Audrey Suzanne, Brown Lindsey, Campbell Rona, Boyd Andy, Macleod John
School of Social and Community Medicine, University of Bristol, Canynge Hall, Whatley Road, Bristol, BS8 2PS, UK.
School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.
BMC Med Ethics. 2016 Sep 2;17(1):53. doi: 10.1186/s12910-016-0133-1.
Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees.
Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management.
The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'.
There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance the rights of individuals with the wider benefits from research. The suggestion that public opinion should be represented through random selection similar to jury duty may be worth pursuing in the light of the need to ensure diversity of opinion and establish trust amongst the general public about the use of 'big data' for the wider public good.
雅芳亲子纵向研究（ALSPAC）是一项出生队列研究，在此研究中设立了通过记录链接增强ALSPAC项目（PEARL），以通过将ALSPAC参与者与健康和社会数据的常规来源相链接来丰富ALSPAC资源。PEARL纳入了定性研究，以征求年轻人对数据链接的看法，包括他们对适当保障措施和研究治理的意见。在本文中，我们重点关注关于研究伦理委员会的目的和组成所表达的观点。
对48名17 - 19岁的参与者进行了数字录音访谈。询问参与者医学研究是否应该受到监督和控制、他们对研究伦理委员会的了解、哪些人应该在这些委员会任职以及其职责应该是什么。访谈录音被全文转录并匿名化。在数据管理框架方法的辅助下进行了主题分析。
大多数受访者对伦理委员会几乎没有或根本没有具体了解。在获得关于研究伦理委员会的基本信息后，只有三名受访者认为此类机构无需审查研究。伦理委员会的关键任务被确定为监督研究过程和保护研究参与者。人们认识到在抑制研究的可能性与保护研究参与者的需求之间取得平衡的困难。确定了相关研究和专业知识的重要性，但也认为代表更广泛的公众意见很重要，并且可能通过类似于“陪审团职责”的选拔过程来抵消可能与自我选择相关的偏见。
需要对研究伦理委员会的作用和组成进行更多的教育和提高公众意识。尽管最初缺乏了解，但受访者能够提出他们的想法，并在个人权利与研究的更广泛利益之间取得平衡。鉴于需要确保意见的多样性并在公众中建立对利用“大数据”实现更广泛公共利益的信任，类似于陪审团职责通过随机选择来代表公众意见的建议可能值得探讨。
