Newcombe J P, Kerridge I H
Centre for Values Ethics and the Law in Medicine, University of Sydney, Sydney, New South Wales, Australia.
Intern Med J. 2007 Jan;37(1):12-7. doi: 10.1111/j.1445-5994.2006.01234.x.
Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.
We conducted a survey of HREC chairpersons in New South Wales.
HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies.
These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.
制药行业对临床研究的资助所引发的利益冲突有可能使研究结果产生偏差，并最终损害患者护理。目前尚不清楚澳大利亚人类研究伦理委员会（HREC）如何评估和管理此类利益冲突。我们旨在了解HREC如何处理制药行业资助临床研究引发的潜在利益冲突问题。
我们对新南威尔士州的HREC主席进行了一项调查。
HREC在处理利益冲突的方式上差异很大，包括在使用国家卫生与医学研究委员会的指南方面，这些指南常常被误解或忽视。许多委员会主要依赖研究人员披露潜在的利益冲突，而大多数HREC将向研究参与者披露作为预防和管理利益冲突的主要工具。几乎没有HREC对研究人员与制药公司的关系加以限制。
这些发现表明，HREC不愿对研究人员与制药赞助商之间的许多潜在利益冲突进行监管，这可能源于对研究中利益冲突的含义或重要性存在不确定性，源于HREC在评估和管理研究中的利益冲突方面的作用不明确，或者源于对当前国家卫生与医学研究委员会指南的误解或忽视。对这一重要领域的政策和实践进行进一步审查，可能有助于保障临床研究和患者护理，同时促进与制药行业的持续建设性互动。
