Human research protection education has evolved into a practice that is both easier and more challenging than it was decades ago. On the one hand, IRBs and research institutions have online tools and best practices available at the click of a button. On the other, they now know through evidence-based practices that the easiest ways to educate IRB staff and researchers often do not work as well as innovative educational methods.
So where do you begin?
“The biggest message is clear and consistent communication,” says Pamela Johnson, MPH, research education and quality improvement specialist at Hartford HealthCare in Hartford, CT.
Hartford HealthCare needed an effective and efficient educational process prior to launching a new electronic submission system.
“We started with live computer classroom-style education and held a dozen live classes,” Johnson says. “But after we went live and did all of this training, we started noticing problems: IRB administrators and investigators alike were all complaining that they didn’t know how to do this, and the same mistakes kept happening.”
This led to Johnson putting together a common pitfalls document to supplement the education and share with all users of the new electronic system. (For more information on Hartford’s educational effort, see story in this issue.)
IRB leaders at Christiana Care Health System in Newark, DE, revamped their research education sessions in response to dwindling attendance numbers, says Janet Leary-Prowse, MSEd, CIP, IRB research education specialist and IRB member.
“People would leave partway through the sessions because they were tired of hearing only IRB staff talk about rules and regulations,” Leary-Prowse says.
Melanie Chichester, BSN, RNC-OB, CPLC, an IRB member and labor and delivery nurse, suggested they make the sessions interactive so attendees still would learn about rules and regulations, but also hear examples of implementing these rules from research nurses.
“I educate peers in the institution I work in and I speak at a national level, and most adult learners don’t like hearing, ‘Here’s the background and here’s what you do,’” Chichester says. “They want evidence-based practice information about what the current literature says they should be doing, and they want examples of how they should do it.”
The idea was to polish up the decades-old research sessions by asking research clinicians to talk briefly about their challenges and best practices, Chichester says.
“We said to research nurses, ‘All you have to do is talk for five minutes, but tell us of a challenge in your practice,’” she says. (See story on revamped educational sessions in this issue.)
The IRB at the University of Miami has found that holding IRB grand rounds is an effective way to educate researchers and others involved in human research protection, says Kenia Viamonte, MA, senior manager of IRB affairs.
Previously, the IRB’s educational sessions were poorly attended and cumbersome, with sessions occurring at 20 different places. Topics did not appear to interest much of the research community, Viamonte notes.
“We were moving things along and getting things done, but it wasn’t fluid, harmonious, or collaborative,” she says.
Dr. Dushyantha Jayaweera, interim executive dean for research and research education and former associate vice provost for human subject research, was concerned about the low attendance of regularly scheduled training, Viamonte says.
“He wanted to ensure regular attendance, but also greater cohesion and harmonization of educational opportunities,” she explains. “There was an increasing need to have our research enterprise work less in each respective silo and more like a high-performing team for the greater good of the institution and our human research enterprise.”
Jayaweera suggested they try a different style of education. “He said, ‘Why don’t we do grand rounds? People have to be there, and they carve out this hour in their schedule, and they know they’ll get continuing education credits,’” Viamonte recalls. “We reached out to different speakers to see when they were available, and we reached out to the logical stakeholders in HRPP, plus leadership.”
Everyone — including senior leadership — liked the idea, so Viamonte worked to develop the content and communication strategy.
The idea was to hold educational sessions on topics that were of particular interest to researchers and to vary them between biomedical and socio-behavioral, Viamonte says.
Instead of having IRB educators and lecturers move from department to department, the attendees move to them.
“They get all the information in one place that’s relevant,” Viamonte says.
The grand round sessions are held the second Tuesday of each month, from 2-3 p.m. “That’s the time that makes the most sense,” Viamonte says. “It’s not too late in the day, and it’s not in the busy morning rush of the clinics; it’s right after lunch when things dwindle down somewhat, and it’s easy if they want to take a late lunch.”
The IRB grand rounds are not mandatory, but attendees can earn continuing education credits toward CIP renewal or for licensing purposes.
Once the new process was underway, educational session attendance increased from 20-30 to as many as 100 attendees, including principal investigators, study teams, compliance professionals, IRB members, staff, and chairs, she says.
The grand round sessions cover a variety of topics, including the following:
- • applying the approval criteria and the inner workings of an IRB,
- • trusted governance and biobank research,
- • ethics, translational science, and the IRB,
- • social and behavioral research,
- • consenting study participants in the 21st century, and
- • IRB library and policies: What you need to know.
Viamonte identifies people at the university who have expertise in an educational topic area and reaches out to them via email. The email tells them about how the IRB designed the Grand Round Series to include best practices, quality improvement initiatives, and other topics. Then it includes a direct ask: “We are reaching out to you because of your compliance charge and how your scope includes a topic of great interest for our community,” according to one email.
The speakers are encouraged to open up their sessions to questions and discussions and to use visual aids, Viamonte says.
“These sessions provide our research community with real-time information of what they need to know about our HRPP and how we can better serve them,” she says.