The Human Research Protection Program (HRPP) is the global USC program that oversees the safety and welfare of participants in Human Subjects Research in accordance with all applicable federal regulations, state laws, and USC policy. At the institutional level, the HRPP includes five areas: USC as an academic institution; the Office for the Protection of Research Subjects (OPRS), which includes the Institutional Review Boards; the investigators and their study personnel; the study sponsors; and the research participants themselves.
OPRS, in partnership with the research community, is responsible for:
The Mission of OPRS is:
USC received full re-accreditation Sept 15, 2020
The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) is an independent accrediting body that works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.
By obtaining AAHRPP accreditation, USC is now part of an elite group of institutions internationally renowned for promoting exceptional ethical and professional standards in the conduct of human subjects research. Also, in working towards accreditation, OPRS implemented a number of improvements to the USC Human Research Protection Program (HRPP) including the creation of HRPP Policies and Procedures, launching of the HRPP website, switching to an online application system (iStar), and increased education for faculty, administration, staff, and students involved in human subjects research.
To maintain excellence in the protection of human subjects and to meet federal and Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements, a successful monitoring program is essential. At USC, the Quality Improvement program serves to keep investigators cognizant of rules, to correct procedural errors, and most importantly, to increase protections for subjects enrolled in research projects. Quality Improvement procedures include assessing investigator compliance with the IRB, monitoring the IRB review process, and inspecting study records and documentation.
Not-for cause, non-putative auditing tools:
USC’s Human Research Protection Program (HRPP) publishes a dashboard every fiscal year on IRB performance and metrics. This is an effort to increase transparency between the IRB and our research community. These metrics are associated with the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standard I-5, and inform our quality improvement initiatives.
STANDARD I-5: The organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.
OPRS is committed to furthering education at all levels of the Human Subject Protection Program. We have implemented an education policy that requires all USC human subjects researchers to complete training in Human Subjects Protection regardless of the researchers’ funding source, or study risk-level. We offer regular and ongoing human subjects educational training sessions covering federal regulations, human subjects ethics and history, the Institutional Review Board process, conflicts of interest, and more. We provide IRB members with monthly education and refreshers in research regulations as needed.
OPRS launched a new committee that brings together members of the USC research community to provide advice and support regarding the Human Protection efforts at USC. The charter for the group will be to: