The
Committee consisted of the following
Members:
Chairman:
Mr.
Eric
Martlew
Cryer,
Mrs. Ann
(Keighley)
(Lab)
Field,
Mr. Frank
(Birkenhead)
(Lab)
Gidley,
Sandra
(Romsey)
(LD)
Gilroy,
Linda
(Plymouth, Sutton)
(Lab/Co-op)
Goodwill,
Mr. Robert
(Scarborough and Whitby)
(Con)
Gray,
Mr. James
(North Wiltshire)
(Con)
Hepburn,
Mr. Stephen
(Jarrow)
(Lab)
Hollobone,
Mr. Philip
(Kettering)
(Con)
Jackson,
Mr. Stewart
(Peterborough)
(Con)
Kilfoyle,
Mr. Peter
(Liverpool, Walton)
(Lab)
Loughton,
Tim
(East Worthing and Shoreham)
(Con)
Prosser,
Gwyn
(Dover)
(Lab)
Pugh,
Dr. John
(Southport)
(LD)
Tami,
Mark
(Alyn and Deeside)
(Lab)
Ward,
Claire
(Lord Commissioner of Her Majesty's
Treasury)
Winnick,
Mr. David
(Walsall, North)
(Lab)
Winterton,
Ms Rosie
(Minister of State, Department of
Health)
Mark
Oxborough, Committee
Clerk
attended the Committee
Fifth
Delegated Legislation
Committee
Thursday 8
February
2007
[Mr.
Eric Martlew
in the
Chair]
Draft Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007
8.55
am
The
Minister of State, Department of Health(Ms Rosie
Winterton):
I beg to
move,
That the
Committee has considered the draft Mental Capacity Act 2005 (Loss of
Capacity during Research Project) (England) Regulations
2007.
The
regulations make transitional arrangements to assist in the
introduction of new safeguards relating to research involving people
who lack capacity to consent. First, I want to put the regulations in
context. The Mental Capacity Act 2005 provides a statutory framework
for people who lack capacitythat is, who cannot make their own
decisions because of an impairment, or disturbance of the mind or brain
such as dementia, brain injury or mental health problems. The Act
includes a statutory framework for research involving people who lack
capacity to consent to their participation. These provisions in
sections 30 to 34 of the Act balance the importance of properly
conducted research on the treatment or care of people who lack capacity
with the need to protect their interests and respect their current and
previously expressed wishes and
feelings.
The Act
applies to research that is defined as intrusive, which
would normally require a persons consent in order to be
lawfulfor example, consent to the taking of blood during a
medical check-up that is part of a research project. The Act applies to
a wide range of research and is particularly relevant to health and
social care research. However, it does not cover clinical trials of
medicines, which are governed by separate regulations that implement
European Union
directives.
The Act
requires a researcher to obtain approval from an appropriate
bodya properly recognised research ethics committee, as
defined in separate regulations made on 19 December 2006 and laid
before Parliament on 11 January 2007. The research ethics committee
must be satisfied that the research project meets certain requirements
set out in the Actbroadly, that the research relates to a
condition that impairs or is thought to impair the persons
capacity, and that it is necessary and safe. It must also be satisfied
that arrangements are in place to consult a suitable person, as set out
in the Act, about the participants previous wishes and
feelings, and to ensure their safety. For example, if the person at any
time says no, or shows any signs of distress or dissent, the researcher
must not include them, or must stop including
them.
The
general policy intention of the regulations was signalled during the
passage of the Act in Parliament. The Government recognised the
importance of a smooth
transition to the new arrangements, to give protection to people without
capacity, without having to stop long-term research studies or causing
unnecessary bureaucracy for researchers or research ethics
committees.
We are
aware that there are a number of extremely important long-term health
studies that track thousands of people over many years or
decadesfor example, the Whitehall study of
10,000 civil servants to investigate links between work, lifestyle and
ill health, such as heart disease. In that, and in most other cases,
people have capacity to consent to participate in the study. They
attend regular check-upsperhaps annuallyand provide
health information and blood samples. Between these check-ups,
researchers analyse the information and blood samples in a laboratory.
There may also be links to a patients medical records to
identify particular diagnoses, such as heart attacks or angina. Over
time, some of the participants might suffer injury or ill health and
lose the capacity to consent to continue participating in the
study.
When
the Act is fully in force in October, researchers will need to comply
with the arrangements that I have referred to, in order to continue to
involve the person in the research studyfor instance, to take
fresh samples at a medical check-up. If they cannot comply with these
requirementsapproval by a research ethics committee,
consultation with an appropriate person and the other
protectionsthey will have to withdraw the person from the
study. However, we have used the powers in section 34 of the Act to
make these regulations, enabling researchers in certain circumstances
to continue research on the information and blood samples taken before
the person lost
capacity.
The
Government listened carefully to the debate in Parliament and the views
of research groups such as the Medical Research Council and the
Wellcome Trust about the status of consent given by a person with
capacity. Sometimes consent will clearly have anticipated the loss of
capacityfor instance, consent to research done during
surgerybut other consent might not have anticipated it, or the
cause of the loss might have little to do with the subject being
researched. Consent previously given cannot necessarily be relied
on.
When we developed
the proposals for consultation, we took all those views into account.
We are proposing the development of a mechanism allowing researchers to
continue research where the Act would otherwise have applied, if a
person has consented to participate in an existing study and then loses
capacity. However, that transitional easement applies only to
information and material collected prior to the persons loss of
capacity. It does not cover any new intervention, or the collection of
new
material.
Mr.
Peter Kilfoyle (Liverpool, Walton) (Lab): I think that my
right hon. Friend has already answered this, but can she confirm that
we are talking about permanent
incapacity?
The limits on the
transitional easement mean that if a researcher wants to take more
samples, or carry out another health check, they will have to meet the
full requirements of the Act. The easement applies only in
cases where the research has started before 1 October 2007, and where
the person consented to take part in it before 31 March
2008.
Although
the regulations are transitional, they will have a long-term effect. To
reiterate, they will apply only where, before 31 March 2008, a person
has consented to take part in a research project that started
before1 October 2007. That allows for projects that will have
started when the Act comes into force but have not finished recruiting
participants. If those conditions are met, the regulations will apply
regardless of when the participant loses capacity. For example, a
person could join an existing study in October 2007, or January 2008,
and might lose capacity in the 2020s, and the regulations would
apply.
Tim
Loughton (East Worthing and Shoreham) (Con): I may be
missing something, but is there any reason why the regulations could
not be superseded simply by bringing forward the implementation of the
Mental Capacity Act
2005?
Ms
Winterton:
When the Act comes into force, an entirely
different code will apply. I will come to that. Any new research will
be covered by different guidance stating that before any research is
started, the loss of capacity will be anticipated in the consent that
is given. That is what we would advise people to do. We are enabling
people to prepare for when the Act comes into force and to take
advantage of the transitional arrangements for the use of material that
might already have been collected. We are seeking to ensure that the
research community has enough time to prepare for the
changes.
Regulation
3 states that in cases where the regulations apply a researcher can
continue using information obtained before loss of capacity if they
satisfy the requirements in schedules 1 and 2.
Information means data as defined in the Data
Protection Act 1998, or material containing human cells or DNA.
Schedule 1 requires that the research ethics committee has approved a
protocol and is satisfied that there are suitable arrangements for
complying with the requirements of schedule 2. We certainly envisage a
central role for the research ethics committees expertise in
judging what is appropriate for different types of
research.
Schedule
2 sets out what the researcher needs to put in place when they become
aware that a participant has lost capacity to consent. It repeats the
relevant safeguards from sections 32 and 33 of the main Act. That means
that a suitable consultee, normally someone who cares for the person or
who is interested in their welfare, must be identified and given
information about the project. They will be asked to advise on whether
the person would want the samples or data already taken to continue to
be used in the research in line with the arrangements set out in the
protocol.
The
consultee will, of course, need to consider the fact that the person
without capacity would originally have consented to take part and that
that should be a powerful indication of their wishes and feelings at
that time, but they may also be aware of other factors that are
relevant to the decision, such as other views made known by the person
who lacks capacity. The researcher must also respect the wishes and
feelings
expressed by the person involved, so they must not do anything that
contradicts any advance statement of wishes of which the researcher
knows and they must not continue if the person indicates in any way
that he has an objection. The interests of the person must be assumed
to outweigh the interests of science and society.
On a practical note, the
Government have made it clear to the research community that there is
not a new duty continually to monitor the capacity of all of the
research subjects. In keeping with section 2 of the Act it must be
assumed that a person has capacity unless shown otherwise, but if
information becomes known to the researcher, for example, via contact
from the next of kin, from direct observation or from other medical
diagnoses, they will need to apply the protocol.
The Government are aware that
researchers and research ethics committees need further advice and
guidance on how to apply the 2005 Act. There is also a need to
understand how it aligns with the Data Protection Act 1998 and the
Human Tissue Act 2004. We are including a chapter on research in the
2005 Act code of practice that will be laid before Parliament soon. We
are also working with the Central Office for Research Ethics Committees
and the Medical Research Council to provide guidance and training
materials. This, and guidance on the selection of consultees, will be
made available between now and 1 October 2007.
The transitional provisions I
have outlined are intended to help researchers on existing projects
with the transition to the new requirements of the 2005 Act. I
emphasise that the Government are extremely supportive of the need for
properly conducted research of this kind. We would not wish to stand in
the way of research to develop the best treatment and care for people
who suffer from conditions that affect their decision-making capacity,
such as Alzheimers disease, dementia or other causes of chronic
ill health. At the same time we are committed to ensuring that the
rights and dignity of those who lack capacity are protected.
The regulations achieve a good
balance between facilitating research and ensuring protection for
participants without capacity. People without capacity have a right to
enjoy the benefits of good quality health and social care research and
to have their wishes and dignity respected. I commend the regulations
to the Committee.
9.9
am
Tim
Loughton:
These are technical regulations and I commend
the Minister on the way she read out the explanation of them. We
support what they are trying to do, just as we supported the Mental
Capacity Bill. It may take those of us who did not serve on that
Committee a little longer to get our heads around the technical
implications of these and other regulations associated with the
measure.
I shall ask
the Minister a few questions for clarification and to obtain more
detail on the proposal. The legal protections that are referred to are
covered only in common law and it is right that they should be
formulated within the Act. It has been widely welcomed by the major
medical bodies, so I do not dispute it, but can she give us an idea of
how widespread the problem is of research being carried out that must
be aborted because of loss of capacity?
She also said that there are a
lot of safeguards in the regulationsI agree, and they are
rightbut that the research would have to be discontinued if the
subject showed any distress or harm. It is difficult to find what that
might mean. A frail old lady suffering from dementia in a home, from
whom a blood sample is taken as part of some of the research that the
Minister described, could easily be deemed to suffer distress. Is it as
simplistic as that? Would the research have to be discontinued? As the
Minister said, we must be able to carry out essential research in
matters about which we do not know an awful lot and about diseases that
affect an increasing number of ageing people. We must be realistic
about how it can be applied, rather than having to discontinue it at
the first wince. Could she elaborate on how that will
happen?
How many
people are we talking about? How many research projects are likely to
run in a normal year? Does the Minister expect that as a result of the
regulations, we will see a proliferation of research projects because
it will now be easier to carry out such research? Is she happy with
that
by-product?
What
sort of research are we talking about? The notes accompanying the
regulations refer to invasive research and the use of tissue; the
Minister mentioned blood samples. I recently had an interesting letter
from a mental health user forum that referred to the practice of
lobotomy, which is technically termed neurosurgery for mental
disorder. I was unawareI have not checked this, and I
would be grateful for her comments, because it is relevant to research
covered by the regulationsthat it is still practised legally in
this country. Indeed, parts of the proposed mental health Bill would
make it more widespread. Is lobotomy covered by the regulations?
Apparently, neurosurgery for mental disorder is performed in two
locations in the United Kingdomthe University hospital of Wales
in Cardiff and Ninewells hospital in
Dundee.
The
Chairman:
Order. We are keeping to research, are we
not?
Tim
Loughton:
Lobotomy is specifically for
research, Mr. Martlew. Previously, it was practised quite
widely in the US, Japan and Britain, and an estimated 50,000 patients
were practised on in the UK alone. Some of that might have been deemed
to be of therapeutic benefit, but a lot of it was deemed to be for
research. The operation involves removing part of the brains
frontal lobes or severing the neural fibres connecting the frontal
lobes to the limbic system, the part of the brain concerned with
emotional response and functions not under conscious control. I was
slightly alarmed when I read the letter. Hypothetically, the
regulations could apply technically to lobotomy. I should be grateful
for the Ministers clarification. It would be useful to know the
invasiveness of the
research.
Schedule 1
refers to protocols having to be established. How are those protocols
to be established? Will they be set down by national bodies? Is their
establishment going to be left to local health bodies carrying out the
research or to the trust effectively controlling them? Will the
Government be setting down parameters for the protocols?
Schedule 2 refers to nominated
persons, a carer or family member perhaps, being kept in touch with the
patients condition and being able to take a decision as to
whether they want the research discontinued. How will they be kept in
touch with that research? These are very technical issues. Again, will
there be protocols set down as to whether they should be notified on a
regular basis as to how the research treatment is taking place? How
will they be judged to be able to make a reasonable judgment themselves
as to whether that research should be discontinued?
Paragraph 6 of schedule 2 says
that the nominated person must
ensure
that nothing is
done in relation to
the
person or subject
during
the course of the
research which would be contrary to...(a) an advance decision of
his which has effect, or (b) any other form of statement made by him
and not subsequently
withdrawn.
What
culpability attaches to the nominated person if those considerations
are breached unwittingly? What liability falls on the nominated person
to make sure that he or she is fully apprised of advance decisions and
statements? The statement may have been made by somebody who has
capacity while in a residential home to somebody else, but is not then
communicated to the person who is or becomes the nominated person. I
foresee the possibility of the nominated person being kept slightly out
of the loopbecause they could not possibly understand the
extent of the researchby some over-keen researchers. We do not
want the whole thing to be aborted because of misunderstandings and
somebody believing on unreasonable grounds that harm is being done to
the patient.
I will
make a couple of other points. The regulations say that any research
must benefit the person directly, or people in the same category. How
does the Minister define that therapeutic benefit? Interestingly, that
is potentially in conflict with what the she wants to achieve with the
Mental Health Bill, in which she is trying to remove the treatability
or therapeutic benefit provisions. Is there going to be an
inconsistency between how we treat one type of person lacking mental
capacity under the regulations and another type of person covered by
the Mental Health
Bill?
The
Alzheimers Society says that many local ethics committees turn
down research applications flat on the basis that people in the later
stages of dementia cannot consent to research. Apparently, positive
proposals are not even considered by ethics committees because of
consent issues. How will the Minister ensure that professionals receive
proper training in, and knowledge of, the new regulations to make sure
that ethics committees are rather more flexible and sensitive to the
value of certain research? What consultations have the Government
carried out to ascertain the effect of the regulations and whether they
achieve the balance between protecting individuals and carrying out
valuable
research?
Finally,
my hon. Friend the Member for Daventry (Mr. Boswell), who
served on the Committee considering the Mental Capacity Bill and is far
more au fait with its contents and implications, has raised a couple of
points, which he has asked me to put before the Committee. He queries
whether it would be possible in practice to differentiate information
or material obtained with consent before the loss of capacity from that
obtained subsequently,
after the loss of capacity and therefore under a different legal regime.
How do the thresholds come in? When is it deemed that someone has lost
their capacity in relation to when the research took place? We are not
necessarily talking about a point on a certain day that observations
were made. We are talking about continuing research observations over a
longer period of time.
Secondly,
are the safeguards set out in the regulations for the exceptional cases
that we are talking about during the transition period absolutely
square with those for research projects undertaken after the start
date? Thirdly, as my hon. Friend the Member for Daventry mentions, in
normal circumstances the research will require sanction by an ethics
committee. There will be additional safeguards such as family consent.
On the other hand, if the person concerned is in a permanent state and
unlikely to recover during the research project, it could be argued
that the clauses are not compliant with the general principle of best
interest. Perhaps the Minister could comment on that.
I have a series of questions,
some of which are almost as technical as the regulations themselves,
but I hope that the Minister can give a general response to them. If
there are further considerations, she may want to come back to those. I
am particularly intrigued by the scenario of lobotomy. Her answer will
enable me to reply to the people who sent me that query. I will be
grateful for any answers that she can
provide.
9.21
am
Dr.
John Pugh (Southport) (LD): I have no problem with the
intent of the regulations. It is their effect that concerns me, and
there remain some residual doubts even after the Ministers very
good explanation. As I understand it, the object is to authorise
research involving, but not necessarily benefiting, people with limited
or no mental capacity.
There are good reasons for
research. Some conditions are extremely dangerous, hazardous and
unfortunate and research needs to take place. However, there are also
real concerns, because we are talking about people who are vulnerable
and often institutionalised. I think that we all accept that there is a
definite need to see that such people are not simply used as research
tools to their obvious detriment, and that is what the regulations
intend to address. They do not insist that there must be a recognisable
benefit.
I will try to
explain to the Minister the situation as I see it, and she can correct
me, presumably from a point of greater knowledge, when I go wrong. The
regulations do not necessarily have to result in a recognisable benefit
for the person being researched on. They seem to include simple
research into data and DNA matters, but they insist on all research
being properly authorised by what is called an appropriate body. The
hon. Member for East Worthing and Shoreham has said that he would like
some more clarification on what an appropriate body might be. I think
that it is specified in the Mental Capacity Act 2005, but the Minister
will no doubt clarify
that.
There
must be prior consultation with a carer who is not professionally
involved in any therapeutic procedure with the patient or the
individual being researched on. The carer must be willing to be
consulted. If such a person cannot be found, a nominee uninvolved in
the research must be appointed subject to the guidance of
the Secretary of State. That guidance is not currently before us.
Further precautions appear to be that the identified personthe
nominee or carermust be consulted on the nature of the research
and give some view on what the patient wishes. Overriding that is any
expressed wish of the patient themselves, which must be attended to and
responded to emphatically. A further caveat is that throughout the
whole procedure, the dominating principle is that the patients
wishes are to be put before the interests of science and society. Based
on that, it could be suggested that the regulations are a
belt-and-braces job.
I have certain reservations,
and I would like the Minister to reassure me about the issues that
concern me. First, the guidance from the Secretary of State about who
is an appropriately nominated person needs to be fleshed out. Who can
be nominated? Can it be any person of appropriate experience? Does it
need to be a person who knows the particular subject of the research?
The relationship of the carer is somewhat loosely defined. Both the
carer and nominated person are the gatekeepers for the research. I am
not convinced that the gate is quite as effectively attended as it
might be.
Secondly and
more substantially, there does not seem to be any procedure for a
sustained audit of the research. In other words, once the research is
under way, I am not satisfied on the basis of what I can see at the
moment that due concern will always be in place. The carer with
permission might be relatively remote, the researcher might be easily
persuaded and the individual might be simply incapable of understanding
what is going on. I doubt whether we will get to a stage at which
pre-frontal lobotomies are done casually in the nature of
researchI understand that, pre-war, that was a standard
therapeutic procedure for violent schizophrenicsbut I cannot
imagine any research project getting through an ethics committee by
suggesting that such a procedure is simply research, however badly
informed the committee might be.
Various other considerations
that are beyond my ken might impact on some of the reservations that I
have put forward. Clearly, there are regulations regarding clinical
trials, and, if things go wrong, there might be a threat of subsequent
liability and court procedures to give a caution to any researcher who
is thinking of pushing the boundaries a little.
I could be reassured if the
Minister told me that the regulations had been properly consulted on
and endorsed by all relevant groups that have an interest. I was not on
the Committee that considered the Mental Capacity Bill, and I have not
seen the subsequent code of practice of which the Minister
spokeI do not think that anyone hasso I remain
sceptical, but open to persuasion. Obviously, I would be more reassured
if I was told that the arrangements and the regulations are of a purely
provisional and technical kind, as they might be. I would be equally
reassured if she said something about what consultation preceded them
and what further pieces of legislation are needed to improve and
clarify the
position.
9.27
am
Mr.
Robert Goodwill (Scarborough and Whitby) (Con): I have
just one question. Has the Minister anticipated circumstances in which
a carer withdraws a
patient from a trial for reasons other than their welfare? For example,
the carer might have strong views on animal testing and part of that
research might also involve animal testing. Would the carer have to
justify withdrawing the patient on the ground that it affects their
welfare, or could the carer make that decision for other reasons that
are not connected to the patient without there being any recourse to
challenge that
decision?
9.28
am
Ms
Winterton:
I thank Opposition Members for their support
for the regulations, which is in keeping with the spirit of the Mental
Capacity Act. We must be clear about what we are discussing with these
regulations. Normally, the Act would cover research that involves
people without capacity. Starting from there, the research would need
to be on something affecting the person without capacity. For example,
research on someone with Alzheimers would have to be related to
that kind of condition or to losing capacity. However, the regulations
are concerned with people who have been involved in a long-term study
that might not be related to capacityI referred to the
Whitehall study that looked at the links between work
and heart disease.
The regulations cover the
information and data collected when such a person had capacity and what
can be done with them when that person loses capacity. If a researcher
wished to continue to take blood samples from such an individual as
part of an ongoing study, they would have to return to the research
ethics committee and follow all the regulations under the Act on
whether they could do so. They would have to consult the carer or other
relevant person on whether tests should continue. The regulations are
about information and data gathered during research prior to a person
losing capacity and how that research can continue.
In future,
when a research study starts, those undertaking it will know our
guidance to the research ethics committees and will anticipate what
might happen if a person loses capacity, so their wishes will be
obtained beforehand. The regulations cover a narrow set of
circumstances. As for ongoing studies, which the hon. Member for East
Worthing and Shoreham mentioned, there are probably about 20 major
projects to which the regulations will be relevant. Those studies will
not have to be aborted; the regulations relate to how information
collected in them on somebody who subsequently lost capacity can be
used.
The hon.
Gentleman asked about people in care homes who show signs of distress.
As I have said, if a researcher wanted to continue to do research on
such people, he or she would have to get permission in line with the
Act. If someone shows any sign of distress, such as pulling their arm
away when blood is to be taken, that will be taken as a sign of their
not wanting to participate and the researcher will have to stop. They
will also have to stop if a person says, No, I dont
want you to do that. That point does not apply to the
regulations, which are just on information and data already
collected.
The hon. Gentleman asked whether
the regulations would lead to a proliferation of new projects. We
expect long-term projects to continue, but we will address in the code
of practice and with the research ethics committees how we anticipate
them working. We anticipate that the projects will remain the same but
that the problem of people losing capacity will be
covered.
Lobotomies
are a procedure quite different from the long-term research projects
that we are discussing today. If somebody were to have a lobotomy and
gave permission in advance for residual tissue to be used, that would
not come under the
regulations.
We are
working with the ethics committees on the protocols that will be
established. It is important to recognise that we are not trying to lay
down what every research ethics committee should do when a researcher
makes proposals to get consent and deal with the matters in question.
We are working with the Central Office for Research Ethics Committees,
which advises and issues guidance to ethics committees, on how to
implement the 2005 Act, and we shall continue to do
so.
Tim
Loughton:
I want to return to the issue of lobotomies,
because I am unclear about the distinction between research and
procedures. The regulations refer to tissues. I presume that some form
of procedure would be required to obtain tissues from somebody. I want
an assurance from the Minister, because my reading of the regulations
is that a lobotomy could take place in the name of
research.
Ms
Winterton:
I am not aware of any long-term studies on
lobotomies. We are talking about somebody who may be participating in a
long-term trial involving taking blood samples over time and storing
those. We are talking about how to get consent to use those blood
samples for ongoing research if a person loses capacity. A lobotomy is
significant surgery that can only be carried out if it is in a
persons best interests and is appropriate as part of their
care. There may be an element of researchthe use of data or
samples gathered as part of the surgerybut the provisions that
we are talking about do not authorise any risks to be taken that would
not be medically
appropriate.
Mr.
Kilfoyle:
On a more relevant point, I echo what the hon.
Member for Southport said about the audit. The Minister knows, as do
other Committee members, that we cannot foresee every eventuality. I am
mindful of what happened with the organ retention scandal at Alder Hey,
which was acting within the parametersset for research at the
time. However, a set of circumstances had evolved that led to quite a
scandal. Without providing details, I can envisage a similar situation
arising, if we were not careful, if such research was not properly
audited.
Ms
Winterton:
We introduced the Human
TissueAct 2004 in response to the tragic events at Alder Hey.
However, research in respect of people without capacity comes under the
Mental Capacity Act 2005. Through a combination of the 2004 Act and the
changes that we are making here, we are trying to establish a proper
legal framework for any research that takes place, so that proper
consent is obtainable and not getting that consent is against the law.
It is important that that legal framework is in place so that people
who go outside it would be breaking the law. We will continue to work
with research ethics committees and to issue guidance so that they can
be clear about what researchers are and are not able to
do.
Hon. Members have
touched on an important question: how do we ensure that a person has
lost capacity? How would that be checked? Much research may take place
after a person has a medical check once a year. Once a person is in
touch with a clinician, I should have thought that it would be obvious
if they had lost capacity. However, some studies have regular
newsletters and so on, and we would expect next of kin to inform the
researchers that a person had lost capacity. We should not expect
researchers constantly to go back to individuals to check whether they
have lost capacity; that is what the research community was worried
about. The subjects are not necessarily people who are constantly in
touch with the medical profession; they might just have an annual check
at which a blood sample is taken. That is the point at which, if it is
obvious that the person has lost capacity, the requirements of these
regulations will have to be met.
The regulations apply simply to
the datablood samples, for examplethat have been
collected, and whether they can continue to be used for research
purposes. For new interventions, researchers have to go back and get
proper authorisation. The regulations do not permit any physical
intervention; that would require full compliance with the Act. That
covers the point that was made about
lobotomy.
Dr.
Pugh:
The audit that I mentioned was not in connection
with whether the person has capacitythat can be clearly
established, and there is probably no disagreement about it. We are
trying to rule out processes that are more intrusive than simple blood
samples, and asking whether a continuing check is taken on research to
see that it has all the benign effects that the people who originally
consented to it thought that it had.
Ms
Winterton:
As I have said, if there is continuing physical
intervention, the researcher has to go back to the ethics committee,
and he has to obtain consent from a relative carer for any new
intervention. Once it has been established that a person has lost
capacity, the
Act kicks in with regard to continuing intrusive intervention. Intrusive
interventions are considered to be procedures for which one would
normally have to obtain consent, such as the taking of a blood
sample.
It is
important to take advice about advance decisions because they concern
areas in which, at some stage, a best judgment must be made. In this
case, if an individual had participated in a research project during
the whole time that he had capacity, had signed up to it and had gone
along willingly, one could safely assume that he would want the results
of what had happened during that time to be used. Of course, if the
person advising on whether that individual would want the research to
continue felt suddenly that it had entered an area that they did not
approve ofthis is so unlikelythey would be able to say,
Stop! But, quite honestly, when people take part in
research, they must be absolutely clear in the first place as to what
is involved.
The
Whitehall study looked in particular at the
relationship between work and lifestyle, and heart disease. If a person
suddenly changed their mind in the last few months of having capacity
and decided that they did not want further research done into heart
disease, a relative could say, Well, they changed their mind at
the last minute and decided that they did not like research into heart
disease. Therefore, that point would be covered. On the points
raised by hon. Member for Scarborough and Whitby, as I have said,
withdrawal from research is not really covered by the regulations
because they relate to previously collected
information.
Finally,
the regulations were consulted on, between June and September 2005,
with a wide range of groups. We received 38 responses, all of which are
addressed in the regulations and the documents relating to them, which
have been provided to the Committee. We also debated the matter quite a
lot during the passage of the Act. We did not want to stop any ongoing
research or create confusion over what was going to happen, and a
transitional process was requested.
I shall check
the record to see if there is anything that I have not covered, but I
hope that with those reassurances, the Committee will support the
regulations.
Question
put and agreed
to.
Resolved,
That the Committee has
considered the draft Mental Capacity Act 2005 (Loss of Capacity during
Research Project) (England) Regulations
2007.
Committee
rose at thirteen minutes to Ten
oclock.