Transcript The Future of Research Governance: what needs to be done

Research, Ethics, Governance:
the evolving regulatory
landscape
Jonathan Montgomery
Professor of Healthcare Law,
University of Southampton
Chair, Health Research Authority
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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
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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
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• Estimated
health + GDP
gain for £1
invested in
CVD
research is
39p each
year in
perpetuity
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Shaping tomorrow’s thinking
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
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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
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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
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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
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Shaping tomorrow’s thinking
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
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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
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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
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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
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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?
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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
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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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