Staffing, collaborations top IRB issues
Workloads up, staffing unchanged in 2013
The last 12 months have gotten busier for IRBs. The results of IRB Advisor's 2013 salary survey indicate that workloads have increased, while IRB staffing levels have stayed mostly the same.
Fifty-six percent of respondents report an increase in workload, and 74% said personnel levels have not changed. Seventeen percent indicated a decrease in personnel. When asked to name their biggest personnel issues, respondents stated federal furloughs, increased demands for efficiency and quality with few added resources, too much work for the small amount of staff, and lack of appropriate resources and formal training.
"Just because there is an increase in the number of studies reviewed doesn't mean there will be an increase in staffing," says Kimberly Irvine, CIP, CIM, executive vice president and chief operating officer of Biomedical Research Alliance of New York (BRANY) in Lake Success. "In the coming year, I expect that there may be decreases. There may be a lot more competition for grants that are available. [At BRANY], we did see a decrease in industry-sponsored studies."
How has your workload changed in the last year?
How has your salary changed?
Nearly 60% of respondents said that they supervise staffs of 0-3 people. Lower budgets and funding issues can put a strain on research programs as staff juggle more work, fewer employees, and following institutional and federal regulations. "Retaining staff is increasingly becoming a challenge for IRBs because many can't afford to do it," says Nichelle Cobb, PhD, IRB director at the University of Wisconsin—Madison. "The more experienced people you have in your office, the better off you are. They know the regulations and can do really well with advising and complying with the regulations. When you get high turnover, it can be very challenging."
Electronic submission systems may mean that fewer people are needed to handle submissions. "You realize some economies of scale in terms of managing submissions — you might need fewer people reviewing, but still need people to handle customer service and maintenance of the electronic system," adds Raffaela Hart, BS, CIP, CIM, vice president of IRB and IBC Services at BRANY. "It may be a wash, depending on how many submissions you get; two people could handle them, but you may need one person to handle the system and anything else that didn't exist before."
There was also a greater shift in 2013 toward research institutions using a central IRB for approval, whether an external IRB or part of a larger IRB collaboration. This can help make multisite research approval more efficient and take some of the burden off of IRBs — but it doesn't necessarily mean a reduction in workload. "There have been some papers on whether institutions should allow external IRBs. Some of the takeaway messages were that even though they are using an external IRB for the review, there are still other things that the institution has to do relative to the research that doesn't necessarily free up a person," Hart says. "People may think it'll alleviate the workload, but it will only alleviate some of that."
Has your department lost or gained staff?
What is your annual gross income?
2013 saw a rise in the number of IRB collaborations and consortia. These collaborations were formed to streamline multisite review by relying on one central IRB. Experts say 2014 will bring an even greater number of collaborations.
"I think that [the use of central IRBs] is one of the few things that people can predictably expect," says Mark Schreiner, MD, chairman of the committee for the protection of human subjects at Children's Hospital of Philadelphia, and a member of the IRB Advisor editorial board. "I think that a lot of the NIH [National Institutes of Health] grants are forcing people to agree to use a central IRB. That's pretty clear."
Federal agencies have been pushing for greater use of central IRBs, Schreiner says, as multisite review is expensive, less efficient, and can simply take too long. "There's a lot of concern that it [multisite review] just takes too long, and having multiple reviews doesn't add any value," he adds.
"Some of the literature suggests that IRBs at different sites are asking for different information, and can affect the scientific validity of protocols," Cobb adds. "There's a lot of support for institutions to work together, especially among institutions that received Clinical and Translational Awards."
Some organizations have been reluctant to defer to a central IRB, Cobb says. They may not want to give up institutional control, or have concerns about who will ultimately be responsible if something goes wrong. "There is also reluctance in cases where institutions don't have a relationship," she says. "You want to really be sure of who you're deferring to."
"Another issue is, what are the qualifications to serve as a central IRB?" Schreiner adds. "There are no established criteria to assess whether or not a local IRB is capable of serving as the IRB of record for other IRBs."
Currently, there are no regulatory guidelines for setting up central IRB review. IRBs may be feeling increased pressure as they try to figure out what it means to have that system, and set up the processes for review. Some institutions and funding agencies may not realize how complicated the process can be, Cobb says. "There's a naivete about what is required and that having an IRB authorization agreement is all you need. However, you might have to hire and train someone to handle a central IRB process, or need a new electronic system to track information, or develop new processes for IRB review, and ancillary reviews. There are no rules, so IRBs are inventing as they go along."
How long have you worked in your present field?
IRBs must have more flexibility when deferring to a central IRB, and be willing to accept a decision as long as the proper procedures are followed. "If they do a substantive review and come to different conclusions than we would, that's all right," Schreiner says. "That's part of what you have to agree to if you're going with a central IRB — be willing to say, 'Even if you come to a different conclusion, as long as you went through the right process, we accept you.'"
UW-Madison is one institution in the Wisconsin IRB Consortium, a central IRB model consisting of the major research institutions across the state. The model is currently being expanded for use in six more institutions across the Midwest, called the Midwest Area Consortium for Health. "It will work in a more regional than statewide basis," Cobb says. As for WIC, "we're still meeting and tweaking what we're doing," she says. "We reach out to get these relationships going and to sustain them and gently get people to respond to that."
Other survey results
The salary survey also found:
- Most respondents have graduate degrees.
- Nearly half work up to 45 hours per week, and 17% indicated work weeks up to 50 hours.
- Eighty-seven percent of respondents were women.
- Most have worked 4-6 years in the field.
- Thirty-nine percent indicated a 1%-3% increase in salary, and 17% said there was no change.