USC
University of Southern California Protection of Research Subjects

Office for the Protection of Research Subjects

The Office for the Protection of Research Subjects (OPRS) was established in 2004 to create a University wide Human Subjects Protections Program (HSPP) that is excellent, innovative, dynamic, and ranks among the nation’s best. The OPRS strives not only to meet, but to exceed regulatory and ethical requirements for all human subjects research activities.

A primary goal for the OPRS is achieving and maintaining AAHRPP accreditation. Accreditation requires the creation and implementation of best practices at all levels of the HSPP and continued improvements to maintain excellence.

To fulfill these goals, the OPRS is committed to:

Communication
The OPRS keeps the USC human subjects research community apprised of evolving practices and expectations on a continuing basis or more often as needed. 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. Each year the HSPP meets with “top customer” schools/departments to keep them apprised of updated practices, upcoming plans, and to hear human subjects issues they want to address. The ongoing dialogue with faculty, staff, and students occurs in both directions.

Education
The OPRS implemented an education policy that requires all USC human subjects researchers to complete CITI (online human subjects training) regardless of the researchers’ funding source, or study risk level. CITI is convenient, user-friendly, used by more than 600 research institutions, is offered in six languages, and provides a course in good clinical practices and another in the responsible conduct of research.

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 IRB 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.

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