Self-audit as part of a research governance framework for health research

Clinical research has been an area of increasing activity for hospitals, universities and research institutions in Australia, rising from 1960 trials in 2000 to 3208 trials in 2009 (Therapeutic Goods Administration, personal communication). To manage the increasing risks for both patients and institutions, strategies to better monitor research governance are now receiving greater attention.

The National Health and Medical Research Council (NHMRC) National statement on ethical conduct in human research1 requires that individual institutions take responsibility for monitoring clinical research conducted at their institutions. One of the most common methods used to monitor research activities is the annual progress report required by human research ethics committees (HRECs). The report includes information about compliance with the approved protocol, as well as maintenance and security of records. Some institutions also undertake random inspections of research sites, data or consent documentation.

To promote attention to ethical conduct and compliance with principles of good research practice,2 the Department of Epidemiology and Preventive Medicine (DEPM) at Monash University and the Alfred Research and Ethics Unit (Alfred) in Melbourne introduced research audits in 2004. The DEPM and the Alfred collaborated to introduce a variety of monitoring strategies, including annual progress reports and detailed audits.3 Other components of the DEPM program included appointing a research governance officer, establishing a research governance committee, developing a manual of clinical and public health good research practice, and introducing an induction program for new staff.

However, although the detailed audits were effective, they proved time consuming and resource intensive (a detailed audit takes about 3 days to complete, and each year it is possible to examine only about 10% of the total number of active projects).

To improve the institutional oversight of research, the DEPM and the Alfred subsequently adopted a tiered approach to audits. Detailed audits were supplemented with short audits that can be completed in less than a day and a self-audit (Box 1), which is completed by researchers themselves, rather than by governance or ethics staff. The self-audit highlights to researchers the issues they need to keep in the forefront of their minds while conducting research and helps them identify any areas where they may not be meeting the expected standards.

The strategy is based on the premise that researchers are keen to conduct their research to the highest standard, provided they know what is required of them. Other health services have since adopted self-audits, and the Victorian Managed Insurance Authority has incorporated them into its Research governance toolkit, which it developed to assist all Victorian public entities conducting clinical research.3

To evaluate whether the self-audit has been an effective tool for highlighting and promoting good research practice, the DEPM and the Alfred designed a short, online questionnaire. The questionnaire was sent out on 3 July 2008, with responses received over the following 8 weeks. Our article reports the findings.

At the time of the evaluation, there were 165 projects being conducted at the DEPM, overseen by 56 principal investigators. Twenty-seven principal investigators or their delegates (48%) completed the self-audit and, of those, 24 completed the evaluation (43% of principal investigators; 89% of those who completed the audit).

At the Alfred, invitations were distributed to about 340 researchers with active projects. Thirty-three researchers completed the evaluation but many of these were responsible for multiple projects.

Results of the evaluation are shown in Box 2. Across both sites, most respondents (92% at the DEPM and 97% at the Alfred) believed that the self-audit promoted good research practice.

One of the aims of the self-audit is to encourage people to think about new ethical issues. However, fewer than half of the participants (25% at the DEPM and 40% at the Alfred) identified new ethical issues as a result of using the self-audit. Our results may have been influenced by selection bias among respondents. Those who were already interested in good research practice were more likely to have completed the questionnaire, making it more likely that the evaluation records an interest in the area but less likely that it raises new issues.

Auditing research is one means by which irregularities can be prevented or discovered before damage is caused.4 This role is recognised by the NHMRC national statement and equivalent international documents (Box 3).

Ongoing HREC oversight of projects has increased in the past decade, with many institutional HRECs now requiring annual progress reports. However, there remains an important and separate institutional role in ensuring that the research conducted conforms to high standards of good research practice.7 The self-audit, completed by principal investigators and project coordinators, provides feedback to researchers concerning the adequacy of their research procedures. It is part of a series of research governance initiatives designed to make an explicit statement to researchers about the standards expected in the institution and to fulfil a preventive role in alerting all those involved in clinical research to the dangers of poor research practice.

It is envisaged that the most important role of the self-audit will be in helping to create a culture that is conducive to the responsible conduct of research. A 2008 study reported alarmingly low familiarity of researchers with the major research governance documents,4 including the NHMRC national statement and the Australian code for the responsible conduct of research.8 The authors suggested that a mandatory training program in research governance along with research auditing would improve researcher knowledge. Indeed, the Australian code requires institutions to train researchers in responsible research conduct.

Although the self-audit cannot address the breadth and depth of issues possible in a formal training course, it can provide a simple checklist encompassing the most important governance principles for researchers to follow. In so doing, it can help to educate researchers about their research responsibilities while at the same time performing an auditing role.

To date, the key difficulty in implementing the self-audit has been encouraging researchers to complete the audit without intervention or follow-up from governance staff. This has been achieved at the Alfred by including the self-audit form with the documents that the ethics committee requires annually to ensure ongoing project approval. The DEPM plans to introduce a similar compulsory system.

Although the self-audit is not intended to replace more comprehensive audits, it appears to be a promising means of reminding researchers of their obligations and encouraging self-monitoring of research activities without requiring the prohibitive resources needed by more extensive audits.