General

The quality of the data available on hPSCreg and its ethics compliance is of utmost importance. The registry has established criteria for quality that are meaningful to the users and it must also consider the needs of the public for unbiased information. Consequently, evaluation of registry data is an open, fair and scientifically rigorous process. Good governance, including the involvement of the Committee of National Representatives, the Ethics Advisor , and the Scientific Advisory Board is vital to ensure strict quality adherence and at the same time allowing for different scientific views and national regulatory differences to be acknowledged. hPSCreg puts strong focus on standardization to enable comparison of data on cell lines from different sources.

Documents and information lodged with the hPSCreg have been received by the project management and made available in conformity with the applicable rules for registration. The hPSCreg management is not responsible for the use that it is put to, or for errors, mistakes and or false declarations made by the named providers of the documents and information.

Code of Practice

All activities involved in the handling of registry data and information are governed by a Code of Practice and Standard Protocols. Through these activities the registry will establish rigorous but pragmatic governance to assure data presented on cell lines is accurate and valuable. The Project management provides a model for resolution of international data on stem cells in a way that is scientifically robust and accommodates cultural and scientific diversity.

hPSCreg documents

• hPSCreg SOPs
• hPSCreg at a Glance
• Cell Line Registration Quick-Start Guide
• Annex 2.1.1 Mandatory Fields
• hPSCreg Guidance for Recording Genetic Information
• Guide to Human Cell Line Authentication
• Cell Line Certification
• Subclones Certification
• Cell Line Validation
• Subclones Validation
• Data Management Plan
• hPSCreg Guidance For Rare Disease Registration

Useful Links

• European Policy and scientific contributions (ESF)
• Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.
• The DISCUSS Project: induced pluripotent stem cell lines from previously collected research biospecimens and informed consent. points to consider.
• EGE Opinion 16- 07/05/2002 Ethical aspects of patenting inventions involving human stem cells
• EGE Opinion n°22- 13/07/2007 - The ethics review of hESC FP7 research projects
• Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
• Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
• Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
• Information regarding the General Data Protection Regulation
• The FAIR Guiding Principles for scientific data management and stewardship.