Principles for organisations integrating with the UKCRC Tissue Directory. This document sets out the core principles that the Centre should adopt when considering any commercial opportunities that may arise from the Directory. These principles shall be used by the legal teams at UCL or Nottingham to draw up an agreement with an organisation wishing to engage with the Directory under one of two possible scenarios: (1) An organisation wishing to… Read More »Commercial Principles
ISO Biobank Standards Assuring researchers as to the quality or standard of a Biobank is an important issue. We are here to keep you abreast of all the latest developments in the field. You may have heard that new ISO Biobank standards are coming soon, but who is writing them and how can you get involved? Gareth Bicknell, HBRC Operations Manager at the University of Birmingham explains more here. What… Read More »ISO Biobank Standards
New HTA codes of practice In April the Human Tissue Authority (HTA) published updated Codes of practice. This guest blog by Regulation Manager, Fiona Maleady-Crowe explains what this means for Biobanks. What are the Codes of Practice? The HTA’s Codes of Practice provide practical guidance on the human tissue legislation and set out the HTA’s licensing standards. The Codes are important resources which help researchers and establishments comply with our… Read More »New HTA codes of practice
The Health Research Authority (HRA) have published new guidance on taking a proportionate approach to consent, particularly in reference to clinical trials.
A recent study has found that only around 9% of biobanks have a publicly available access policy. Given that most biobanks are funded by the public, there is an expectation that the samples they contain are made available for external research purposes that could ultimately have a social benefit. But for this to happen, clear access policies need to govern the conditions under which samples can be used for external… Read More »Only a minority of biobanks have a publicly available access policy
Proposed changes to data security and consent in the healthcare system In September 2015, the Secretary of State for Health commissioned an intensive review of how personal data is used within the healthcare system. This called for recommendations to be made on improving data security and developing a new, clear opt-out and consent model for how a patient’s data can be used. In June the results of this review were… Read More »Proposed changes to data security and consent in the healthcare system