New AAHRPP metrics show less IRB funding

The most recent statistics gathered from the Association for the Accreditation of Human Research Protection Programs' (AAHRPP) client institutions don't look all that different from the baseline metrics released last year.

But in one key area, the numbers changed quite a bit — IRB operating budgets tumbled, as organizations coped with the loss of federal stimulus money, says Marjorie Speers, PhD, president and chief executive officer of the Washington, D.C.-based organization.

"Many of our accredited organizations are universities," Speers says. "Universities had benefited from the stimulus funds and those stimulus funds started to run out. So universities are doing as much or more with less dollars."

The numbers for 2010 were released this summer, based on responses to surveys of AAHRPP's clients. Compared with the 2009 numbers released last summer, nearly every size of human research protection program reported declines in operating budgets. The sharpest drop was reported by institutions handling 101-500 protocols a year — down nearly 65 percent, from $921,903 in 2009, to $325,404 in 2010.

In only one category, relatively large organizations handling 2001-4,000 protocols per year, did the annual budget increase, from nearly $1.3 million in 2009 to $1.6 million last year.

At the same time, AAHRPP organizations reported increases in the number of protocols they handle. The median number of total active protocols in 2010 was 525, up from 306.5 in 2009. Those increases were seen in every category of protocol — exempt, expedited and full convened board.

Workloads up

With only two years of data, it's hard to discern trends at this point, Speers says. In many areas where there were minor changes from 2009 to 2010 it's unclear whether the cause is changes in the organizations themselves or the inclusion of data from newly accredited institutions.

But Speers does see the increase in IRB workloads as a real phenomenon.

"Organizations are growing their research programs and as they grow their research programs, they have to make sure they've got the infrastructure to review and oversee those studies," she says.

One result of this, she says, is the change in the number of IRBs reported by organizations. Fewer reported having only one IRB in 2010, while more reported having two.

Organizations are closely following review times as an indicator of IRB efficiency. The 2010 AAHRPP numbers show slight declines in review times across all categories of research:

— For studies reviewed by a convened IRB, the mean time from submission to approval was 45.7 days, down from 48.8 in 2009.

— For expedited studies, the mean time from submission to approval was 27.9 days, down from 29.8 days the year before.

—For exempt studies, the mean time from submission to exempt determination was 16.9 days in 2010, down from 18.1 in 2009.

"As we said, we only have two years of data, and we don't know exactly whether we have a pattern or a trend," Speers says. "But review times are on everybody's radar screen. Many institutions are using IRB review times, particularly the metric we've put out, as a benchmark. It's very possible because of the sensitivity around IRB review times (that this decline reflects a trend)."

Benchmarking plans

Speers says that to get a real picture of changing trends in human research protection, it probably will take about five years of metrics data. In the meantime, she says, AAHRPP will work with its client institutions to compare their own organization's data with the AAHRPP group as a whole.

"The service we want to provide for our organizations is to provide this information and then do a screenshot of their own information, so they would have the benchmarks," she says. "It's a project that we hope to get started on this year and then put that on the Web."