USC has moved to an online system of submitting proposals for the use of human subjects in research. The reform is part of a multi-year effort, nearly complete, to become one of the first institutions in the country to receive the gold standard of accreditation for human subject protection.
USC President Steven B. Sample, who co-chaired a national AAU committee dealing with human subject protection, has been a proponent of accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Preparing for this accreditation has been a two-year process, and in the coming months will involve 70 to 100 campus interviews by AAHRPP representatives and the submission of hundreds of pages of documents.
Only 28 institutions nationwide, including hospitals, cancer centers, research institutes and universities, have received AAHRPP accreditation to date. USC hopes to submit the final AAHRPP application by the end of this academic year.
“This accreditation shows how serious we are about doing it right and having the highest ethical standards for research,” said Howard Gillman, associate vice provost for research advancement in the social sciences.
Gillman has been working on this issue under the direction of Randolph Hall, the vice provost for research advancement, whose office has jurisdiction for human subjects protection.
There are approximately 2,300 research projects that involve human subjects undertaken annually on the Health Sciences campus and about 700 projects of varying risk on the University Park campus, said Susan Rose, executive director of the Office for the Protection of Research Subjects (OPRS), the office which oversees USC’s Human Subjects Protection Program.
Using a $700,000 National Institutes of Health grant, USC created an online system, called iStar, for researchers to use when submitting human subjects proposals to the Institutional Review Boards (IRBs).
The iStar system has built-in guidance for investigators and provides for quick electronic communication between investigators and the review boards’ staff members, eliminating one of the past bottlenecks. iStar is also used at review board meetings to aid discussion of proposals.
The iStar system now is used at Childrens Hospital Los Angeles and both USC campuses, which will allow administrators to collect a range of useful data on how protocols are being evaluated, including how long it takes for proposals to be reviewed.
The iStar system also enables users to easily send feedback. All of the data will be used to guide further improvements.
Other reforms have grown out of an Academic Senate study completed in 2005. For example, the new position of IRB Liaison has been created, replacing an older system of designated reviewers.
Schools and departments have been encouraged to appoint liaisons that will be trained by the Office for the Protection of Research Subjects to assist student and faculty researchers in preparing high-quality human subjects protocols, but not to act as an extra review hurdle.
“The creation of a Senate Committee to address Institutional Review Board issues reflects the importance to faculty research and teaching of an effective and timely IRB review process,” said Academic Senate President Tom Katsouleas.
One of the surprising facts about research at USC is that the majority of research board proposals on the University Park campus are from graduate students, Rose said. Many graduate students proposing research are doing so for the first time, and the liaisons are expected to provide assistance to students who are submitting protocols.
Maristela Cho, a current doctoral student in the USC Rossier School of Education, is providing assistance as the IRB student mentor. In addition, she staffs the help desk for the iStar system.
Another improvement is the creation of several brochures that explain the submission process, including one that helps investigators determine whether their research fits the definition of human subject research.
A significant number of research proposals that are submitted to the Office for the Protection of Research Subjects, it turns out, don’t fall under federal human subjects guidelines, which adds to the workload of the staff and slows down response time for projects that do need review.
As a general rule, if an investigator is interviewing subjects about non-personal information, the research does not require review board oversight.
A new brochure, “Is Your Project Human Subjects Research?” is available at http://www.usc.edu/admin/provost/oprs/, or can be requested by e-mail at firstname.lastname@example.org.