Research Guidance | COVID-19
Updated August 6, 2021
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.
- In response to recent CDC guidance, masks are now required for everyone on our campuses, whether vaccinated or unvaccinated against COVID-19. Individuals are not required to wear masks while alone in their office or while eating. Masks are not required outdoors.
- Individuals who are not fully vaccinated should continue wearing masks while on campus and maintain physical distancing.
research continuity
Updated August 6, 2021
All research activities may resume without a 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.
Individuals may voluntarily disclose their vaccination status to the PI/RGL to assist in planning and coordinating of research activities and physical distancing. Masks are required for everyone on campus. Individuals who are not fully vaccinated against COVID-19 (two weeks since receiving your final vaccine dose) shall continue wearing masks while on campus and maintain six feet of physical distancing in laboratories and campus facilities. Individuals are not required to wear masks while alone in their office or while eating. Masks are not required outdoors. For field studies and boating see updated Standard Operating Procedures.
Meetings may be conducted in-person with all attendees wearing masks. Personnel who are not fully vaccinated may also attend in-person meetings but must wear face coverings and physically distance.
See additional guidance on lab safety and disinfection through this link.
Check with core facilities Directors for availability of services and 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.
Allowable Costs, Charges, Effort on Sponsored Projects
Updated June 8, 2021
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.
Human Subjects Research
UToledo IRB Guidelines: Resuming Non-Essential Face-to-Face Human subjects Research
Activities
Updated August 6, 2021
| 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 in research 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.
Research activities with human subjects that take place in healthcare settings must follow the protocols established by the healthcare establishment.
This guidance applies only to research taking place in UToledo facilities. 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.
General Considerations
- The IRB recommends researchers use remote technologies to conduct research whenever possible.
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
- Essential studies where the IRB approved site is not 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
OR communicate with the participant before the visit to explain that if they are experiencing
COVID symptoms to reschedule. The results of the screening survey must be saved in
the research record. This document MUST be per subject and properly secured.
See Appendix 2 - Encourage those who are not fully vaccinated to not participate in in-person group research activities ( e.g., focus groups).
- If someone voluntarily discloses that they are not fully vaccinated, masks and distancing requirements are required for the participant(s) and researcher(s).
- Before the participant arrives at the study location, have the participant complete
a screening questionnaire and/or other materials to evaluate their individual risk
OR communicate with the participant before the visit to explain that if they are experiencing
COVID symptoms to reschedule. The results of the screening survey must be saved in
the research record. This document MUST be per subject and properly secured.
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 |
|
In-person research activities |
|
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.
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? |
|
| 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 June 8, 2021
| DLAR IS AND HAS BEEN FULLY OPERATIONAL TO SUPPORT ANIMAL CARE AND RESEARCH |
Individuals who are not fully vaccinated shall continue wearing masks while on campus and maintain physical distancing of 6 feet in laboratories and animal care areas.
In-person DLAR training courses continue, and schedules and be accessed through DLAR's website.
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 fully vaccinated members of your research team are accompanying you to DLAR, only one person needs to have the hood/space reserved.