One of the biggest deficiencies was a lack of sufficient resources for the IRB, he says. Duke's IRB embarked on a massive restructuring, going from one IRB, responsible for all human research, to four IRBs that monitor more specific areas. And the number of full-time IRB staff members went from 2 to 11. Dr. Sugarman was called in to assist in the restructuring and to advise on medical ethics. He helped implement an IRB investigators' training program, which includes a history of the ethics of human subjects research, and the rationale for OPRR regulations.
All clinical investigators involved in human research take part in the educational program.
Dr. Sugarman reports that Duke is also formulating a continuing education component for clinical investigators. He stresses that Duke's turnaround took money, staff, faculty, and upper-level institutional support. UC, Rochester, and Duke report that open communication with the public is helping them honor that obligation. We've admitted our weaknesses, and we explained to the media how we're fixing them.