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Continuity of Research Operations

UTHSC’s campus administration continues to monitor, closely, the COVID-19 situation. Basic laboratory and clinical research infrastructure support remains currently active. Should State or Federal authorities require a partial shutdown of research operations, UTHSC leadership will communicate any future disruptions to the research enterprise at that time.

Researchers are advised to plan now for emergency scenarios that may include, but are not limited to, a decrease in the availability of lab personnel, possible disruptions in laboratory supply chains, as well as a total suspension of all research activities. It should be emphasized that while we hope contingency measures will not be needed, proper planning reduces the impact, should it become required.

Continuity Plans

Continuity plans should consider operational impacts from disruptions both upstream and downstream of the lab. At a minimum, labs should operationally consider:

  • Create a staffing and essential duty coverage plan: prepare for a reduced number of staff by cross training personnel on essential functions
  • Create an emergency contact list: Review and update contact information for personnel and key contacts. Ensure proper distribution of the list (e.g., Chairs business manager etc.)
  • Prepare personnel to work remotely: Consider performing work amenable to remote support, such as data analysis, off campus. Ensure personnel have the appropriate home infrastructure to do so. Please see the resource from our ITS department that may be helpful to those working remotely: https://uthsc.edu/its/remote-work/.
  • Lab equipment: Determine if there is any equipment that cannot be shut down and equipment that requires routine monitoring such as liquid nitrogen tanks, freezers, and incubators. How will they be monitored?
  • Supply Chain: Ensure that adequate supply of materials (e.g. reagents, PPE, etc.) is on hand or accessible. Identify alternative vendors in the event of shortages. Secure hazardous materials (e.g., radioactive materials) and store hazardous materials and waste in the appropriate environment (e.g., containment, shielding, etc) in case access is not available for an extended period.
  • Prioritize: Assess and prioritize critical laboratory activities. Identify personnel able to safely perform essential activities. Research staff should be cross-trained and complete institutional compliance requirements to fill in for others who may be unavailable to come to work. (For example, cross-trained personnel entering LACU facilities must fulfill all IACUC requirements necessary for entering these facilities.)

Laboratory Animal Care Unit

Researchers can plan for LACU facilities to remain open. LACU facilities are staffed by essential personnel and they will continue caring for the animals on campus by performing daily health checks, feeding animals and changing cages, as usual. Any changes in schedules that may be implemented due to staff shortages will be communicated to investigators via the LACU listserve email. PIs should familiarize themselves with the “Save in Emergency" cards that are now present in all animal housing rooms. These cards can be placed on any of your cages that are considered irreplaceable (e.g. unique strains, animals not commercially available, animals on study etc). As part of laboratory contingency planning, PIs should critically evaluate their current census, breeding programs, and both near and long-term needs.

Laboratory Closure Plan

An action plan should be created in the event that a lab needs to be closed. These plans should address, at least, the following topics:

  • Information posted on the outside of the entrance doors, is up to date. This includes both hazard warnings and personnel contact information.
  • General chemicals and reagents have been removed from laboratory benches and shelves, when applicable, and placed into appropriate containment and storage.
  • Ensure that all high-risk materials (radioactive materials, chemicals, biohazards) are properly labeled and secured.
    For example:
    • Flammable materials stored in an appropriate location.
    • Incompatible materials are segregated by hazard class.
  • Hazardous chemical waste, radioactive waste and biohazardous waste has been labeled and a waste pickup requested (chemical and radioactive waste) or packaged in a Stericycle box (i.e. biohazard waste) and removed from the lab.
  • Compressed gas cylinders are secured, in an upright position, with regulators removed and protective caps installed. If appropriate, disconnect compressed gas cylinders from CO2 incubators and other nonessential equipment.
  • Non-essential equipment turned off
  • All items are removed from window ledges.
  • Containers stored above floor level in case of water events (e.g. sprinkler discharge, flooding, etc.)
  • Check liquid nitrogen (LN2) container and assign the responsibility to maintain the level of LN2 to ensure sample preservation.
  • Arrangements made for the protective care of research animals, (see above). Proper shutdown procedures for equipment is in place and performed.
  • Proper power backup systems in place, where applicable. Is your critical equipment tied into the emergency backup?
  • Ensure that intellectual property (lab notebooks, ledgers, CDs) has been removed or is safely stored.

If you have additional questions or would like Research Safety Affairs to review and provide feedback on your continuity of operations plan or temporary lab closure plan, please email us at labsafety@uthsc.edu.

Clinical Research

Clinical Trials Governance Board guidlines regarding human subject research activities at UTHSC (for non-COVID-19 studies) during COVID-19 pandemic.

Effected 4/7/2020

Given the rapidly developing COVID-19 pandemic across the world, clinical research is likewise affected. The risk/benefit calculus for research subjects have fundamentally changed across the research landscape given the increased risk of contracting and being impacted by the COVID-19 pandemic. As such, for each trial consideration must be given to continue patients receiving benefit from experimental therapies while minimizing exposure to the virus for both participants, caregivers, and medical staff. As such, the following guidelines for UTHSC have been developed to attempt to navigate the changing nature of the pandemic. These guidelines are intended to supplement the guidance document entitled “Continuity of Research Operations at https://uthsc.edu/research/covid-19-notice.php.)

The following guidance applies only to trials that do not attempt to study or modify the COVID-19 pandemic. All studies relating to the COVID-19 pandemic, whether observational or interventional, should be prioritized and conducted preferentially.

Observational Studies

No prospective observational enrollments or visits are to be conducted in person going forward. Effective the above date, all observational visits for patients already on these studies are to be moved to telephone or video visits. New patients enrolled on observational studies are to be limited only to those studies that have provisions for online or telephonic enrollment. If remote enrollment is a possibility, consideration should be given prior to enrolling new participants to ensure the participant and study team have the ability to comply with the protocol given no inperson assessments. Retrospective observational studies not requiring patient participation or consent can continue for as long as access to necessary databases and records is maintained.

Sponsors have, as a rule, been compliant with recent FDA guidance and have been amenable to deviations from the protocol or rapid amendments to allow for these types of assessments. The following should be done for each procedure on observational research that deviates from the protocol:

  1. Good records of actions and interactions with participants, third-party providers, and the study sponsor should be kept.
  2. Be in contact with all current study participants to inform them of the change to virtual visits and give them the opportunity to withdraw from the observational trial.
  3. All potential new patients to be enrolled on the studies should be informed of the new guidelines where they do not correspond to the current language in the consent form, and this should be specifically documented.
Biospecimen Only Studies

New enrollments on biospecimen studies (with the exception of COVID-19 related studies) are to halt effective April 7, 2020. Participants currently on biospecimen studies that require further biospecimen collection or further visits should be postponed until the shelter in place orders have been rescinded. IRBs and sponsors should be informed as to this policy change. In instances where a biospecimen study with significant disease-related scientific importance is already established and measures have been taken to greatly reduce or eliminate risks from COVID-19 to study personnel and participants, new recruitment and specimen collection may continue with approval by the IRB and the Medical Director of the clinical research site in consultation with the PI(s) and sponsor. Continuation should not place an undue burden on facilities or staff or interfere with other ongoing studies.

Phase I Studies

Phase I trials utilizing healthy volunteers are to stop enrollment as of the above effective date. Healthy volunteers currently enrolled on these trials should be informed of the increased risk during the COVID-epidemic and given the opportunity to withdraw. Consideration should be given to stop healthy-volunteer studies altogether or postpone visits until the shelter in place orders are rescinded, and this decision is to be made by the responsible investigator.

Phase I studies on participants, with a degree of therapeutic intent, are to be treated as Phase II/III trials below.

Phase II/III Studies (Participants Currently on Study and New Enrollments)

In general, trial participants should stay on study and receive their medical treatments. Staff should stay in contact with study participants to keep up with any safety concerns and changes in subject willingness to remain on trial. When the PI and the Medical Director of the Research Office determine that the risk/benefit ratio is not significantly affected, patients should have key safety and efficacy procedures completed (such as labs and scans) as per protocol. When possible, these procedures should be performed on a day in which the patient was otherwise going to be treated or seen by their physician. Telehealth visits for follow-up will be allowed when appropriate. Good records should be kept for each time-point regarding deviations from the protocol. 

  1. Participants Currently On Study: Highest priority should be given to ensure that participants actively receiving therapy on Phase II/III studies continue to receive investigational product and therapy during the pandemic. Non-therapeutic visits (for scans, labs, etc.) should be limited when possible or combined into visits where treatment or medical care is already being performed. Telehealth visits for follow-up will be allowed when appropriate. In some instances, this will require a protocol deviation. Sponsors will be informed of these guidelines. Additionally, participants on study should be informed as to the risks of COVID-19 and given the opportunity to withdraw should they wish to do so. IRBs should be consulted regarding how best to make changes to protocols, communicate changes to participants, and the guidelines for modifications prior to IRB approval. For UTHSC-Memphis, refer to the updated guidance document from 3/20/2020 at: https://uthsc.edu/research/compliance/irb/covid-19.php

  2. New Enrollments: Generally, persons who sign up for research studies may be doing so because the research study could represent the best possible care opportunity. However, there are instances in which this is not the case, and these cases are often nuanced and complicated. As such, after initial coordinator screening but prior to consent for each new interventional study, specific permission from the Medical Director of the Research Office in consultation with the study Primary Investigator is required as to whether the person’s risk/benefit ratio is commensurate with that person going onto a study. Only after this permission has been granted may consent occur.
Phase IV Studies
Generally, Phase IV studies test accepted or standard therapies with additional safety and efficacy measurements and monitoring. Enrollment may continue on Phase IV studies after a determination by the study PI that any in-person visits occurring only due to participation in the study are minimized (research-only laboratory measurements, CT scans, etc.)  
Risk Mitigation During Study Visits
When in-person visits are required for patients enrolling or currently enrolled in clinical trial, the most recent guidelines regarding pre-screening personnel and participants for COVID-19 symptoms should be utilized. Personal protective equipment should be utilized as per the most updated guidelines from the US Centers for Disease Control (CDC). These guidelines can be found at https://www.cdc.gov/coronavirus/2019-ncov/infection-control/infection-prevention-control-faq.html. Additionally, state guidelines should be followed where applicable. Current statewide information and guidance can be found at https://www.tn.gov/governor/covid-19.html. 
New Studies
While the guidelines for enrollment of participants on existing studies already open to enrollment are covered in Section 4.B., this section is to address the initiation of studies not yet open to enrollment. No new interventional studies that have not yet opened to enrollment at the site (other than COVID-19 related studies) should activate and begin enrollment until further notice. This is in line with guidance received from study sponsors, experts in the field, and the FDA. Study start-up activities may continue for studies to which a CDA has been signed. New trial opportunities may have CDA’s signed but study activities should be limited to ones that can be done at home while the shelter in place orders are in effect. 
Study Monitoring
Effective the above date, UTHSC will discontinue on-site monitor visits until such time as it is deemed safe to host external sponsor/CRO employees at our facility. Some Clinical Research Offices allow remote monitoring where access to the EMR is required. Care should be taken to maintain data and participant confidentiality should remote monitoring be implemented. Monitors may request periodic calls with staff to maintain appropriate study oversight during this time. Given the current increased demands on staff and the possible reduction of staff levels, each Clinical Research Office will consider these requests on a case by case basis to determine if we are able to entertain such calls at their requested frequency.  
Data Entry
All attempts to ensure timely and accurate data entry will be made, as this directly impacts participant safety for those on clinical trials.
Guideline Sharing and Communication with Sponsors and IRBs

As per current FDA guidance (https://www.fda.gov/media/136238/download), these guidelines are to be shared with all CRAs. IRB/IBCs will be informed of this guideline on a study-by-study basis when deemed appropriate by the regulatory staff of each Clinical Research Office. IRBs should be consulted regarding how best to make changes to protocols, communicate changes to participants, and the guidelines for modifications prior to IRB approval. For UTHSC-Memphis, refer to the updated guidance document at: https://uthsc.edu/research/compliance/irb/covid-19.php.

All attempts should be made to secure COVID-19 related deviation submissions free of charge from the IRB of record. Where this is not possible, sponsors should be informed as to the added costs incurred and attempts should be made to obtain compensation for these submissions. CRAs should be used as a sponsor point of contact for these guidelines and for individual study deviations. 

Conflicting Guidelines

Some study sponsors have provided additional guidance/requirements for their studies (such as forbidding further enrollment without access to remote monitoring). Where a sponsor’s policy is stricter than these guidelines, the sponsor’s policy takes precedence. Where the sponsor’s policy is less strict than these guidelines, the UTHSC Guidelines take precedence.

Some individual Clinical Research Offices affiliated with UTHSC have internal policies already in place for Clinical Trials during the COVID epidemic. Where those policies are stricter than these guidelines, those internal policies should take precedence. Where those policies are less strict than these guidelines, these guidelines should take precedence.

Summary

Wherever possible, participants should continue to receive effective therapy on clinical trials while minimizing risks related to exposure to healthcare environments unnecessarily. Study deviations may and should occur to meet the above goals, and communication with IRBs, sponsors, and internally is paramount. The situation is fluid and the above guidelines may change at any time. We look forward to resuming normal operations in the near future.

Ari VanderWalde, MD, MPH, MBioeth
Associate Vice Chancellor for Clinical Trials
Chair, Clinical Trials Governance Board
University of Tennessee Health Science Center

Karen Johnson, MD, MPH
Chair, Department of Preventive Medicine
Co-Chair, Clinical Trials Governance Board
University of Tennessee Health Science Center

On behalf of The UTHSC Clinical Trials Governance Board 

 

May 26, 2022