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Research governance regulations and paediatric research

机译：研究管理法规和儿科研究

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The publication of 'The Research Governance Framework for Health and Social Care' and the new rules for ethical committees will have a profound impact on the conduct of research within the National Health Service (NHS). Organizations will be required to work together to assure the quality of research. This will involve independent peer review. Monitoring arrangements, particularly around documentation and consent will be developed. Prioritization, according to local and national research strategy, will also be required. New approval mechanisms will take account of strategic fit, scientific validity and the ability of the host organization to provide support for the project. Ethical committees will require assurance on these points before considering a project. Clinical trials involving medicinal products will fall into a new system of registration to ensure quality control. Chief investigators will be required to demonstrate good practice in relation to all aspects of research. This paper aims to provide practical guidance to assist researchers in understanding and dealing with the new rules and in demonstrating good research practice. The implications for the future of research are discussed.
机译：“健康与社会关怀研究治理框架”的发布以及伦理委员会的新规则将对国家卫生局（NHS）内的研究行为产生深远影响。组织将需要共同努力以确保研究质量。这将涉及独立的同行评审。将制定监督安排，尤其是围绕文件和同意的监督安排。根据地方和国家研究策略，还需要确定优先级。新的审批机制将考虑战略契合度，科学有效性以及东道国组织为项目提供支持的能力。伦理委员会将在考虑项目之前要求对这些观点进行保证。涉及药品的临床试验将纳入新的注册体系，以确保质量控制。将要求首席调查员表现出与研究各个方面有关的良好实践。本文旨在提供实践指导，以帮助研究人员理解和应对新规则并展示良好的研究实践。讨论了对未来研究的意义。

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