This policy addresses in-person human subjects research (HSR) conducted by CGU personnel during the COVID-19 epidemic. “In-person” research refers to research involving activities in which investigators are physically in the presence of research subjects. Effective August 30, 2021, this policy replaces CGU COVID-19 Policy for Research Involving Human Subjects. The policy provides guidance for in-person HSR activities to minimize risk and to ensure health and safety of research subjects, investigators, and staff. In addition to the details included here, CGU investigators are expected to follow all general CGU guiding principles, policies, and protocols applicable to their activities. Current CGU policies and information regarding the pandemic can be found here: https://my.cgu.edu/covid-19-response/. Research that involves travel is also subject to CGU’s travel policies. (For more on travel requirements, see https://cgu0.sharepoint.com/sites/ProvostForms.).

Given the risks due to COVID-19 exposure, all research team members have the right to avoid involvement with on-site or in-person research activities without fear of reprisal. Employees with concerns about infringement of these rights should contact CGU Human Resources. Students with such concerns should contact the Dean of Students Office.

To mitigate the impact of COVID-19, it is expected that CGU investigators will explore alternative means to in-person research and employ these means whenever possible during the COVID-19 pandemic. Risk and potential benefit to subjects should be balanced while implementing appropriate risk reduction strategies to maximize the health and safety of all involved. All research that can be conducted remotely should be done so. Conducting research remotely means investigators are not in the physical presence of research subjects (e.g., interviewing via videoconference).

Permissibility of Research and General Guidelines

CGU investigators may conduct in-person human subjects research (HSR) if

  • the feasibility of conducting the research remotely has been ruled out, and
  • local authorities in the proposed research location are allowing activities and gatherings such as would be required to conduct in-person research.

It is the responsibility of the investigator(s) to ascertain whether

  • the proposed research is permissible under local public health orders and restrictions, and
  • prevailing local conditions are conducive to safely conducting research involving in-person contact with research subjects.

As part of the IRB protocol process, investigators proposing to conduct in-person research will be expected to describe COVID-19 infection risk mitigation procedures and to provide information regarding local governmental and or public health permissions and COVID-19 conditions. See the Procedures section and appendices 1 and 2 for more about the risk mitigation procedures. The sites listed below provide useful information for COVID-19 conditions over broad regions, but when available, credible information from local public health authorities will be given precedence.

In view of CGU’s current COVID-19 vaccination policy, all CGU investigators and research team members conducting in-person research must provide proof of vaccination or apply for a medical or religious exemption. (See https://cgu0.sharepoint.com/sites/ProvostForms for full faculty and staff vaccination policy information. For student vaccination policy information, visit https://cgu.policystat.com/policy/9445211/latest/.) Although research team members on CGU research projects who are otherwise not affiliated with CGU are expected to follow CGU’s vaccination policy, team members in non-U.S. locations with severely limited vaccine accessibility may also request an exemption on this basis. Note: Individuals who are approved for an exemption are considered unvaccinated and are required to adhere to COVID-19 testing protocols and other protocols for non-vaccinated persons whenever they interact in-person with research subjects or other research team members. For more information, visit CGU’s Covid-19 Response page (https://my.cgu.edu/covid-19-response/).

For research conducted in CGU labs and other sites on campus, research subjects that are not CGU personnel must adhere to CGU’s Campus Visitors policy. (https://my.cgu.edu/covid-19-response/campus-visitor-policy/) All campus visitors must be vaccinated. Visitors are required to check in when arriving on campus, and must present their COVID-19 Vaccination Record Card as proof of vaccination at that time.

Procedures

Investigators wishing to conduct in-person human subjects research should follow the standard IRB protocol submission process, indicating on the protocol creation page that their research involves in-person interaction. This will prompt Axiom Mentor to load the Risk Mitigation Procedures (RMPs) section of the protocol outline. This portion of the outline prompts the investigator to provide the information the IRB needs to make an assessment of the COVID-19 risks associated with the particular proposed study. Appendices 1 – 3 (See below) provide guidance for responding to the prompts in the RMP section of the outline.

When Amendments are Required

Changing Conditions. The IRB assesses research risks and benefits based on the prevailing at the time the protocol is submitted. Investigators choosing to conduct in-person research during the pandemic should monitor local conditions as closely as possible. In particular, if COVID-19 case numbers and or mortality rates increase such that in-person interaction becomes less safe or approved safety measures may no longer acceptably mitigate risk of infection, investigators should contact the IRB before continuing with the research. Under these circumstances, investigators may be required to submit amendments to address the changed risks. The IRB will give such amendments priority to minimize delays to the research. Because COVID-19 conditions tend to fluctuate and can change quickly, it is recommended that investigators adopt more conservative safety measures than may initially appear necessary.

The PI should submit an amendment if/when:

  • COVID-19 case numbers and or mortality rates increase such that in-person interaction becomes less safe or approved safety measures no longer acceptably mitigate risk of infection
    The PI should immediately notify the IRB if/when:
  • any research team members discover that they or a research subject has been in contact with a person who has tested positive for COVID-19

The PI should immediately suspend research and notify the IRB if/when:

  • a research team member or research subject who tests positive for COVID-19 has had close contact (within 6 feet of someone for a cumulative total of 15 minutes or more over a 24-hour period) with other research team members or research subjects.

In each of these cases, precautions following CDC guidelines should be immediately taken to reduce risk of transmission. (Please see Appendix 3 for guidelines adapted from CDC guidance.) An IRB representative will assess the situation and advise whether in-person research activity may continue and under what conditions. You may contact the IRB office at 909-607-9406 or irb@cgu.edu.

Appendix 1. Pre-screening of Investigators, Research Team Members, and Research Subjects

All CGU investigators and research team members are required to self-screen for COVID-19 symptoms prior to engaging in any HSR with in-person contact/engagement following CGU guidelines. For research conducted on campus, use research team members should complete the Daily health check form in their MyCGU portal as they would when coming on campus for any other reason. For research conducted elsewhere, research team members should screen themselves using the same questions, but without submitting the form. Any team members who do not pass a temperature check and symptom screening should not engage with research subjects or come to campus. If another research team member is not available to cover the planned study visit(s), that/those visit(s) should be rescheduled.

Research team members who have experienced COVID symptoms should not engage with research subjects or return to campus until the following conditions have been met:

  • 10 days since first appearance of symptoms and
  • 24 hours since the subject has had no fever without the use of fever-reducing medications and
  • Other COVID-19 symptoms are improving (note that loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation)

Research subjects must be pre-screened for COVID-19 symptoms the day before data collection via telephone or videoconference, and then screened again upon arrival at the lab or research site. A checklist including all the items in the sample checklist below should be used for screening and pre-screening. On-site screening must also include a temperature check. Digital infrared thermometers for this purpose can be borrowed from Human Resources.

Pre-Screening Checklist for Research Subjects

  1. Are you fully vaccinated?
  2. Symptoms
    1. Is forehead temperature <100.4° F? ☐Yes ☐No
    2. In the last 30 days, have you had a positive COVID-19 test?   ☐Yes ☐No
    3. In the last 14 days, have you had sustained close contact (such as a household contact) with a person with a positive COVID-19 test?   ☐Yes ☐No
    4. In the last 14 days, have you had a fever, cough or diarrhea? ☐Yes ☐No
    5. In the last 14 days, have you had cold or flu-like symptoms?   ☐Yes ☐No
    6. In the last 14 days, do you have concerns regarding other potential symptoms (loss of taste, loss of smell, eye redness or discharge, confusion, dizziness, unexplained muscle aches) related to COVID-19?   ☐ Yes ☐No

If the response to #1 is Yes AND all other responses are NO, the in-person visit may proceed.

PI/Sub PI who is providing approval: __________________________

                                                                                
Enter the date approval received for in-person visit: _____________

Only subjects who are vaccinated and answer “No” to all other questions on the checklist are eligible for participating in data collection or other study-related procedures. Research team members are responsible for maintaining a record of completed pre-screening checklists for all research subjects. Audits to ensure compliance may occur.

Appendix 2. Safety Procedures for Interactions with Research Subjects

All CGU investigators and members of research teams should be aware of and comply with strategies for maximizing the safety of themselves and research subjects.

  1. Location and Travel
    • For research conducted off the CGU campus at locations within the community, CGU investigators should aim to travel in separate cars to research sites. If investigators must travel together, no more than two people should occupy a vehicle to, from, and at the community site. Cloth face coverings are to be worn in vehicles when two people are traveling together. Whenever possible, travel with windows open or with outdoor air entering and circulating in the cabin of the vehicle. High touch areas (e.g., vehicle keys, door handles, steering wheel) should be disinfected before and after the field work day.
    • For day trips, all investigators should bring ample food and fluids for themselves. No sharing of food or drinks is allowed.
  2. Scheduling, if applicable
    • For subjects without COVID symptoms, offer subjects the option of either a virtual visit (if possible per study protocol) or an in-person visit with the PI/research team members. Research team members must specifically inform subjects if the research study protocol requires an in-person visit.
    • For subjects with COVID symptoms, PI must be notified and the subject should be scheduled for a remote visit OR scheduling for the in-person study visit shall be delayed until it has been
      10 days since first appearance of symptoms first appeared and
      24 hours since the subject has had no fever without the use of fever-reducing medications and
      Other COVID-19 symptoms are improving (note that loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation)
  3. Face covering/masks, PPE and Handwashing
    • All CGU investigators and members of research teams must wear a mask while in the presence of research subjects or other research team members.
    • Research subjects should be instructed to wear a cloth or similar face covering. Masks will be provided to research subjects prior to the screening process if they did not bring their own.
    • Masks or cloth face coverings must be worn at all times by research team members around subjects and other members of the study team. Face coverings are always required when conducting tasks involving personal interactions at less than six feet distance.
    • Masks or cloth face coverings should be changed whenever soiled, wet, or damaged. Cloth face coverings should be laundered with warm water and detergent daily or whenever they are visibly soiled.
    • The mask or cloth face covering may be removed when eating/drinking.
    • All CGU investigators and members of research teams should wash their hands before and after any interaction with research subjects.
  4. Arrival/Check-in/Waiting
    • Ask research subjects to check in via a phone call or text message to a research team member who will coordinate the subjects’ entry into the facility.
    • When subjects call to check in, let them know that they should wait in their car or outside the building until the research space is ready.
    • A designated member of the research team will meet the subject at the entry to the building.
    • This research team member will conduct symptom and temperature screening at the entry to the building.
    • Subjects with a positive screen will not be allowed to continue their research visit and will be rescheduled following the conditions outlined in #2 above.
    • Every subject will be asked to wear a mask upon arrival, and will be provided one if needed. Visitors will also follow the same policy.
    • This research team member will then escort the subject to the research space.
    • Hand sanitizer will be made available for subjects, and research team members will ask subjects to sanitize their hands upon entry to the research space. Study team members will point out bathroom locations where there is soap and water for handwashing.
    • Adhere to all other CGU visitor guidelines (https://my.cgu.edu/covid-19-response/campus-visitor-policy/).
  5. Research Spaces/Data Collection Areas
    • Seating or other congregating in research areas should be set up to allow for 6 feet of physical distancing between persons.
    • Separate entrances and exits and or “traffic” flow designations should be utilized to allow for one direction of travel in research/data collection areas.
    • Direct subjects into the designated research office as soon as the space is available.
    • Research teams should designate an “air traffic controller” to optimize the flow of subjects safely through the research area from check in to check out, if and when there are multiple research visits scheduled close in time.
    • Maximum capacity in-person for the research space that allows for appropriate physical distancing of 6 feet between persons should be assessed. Use the procedures described below to ensure volume does not exceed this capacity at any given time.
    • Investigators will stagger the schedule of virtual/remote visits with in-person visits to minimize the number of subjects waiting at any point in time.
    • Investigators will implement extended hours (in the early morning or evening) for research visit types to minimize the number of subjects waiting at a given time.
  6. Physical Workspaces
    • Utilize additional offices in designated building to ensure physical distancing between study team members as needed.
    • Consider plexiglass partitions between workstations to facilitate infection prevention.
    • Ensure that all computers have necessary software and webcams to conduct remote/virtual research visits.
    • Consider using noise cancelling headphones or headsets with directed microphones (for individual use only).
  7. Cleaning and Disinfection
    • Once the visit is complete and the subject has left the research space, study materials and equipment should be immediately disinfected following standard precautions. According to the CDC, diluted household bleach solutions, alcohol solutions with at least 70% alcohol, and most common EPA-registered disinfectant should be effective. Disinfecting wipes may be used to disinfect surfaces, tablets, pens, and any other items involved in the data collection. CGU Facilities can provide disinfecting products.
    • Where applicable, research team members’ desk spaces should not be used by other research team members. Any shared items should also be promptly cleaned in between use.

Appendix 3. Procedures to Reduce Risk of Transmission of COVID-19 After Testing Positive or Interacting with Someone Who Tested Positive1

Research team members and research subjects who test positive for COVID-19 should isolate and not engage in research activities until the following conditions have been met:

  • 10 days since first appearance of symptoms and
  • 24 hours since the subject has had no fever without the use of fever-reducing medications and
  • Other COVID-19 symptoms are improving (note that loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation)

Investigators should immediately notify all research team members and research subjects who are close contacts of the confirmed cases.

Those deemed as close contacts should quarantine and do the following:

  • Stay home for 14 days after last contact with the confirmed case and maintain social distance (at least 6 feet) from others at all times
  • Self-monitor for symptoms until 14 days after exposure: check temperature twice a day; watch for fever (100.4◦F), cough, shortness of breath, or other symptoms of COVID-19.
  • If symptoms develop, immediately self-isolate and contact your local public health authority or healthcare provider.
  • Close contacts who test positive for COVID-19 can only engage in research activities once the aforementioned conditions have been met.

Research team members and research subjects who are a “close contact” of someone with COVID-19, regardless of their involvement in the research project, must immediately inform the PI, quarantine, and follow the aforementioned guidelines.

  1. ^ Adapted from CDC guidance at https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html and https://www.cdc.gov/coronavirus/2019-ncov/php/public-health-recommendations.html