SPECIAL REPORT 10.2217/17460751.3.1.105 © 2008 Future Medicine Ltd ISSN 1746-0751 Regen. Med. (2008) 3(1), 105–116 105 part of hESCCO: development of good practice models for hES cell derivation Sarah B Franklin 1† , Charles Hunt 2 , Glenda Cornwell 3 , Valerie Peddie 4 , Paul Desousa 5 , Morag Livie 6 , Emma L Stephenson 3,7 & Peter R Braude 8 † Author for correspondence 1 London School of Economics and Political Science, BIOS Centre, Houghton Street, London WC2A 2AE, UK Tel.: +44 207 955 6465; Fax: +44 207 955 7405; E-mail: s.franklin@lse.ac.uk 2 UK Stem Cell Bank, National Institute for Biological Standards and Control, Potters Bar, UK 3 King’s College, London, UK 4 Department of Obstetrics and Gynecology, Aberdeen, UK 5 Division of Gene Function and Development, Edinburgh, UK 6 Department of Midwifery, Dundee, UK 7 Advanced Centre for Biochemical Engineering, University College, London, UK 8 Department of Women’s Health, London, UK Keywords: embryo donation, hES derivation, hESCCO, informed consent, stem cell coordination, UK Stem Cell Bank One response of the UK research community to the public sensitivity and logistical complexity of embryo donation to stem cell research has been the formation of a national network of ‘human embryonic stem cell coordinators’ (hESCCO). The aim of hESCCO is to contribute to the formation and implementation of national standards for hES cell derivation and banking, in particular the ethical protocols for patient information and informed consent. The hESCCO project is an innovative practical intervention within the broader attempt to establish greater transparency, consistency, efficiency and standardization of hES derivation in the UK. A major outcome of the hESCCO initiative has been the drafting and implementation of a national consent form. The lessons learned in this context may be relevant to other practitioners and regulators as a model of best practice in hES cell derivation. Increasing interest in the potential of stem cell research within the scientific community and the general public has been occasioned by a pro- liferation of both practical and ethical concerns – some of which are unique to this field [1,2]. These concerns range from specific questions regarding patient information, feedback and consent, to broader principles of governance, regulation and commercialization in order to ensure the safe and responsible distribution of benefits from this promising new field [3,4]. While some stem cell research is carried out on adult and fetal tissues, which themselves give rise to specific questions of ethical regulation and governance, human embryonic stem cell (hES) research remains the most controversial area, around which there is substantial debate regarding best practice, accountability, limits to research and transparency [5]. Alongside new possibilities for the derivation of pluripotent human cell lines, such as induced pluripotent stem cell (iPS) cells derived from direct repro- gramming [6,7], patients willing to donate sur- plus embryos to stem cell derivation efforts remain an essential component of research that must be protected by rigorous ethical guidelines. The high ratio between the numbers of embryos needed and successful hES cell deriva- tion for research or intended therapy is accompa- nied by significant public concern raised by the ‘special’ qualities of human embryos [8]. As a consequence of this, a high social value is placed on the maintenance of robust ethical standards for human embryo research, and a limitation or reduction of numbers of embryos used for such research is a priority for many governments and regulatory authorities, including in the UK [9]. National coordination of hES research combined with publicly-accessible hES banking and strict oversight of both activities offer a pragmatic response to both the ethical and technical con- cerns raised by hES cell derivation [101]. In com- bination with the use of pluripotent cell lines (such as iPS cells, and those that might eventu- ally be derived from parthenotes, from artifi- cial gametes/embryos, tripronucleate embryos, reprogrammable fibroblasts or from umbilical cord blood), regulated donation of embryos and banking of hES cell lines offer the most socially responsible course of scientific research and ethi- cal governance. Initiatives such as the publicly funded UK Stem Cell Bank, inaugurated in 2003, ensure that the benefits of stem cell research will be publicly accessible, and that the need for additional embryos will diminish over time (Figure 1 & 2) [10]. In order to reach the desired outcome of a national stem cell bank that can draw upon a large stock of reliable lines of suffi- cient diversity and quality to meet a variety of clinical requirements, improvements in the pro- curement and use of embryos donated specifically to stem cell research will remain a priority. Attainment of these goals is likely to require the initial availability of significant numbers of high-quality embryos, and standardized deriva- tion protocols and facilities that can make maxi- mum use of these [11]. Such protocols are time- consuming to establish, laborious to standardize, and must be ethically and technically robust [12]. The obligation to maintain the highest ethical For reprint orders, please contact: reprints@futuremedicine.com