The Nuffield Council on Bioethics have today published their report: ‘The collection, linking and use of data in biomedical research and health care: ethical issues’ following months of inquiry by an expert working group Chaired by Professor Martin Richards.  Here’s a copy of the actual report.

There is much coverage in the media already including the Financial Times, The Guardian, Science 2.0, and The Independent.  Given the report makes a number of interesting and sometimes pointed observations on a number of data intitiatives including care.data, the 100k Genome Initiative and Biobank I am sure it will continue to generate a great deal more comment.

The overriding message of the report is pretty clear: public participation in the governance of initiative using data for medical research and health care is essential to building and maintaining public trust.  One of the panel members, Susan Wallace is widely quoted as saying: “Any data project should first take steps to find out how people expect their data to be used and engage with those expectations through a process of continued participation and review.”

The report has an interesting section on participant-led research (Page 146 onwards).  But the key bit of the report is Chapter 5 which looks at ‘Ethical Governance.’  It puts forward four principles for guiding future governance on the use of data including: respect for persons, human rights; participation and accounting for decisions.  It summarises the principle of participation as:

Principle 3 – Participation
The set of expectations about how data will be used (or re-used) in a data initiative, and the appropriate measures and procedures for ensuring that those
expectations are met, should be determined with the participation of people with morally relevant interests. This participation should involve giving and receiving public accounts of the reasons for establishing, conducting and participating in the initiative in a form that is accepted as reasonable by all. Where it is not feasible to engage all those with relevant interests – which will often be the case in practice – the full range of relevant values and interests should nevertheless be fairly represented.

The report has laid down an important and powerful principle here which – alongside the other three – should be a benchmark forr how all data access and sharing is governed and managed.

Some people are not going to like this report, that’s for sure. But, in my view, it’s spot on about public involvement being essential to building public trust.