The trusted source for
healthcare information and
eIRB will integrate IRB with everyone else
Efficiency, ease of use are benefits
The IRB office at the Washington University in St. Louis, MO, (WUSTL) will soon have an electronic system that will connect the IRB submission with every other application principal investigators (PIs) need to make.
WUSTL first implemented an electronic system in 2004 and replaced it last year, says Diane Clemens, DC, CIP, the eIRB education specialist at WUSTL.
The old system collected only serious adverse events (SAEs), which helped the IRB office learn more about working within an electronic system, she notes.
"We decided to get our feet wet and learn a lot, which we did," Clemens says. "Now we're going into the second phase of a much more in-depth system."
PIs can submit all of their AEs to the new system, and the system will triage the reports according to those that appear to be unanticipated problems that will be reviewed by an expert IRB reviewer, and those that will be placed in a report that's available for the full IRB to see during a continuing review session.
The new eIRB system also can be used for IRB review submissions, and it can communicate with other review boards at WUSTL.
"Now we can do new IRB applications, amendments, IRB notifications, continuing reviews, and final reports," she says. "We're still rolling out some applications."
The goal is to fully integrate the eIRB system with all 34 ancillary bodies that will conduct reviews of research studies, and to have all of the submission and approval processes conducted and documented electronically, Clemens explains.
For instance, the university has a review group that monitors all cancer studies and another that reviews research involving radioactive drugs.
"All of these different groups are separate entities and they have their own internal review process," Clemens says.
When the eIRB is fully implemented, it will be a one-stop shop for investigators and IRB members.
The eIRB application contains trigger questions for the ancillary review committees. When PIs submit their IRB application electronically, the eIRB system automatically will route the application to all of the other boards that would need to review the protocol. Many ancillaries use the same information as the IRB, but some of the trigger questions also trigger additional questions in the application specific to the ancillary review.
The current system involves multiple applications, duplicate questions, is time-consuming and somewhat confusing, Clemens notes.
"Especially when there is a change requested by any of these review processes, it will throw investigators for a loop," she says. "They submit to all of these different areas and then get changes requested from different directions, and it can be very confusing."
The different review bodies have different priorities and their interests sometimes conflict, she adds.
"Investigators wonder, 'Do I respond to one review body, or do I let everyone know about the change?'" Clemens says.
One goal for the eIRB is to streamline the entire research application process, she says.
So PIs and others will find links to the eIRB through a research Web page, called the Research Gateway, which is an on-line resource that Washington University faculty and staff access to view research tools, resources, forms, and applications.
"The login process for eIRB goes through the Research Gateway," Clemens says. "In addition to trying to streamline information, we're minimizing the number of passwords investigators use by having a single, sign-on process that we share with other university systems, including human resources."
Research staff will use the same password to review the status of a protocol as they would to view their paycheck.
This also provides an additional benefit of discouraging PIs from sharing their passwords with their staffs, Clemens notes.
"So when we require investigators to submit an item to the IRB, we'll have greater confidence they actually logged on and did it themselves," she explains.
The new eIRB system currently has new submissions and amendments in a pilot phase, and the IRB notifications and final reports are implemented fully with more than 8,000 users, Clemens says.
The complete roll-out had been set for early summer 2009, but likely will be a little later than that, she adds.
However, training is underway.
"We have identified several levels of training, including a basic system navigation training and an application-specific training," Clemens says.
As PIs and research staff learn how to use the eIRB system, they'll be able to find easy and fast answers to their questions.
For example, if a PI wants to know the review status of his protocol, he can look that up on-line and not have to call the IRB for that information, Clemens says.
"We anticipate receiving fewer questions once people are more familiar with the electronic process," Clemens says.
Another benefit to the eIRB is that it incorporates some efficiencies that were lacking in the paper system.
"Many institutions use an electronic application that looks similar to the paper application, and that's not the case here," Clemens says. "We combined the biomedical and behavioral IRBs at the same time we developed our electronic application so we had a merging of forms and review processes that has made it look very different from the two separate paper processes."