Ramp-up checklist for research with human participants

Study team preparation

  • Update as necessary the contact list including all study team members, other personnel, Principal Investigator, and/or department administrator. Ensure that the phone tree or email group is up to date to facilitate emergency communication.
    (Yes / No)
  • Train and monitor research team members regarding protocols for escorting participants to and from the research space to maintain 6 feet of space. No more than one person should be in the same room unless the required 6 feet of distancing can be consistently maintained.
    (Yes / No)
  • Train and monitor research team members regarding protocols for cleaning and disinfecting frequently touched surfaces, objects or equipment to prevent virus spread among participants and study team members.
    (Yes / No)
  • Ensure sufficient supplies, including masks for study team members and participants, hand hygiene supplies and cleaning/disinfectant supplies are readily available in the research space. Masks/face coverings should be used when inside any University of Nevada, Reno facility where others are present, including walking in narrow hallways where others travel and in break rooms, conference rooms and other meeting locations.
    (Yes / No)
  • Post occupancy limits, social distancing and disinfection plan by doors or entryways. These must be visible to those entering the space.
    (Yes / No)
  • Perform a practice session in the research space to demonstrate proper setup and take down and rehearse protocols for managing participants and activities.
    (Yes / No)
  • Verify all study team members have taken the required online training. Visit edu/hr/alternative-operations for information.
    (Yes / No)
  • Ensure study team members know to do self-health checks prior to coming to work and to stay home if they are experiencing any symptoms.
    (Yes / No)
  • Ensure study team members are informed to communicate with colleagues and supervisors as needed by email, instant message, telephone or other available technology rather than face-to-face.
    (Yes / No)

Prepare for participants

  • Determine the number of participants and key study personnel at a site at any time and ensure 6 feet of social distancing. No more than one person should be in the same room unless the required 6 feet of distancing can be consistently maintained.
    (Yes / No)
  • Verify scheduled participant appointments to not overlap with those of other participants. Post an hourly schedule or utilize a shared calendar regarding the schedule.
    (Yes / No)
  • Prior to participant arrival on site, verbally pre-screen that each participant:
    • Has not received a diagnosis of COVID-19 in the past fourteen days
    • Does not exhibit any of the COVID-19 symptoms:
      • Cough
      • Shortness of breath or difficulty breathing
      • Chills
      • Repeated shaking with chills
      • Muscle pain
      • Headache
      • Sore throat
      • Loss of taste or smell
      • Diarrhea
      • Feeling feverish or a measured temperature greater than or equal to 100.0 degrees Fahrenheit
    • Has not had known close contact with a person who is lab confirmed to have COVID-19 within 14 days
    (Yes / No)
  • Clearly inform that all participants must wear masks, to be provided by the lab
    (Yes / No)
  • Ensure that study team members maintain a list of all participants who come to the lab and who interacted with them. Train study team members in completion of the list and storage of the list for easy access.
    (Yes / No)

Conduct of study revisions

  • When a study visit needs to be canceled or changed to a phone call or online encounter, the subject should be told the reason. These messages to subjects do not require IRB approval.
    (Yes / No / Not Applicable)
  • Modifications to the approved protocol must be submitted using an Amendment form and must receive IRB approval prior to implementation. If it is in the best interest of the participant to eliminate an immediate apparent hazard to one or more participants and there is no time to obtain prior IRB approval, modifications may implemented and the IRB should be notified within 5 days.
    (Yes / No / Not Applicable)
  • Clinical trials listed on ClinicalTrials.gov that have paused recruitment should have their recruitment status changed from “Recruiting” or “Enrolling by Invitation” to “Suspended” within 30 days of the change.
    (Yes / No / Not Applicable)
  • For clinical trials, many study teams are switching their consenting process from an in-person interaction to obtaining consent through remote means. For research that is FDA-regulated, electronic signatures must be obtained through software that meets the requirements of 21 CFR Part 11. Investigators can use DocuSign or another method approved by the study sponsor. IRB review and approval is required.
    (Yes / No / Not Applicable)