Plans for resumption of clinical and human participant research, education, and service activities

June 8, 2020

 

Sent on behalf of Mark A. Barteau, Vice President for Research

 

As described in the May 7, 2020 Plan for Resuming Research Operations resumption of clinical and human participants activities requires the approval by the vice president for research of plans for safe operation that include infection control. Since then, at the direction of the provost and deans, we have formed a Clinical Research, Education and Service Advisory Committee (referred to hereafter as the Committee) to review plans, including those for clinical education and service activities and non-clinical human participants research that involves face-to-face interaction of researchers and participants. The Committee is co-chaired by the vice president for research of Texas A&M University and the associate vice president for research of the Health Science Center. Plans may be submitted for review to vpr@tamu.edu only after they have been approved by the unit head and dean. The purpose of Committee review is to ensure the adequacy and responsiveness to the criteria described in this guidance. The principal responsibility for detailed evaluation of plans rests with unit heads and deans.

 

The paramount principle is the health and safety of our communities, especially of vulnerable individuals. This includes Texas A&M personnel and those with whom they interact face-to-face in the course of clinical research, education, and service activities and human participants research, whether on-campus or off.

In evaluating individual plans, the Committee will consider the key issues listed below, in addition to specific plan details. We recognize that some of the items below may not be applicable to all situations, but request that in those cases a justification be provided.

Human Participants Research Plans

Responsibilities

  • All researchers (PIs) are responsible for developing an infection control plan and associated procedures for safe human participant research that are appropriate for the type of human participant research activity conducted and the unique research space in which they occur.
  • All research personnel are required to complete on-site training in the approved infection control procedures (e.g., hand hygiene, correct don and doff methods for gloves and masks, cleaning and disinfecting protocols, temperature checks, and requirements for pre-screening information).
  • Research personnel are responsible for reporting issues and infection concerns to directors of research labs and units or their designated representative.
  • Directors of research are responsible for the regular review of their policies supporting face-to-face interactions with participants in order to ensure the policies comply with the changing national evidence-based guidelines for standard precautions and COVID-19 spread prevention.

To facilitate review, please use the Human Participants Research Infection Control Plan form available at

https://vpr.tamu.edu/wp-content/uploads/2021/08/human-participants-research-infection-control-plan.pdf

Critical plan elements include

  • Social Distancing/Density Control
  • Hand hygiene
  • PPE (e.g., masks, gloves)
  • Cleaning/Disinfecting
  • Physical Barriers
  • COVID-19 Health Assessments
  • Contact Tracing

 

The requirements of the human participant research plan occurring in Texas A&M controlled buildings include a floor plan illustrating, where applicable, the management of space to achieve appropriate safe human participant research.

Social Distancing/Density Control

The size and complexity of space where human participant research occurs varies considerably across research labs or units.  In general, the following guidelines apply to research spaces occupying more than one individual:

  • Spacing –1 individual per 100 SQFT, desks 10 FT apart
  • Staggered work and human participant testing schedules posted in accessible area with 15-minute gap between shifts and participants
  • Restrictions on face-to-face lab meetings and use of break rooms

Hand Hygiene

In addition to the hand hygiene expected of all researchers, those interacting with human participants must practice hand hygiene before and after contact with each participant, including contact with the participant’s surroundings (e.g., objects touched by the participant).

Personal Protective Equipment

Face Masks and Face Shields

  • Face masks are required for participants and research personnel during human participant testing sessions at all times unless participating in an assessment where taking off the masks is required. Alternative means of protection, including face shields and/or physical barriers should be described and justified in the plan submitted for approval. Surgical masks should always be donned prior to putting on gloves and taken off after gloves have been thrown away. When not engaged in face-to-face interactions with human participants, researchers may wear a cloth face covering.  Face coverings may not have an exhalation valve unless the mask also contains a filter. Cloth masks must be washed at least twice a week.

Gloves

Cleaning/Disinfecting

All surfaces and equipment that come into direct contact with participants must be cleaned using EPA-approved disinfectant that is effective against COVID-19 at the end of each visit. The complete list of EPA-approved disinfectants can be found at https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2.

Cleaning is required between every participant and additionally when surfaces are visibly soiled. EPA-approved disinfectant can be used to clean chairs, stools, railings, etc. Small individually packaged alcohol wipes may be useful when cleaning smaller measurement instruments and research equipment. Follow manufacturer’s instructions for disinfecting equipment used for taking vital signs and sterilization methods for oral appliances or any other equipment that comes in contact with mucous membranes (eyes, nose, mouth). Hand sanitizer and disinfectant used to clean before and after individual work tasks must be provided at all shared work-station locations.

Physical Barriers

Where feasible, the use of transparent physical barriers to separate subjects and researchers is recommended. Examples may include protocols in which the participant and/or researcher remains stationary at a desk or workstation, or where the participant is observed at a distance. Researchers should describe the use and location of physical barriers in their submitted plans.

COVID-19 Health Assessments

Verbal pre-screening of participants is required prior to their coming on campus. A sample prescreening checklist is available at https://vpr.tamu.edu/wp-content/uploads/2021/08/Human-Participant-Health-Checklist.docx. A screening acknowledgment form recommended for use with all participants upon arrival is available at https://vpr.tamu.edu/wp-content/uploads/2021/08/Screening-Acknowledgement.docx. COVID-19 symptom assessments of participants and research personnel must be obtained or reported immediately upon arrival to the research space and noted in a daily log (sample available at

https://vpr.tamu.edu/wp-content/uploads/2021/08/Employee-and-Participant-Temperature-Log.docx). Any participant or research personnel with a temperature over 100.0F (obtained with a non-contact thermometer) is required to exit the lab space, reschedule their study visit, if applicable, and encouraged to seek medical care. 

Contact Tracing and Reporting

For individual contact tracing purposes, research directors are required to maintain in an onsite confidential location a list of all participants who come to the lab and the identities of all personnel who interacted with them. Instructions for responding to confirmed or suspected cases of COVID-19 of personnel may be found at https://employees.tamu.edu/covid-19/faqs/ and the form for reporting is available at https://redcap.tamhsc.edu/surveys/?s=N38DRD4EMK.

 

No state or county reporting is required if a participant self-discloses that he/she has had a lab-confirmed case of COVID-19. However, if you have a new or updated IRB protocol that requires the testing of human participants for research purposes with an FDA-approved COVID-19 test, both positive and negative cases must be reported to state and local health authorities.

 

 

 

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