Rejuvenating a foundering institutional review board: one institution's story.
This report recounts one institution's experience in the fundamental reorganization of its institutional review board (IRB). With an appropriate approach, organizational structure, and ethos, the goals of research participant safety, regulatory compliance, and efficiency are not in conflict but, rather, mutually reinforcing. These important goals were realized because all aspects of the IRB reorganization were guided by and measured against five related principles: (1) expertise, (2) service, (3) credibility, (4) efficiency, and (5) accountability. This medium-sized academic IRB was successfully reorganized to increase the scrutiny of protection of human subjects and to promote efficiency and investigator services. On average, the office returned expedited submissions to investigators with approvals or queries within two working days of submission. On submissions requiring full committee review, letters and faxes were issued to investigators within 48 hours of committee meetings. This turnaround time (combined with a nine-day premeeting submission requirement) meant that investigators who had submitted new studies for full committee review received an approval, request for modifications, queries for more information, or disapproval within 11 days from the reorganized IRB. In contrast, an Office of the Inspector General study noted that IRBs in academic medical centers typically report decisions within an average of 37 days. The reforms included mechanical and operational changes within office procedure, a robust educational program for committee members, and a revamped IRB office staff that decreased the total number of office employees from five to four but that increased educational levels and skills of the staff members.
De Ville
Kenneth
K
Brody School of Medicine, Greenville, NC 27858, USA.
Hassler
Gregory
G
Lewis
Michael J
MJ
D000046:Academic Medical Centers; D002986:Clinical Trials as Topic / Q000592:standards; D032802:Committee Membership; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D009657:North Carolina; D016134:Organizational Policy