The Health Insurance Portability and Accountability Act (HIPAA) has radically changed the way healthcare is conducted, and its relevance continues to expand as healthcare technology evolves. This article describes a method for training inexperienced undergraduate students to become HIPAA-compliant clinical research volunteers in a pediatric traumatic brain injury (TBI) study. Volunteers are trained to use the hospital's electronic health records (EHR) system to identify potential study candidates for approach, and they develop this skill set through google classroom modules/quizzes along with routine zoom calls to solidify their consenting approach. Since the inception of this study in 2018, there have been over one hundred different undergraduate research volunteers involved, and there has not been a single HIPAA violation to date. This compliance success rate is indicative of the efficacy of this training protocol. This paper serves as a guide to implementing HIPAA compliance training and ensuring accountability in new and existing clinical research studies.
Keywords: Public health research; educational research; ethics and public policy; informed consent; legal and regulatory issues in research; public policy; responsible conduct of research; science policy.