QI review finds problem with IRB's IC form
IRB New Year's Resolution: Focus on QI
Solution is multifaceted
An informed consent form with two parent signatures is an IRB requirement of some studies at Boston Children's Hospital. But when a study review found that one research office was failing to meet this requirement, the resulting quality improvement (QI) investigation turned up a trend and an even bigger problem: The IRB's approved informed consent (IC) form made it difficult to obtain those two required signatures.
The Education and Quality Improvement Program (EQuIP) found that only one signature was obtained during a routine, not-for-cause study review of an investigator's files. The EQuIP reviewer also found that even when there was a second parent present during the IC process, there wasn't a place on the IC form for that second parent's signature.1
Plus, some research staff were unaware that the second signature was required, although the IRB specified the requirement in the initial IRB approval letter.1
"We saw the problem of the consent form not being formatted correctly, and we thought it could be a bigger problem," says Susie Corl, MSW, MPH, CIP, CCRP, quality improvement specialist at Boston Children's Hospital's EQuIP.
The EQuIP findings at the single site led to a review of IC forms at all sites to determine whether this two-signature noncompliance was a systematic trend.
"We saw that it was a bigger problem, so we took it to the IRB after all the studies were reviewed," Corl says.
Through the QI process, EQuIP staff discovered a trend that was immediately addressed and fixed. Here's how it worked:
1.Identifying a problem through not-for-cause on-site reviews: Conducting routine, not-for-cause audits/reviews is essential to research compliance, but these also are crucial to identifying cultural, systemic, workflow problems that can lead to inefficiencies and regulatory issues, Corl says.
Besides looking at investigators' work, EQuIP reviews the IRB's work, creating an Excel spreadsheet based on identified issues, she explains.
When a research site is reviewed, the results are kept confidential and not released to the IRB, except in rare circumstances of subjects being placed at risk, she adds.
The promise of confidentiality has been instrumental in building trust between researchers and the research protection program, Corl notes.
"We want to be seen as an educational resource for principal investigators," Corl says. "But we keep track of who didn't do something correctly."
The findings are placed in a database where they are compiled to identify trends. If one site has a recurring problem, then perhaps other sites are experiencing the same issue. This was how the EQuIP office identified a trend of sites not obtaining second parent signatures when required to do so by the IRB.
On-site reviewers found the problem at one research site and quickly realized it might not be an isolated incident. They reported the problem to the site's PI confidentially, requiring a summary of corrective actions taken. But they also took an additional step to address the bigger issue of a systemwide problem.
"We considered it a bigger concern that could result in pretty big regulatory noncompliance," Corl recalls.
2.Report suspected systemic problem to leadership: When the EQuIP office found that one site had repeated problems with obtaining second parent signatures, the office sent their findings and suspicions to the director of research compliance, who asked that they conduct an internal audit of all studies to see if other sites also were omitting the second parent signature, Corl says.
The systemwide review revealed a problem with the two-parent permission documentation at more sites, Corl says.
There was an inconsistency between the IRB's two-parent permission determination, as stated in the IRB minutes and approval letter, and in the IRB's informed consent format, which had room for only one signature.1
3.Give findings to IRB and leadership: The EQuIP office reported its findings to the research compliance director, recommending the consent template signature section be reformatted to facilitate compliance. They also sent the report to the IRB at the director's request.
"There were a number of studies where the IRB made a two-party determination, and it was something that could have resulted in confusion," Corl says.
4.IRB implements response and solution: The research compliance director had the IRB change its practices and policies to resolve the issue. One change was to revise the consent form template to make it easier for investigators to document the second signature or to use a check box if the second parent wasn't there, Corl explains.
5.Follow up and monitor: Once corrective actions are made, it's important to follow up and monitor to see that these are done correctly and to see that the changes result in optimal compliance, Corl says.
EQuIP reviewers will schedule a follow-up every six months to analyze the corrective action plan and make certain it's being implemented effectively, she adds.
"I think the quality improvement process worked well," Corl adds.
Part of its success is due to how well integrated QI and research compliance are with the IRB, she notes.
"Since we go to IRB meetings and are somewhat connected to the IRB, we understand IRB work."
- Corl S, Newbert EY. Continuous quality improvement: encouraging the feedback loop. Poster presented at the 2013 Advancing Ethical Research Conference, held by Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston.