General Guidance

As the COVID-19 positivity rates have fallen and vaccination percentages for Dallas and Collin counties have risen, our research community has continued to demonstrate strong compliance to safety precautions. We have navigated what appears, at least from this vantage point in time, the worst of the pandemic. You have my appreciation for the efforts that you have made to ensure that students and staff in your laboratory demonstrate social responsibility during this crisis.

We are now prepared for full restoration to 100% of our research presence on campus. Effective May 17th, the use of the laboratory scheduling system will no longer be required for your laboratory groups. At that time, there will be no limitations to the percentage of your team that can be concurrently within your research space. However, until the further notice, likely extending through the summer, we will observe the following safety restrictions:

1. We will continue to make use of face coverings and maintain hand hygiene practice within research buildings. Conference rooms within research buildings may be used for group meetings. Each of these rooms has an upper limit posted by the fire marshal. Should you decide to hold a group meeting in person, choose a meeting space such that the number of attendees does not exceed 50% of the level posted and you ensure that individuals are well-spaced in the room.
2. The research buildings are not cafeterias. Students are not permitted to eat at their desks or in common kitchen areas within research buildings. Instead, students and staff should take advantage of the outdoors at benches or on terraces. While at carrels in open spaces, students/post-docs must wear face coverings allowing for transient removal for consuming beverages. Faculty within single occupancy offices in research buildings may eat alone within their offices.
3. Last September, we provided a reservation slot for undergraduate students in the research laboratories and further increased the number of slots possible over the last few months. Effective May 17th, there are no prohibitions for the engagement of undergraduates to participate in your on-site research activities.
4. IRB issued guidance for in-person humans subjects research. 

Human Subjects Research

On October 12, 2020, the Office of Research authorized the resumption of in-person procedures for human subjects research during the COVID-19 pandemic. IRB issued guidance on safety protocols are stated below. This page will continue to be updated should IRB recommendations and / or requirements change as appropriate to meet pandemic conditions in the North Texas area. It is the responsibility of each researcher to ensure they are following the approved safety protocols.

As with any activity involving person-to-person contact, there is a risk that investigators might unknowingly expose participants to COVID-19. While vaccination status may be voluntarily disclosed by participants, it cannot be requested or used as exclusion criteria unless specifically approved by the IRB. Some individuals (regardless of vaccination status) with certain medical conditions, a weakened immune system, or those who are unable to get the vaccine based on age or other factors are at a higher risk for getting very sick from COVID-19. While children have been less affected by COVID-19 compared with adults, children can be infected with the virus that causes COVID-19 and some children develop severe illness. Additional information about potentially vulnerable participants can be found on the website.

• IRB Approval. IRB approval to resume in-person procedures is required for individual studies to ensure inclusion of specific consent form language and procedures associated with COVID-19 precautions. All projects conducting in-person data collection at this time must specify the pandemic protocols, including Legacy projects involving in-person data collection (studies originally approved prior to August 2020). In order to resume in-person human subjects research, a modification must be submitted via Cayuse. For additional information on how to modify Legacy studies in Cayuse, please reference our guidance documentation.

• Researchers are required to elect at least one of the following options:

• • Face Masks: Investigators can elect to voluntarily wear face mask while interacting with research participants.
    
    OR

• • Proactive Testing Program: Investigators can obtain 1 - 2 COVID-19 tests each week through the UTD proactive testing program.
    • All researchers who choose this option are required to test negative for COVID-19 no less than one week prior to testing sessions with research participants.
    • The study PI is responsible for maintaining COVID-19 testing documentation for all study members.

• Pre-screen Checks. Conduct the pre-screen with study participants (and their accompanying family member if they are a minor) 12-24 hours before the study visit to determine if they have symptoms of or have been exposed to COVID-19. The pre-screen checklists should also be completed when they arrive for their in-person procedures. The screening questionnaire templates can be accessed via REDCap.
• Face Coverings. The use of face coverings while conducting in-person procedures is strongly recommended. Investigators are required to provide information to participants about what to expect while on campus and when interacting with researchers. Information about the risks involved with in-person procedures as related to use of face coverings and possible limitations of vaccinations must be provided as well. 
  • All investigators are required to have face masks available for participants should they choose to wear a mask. 
  • Callier Center Research: Investigators conducting research at any Callier Center location must comply with Callier Center COVID-19 safety protocols, including wearing face masks if required.

• Consent Form. The consent forms should be updated to include the risks associated with participating in research involving in-person procedures during COVID-19. The consent form should be updated with the COVID-19 language and submitted with the request to resume in-person procedures.
• Study Participant Contact. The number of investigators in contact with a research participant at any given time shall be limited as needed to complete the experimental procedures. It is strongly recommended that investigators maintain a distance of six (6) feet from participants when experimental procedures allow. If social distancing is not feasible, it is recommended that researchers use appropriate precautions, including a medical grade mask, gloves and eye protection (if necessary). A gown could be considered if extensive contact with the participant is anticipated, such as placing an EEG cap, etc.  
• Disinfecting Procedures. Lab spaces where in-person procedures are conducted, and all surfaces and items (keyboards, EEG, etc.) participants come into contact with are required to be disinfected in accordance with CDC guidance after each experimental session with a participant.  Subject appointments should be scheduled to allow for proper disinfection between sessions.
• Post-screen Checks. Post-screens are recommended but not required to check for changes in health status as related to COVID-19. The screening questionnaire templates can be accessed via REDCap.

*Contact Tyler Tornblom with questions about procuring PPE.

*Contact Research, Campus, and Environmental Safety with questions about PPE best practices.

*Contact the IRB Office with questions about obtaining approval to resume in-person human subjects research.

Additional Resources

Resources for training student researchers

• Social Ethical Responsibility of Conducting Academic Research in the Pandemic Era (non-Human Subjects Research)
• Social Ethical Responsibility of Conducting Academic Research in the Pandemic Era (Human Subjects Research)

Signage for campus use

• Masking, distancing, and general signage