IRB cuts 35 days from protocol turnaround
November 1, 2009 4 minutes read
IRB cuts 35 days from protocol turnaround
Pre-review processes help a lot
When a Yale University research facilitation office first looked at improving protocol review turnaround time in late 2007, the time from intake, through development, to IRB submission and approval averaged 80 days.
Now the same process takes 45 days.
The IRB and research office have cut 35 days from that timeline through efficiencies in both the office and the IRB processes, says Stacey N. Scirocco, associate director at the Yale Center for Clinical Investigation and administrator for the office of research services at Yale University in New Haven, CT.
About three-and-a-half years ago, the university opened the Yale Center for Clinical Investigation, which houses the office of research services, with funding from its Clinical and Translational Science Award (CTSA). The CTSA is funded by the National Center for Research Resources of the National Institutes of Health (NIH).
One of the functions of the office of research services is to facilitate regulatory compliance and help investigators prepare protocols for submission to Yale's human investigation committee, which is what the IRB is called.
A central mission was to reduce redundancies between its internal protocol review process, inherited from the former General Clinical Research Centers (GCRC) structure, and the IRB's review, and this was done through a lean analysis process, Scirocco says.
"We also looked at the system to see if there was any wasted time in the timeline," she explains. "And we wanted to make sure there was value added in every process."
For instance, some of the existing internal protocol review processes were streamlined, so that functions are performed in tandem instead of end to end.
In all, the research services office shaved 17 days on average from the protocol review and development process, Scirocco adds.
"Part of how we did that was by providing a high level of service to investigators and maintaining a good level of communication so as to minimize delays in all parts of the process," she says.
Need for speed, accuracy
A major goal is to give investigators some of their time back by providing quality services that are fast and efficient, she adds.
Other strategies the research services office has employed include maintaining a collaborative relationship and good communication with the IRB so the IRB will know which protocols will be coming their way, she says.
"We have close ties and a trusting relationship with the IRB," Scirocco says. "We communicate almost daily and work together to coordinate the timeline for review."
"Also, once we send a protocol to the IRB, our employees in the office of research services (ORS) are on the line to see it through to approval," she adds.
In a recent example, ORS and IRB staff worked cohesively for a compassionate use protocol to provide a drug to patients when the standard treatment drug became unavailable. Through a high level of effort and communication, they were able to go through the process to IRB approval in 25 days, Scirocco says.
Another change that helped to reduce the overall submission to approval timeline involved changing which protocols would need review by the internal, science, and safety committee.
This committee conducts a review of protocols requesting to use Yale Center for Clinical Investigation research clinic space before they are sent to the IRB. To avoid duplicating IRB activities, the research office changed the SSC review requirement to only high risk and some moderate risk studies, Scirocco says.
"The science and safety committee has the additional expertise to look at these protocols in depth, and once they've requested changes to it and approved it, the protocol is in better shape and typically addresses most questions the IRB might have," she says.
Yale's IRB reduced its protocol approval time by 18 days, partly through the adoption of an electronic institutional review board module that streamlined their IRB office functions, Scirocco says.
"The electronic system enables online entry and submission of human research protocols to the Yale institutional review boards and other oversight authorities charged with the protection of Yale's research volunteers, and it gives investigators one place to go for finding their protocol's status," she adds.
This in turn reduces IRB staff and reviewer time.
Also, the IRB has administrative reviewers check out newly-submitted protocols to help get them in good shape before they go through the review process, Scirocco says.
So between the office of research services, work, and the IRB office's work, investigators receive ample help with designing their protocols, improving them, and making any IRB-requested revisions, she adds.
"We stay with the investigator along the IRB review process," Scirocco says. "Our investigators are very happy with the changes."
The research review office's assistance can be requested voluntarily, and since it was begun, the volume has increased by 100%, Scirocco says.
Early 2009 estimates show an even greater increase, she adds.
"We have many new investigators using our services, and we feel we're helping to facilitate clinical research," she says.
When a Yale University research facilitation office first looked at improving protocol review turnaround time in late 2007, the time from intake, through development, to IRB submission and approval averaged 80 days.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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