Guidance in Response to COVID-19
To minimize risk to human subjects, all research should be conducted remotely whenever
possible. However, for those instances when remote research is not possible, the below
guidelines should assist with the preparation and review of applications for research
involving human subjects during periods when COVID-19 restrictions are in place.
- PIs must first obtain approval to Conduct in-Person Human Subjects Research from their
Department Chair, College Dean, and the Provost using the Return to Research Planning Form (RTRF).
- PIs must submit a new IRB application or amend an existing application prior to conducting
- PIs must outline a remote consent process to be used until COVID restrictions are
lifted. The consent process will include a University-developed document (COVID-19
Risks Statement) that outlines risks specific to participating in research when COVID-19
restrictions are in place.
- PIs must require participants to complete and return the Screening Questionnaire to
the PI on the day prior to their scheduled appointment on campus, and repeated in
person as the first activity of their on-campus visit. This form must be included
with your amendment or new application materials and be approved by the IRB before
screening can commence.
For complete detail and step-by-step instructions, follow the guidance posted below:
- HSR Guidelines (DOCX)/(PDF)
- HSR Procedures (DOCX)/(PDF)
- Return to Research Planning Form (RTRF) (DOCX)/(PDF)
- Screening Questionnaire (DOCX)/(PDF)
- COVID-19 Risks Statement (to be included in the consent process) (DOCX)/(PDF)
You may also visit the Provost’s website or Return to TU Guidance & Protocols webpage for information on the Return to Research phases.
MOVING STUDIES TO AN ONLINE PROCESS
The IRB has issued the following guidance for IRB approved studies that need to move online for data collection.
The IRB continues to strive to respond to protocols in a timely manner, however, delays
may occur given the unique situation.
Ultimately, protocol approvals rely on the completeness of the application, timeliness of the PI returning
any revisions, and reviewer approval. We sincerely appreciate your understanding and look forward to working with you for
the Fall 2020 semester.