Human Research COVID-19 Precautions

In the context of rapidly evolving circumstances regarding COVID-19, and the University’s focus on physical distancing and the health and well-being of the community, the Institutional Review Board in consultation with Risk Management and Safety and the Office of Research Compliance has issued guidance for continued human subjects research. This guidance is being implemented with the primary focus to protect research participants, researchers, and the larger community from risk of infection with COVID-19. This guidance will be revised when appropriate based on new information. 

NOTIFY PARTICIPANTS OF INFECTION RISK

Participants should be provided with information regarding the current COVID-19 epidemic, how risks may arise from participation in research, and the precautions that will be used to reduce the risk of infection. This information may be provided in multiple forms suited to the type of interaction, including website link or a telephone script. If possible, this information should be shared before the research visit. Further, a description of the risk of exposure and potential infection from COVID-19 along with precautions implemented to reduce the risk should be included in the consent documents. See the following CDC COVID-19  for reference material. 

All research participants should be screened remotely (by phone or Zoom) for fever, cough and flu-like symptoms the day before, with repeat screening at the time of an in-person visit. Appropriate screening questions might include the following, which could be modified to fit your participant population and the location of in-person interactions:  

  1. Have you had any of the following symptoms in the past two weeks, even if they were mild? 

  • Fever or chills 
  • Cough 
  • Shortness of breath or difficulty breathing 
  • Fatigue 
  • Muscle or body aches 
  • Headache 
  • New loss of taste or smell 
  • Sore throat 
  • Congestion or runny nose 
  • Nausea or vomiting 
  • Diarrhea  
  1. In the past three weeks, have you visited another state, country, or facility with sustained (ongoing) occurrence of COVID-19? 

  1. Have you had close contact with a person that has tested positive for COVID-19 or who is under investigation for possible COVID-19? 

  1. Is there any additional information you would like to provide related to your possible exposure to COVID-19? 

Although COVID-19 may present with multiple symptoms or no symptoms, any YES answer should be considered sufficient reason to postpone in-person visits or not enroll the individual in the study. Those who screen positive should be directed to contact their primary care provider. For a sample screening form, see EAMC Screening Form

As a reminder, researchers should follow the Auburn University COVID 19 Guidance on Self Screening prior to coming to campus and/or conducting human research which involves direct contact with participants.   

Higher Risk for Severe Illness Screening 

Before an in-person visit, research participants should be screened remotely (by phone or Zoom) for risk factors of severe illness from COVID-19. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations. Appropriate screening questions might include the following, which could be modified to fit your participant population and the location of in-person interactions: 

  • Based on what we know now, those at high-risk for severe illness from COVID-19 are: 
    • People 65 years and older 
    • People who live in a nursing home or long-term care facility 
  • People of all ages with underlying medical conditions, particularly if not well controlled, including: 
    • People with chronic lung disease or moderate to severe asthma 
    • People who have serious heart conditions 
    • People who are immunocompromised 
      • Many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDS, and prolonged use of corticosteroids and other immune weakening medications 
    • People with severe obesity (body mass index [BMI] of 40 or higher) 
    • People with diabetes 
    • People with chronic kidney disease undergoing dialysis 
    • People with liver disease 

COVID-19 transmission is more likely in indoor spaces based on current epidemiologic understanding. If indoor spaces have inadequate ventilation, viral particles may persist in the air longer than they would outdoors, or in indoor spaces with good ventilation.  Auburn University Facilities Management has been preparing campus buildings in response to COVID-19, including modifying ventilation systems.  You can use the Facilities Management COVID Building Readiness Dashboard to verify the status of ventilation modifications to the building where your research will take place.   Look for the following modifications for your building on the dashboard summary table:  

  • Increased outside air delivered to the building
  • Increased HVAC runtime
  • High efficiency filters installed 

Depending on the proposed project, certain risk factors may necessitate supplemental ventilation in the room where research will take place, or consideration of alternative locations.  Risk factors may include:

  • close contact between investigators and participants
  • procedures that produce increased exhalation, such as exercise
  • high-risk populations or participants such as older adults, individuals with underlying medical conditions, or groups that are at higher risk of transmitting COVID-19
  • lengthy procedures (longer duration of exposure may increase risk)
  • high occupant density (the more crowded the room, the greater the exposure risk)

If feasible, the following measures can be used the enhance ventilation when one or more of the above risk factors is present:

  • opening windows and doors
  • using fans to increase the effectiveness of open windows
  • using portable high-efficiency particulate air (HEPA) units 

While it may not be necessary to apply every consideration to be protective, exploring multiple mitigation strategies is recommended when risk factors are present.  For more information, see the CDC’s guidance for ventilation in buildings

If you have any questions or need assistance please contact David Acker, Risk Management and Safety Associate Director Laboratory and Radiation Safety: daa0002@auburn.edu or 334-703-1471.  

The following Personal Protective Equipment (PPE) may be used as appropriate depending on the risks involved with the study: 

  • Surgical masks 
    • Provides the wearer protection against large droplets from a sneeze or cough and protects others from the wearer’s respiratory emissions 
    • Does not provide the wearer or others protection against smaller respiratory aerosols 
  • Cloth face coverings (not considered PPE for the wearer but does provides additional protection for anyone near the wearer)
    • Protects others from wearer’s respiratory emissions 
    • Does not provide wearer or others protection against smaller respiratory aerosols 
    • Additional guidance can be found on the RMS Cloth Face Mask Resource page
  • N95 respirator 
    • Filters out large droplets and smaller respiratory aerosols 
    • Designed to protect the wearer from inhaling airborne particulate contaminants such as dusts, fumes, and infectious agents 
    • An N95 respirator with an exhalation valve does not protect others from the wearer’s respiratory emissions
    • Additional guidance can be found on the RMS N95 Resource page 
  • Eye protection 
  • Gloves 
    • Disposable type nitrile or natural rubber 
  • Disposable lab coat 

The following provides guidance to investigators for determining the appropriate PPE for a given project/activity. For projects or activities involving higher risk participants or procedures please refer to the sections below on N95 respirator use and contingency planning. 

  • If the research requires interaction with the participant within 6 feet without any barrier the following PPE is appropriate: 
    • Participant - Cloth face covering (see the CDC guidance on cloth face coverings for reference.)
    • Research Personnel – disposable lab coat, gloves, face shield or goggles, and a surgical mask. 
  • If the research requires interaction with the participant within 6 feet with an effective barrier the following PPE is appropriate: 
  • If the research requires interaction with the participant and can maintain a minimum of 6 feet at all times the following PPE is appropriate: 

The following alternate and re-use guidance can be applied for extending PPE supplies:

N-95s are strongly recommended for studies involving certain risk factors, including: 

  • close contact between investigators and participants
  • older adults, individuals with underlying medical conditions, or groups that are at higher risk of transmitting COVID-19 (i.e. prison populations).
  • high occupant density (the more crowded the room, the greater the exposure risk)
  • procedures involving potential for increased respiratory secretions such as administering oral or nasal swabs, and VO2 max measurements.  
  • lengthy procedures (longer duration of exposure may increase risk)

In certain cases when there is a prevalence of risk factors, the IRB may require the use of N-95s.

If N-95s will be used:

  • Understand your current inventory, and the utilization rate that will be required for your research team to maintain an adequate supply. 
  • Provide personnel with required education and training, including having them demonstrate competency with donning and doffing.

 

Additional guidance can be found the RMS N95 Resource page.

Consideration can be made to use of filtering facepiece respirators (FFR) such as an N95 beyond the manufacturer-designated shelf life. However, the CDC recommends only reusing N95 respirators as a contingency capacity to conserve available supplies for healthcare environments during a pandemic. Strategies for extended use and reuse of N95 and other FFRs without decontamination are currently available from CDC’s National Institute for Occupational Safety and Health (NIOSH). Decontamination of N95s might cause improper fit, filtration efficiency, and breathability as a result of changes to the filtering material, straps, nose bridge material, or strap attachments. Therefore, decontamination and subsequent reuse of N95s should only be practiced as a crisis capacity strategy. Guidance is available at the CDC web page Decontamination and Reuse of Filtering Facepiece Respirators

Any physical item that participants need to make physical contact with should be decontaminated BEFORE and AFTER each participant. Ensure that your research staff and participants have necessary supplies, such as hand sanitizer that contains at least 60% alcohol, tissues or paper towels, trash baskets, and cleaners and disinfectants. Clean and disinfect all surfaces in the room that may have been contacted by participants. For disinfection, an EPA approved disinfectant  should be used. 

PROJECTS COVERED BY A BIOLOGICAL USE AUTHORIZATION

If your project is covered by a BUA, you will need to contact the Biological Safety Officer (Deepika Suresh, dzs0023@auburn.edu, 334-750-8040) to determine if the current biological protections are appropriate to address the risk of COVID-19.