Drama queens (and kings) help IRB training
Office was informed by participant survey
A Los Angeles, CA, research institution has found a way to bring a little Hollywood flare into the otherwise dry informed consent process by making use of local acting talent, video directing, and role-playing.
"We found it's useful to do mock sessions where we play out what can happen in the informed consent process," says Rebecca Flores Stella, CIP, manager for operations and education in the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA.
The facility's quality improvement (QI) team administered various surveys at Cedars-Sinai, asking research participants about their backgrounds, experiences, and comments on informed consent, Stella says.
The survey broke down the elements of informed consent and asked participants to rate whether they felt the information they received addressed these, Stella says.
None of the ratings were lower than 75%, but those that were not as high as desired tended to be items that participants had difficulty understanding and would need to be addressed.
Based on the survey, some questions they determined needed to be better understood by research participants included these:
- Why is the doctor/investigator talking to me about a research study?
- What do I hope to learn from this study?
- How is this study different from the care I would normally receive?
- Is this a treatment, and can I expect it to help me?
- What are my options if I don't wish to participate?
- What will my participation involve?
- What are the possible risks and benefits?
Unmixing the message
"Based on survey results from the prior year, we felt these were questions and areas we could improve on," Stella explains. "We thought we could get our research community to better focus on these issues and concerns that our subjects really wanted to know."
For example, a research physician's good intentions could result in mixed or confusing messages, crossing the line between clinical research and medical care, Stella notes.
When the research compliance office asked staff for ideas of how they could educate IRB members and staff about ethical nuances in informed consent (IC), Jessica Spotts, an IRB analyst, who also was an aspiring actress and director, suggested they create a short film.
"We had our staff think about difficult consent situations or studies that had challenging consent situations," Stella says.
These challenges might involve new technology, therapeutic misconception, or highly sensitive research data.
"Our staff members helped us come up with scenarios for challenging consent processes," Stella says. "We asked coordinators to think of the best way they did informed consent, incorporating all of the elements of consent."
The IC team used consent forms that had been approved by the IRB to prepare for the mock informed consent session. Also, they brought in four IRB community members to serve as prospective subjects. Two principal investigators and two research coordinators also participated, using one of their own study informed consent documents in the mock session, Stella adds.
Spotts directed the video of mock informed consent sessions.
For the video vignettes, Stella asked the investigators to blur the lines between their roles as a research investigator and as a clinical care physician.
"We asked them to make that as blurry as possible," she says.
"For each study we did a 'good take' and a 'bad take,'" Stella says. "As part of the education, we identified four key areas which we felt should be part of any comprehensive informed consent process, and we let them know this is what we were focusing on."
Research staff proved to be naturals as the camera rolled.
"We interrupted very minimally," Stella says. "On the first session we offered a little more guidance, but they took it from there."
The end result was an informed consent teaching video that has been well-received when used to instruct staff and IRB members, she says.
"We're sure there are better quality professional videos out there, but the feedback we received is that people were seeing their peers walk through the consent process, and this helped make the information resonate a little bit more," Stella says. "We repeated this workshop three times, and it was received very well."
Now the video also is available for staff online, and more than 300 people have seen the informed consent video, she adds.
Based on a survey of research participants, the office of research compliance and quality improvement at Cedars-Sinai Medical Center in Los Angeles, CA, has come up with these four key areas to demonstrate informed consent.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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