research, ethics, governance: the evolving regulatory landscape jonathan montgomery professor of...

Shaping tomorrow’s thinking

Research, Ethics, Governance: the evolving regulatory landscape

Jonathan MontgomeryProfessor of Healthcare Law,University of Southampton

Chair, Health Research Authority


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


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


• 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

research, ethics, governance: the evolving regulatory landscape jonathan montgomery professor of...

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