Human Research COVID-19 Precautions

Updated 01/02/24

Although COVID-19 is transitioning from pandemic to endemic, it remains a potential public health threat, particularly for individuals at higher risk of serious illness. Currently, investigators are advised to follow the same guidelines as other students, staff, faculty, and visitors at Auburn University.  However, investigators should be prepared to revise their safety practices if the COVID-19 risk escalates in locations where in-person research is conducted.  

CDC COVID-19 RISK GUIDANCE

The CDC currently uses COVID-19 hospital admissions by county to guide prevention decisions.  Hospital admission levels can help individuals and communities decide which prevention actions they should take based on the latest information.

The CDC also advises that some people, such as those who are older, or those with certain underlying health conditions, continue to be at higher risk for serious illness.

COVID 19 DATA TRACKER

If your study involves individuals at higher risk for serious illness, and the CDC COVID-19 hospital admission levels are “High” at the location(s) of in-person research, participants should be notified of risk, and COVID-19 precautions should be implemented as described below.

NOTIFY PARTICIPANTS OF INFECTION RISK

Participants should be provided information regarding how COVID-19 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 a 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. 

Sample statement for consent documents:

"This study involves in-person research activities that involves risk for COVID-19 transmission. Should community hospital admission levels increase to ‘high’ (as defined by the CDC COVID Data Tracker), CDC and university guided precautions will be implemented."

COVID-19 PRECAUTIONS

Precautions include screening participants and investigators for COVID-19 symptoms, and wearing personal protective equipment (PPE) such as N-95 respirators and gloves for direct contact.  Choosing well-ventilated spaces can also help mitigate the risk of exposure.  See the menu below for further guidance.

 

Screening for Participants with Increased Risk of Severe Illness

All research participants should be screened remotely (by phone or Zoom) for fever, cough, and flu-like symptoms the day before, with a 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. Do you have a fever or Respiratory Symptoms?

Symptoms include fever, acute respiratory infection, persistent cough, sore throat, fatigue and shortness of breath, or sudden loss of taste or smell with or without a fever.

  1. Are you waiting on COVID-19 test results?
  2. Have you been asked to self-isolate by your doctor?
  3. In the past three weeks, have you visited another state, country, or facility with a substantial or high community COVID-19 level (see CDC COVID-19 Hospital Admissions)?

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. 

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.   

Screening for Increased Risk of Severe Illness

Before an in-person visit, research participants should be screened remotely (by phone or Zoom) for factors that put them at increased risk of severe illness from COVID-19. Decisions about in-person visits should be especially conservative for these individuals. Based on what we know, possible yes/no screening questions for those at high-risk for severe illness from COVID-19 are:

 

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.  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 adultsindividuals 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, Director Laboratory and Research 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: 

  • Procedural 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 
  • N95 / KN95 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 
For studies involving participants at higher risk for severe illness, when CDC COVID-19 hospital admission levels are “High”:
  • Research Personnel – N95 or KN95 respirator; eye protection; gloves (for procedures involving direct contact)
  • Participants - Cloth mask or procedure mask

If you will be using an N95 or KN95, you should consider the following:

  • 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 on the RMS N95 Resource page and the CDC’s How to Us Your N95 Respirator page.

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.