This presentation will provide an additional perspective to that of the scientific and ethical issues that surround biosamples, by considering the appropriate role of regulation in this area. A regulatory regime can be used to ensure that the individuals, organisations and activities are governed in such a way as to ensure the highest ethical and scientific standards are maintained. Right touch regulation should promote innovation and should not be overly burdensome, but it is required to ensure that, in the highly sensitive area of biosampling, there is an appropriate framework in which high calibre operators can function and unsafe or unethical practise is prevented. As stem cell and biosample banking expands into new scientific and geographic areas regulation has to be sufficiently flexible to adapt to the unknown. It is also required if the bio banking communities are going to operate internationally.The presentation will consider what the international community might expect to see in regulatory terms as the Middle East expands into these opportunities. Regulation should be understood as key to ensuring confidence in the processes involved in biosampling. The presentation will look at some of the regulatory issues and challenges encountered in Europe and beyond and discuss the perspective and lessons to be learned. Central to the discussion will be consent issues and how consent may be embedded in regulation to underpin approaches to the storage, import and export and research with human tissue and cells.


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  • Received: 05 March 2012
  • Accepted: 28 March 2012
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