IRBs say there’s too much work, not enough help
There are federal regulations that are supposed to ensure IRBs have appropriate staffing levels, but respondents to the IRB Advisor 2005 Salary Survey could easily make one believe there are very few IRBs that meet that regulation.
Of the 80 comments offered by respondents, 45 deal directly with staffing levels, appropriate types of staff, or having the resources to pay for enough of the right kinds of staff.
In fact answers to the question, "What is your biggest personnel issue?" included:
• "Lack of resources! Can't get my organization to understand that I need more staff."
• "Research volume is upThey want me to decrease staff by 0.5 FTE."
• "Finding professionals for the low rate of pay we can offer."
• "We have over 300 studies and only 1.25 FTEs!"
• "Never enough qualified help because of institutional belief that the job requires clerks.’"
Is it just the luck of the draw that so many comments related to this issue? No, says Katrina A. Bramstedt, PhD., Director of the GCRC Research Subject Advocate Program at the Cleveland Clinic Foundation. "I would say that it is a pervasive issue. In my own experience I have had to change the title of a position just so that I could get someone who was qualified for what I really wanted. You just can’t pay someone with a master's degree $10 an hour."
Show, don't tell
Bramstedt says she was able to get more resources just by showing that the job required someone with more than clinical skills. "I went to the administrator of the department and said that what we have won’t work," she recalls. "I showed them what I needed, and explained that the previous person had only stayed three months — the length of time it takes just to train someone. I outlined what the job really entailed, which was beyond what the duties in the job description said. Once I redefined the job in a more accurate manner, I was able to get more resources. I now have a great person in that position."
She says that people at a higher level don’t always understand what it is people in human research protection do. "They may hear things passively. But show them. Itemize it in a report. Detail all your tasks. Be an eye opener. And be sure you update your job descriptions regularly."
Burning through people is a waste of time and money, she says. It is a powerful argument you can make to the folks who set the budgets for more people.
Not that it will necessarily pay off, says John Isidor, JD, the CEO of Shulman Associates IRB in Cincinnati. "My gut feeling is that most people understand staffing is an issue, but there are other competing priorities for the money," he says.
He likens it to the situation with levees in New Orleans. There were plenty of people who knew and said that they needed to be reinforced, that a disaster was bound to occur. "The way our society works, though, is that no one wants to pay for anything until they are forced to. That includes staffing for IRBs."
The best of them, he says, are places like Duke, Johns Hopkins, and the University of Pennsylvania, where regulators have come in and forced the issue.
Part of the problem with the regulations about appropriate staffing is that they do not define what it is, says Marjorie Speers, Ph.D., executive director of the Association for the Accreditation of Human Research Protection Programs, a calculated move. "I agree with the wording because there is no one way to staff an IRB or human research office," says Speers.
AAHRPP has accredited 27 organizations, representing 87 entities. Another 200 are in the pipeline, she says. She says that staffing issues have turned up at some of those organizations whose applications have been denied.
More importantly, she says that the self assessments or site visits for those who have been accredited often turn up problems with appropriate staffing — either the right kinds or the right numbers of staff — and those organizations are able to use that information to justify increased funding. The accreditation process becomes a means to an end, she says.
One of the issues, says Speers, is that things have changed so greatly in the field over the last two decades. "If you go back 20 years, it was an administrative person who helped the IRB chair manage a couple hundred protocols that an institution was involved in. That staff person was a clerical person." In addition, there was no real awareness of federal regulations, nor was there much guidance about those regulations.
That same institution is now doing maybe 10 times as many studies, and there is awareness of government rules, as well as guidance on those rules, Speers says. "Now, that clerical person is not sufficient for the job. Directors of IRBs need to have a master's degree or even a doctoral degree. The field has professionalized."
Change is hard, she says, and many institutions have been slow to adapt. They also have greater demand on them. They have to fund radiation safety, bioterrorism, and follow animal research regulations. "There are many competing needs," says Speers.
There are some clear clues to whether you have enough staff or not, she says. "If it's taking a couple weeks for a protocol to get on the IRB agenda, you're probably fine. If it is taking a few months, that's not reasonable."
Keep track of your staff’s hours, and their morale level. Most importantly, pay attention to what they are saying and be proactive. "It's not a good idea to wait until you have a serious problem," Speers concludes.
There are federal regulations that are supposed to ensure IRBs have appropriate staffing levels, but respondents to the IRB Advisor 2005 Salary Survey could easily make one believe there are very few IRBs that meet that regulation.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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