Last summer, the Health Research Authority (HRA) and the Human Tissue Authority (HTA) - in partnership with the Department for Business, Enterprise, Innovation and Skills’ (BEIS) Sciencewise programme and Ipsos MORI - published the report Consent to use human tissue and linked health data in health research. The report presented the findings of a public dialogue to explore peoples’ views on consent procedures used by researchers to link patient data with human tissue samples in health research.
In this update, we summarise how the key findings and recommendations are informing our work, one year on.
The dialogue identified a need for absolute clarity on the uses of tissue and data; in particular, the need to provide a straightforward, accessible and future-proofed consent process. The report set out ‘six key tests’ - addressing the challenge of providing adequate information without overloading donors - and more detailed recommendations were made in the following areas:
· Educating potential donors
· Defining how health data might be used in research in the present and future
· Transparency on who can access tissue and data at an individual level
· Transparency on sharing overall research findings with participants
· Specifics on the harms arising from tissue donation and data linkage
· Reassurance provided by access committees
· Future-proofing consent
· Making consent easy to understand and use
· The administration of consent
Following publication of the report, the HRA and HTA carried out an extensive review to identify those areas not already covered by our existing guidance. We found that the majority of the recommendations are either addressed by our existing guidance or can be addressed with minor modifications that will be made as part of our routine review procedures.
Furthermore, the HRA, in collaboration with the HTA, will be leading on three important projects over the rest of this year and beyond:
· Working with key voices in the biobank field to identify and share good practice examples of tissue donor information sheets and consent forms
· Developing guidance on appropriate governance procedures for the sharing of tissue by Research Tissue Banks
· Research transparency: be clearer about what we expect of Research Tissue Banks
Through this and our other joint initiatives, the HRA and HTA aim to continue to make the UK a great place to do health research, building public confidence and trust so that more people are willing to donate their tissue for scientific and medical research.