Research planning and continuity

The Office of the Vice President for Research remains open and fully operational

The Office of the Vice President for Research (VPR) remains open and fully operational as we closely monitor the ongoing coronavirus (COVID-19) outbreak, and continuance of research operation plans are in place.

The VPR office is also encouraging research laboratories to develop and/or review established local continuance plans. Due to the COVID-19 outbreak, or other infectious agents in the future, it is possible that a significant number of laboratory personnel will be absent. We recommend that each facility/laboratory develop a written continuity plan.

Examples of elements to consider include:

Identify the minimum essential personnel and ensure they know what to do in the event of suspended operations.

  • Encourage employees to telecommute, especially job duties that do not require them to be on campus. Note that telecommuting is not appropriate for all jobs. All employees who telecommute are required to follow the University’s Telecommuting Policy for Staff Employees (Policy 5-140) and Telecommuting Guides (Guideline 5-140) and complete the University of Utah Telecommuting Form.
  • Review important operational questions, such as: Are there sufficient back-up personnel if these personnel become unavailable? How will employees be trained to ensure their safety while they are at work?

Create a communication plan. All emergency contact information should be shared between personnel and departmental leadership (e.g., cellphone numbers).

Identify critical processes that will need to be maintained if the campus is shut down and review samples/facilities that are at risk of harm in the laboratory or facility. For example, do you have live animals that will need feeding? Do you have equipment that cannot be shut down and will need regular maintenance? Are all critical equipment on emergency power and are all refrigerator/freezers connected to alarms with remote monitoring?

Review telecommuting needs. Ensure that you and your key personnel have remote access to files, data, servers, IT devices, etc.

Keep amounts of hazardous materials waste to a minimum. Be mindful that the Environmental Health & Safety (EHS) waste disposal group may also be affected by illness, increasing pick up wait times.

Start prioritizing experiments. If you are carrying out a long-term experiment, and if it is feasible to freeze samples at specific steps, you might consider doing this more often. Ensure that critical materials are secured.

Prepare for delays in ordering. Ensure that you have sufficient materials/supplies for critical functions, e.g., PPE, CO2 tanks, liquid nitrogen tanks. Contact vendors/collaborators to discuss plans to suspend regular shipments (receiving and outgoing).

Be cognizant of upcoming deadlines. Although central research administration remains open, reviews by the Office of Sponsored Projects (OSP), Institutional Review Board (IRB), Institutional Animal Care & Use Committee (IACUC), Institutional Biosafety Committee (IRB), etc., may be prolonged or delayed.

Keep personnel up-to-date on wellness training. All personnel should be trained on what to do if they are concerned that they have been exposed to an illness. This also includes training on prevention methods to keep a healthy and safe work environment. Please print and post the Safe Laboratory Guidance document in your laboratories/facilities.The Center for Disease Control and Prevention (CDC) also has helpful tips on what to do if you are exposed to the coronavirus.

The VPR office has created an example template regarding instructional laboratory guidance. Your written plan should be shared with your Department Chair or Division Chief. We hope that advance planning will allow everyone in your group to focus on their own efforts and work together as a team. Be prepared and stay safe!

IRB & RESEARCH PREPARATIONS FOR COVID-19

The University of Utah Institutional Review Board is heeding current guidelines from university leaders in response to the COVID-19 outbreak. We want to provide the research community with information regarding the review and conduct of human subject research during this time.

The University of Utah IRB will be fully operational

There will be no reduced IRB review or consultation services. There may be periods of time that the IRB staff are expected to work remotely to support social isolation efforts. Though it may not be possible for the IRB staff to meet with study teams in person, phone and web conferencing will be functional for all IRB staff members. The IRB staff will be unable to answer direct phone calls while working remotely; however, all IRB staff will receive voicemails and can return calls or respond to emails.

Researchers need to prepare their studies for possible interruptions or complications in conducting procedures

Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your research plans in order to keep study team members and research participants safe. Please make the following considerations for each active study:

Additional clinical services, testing, and screening related to COVID-19 that need to be performed for research participants do not need IRB approval prior to initiation. Such procedures would be considered usual care outside of the research context.

Consider whether your study or parts of your study should be placed on hold during this time. This hold may be for all research procedures. Perhaps placing a hold on enrollment, study visits, data collection, or data analysis separately is reasonable.  It is recognized that discontinuing a participant’s care during this time may not be safe or may dramatically jeopardize the results of the project. The decision to place a hold on your study needs to be made on a study by study basis, likely in consultation with your department leadership to ensure department and participant needs are met. You are not required to report study holds to the IRB; however, you must document them in your research records and report them to sponsors as necessary.

Any changes to your protocol or the conduct of your research procedures still requires an amendment with the IRB.  The IRB does not pre-approve deviations from protocol outside of the amendment process.

There may be an urgency to deviate from the protocol or the conduct of research procedures before an amendment can be approved by the IRB.  Some deviations will be minor. Some may have major effects on the welfare of participants and/or study validity. All deviations must be reported according to the IRB’s reporting policy.

The IRB acknowledges that the COVID-19 outbreak and isolation/quarantine requirements may result in deviations that are intended to eliminate apparent immediate hazard to a research participant. The IRB recognizes that some deviations pose little to no threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window, though no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject's safety and welfare.  As such, reporting is left to the discretion of the investigator within the context of the IRB’s reporting policy.

Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance if an amendment is not pursued with the IRB.  All deviations must be documented in the research record, regardless of whether they meet the IRB’s reporting criteria.

The IRB supports the use of home visits and phone calls for participant data collection and monitoring, so long as no procedures would be performed that are unsafe in this setting. Home visits and phone calls need to be conducted by a member of the study team that is approved in the IRB application. Your IRB application should be amended to include these methods if you choose to use them.

Do not store electronic research data on unsecure devices in order to work remotely. The IRB encourages the use of University-approved cloud services and VPN access while working at home instead of storing data directly on your devices. Do not take home physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.).  All physical records must continue to be stored in IRB-approved, secure locations.

More information

Updates and additional information will be posted here.