Nuffield report underlines importance of public participation if people are to trust how their medical records are used for research

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, 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.

MRC publishes new communications and engagement strategy (plus new film!)

The Medical Research Council (MRC) has published a refreshed communications and engagement strategy.

There is a section on public involvement on P12 of the document which is the fullest narrative I have seen of their corporate intentions around this aspect of working in partnership with the public.

It is a good document and important to have in the public domain. But I wish the public involvement part had a bit more ‘oomph’ in making a stronger commitment to involving the public in strategic and operational decision-making by the MRC. Also that it appeared earlier in the document and as part of the main strategic aims.

That might help to counter the views some people hold that the MRC’s default way of working with the public is to broadcast high quality
information. For the fact is that there are many excellent examples from the root and branch parts of the organisation which demonstrate how its researchers increasingly see what they do as a joint venture with patients and the public.

The MRC Clinical Trials Unit at UCL has, for instance, produced a set of stunning new videos about all aspects of public involvement including this one.

The strategy does these activities a slight disservice by underselling their importance to the overall strategy of the MRC. However, it does mark a degree of progress.

[This post is on the ‘asides’ pages where I tend to post short pieces. My full posts are on the main pages as usual]

Patients hack medical research in planned attack

Hacking in this context is what we call ‘bringing people with different views and skills together to work on problems.’

[Sorry to disappoint the headline chasers but I hope you’ll stay with me]

And ‘hackathons’ – events where such hacking activity can take place – are increasingly common across the health arena as a means of solving problems.

In fact Cancer Research UK did a very successful one recently to design a mobile phone game which would help them analyse gene data.

Well, those extremely creative and clever people at the University of Manchester Centre for Primary Care, supported by the Economic and Social Research Council (ESRC) , the NIHR School for Primary Care Research, NOWGEN and others, are applying the principle to health research.


Members of the public are being invited to pitch ideas to a mixed audience of the public and researchers who will then work on turning them into possible research projects.

In the afternoon they will also be turning their minds to patient and public involvement and some of their thoughts will no doubt find their back to the NIHR Strategic Review of Public Involvement: ‘Breaking Boundaries’ announced last week.  Did I tell you about that?

The bad news is that the ‘Patient Hack Day’ on 30th April is already full up!

The good news is that this is as simple as it gets as an idea and could easily be adopted and adapted around the country.  How about doing one for the ‘Ok to ask’ campaign about clinical research which is running again this year on 20th May?

I had another thought as well.

We now have an excellent methodology in the James Lind Alliance Priority Setting Partnerships (PSPs) for identifying national condition-specific priorities – or rather priorities as defined by patients and clinicians.  But as health research becomes more local in its organisation there seems value in thinking of ways and means to enable priority-setting at a local level as well.  Both in formal and informal ways.  And this ‘Patient Hack Day’ has much to commend it.

Have a good weekend.


Health Research Authority looks for good practice in identifying research participants – survey.

Excuse my laziness but it is Saturday. Here’s a copy of a press release put out by the a Health Research Authority (HRA) on Wednesday about a call (in essence, a survey) they are doing for good practice in identifying potential participants for research studies. The results of the work will be published by HRA in due course.

What it will mean for patients and the public?

Well, I’ll get more on this in the coming week but the statements in paragraph four about consistency, transparency and privacy are the key ones. HRA clearly sees improvements in practice as necessary to ‘protect and promote the public interest.’ And you’ll see the regulator is also asking in the survey for practical examples of public engagement in recruiting people to research.

The survey can be found as a link in the text below but you can also go straight to the new release and survey the HRA website here.

Published on 11 December 2013

The HRA is launching a call for evidence to identify good practice in identifying potential participants in health research.

Building on our remit to protect and promote the interests of patients and the public in health research, we are asking for examples in the areas in which we are directly involved as well as broader successful participation initiatives.

The revisions to the NHS Constitution have committed the health service to recognising and promoting the value of research, and the Health and Social Care Act 2012 placed obligations on NHS organisations to support this. The Caldicott 2 Review report and recent Government response agree that more should be done to increase people’s understanding of the benefits of research and to inform them about how to get involved. The NHS Constitution sets an expectation that, as an NHS patient, you can be asked to participate in research.

The HRA recognises that there is considerable variation in perspective and practice about the ways in which patients and the public are offered opportunities to take part in research. We want to explore the potential for providing clarity for the research community by identifying ethical, practical and efficient models for identification of potential participants. In accordance with our remit to protect and promote the interests of patients and the public in health research, such approaches should be transparent, maintain patient and public confidence in research, and protect the privacy of personal medical information. They should also enable appropriate access to information that will give more patients the opportunity to take part in research.

Our request for information on current practice will help us to identify the need for any further guidance and advice for researchers. People can contribute by completing the brief survey and returning it to by 31 January 2014.

We are interested to hear about the impact of changing recruitment strategies on recruitment and retention rates. We are also particularly keen to hear about examples of patient and public engagement around models of recruitment, and evidence about patient and public expectations relating to the identification of participants.

We will publish the outcome on to enable the research community to benefit from the best ideas in the NHS.

– See more at:

Young people in research have sent me a postcard, have a look….

The Generation R event – organised and delivered by young people in research – has to be one of the highlights of my year.  You can find a write-up from the September event here.

Today the Generation R crew sent me a postcard about what is happening next.

Note the key messages to emerge from the event with respect to the reporting of research results and the involvement of young people in research design and delivery.  The latter chimes with this year’s recommendation in the CMO’s report.  The former is in tune with the #AllTrials campaign.

Really can’t wait to see what these impressive research champions emerge with in the New Year.


GenR key messages

Take part in a live trial now as part of NIHR’s visit to the British Science Festival #NIHRCOMETtrial

I hope you’ll forgive the fact that what follows is the news release but I am part of the team presenting with Jonathan Sheffield at next week’s British Science Festival and I really couldn’t put it better than this.  The ‘live trial’ is very exciting indeed and the first dip in the water for a concept that we have been bouncing around for some time which I loosely call either ‘Trialwatch’ or ‘TrialInADay’ – using media and new technology to encourage mass participation in studies to answer serious research questions…….

National Institute for Health Research to make debut at British Science Festival with live trial

This September will see the National Institute for Health Research (NIHR)’s debut show at the British Science Festival and the organisation’s first ever live trial.

The British Science Festival is an annual celebration of science, engineering and technology, with over 250 events, activities, exhibitions and trips taking place over six days from Saturday 7 September to Thursday 12 September. The festival, which is hosted by Newcastle this year, will make a big ‘noise’ for science, technology and engineering regionally, nationally and beyond.

This year’s theme is ‘Making Waves’ and is focusing on discoveries, inventions and research that have made an impact on our lives, and more importantly, what will make an impact in future.

The NIHR’s show called “From bench to bedside: how clinical research is making waves in patient care” will take place on Thursday 12 September from 4-5:30pm at Northern Stage, Stage 2 in Newcastle. The show, hosted by Chief Executive of the NIHR Clinical Research Network Jonathan Sheffield, will include the unique opportunity to take part in a piece of live research called The COMET trial which tests reaction speed.

The event is an interactive and fun show aimed at the general public. Alongside the live trial it also includes audience interaction and a piece of original theatre. The event is free to attend and people can book their place online.

People can find out more about The COMET trial which members of the public can also participate in online at:


A bit of a public involvement mash-up including that idea for an NHS Civil Society Assembly

So here’s my unsubstantiated personal theory.

It is that one of the root causes of the problems besetting today’s NHS’ is our failure to pay proper heed to the growing crisis in accountability and responsibility that has been a feature of our increasingly complex health system over the last seventy years.  From almost the day that the NHS was born in the arms of a post-war nation, we have shown a lack of courage towards involving the public appropriately in the maturation of the service.  In this vacuum, the evolution of the health service has been driven as much by unchecked romanticism (think of the Olympics ceremony) as anything else.  Ideology has stymied the pragmatism that was needed to meet successive challenges.  These challenges only get more daunting and difficult the more we delay.  In my view, we can only resolve them by reforming its corporate governance so that patients and the public are involved in the running of the NHS from top to bottom.

With that in mind, that’s why I tweeted yesterday in support of the idea going before the NHS Commissioning Board to explore the idea of a citizen and community assembly (NHS Civil Society Assembly).  You can find out more details about the proposal being considered at the Board’s meeting on Thursday 28th February in Manchester (you can register to attend) here (see Item 4).  It’s a start.

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The Guardian has posted its round-up of the on-line chat that I and others took part in regarding patient feedback in the NHS.  The conversation ranged far and wide with little focus but it was interesting nonetheless. The ‘Francis report’ was published the day after and I seem to recall someone somewhere tweeting that patient feedback would be the source of trust in the NHS.  Seemed a faintly overblown and risky claim to make.  Ensuring that people can give their feedback and know that their concerns will be taken up is critical.  But it will take more than this to restore people’s faith in the service.

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Rare Disease Day is coming up later this week on 28th February (see Rare Disease UK website), so it seems worth pointing to several recent news items that have focused on efforts to bring about greater flexibility in how we do clinical trials.  All with the intent of getting new treatments to people faster.  First, this from the USA where the Food and Drug Administration’s (FDA) is talking about approving so-called  ‘Breakthrough’ therapies after only a limited number of research studies.

Closer to home you may have picked up on the Empower: Access to Medicines campaign including e-petition to the UK Government which, as of today, has 711 signatures.  Les Halpin, who has MND and is one of the founder’s of ‘Empower’ was interviewed on the ‘Today’ programme in a curious piece which seemed to mash-up several issues: the right of people to choose to receive treatment with untried medicines (see also Lord Saatchi’s Bill in the House of Lords right now); how regulation is slowing up medicines development and; the problems with the EU Clinical Trials Directive.  The discussion is important but so is clarity of purpose, motivation not to mention the solution.

Talking of regulation, if you check out the Health Research Authority (HRA) website and the presentations from its recent ‘stakeholder forum’  you’ll see there is an update on its public involvement activities including the Sciencewise project looking at public attitudes to health research regulation.  I imagine we will see the results in late Spring and they should be fascinating.   Plaudits to the HRA for taking up the challenge to improve the evidence on what the public think in this area.

*      *        *

And in other news, the NIHR School for Social Care Research has published the scoping review of ‘User Controlled Research’ by Peter Beresford and Suzy Croft.  A must read.  And finally, this looks wonderful, a new charity devoted to improving mental health research through the involvement of service users – ‘The McPin Foundation.’  Hopefully I will have cause to write at greater length about them in the near future.

Help us make sense of the placebo effect…

I am involved in this follow-up study to one published a few months ago (and covered on this blog) about the poor information given to patients about the placebo in clinical trials.  In the first instance the researchers are looking for people to input into the design of a leaflet.  Details and contact email follows:

Have you ever taken part in research before?  Would you like to help improve the way research is communicated to patients?  Researchers at the University of Southampton are writing a new leaflet to explain placebo-controlled trials to patients and would like some volunteers to help.
We are looking for 10-20 people who have taken part in a clinical trial or other medical research.  We will send you a copy of our leaflet and you can either write to us with your comments, email us, or talk to us over the phone.  The leaflet is only one-page long, so we do not anticipate it will take you too long to tell us what you think about it.  For more information or to volunteer, contact Dr Felicity Bishop on

Healthtalkonline looking for people to talk about their experiences of patient and public involvement

Healthtalkonline is looking for volunteers to be interviewed about their experiences of patient public involvement in research design and delivery.  Flyer with contact details below.

Cancer patient experience survey results show variations in access to clinical trials and research

The results of the annual cancer patient experience survey are out today.

For those of us committed to improving patient access to clinical trials and other research, this year’s report is particularly interesting.  As far as I know, this is the first year that the survey asked patients whether taking part in research had been discussed with them.  You can find the results of these particular questions on p57 of the report linked-to above.

The overall finding is that 33% of cancer patients said that taking part in research had been discussed with them but 67% of patients said it had not.  There are considerable variations according to tumour type with urological cancer coming out worst.  By Trusts the percentage of patients who were asked about research ranges from 14% to 62%.  Whatever way you cut it – by tumour type or geographical area – the majority of people who were asked were glad that the subject had been broached.

In a field which has built a significant reputation for improving patient access to research – thanks to the National Cancer Research Institute (NCRI) and the National Cancer Research Network (NCRN) – these figures show the work still to be done to bring research to the fore of the conversation that cancer patients have with their doctor. I would suspect that other conditions have a steeper hill to climb in comparison.

There is no magic bullet to improving access.  The survey highlights the future importance of things like the NHS Choice Framework and the strengthening of patient rights through the NHS constitution in empowering patients to ask the question. But a lot will also rest on ensuring NHS Trusts prioritise the access agend; that they make it their job to raise awareness of their research activity and the importance of patient participation in it.

This week, through NIHR CRN CC, we kicked off a piece of work – Involvement4Access – to bring together patients and support them as leaders within Trusts environment to improve patient access to research.  On Wednesday I had the opportunity to attend a Royal College of Paediatrics and Child Health (RCPCH) workshop about research where parents and young people reported very real differences in the willingness of hospitals to advertise research openly on wards, receptions areas etc.  The reasons put forward by hospitals for not being more open about research are often misconceived if not plain bunkum.

But improving access will also require patient groups and charities to do more to support the patient voice in lobbying Trusts, health professionals and others to change their approach.  There is much in this report and in the recent NIHR league tables of research activity to aid this work.  Yet patients need the right tools and information that they and their families can use confidently in order to broker the conversation with their GP or consultant. They also need to hear more from their representative bodies about how they should consider taking part in research as part of their overall treatment.

At the same time, the survey findings about people who were not asked about research on whether they would like to have been, highlights the fact that to participate or not is a  ‘personal choice’ which must be respected.  53% of people said they would like to have been, 47% said they would not have liked a discussion.  Insight into the patient experience from a research perspective – at what point in their care and treatment should the conversation take place, with whom and how – will increasingly be important.  That’s why today’s survey must be repeated but also used as a prompt for further inquiry.  It should also be repeated in other disease and conditions areas as well.

At the end of the day, providing better patient access to research is about improving patient choice, leadership, insight and voice.

There is no point to the javelin

It has come to this.  The world’s top tennis players rush their shots to beat an 11pm curfew.  Bruce and Sir Paul are turned-off mid-performance.  And they don’t use real javelins in schools.

Looking across the the athletics field at my sons’ school sports day, I spied a clutch of children competing in the javelin.  Except this is not a javelin as I remember it.  It’s more like one of those foam beach toys.  But nowehere near as good.  In fact it’s probably more like throwing a giant, over-ripe banana.  I admire the optimism of a small boy as he lets fly.  I imagine his disappointment as it is carried sideways by the wind and belly-flops to the ground.  There is no point to the javelin I mused.

UK scientists who have long complained about the blunt and risk-averse nature of the current EU Clinical Trials Directive, will no doubt be pleased by the Commission’s announcement today to bring in a sharper legislative instrument.  The new ‘Regulation’ will mean lighter touch regulation for ‘low-risk’ clinical trials and a streamlining of the regulatory process across the EU.  This, married with the EU’s recent enthusiasm for making trial data publicly available, also looks like good news from a patient perspective. Nature coverage here.

Whether it stacks-up against the five ‘wishes’ that the European Patients Forum (EPF) expressed during the consultation about the existing Directive remains to be seen.  The Forum hoped that any revision of EU law would result in:

1. Ensuring meaningful patients’ involvement across all aspects of clinical trials;

2. Giving patients access to quality information regarding clinical trials;

3. Meaningful informed consent;

4. Transparency concerning the results of clinical trials;

5. Access to treatments after the end of clinical trials.

Faster, quicker, leaner trials, yes.  Rules that reflect patient choice, voice and experience, I fear not.

The Commission’s own web pages have a stack of information available about the new Regulation including a ‘Citizen Summary.’ That all other documents constantly refer to research ‘subjects’ betrays the fact that the full extent of the patient agenda is not quite part of their core philosophy.  Indeed. the summary is just that, it doesn’t really convince in explaining how citizen rights and interests have been reflected in the proposals.

When is science, or more particularly medical research, going to wake-up to the fact that the effectiveness of modern regulation and modern regulators hinges on a partnership between those being regulated and their consumers?  Perhaps closer to home we might have greater cause for optimism.  The new Health Research Authority (HRA) has just had its second public involvement workshop and is working through the options of what might be tangible outcomes of this work as part of its business plan.

Back in Brussels, I hate to say it, but it still feels like we are being given foam arrows.  And with none of the fun of the beach.

Enjoy your summer holidays.

My key points to the ‘Caldicott 2′ Review of Information Governance earlier today

Actually that’s not quite true because, as is not uncommon with these things, the evidence session I attended today was more of a discussion, and a very good one it was too.  But I did more or less cover the following points.  At the end we were asked to express one wish about what happens next.  I had a two-part wish:

  • That the NHS Constitution consultation does not become a referendum but is seen as the beginning of a deliberative exercise with the public and patients.
  • That the governance system which emerges enshrines the role of the public as effective co-custodians of good research.

‘Caldicott 2′ speaking notes

 The public and health research

Strong public support for health research – ‘instinctive and altruistic goodwill’ towards it – emotive response not too dissimilar to that which causes people to donate to research charities. Nature of a person’s relationship changes as they begin to have direct contact. Value needs to be better articulated, however, and we need to do a better job of harnessing support.

But low awareness and understanding of how it works generally and, even more so, of particular elements such as use of patient data.  Clearly need to do more to change this but not sure that ‘the fluoridation of water’ population-wide approach to raising awareness will get us very far.  What happens via NHS and Trusts in the context of care much more important – see below.

I suspect people, however, would take issue with the definition of research that some suggest.  Would be an expectation of delivery in terms of treatments, new interventions etc not just advancement of scientific knowledge and understanding.  Real need to de-jargonise information governance debate and try to arrive at consistent definitions and terminology.


Context for people’s individual participation in research is changing.  Now being framed as a ‘choice,’ as an entitlement as part of their care and treatment – NHS Commissioning Board Draft Mandate.  Vision of ‘citizen-driven’ research where people are asserting this right with their doctor.

Changes dynamic.  People will have greater expectations over their rights as well as responsibilities and I am not sure we have thought this through sufficiently within the research community.  It’s no longer a simple exchange or gift relationship. Support is not unconditional.

Strong case for patients and researchers to begin to ‘codify the expectations’ that people can have about their participation and involvement including how their data is used.  Public meetings I have done recently suggests growing frustration over things like consent and the lack of a relationship feel to their interaction. Something I am looking at in my role at NIHR.

Building on the evidence

Have been involved with a number of exercises to gather public opinion an insight into public perspectives on information governance – ‘Your medical records saves lives,’ Academy/AMS report.

Evidence is indicative of public support for sharing data and understanding of benefits but important we don’t overwork or overcook it as if it is a ‘mandate for change’ in itself. It merely gives us license to examine further with them how policy and practice could change.  That is why NHS Constitution consultation so very important.

4 small points about the ‘Your medical records..’ exercise.  First, people assumed their records were being shared anyway. Second, it was a deliberative exercise which enabled people to have their concerns explained away. Third, the biggest barrier to change seemed to be their GP. Fourth, in designing the leaflet people really put a premium on simple, direct information but with clear signposts of where to find out more according to their interests and needs.

NHS Constitution

Welcome the consultation. Need to take a deliberative approach to it. Important to have right mechanisms to hear and understand what people are saying, not just organisations. Also important that we involve the public in the design of the consultation, the framing of its questions and the evaluation of the responses.

Building trust – consent, research governance and public involvement

Three key elements:

Important for people to feel in control of their information and its uses. So, absolutely critical that people are clear about what is being proposed, the pros and cons of opting out, what this means in practice, how data use is going to be monitored etc. In the Facebook era it seems unwise to have a system which does not allow people to choose areas of information they are happy to share, review their decision at appropriate points and re-boot their involvement etc. Or if not, the reason why needs to be clear.

Public involvement in the overall research governance is important to getting the system right from a patient perspective and will help instil trust – patients are effective partners in ensuring good custodianship of research.

Important to have a governance system which is less about transparency and the production of data (as opposed to information) and more about the ability for people to track how decisions were made, by whom and why. Plus what is done if things go wrong.

The NHS Commissioning Board Draft Mandate and patients in health research

The Shard went up (officially).  And the NHS Commissioning Board Draft Mandate came down from on high.  All on the same day.  Add the odd torrential downpour with its associated misery and these could be Biblical times.

I have come to the conclusion that it is my fate to be locked away somewhere remote and with an intermittent phone signal when such momentous events occur.  On this occasion I was taking part in the Third NIHR Experimental Medicine Research Training Camp; a three-day residential meeting where over 60 NIHR doctoral students were learning the art of science communication.  By their own confession they were taken out of their comfort zone.  No more so than when they had to test their ideas in front of our excellent lay advisory panel.  It forced them to think differently, to re-interpret their knowledge and expertise from a public and patient viewpoint.  But the outcome in terms of their plans and ideas was superlative.

So what about the NHS Commissioning Board Draft Mandate from the point of view of public and patient involvement in research?

Unsurprisingly most attention has been drawn to page 26 of the Mandate headed’Promoting growth, research and innovation’ which looks at the role of the Board in promoting research by:

  • Working with research funders
  • Improving adoption and spread of new technologies
  • supporting patient participation in research

Objective 17 and associated Annex B set out more precisely how this will be achieved and measured.  The commitment to measure increasing patient recruitment is important.  It is my view that this data should not only be about participation rates (already available through the clinical research networks), but also the extent to which patients are being offered the opportunity to take part in research  (a possible role for the Care Quality Commission (CQC) through its annual patient survey).  Together, these measures would tell us much about the extent to which the NHS is realising its duties in terms of research and patient choice.

For what it is worth, my own view is that the real game-changer in the Mandate when it comes to participation, falls within the ‘Choice Framework’ set out in Annex D.  For this begins to set – for the first time and in some detail – the expectation that patients should be offered the opportunity to take part in relelvant and appropriate research as part of their care and treatment.  It gives them and us license to challenge the system to make that choice a reality.  As will the reviewed and renewed NHS Constitution when it comes out in draft form this autumn.  Or I hope it will anyway!

The less satisfying aspect of the Mandate is the weakness of its statements on public involvement – as National Voices has already pointed out.    In fact, it is very poor indeed.  I already have a growing sense of unease over the new corporacy which may be creeping over some Clinical Commissioning Groups (CCGs) as they tackle the issue of public involvement.  A number of CCGs are clearly in the search for those with specialist expertise and skills, as opposed to finding those who can reflect and articulate the patient voice.  Others, on the other hand, are doing their best to get it right.  But it is difficult to get a cohesive picture of what is happening because the signals are intermittent and often broken-up.

So I would say this.  It is important that we respond to the consultation on the Mandate to support and strengthen its statements about patient choice and research.  But equally important is to hear people’s experiences about what is happening with public involvement locally, good and bad.  For we must make the case that, in order to meet its objectives, the NHS Commissioning Board has to ensure a better foundation for public involvement than it has thus far.

Only if we provide space for patients to challenge the system will we see improvements in the way that care and treatment is provided and people’s choices honoured.