IRB costs are greater than previous estimates

New figures include indirect costs

The cost of operating institutional review boards is higher than previous estimates had indicated, according to a survey published recently in the New England Journal of Medicine.

The survey of 63 U.S. academic medical centers found annual operating costs ranging from $171,014 to $4,705,333, with a median operating cost of $741,920.

It’s a finding with implications for IRBs, as they seek to make their institutional officers aware of the real price tag that comes with protecting human subjects in research.

"I think that the activity has significant costs — that’s not a surprise," says Jeremy Sugarman, MD, MPH, MA, professor of bioethics and medicine at the Phoebe R. Berman Bioethics Institute at Johns Hopkins University in Baltimore. "But the costs are real, and as additional mechanisms are put into place to protect the rights and interests of participants, we need to understand that there are costs associated with the activities of IRBs."

Getting at the true costs

Sugarman, the lead author for the article1 that ran in the April 28 issue of the publication, says that to arrive at the true costs of IRBs, his group made an effort to calculate costs that often don’t get attributed to IRB activities.

For example, 43% of the institutions surveyed don’t provide monetary compensation to faculty members and others who serve as IRB members. But Sugarman says the time faculty spends doing the work should be seen as an opportunity cost: It prevents them from doing other work. So his group calculated the amount of time spent reviewing protocols, the amount of training needed to perform the task and arrived at a calculation of the cost of that activity. Using that method, they found that board salaries ranged from $23,303 to $2,476,471, with a median of $219,349.

"Just because it is not a direct cost doesn’t mean it’s not a true cost," Sugarman says. "We have to account for those costs, and so that’s what we did. We asked people, who is doing the job? What is their degree and experience? We found out what the average cost of paying someone like that would be and then figured out how much time they spent on those activities and then did the math."

Other costs, such as office space or information technology, which may not have been covered in budgets as direct costs, were calculated in a similar way, he says. Some of the results:

  • staff salary — $85,246 to $3,103,397, with a median of $463,107;
  • space — $504 to $226,800, median $37,800;
  • outside services — $0 to $275,469, median $13,347;
  • equipment — $0 to $19,500, median $4,817.

The researchers also calculated how IRB staff time was apportioned: 29% on general administration, 27% to review protocols, 12% to monitor compliance, 11% on training, 9% on adverse-event reporting, and 7% on compliance with HIPAA.

Sugarman says the HIPAA result was likely as high as it was because institutions were surveyed in 2002, as they were preparing for the new privacy rule to take effect in April 2003.

"That was the HIPAA panic — no one knew what to do with it," he says. "If you looked around medical centers, the amount of attention people were placing on that new privacy rule was enormous."

Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), agrees that IRBs probably spend less time these days complying with HIPAA than they did at the time of this survey.

"I think institutions are still spending a fair amount of time on it," she says. "I don’t know how much now, but they wouldn’t have as much of the start-up costs that they were experiencing in 2002."

The researchers used their cost information to calculate the costs per protocol, based on three different categories of institution: low volume (fewer than 350 new protocols a year), intermediate volume (350-699 protocols) and high volume (more than 700 protocols).

Expedited reviews costlier?

They also broke down the costs according to type of review: full, expedited, or continuing. That breakdown led to a notable finding: For low-volume institutions, and for all the institutions as a group, the average cost per protocol was higher for expedited reviews than for full reviews.

At first glance, Sugarman says, that result may seem counterintuitive, but it makes sense when you examine how the expedited reviews are conducted.

"Federal rules require that that’s done by a chair or one of his or her designates, and that’s likely more expensive," says. "If the work isn’t done by less expensive people, it’s probably done by more expensive people."

Speers notes that expedited reviews also require all the pre-review activities that an IRB does with any protocol.

Even though previous studies have indicated that expedited reviews can also take longer to complete than full reviews, she says that doesn’t necessarily indicate a problem with expedited reviews.

Improve efficiency, save money?

"I think IRBs have spent a lot of time in the last few years trying to put all the policies and procedures in place to have a program that’s compliant with the regulations," Speers says. "I think that what IRBs need to do now is look at whether what they’re doing is the most efficient way to do it.

"In the past, there’s been major concentration on compliance and not necessarily on streamlining and efficiency. I think once they have a system in place that meets federal regulations, then they can begin to address questions around efficiency," she says.

The survey’s breakdowns of IRB staff — ranging from an average of six staff members at low-volume institutions to 14 at high-volume centers — can begin to give IRBs a better idea of how their own institutions stack up, Speers says.

But she says more surveys like this one are needed to help refine that process.

"Everybody in the field would like to have some benchmarks, to have a good idea how many staff you need per X number of protocols, but that’s very difficult to get," Speers says. "It’s very dependent on the type of system you use, the qualifications or the competency of the IRB, the number of IRBs, a lot of factors that influence those figures.

"I do think that if I were an institution trying to gauge where I am, I would look to these numbers to see if they feel right, if I feel like I’m in the range of similar institutions."

Sugarman says his group will continue to analyze the data from this survey. In the future research, he hopes to concentrate more on the relationship between the cost of IRB activities and the quality of the resulting reviews. But he concedes that will be a tough nut to crack.

"It’s an enormous challenge to evaluate quality of review," he says. "There aren’t really good metrics yet for quality of review."

Reference

  1. Sugarman J, Getz K, Speckman JL, et al. Consortium to evaluate clinical research ethics: The cost of institutional review boards in academic medical centers. N Engl J Med 2005; 352(17):1,825-1,827.