Research, Ethics, Governance: the evolving regulatory landscape Jonathan Montgomery Professor of Healthcare Law, University of Southampton Chair, Health Research Authority

History Nurembergprinciples – now WMA Helsinki Declaration Henry Beecher & Maurice Pappworth –Ethical review North Staffordshire babies –Research Governance Sponsor and organisational responsibilities Sector scandals –Alder Hey & Human Tissue Act 2004

A new context From malfeasance to non-feasance – % of EU products in clinical trials being developed in UK % –2004 global market share of patients in trials 6% % (AMS Report) Public expectations –Evidence-based care –Data usage Recession

Estimated health + GDP gain for £1 invested in CVD research is 39p each year in perpetuity

Main problems Delays and duplications in getting permissions Complexity and inconsistency Lack of proportionality in clinical trials Inappropriate restriction on use of patient data Unsupportive NHS culture

Four Principles Safeguard well-being of participants Facilitate high quality research to public benefit Proportionate, efficient, co-ordinated Maintain and build confidence in the conduct and value of health research through independence, transparency, accountability and consistency

Solutions… Health Research Agency –National research governance checks –Single ethical approvals system Improving clinical trials –Consistent interpretation of EU Directive –Revision if necessary Access to patient data Cultural change

Public support UK Biobank has recruited 500,000 without difficulty Wellcome Trust survey of 1,000 –71% would give blood or tissue sample for research –62% willing to test new treatment for disease from which they were suffering Reasonably wide support for use of date for research with consent

Consultation Clarified Patients’ rights To be informed about data usage Objections to use beyond personal care –to be considered –Told why wishes cannot be followed, including legal basis

Consultation NHS commits (pledges) –Ensure data available to support care –Anonymise patient data & use to support research and improve care for others –Where identifiable has to be used, chance to object where possible –Inform you of research in which you may be eligible to participate

The HRA Vision For the UK to be a great place to do research, where more money invested in research goes into carrying out relevant, good quality research Duties to protect and promote the interests of patients and the public

Interests to promote Evidence-based care –Care and research complementary not contradictory Collaborators as ‘investors’ who deserve the best returns we can deliver Choices that are participants value –More than the right to say yes or no

Protection REC opinions –Independence of considerations of projects crucial –Process values: consistent, transparent, timely NREAP –Service to researchers not just RECs –Membership supplemented –HRA Board not an arbiter of ‘Ethics’ Proportionality?

HRA as a service provider Who are we serving? –Work on understanding public attitudes to risk –Commitment to responding Identifying and addressing problems –Steering group for projects –IRAS dataset – fitness for purpose –HRA Assessment

The Law Health and Social Care Act 2012 –Duties to promote research and use of evidence Draft Care and Support Bill –HRA as NDPB Clinical Trials