Rebuilding a research ethics committee.

Author:Biggs, John S.G.

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.

Low or Minimal Risk Research

One of the first observations of the new administration was the length of HREC (henceforth, The Committee) agendas, and a decision was taken to pass all appropriate items to a newly established low-risk subcommittee. The Australian National Statement endorses expedited review processes for low-risk research including the role of specialized subcommittees. The National Statement defines research as low-risk where ... the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. (Australian Government, 2007). In the U.S., expedited ethical review is available for research of no more than minimal risk (U.S. Department of Health and Human Services, 2009). The review may be undertaken by the IRB chairperson or nominee. The term minimal risk is defined as where ... the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (U.S. Department of Health and Human Services, 2009).

A review of ethical and policy issues in human research by the U.S. National Bioethics Advisory Commission (2001) recommended (Recommendation 2.5) that research ethics review should be ... commensurate with the nature and level of risk involved. The principle was taken further in a paper entitled Pruning the regulatory tree (Kim, Ubel and De Vries, 2009), where it was proposed that minimal risk research be no longer subject to IRB review. Instead, the protocol would require a brief application containing research procedures, risks and burdens to participants. Review of the protocol would be done by a person designated by the researcher's institution, a system almost identical with the minimal risk procedure, though not connecting with an IRB. The plan was rejected in a subsequent paper Pruning or poisoning the regulatory tree?, in which the value of IRB consideration of minimal risk research was substantiated (Ananth and Scheessele, 2012).

The inconsistent response to minimal or low-risk submissions by different committees continues to worry researchers. Dyrbye et al, (2007) tell of sending an educational research project that involved medical students to six IRBs at different institutions. One institution approved the project at once; two different institutions said it wasn't minimal-risk; those not initially approving the project requested an average of 13 pieces of additional information or changes, most of which related to participant information and consent forms. Eventual approval took between 6 and 164 days. The conclusion was drawn that IRBs are not familiar with education protocols. However, the range of responses from the boards could also suggest problems in their management or even capacity.

A low-risk subcommittee was a successful addition to the resources of the ACT ethics...

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