When an IRB office received feedback from new hires that its training and guidance for new IRB employees was lacking, something had to be done.
IRB leaders decided to address concerns through development of a standardized training program for all new staff members. The program involves having multiple people in the IRB office provide training, says Scott S. Katz, MS, CIP, research protocol analyst for the Emory University IRB in Atlanta.
“We decided on a written format,” Katz says. “We wanted to reduce errors.”
The changes led to a more effective training program, according to staff feedback and internal audit data.1
“The training fosters relationships and is about improved office relationships,” Katz says. “Everyone is getting to know each other, and it re-educates staff members as they are teaching the new employees.”
It has reduced the amount of errors new staff members make, and it has reduced overall errors as well, he adds. “We’re finding that everyone is better trained, and they’re more on the same page now; the office is a lot more efficient than it was before.”
This is how the program works:
• Advance preparation: The first step is preparation for the new employee, Katz says.
“Our training process starts roughly one to two weeks before the new staff member joins our team,” Katz says. “During this time, the staff training liaison makes sure that the desk is ready for the new member, checks to see that all materials and permissions are present, and sends out a sign-up list — a Google doc — for all of the current staff members to sign up for a specific day to conduct the training.”
Once the training begins, the liaison will monitor the training and make sure that all of the staff who signed up know what and when they are signed up for, and covers for any days that were not selected, he adds.
“The liaison makes sure the go-to staff member is introduced to the new staff member,” Katz says.
The new staff member is given access to a website that can only be accessed with a specific URL. The website has all of the information the new employee will need to know, he adds.
• Go-to staff member: Each day of training is organized around a specific type of training, and different staff members participate in training the new employee.
“The current member who is doing the training for that day is known as the go-to staff member,” Katz says. “The go-to staff member will then meet with the new staff member for an hour or more to discuss the daily training, show the new member how to process studies using eIRB, and then quiz the new member on what they have learned.”
For example, on the first day, the go-to staff member will meet with the new employee and discuss the IRB’s background and why the IRB review process exists, Katz says.
• Background reading: “During the day, the new member is not only learning by instruction, but also reading over all of the relevant regulations, policies, and readings,” Katz says.
For example, the new employee is expected to read through the standard operating procedures (SOPs) and then apply them in the next day’s training, he explains.
• Daily modules: IRB new staff training includes the following modules:
- Historical and administrative: “We introduce them to SOPs and the Common Rule,” Katz says.
- Expedited review: The go-to staff member walks the new employee through the expedited review process, using actual studies in the IRB office’s inbox, Katz says.
- Non-human subjects research determinations.
- Informed consent and HIPAA — a deeper look: Training about informed consent includes reviewing multiple informed consent documents, he says.
- Exempt review: “We go over all of the regulations, policies, and procedures involved with exempt studies and making those determinations,” Katz says.
- Laying foundation for a full board review.
- Full-board study review: “Sometime during the two weeks, we want the new employee to attend one of our full board meetings to get a feel for how it works and to see how the reviewers make these determinations,” Katz explains.
- Amendments, continuing reviews, misc.
- Putting it into practice: minimal risk studies.
- Putting it into practice: more than minimal risk and adverse events.
- New staff training feedback and pod assignment: On the feedback day, the new staff member meets with the IRB director and discusses whether he or she feels comfortable moving forward. The new member also gives feedback on the training program, what worked, and whether any improvements could be made, Katz says.
During each day and module, the go-to staff member is there to provide guidance and to show the new employee where to access information.
• Feedback of training program: “At the end of each day and upon the completion of the course, both the new staff member and the go-to staff member are asked to provide anonymous feedback through a Google doc,” Katz says. “This feedback is then used to enhance our training program for the next new employee.”
New staff members can use an anonymous feedback form.
Feedback has been very positive, he notes. “People have praised the new training program and how well structured it is.”
The feedback also has identified areas where additional information was needed, he adds.
The training program’s greatest asset is its structure, Katz says.
“Everything is on a website the new member can access, so each day the person is not lost; they understand what needs to be accomplished during the day,” he says. “Because it’s online, they can go home at the end of the day and read up on regulations.”
REFERENCE
- Katz SS, Wack K, Arenson M, et al. Transcending turnover by standardizing staff training. Presented at the 2015 PRIM&R AER Conference, held Nov. 12-15, 2015, in Boston. Poster 3.
Leaders at one IRB decided to address concerns about new hire training through the development of a standardized training program for all new staff members.
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