A survey of 196 research organizations by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) found that 87.6 percent reported an increase in the workload of their human research protection program (HRPP) staff in the past year, while 5.4 percent reported a decrease and 7 percent said there was no change. In addition, 76.4 percent reported an increase in the HRPP resources required, while 19.7 percent reported no change and 3.9 percent reported a decrease.

The results are part of a 2009 HRPP performance study conducted by AAHRPP of its clients. "The availability of objective data should drive bench-marking efforts to improve quality both within an organization and across the research enterprise," said Marjorie Speers, AAHRPP president and CEO.

Nearly all of the organizations followed the FDA regulations (99 percent), with 86 percent following HHS regulations. Other U.S. regulations followed by the organizations were: Department of Veterans Affairs, 43 percent; Department of Defense, 29 percent; Department of Education, 16 percent; Department of Justice, 15 percent; and Department of Energy, 13 percent. In addition, 45 percent follow the International Conference on Harmonisation Good Clinical Practice guidelines and 15 percent followed other countries’ regulations.

Of the organizations that have federalwide assurances nearly half (49 percent) do not apply the HHS regulations to all of their research; 51 percent apply Subpart A (the Common Rule) and 42 percent apply the HHS regulations regarding prisoners, children, pregnant women, human fetuses and neonates.

The organizations that conduct research or oversee a single set of investigators for each protocol reported an average of 30.5 deviations per 100 protocols and an average of 6.2 complaints per 1,000 protocols. The data did not include independent institutional review boards that oversee multiple investigative sites for each protocol. In addition, 15 percent of the organizations reported that they did not track protocol deviations.

The organizations reported an average of 56 allegations of non-compliance and 14.1 determinations of serious non-compliance and 4.1 determinations of continuing non-compliance per 1,000 protocols.

More on the AAHRPP Metrics on HRPP Performance — 2009 will be in the August issue of the Guide to Good Clinical Practice.