Grange Simon
Alberta Bone and Joint Health Institute, McCaig Institute, University of Calgary, Canada.
Open Orthop J. 2011;5 Suppl 2:276-82. doi: 10.2174/1874325001105010276. Epub 2011 Jul 28.
The rules of governance are changing. They are necessarily becoming more stringent as interventions offered to treat conditions carry unpredictable side effects, often associated with novel therapeutic vectors. The clinical relevance of this relates to the obligations of those involved in research, to ensure the best protection for subjects whilst encouraging the development of the field. Existing evidence supports the concept of e-Governance both in operational health research and more broadly in the strategic domain of policy formation. Building on the impact of the UK Comprehensive Research Network and recent EU Directives, it is now possible to focus on the issues of regulation for cell therapies in musculoskeletal science through the development of the Advanced Therapeutic Medicinal Products (ATMP) category of research products. This article reviews the framework that has borne this and the need for more detailed Virtual Research Integration and Collaboration (VRIC) systems to ensure regulatory compliance. Technology research and development plans must develop in close association between tissue engineering and treating clinicians. The scope of this strategy relates to the handling of human tissues the transport and storage of specimens in accordance with current EU directives and the Human Tissue Authority (HTA) regulations.
治理规则正在发生变化。随着用于治疗疾病的干预措施会带来不可预测的副作用，且这些副作用往往与新型治疗载体相关，治理规则必然会变得更加严格。这在临床上的相关性涉及到研究相关人员的义务，即在鼓励该领域发展的同时，确保为受试者提供最佳保护。现有证据支持电子治理的概念，无论是在运营性健康研究中，还是在更广泛的政策制定战略领域。基于英国综合研究网络和近期欧盟指令的影响，现在可以通过开发研究产品的高级治疗用医药产品（ATMP）类别，来关注肌肉骨骼科学中细胞疗法的监管问题。本文回顾了支撑这一情况的框架，以及对更详细的虚拟研究整合与协作（VRIC）系统的需求，以确保符合监管要求。技术研发计划必须在组织工程和临床治疗医生之间紧密结合的情况下制定。该战略的范围涉及人体组织的处理、标本的运输和存储，需符合当前欧盟指令和人体组织管理局（HTA）的规定。
