Research and Sponsored Programs

Research Guidance | COVID-19

Entering University Facilities Research Continuity
Allowable Costs, Charges, Effort on Sponsored Projects  Human Subjects Research 
Research Involving Animals Lab & Field Safety and Disinfections 
 Research Involving Coronavirus
 

Updated March 22, 2022

ENTERING UNIVERSITY FACILITIES

See the University "Keeping Campus Safe" website for updated information on requirements for masks and physical distancing and for guidelines on COVID-19 exposure or voluntary reporting.

  • Masks are optional in all non-clinical areas on our campuses, including classrooms and teaching laboratories. This change fully aligns The University of Toledo’s protocols with the most recent CDC guidance on face masks, which ties mask recommendations to community levels of infections and hospitalizations.

research continuity 

Updated March 22, 2022

All research activities may continue without Research Operation Plans (ROP) or associated approved laboratory personnel instituted during the pandemic. PIs/Research Group Leaders (RGL) will continue appropriate laboratory and field study safety practices. See additional guidance on lab safety and disinfection through this link.

Check with core facilities Directors for personal protective equipment requirements.

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.

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Allowable Costs, Charges, Effort on Sponsored Projects

Updated March 24, 2022

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.

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Human Subjects Research
UToledo IRB Guidelines:  Face-to-Face Human subjects Research Activities

Updated March 24, 2022

June 8, 2021 - Update on Human Subjects Research and COVID-19 Concerns
from Dr. Frank Calzonetti

If you have any questions, please email or call your Human Research Protection Program staff member

The IRB’s primary focus is to protect research participants during the COVID-19 pandemic. UToledo has additional guidelines and policies, such as The University of Toledo Keeping Campus Safe, which can be found at https://www.utoledo.edu/coronavirus.

This guidance applies only to research taking place in UToledo facilities.  Research activities with human subjects that take place in healthcare settings such as the University of Toledo Medical Center must follow the protocols established by the healthcare establishment, which may be different from the broader campus requirements. If research is taking place at an external location (e.g., external performance site), the site permission letter must describe the safety precautions in place at that location and UToledo researchers must adhere to those precautions.

General Considerations

  • The IRB recommends considering current community case rates and the vulnerability of the target study population when designing in-person research activities to ensure appropriate precautions are in place. The IRB may evaluate the risk of exposure to COVID-19 for vulnerable populations (such as the elderly or immunocompromised) relative to the potential benefits of the research.

Screening requirements before Study Visits

PARTICIPANTS

  • Research taking place in a typical medical setting (e.g. UTMC of a UTP clinic)
    • Follow all current COVID-19 protocols in place in the facility, including appropriate PPE for researchers and participants, symptom screening, temperature checks, etc.
    • If the researcher anticipates that the group of subjects targeted for enrollment cannot wear protective face coverings/mask due to personal health issues or the nature of the research, then this must be stated in the study protocol.
      See Appendix 1
  • Research taking place at an IRB approved site is not a typical medical setting
    • Before the participant arrives at the study location, communicate with the participant to explain that if they are experiencing COVID symptoms they should reschedule. If preferred, you may also have the participant complete a screening questionnaire and/or other materials to evaluate their individual risk.  If completed, the results of the screening survey must be saved in the research record. and be properly secured, though it is not considered research data unless described as such in the IRB protocol. Participants should be made aware whether the screening questions will be used as research data.
      See Appendix 2

RESEARCHERS

  • Researchers who are experiencing COVID symptoms may not engage in face-to-face research activities with participants. Researchers must complete any symptom screening required by the study location, as applicable, prior to engaging in any face-to-face contact with research participants.
    See the sample screening questions in Appendix 2

Research Activities and Required Safety Measures

Research Activity Guidelines

In-person research activities

  • Follow all current COVID-19 precautions required by the site where the in-person research is taking place
  • COVID-19 symptom related communication (or COVID-19 pre-screening questionnaire) with the participant in advance of the visit
  • Schedule participants to avoid overlap and minimize waiting time
  • Disinfect research area between participants
  • If offering snacks, they should be individually wrapped servings.
  • If asking more than one person to participate at the same time in the same location (e.g., focus group), include a statement regarding risk of contracting COVID in the informed consent form.
  • Mask requirements should reflect current UToledo requirements. If no mask requirement is currently in place, inform participants that they are welcome to wear one if they choose. If the research activities would require removal of a mask, ensure that this information is in the consent form.
  • Researchers should not inquire about COVID-19 vaccination status as a condition of research participation UNLESS the information is needed for participant safety (e.g. while participating in a clinical drug trial) or is relevant to study design (e.g. recruiting people for a survey on attitudes toward getting or not getting the vaccine). 

Modifications to Approved 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.

Frequently Asked Questions

Updated June 8, 2021 

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.

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 March 22, 2022

DLAR IS AND HAS BEEN FULLY OPERATIONAL TO SUPPORT ANIMAL CARE AND RESEARCH

In-person DLAR training courses continue, and schedules and be accessed through DLAR's website. Check with the DLAR Director and supervising staff for personal protective equipment requirements.

All researchers must continue to electronically reserve an animal room hood or procedure room before entering DLAR. This reservation system was created during the pandemic and will continue as a standard practice in DLAR as it ensures unimpeded access to the appropriate spaces in DLAR.

What if I just want to check my cages but not use a hood?

While checking cages in DLAR facilities you may find that you need access to a laminar flow hood.  Please check the calendar(s) and sign up accordingly.  If members of your research team are accompanying you to DLAR, only one person needs to have the hood/space reserved.   

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Last Updated: 6/27/22