Update on COVID-19 and Human Subjects Research
Updated March 18, 2020
This guidance is effective immediately for all human subjects research conducted by UT researchers and students. This revised guidance is due to the rapidly evolving circumstances related to COVID-19, the need to protect research participants, and the University’s focus on minimizing in-person contact to better protect faculty, staff, students, and the community.
UT Knoxville HRPP/IRB Operations
The Human Research Protection Program and Institutional Review Board are fully operational. HRPP staff are working remotely. The UT IRB will hold its meetings remotely as necessary.
Researchers can contact staff via email (utkirb@utk.edu), phone message (865-974-7697), or by contacting a staff member directly. All phone messages and emails will be answered as soon as possible.
In-Person Contact with Research Participants
All research activities involving in-person contact with participants must be postponed. Only research involving in-person contact that is critical to the treatment of a participant’s significant and life-threatening condition may continue at this time. UT has very few, if any, active studies that meet this threshold.
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 (see Modifying Study 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.
We strongly advise researchers to use commonly approved resources available to them through the University (e.g., Question Pro, Qualtrics and Zoom conferencing) in lieu of new apps or software. Using these resources will avoid delays in the review process.
Modifying Study Procedures For Full Board and Expedited Studies:
Submit an Amendment Request in iMedRIS. Researchers can assist staff by listing Coronavirus as the rationale for the amendment in section 2.0 (200) Revisions of the Study/Project Application of the Amendment Request Form. This will help flag these submissions so we can review them as quickly as possible.
For Exempt Studies Only:
Below we list some changes that can be made to exempt research studies without submission of an Amendment Request. Any changes to exempt studies that are not explicitly listed as not requiring an amendment request must be reviewed and approved by the IRB through an Amendment Request. We have also included examples of changes that do require an Amendment Request.
