Non-punitive post-IRB approval monitoring program emphasizes education
Non-punitive post-IRB approval monitoring program emphasizes education
Monitoring working group makes final call
When research officials at the University of Virginia of Charlottesville, VA, began to ask what happens to a study once it's approved by the IRB, the answer became a new program: a post-IRB approval compliance monitoring and education program.
IRBs put a lot of time into approving a study, but are IRB members sure the study's protocol is being followed, asks Karen N. Parks, RN, CCRP, a research compliance monitor at the University of Virginia in the office of the vice president for research and graduate studies.
"Also, what resources do investigators need once they get started?" Parks asks. "And do study coordinators and principal investigators have access to the education they need?"
The best way the institution could answer these questions was by forming a separate research compliance program that is affiliated with the IRB and works side-by-side with the IRB, but doesn't report to the IRB, says Jane Lehmbeck, RN, CCRP, a research compliance monitor.
Compliance monitors often attend IRB meetings, and they meet with a small group of IRB members to discuss review issues and details, Lehmbeck notes.
"We read the protocol and look at the tools the study team is using to make sure they're following the protocol," she adds. "If we have questions where we didn't understand something, we might go back and look at the IRB minutes, but we generally haven't done that."
Lehmbeck and Parks explain how the compliance monitoring and education program works:
• Studies are selected at random. "We try not to repeat monitoring an investigator more than once a year if they've had a good review already," Parks says.
"We also will review a study if the principal investigator makes a change in the middle," she adds. "The IRB will request us to go in and review it when they approve a principal investigator's change."
The IRB also might request a review if IRB members are concerned about a problem, a violation, or questionable paperwork, Parks says.
"Once the study is selected we notify the study team and investigator and set a date for the review," Parks explains. "We review IRB files and update ourselves about the study, and we also review the IRB process."
If monitors find any problems with the IRB process or errors the IRB might have made, then they'll write a report that is sent to the IRB, Parks says.
• The monitoring visit is systematic. "We use a regulatory binder and look at all consent forms and select patient data to make sure patients were eligible," Parks says. "We make certain the study team followed the informed consent process properly, and we review the protocol."
Monitors also review information about any investigational drugs involved in a study.
When the monitoring visit is complete, monitors will write a report that is sent to the principal investigator, who has a chance to respond, Parks says.
• Monitoring report data are accumulated and analyzed. A post-approval monitoring working group that includes educators, IRB members, and others analyze the monitoring reports from the past month, looking for consistency and trends, Parks says.
They collect minimal data, including how many reviews are done, Parks says.
"The working groups tries to categorize studies into groups of exceptional, satisfactory, marginal, and unacceptable, which means serious noncompliance," she adds.
For instance, in 2007, there were 164 monitoring reviews of which 47 were exceptional, 45 were satisfactory, eight were marginal, and none were unacceptable, she adds.
This was an improvement over 2006 when of 143 reviews, 42 were exceptional, 39 were satisfactory, 19 were marginal, and less than 1% (one or two studies) was unacceptable, Parks says.
"We were excited that in 2007 there were none in the unacceptable category," Parks says. "Basically the only situations that fall into that category of serious are those in which an investigator doesn't want to work with us at all because anyone who tries to communicate with us won't be in the unacceptable category."
The working group also makes recommendations based on the monitoring reports.
"Sometimes we see more problems with a system or department, and there are questions of whether we would handle those," she explains. "Then the group of IRB members and educators makes recommendations, and these are sent to an IRB subcommittee."
In an extreme case, the IRB might stop a study.
If monitors find a problem that is immediate, then the vice president for research will convene a group to discuss the study and decide what to do about it, Parks says.
"We have had situations come up where we were reviewing a study and we were very concerned with safety," Parks says.
In most cases, there is time for the report to be sent to the IRB for review and comments.
"The IRB will look at notes from the working group, and if they have additional recommendations to make, they make them," Parks says. "As a final step in the process, they decide whether education is needed."
If so, the educator from the school of medicine sets up an appointment with the investigator.
A final touch is that the vice president of the office of graduate studies, which oversees the IRB, sends out letters to investigators, thanking them for their participation and summarizing the consensus of the IRB subcommittee and the working group, Parks says.
• Educate investigators and research staff. "We've always touted the monitoring as educational, and it's one-on-one time with the monitor," Parks says.
"As time has gone on, we've incorporated an educator in the program, and we've done more mentoring," she adds. "We've eventually added an IRB educator who helped us do education on our web site."
The web site features voice-over slides in which people can view a brief educational session at their leisure, she says.
These are created to address trends identified through the monitoring visits.
For example, one trend noted was of investigators not obtaining surrogate consent properly, Parks says.
"So we developed a 'learning shot' about surrogate consent," she adds.
One of the biggest issues involved data safety monitoring board (DSMB) plans, Parks says.
"The IRB develops a template of how they want monitoring done and the questions they want answered," Parks says. "But what happens is a lot of people would mark these examples without reviewing them, and that was not what they intended during the study."
So the IRB has spent a lot of time educating researchers about what a DSMB plan should be and how to fill out that template, she adds.
"We have seen improvement," she says. "Most of the errors are small paperwork errors."
The IRB educator has held several different investigator workshops in two to three hour sessions, Lehmbeck says.
These quarterly sessions are voluntary and are so popular among investigators and study coordinators that there are waiting lists.
Also, there's a mentoring program for new study coordinators or investigators, Lehmbeck says.
"A staff member will go out to the site and work with the new coordinator to see what the person needs," she explains.
When research officials at the University of Virginia of Charlottesville, VA, began to ask what happens to a study once it's approved by the IRB, the answer became a new program: a post-IRB approval compliance monitoring and education program.Subscribe Now for Access
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