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Supply and demand: Volumes are going up
Increases have resulted in efficiencies
A few years back, the Office of the Inspector General (OIG) released a report that referred to the IRB process as "A System in Jeopardy." Among the problems and challenges described were "conflicts that threaten independence," "lack of training for investigators and board members," and the fact that "IRBs review too much, too quickly, with too little expertise."
Over the years, there has been a focus on recognizing and eliminating conflicts of interests among those who are conducting or overseeing research involving human subjects.
There also has been a big education push with programs springing up locally and on the web that are designed to present ethical concepts related to human subject research, as well as an overview of federal regulations that govern research activities.
No such national campaigns for managing volume have sprung up. In fact, securing resources and developing efficiencies has become the responsibility of individual IRBs, and if data collected for the IRB Advisor Salary Survey report, appearing in the November 2003 issue, is any indication, it’s a big job. For example, in October 2003, there were more than 7,000 trials listed on the National Institutes of Health’s web site, ClinicalTrials.gov. In 2000, there were 4,000 clinical trials listed.
"There has been a significant increase over the last five years, attributable to the increased and improved educations of researchers. There has also been a corresponding increase in the ancillary requests — e.g., amendments, adverse events, review of IND [investigational new drug] safety reports, deviations, etc.," says Margaret T. Feeney, MBA, RAC, Committee on Clinical Investigations Liaison for Quality Assurance and Audit, Beth Israel Deaconess Medical Center in Boston. Improved education has increased awareness among investigators of the need for IRB review, she explains. "For example, a principal investigator now understands that they can’t simply go and advertise for study participants, but must first bring that advertisement to the IRB for review."
Growth at St. Joseph’s Hospital of Atlanta has been exponential, says W. Parker Nolen, MBA, IRB administrator for the hospital. According to Nolen, the full board reviewed 30 protocols in 1999, as many as 54 in 2000, 60 in 2002, and 90 in 2003. Recently, the hospital formed St. Joseph’s Research Institute and has seen even more growth. "There has been an 11% increase in one month alone. In January, we expect 17 new protocols alone, so 2004 looks to be a watershed year," says Nolen.
With growth has come some challenges, the most obvious being staffing. The simple solution is to simply hire more people, which is what St. Joseph’s — and a lot of other IRBs — did. "In the mid-90s, there was one administrative person, a medical secretary whose role was more clerical," Nolen says. Currently, there are two full-time staff members, and the hospital is looking for a third. "It’s difficult to find and hire the most qualified people," he reports, "particularly since St. Joseph’s now requires professional certification [CIM or CIP], or a willingness to be certified within six months after hiring, before consideration for any position in the IRB."
It’s not always as easy to hire more staff as it was at St. Joseph’s, whose management, Nolen says, recognized the need to provide the resources.
One Boston organization’s IRB administrative staff solved their staffing problem by doing a little research of their own, says Lynette M. Schenkel, administrative director of research and academic affairs at Beth Israel.
"We collected data on our own volumes, the number of staff compared to the number of active protocols, and compared them to benchmarked data from six of the Boston-area medical center-based IRBs and other medical center-based IRBs throughout the country," she says. "The data were presented to medical center management, which responded very favorably to the documented needs."
Whether the challenge is staffing or workflow, IRBs have buckled down or just gotten creative to meet do the jobs they’ve been charged to do. Here are a few tips on how to efficiently and effectively manage IRB volume:
• Evaluate workflow. Beth Israel created an IRB executive committee, made up of senior medical center management, administrative staff, legal counsel, and the chair and vice chairs of the IRB. "The group examines policy, procedure, and process, and has recently sponsored two important retreats, one resulting in the revision of our informed consent template and the second resulting in an updated IRB manual," says Schenkel.
• Educate IRB members. In addition to basic ethics and regulatory training, St. Joseph’s provides monthly updates of standard operating procedures (SOPs) to board members.
"It may not sound like it increases efficiency, but it does," says Nolen. "The members are not involved in the day-to-day operations of the department — in the trenches, so to speak. Educat-ing the IRB on the SOPs helps them understand the administrator’s role better and what is expected from the investigators. Ultimately, it leads to more focused reviews, more germane comments, and a better IRB experience for everybody."
• Fast-track expedited and exempt studies. Nolen says St. Joseph’s is being more diligent about expedited and exempt protocols.
"Any protocol is likely to have several changes during the approval period which do not impact the risk/benefit ratio of the study subject," he says. "For example, suppose a sponsor wishes to advertise. An advertisement usually does not require a full board review and should not take up valuable agenda time."
In some cases, the IRB administrator has been given authority to review materials. "If an institution has a large volume relative to its staff and IRB frequency, they might want to consider relegating some of the expedited and exempt items to the IRB staff — provided the IRB staff are experienced. 21 CFR 56.110 states Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers . . . ,’" Nolen explains.
• Create checklists. St. Joseph’s considers checklists "tools that allow for clearer tracking and clearer evaluation of steps," says Nolen. St. Joseph’s checklist is taken directly from federal regulations. "Our tools provide a way to document the review, recommendation, and action."
• Create subcommittees. After a routine U.S. Food and Drug Administration audit, First Dynamic Health Care Services Inc., an independent IRB headquartered in Waco, TX, reevaluated some of the IRB processes and decided to create subcommittees to handle increased request demands.
The subcommittees included an ethics committee, a site review committee, and a committee charged with evaluating consent forms and all proposed advertisements, explains Robert Allison, PhD, president and CEO of First Dynamic. "All activity of the IRB is reviewed by physician members," he says.
Beth Israel created a continuing review committee in 2002. "The process for notifying the clinical researchers regarding need for continuing review was evaluated, refined, and implemented, and committee members and the IRB staff created comprehensive continuing review report forms that undergo review and revision on a regular basis," says Schenkel.
• Automate. A number of programs exist to reduce the paperwork associated with submitting protocols and permit on-line tracking. Baylor College of Medicine created its own proprietary system — BRAAN (www.api.md) — two years ago in an attempt to increase efficiency without increasing staff, and St. Joseph’s is doing the same. "It’s a proprietary productivity tool designed to take away the clerical aspect of the job," says Nolen.
"Not only is our tracking system designed to eliminate a large part of the clerical aspects of the job, it is also designed to be a productivity enhancement for the investigator — no longer will they have to resubmit the same information to us, such as site address, license number, etc.," he explains.
"Most importantly," Nolen points out, "it is a compliance tool for the institution. At the touch of a button, we will literally be able to have a snapshot of a protocol, trending on its SAE [serious adverse event] profile, medications, amendments, and anything else an auditor may wish to see. A quality tracking system not only enhances staff productivity by automating repetitive tasks, it also helps the institution remain compliant with federal regulation and guidelines."