If you have questions related to faculty scholarship affected by COVID-19, visit Research Central, an online portal to receive your inquiries and requests.
The Institutional Research Board (IRB), Human Research Protection Program, Export Control unit, and the Institutional Animal Care and Use Committee (IACUC) are fully operational and continue to serve the university research community. New and updated information will be added to this guidance as it becomes available.
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IRB and Human Subject Research
The Institutional Research Board (IRB) and Human Research Protection Program (HRPP) are fully operational. New and updated information will be added to this guidance as it becomes available. In addition, the HRPP will email any alerts on updates directly through the UT Knoxville iMedRIS listserv (i.e., those with active accounts in iMedRIS). To ensure you receive these updates, confirm that email@example.com is included in your safe senders list.
For comprehensive information regarding necessary changes to human subjects research protocols due to the COVID-19 pandemic, please see irb.utk.edu/covid-19.
UT Knoxville HRPP/IRB Operations
The Human Research Protection Program and Institutional Review Board are fully operational. HRPP staff are working remotely. The IRB will hold its meetings remotely as necessary.
Researchers can contact the staff by email (firstname.lastname@example.org), phone message (865-974-7697), or by contacting an HRPP staff member directly. All phone messages and emails will be answered as soon as possible.
The HRPP has designated that all research activities involving in-person contact with participants must be postponed or remain on hold effective March 18, 2020 unless a formal exception was granted based on limited criteria. However, as the University is entering Phase 2 of reopening, the process of requesting exceptions to resume in-person research has expanded to include a wider set of criteria. Procedures that do not require in-person contact with participants that have been approved by IRB can continue. If appropriate to the research, investigators may submit protocol changes to the IRB that change procedures to those that do not require in-person contact. Investigators may also submit new protocols for review that include in-person contact to be ready to immediately start research when in-person contact is allowed by HRPP.
In-Person Contact with Research Participants
All research activities involving in-person contact with participants must be postponed unless a formal exception is granted by the HRPP. Exceptions may be granted by the HRPP for research that meets the following criteria:
- Protocols that are critical to the treatment of a participant’s significant and life-threatening condition
- Protocols that provide the potential for direct benefit to participants
- Protocols studying COVID-19 that could provide beneficial information to the County and State Public Health Departments
- Protocols that are off-site at other facilities (e.g. clinics, hospitals, etc.) that follow guidelines for reducing risk and exposure to COVID-19
This includes international research that involves in-person contact. The university has very few active studies that meet the criteria listed above. These restrictions on in-person contact with research participants are mandatory and will be in effect at least until such time as the University enters Phase 3 of the Return to Work Plan.
Permitted Interactions with Research Participants
Procedures that do not require in-person contact with participants can continue as approved in the IRB application. Procedures that are approved involving in-person contact need to be postponed or, if possible, modified to utilize remote procedures.
Depending on the research, a variety of procedures with participants can be conducted remotely. Examples include, but are not limited to, data collection, some interventions, recruiting, screening, consenting, and administering compensation. Remote procedures to consider include online surveys, video conferencing, phone, email, postal mail, etc.
Restrictions on in-person interaction apply to all human subjects research conducted by UT employees, staff or students, even if the study is under review by an External IRB. The research team should notify the External IRB and follow all External IRB requirements for any modifications or reporting that occurs from these restrictions.
Interacting with Research Participants
In-person research interactions are on hold until further notice unless the HRPP has approved a Request to Resume In-Person Research during COVID-19
Research interactions performed remotely with participants may continue.
Caring for Laboratory Animals
In coordination with University leadership, the Institutional Animal Care and Use Committee (IACUC) and the Office of Laboratory Animal Care (OLAC) strongly recommend that faculty, staff and students take a proactive approach and develop plans to ensure that you are prepared to care for your animals and to safeguard your research projects in the event that the evolving status of COVID-19 leads to a disruption in research activities/access and staffing.
It is imperative that investigators have contingency plans in their labs for ongoing research protocols and any unique care requirements for their research animals. Items to address and consider include:
- A plan for ongoing non-routine care requirements for animals currently on study (e.g. special diets, post-surgical care, special housing).
- The impact of truncated study timelines or data collection. Consider delaying initiation of protocols with long study durations.
- Addressing any staffing concerns for ongoing studies through cross-training and personnel amendments.
- Updating all contact information to prepare for potential personnel absences.
- Updating contact information for members of the lab authorized to make decisions in the event of an emergency related to your animal work. This contact information should be readily available in your workspace within the lab animal facilities (LAF) in the event that someone who is not familiar with the facility needs additional information.
Personnel working in our dedicated LAFs are considered essential and will continue to provide animal care. Please note that while the LAF staff will continue with basic, essential husbandry practices (i.e. cage changes, cleaning, feeding), in the event of reduced staffing, they will not be able to provide extra services (i.e. weaning mice, enrichment, etc.). The husbandry staff cannot engage in protocol-specific research activities. Additionally, OLAC staff will not be able to provide research-specific services should the LAFs experience staffing issues, as they will be providing husbandry support as required.
Contingency plans are also in place to manage animal care at our Research and Education Centers (RECs) in east and middle Tennessee. Personnel not normally tasked with animal care are undergoing training to assume basic husbandry responsibilities, should this prove necessary. Please contact the REC director at your specific facility for more information should you have any questions regarding your ongoing studies.
As always, animal welfare is our primary concern and we will all work together to ensure that appropriate care is delivered without interruption. Please contact the IACUC Office (email@example.com) or OLAC (firstname.lastname@example.org) for additional assistance.
All export-controlled research must be performed in accordance with pre-approved technology control plans. The requirements for physical security and cybersecurity associated with each project, as defined in the project-specific technology control plan and in accordance with federal regulations, are unaltered.
Deemed exports can occur when an individual from a particular disallowed (as defined by the sponsoring agency or the US government) country of origin gains access, information, or experience with restricted technology, materials, or equipment.
Also, deemed exports can occur through visual inspection without any direct contact with the restricted items. All export-controlled projects have a pre-approved personnel list defining who is allowed to work on the project. For situations where laboratory personnel are limited, this restriction must remain intact to prevent deemed exports. Alternate personnel must be reviewed and documented in accordance with the restrictions in the technology control plan before being allowed to work on the project. For any questions, please contact the export control officer Dairin Malkemus (email@example.com).