Guiding researchers every step of the way
Education program vital to QI
At Cedars-Sinai Medical Center, research compliance depends on a continuous loop of quality improvement and education, each enhancing the other.
And that loop starts early — often before an investigator even begins work at Cedars-Sinai, says Eifaang Li, DVM, MPH, CIP, director of the office of research compliance and quality improvement for the Los Angeles-based institution.
"Whenever they recruit a new researcher, we receive a notification of where they're coming from and what their start date might be," Li says. "We reach out to those new investigators while they're still at their previous institutions, introduce ourselves to them and recommend that they contact us and work with us for the submission of their first IRB applications, because we have online submissions.
"We have many investigators who actually submitted their first IRB application to Cedars-Sinai while they were still at their previous institutions."
The education and quality improvement program has evolved over the past decade to support investigators and research staff from that very early point, through their first submissions, into post-approval and beyond, says Rebecca Flores, CIP, manager of operations and education.
"We work in close partnership with our quality improvement program," Flores says. "Quality improvement helps to develop surveys and obtain feedback from the research community. We do post-approval audits, we do audits of the work done by our analyst team that processes submissions and we find trends and areas for improvement and then structure educational programs based on that."
Cedars-Sinai's education initiatives were recognized by the Health Improvement Institute as a best practice in HII's 2011 Awards for Excellence in Human Subjects Protection.
Flores says Li completely redesigned the research compliance program when she arrived at Cedars in 2000, establishing the education component.
Over the past decade, it has grown to include different elements:
• Grand Rounds: The IRB holds quarterly presentations, bringing in nationally recognized speakers to talk about topics pertinent to the research done at the institution.
"We try to bring in speakers who bring a unique perspective and that are in alignment with our philosophy as a research institute," Flores says.
• Continuing education: Like other institutions, Cedars-Sinai has required education in human subjects protection for investigators, incorporating the online CITI course. When that program is completed, the investigator must continue to update his or her education by attending IRB Grand Rounds or by taking online courses developed at Cedars-Sinai.
"In those online modules, we focus on particular topics that have come up in our interactions with research teams, information we pick up as part of our post-approval monitoring program or the feedback we receive from surveys we put out," Flores says.
A researcher must earn four of these IRB credits within four years in order to be renewed to conduct further research, she says.
Research support staff must complete a course called IRB 101 within six months of hire as part of their initial orientation. The course introduces staff to concepts related to the ethical conduct of research, going into detail about issues such as the consent process.
• Mandatory pre-review: Any investigator who submits a study undergoes a pre-review by an assigned analyst, who looks at all of the documentation with a focus on meeting the regulations.
"They're looking at whether there is enough information in that submission for the IRB to make the required determination for approval," Flores says. "They work with that study team to make edits and to get it to the point where hopefully, if it goes to committee, it can be approved with very minor changes or no changes at all."
Flores says that since the pre-review was implemented in 2007, the number of IRB submissions that have obtained straight approvals has increased.
The office continues to seek information past the point of IRB approval, through post-approval audits and by studying the metrics it collects about the time taken to process submissions, Flores says.
"We have an online system that has a robust auditing and tracking mechanism, so our quality improvement team gives us very detailed and robust data," she says. "We could say, 'Wow, we're spending a lot of time on pre-review. Why are we spending so much time?' We're able to critique where we're holding things up and try to problem-solve around that."
The office can audit requests for changes made by IRB staff, to make sure that the changes are needed.
"So we're constantly looking at what we're communicating and making sure it's on the mark and not going beyond where we want to be and unnecessarily delaying the submission," Flores says.
The compliance office also surveys investigators immediately after they've received IRB approval, which can often lead to useful feedback that helps the office make changes, Li says.
For example, Cedars-Sinai's online IRB application form prompts investigators to fill in certain categories based on the type of research involved. An investigator working on a compassionate use protocol noted that the form didn't address that situation's special circumstances, Flores says.
"They were directed to all questions related to clinical trials, which for a compassionate use protocol, are difficult, if not impossible to answer," she says.
Now, she says, the online form automatically directs an investigator working on a compassionate use protocol to the questions directly related to that type of activity.
Feedback on the survey also led the compliance office to institute "IRB live chat," a 9 a.m. to 5 p.m. service each weekday that allows investigators to talk to IRB professionals to ask specific questions about their submissions.
Flores says the idea was proposed by a senior staff member. She says IRB staff have opportunities for advancement based on coming up with new ideas to help the office in its educational goals.
"They come in as entry-level analysts and if they're interested in promotion, they can go up two to three steps from that entry level," she says. "Part of their promotion involves creating an educational initiative or an operational initiative to help address a need. It really helps with staff retention. We want to give staff leadership opportunities. Even though we don't have 10 managers in our office, our staff can gain some of the skills they could be developing as a supervisor or manager."
Flores says one key to the success of the Cedars-Sinai education program is that it is seen as an integrated part of the research compliance function.
"I think if you can become comfortable with the idea that education actually enhances your ability to run a compliant program, you'll see that it's not so much an extra investment but something that's critical to your success."