IRB offices need to plan for when boss leaves

Key is having back-up personnel

All IRBs and IRB offices need to set up succession plans to ensure continuity in the event the IRB director or chair leave abruptly.

The goal is to keep the IRB program running during the short term in event of a chief person's retirement, illness, or other type of departure.

This is especially important for institutions at which one person handles the IRB office solely or with only a little administrative help, says Kathy Ertell, MS, CIH, program manager for the human research protection program at Pacific Northwest National Laboratory in Richland, WA.

"We are a small site with about 100 active protocols in our system, and we have a staff of one program manager, one part-time clerical assistant, and our IRB," Ertell explains.

The IRB office has a succession plan in place that includes procedures for how various tasks will be performed when Ertell is unavailable. The plan includes having a succession team, consisting of Ertell, the IRB chair, vice chair, and chair-in-training, stay in communication about projects so that one or more of the four could handle daily IRB activities when one person is unavailable.

"We've had several opportunities to exercise this program," Ertell says.

For instance, when Ertell was on six weeks medical leave in recent years, the office might have come to a standstill without implementation of its succession plan.

"Things went pretty well with the secretary screening all my emails and referring emails to the right person, and the administrative team kept things running while I was gone," Ertell says.

The IRB succession team filled in, handling paperwork, using email templates, and determining which new projects met the criteria for human subjects research, which usually are Ertell's tasks.

"They took the day-to-day phone calls asking whether something is human research and how to complete an IRB application," Ertell says. "We have a phone system that records phone voice mail on the computer, so the IRB assistant could listen to the messages and forward them to the right people."

Ertell offers these tips on how IRBs can plan for IRB administrator or chair succession:

• Plan for various types of succession.

There are various types of succession, including medical leave, death, job changes, and retirement. The IRB office should have succession plans for both long-term and short-term staffing issues, Ertell says.

Also, there should be a plan for what will happen if the IRB chair suddenly is not available.

"Transitions are very difficult for smaller organizations," she notes. "Larger organizations have lots of knowledgeable people in the work group, but smaller organizations in small metro areas have to think quite a ways ahead of they're going to replace a staff member."

With IRB chair succession, the key is to always have someone qualified who is waiting in the wings.

For example, the IRB chair's role could be taught to IRB vice-chairs, or IRBs could go with a co-chair model. Another option is to have a chair-in-training who could fill in at a moment's notice.

In large urban areas, an IRB office might be able to find qualified leaders who are available for transitional coverage, but this may not be an option for IRBs in more rural or smaller metro areas.

One way to prepare for IRB leadership transitions is to cross-train staff, Ertell suggests.

• Create an IRB office desk manual.

The desk manual provides detailed task information. The Pacific Northwest National Laboratory IRB office's desk manual is about 100 pages with an index and examples of documents used in research. It's kept right at the office assistant's fingertips, Ertell says.

"The desk manual tells someone that this is the day to send out continuing review notices to principal investigators," Ertell offers as an example.

"It lists the scheduled board meetings, who the members are and how to contact them, and which projects are due for full review and on which dates," she explains. "It sets up the mechanics for the meetings, listing what paperwork is distributed to members, how to distribute it — electronically or by mail, and which forms are needed and where they're located."

Other details the desk manual provides are as follows:

— What type of letterhead is used for approval letters?

— Where are the examples of continuing review letters?

— Which checklist is used to review projects?

— What should be done if someone calls to ask if their project qualifies as human subjects research?

— Who should speak with investigators?

The idea is for the desk manual to provide information about which IRB office tasks, including those that are critical and time-sensitive, and instructions on how to do these.

The desk manual might also include a list of valuable contacts in the areas of finance, legal, medical, research, and human resources, Ertell says.

• Look for qualified personnel in the region.

When it's time to replace someone, it helps to know the availability of qualified staff in a particular region.

For instance, IRBs in large urban areas might be able to find qualified IRB directors more easily than IRBs in a rural region, Ertell notes.

There might be people who have retired from IRB work or research work that would be willing to work on an interim basis. Someone who has experience might be moving to the area because of a spouse's work. So it is worthwhile searching for potential job candidates locally. But in some areas, IRBs need to expand their search.

"We are in the Eastern part of Washington state and have to think more creatively about hiring people," she says.

Finding someone with experience directing an IRB office or even working for an IRB office might not be an option. Instead, IRB directors could look for people who have the qualities and some of the research experience that is desired.

"We think about what kind of people would be good at this work," she adds. "I think ideally we'd want someone with some research background so they'd understand what the researchers are doing."

It also helps if the potential new hire has good interpersonal skills and has a background in interpreting organizational culture.

Another option is to ask sister organizations for help in filling a position. For instance, Pacific Northwest National Laboratory is part of the U.S. Department of Energy (DOE) national laboratory system. This means there are qualified IRB professionals across the country that might be retiring and willing to work at the Richland office while a permanent IRB director is recruited, Ertell says.

"Your human resources department could be in a position to assist you in finding someone on a temporary basis if need be," Ertell suggests. "They know the internal workings of the organization and how you staff, and they know how to find temporary staff."

At the very least, human resource departments can serve as a planning resource for getting the job descriptions accurate and assisting with continuity planning, Ertell says.

"Anytime you bring in a new staff member they're certainly going to be involved," she adds. "It behooves any manager to know what the procedures are ahead of time and what will happen so you can be ready to act quickly."