Dr. Tsan was the deputy chief officer (now retired), Dr. Nguyen is the deputy associate director for education and training, and Dr. Brooks is the associate director for education and training in the VA Office of Research Oversight, Washington, DC.
The HRPP QI data was collected from 2010 through 2012 from all 107 VA research facilities (Table 1). There were a total of 25 QIs; 18 had all 3-year data available and 7 lacked 2010 data. Only those 18 QI data available from all 3 years were included for this analysis. The 2010 data collected for QIs related to for-cause suspension or termination of protocols and research personnel scopes of practice and training requirements were derived from all human, animal, and safety research protocols audited, not just the human research protocols audited. However, these data were included for comparison with the 2011 and 2012 data, because nonhuman research protocols audited constituted < 30% of the total. Based on VAORO on-site routine reviews of facilities’ HRPPs, animal care and use programs, as well as research safety and security programs, the authors believe that the QI rates in these nonhuman research protocols were similar to those of human research protocols.
From a total of 18 QIs with all 3-year data available for analysis, 9 QIs did not show any statistically significant changes; whereas 9 QIs showed statistically significant changes from 2010 to 2012 (Table 1). These 9 QIs were: (1) incorrect ICDs used; (2) number of protocols suspended or terminated due to cause; (3) protocols suspended or terminated due to investigator concerns; (4) informed consent not obtained prior to initiation of the study; (5) research personnel without research scopes of practice; (6) research personnel working outside of scopes of practice; (7) required training not current for research personnel; (8) research personnel working without initial training; and (9) research personnel lapsed in continuing training.
Table 2 shows the percent changes and the actual numbers impacted by the changes in the 9 QIs that showed statistically significant changes. The percent changes describe the magnitude of changes, and the numbers impacted provide information on the actual numbers of events (ie, ICDs, human research protocols, case histories, or research personnel) affected by these changes in 2012 if the QI rates had stayed the same as those of 2010.
All 9 QIs with statistically significant changes showed improvement, ranging from 25% improvement in incorrect ICDs used to 92% improvement in research personnel without scopes of practice (Table 2). The actual numbers impacted (ie, the difference between numbers expected in 2012 based on 2010 QI rates and the actual numbers observed in 2012) ranged from 55 protocols suspended or terminated for cause to 1,177 research scopes of practice.
Of the 9 QIs with no statistically significant changes, all but 2 QIs had QI rates of < 1% in 2010, suggesting that these QI rates were already so low that further improvement was difficult to achieve. The 2 exceptions were lapses in IRB continuing reviews and international research conducted without VA Chief Research and Development Officer (CRADO) approval.
The rates of lapse in IRB continuing reviews remained high at 6% to 7% between 2010 and 2012 (Figure). In contrast, the rates of research personnel lacking scopes of practice and required training not current, which had comparable high rates in 2010, decreased sharply from 2010 to 2012.
Federal policies require that all individuals participating in research at international sites be provided with appropriate protections that are in accord with those given to research subjects within the U.S. as well as protections considered appropriate by local authorities and customary at the international site.1 VA policies require that permissions be obtained from the CRADO prior to initiating any VA-approved international research.4
Likewise, federal policies require additional protections when research involves vulnerable populations, such as children and prisoners.1 VA policies require that permission be obtained from the CRADO prior to initiating any research involving children or prisoners.4
Data on international research were available for all 3 years (Table 1). However, data on research involving children and prisoners were available only in 2011 and 2012. Although the numbers of these research protocols were small, ranging from 0 to 8 protocols, a high percentage of these protocols, ranging from 21% to 100%, did not receive CRADO approval prior to the initiation of the studies.
Discussion
The data presented in this report reveal that there has been considerable improvement in VA HRPPs since VAORO started to collect QI data in 2010. Of the QI data available from 2010 through 2012, 9 showed improvement, none showed deterioration. Of the 9 QIs that showed no statistically significant differences, 7 had very low QI rates in 2010 (most were < 1%). Consequently, further improvement may be difficult to achieve. On the other hand, VAORO identified 2 QIs to be in need of improvement.
