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Accomplishments in Human Subjects at IUPUI

June 9, 2008 - The role of Research Compliance Administration (RCA) is to ensure compliance with university policies and state and local laws applying to human subjects research. RCA coordinates the oversight activities of and serves as liaisons for investigators to IUPUI's seven Institutional Review Boards. This includes research involving recombinant DNA research and biohazardous materials research.

Indiana University has executed an agreement with Western Institutional Review Board (WIRB), commercial, or external IRB. WIRB's services are available to Indianapolis researchers who are conducting phase II, III, or IV industry-sponsored clinical trials not involving planned emergency research, xenotransplantation, gene transfer, embryonic stem cells, VA facilities or patients, medical devices, a pediatric population, or waivers of informed consent or authorization. The application process, training, and roll-out are in development. Currently, regulatory matters such as updating federalwide assurances and new standard operating procedures are in the works and must be complete before the services of WIRB may be offered. RCA is very excited about WIRB and sees it as a great complement to the University's Human Research Protection Programs. It is anticipated that the services of WIRB may be offered to IUPUI investigators later this summer.