People working in human research need to be well-educated about IRBs and federal regulations, but how well are the classes really working if learners appear glassy-eyed and confused?
This is the question that led one IRB to create a novel way to teach regulations: ReguBingo.
Instead of relying on didactic lectures, IRB instructors hand out ReguBingo cards and let the games begin.
“People were folding their arms and didn’t want to hear another presentation,” says Armida Ayala, MHA, PhD, director of the Southern California Kaiser Permanente IRB in Pasadena.
“We were using the didactic method, a teacher-student relationship, to teach the regulations, so we decided to shift toward a more interactive method,” Ayala says.
“The didactic method is very important because it creates consistency,” she explains. “But it results in little interaction between students and teacher.”
Ayala had mentored under Paulo Freire, who had been an education director in Brazil. Freire’s education model called for not treating learners as empty accounts to be filled by the teacher, but rather as active partners in learning, Ayala says. “He taught me the participatory impact of education.”
It seemed to Ayala that she could use those skills to improve IRB regulatory education.
“I asked people about their glassy eyes and why the lectures were not filling their needs,” she recalls. “They said those were very boring and not fun and that regulations are boring.”
Taking up the challenge, Ayala came up with Bingo-type game designed with illustrations, regulatory terms, and definitions. (See how ReguBingo works, page 100.)
“Gamification is an approach to engaging employees in training activities and to reinforce the value of a company,” Ayala says. “Sessions have to be fun and designed to increase awareness of regulations.”
After piloting the ReguBingo game with 25 nurses, she found that their knowledge of the regulations covered in the game had increased by 80% between the pre-test and post-test.
“We thought, ‘This can’t be,’” Ayala says.
The game also was successful, although not by such a large difference, with IRB staff and researchers, she says.
With positive initial results, the IRB made ReguBingo games to cover a variety of topics, including conflict of interest, generalizable knowledge — quality versus research, continuing review, elements of informed consent, and HIPAA.
Each ReguBingo game begins with a teacher whose goals are to be quick, witty, and make it fun, Ayala says.
Attendees have incentives, such as inexpensive water bottles, rain jackets, and healthy food, offered as prizes for winners. Teachers tell knock-knock jokes about HIPAA and do whatever it takes to generate excitement. Participants are encouraged to shout out if they win.
“We have so many funny things around this, and people laugh a lot because it’s silly,” Ayala says. “It’s a way we can get them excited.”
So far, more than 60 people, including nurses, doctors, pharmacists, IRB members, IRB staff, researchers, and others, have taken the ReguBingo class over five different sessions.
ReguBingo instructors also offer case study examples to illustrate any particular regulatory policy.
“We do case discussion and policy guidelines, presenting these along with a game so they relate to conflicts of interest in research,” Ayala says.
IRB staff answer questions from the audience and introduce other experts.
For example, the compliance department joined the sessions to talk about how to mitigate conflicts of interest or HIPAA breaches.
“One case we discussed at length involves Andrew Wakefield, the British gastroenterologist who was stripped of his medical license after conducting fraudulent research involving the vaccine for measles, mumps, and rubella,” Ayala says.
Wakefield published a paper in 1998 in the Lancet that suggested there was a link between the MMR vaccine and autism in children. Later, he was found by the British General Medical Council to have engaged in misconduct, including failure to obtain informed consent, and having conflicts of interest.
“Wakefield was charged with conflicts of interest because he recruited children through his son’s birthday party and would draw their blood without parental consent,” Ayala notes. “He conducted his study without IRB approval, and he developed a company that he owned and that was in his wife’s name.”
The study created hysteria over vaccination and misrepresented the results of his research, and he planned to benefit financially from his anti-vaccine claims, Ayala says.
“So the teacher has to be very knowledgeable about cases and things people may not know about,” Ayala says.
Plans are to create more ReguBingo games until all of the human research protection regulations are covered, Ayala says.
The IRB started with games related to topics where researchers appeared to have confusion or questions, she says. “Right now, we’re covering those things that are very controversial and in-demand.”