July 10, 2006
58, Number 34
July 10 , 2006
Enhancements to IRB
follows decade of growth
BY Holly korschun
Significant enhancements in funding, personnel, procedures, systems, structure, accountability and communication in Emory Institutional Review Board (IRB) are aimed at bringing this critical component of the research enterprise in line with Emory’s phenomenal growth in sponsored research during the past decade.
A recently approved new budget for the Emory IRB reflects an 80 percent increase in funding and a doubling of the number of individuals tasked with analyzing research protocols. A series of additional steps is underway to expedite reviews, monitor and benchmark performance, enhance communication, reward faculty participation and improve student research review. At Emory, as with most other research institutions that have experienced similar growth in the past decade, IRB funding, personnel and procedures have lagged behind its research growth. This has resulted in frustration from faculty and students due to delays in research approvals. For example, a survey of other top-tier institutions by Huron Consulting Group found that these institutions perform about 13 new and continuing reviews per IRB meeting, while Emory’s average last year was closer to 21, and recently has grown to more than 30.
“The steps we are taking to strengthen the Emory IRB will help ensure maximum compliance with the U.S. Department of Health and Human Services requirements for optimal safety and protection for human research subjects,” said Michael M.E. Johns, executive vice president for health affairs and CEO of the Woodruff Health Sciences Center (WHSC). “In addition, these changes should help guarantee the highest level of service to Emory faculty and students conducting research in which IRB review is required.”
Huron Consulting Group provided data and helped facilitate meetings of an ad hoc committee comprising Emory faculty from throughout the University who volunteered to help shape recommendations for the IRB. Many of the recommendations will be acted on immediately, and some will require active participation from faculty, who share responsibility for the smooth functioning of the IRB.
Johns emphasized that some of the steps outlined can be accomplished quickly, while others will require sustained effort over the coming year. “Our work is not completed by any means,” he said. “As additional recommendations are brought forward and the report is finalized, I will send messages to the faculty that address these additional recommendations, and to update them on progress made toward implementing those outlined in my earlier e-mail message to all faculty.”
Members of the ad hoc faculty committee include chair David Stephens, executive associate dean for research and strategic initiatives, School of Medicine; Allan Levey, professor and chair of neurology, School of Medicine; Ken Hepburn, associate dean of research, School of Nursing; Richard Rubinson, associate dean, Graduate School; Chris Larsen, director of the Emory Transplant Center and vice chair for research, School of Medicine; Joanne Brzinski, associate dean for undergraduate education, College; Gary Smith, professor, School of Law; Roberd Bostick, professor of epidemiology, School of Public Health; and Roger Rochat, director of graduate studies, Hubert Department of Global Health, School of Public Health. Gary Teal, WHSC senior associate vice president for administration, is the staff member assigned to the committee, and Rick Rohrbach and Kendra Dimond represent Huron.
“We are very grateful for our faculty who did the essential and difficult work of reviewing outside recommendations for the IRB and helping turn those recommendations into positive results,” said Johns.
“Emory’s capacity for generating funded research has far outstripped the infrastructure needed to address it,” said Emory College Dean Bobby Paul. “These changes in the IRB will help us catch up to where we should be. The IRB committee on social, humanistic and behavioral research, which mainly serves the College, School of Public Health, and the Business School, is now being reconstituted with a full complement of faculty members. These IRB changes will improve overall communications and benefit faculty and students who have unique timing requirements for their research and the required approvals.”
Faculty response to Johns’ June 20 e-mail about the IRB enhancements has been overwhelmingly positive and supportive. Many faculty already have agreed to volunteer for IRB committee work, and others who cannot participate on committees have volunteered to assist in other ways.
The following administrative steps are being taken to enhance the function of the IRB:
• Additional IRB committee members— not just the committee chairs—will be designated to perform expedited reviews.
• A new electronic IRB (eIRB) system will allow researchers to submit their proposals online and also create “IRB Dashboard” reports to help monitor IRB volumes, work load, service and performance, including metrics that summarize the time required to complete each step within the IRB review process and new benchmarks.
• An IRB Advisory Council, including deans and other representatives from each school, will meet quarterly to provide a forum for receiving information about the IRB and communicating suggestions about IRB operations.
• Stipends for IRB committee vice chairs will be increased, and incentives will be provided for designated reviewers.
• Each school or department will designate a primary contact for students conducting research with human subjects. The IRB also will designate one of its senior analysts as the primary committee contact for students.
• Emory will expand the number of IRB committees from five to seven.
• Faculty who advise student researchers are asked to guide these students through the IRB process. Faculty advisors must complete the web-based CITI certification program, be familiar with Emory’s IRB procedures, communicate information to students and help ensure students meet IRB deadlines.
“Improvements in the IRB process will require not only administrative improvements, but also greater faculty participation to accommodate current IRB volumes and continued growth, to ensure the efficient and thorough review of all studies and to work effectively with students,” Johns said. “I urge faculty to contact the IRB and your committee chair if you are interested in service on the IRB.”