Bortolussi Robert, Nicholson Diann
Department of Pediatrics, Dalhousie University, Halifax, NS.
Clin Invest Med. 2002 Jun;25(3):83-8.
Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process.
Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records.
Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type.
Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits. The research audit is a valuable tool in improving research ethics performance but requires considerable resources.
加拿大及国际研究伦理实践指南主张，研究伦理委员会（REB）应实施审查和监督人体研究的机制。尽管如此，很少有加拿大的研究伦理委员会能达到这一期望。本报告的目的是总结1992年至2000年期间在加拿大一家儿童与妇女专科医院进行的6次临床研究伦理审核的结果，以便为其他计划开展类似流程的学术中心提供指导。
研究审核由一个由研究伦理委员会志愿者组成的研究审核评审委员会成员进行。通过随机和选择性程序，约10%的研究方案通过与研究调查人员和研究协调员访谈以及抽取研究记录进行审核。使用预定标准评估研究期间良好记录保存、数据监测、方案依从性、知情同意及不良事件记录的证据。通过回忆参与者和记录估算进行一次审核所需的时间。
共审查了35项研究，包括16项多中心临床试验和19项单中心临床研究。记录保存和研究实践审查发现了一些缺陷：研究人员未保留原始授权（7%）或续签文件（9%）；有1例药物储存不当；在174名接受知情同意审查的参与者中，5%使用了过时的知情同意书，4%的入组者签名未正确显示。知情同意文件的其他缺陷发生率不到2%。针对缺陷和流程问题提出了19项建议。在这类典型审核中，审查每个方案总共需要9至20人时。
研究审核提供的信息有助于制定教育计划，以纠正审核中发现的缺陷。研究审核是提高研究伦理表现的宝贵工具，但需要大量资源。
