03/30/20 | 3:00 pm | A message from the Vice President for Research
Dear Research Community,
UT Health San Antonio is following the WHO and CDC guidelines to protect the health and safety of our workforce and mitigate the spread of coronavirus in our community. The institution’s COVID-19 website is continuously updated and research-specific communications are available under the Research Continuity tab. Below are the latest updates on:
- Clinical trials requiring face-to-face interactions
- In-person sponsor monitoring visits
- Department of Laboratory Animal Research (DLAR) operations including new animal orders and breeding colonies.
A. New limitations on direct person-to-person interactions for non-therapeutic human research.
All study activity for non-therapeutic human research involving direct contact must immediately be paused (e.g., discontinue in-person interactions)*. Study procedures that can be modified by using alternative methods of gathering data (e.g., telephone interviews, email, etc.) should be implemented (see previous communications regarding Institutional Review Board (IRB) reporting requirements). All other study activities not involving direct contact may continue.
* COVID-19 related research in this category is EXEMPT from the limitations.
Why are limitations on human research involving direct contact being implemented?
Limitations on human research involving direct contact with participants are needed to comply with social distancing guidelines.
These measures are being implemented to:
- mitigate the risk of direct contact for both study staff and research participants
- ensure the health care professionals are available to perform clinical duties
- preserve personal protective equipment (PPE) for clinical care
Is the pause in human research applicable to all human studies?
No. Categories of human research and the required limitations are as follows:
- Category 1/Non-Therapeutic – studies involve direct person-person interactions but do not provide therapeutic benefit to participants. Required pause; see Section A for details.
- Category 2/Therapeutic – studies involve direct person-person interactions and interventions that provide therapeutic benefit to participants. The following do not need to pause*:
- Therapeutic research studies wherein there are limited/no treatment alternatives.
- FDA “Treatment” or “Emergency Use” studies.
- Studies in which interruption/delay of research could cause significant harm to current research subjects.
*- Study teams should consider alternatives to direct contact with participant, if possible (e.g., telephone follow-up or electronic data collection). See previous communications regarding Institutional Review Board (IRB) reporting requirements.
*- Study teams should also evaluate how illness and absences, drug shortages, facility closures, or lack of required personal protective equipment may impact treatment delivery or monitoring.
- Category 3/No Direct Contact – studies do not involve direct person-person interactions. Do not need to pause.
B. Postponement of In-Person Sponsor Study Monitoring Visits
Out of concern for the safety and welfare of research participants and study staff, all visits to UT Health San Antonio facilities unrelated to patient care are indefinitely pauseduntil further notice. This policy applies to in-person study monitoring visits and adheres to the social distancing guidance of the CDC and WHO.
Other forms of study monitoring that do not require direct contact can continue. These include communication with the clinical investigator and study site staff, as well as review of the study site’s processes and procedures. Currently, remote access to our electronic medical record (EMR) by sponsor’s monitors to verify data accuracy is not possible. In addition, we will not be able to transmit de-identified copies of the EMR to monitors.
This policy is fluid and guided by university leadership, our affiliate organizations, and elected officials. Updates will be communicated as conditions warrant.
As previously mentioned, DLAR personnel are currently divided into two teams and providing animal care services on a split shift to limit exposure of the entire workforce to COVID-19 (i.e. ½ staff in-house with one supervisor and 1 veterinarian 7 days a week). Further details on the services provided by DLAR are available here. At this time, all investigators should scale down experiments and animal use and conserve supplies, particularly PPE.
DLAR management, office and veterinary staff are available during normal office hours via email and cell phone (Dr. Sander Hacker,firstname.lastname@example.org/cell 210-288-2819; Dr. James Elliott, email@example.com/cell: 979-450-2070). Please be aware that DLAR contact numbers are also posted in all vivaria. Investigators will be notified of adjustments to animal care operations if/as the severity of the COVID-19 pandemic increases. As of today, there are no plans to limit access to research animals.
- All investigators should limit animal orders to what is absolutely necessary to complete ongoing experiments. PLEASE DELAY initiation of new, approved animal experiments that would increase the number of cages in-house that need DLAR services. Effective immediately, new animal orders are suspended, with the exception of those linked to COVID-19-related research projects (see below*)
- All investigators with breeding colonies should focus their efforts on maintaining or decreasing the current number of cages in their rodent colony. PLEASE DO NOT increase the number of animals/cages in rodent colonies at this time.
- All investigators should review current rodent cage counts with their staff and remove excess from their census.
*Investigators using animals to conduct COVID-19-related research should send an email to Dr. Mark Nijland (firstname.lastname@example.org) and include the IACUC protocol number(s) linked to their specific project(s).
Note: The VPR Office has compiled a list of mouse lines to be considered for sperm cryopreservation. If you are interested in this service, send an email to VPR@uthscsa.edu indicating how many lines you would like to cryopreserve.
Andrea Giuffrida, Ph.D.
Vice President for Research