Office for the Protection of Research Subjects

The Office for the Protection of Research Subjects (OPRS) was established in 2004 to create and oversee a University wide Human Subjects Protections Program (HSPP) that is excellent, innovative, dynamic, and ranks among the nation’s best. The OPRS strives to exceed regulatory and ethical requirements for all USC human subjects research activities.

In 2007 the OPRS achieved full accreditation from the Association for Accreditation of Human Research Protection Programs. Accreditation requires the creation and implementation of best practices at all levels of the HSPP and continual improvements to maintain excellence.

A primary goal for the OPRS is to maintain AAHRPP accreditation through sound HSPP Policies & Procedures.

To fulfill these goals, the OPRS is committed to:

  • USC HSPP Policies and Procedures
    These guiding principles were created by OPRS with input and validation from the entire HSPP. The policies are current, topical, and extremely comprehensive. They number over 400 pages in length and have been adopted by other institutions. HSPP Policies and Procedures are continually updated as standards and regulations evolve.

  • Communication
    OPRS keeps the USC human subjects research community apprised of evolving practices and expectations on a continuing basis. Information is disseminated through the USC Human Subjects Newsletter, HSPP community listserv, administrative memos, education sessions, speaking events, HSPP website, and a variety of meetings. OPRS also meets with USC schools and departments to keep them informed of updated practices and an ongoing dialogue is maintained with faculty, staff, and students to address issues of mutual concern.

  • Education
    OPRS is committed to furthering human subject education at all levels of the HSPP. OPRS has implemented an education policy that requires all USC human subjects researchers to complete CITI regardless of the researchers’ funding source, or study risk-level. CITI is convenient, user-friendly, and used by more than 800 research institutions. It is offered in six languages, and provides courses in good clinical practices and the responsible conduct of research.

    Training in Good Clinical Practice (GCP), the international ethical and scientific standard expected in design, conduct, performance, monitoring, recording, analysis, and reporting of clinical trials, will be mandatory for all USC full-board clinical trial personnel after January 2010. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial subjects are protected. This requirement can be fulfilled by taking the GCP program on the CITI website.

    The OPRS offers regular and ongoing human subjects educational training sessions at the University Park and Health Sciences campuses covering federal regulations, human subjects ethics and history, the Institutional Review Board process, conflicts of interest, and more. In addition, the OPRS provides monthly education for IRB members on a variety of relevant and current topics, as well as refreshers in research regulations. The OPRS regularly conducts a variety of classroom presentations on human-subjects research at the Keck School of Medicine, the USC School of Pharmacy, and at various University Park schools and departments.

  • Best Practices
    The OPRS is committed to best practices and the proper application of ethics and regulations. Leading the HSPP team, the OPRS coordinates and implements Federal, State, local and University policies. The OPRS routinely performs policy revisions, quality improvement, and seeks to adopt new practices as needed. Based on best practices noted internally or externally, the OPRS will set policies after consultation and dialogue. OPRS oversees four IRBs to ensure that regulations, institutional polices, and USC’s Code of Ethics, are being upheld. The OPRS Executive Director and staff routinely communicate with peers at other institutions and government offices to ask questions, seek new and better ways of doing this and validating policy choices made locally.

  • National Leader
    The OPRS is proud to share its ideas and practices with the local, regional, and national human subjects research communities. Educational materials and innovative practices created by the OPRS have been implemented by many other research institutions. The OPRS Executive Director regularly serves as a faculty and planning committee member at premier national conferences, is a writer and contributor to the CITI human subjects education program, and sits on the planning committee for the AAHRPP national conference.

  • Outreach
    The OPRS office is committed to outreach beyond USC and promotes this in a variety of ways. This includes distributing educational brochures at USC affiliated hospitals and clinics, participating in health fairs and events, serving on USC community outreach committees and the CBLC (Community Based Learning Collaborative), networking through IRB community members, and volunteering at local schools and churches.

  • Monitor Regulations
    The OPRS monitors local, state, and federal regulations, and translates these into best practices at USC. New information on regulatory changes is disseminated to the research community through education sessions, listserve, newsletters, and IRB meetings.

  • Innovations
    The OPRS prides itself on developing novel, effective, and innovative best practices. Some of these efforts include: the creation of the IRB Student Mentor/Member (a graduate student who not only serves on the IRB as a voting member but also assists students in the IRB process), the placement of undergraduate students as voting members on the IRB, the publication of the “Not Human Subjects Research” brochure which has garnered national attention, and the building and management of a comprehensive HSPP website which receives over a quarter million hits annually.

  • Staff