Rebuilding a Research Ethics Committee

The ethical review of research protocols is an essential aspect of research administration. It is undertaken in many countries by committees, under the guise of Institutional Review Boards (IRBs) in the USA, Research Ethics Boards (REBs) in Canada, Research Ethics Committees (RECs) in Britain and most of Europe, and Human Research Ethics Committees (HRECs) in Australia. In the interests of maintaining research standards and protecting research participants, government regulations overriding the review process, such as required committees, supporting infrastructure and methods of administration exist in many countries (National Bioethics Advisory Commission (2001), Department of Health UK (2011), Australian Government (2012). There is remarkable growth in the number of oversight committees. Catania et al (2008) reported an increase in U.S. IRBs of 685% (491 to 3853) from 1993 to 2008. At the same time there is unease and dissatisfaction in the research community about restrictions, added burdens and delay coming from IRBs and ethics committees. This is evident through publications such as: Communication difficulties in Research and monitoring by ethics committees, (Karunaratne, Myles, Ago and Komesaroff, 2006); Current research ethics forms are an over-reaction that will stifle research (Oliver, 2006);Research and survival in the IRB iron cage (Bledsoe et al, 2007); Counteracting IRB mission creep (Gunsalus et al, 2007); Grinding to a halt: the effects of the increasing regulatory burden on research and improvement efforts (Infectious Diseases Society of America, 2009); In the lion's den?, (Fistein and Quilligan, 2011); The ethics police?, (Klitzman, 2011). Human research ethics in Australia is regulated by the Australian Health Ethics Committee (AHEC), and is under the direction of the National Health and Medical Research Council (NHMRC), (NHMRC, 2012). There are 228 HRECs registered with AHEC, or a round figure of one committee to 100,000 of the general population, fewer than the U.S. figure of one to 79,000. Australian committees operate under the guidance of the National Statement on Ethical Conduct in Human Research (the National Statement), developed jointly by NHMRC, the Australian Research Council and the Australian Vice-Chancellors' Committee (Australian Government, 2007). The National Statement prescribes the structure and responsibilities of committees and the process of ethical review. The Australian Capital Territory (ACT) Government in Canberra, Australia's capital, requires all medical research involving its citizens to receive ethical approval from the ACT Health HREC. The committee reports ultimately to the ACT Director-General of Health. This paper describes ethics review in the ACT and the rebuilding that occurred in the last three years. We believe rebuilding is an appropriate term as the committee was somewhat like an old house: still standing, still livable, but in desperate need of modernizing. Much work was done at the ground level to secure the foundation of the committee, its processes and standing within the research community, akin to reinforcing the foundations of an old home. The issues raised below include administrative processes that were not reassessed for more than ten years such as its leadership needs and its reputation within the local research community. There were two main prompts for the changes in ethics administration. An organizational shift in reporting structure meant that in 2009 the committee came under the ACT Health Research Office. The Director of Research was determined to have the committee certified by NHMRC for the impending Harmonization of Multicentre Ethical Review (HOMER) process. The same year also saw the appointment of a new chairman and new HREC administrator. Together these three led the drive for the necessary changes in HREC administration/management. The steps taken to determine the issues and initiate change may be familiar to many research administrators, but we believe there are still lessons to be learned. …

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