Tissue Engineering Stem Cells – An e-Governance Strategy
Identifiers and Pagination:Year: 2011
Issue: Suppl 2
First Page: 276
Last Page: 282
Publisher ID: TOORTHJ-5-276
Article History:Received Date: 1/3/2011
Revision Received Date: 16/4/2011
Acceptance Date: 24/4/2011
Electronic publication date: 28/7/2011
Collection year: 2011
open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
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.