Pathology: coming in from the cold.

ABSTRACT

Following the UK's organ retention scandals that occurred a decade ago, politicians unleashed a deluge of well-intentioned but naïve and unnecessarily burdensome regulations that have progressively stymied human tissue-based research, stifling development of improved diagnostic and prognostic tests as well as discovery of new treatments based on sound knowledge of human-specific biology. For the UK to maintain a leading role in medical research, more sensible levels of regulation need to be introduced that recognise differences between tissue from donors who have passed-away and surgical tissue that is surplus to diagnostic requirements and that otherwise will be incinerated. While it is important to reassure the public that research using their tissues will be conducted within an approved ethical framework, it is equally important to ensure that, as hospital staff and academic researchers, we are able to fulfil our unwritten covenant with patients to do our utmost to seek better diagnostic assays and more predictive prognostic indicators, while collaborating with our colleagues in academia and industry and hence bring hope to patients with illnesses for which no effective treatments are yet available. There is a clear case for introducing an opt-out system as the default to allow all surplus surgical tissues to be immediately available for research, concomitant with an education campaign. This is the optimal and most ethical approach to ensure the wishes of the vast majority of patients are respected by allowing their residual surgical tissues and relevant clinical information to be made available for research without the current levels of obstruction and hindrance.