Forms and Templates

COVID-19 Tool Kit for Human Subjects Research

Released June 24, 2020
Last updated: March 16, 2021

Because of the situation COVID-19 has presented us, there has been an increased need to ensure that we have clear explanations and documentation in the research record of protocol deviations and IRB-approved modified processes.

For information regarding monitoring, please see the Human Subjects Monitoring Guidance.

This toolkit has been designed to provide you with some templates that can be used to document protocol deviations, verbal consent processes, and written consent processes given the constraints of COVID-19. These documents should aid you in documenting this information in an efficient manner. They are intended to be downloaded and manipulated by researchers to fit their studies.

Please see HRPO’s reporting guidelines to determine appropriate reporting of protocol deviations. 

For questions about best practices for documentation in the research record, please contact Andrea Morris, Manager of the Human Research Quality Assurance Program (HRQA), at 314-747-5525 or