"Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study.
"Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study.
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DOI：
10.1186/1471-2288-13-72
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发表时间：
2013-06-04
影响因子：
4
通讯作者：
Donovan JL
中科院分区：
文献类型：
--
作者：
Hill EM;Turner EL;Martin RM;Donovan JL
研究通常需要选择同意，但众所周知会引入选择偏见。对于只使用预先收集的健康数据的大规模流行病学研究来说，这是一个特别的问题。大多数先前的研究表明，公众成员重视选择同意，并且可以将未经同意的研究视为侵犯隐私。过去的研究表明，人们通常不了解研究过程和现有的保障措施，教育可能会增加未经事先知情同意的研究的可接受性，但这一建议尚未得到正式评估。我们的目标是确定公众对使用现有医疗数据进行研究的意见范围，并探讨是否同意对医疗记录进行二次审查以进行研究的意见。我们还调查了提供关于选择偏差对公众接受研究数据使用的潜在影响的详细信息的影响。我们通过检索PubMed（1966年至今）、Embase（1974年至今）和已确定研究的参考文献列表，对公众对二次使用现有健康记录的态度进行了系统回顾，以提供总体概述，然后对从英国农村和郊区初级保健实践中招募的19名老年男性进行了定性焦点小组研究，以详细探讨关键问题。系统审查确定了27篇相关论文，研究结果表明，男性和老年人更有可能同意审查他们的医疗数据。许多研究指出，参与者对研究过程和现有保障措施缺乏了解，这在焦点小组中得到了反映。焦点小组参与者在被告知有关选择偏见和研究过程的信息后，更加接受未经同意使用预先收集的医疗数据。所有与会者都热衷于为与国民保健制度有关的研究作出贡献，但有些人担心为了商业利益共享数据和可能滥用信息。加强关于研究和提供有针对性的具体信息的公众教育可以促进对研究过程和保障的信任，这反过来又可以提高未经具体同意的研究的可接受性，因为需要同意将导致有偏见的结果并阻碍改善公众健康所必需的研究。
Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants’ lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health.
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影响因子：
3.4
作者：
Damery, S.;Ryan, R.;Wilson, S.
通讯作者：
Wilson, S.
影响因子：
8.4
作者：
Lane, J. A.;Hamdy, F. C.;Donovan, J. L.
通讯作者：
Donovan, J. L.
影响因子：
--
作者：
Beckjord, Ellen B.;Rechis, Ruth;Hesse, Bradford W.
通讯作者：
Hesse, Bradford W.
影响因子：
--
作者：
Al-Shahi, R;Vousden, C;Warlow, C
通讯作者：
Warlow, C
影响因子：
2.2
作者：
Barber, Julie;Muller, Sara;Hay, Elaine
通讯作者：
Hay, Elaine