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Research, Ethics, Governance : the evolving regulatory landscape

Research, Ethics, Governance : the evolving regulatory landscape. Jonathan Montgomery Professor of Healthcare Law, University of Southampton Chair, Health Research Authority. History. Nuremberg principles now WMA Helsinki Declaration Henry Beecher & Maurice Pappworth Ethical review

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Research, Ethics, Governance : the evolving regulatory landscape

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

  2. History • Nuremberg principles • 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

  3. A new context • From malfeasance to non-feasance • 2002 46% of EU products in clinical trials being developed in UK. 2007 24% • 2004 global market share of patients in trials 6%. 2008 2-3% (AMS Report) • Public expectations • Evidence-based care • Data usage • Recession

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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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?

  14. 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

  15. 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

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