IRB offices face staffing changes as leaders age
IRB offices grew in past decade
IRB offices have evolved in the past 15 years. Early IRB offices often had limited support staff. But as the field of human subjects protection evolved, IRB offices' staffing needs increased, creating IRB office leadership roles and the need for more IRB coordinators and other support staff.
Now these same IRB offices and leaders are facing a new challenge: How do you develop the next generation of IRB leaders?
The anticipated gap in research enterprise leadership coincides with the current trend of a graying health care field. According to a 2010 report by the Sloan Center on Aging & Work at Boston College (MA), a large number of baby boomer health care professionals are expected to reach retirement age by 2020. This will leave a vacuum of skills at a time when the general population is aging and will need more health care services.
But the leadership transition problems confronting research ethics boards is also a result of the way the field has developed in recent years, experts say.
"This wasn't a profession when many of us started in this field," notes Yvonne Higgins, CIP, director of quality management at Copernicus Group Institutional Review Board in Durham, NC.
"You didn't grow up thinking, 'I want to be in an IRB,'" she adds. "This whole career path was created by our generation."
In the old model for an IRB office, there was an administrator and an IRB, and the administrator did all of the support and organizational work, Higgins says. (See story on developing career ladders within an IRB office, p. 27.)
"Then, as these programs grew, the research portfolios became more complex," she explains. "Most offices would add another IRB and another IRB administrator, so you ended up with an organizational chart that was flat with a lot of people living in parallel universes, doing the same thing."
Career ladders were unheard of, and this meant there often were no leadership understudies in the wings.
As this group of pioneering administrators is reaching retirement age, the question on many IRB directors' minds is "Who will step in to take my place if I suddenly have to leave?"
This truly is a problem that IRB directors and administrators should address since their organizational leadership might not realize it's an issue.
"I think it's important to address the sustainability of an organization's human research protection program," says Karen Hansen, director of the institutional review office at Fred Hutchinson Cancer Research Center in Seattle. (See story on restructuring and improving IRB staffing, p. 29.)
"This would include appropriate IRB leadership, skills training, and succession planning," she adds.
With a goal of creating a sustainable human research protection program, a consultant was hired to assist Hansen with identifying ways the IRB office could improve its leadership and skills training and succession process.
"This is about leadership, and it's the leader's responsibility to think about the organization's future without themselves," says Dan Oestreich, MA, principal with Oestreich Associates in Renton, WA. Oestreich worked with Fred Hutchinson Cancer Research Center to develop a career ladder, leadership skills and training, and a sustainable staff model.
Sometimes, administrators and directors get caught up in the belief that they're the only ones who know how to manage the office, and they fail to train and develop their replacements, Oestreich notes.
"If you're in that role, you're not leading," he says. "The way to support your organization is to help other people learn leadership skills."
While leaders can emerge from an IRB's coordinator and administrative staff, sometimes it's challenging finding people who can perform well at entry-level IRB jobs.
Few college courses and programs teach IRB professional skills, so it's difficult to find new college graduates with precisely the right training and background for working in a human research subjects office, says Charlotte H. Coley, MACT, CIP, director of IRB educational programs at Duke University in Durham, NC.
"You have to find staff that has the same skill sets you need for working in an IRB office," Coley says. "These would be things like good analytical and communication skills, and teamwork is very important."
When an IRB director has hired bright, capable workers, the need for specific skills is less of an issue, notes Kelly Dornin-Koss, MPPM, RN, CIP, director, education and compliance office for human subject research at the University of Pittsburgh (PA).
"We're at a large institution and have many different staff members, so we are always encouraging training that will make it easier for people to transition into new positions," Dornin-Koss says. "You always have your certain experts in institutions, but we really encourage education at our site and certification, and the IRB at our institution encourages training."
Finding new staff with potential is only the beginning. IRB leaders, many of whom now are in their 50s and 60s, have to plan for leadership succession when there is no one else in the office who could step into the job.
"I think about this a lot because I'm in my early 60s, and I care about my employer," says David Wynes, PhD, vice president for research administration at Emory University in Atlanta.
"In most of these areas of research administration, including IRBs, you don't go to school to get a degree to be an IRB administrator," he says. "So we look for people who are intelligent, energetic, and, hopefully, come from some background that gives them exposure to the research process."
Grooming IRB leaders takes time, and sometimes it can result in a super employee who decides to move to another organization, he notes.
"Honestly, I've hired a number of people who advanced and moved on to much larger institutions and medical centers, where some of them have become directors of other research programs," Wynes says. "I hate to lose people, but that's also what you want."
Another challenge for the current crop of IRB leaders is that the field has become very complex. Those who have grown with human subjects protection since the 1990s have decades of knowledge that is difficult for even eager and willing new staff to accumulate.
"The danger is that many of us who have been doing this for a long time can get a bit complacent and rely on what we know," Wynes explains. "It might not be written anywhere, and so we'll say, 'Just come and ask me and I'll tell you the answer,' but that's not moving us ahead."
IRB leaders need to create standard operating procedures, checklists, and training materials that make their knowledge and experience more accessible to new and younger staff.
"When you have these processes and engage that next generation in these processes, then they start to understand the various pieces and mechanics at work," Wynes says.
Another solution that can work when there's an urgent and short-term need for someone to take a leadership role is to cross-train various research department directors. For example, a research organization could have a compliance office director fill in for the IRB office director or vice versa, Coley suggests.
"I had knee replacement, and the IRB compliance specialist staff worked with me to help with education and they were able to pick up this work," she says.
There's another issue related to aging leaders that some IRBs are dealing with, and it involves having older IRB chairs, Coley says.
"The more urgent issue has been the graying of our chairs," she says. "Our office has worked to bring in younger chairs to help, as our senior chair cut back on his time, thus allowing us to groom new leadership in the IRB."
IRB offices have evolved in the past 15 years. Early IRB offices often had limited support staff. But as the field of human subjects protection evolved, IRB offices' staffing needs increased, creating IRB office leadership roles and the need for more IRB coordinators and other support staff.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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