Competent human research personnel

The process of conducting human research is highly regulated, rigorous, detailed oriented, potentially harmful, and, hopefully, beneficial. Health professionals learn how to critique, design, analyze, and apply human research but have minimal education in how to conduct human research. Successful completion of a 24-hour course was mandated for research support personnel to enhance the protection of human subjects, improve the integrity of data collected, and ensure cost-effective results. Routine audits demonstrated that the course substantially improved the documentation of the informed consent process, source documentation, protocol adherence, and regulatory compliance.