Review process for unforseen problems is simple
Four reviewers handle bulk of work
The two-part process of electronic submission of unanticipated problems at Washington University School of Medicine in St. Louis, MO, requires investigators and clinical trial staff to enter information about the events after passing the chief screening criteria, and then it requires a reviewer to look at what has been submitted.
Four reviewers who have registered nurse backgrounds look at the nearly 1,000 submissions sent to the university's IRB, says Diane Clemens, DC, manager of research for the Human Studies Committee at Washington University School of Medicine.
If an unanticipated event involved a subject's death, then it's routed to the IRB chair, Clemens notes.
Reviewers see both the electronic information submitted and the paper file that contains a history of the study, since the electronic submission process is still too early for everything to be on the system, Clemens says.
"The reviewer assesses the risk to participants and looks at the rate of occurrence before determining whether or not the consent form has been adequately revised," Clemens says.
Reviewers also assess whether the investigator has proposed adequate changes to the protocol to minimize newly-found risks, she says.
The system compiles all the information into one area for the reviewer and a reviewer's sheet, and the reviewer can add comments when necessary, Clemens says.
"Sometimes it will be that they send an email back through the system, asking for clarification or further justification, and the system keeps track of all that documentation," Clemens says.
When the nurse reviewer believes a particular event needs additional review then the reviewer can refer it to the full IRB, Clemens notes.
Submission of deviations is more free-form than unanticipated problems, Clemens says.
"Deviations can encompass a wide variety of things," Clemens explains. "Generally, the submission includes, 'Here's what we're supposed to do, here's what happened, here's why it happened, and here's what steps we're taking to prevent it from happening again."
For example, a deviation might be that someone was supposed to have a blood draw five days after the procedure, but the person cancelled the appointment and didn't get the blood drawn until the sixth day, Clemens says.
"Or maybe the person missed a scheduled dose," she says. "At that point the charge of the reviewer is to identify when a deviation may be indicative of something more serious where maybe a research team needs additional education, or maybe there was a communication breakdown between two different processes."
When deviations seem to indicate a communication problem or organizational problem, the IRB will work with the principal investigator to correct the situation, Clemens says.
Also, deviations might be discovered during an internal documentation audit, Clemens says.
So the investigator will submit notice of maybe five instances in which an activity took place a day later than it was supposed to have, according to the protocol, Clemens says.
The investigator's report will note that the problem involved a misunderstanding that was discovered during an audit and now is being corrected, Clemens adds.
"The reviewer determines which events qualify to be submitted to the Office for Human Research Protection (OHRP)," Clemens explains. "We send a report once a month via email to OHRP."
The two-part process of electronic submission of unanticipated problems at Washington University School of Medicine in St. Louis, MO, requires investigators and clinical trial staff to enter information about the events after passing the chief screening criteria, and then it requires a reviewer to look at what has been submitted.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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