Far beyond informed consent

A spate of suspensions by the Office for Protection from Research Risks (OP RR) has many federally funded US research institutions concerned about the sudden escalation in enforcement, OPRR's first suspension in recent years c ame in October 1998 when research was halted at Rush-Presbyterian St. Luke' s Medical Center. In April, OPRR shut down the Veterans Administration hosp ital in West Los Angeles for similar reasons. In May, OPRR lifted Duke Univ ersity Medical Center's authority to conduct federally funded research. Fin ally, OPRR recently visited Mt. Sinai School of Medicine and placed certain restrictions on their multiple project assurance (MPA). OPRR, a federal watchdog agency that is part of the National Institutes of Health in Bethesda, Maryland, has put every US research institution on noti ce that its right to conduct clinical research could be instantly removed. In an attempt to understand OPRR's latest suspensions, the Journal of Inves tigative Medicine has interviewed representatives of those institutions and the director of OPRR's Office of Regulatory Affairs.