Using Quality Indicators to Assess and Improve Human Research Protection Programs at the VA
An analysis reveals considerable improvements in human research protection programs at the VA, though more effort is needed to improve institutional review board procedures and practices.
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.
Protection of human subjects participating in research is critically important during this era of rapid medical progress and the increasing emphasis on translating discoveries from basic science research into clinical practices. The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, was established based on the Belmont Report’s ethical principles of respect for persons, beneficence, and justice.1,2 Under the Common Rule, institutional review boards (IRBs) are responsible for reviewing and approving human research protocols and providing oversight to ensure protection of human research subjects.1
In addition to IRBs, investigators, institutions, research volunteers, sponsors of research, and the federal government share responsibilities for protecting research subjects.3 Institutions conducting research involving human subjects have thus established operational frameworks, referred to as human research protection programs (HRPPs), to ensure the rights and welfare of research participants and to meet the ethical and regulatory requirements.3,4
In the late 1990s and early 2000s, a number of major academic institutions’ federally supported research programs were suspended due to persistent noncompliance with federal regulations, including some issues that resulted in the death of healthy volunteers.5,6 In response to increased public scrutiny of clinical research, considerable efforts have been made to improve the protection of research subjects.5,7-9 These efforts included stronger federal oversight of research, voluntary accreditation of institutional HRPPs, increased institutional support for HRPPs, improved training for investigators and IRB members, improved monitoring and reporting of adverse events (AEs), and greater involvement of research participants and the public.9
Despite considerable investment to improve research subject protections, scant data exist showing that these efforts have made human research safer than before. Although research subject protection cannot be directly measured, quality assessment of HRPPs is possible. High-quality HRPPs are expected to minimize risk to research participants to the extent possible while maintaining the integrity of the research.10
The VA health care system is the largest integrated health care system in the country. Currently, there are 107 VA facilities conducting research involving human subjects. In addition to federal regulations governing research with human subjects, VA researchers must also comply with requirements established by the VA. For example, in the VA the IRB is a subcommittee of the research and development committee (R&DC). Research involving human subjects may not be initiated until approved by both the IRB and the R&DC.4,11 All VA investigators are required to have approved research scopes of practice and training in ethical principles and current good clinical practices.4
Recently, the VA Office of Research Oversight (VAORO) developed a set of indicators for assessing the quality of VA HRPPs.10 Since 2010, VAORO has been collecting quality indicator (QI) data from all VA research facilities for quality improvement purposes.12-14 In this study, VAORO analyzed these data to assess changes in VA HRPP QI data from 2010 to 2012 and identify areas for improvement.
Methods
As part of the VA HRPP quality assurance program, each VA research facility was required to conduct annual audits of all informed consent documents (ICDs) and regulatory audits of all human research protocols once every 3 years by qualified research compliance officers (RCOs).15 Protocol regulatory audits were limited to a 3-year look back of the protocols. Tools were developed for the annual ICD and triennial protocol regulatory audits (available at http://www.va.gov/ORO/Research_Compliance_Education.asp). Facility RCOs were then trained to use these tools to conduct audits.
Data Collection
Data were collected annually from all 107 VA research facilities. Information collected included compliance with ICD and Health Insurance Portability and Accountability Act authorization requirements; compliance with requirements for IRB and R&DC initial approval of human research protocols; compliance with selected informed consent requirements; for-cause suspension or termination of human research protocols; research-related serious AEs; compliance with continuing review requirements; subject enrollment according to inclusion and exclusion criteria; research personnel scopes of practice; investigator human research protection training; international research; and research involving vulnerable subjects. No individually identifiable personal information was collected. As this was a VA quality assurance project and no individually identifiable information was collected, no IRB review and approval of the project was required.16
All data collected were entered into a database for analysis. When necessary, facilities were contacted to verify the accuracy and uniformity of data reported.
Data Analysis
The Mantel-Haenszel chi-square test for trend was used to determine the trend of changes from 2010 through 2012.17 A P value of < .05 was considered to be statistically significant. For those QIs with statistically significant changes, VAORO calculated the percent changes and the actual numbers impacted, ie, the actual numbers of ICDs, human research protocols, case histories, or research personnel affected by these changes.18
