Create "recipes" of job roles

Look to the future

IRB offices seeking to create a sustainable leadership role might need to re-organize, examining their current processes and culture, experts suggest.

"Too often you hear the story of an institution where the IRB administrator moves along or passes away or retires, and there's nothing left in terms of a roadmap, and there's no one who has been trained to do things that go beyond running the IRB," says Yvonne Higgins, CIP, director of quality management at Copernicus Group Institutional Review Board in Durham, NC.

"You have to make a detailed roadmap with defined processes of how to do things," Higgins says.

"If it's the recipe of how to do the minutes, then someone can at least follow the recipe," she adds. "Too often IRBs don't have defined processes written down that are accessible to everyone."

A good place to start is to take a look at the direction the office is heading if current staffing trends continue. Then work with staff and institutional leaders to create a model that will improve leadership succession, reduce staff turnover, and improve quality.

"We were seeing some trends in turnover in 2008, and we wanted to regroup," says Karen Hansen, director of the institutional review office at Fred Hutchinson Cancer Research Center in Seattle.

After the organization received accreditation, it appeared to be an opportune moment to make further long-term improvements, so Fred Hutchinson Cancer Research Center brought in a consultant to assist with this work.

The IRB had an informal system that had grown from a small group of people. IRB staff experienced increasing workload pressure and organizational issues, says Dan Oestreich, MA, principal with Oestreich Associates in Renton, WA.

Oestreich worked with the IRB office for about six months and helped identify work logjams.

"People were unclear about their jobs and roles," he recalls.

This seemed to be a good place to start, so Oestreich met with staff to discuss their roles and job descriptions.

"It's not so much a formal job description as a role description," he explains. "This is less about the tasks and assignments as it is about the expectations placed on specific positions, including quantitative and qualitative expectations of how well this is going to be done."

For example, the role description for the position of operations manager might include five major areas of expected excellence. This description might include specifics, such as having the person manage three IRB meetings per month and making sure analysts are supported in their conduct, Hansen says.

"We focus on what does it mean to provide support," Oestreich says. "Do board members feel their relationship is highly cooperative and collaborative? Do they get adequate warning of new development? Do analysts feel they are getting adequate guidance about how to do their work?"

Descriptions can be expansive while including specific goals. For instance, the description of the assistant director position includes these items:

— effective management of the center's institutional review office (IRO);

— full awareness of center's stakeholders;

— effective management of daily demands;

— effective management of day-to-day crises and high-demand situations;

— effective operation of IRB operations.

Each of these can be explained, as well.

"Take one example: effective management of day-to-day crises," Hansen says. "Was the center director calm under duress and using good judgment in managing crises?"

With Oestreich's guidance, the cancer center's leadership decided a structural workforce change also would be necessary.

"Staff members were concerned that workloads were not equal," Oestreich recalls. "Some were overwhelmed, and others did not have the same kind of volume."

Also, the office's overall volume of work was increasing. This pointed to a need to redistribute management efforts to better handle the workload, Hansen says.

"Formerly, we had a director and an assistant director as the main management leadership positions," she explains. "We decided to split the assistant director position into two jobs with one being an IRB operations manager position."

Now the management structure has greater depth.

"We have well-defined duties, and the organization's institutional review office is prepared for today and can effectively plan for the future," Hansen says.

Even small IRB offices can create sustainability and depth through encouraging staff to increase their skills and through cross-training, Hansen and Oestreich suggest.

"You can create new positions or create opportunities in current positions that allow people to move up and grow," Oestreich says.

"When you find little opportunities for people to learn higher-level work, then you begin to offer these," he adds. "Do this in a way that corresponds to what people say they want to be doing."