HRPP
About The Human Research Protection Program
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 Institutional Review Boards; the investigators and their study personnel; the study sponsors; and the research participants themselves.
HRPP, in partnership with the research community, is responsible for:
- Providing the highest level of research participant protection standards.
- Ensuring the ethical and equitable treatment of all human research participants in studies being conducted at USC and its affiliates and partners and/or being conducted by USC faculty regardless of site of activity.
- Ensuring compliance with federal regulations, state laws and USC policies as well as national standards for research involving human participants.
The Mission of the HRPP is:
- Promoting the adherence to and enactment of the Belmont Report principles of Respect for Person, Beneficence, and Justice.
- Facilitating the protection of rights and welfare of human research participants.
- Helping ensure compliance with federal regulations, state laws and USC policies as well as national standards for research involving human research participants, and
- Providing timely high-quality education, review, and monitoring for human research projects.
USC received full re-accreditation Sept 15, 2020
About AAHRPP
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.
The Benefits of Accreditation
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.
Quality Improvement Tools & Results
Not-for cause, non-putative auditing tools:
- Pre-visit Assessment
- Site Visit Guide
- CQI Interview Questions
- Lessons Learned from CQI Assessments
- Problems Frequently Identified During an Audit/Assessment
- Continuous Quality Improvement Visit Tip Sheet
Continuous Quality Improvement Efforts
Study Documentation Templates
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.
Fiscal Year 2021-2022
The HRPP 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.
The HRPP 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:
- Identify pain points with the IRB submission and review process and brainstorm solutions.
- Operate as a sounding board for plans being made to improve efficiency in relation to the IRB review and approval process.
- Operate as a sounding board regarding educational needs for faculty, staff, and students regarding the ethical conduct of human subjects research and the IRB review and approval process.
- Advocate on behalf of the HRPP with USC leadership and members of the research community regarding the ethical conduct of human subjects research and the IRB review and approval process.
