COVID-19 Considerations for Human Subject Research

Studies that were previously determined to be exempt can change study procedures to  remote interactions without submitting a study amendment to the IRB if such a change will not affect the category of exempt determination, risk benefit analysis, change the PI, or significantly change the rationale under which you received a waiver of HIPAA authorization. If you have questions as to whether or not your exempt study requires an official amendment, please email irb@austin.utexas.edu or use our website’s chat feature (https://research.utexas.edu/ors/human-subjects/) for a more rapid response.

If your study is expedited or full board and requires an official amendment, follow normal amendment procedures for submitting a modification. Please be aware that an amendment will need to be filed for each study you wish to modify. To expedite the review of a significant volume of similar modifications, the Office of Research Support and Compliance has developed a template amendment summary specific to COVID-19. Use of this document will expedite your modifications and offer flexibility for returning to normal operations in the future.

Note: Any changes to study procedures made to eliminate apparent immediate hazards to research participants or to continue to provide medically necessary study care to participants who have been placed in isolation do not need prior approval by the IRB. All such changes should be reported to the IRB as an unanticipated problem involving risk to subjects or others within 5 days.

Some ongoing clinical studies require in-person follow-up visits to monitor participant safety. For example, a treatment and intervention trial may require physical examinations, laboratory tests, or interviews.

Participants in clinical (treatment) trials should be managed remotely whenever possible. If participants require in-person evaluation to receive treatment or medication or for clinical safety, the PI is responsible for providing this service in the safest way possible, based on risk mitigation procedures put in place within the clinical facility where treatment is occurring.

You should plan for the possibility that in-person visits may not be possible or practical, such as if a participant has a positive COVID-19 diagnosis or is at greater risk for serious outcomes from COVID-19. Consider some of the following as possibilities that may or may not work for your study:

• If your study is sponsored, contact the sponsor for recommendations and/or changes in procedures that are being implemented study-wide.
• Conduct interviews by phone, video, or email questionnaires.
• Attempt to combine follow-up visit procedures with other clinical visits participants’ may already be doing (i.e., visit with another physician specialist) to minimize exposure.

Any changes to study procedures made to eliminate apparent immediate hazards to research participants, including those to reduce potential exposure to SARS-CoV-2, or to continue to provide medically necessary study care to participants who have been placed in isolation do not need prior approval by the IRB. All such changes should be reported to the IRB as an unanticipated problem involving risk to subjects or others within 5 days.

• Office of Human Research Protections (OHRP) Guidance on COVID-19
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

UT Austin allows for paying research participants, including UT employees, via Tango Card, an electronic gift card service provider. Participants receive an email notifying them that they have an electronic gift card to claim in the amount designated by the PI / study coordinator. Read Tango Card details and instructions on the IRB Guidance page.

Dell Medical School has implemented procedures specific to conducting research throughout medical school and clinic facilities. Refer to DMS COVID-19 Research Guidelines for details.

The UT IRBs and IRB staff will continue operations regardless of potential disruptions caused by an outbreak of COVID-19 at UT Austin or in the Austin area. Researchers are encouraged to conduct communications with the IRB office via email, online chat (available from the main page of the IRB website), and telephone to maximize social distancing.

All human subjects research being conducted in-person must now include an additional participation consent form – a COVID-19 addendum. This form is available in English and Spanish on the Human Subjects Research Restart webpage. Participants must sign this consent form in addition to the standard consent form that you provide in your studies.