7230 module 3.1

7230 module 3.1 - Research ethics committees and the...

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Unformatted text preview: Research ethics committees and the changing research environment Davina Ghersi National Health and Medical Research Centre, Clinical Trials Centre, University of Sydney, NSW, Australia. Email: [email protected] There has been a striking increase in the amount of clinical research done in the past 10 years. In the USA alone, CenterWatch (a US organisation that lists clinical trials) estimated that 80 000 clinical trials were under way in 2001. 1 Clinical trials are also becoming larger and more complex, with an increasing number of trials enrolling thousands of patients across multiple centres in multiple countries. To comply with the requirements of the Declaration of Helsinki, all experimental procedures that involve humans must be assessed and approved by an appropriately constituted research ethics committee (REC). 2 As the amount and complexity of clinical research continues to increase, a concomitant increase in the workload of RECs is inevitable. A review of US institutional review boards (IRBs) by the US Department of Health and Human Services reported that the amount of work done by most IRBs had increased by 42% since 1974–75, when the average number of proposals reviewed by an IRB was 43 per year. 3 By 1998, some IRBs had as many as 2000 proposals per year to review. RECs are also expected to monitor studies they have approved, to review amendments to research protocols and any adverse events that occur in a study. The burden on RECs is further complicated by external pressure to make decisions quickly, and by regulatory, legal, and indemnity issues that are taking up increased amounts of time on REC agenda. 4,5 A European Commission Directive clearly states that the tasks of an REC extend beyond ethical issues to include consideration of the relevance of the trial and its design, responsibility for insurance and indemnity provision, and the specific timeframe in which ethical review must be completed. 6 RECs are also expected to include lay people among their members, but such individuals are required to have sufficient scientific knowledge to meet their ethical obligations. In many cases, RECs recognise that they do not have the necessary expertise to fully assess scientific and safety issues because they are generally a group made up of “conscientious, sincere, and disinterested” amateurs who are “reviewing too much, too quickly, with too little expertise”. 3,7,8 From the perspective of clinical researchers, the time and effort it takes for multicentre clinical research to be submitted to, and processed by, RECs can be prohibitive. It is common practice for the research protocol to be approved by REC at every institution that participates in a study. Thus, if the study is being done in 20 hospitals, there are usually 20 associated THE LANCET Oncology Vol 5 May 2004 http://oncology.thelancet.com 325 The future of institutional review boards RECs, often with 20 different application forms, all with different requirements. If the study involves more than onedifferent requirements....
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7230 module 3.1 - Research ethics committees and the...

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