Search

The United States federal animal welfare regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that institutional animal care and use committees (IACUCs) conduct continuing reviews of all animal research activities. However, little is known about the lapse rate of IACUC continuing reviews, and how frequently investigators continue research activities during the lapse. It is also not clear what factors may contribute to an institution’s lapse in IACUC continuing reviews. As part of the quality assurance program, the Department of Veterans Affairs (VA) has collected performance metric data for animal care and use programs since 2011. We analyzed IACUC continuing review performance data at 74–75 VA research facilities from 2011 through 2015. The IACUC continuing review lapse rates improved from 5.6% in 2011 to 2.7% in 2015. The rate of investigators continuing research activities during the lapse also decreased from 47.2% in 2012 to 7.4% in 2015. The type of IACUCs used and the size of animal research programs appeared to have no effect in facility’s rates of lapse in IACUC continuing reviews. While approximately 80% of facilities reported no lapse in IACUC continuing reviews, approximately 14% of facilities had lapse rates of >10% each year. Some facilities appeared to be repeat offenders. Four facilities had IACUC lapse rates of >10% in at least 3 out of 5 years, suggesting a system problem in these facilities requiring remedial actions to improve their IACUC continuing review processes. [ABSTRACT FROM AUTHOR]

The article focuses on the importance of conducting continuing review of human research by the institutional review boards (IRBs) to measure the degree of risk in a period less than one year. Topics discussed includes a 1996 Government Accountability Office (GAO) report on the performance of IRB continuing reviews and methods of data collection and data analysis for these reviews.

The article discusses research participant protection programs within the U.S. Department of Veterans Affairs (VA). The protection of human subjects in research has been a priority of institutional review boards (IRBs) and the U.S. federal government. The authors describe the development of quality indicators that aid in assessing human research protection programs including informed consent requirements, the monitoring of adverse events and the accreditation status of the program.

Study objective: To examine the relationship between packed RBC (pRBC) transfusion and the development of ICU-acquired bloodstream infections (BSIs) Design: Secondary analysis of a large, prospective, observational study of transfusion practice in critically ill patients. Setting: A total of 284 adult ICUs in the United States. Patients: Critically ill adults who lacked BSIs both at ICU admission and 48 h after ICU admission. Interventions: None. Measurements and results: BSIs were prospectively tracked in this study, and diagnosis of a new BSI represented the primary end point. Transfusions administered in the ICU prior to development of a BSI were also prospectively recorded. Of 4,892 patients enrolled in this investigation, 3,502 patients lacked BSIs both at ICU admission and 48 h later. Among these individuals, 117 patients (3.3%) had an ICU-acquired BSI. In multivariate analysis adjusting for severity of illness, primary diagnosis, use of mechanical ventilation, placement of central venous catheters, and ICU length of stay, three variables were independently associated with diagnosis of a new BSI: baseline treatment with cephalosporins (odds ratio [OR], 1.84; 95% confidence interval [CI], 1.26 to 2.68), higher sequential organ failure assessment score measured on ICU days 3 to 4 (OR, 1.11; 95% CI, 1.06 to 1.16), and pRBC transfusion (OR, 2.23; 95% CI, 1.43 to 3.52). The relationship between pRBC transfusion and BSI was evident with both small transfusion volumes (OR with 1- to 2-U pRBC transfusion, 1.89; 95% CI, 1.10 to 3.23) and larger transfusion volumes (OR with > 4-U pRBC transfusion, 2.63; 95% CI, 1.52 to 4.53). Conclusions: pRBC transfusion is associated with subsequent ICU-acquired BSI. Avoiding unnecessary transfusions may decrease the incidence of BSIs. [ABSTRACT FROM AUTHOR]

Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 implemented remedial action plans. Using data from 2011 through 2018, we demonstrated that 70% of these facilities' lapse rates remain significantly improved. In contrast, none of the 10 facilities with their lapse rates that were higher than the national averages in 2 out of 3 years from 2011 to 2013 and that did not implement remedial action plans showed any improvement. Thus, implementation of effective remedial measures in facilities with high lapse rates can result in long-lasting improvement in the majority of these facilities.

Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% ( M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.

Introduction: Institutions conducting research involving human subjects establish human research protection programs to ensure the rights and welfare of research participants as well as to meet ethical and regulatory requirements. It is important to determine whether human research protection programs have achieved these objectives., Methods: The Department of Veterans Affairs has developed quality indicators and annually collected human research protection program quality indicator data from its 108 research facilities since 2010., Results: Analysis of Department of Veterans Affairs human research protection program quality indicator data revealed that facilities using affiliated university institutional review boards performed as well as those using their own Department of Veterans Affairs institutional review boards and that facilities with small research programs, that is, less than 50 human research protocols, performed at least as well as those with larger research programs. These quality indicator data also provided Department of Veterans Affairs facilities with valuable information for quality improvement. Many of these quality indicators have improved in subsequent years, and none has deteriorated. Lapse rates in institutional review board continuing reviews remained high and relatively constant at above 6.0% over a 4-year period from 2010 through 2013., Discussion: Future efforts should be directed at developing a set of human research protection program quality indicators truly reflecting the quality of human research protection programs that are applicable to both Department of Veterans Affairs and non-Department of Veterans Affairs institutions and determining whether high-quality human research protection programs as measured using these quality indicators translate into better human subject protections., (© The Author(s) 2015.)

We compared the Human Research Protection Program (HRPP) quality indicator data of the Department of Veterans Affairs (VA) facilities using their own VA institutional review boards (IRBs) with those using affiliated university IRBs. From a total of 25 performance metrics, 13 did not demonstrate statistically significant differences, while 12 reached statistically significance differences. Among the 12 with statistically significant differences, facilities using their own VA IRBs performed better on four of the metrics, while facilities using affiliate IRBs performed better on eight. However, the absolute difference was small (0.2-2.7%) in all instances, suggesting that they were of no practical significance. We conclude that it is acceptable for facilities to use their own VA IRBs or affiliated university IRBs as their IRBs of record.