IRBs Train Staff to be Experts
Training can take years
IRB professionals often need specialized, intensive staff training, as well as the standard online educational sessions such as CITI. This is why one human research protection program developed a formal training program that empowers staff to become experts.
“We found that CITI does not address the operations of our office because of its broad, educational-awareness program that generally covers research ethics and regulatory issues,” says Martha F. Jones, executive director of the human research protection office at Washington University in St. Louis.
“It’s hard to have a single program that will provide appropriate training at the institutional level,” Jones says. “So we developed our training tools in a way to make them portable to other institutions, as well.”
Jones has discussed and shared information about the training program at a Public Responsibility in Medicine & Research (PRIM&R) conference and received overwhelming requests for more information, she notes.
“What we have are some tools we’ve developed that are modular in nature,” Jones says. “Because they’re specific to each position in our office, they start with basic template everyone goes through.”
For example, new employees are expected to learn the university’s telephone exchanges, website URLs, software and email programs, and Web browers. On their first day, employees also register for research news, sign the IRB assurance form, schedule a meeting with the operations manager, and get acquainted with the office’s kitchen, suite access, equipment, and supplies.
Each new employee has a designated trainer who is responsible for overall training. Employees also train with content experts. A 43-page training tool provides a clear overview of staff training, including very brief descriptions of each step in a chart that includes columns for employees and trainers to initial and date.
“There’s a spot in the tool where you can document each item, writing down who trained the person, and show the date it was complete,” Jones says.
The idea is to make the training all-dimensional and not just reading material and passing tests. “They read first and then watch a trainer,” Jones explains. “The trainer watches them doing it and reviews what they’re doing.”
As a progressive training process, it uses different methods that might engage adult learners, she adds.
“We use different tools, understanding that not everyone learns in the same way,” she says. “Some people are very visual, and others are hands on; some learn by hearing, and we try to incorporate as many different methods as we can.”
The tool provides a stated path to follow for the training, but it’s also flexible to be adaptable with employees who have different backgrounds, Jones says.
“They can go through the training at different speeds,” she adds. “Some people who come from a clinical training background can go through the training quickly.”
The idea is to not require new employees to complete it within a set time frame. For many people, it will take months or even a couple of years to fully complete the training, Jones says.
“Some people will be up to speed within six months, and others will take longer, and that’s fine,” she adds. “They’re not handed all their responsibilities at once.”
Quizzes at each level identify the employees who have retained the knowledge and those who need more training. Its interactive features allow for trainers to give new staff responsibilities as they demonstrate competency in those particular tasks. The new hire’s independence grows as he or she goes through the training course, Jones explains.
Besides being useful for training staff, the tool has been used for quality assurance efforts, she notes. (See sample items from the training tool in this issue.)
“If we have someone who is having an area of trouble and maybe needs more training or re-education, then once we identify that area, we can go back to our training tool and pull out that section to use as a guide for the quality assurance activity,” Jones says. “We want the tool to be a living resource for them — that’s where quality assurance comes in.”
The training occurs both in electronic and hard copy formats. “The layout looks like a spreadsheet or database visually,” Jones says.
All IRB staff are expected to obtain a CIP designation, so the tool also can be used as training for the CIP exam, she notes.
“It’s been very effective in providing that training, as well,” Jones says. “It’s extremely comprehensive and has everything they need to learn for the CIP exam.”
Here's how one human research protection program developed a formal training program that empowered its staff.
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