Human research protection program (HRPP) training at the institutional level often lacks uniformity and evidence-based strategies, some experts say. Some organizations and research programs require new investigators and IRB staff to have extensive online coursework or on-campus classes, and others provide only general guidelines and requirements.
A centralized, evidence-based approach could be an answer to making certain all parties affiliated with a large research organization are well educated on regulatory topics — this was why one HRPP’s mission was to create an educational session that ensured all investigators were familiar with what they needed to navigate clinical research and ensure compliance.
“This class helps all students go back to their offices and operationalize, and that’s why it’s called ‘navigating clinical research,’” says Tina Chuck, MPH, manager of research policy and training at North Shore-Long Island Jewish (LIJ) Health System in New Hyde Park, NY.
The interactive class includes classroom-style learning combined with technology, group discussions, and hands-on activities.
“We transformed the lecture into more interactive adult learning, which makes it more effective,” Chuck explains.
Chuck and co-authors studied the training course’s effectiveness and found that the course was well received by researchers and research staff and that participants found the information to be simple and appealing.1
Three tests are given to course attendees: one before taking the course, one immediately after completion, and one three months afterward. The results showed that people retained the information they were taught, and — even more importantly — they returned to their offices and made changes based on what they had learned, says Dorean J. Flores, CIP, IRB manager at North Shore-LIJ.
“They told us the course helped them, and it did what it was intended to do to provide information about the overall process of clinical research,” Flores says.
“We’ve had a lot of positive feedback, especially from investigators on research compliance,” says Richard Ramdeo, CIP, IRB manager at the health system.
“The course gives them a good overview of everything they need to know,” he adds. “Our staff and employees taking the course also gave positive feedback.”
After taking the course, communication between the IRB and other departments improved, and IRB reviews were more efficient for investigators, Ramdeo says.
The training course was created as a one-day class, offered once a quarter, with 25 to 30 attendees. Based on early feedback, they converted into a two-day class. The health system does not require all research staff to attend the class, but some research programs make it mandatory for new hires, Chuck notes.
Also, the IRB will mandate the course for researchers and their staff on a case-by-case basis. For instance, if the IRB is aware of a regulatory compliance issue with an investigator or research team — such as deficiencies in obtaining informed consent — then the IRB will require them to take the Navigating Clinical Research course before continuing with the study, Flores says.
The first day shows attendees how to navigate the HRPP process, and the second day covers good clinical practice and clinical trials of devices and drugs, Chuck explains. (See story on day-to-day coursework, page 55.)
Part of the course’s success is due to the way it relies on multiple types of learning strategies. There are lectures, but there also are group discussions and activities. The class is held in a room with dry erase tape on the walls and attendees are encouraged to write on the tape during group activities, Chuck says.
“The first thing we do is ask them what do they want to learn in taking this course, and we have them pair up as a group and write down the questions they have,” Flores explains. “Then they can look at the walls and see all of the questions being asked.”
Instructors also use humorous videos about research — found online — to keep it interesting. “Students pick up on that and laugh, and that provides an opening for us to feed them the right information,” Flores says.
For example, one YouTube video is a cartoon with an investigator coming into an IRB office and stating in a robotic voice that he wants to conduct an investigational drug trial on children and neonates in an international setting. The investigator character says he doesn’t understand the IRB process and wants his review expedited and approved by tomorrow because the drug is safe since it was tested on animals and a handful of adults, Flores says.
“The audience enjoys it,” she adds. “We understand there are many different ways people learn, and we incorporate the many different types.”
“As we start to find things that engage them more, we incorporate them into the course,” she adds.
Another strategy was to employ technology in the form of remote control pads with clickers and numbers/letters students can press to answer multiple choice questions, Chuck says.
“When we start the PowerPoint, we open polling questions to the entire audience, playing ‘Jeopardy!’ [game show] music to make it fun,” she explains. “Everyone picks up their clickers and votes, and when the polling closes, we can see a bar graph of votes, showing how many got it wrong and how many go it right.”
This gives presenters an opportunity to engage with attendees, she adds.
The course was developed by senior IRB managers. Entry-level IRB staff helped them determine how to tweak and improve the material. IRB staff also take the entire course as students and can offer feedback from that experience as well, Flores says.
“After doing this job for a while, things become pretty routine, and you’re under the perception that everyone gets it when that’s not necessarily the case,” she adds.
Initially, new research staff took the course. Now, some experienced researchers have taken it as a refresher course, Flores says.
“This class is more than a class,” Chuck says. “It’s a networking opportunity for all the students.”
As they discuss obstacles and issues, attendees learn that others have experienced similar problems, and they can learn solutions from one another, she adds.
“We’re trying to be proactive in educating our staff and researchers and entry level personnel,” Flores says. “By having a lot of staff members contribute to it provides us with different perspectives consistently.”
- Flores DJ, Chuck T, Ramdeo, R. A pilot study on the effectiveness of the “Navigating Clinical Research” training course. Presented at the PRIM&R Advancing Ethical Research Conference, held Dec. 5-7, 2014, in Baltimore, MD.