Seattle Children’s Research Institute in Seattle found that an eFeedback tool helps the organization improve and ensure the safety of pediatric patients who are enrolled in clinical trials.
“The IRB and research institute at Seattle embraces performance improvement, and we realized that we have an untapped resource in the patient safety office that we could leverage to improve research subject protections,” says Jessica Huening, JD, human subjects protection analyst at Seattle Children’s Research Institute.
After discussions on how to improve study participant safety and better integrate processes, they decided on a systems approach that incorporates an electronic feedback model, using the patient safety office’s eFeedback.
The eFeedback process was created for the health system’s employees to report any safety or care issues pertaining to patients, families, visitors, and staff. Submissions to eFeedback contain summaries of potential safety concerns that are sent to specialists and experts to determine how they should be handled.1
Research staff or others who identify an adverse event or other safety issue can write about what happened in eFeedback, and the information is sent to the patient safety office. The office staff reviews it and triages it based on the incident’s specific details, and they send the information to the hospital’s experts on that particular subject, Huening explains.
The IRB’s idea was to leverage the eFeedback process to identify the root causes of protocol deviations that are associated with adverse events or might cause harm to participants. The IRB reviews the eFeedback recommendations to determine whether additional actions are required.1
“It was one of those things where we said, ‘Why didn’t we think of this before?’” Huening says. “Everyone was excited to optimize more protection for our patients and our participants, so it was a very collaborative process.”
Here’s a theoretical example of how eFeedback works for the IRB: A human subjects research study has a problem where, possibly due to how supplies were organized in a department, the wrong supplies were used in a trial and this resulted in some type of harm, Huening says.
“That’s a good example of the type of scenario that would benefit from our leveraging the eFeedback process,” she says. “Generally, it could be used when there are institutional failures beyond the scope of the investigator or an institutional process that could benefit from changing.”
So in the theoretical example, investigators might submit information to the patient safety office, via eFeedback, about the supplies mix-up. The eFeedback analysis might respond, saying, “Okay, it looks like the materials are organized in a way that is unclear and maybe we need to have better labeling,” Huening suggests.
“Or maybe we need to institute an institutional change and manage our materials so this does not happen again,” she says.
These suggestions can be included in the study team’s corrective actions, as well.
The idea is that the entire institution will benefit from changes made as a result of eFeedback because the incident could have been the result of an institutional process failure, Huening notes.
Although eFeedback is Seattle Children’s Research Institute’s solution to improving safety, the idea of having an IRB leverage infrastructure from within a hospital is not unique, Huening says.
“Other institutions might have infrastructure they can leverage to optimize human research subjects protection and improve overall patient safety,” she adds.
REFERENCE
- Huening J, Vazeux R, Grienauer M, et al. IRB and patient safety office collaboration to improve participant safety in clinical research: a systems approach electronic feedback (eFeedback) model. Presented at PRIM&R’s AER Conference, held Nov. 12-15 in Boston, MA. Poster: 31.
Seattle Children’s Research Institute in Seattle found that an eFeedback tool helps the organization improve and ensure the safety of pediatric patients who are enrolled in clinical trials.
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