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Human biomonitoring data interpretation and ethics; obstacles or surmountable challenges?

机译:人体生物监测数据的解释和道德规范;障碍或难以克服的挑战?

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摘要

The use of human samples to assess environmental exposure and uptake of chemicals is more than an analytical exercise and requires consideration of the utility and interpretation of data as well as due consideration of ethical issues. These aspects are inextricably linked.In 2004 the EC expressed its commitment to the development of a harmonised approach to human biomonitoring (HBM) by including an action in the EU Environment and Health Strategy to develop a Human Biomonitoring Pilot Study. This further underlined the need for interpretation strategies as well as guidance on ethical issues. A workshop held in December 2006 brought together stakeholders from academia, policy makers as well as non-governmental organisations and chemical industry associations to a two day workshop built a mutual understanding of the issues in an open and frank discussion forum. This paper describes the discussion and recommendations from the workshop.The workshop developed key recommendations for a Pan-European HBM Study:1. A strategy for the interpretation of human biomonitoring data should be developed.2. The pilot study should include the development of a strategy to integrate health data and environmental monitoring with human biomonitoring data at national and international levels.3. Communication strategies should be developed when designing the study and evolve as the study continues.4. Early communication with stakeholders is essential to achieve maximum efficacy of policy developments and facilitate subsequent monitoring.5. Member states will have to apply individually for project approval from their National Research Ethics Committees.6. The study population needs to have sufficient information on the way data will be gathered, interpreted and disseminated and how samples will be stored and used in the future (if biobanking) before they can give informed consent.7. The participants must be given the option of anonymity. This has an impact on follow-up.8. The pilot study should develop guidelines and best practice for Ethics for pan European studies.In conclusion all participants felt there that there has to be stakeholder involvement in any planned pan-European Human Biomonitoring Study and the format of the workshop was appropriate for such dialogue.
机译:使用人类样品来评估环境暴露和化学物质吸收不仅仅是分析工作,而且需要考虑数据的用途和解释以及适当考虑道德问题。这些方面有着千丝万缕的联系.2004年,欧盟通过在欧盟环境与健康战略中开展一项行动来开展人类生物监测试点研究,表达了对开发人类生物监测(HBM)统一方法的承诺。这进一步强调了对解释策略以及道德问题指南的需求。 2006年12月举行的研讨会将学术界,政策制定者以及非政府组织和化学工业协会的利益相关者聚集到了一起,为期两天的研讨会中,在一个公开坦率的讨论论坛上建立了对问题的相互理解。本文介绍了研讨会的讨论和建议。研讨会为泛欧洲HBM研究提出了关键建议:1。应制定解释人类生物监测数据的策略。2。试点研究应包括制定一项在国家和国际两级将健康数据和环境监测与人类生物监测数据相结合的战略。3。设计研究时应制定沟通策略,并随着研究的进行而发展。4。与利益相关者的早期沟通对于最大程度地提高政策制定的效率并促进后续监控至关重要。5。成员国将必须分别向其国家研究伦理委员会申请项目批准6。在获得知情同意之前,研究人群需要有足够的信息来收集,解释和传播数据的方式以及将来如何存储和使用样本(如果是生物银行)。参与者必须具有匿名选项。这对后续行动有影响8。试点研究应为泛欧研究制定道德规范和最佳实践,总而言之,所有与会者都认为,任何计划中的泛欧人类生物监测研究都必须有利益相关者的参与,并且讲习班的形式适合此类对话。

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