By increment, our freedoms do they steal; by notch and by notch, they raise their banner high.
Just over a year ago, there was a police
intrusion at our scheme which caused upset and concern to certain of our clients; dismay and alarm to
others...
Liverpool Care Pathway - Data Is Power
Police have powers of entry to search a property without a warrant and this may be authorised
by a senior officer. Whether those powers were crossed on this occasion by entering our client's room is a fine line.
By ruse and by subterfuge, the Kings men may make an entry by manipulation of the tools provided to them. The Barons must make good and renew
their Great Charter.
Provision of support to our clients may extend to accompanying them in pursuit of claims.
Information is shared between departments at national and local level. The Local Government benefits department at a Council office near you has apparent full access to the DWP system.
Confidentiality was once respected as a matter of duty. It did not require laws to protect this. There were ways to behave and ways not to behave. Information provided was not passed on. It was in confidence.
Since the advent of laws to 'protect' personal information, this has broken down entirely. The Data Protection Act, for instance, acts only as a hurdle the legitimate user must jump, not as a protective device at all.
Recently, a client made a first claim for JSA (Job Seeker's Allowance). That is not such a simple thing these days. You have to prove who you say you are.
Our client took all the documents required of them and went upstairs for the interview. Twenty minutes later the client reappeared in a state of dismay. The interview could not proceed.
The photo ID, a passport, was three years out of date. It was the only photo ID they had. A barrage of 'security questions' had been thrown at them. Not normal things like date of birth but what was the last ESA payment that went into their account and when was it paid. They didn't remember; it isn't the thing you necessarily commit to memory.
They remembered the full amount of the benefit payment and that was the figure they gave. They were told this was wrong. This did cause consternation because the figure was correct. And they were being told it was incorrect.
Do they have a credit card? No, they have no credit card. Utility bills? No, they pay a service charge.
They were asked the name of their GP practice. They gave this. And before that? There was none, not that they knew. The practice had moved. Was this a trick question?
Protest was made on the client's behalf. We could verify who they said they were. No, the client would have to return at two o'clock with further requested documents and information.
The client ascertained that there was a prior GP practice. This was when they were barely old enough to remember anything at all. How would they know? How did the Job Centre know?
We returned, armed with what was required.
We challenged them directly. Do they have access to medical information on line? Only what the client provides. But the client could not and did not provide information which they were not aware of, that they had been too young to remember at the time.
Would we please permit the interview to proceed.
Just answer the question and we will retire. We said we would complain to Caldicott.
They have access only to what the client provides.
What is going on?
Benefit provision is integral in health and social care. It is inefficient not to share information. Information is power. Information is control.
Ask them their three main priorities, Number Six, and they will tell you:
information, information, information.
Our part and complicity in this is integral. Once the information bucket is dipped into the temptation is going to be to dip into it some more.
Once permitted and left unchecked, this will slip and slide down a slippery slope, as all things inevitably do, and spread inexorably.
The way we manage and share information about people who are
in contact with health and social care services plays a pivotal role in
achieving higher quality care and improving outcomes for patients and service
users.
The way we manage and share information about people who are in contact with health and social care services plays a pivotal role full stop.
The 10-year National Strategy for Information and Technology in Health
and Social Care identifies significant financial benefits, including cost
savings, efficiency and productivity improvements, as well as non-financial
benefits from investment in appropriate information and technology.
ACDs are 'Good Practice'.
The
National End of Life Care Programme (NEoLCP) sees the introduction of
Electronic Palliative Care Coordination Systems (EPaCCS) as a key contribution
to this wider strategic objective. The sort of benefits envisaged are, for
example, demonstrated in a case study of an economy-wide electronic care record
where improvements in diagnosis, reductions in unnecessary appointments and
tests were demonstrated.
- Economic Evaluation of the
Electronic Palliative Care Coordination System (EPaCCS) Early Implementer Sites
Is information sharing now dipping into the NHS dot Data bucket?
It is ‘okay to ask’...
The NHS is a data pot.
The potential of the NHS as a research platform is now being exploited
and realised.
The National Institute for Health Research (NIHR) was created in April 2006 under the 2005 Government strategy for health research: Best Research for Best Health.
Achieving appropriate levels of participation has always been a
significant hurdle to research.
This is Trials Journal –
In the United Kingdom, the overarching vision of the National Institute for Health Research (NIHR) is to see ‘more patients and health professionals participating in health research’
Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.
We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions.
All trials which take place in the UK have to be authorised by the MHRA (Medicines & Healthcare products Regulatory Agency). The MHRA decides if they are scientifically valid and properly designed.
But, now, it's okay to ask.
There are three stages of drug testing in humans. Trials are
approved by an ethics committee.
Phase one tests for safety. People, sometimes
healthy and sometimes with a medical condition, are given a small dose of the
drug, not to test if the drug works, but in order to
check for any side effects.
Phase two tests the drug on a small scale.
Phase three involves larger scale studies.
Participants are
often randomly allocated to either get the drug or a dummy version. In most cases neither the researchers nor the patients know who
has got the real drug so that the results can't be skewed by expectations.
Commercial companies may offer a ‘generous payment for your time and inconvenience’.
The Association of the British Pharmaceutical Industry (ABPI) says
people should not be given financial incentives to take part in research but
they should be recompensed for the time they are giving up. The standard rate
is between £150 and £200 a day.
Patients who agree to join trials are volunteers and may receive
money ‘to cover expenses, loss of earnings or their time’. Doctors may be paid
to recruit patients into trials.
When receiving payments, it might be handy to know that...
HMRC agrees that the amounts paid to those concerned are unlikely to fall within the definition of “earnings” for PAYE or NI purposes. No employment relationship exists and as such PAYE and NIC would be inappropriate.
Under Section 16, Taxes Management Act 1970, HMRC is entitled to ask for details of payments to non-employees at their discretion; but they would not routinely ask for details for small payments such as these.
There will be no tax or
NIC liability arising on the individual if the sums received do no more than
reimburse the individual’s reasonable costs of participating in the trial or
research, including costs of travel and subsistence.
However should the sums
paid exceed those reasonable expenses then the excess may fall to be chargeable
to tax as Miscellaneous Income, potentially giving rise to personal tax
liabilities of the individuals which should be notified to the Inland Revenue
under Self Assessment.
- HMRC
Research may be carried out in the NHS, but some takes place in
universities and research institutes, in social care services, or in the
private sector.
Research that takes place in the NHS may be paid for by one of a
number of different organisations, and often more than one organisation working
in partnership - the Triple Alliance or Triple Entente of State, Third and Private Sectors.
They include: the NHS, through the National
Institute for Health Research (NIHR); the Medical Research Council (MRC);
the Department of Health and
other government departments; medical research charities; pharmaceutical and
other healthcare companies.
Everywhere, wherever, at every NHS facility, you will now be confronted with the comforting knowledge that it is...
Because their funding is dependent on that...
In future, our funding to providers of NHS services is becoming conditional on meeting benchmarks, including a 70-day benchmark to recruit first patients for trials. This was made a condition of new contracts from Autumn 2011 and performance affects funding from 2014.
NHS providers holding NIHR contracts issued after Autumn 2011 are required to provide, on a quarterly basis, information on recruitment to clinical trials, including commercial contract clinical trials.
Wherever there is a financial motivation can this be said to be either moral or safe?
The Healthcare and Life Sciences section of the Plan for Growth (in March 2011) sought ‘simpler’ regulation of
health research at the national level, to remove ‘barriers to enterprise’ and stressed
that health research has a key role in the national economy.
The Government combined and streamlined approvals under a health
research regulatory agency, the NHS NIHR, working closely with the MHRA to
create a unified approval process for clinical trials and promoting ‘proportionate’
standards for compliance and inspection.
Does 'simpler' mean less thorough?
Does 'proportionate' mean less stringent?
It's okay to ask...
Trials are approved by a streamlined ethics committee. Even so, north of the border, up Scotia way, in the circumstance of “Emergency” research...
Subject to the trial having been approved by an ethics committee such "emergency" research can proceed without ethics committee approval and without the consent of any guardian or welfare attorney, or the adult's nearest relative, if :-(i) it has not been practicable to contact any such person before the decision to enter the adult as a subject of the clinical trial is made, and(ii) consent has been obtained from a person, other than a person connected with the conduct of the trial, who is:-(a) the practitioner responsible for the medical treatment provided to the adult, or(b) a person nominated by the relevant health care provider.
- Incapacity (Scotland) Act 2000: Code of Practice
NHS England is enacting a policy of negative rights and 'presumed consent' in their
Business Plan -
We will act as a
facilitator of research – for example, we are planning to investigate a system
of ‘presumed consent’ to take part in research studies for all patients treated
in teaching hospitals.
- NHS England Business Plan
A 'teaching hospital' is a hospital affiliated to a university. And they are all become 'associated university hospitals'.
Further reading -
Liverpool Care Pathway - A Golden Opportunity
They are 'Health Partners'.
At SHP (Surrey Health Partners) -
SHP complements
the University’s ‘One Health’ strategy and is one of several phases of
strategic developments between the NHS and academia. The partnership will
provide a strong platform for NHS and University to achieve their strategic
ambitions of developing Surrey as a major
‘hub’ of excellence for clinical research and education.
Research and
trials in SHP are supported by the Surrey Clinical
Research Centre (CRC). The
Surrey CRC is a MHRA Phase I supplementary accredited experimental medicine
facility that is part of the Faculty of Health & Medical Sciences at the University of Surrey. It is adjacent to the Royal Surrey
County Hospital
and is a specialist clinical pharmacology unit with over 12 years’ experience
of undertaking clinical trials in both volunteer and patient populations.
Developments in clinical technology have had a revolutionary impact on healthcare over the last 30 years, and the arrival of the electronic patient records more than 20 years ago has delivered enormous benefits, to patients, clinical practice and research.
Such as EPaCCS...
The health data held in GP surgeries, NHS Trusts as well as by the Health and Social Care Information Centre (HSCIC), Public Health England and the Clinical Practice Research Datalink service, is world class and is recognised internationally as a major research asset for the UK.
They are 'delivering clinical research'.
They are committed to ‘ensuring faster and easier clinical research,
increase the number of patients who have the opportunity to participate in
research, and enhance the attractiveness of the UK as a host for commercially
sponsored research’.
It is 'good practice'.
And down at a local CMHRS (Community Mental Health Recovery Service) near you they’re promoting OK to Ask, inviting you to visit NIHRC on line and to like them on their Facebook page.
It used to be CMHT (Community Mental Health Team), but that's just politics.
And a new breed of health professional has come on board - the Facilitator.
No, these are not the now familiar EoLC Facilitators; these are Research Facilitators. And they know how to 'deliver NIHR portfolio studies to time and
target'.
They recruit health professionals, patients and collect actual patient data.
They promote initiatives such as the Research Site Initiative (RSI) scheme to GP practices to take part in primary care research...
Funding is available for your GP Practice to cover research infrastructure costs in addition to the usual SSCs paid to cover all agreed study activity related to specific research projects undertaken by the practice. In return for this additional funding, your practice will need to meet specific research related requirements such as Good Clinical Practice (GCP) Training and RCGP Research Ready accreditation.
There are two levels of RSI to match your practice’s research experience and these are summarised below:
Level 1 (£1000)
Level 2 (£2000)
Medical professionals have received payment and been trained to
recruit for the death lists; they are now receiving payment and being trained to recruit for clinical studies.
It is all 'good practice'.
The pool of Data is 'world class' and provides a vast pool of opportunity. All that is necessary is engagement.
How to broach the subject and approach the punter requires coaching and that is part of the Facilitator's role.
A client has recently informed us they will be participating in a trial. They will be paid "ten or fifteen pounds a day".
This is an Orwellian world in which we live. Like Alice, we have, well and truly, stepped blithely Through the Looking Glass.
Is this 'good practice' or malpractice?
'Rights' are not given or granted. They are yours. The Life that is yours was not given or granted; it may only be denied or taken away.
That is the principle and uniqueness of the US Constitution. It is, indeed, a document of negative liberties and positive rights.
We have proceeded to a world of opposites.
We have absorbed the Europa model that Kafka would have so readily recognised. Permission is not sought; it is assumed. Be that Organ Donation, DNR or dot Data.
We challenged them directly. Do they have access to medical information on line? Only what the client provides. But the client could not and did not provide information which they were not aware of, that they had been too young to remember at the time.
Would we please permit the interview to proceed.
Just answer the question and we will retire. We said we would complain to Caldicott.
They have access only to what the client provides.
What is going on?
Our client did not give permission because they did not need to; it was assumed. They did not need to know: it was recorded.
This is Big Data, a pool of opportunity.
Further reading -
Liverpool Care Pathway - Twenty Four
Liverpool Care Pathway - So This Is New Year...
Liverpool Care Pathway - A Cost Efficiency
An Afterword –
Our clients have, and regularly have to endure, 'side effects'. A common one is lumps appearing at the site the depot is given. The medication is suspended in oil to slowly release the drug until the next depot is due. Clients have been told they are 'too skinny'; the oil does not disperse. A previous client's arm was "full of lumps".
Medication commonly has side effects for which 'side-effect' medication may be given which, itself, may be problematical.
There has always been recommendation and facility to report side
effects. The BNF (British National Formulary) - the ‘Doctors’ Bible’ - recommended it; the Yellow Card provided means...
There has always been the ‘blame game’
and these have gone unreported, unadmitted and denied.
My dear mum, just months before her life
was taken, fell victim to a rare condition. This resulted from a topical application.
The condition appeared upon application; the one followed from the other but this was denied. Our own research showed that the condition did result from
allergic reaction to medication. It was still denied. It was the ‘blame game’.
Will the 'blame game', which is endemic in the NHS, also 'skew' results...
Things can, and have, gone wrong...
Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London.
The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction.
Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.
