HRPP Investigator Manual
Estimated Reading Time: 1 MinutesThe Investigator Manual (HRP-103) is a comprehensive guide designed to support principal investigators and research teams in conducting human subjects research at The Ohio State University. This essential reference document provides detailed guidance on navigating the institution's Human Research Protection Program (HRPP), including step-by-step procedures for IRB submissions, regulatory compliance requirements, and ethical responsibilities. The manual covers critical topics such as determining what constitutes human subjects research, required training and financial disclosure obligations, consent documentation procedures, multi-site study coordination, and specific requirements for federally funded research. It serves as both a practical handbook for day-to-day research operations and a regulatory reference to ensure compliance with federal regulations (DHHS, FDA, DOD, DOE, DOJ, ED, EPA), ICH-GCP guidelines, and university policies. Whether you're submitting your first protocol or managing complex multi-site studies, this manual provides the institutional framework and procedural roadmap necessary for conducting ethical and compliant human subjects research at Ohio State.