When an IRB office aimed to improve its staff training and work efficiency, the solution was to create a new program, called the IRB Staff Training and Onboarding Program (ISTOP).1

The process began with the IRB’s internal staff training and member work group and leaders identifying ways to improve training and onboarding of new IRB staff, says Beth Irwin, CIP, MA, senior IRB analyst at Northwestern University in Chicago. The human research protection program (HRPP) lacked formal standardized onboarding for staff, so the institution’s social-behavioral team, reliance/compliance team, and biomedical team worked together to create consistency with training and documentation of onboarding, she explains. (Find out more at: https://www.irb.northwestern.edu/citi-training/.)

The IRB created a 31-page IRB staff training guide, dated Sept. 5, 2020. The guide covers IRB oversight, the HRPP’s organization, institutional organizational information, onboarding information, and continuing education requirements. The PDF provides links to policies and additional information.

IRB staff often come from other institutions. They have experience but may not know about particular institutional goals and standards.

An internal survey showed the Northwestern IRB used non-formal training, which resulted in inconsistencies, Irwin says. Without formal training, IRB decisions and outcomes may be inconsistent, creating a more difficult and frustrating review process.

“We desired a more professional development approach,” Irwin says. “We wanted something where you would not just go to the website to find information; we wanted something more personal and supportive.”

An informal, self-guided training process can work adequately for highly motivated new employees, as it did for Nazneen Ali, PhD, CIP, senior IRB analyst at Northwestern University.

“What my supervisor and colleagues were saying to me was, ‘You’re really taking the initiative to learn about Northwestern policies on your own,’” she says. “It was very self-guided, and I’m someone who is not shy.”

But some IRB employees were not as proactive in directing their own training. “Our analysts had the same approach, same materials and expectations, but in terms of asking questions, I might ask 10 times as many questions as my colleagues next to me,” Ali says. “It was very self-guided, and you don’t know what you don’t know, so that created gaps in competencies.”

When new employees become stressed or run out of time to complete tasks, they may not get to self-guided learning information, and that can create inconsistency, Irwin says. Inconsistency in onboarding and training also occurs when people are hired at different points in an IRB’s work or growth cycle.

“A lot of [training variation] came from new staff coming on board and new positions being created when a team was [only] one woman for a while,” says Priya Tripathi, MS, manager of compliance and oversight at Northwestern.

For instance, when an IRB is growing quickly and needs more staff, there may not be as much focus on formal, standardized training. The IRB may need quick hands on deck.

“If we’re thrown into the deep end of the pool, some of us for various reasons can swim, while others need that life raft to feel more comfortable, and that’s universal,” Irwin explains.

With ISTOP, the IRB can ensure everyone — no matter who they are and what their professional experiences have been — can swim. “The only way to do that is through standardization; ‘Here’s the path that is meaningful,’” Irwin says.

The ISTOP process includes a standard operating procedure (SOP) that lists the IRB staff training purpose, policy, responsibilities, procedure, and materials.

The following is a sample of the SOP’s procedures:

Onboarding education and training. Each new IRB office employee receives at least six weeks of initial training, guided by the employee’s direct supervisor. The first phase of this training includes Northwestern University’s new employee onboarding requirements, as well complete human subject protections training, such as CITI courses and focus on the Belmont Report and federal regulations.

The second phase involves application and learning, in which the new IRB staff member, under direction of a supervisor, applied knowledge from Phase I to specific IRB activities, including IRB submission reviews, IRB compliance activities, and external IRB administrative review.

Continuing education and training. Each IRB staff member receives a refresher course in human subject protections training every three years and attends at least four continuing education opportunities per calendar year. These can be webinars, workshops, and institutional continuing education opportunities.

A PowerPoint presentation is used for onboarding new staff for both biomedical and social-behavioral IRBs. Before the COVID-19 pandemic, activities were balanced between online and in-person. During the pandemic, in-person activities were held via Zoom meetings.

“We have professional development activities, including brown bag [lunches], staff presentations,” Irwin says. Staff brown bag lunch meetings were converted to Zoom presentations during the pandemic, Tripathi adds.

When the ISTOP group began to meet, they researched onboarding and training practices at other research institutions. Some of SOPs were more detailed than others. “We couldn’t find anything that spoke to comprehensive staff training,” Irwin says.

The group was intentionally diverse and focused on identifying the type of content and knowledge that staff members needed to educate new staff. “We outlined that, and looked at what kind of messages we needed to have to educate our staff, and we looked at content and methods and melded those two together,” Ali explains. “ISTOP became pretty organic; we knew what we needed.”

The group surveyed key people to learn more about what an optimal training experience might look like. “One of the takeaways from the survey is that it wasn’t just the inconsistent reviews, it was the sense that the new staff needed some space to feel more comfortable and to know how Northwestern does things,” Irwin explains. “Even if someone came here with years of knowledge and experience, they needed to know how we did it here.”

They added training curriculum guides and two phases to training. The first phase is about a month long, although it can be completed more quickly, depending on the person. “It’s about getting to know our policies and procedures and the internal people in the office,” Irwin says. “It’s observing other IRB panels, not just your own.”

Phase II goes into detail on IRB applications and compliance. It is about helping people become more comfortable in their jobs.

“We created a couple of checklists,” Tripathi notes. “One is for basic onboarding, and one is for more general items. We have a role-specific checklist with items an individual needs to get trained on.”

For example, when Tripathi was onboarding a new social-behavioral analyst, she created a PowerPoint with all the high-level information the new employee would need.

“We did a Zoom call to give her an opportunity to ask questions,” Tripathi adds. “We created a robust curriculum guide that people can use, and left it up to their supervisors to direct how they want that training to work.”

They also started a monthly, all-staff meeting with a 15-minute presentation on a specific topic, such as compliance. “We also have an account with CITI training and some courses that people can access online,” Tripathi adds. “We’re basically leveraging Zoom and more training like that.”

On a positive note, the brown bag lunch attendance increased because of Zoom. “The same thing happened with the cross-panel observations, where before, people would have to take the shuttle bus for 45 minutes [or make] one-hour drives,” Irwin says. “Now [on Zoom], they’re attending the meetings more often.”

One IRB employee was hired just a week before the pandemic caused a nationwide shutdown. Despite working from home, the new employee navigated the onboarding process well, Irwin says.

“Because our work is electronic and in the system, and the documents we were creating were electronic, the pandemic didn’t put a lot of dampers on our program and in how we could manage things,” Tripathi says.

The pandemic has made IRBs and research institutions aware of the need to attend to staff’s mental and emotional health. The institution’s compliance team includes a dedicated person to provide health and wellness check-ins. “That has gotten a lot of attention from the office of research and neighboring programs,” Ali adds. “It’s been a good community-building activity that is regularly scheduled.”

For wellness activities, Tripathi led staff in 20 to 30 minutes of stretching, yoga, meditation, and art therapy, which included drawing and playing music.

“Those are once a week or every other week,” Tripathi says. “Northwestern has an entire wellness group that sends out emails through a listserv that provides resources to people, including sharing a fun quote of the day.”

To build staff rapport during the pandemic, the IRB held a virtual escape room party, Irwin says.

“This reminds us we’re all human,” Tripathi says.

REFERENCE

  1. Irwin B, Tripathi P, Ali N, et al. The IRB Staff Training and Onboarding Program (ISTOP): A response to an HRPP training deficit. Presented at the PRIM&R Advancing Ethical Research Virtual Conference, Dec. 1-2, 8-9, 15-16, 2020. Poster/Abstract:10.