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  1. Human subject research studies that do not include direct participant contact may continue.
  2. Human subject research studies that include participant interactions and can be completed virtually should be conducted virtually provided the IRB has approved the virtual/remote interaction for a particular study.
  3. Human subject studies that require participant contact should adhere to the following guidelines.
    1. Studies that require face-to-face assessments or visits can continue, weighing risks and benefits for the participants. The CDC recognizes high-risk groups for severe outcomes with COVID-19. As part of the ongoing consent process, research participants at high risk for severe negative outcomes should understand the risks of breaking physical distancing.
    2. Prior to a face-to-face visit, research personnel must confirm the participant’s appointment and perform telephone wellness screenings no more than 24 hours prior to the scheduled visit, if applicable.
    3. Participants visiting a UNC Health facility must be rescreened by front desk staff upon arrival. Research personnel must rescreen participants upon arrival for all visits that will occur in non-clinical spaces before the visit begins (i.e., confirm there are no symptoms, etc.). Any participant who fails rescreening should be immediately masked and isolated in a private room. Clinical study personnel should be contacted and recommendations from Infection Prevention regarding referral for testing should be followed.
    4. During face-to-face visits, research personnel should maintain a physical distance of 6 feet whenever possible, wear face-masks (see Section g. below), and wash hands before and after face-to-face interaction with a human research participant.
    5. Interactions should take place in an outdoor setting, if possible.
    6. Cleaning: Individual laboratories and research cores must: (1) Develop and use a regular schedule for frequently cleaning and wiping touched surfaces and objects (e.g., door and cabinet handles, faucets, light switches, keyboards, and other frequently touched objects) with an approved disinfectant or disinfectant wipes. (2) Follow routine surface decontamination of common equipment like instrumentation and computers. (3) Disinfect any surface that may be thought to be contaminated. (4) Use an approved disinfectant such as a 10% bleach or 70% alcohol solution. Please refer to the EPA list of acceptable disinfectants for use against SARS-COV-2 for more information.
    7. Face Masks: All research personnel conducting research at a UNC Health facility must follow UNC Health’s mask policy regarding proper usage and storage of masks for employees, and masks for participants and guests.
  4. As part of the ongoing consent process, if the participant is visiting campus, he or she should also understand the potential harms of visiting the research site during the COVID-19 pandemic and agree willingly to the visit. Each participant should be given the chance to discuss the expected risks and benefits and make an informed decision regarding participation, along with support from the study team. Remote consent is encouraged if approval has been granted by the IRB.
  5. Research that involves participants of 10 or fewer individuals in a group, such as a focus group, is allowed. Seating should be arranged to allow 6 feet between group members, and all focus group participants must wear masks.
  6. If research involves travel or overnight stays, accommodation and meals should allow for adequate physical distancing (6 feet or more) wherever feasible. Vehicle occupancy should be limited to no more than two people in a standard car, with open windows while travelling, if possible. Vehicle occupants should wear masks.
  7. For additional UNC Health Guidance on COVID-19, please visit the Clinical Research Support Office (CRSO)’s response page.