Human Research Protections Office (HRPO)
About
The mission of the Human Research Protections Office (HRPO) is to provide regulatory guidance and oversight to ensure that Madigan investigators adhere to all federal, state, Department of Defense, local and institutional regulations, laws and policies, related to human subjects protection and the ethical conduct of research. The HRPO staff oversee the regulatory compliance of research at Madigan, including determination of human subject risk for submitted proposals, appropriate review processes, and post-approval compliance monitoring. The HRPO includes the Madigan Institutional Review Board (IRB). The Madigan IRB reviews non-exempt protocols for Madigan, Tripler Army Medical Center, David Grant Medical Center, other Medical Treatment Facilities, and Department of Defense Institutions via agreement.
Facilities
Offices are located within the administrative area of the Department of Clinical Investigation.
Personnel
The HRPO staff includes the Human Protections Director, Institutional Review Board (IRB) staff, and compliance monitoring.
Capabilities
HRPO staff advise and educate researchers with relevant administrative, technical, and policy guidance. More specifically, staff expertly assist researchers with proposal and consent development, proposal submissions and identification of appropriate letters of support and impact statements. Alternatives for potential regulatory challenges associated with the research, including fiscal and legal implications, are identified and offered. Research proposals are confirmed for completeness and accuracy, ensuring that administrative, legal, and regulatory standards are met. Staff coordinate and facilitate the appropriate review pathway in obtaining scientific, statistical, and IRB reviews. HRPO continually verifies the protection of human subjects in research through post approval compliance monitoring and provides education to researchers in the most up-to-date human subject research best practices.
Key Ethical Codes and Regulations
- DODI 3216.02, including References
- DODI 6025.18-R
- Title 32, Part 219 of the Code of Federal Regulations (32 CFR 219)
- Title 45, Part 46 of the Code of Federal Regulations, subparts B, C, and D (45 CFR 46)
- Title 21 of the Code of Federal Regulations
- The Belmont Report
- The Declaration of Helsinki
- The Nuremburg Code
- Office of Human Research Protections (OHRP) Human Subjects Document Library
- Defense Health Agency Office of Research Protections policies and guidance.