essential" levels is June 1, 2020, pending further guidance from the Ohio Governor's office.

If there is a significant increase of infections, it may be necessary to return quickly to critical research activities and essential functions after resumption of non-essential research activities. See a Checklist for Laboratory Ramp Down.

Check with core facilities Directors for availability of services.

General Research Activity Guidance

All researchers should observe the 6' social distancing in any shared usage space and wear face coverings. 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. See the information posted on Research Lab Safety Procedures.

All group meeting should be held remotely.

Should Researches 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 maintain supplies required for regular disinfection and operation.  For critical lab functions limit the number of personnel entering lab spaces that require donning and doffing of PPE (masks, gowns, face shields, etc.). 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. Ensure that you have access to contact information for your staff. 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. Finally, complete steps outlined in the Preparation for Resumption of Research document.

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.

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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

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Allowable Costs, Charges, Effort on Sponsored Projects

Updated April 14, 2020 - 12:00 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.

Where May I Find Answers to Other questions about allowable costs?

The Council on Government Relations (COGR) maintains several useful pages of resources accessible from here.  Be sure to check the COGR FAQ on COSTS.

Human Subjects Research – UToledo IRB Guidelines: Resuming Non-Essential Face-to-Face Human subjects Research Activities

Updated September 3, 2020 

September 3, 2020 - Resuming Non-Essential Face-to-Face Human Subjects Research Activities
from Dr. Frank Calzonetti
May 28, 2020 Notice - Additional Ease of Restrictions on Face-to-Face Interactions with Human Subjects
from Dr. Frank Calzonetti
April 28, 2020 Notice - The Status of Human Subjects Research & COVID-19 Situation
from Dr. Frank Calzonetti
March 17, 2020 Notice of Pause in Face-to-Face Studies
from Dr. Frank Calzonetti

The IRB’s primary focus is to protect research participants in research during the COVID-19 pandemic. UToledo has additional guidelines and policies aimed at protecting the general population (e.g., restriction of visitors to campus, lab workers, students).  Please see the following website for more information: https://www.utoledo.edu/coronavirus.

Face-to-face with human subjects on non-essential research studies must at least adhere to the following UToledo IRB guidelines below to resume.  The two scenarios not yet addressed in prior communications and guidance are: (i.) non-essential research taking place in a typical medical setting where there is additional researcher/participant scheduled visit(s) required to participate in the study and (ii.) non-essential studies that do not take place in a typical medical setting.

This guidance applies only to research taking place in UToledo facilities.  If research is taking place at an external location, researchers must submit the FYI X-form to the IRB for review of proposed face-to-face interactions with human subjects.  This includes research taking place at ProMedica.  

General Considerations

  • The IRB expects researchers to continue to use remote technologies to conduct research whenever possible.
  • Participants must be asked the COVID screening questions and informed of personal protective equipment (PPE) requirements, such as wearing a mask, BEFORE they travel to campus. This must be documented.
  • All in-person research MUST incorporate appropriate risk reduction strategies (distancing, disinfection, PPE, symptom screening) describe below.
  • When face-to-face interactions occur for research purposes, groups cannot exceed 10 people.
  • Participants are NOT allowed to bring others with them to the study appointment. This includes a prohibition from minors accompanying research participants. If your participant requires an exception, please submit the FYI X-form for IRB review.

Screening requirements before Study Visits

PARTICIPANTS

  • Being seen in a typical medical setting
    • Appropriate PPE per UTMC procedures are required.
    • If the researcher anticipates that the group of subjects targeted for enrollment cannot wear protective face coverings/mask, then this must be stated in the study protocol (or submit the FYI X-form.
      See Appendix 1
  • Not being seen in a typical medical setting
    • Before the participant arrives at the study location, have the participant complete a screening questionnaire and/or other materials to evaluate their individual risk.
      See Appendix 2
    • Check the participants' temperature with a non-contact infrared thermometer as they enter the building or area where the research will be conducted.
    • If the subject's temperature is higher than 100 F (37.8 C), and this could be explained by an external factor (for example, walking a long distance), wait five minutes and retake.
    • If you (study team) are conducting the screening survey and temperature readings, the results should be saved in the research record. This documentation MUST be per subject and properly secured.
    • See PPE and distancing requirements in the table below.

RESEARCHERS

  • Researchers must complete and document a symptom screen for themselves, including temperature, on each day that in-person contact is planned with one or more research participants. The symptom screen only needs to be completed once per day but must be completed prior to in-person contact with a research participant.
    See the sample screening questions in Appendix 2

Research Activities and Required Safety Measures

Research Activity Guidelines

Verbal interactions with no physical contact

  • Interviews
  • Focus groups (10 or fewer people)
  • Behavioral tasks and observation
  • Education
  • COVID-19 pre-screening questionnaire and temperature recordings for the researcher and participant prior to the visit
  • Schedule participants to avoid overlap and waiting time
  • Disinfect research area between participants
  • Researchers and participants wear masks at all times.
  • Minor participants must be mature enough to follow safety guidelines.
  • Adhere to the most protective guidelines re: density, face covering, and physical distancing
  • If offering snacks, they should be individually wrapped servings.
  • If the participants can not wear masks due to the nature of the research, then you must submit the FYI X-form for IRB approval before initiating activities. PPE options can include a plastic room divider OR eye protection, surgical mask, and face shield for the researchers.
Physical contact with participant or other procedures that require proximity
  • In addition to the guidelines above, researchers must use eye protection and surgical masks.
  • If the participants can not wear masks due to the nature of the research and saliva, throat and/or nasal specimens are being collected, then you must submit the FYI X-form for IRB approval before initiating activities. Required PPE must include gloves, protective gown, eye protection, surgical masks and face shields for the researchers.

Modifications to IRB Protocols

  • SOPs for personal protective equipment (PPE) and COVID-19 screening questionnaires do NOT require approval by the IRB, as long as the screening data are not used for research.
  • However, if existing IRB-approved procedures must be revised (e.g. to adjust the number of study visits, or to make some data collection remote), please submit an amendment to the IRB for review.
  • Exception Requests: If a research study cannot adhere to the applicable safety guidelines for scientific or other reasons, the PI must request an exception by submitting the FYI X-form to the IRB.
    Appendix 1
    • Not being able to procure PPE is not an acceptable reason to grant an exception.
    • For external IRB studies, you must still submit an FYI X-form to the IRB to ask for an exception for your study. Please contact the HRPP staff for any questions.

Frequently Asked Questions

What if a participant refuses to wear a mask or comply with other safety precautions?
The study visit should either be rescheduled for a time when the participant agrees to comply or terminated if the participant states that they will not comply (in which the subject should also be withdrawn from the study).

What if I cannot follow all the guidelines while conducting my in-person research activities?
Submit the FYI X-form to the IRB to request an exception. Do not initiate research activities before the request has been reviewed and approved.
See Appendix 1

What if I'm not sure how to apply the above guidelines to my unique research activities?

Please email or call your Human Research Protection Program staff member. A modification may be required to document the specific precautions needed for your study.

What if my participant tested negative for COVID yesterday?
You MUST still follow the procedures in this guideline, including the COVID screening questionnaire.

Appendices

APPENDIX 1: 
What to include in your FYI X-form when requesting an exception?
  1. Which specific safety precautions are impossible to perform while maintaining scientific integrity?
  2. Why is it not possible to comply with those precautions?
  3. What steps will be taken to mitigate risk in lieu of those precautions?
APPENDIX 2: 
Example COVID-19 Screening Questionnaire/Script

EXAMPLE SCREENING QUESTIONNAIRE/SCRIPT

Screening questions can include those listed in the sample COVID-19 Screening Tool below, which can be modified to fit the participant population and the location of in-person interactions.

Any YES answer should be considered sufficient reason to postpone in-person visits if it cannot be explained by an underlying medical condition.

Note: Using these screening questions does NOT require an IRB modification if the data will not be used for research.


 
Research involving animals

Updated May 12, 2020

May 12, 2020 Notice - Animal Related Research Plan - Effective May 11, 2020
from Dr. Lisa Root
April 30 , 2020 Notice - Status of Animal Research & COVID-19 Situation
from Dr. Frank Calzonetti
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.

I understand that I must electronically reserve an animal room hood or procedure room before I enter DLAR. What if I just want to check my cages but not use a hood?

In order to even enter DLAR you must have a room/laminar flow hood reservation for the area you are going to occupy. Even if you don't plan on using the laminar flow hood you must sigh up for the room. This will limit the number of people in a room at a given point in time.

I understand that I should have my own respiratory protection (homemade mask) to enter DLAR but how many times can I wear this before cleaning and how should I clean it?

It’s recommended to wash your mask routinely depending on how much you wear the mask.  You can launder this mask in your own laundry or wash it in the sink with antibacterial soap and hang dry overnight so it’s ready to wear the following day.  

Will there be interruptions in animal experiments, Due to Coronavirus?

Current studies and critical and essential research may continue. Beginning May 11, 2020, breeding may begin for those studies approved as critical and essential. 

Can orders Still be Placed for New Animals and Are Exports of Animals Permitted?

Beginning May 18, 2020, those personnel approved for critical and essential research may order animals. Exports of animals will be allowed beginning on May 25, 2020, of those studies approved and critical and essential.

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.

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Last Updated: 11/23/20