Principles Set for Human Subjects Research
Photo/Irene Fertik
USC is committed to conducting its biomedical and behavioral research involving human subjects under rigorous ethical principles, according to Cornelius W. Sullivan, the vice provost for research.
The university’s Institutional Review Boards are empowered to review all human subjects research proposals, funded or not, which are conducted by faculty, staff, graduate or undergraduate students which involve the use of human subjects, Cornelius said.
If approval is not granted, a study cannot proceed.
Most of the human subjects research on the University Park campus is conducted by students. However, until recently, students were not involved in the formal IRB review process, said Susan Rose, executive director of the Office for the Protection of Research Subjects (OPRS).
Rose was instrumental is establishing an IRB student mentor/member position in order to represent and assist student researchers on the UPC and to give students a “voice” in the process.
Rose said she saw the value of such a program after attending a meeting on community-based research and meeting Nancy Shore, a student mentor from Washington University, who was also a doctoral student in social work.
Rose stayed in touch with Shore and gathered materials to support the need and start the process for student representation at USC. Rose said funding for the graduate assistantships comes through the provost’s office, with full support from the provost.
All human subjects research at USC is done under the direction of a faculty member, Rose said. For instance, one student is currently doing research on an intervention program for those with phobias and another is doing research on whether Asian students are more gifted in mathematics than non-Asian students.
Each year, approximately 350 new projects go through the review process.
“This is an academic institution,” Rose said, “and students are our ‘currency’. It’s important to have students included in the entire process and that includes participation in the review process.”
The issue of protection of human subjects in biomedical and social research dates back to 1974, Rose said, with the current regulations in effect since 1991.
While the bulk of human subjects research at UPC is unfunded, regulations only apply to federally funded projects. Rose said USC has agreed to give the same scrutiny to all human subjects research.
Student mentors are chosen for their research experience in their own field of expertise; commitment to the USC community; knowledge on human subjects protection in research; and desire and ability to mentor undergraduate and graduate students.
A student mentor/member is already in place, and another will take over in the summer.
Shuang Frances Wu began her position in the fall 2004 and Maristela Cho will assume the role this summer.
Wu and Cho are in the USC Rossier School of Education. Wu is a doctoral student in higher education policy and organization and will graduate in August. Cho is a doctoral student concentrating on teacher education in multicultural societies with a specialization in language and literacy education and is on track to graduate in 2007.
Wu said she wanted to be a mentor because she believes in the mission of the position. “And as a graduate student,” Wu said, “I’d like to help my fellow students succeed.”
If a student conducting research has any misgivings or questions about a project, they can approach the IRB student mentor, who will assist student investigators on issues related to human subjects protection and on the IRB application process itself.
The student mentor helps students ensure that their research meets the legal and ethical principles on human subjects protection so as to get their IRB applications approved. The mentor will advise individuals and may conduct group workshops to help students who are doing research.
In addition to supporting students as mentors during their tenures, Wu and Cho will also represent student investigators on the IRB committee.
The student mentor works closely with the OPRS, the UPIRB office and individual schools and departments on the campus to plan and implement outreach programs for the USC community.These programs educate faculty, students and staff on key issues pertaining to human subjects protection in research activities.
The student mentor is a bridge between USC students and the OPRS, ensuring that the office develops a better understanding of students’ needs and concerns.
The student mentor can be reached via email at: irbgara@usc.edu.
