In the 11 years since she founded Cincinnati-based Goodwyn IRB, Ellen Kelso says she’s noticed a great deal of non-compliance among investigators on the trials she’s overseen. Those making the mistakes had good clinical practices (GCP) training, but they somehow weren’t able to apply it to real-life situations in the course of a trial, she said.
What investigators and their staff needed, said Kelso, was GCP training that didn’t just list regulations and requirements, but instead offered guidance in the nuances and meaning behind the regulations, providing examples of how each regulation might play out during a study.
Kelso today is launching Goodwyn University, a “site school” that offers training for sites and others involved in clinical research. The university will be mostly an online endeavor but will also offer some in-person seminars and roundtable discussions. It will offer courses other than GCP, but that’s the one Kelso is most proud of.
“It’s called Integrated Ethics,” she explained, “and it maps each of the principals of GCP to actual actions, showing examples. It doesn’t just go over GCP, but illustrates it. The point is to develop a true understanding of the framework behind GCP. Sites are told ‘You have to have this and you have to have that,’ but people might not understand the whys behind each requirement. In my observations over 11 years, this is what’s behind the noncompliance.”
In addition, the university will offer a track for IRB professionals who are new to the field or looking to bone up on their skills. This track, said Kelso, was born out of the fact that most training for IRB personnel is currently geared toward IRBs in a university setting—not in commercial industry. “We know there’s a gap,” she said.
The cost is $200 for a set of five training modules. Sites or IRBs can buy a subscription if they have more than one employee who needs training.
A year ago, Kelso—who formerly worked in compliance for Kendle International and Procter & Gamble—launched Goodwyn Research Trust, an extension of the IRB that offers extra support for sites currently engaged in a study and already using Goodwyn as their IRB. Interestingly, there’s no added cost. “We can do it without charging because our technology is really good,” said Kelso. “Once we detect a specific need and pass the word to the trust, we push out these specific training modules to investigators, which they’re then required to complete.”
The trust and the university don’t have their own employees, but instead borrow from Goodwyn IRB’s 46-person staff. Kelso expects last year’s launching of the trust and today’s university launch to bump the IRB’s business up about 25 percent.