Overview: SOM Guidelines and Processes
The UNC Office of the Vice Chancellor for Research (OVCR) oversees clinical research operations in the context of COVID-19 with focus on resuming “normal” operations as much as possible while protecting faculty, staff, students, and research participants by employing measures to limit risks. This below information is intended to serve as a quick reference guide for SOM faculty and staff involved in research.
Version Date: June 17, 2021
Click here to download a full PDF of the quick reference guide.
- All research faculty, employees and trainees must conduct a daily self-monitoring of COVID-19 symptoms before coming to campus
- No individuals may report to campus if they:
- Are experiencing any symptoms of COVID-19
- Have tested positive for COVID-19
- Have been referred for COVID-19 testing and are awaiting results
- Any individual who has experienced symptoms or tested positive for COVID-19 may not return to campus for any reason until approved to do so by UNC EOHC
- If you have questions about your wellness, you are advised to contact a health care provider, University Employee Occupational Health Clinic (employees), or UNC Campus Health (students, post-docs)
Documenting Participant Wellness Checks
- Study teams are responsible for conducting and documenting a wellness screening for all participants at the initiation of each in-person study visit
- For visits in UNC Health facility, the completed wellness screening must be documented in Epic
- For visits in non-clinical spaces or for studies that do not utilize Epic, completion of the participant wellness screening must be documented in the study records
Personal Protective Equipment
- All individuals must wear a University-approved face mask while in any UNC or UNC Health facility, unless in a private and closed space (such as private office with the door closed)
- Personnel must wear eye protection (in addition to a face mask) for all face-to-face patient or participant encounters
- Gloves are not necessary for general use and do not replace good hand hygiene
- All individuals should thoroughly wash their hands or use provided hand sanitizer:
- At least hourly
- Before entering or exiting buildings, laboratories or offices if they have been in a public space or near others
- Before and after any direct interactions with colleagues, patients, or participants
- Before and after handling their face mask
- Please view the CDC’s “Five Steps to Wash Your Hands the Right Way”
Cleaning and Sanitizing
- All faculty, staff, and students share the responsibility of cleaning and sanitizing high-touch surfaces in their workspaces (e.g., light switches, doorknobs, etc.)
- Shared equipment should be cleaned thoroughly after each use
- Activities and meetings that can be conducted remotely should continue in a remote matter to avoid unnecessary contact and risk
- Avoid large groups whenever possible
- Consistent with Campus Summer COVID-19 Community Standards, all centrally scheduled classrooms and all other meeting and conference rooms will operate at reduced capacities to allow for 6’ distancing from now through 7/31/21.
- When face masks are removed for eating/drinking, individuals must maintain at least 6 feet of physical distance from others; eating outside is encouraged
- SOM buildings will assess occupancy after June 1 determine when to open buildings safely. We expect to resume normal access over the summer and will inform researchers when this change is expected.
Additional Considerations Specific to Human Subjects Research
- Every study PI should review and carefully consider the expected benefits vs. risks for study participants to determine if the study should continue with direct contact visits or assessments in the context of COVID-19. Study activities that can be completed remotely, should be (as approved by the IRB) in order to limit the amount of time spent interacting directly.
General Reminders and Considerations
- UNC policy does not permit asking employees or students to disclose their vaccination status
- Individuals who have been instructed to return to on-site work and wish to request a disability accommodation (e.g., for disabilities that place individuals at higher risk for severe illness from COVID-19) should contact the UNC Equal Opportunity and Compliance Office
- Compliance with required practices is a shared community responsibility
- Individuals may report concerns of non-compliance by contacting Ethics Point
- All visitors (including vendors) to the UNC campus must adhere to Carolina’scommunity standards and county requirements to help stop the spread of COVID-19. When indoors, all individuals must wear a face covering or face mask and observe all facility-specific requirements. Observations of non-compliance should be reported to the SOM Planning Office (919-966-2441; firstname.lastname@example.org ).
Additional Information and Resources
- Office of the Vice Chancellor for Research: COVID-19 Information for Researchers
- Carolina Together
- Carolina Together: Travel Guidance
Note: In North Carolina, as of May 23, 2021, only 42.5% of residents have been vaccinated with a single dose and 35.2% with two doses of the COVID-19 vaccine. Given these statistics, to protect all employees and their families, UNC and the SOM have adopted requirements that may be more stringent than current CDC guidance. These will be assessed as the situation evolves.