15 Chapter 15: Medical Research
275. The Draft Mental Incapacity Bill makes no provision
to enableincapacitated adults to take part in medical research.
We have received evidence from the BMA, Royal College of Psychiatrists,
the British Psychological Society (BPS), and the Law Society claiming
that such a clause should be included. We have also received letters
from people who would be extremely concerned to see such a clause
added to the bill. We realise that "this is an ethically
276. We understand that properly-constituted medical
research is the process whereby knowledge about a specific disorder
or problem is obtained in order to inform the development of new
treatments or support strategies that can then be demonstrated
to be effective or not through the use of controlled trials. Such
information is essential if new treatments are to be developed
and if the National Institute of Clinical Excellence (NICE) is
to advise whether those treatments should be freely available.
If properly-regulated research involving people who may lack capacity
is not possible then treatments for incapacitating disorders will
not be developed.
277. We are aware of the stringent arrangements
necessary before any medical research, particularly that involving
human participation, can take place. Most importantly, there is
a requirement that all research must be submitted to an ethics
committee for their approval. These ethics committees always include
lay representation and specifically address significant ethical
questions such as that of informed consent.
278. The AWI Scotland Act does include a clause on
research. Dr Lyons, the Scottish clinician, told us that the Scottish
Act "does permit research involving people with incapacity
under certain restrictions. It must be research into the care,
treatment, causes, et cetera, of the incapacity itself. It must
be research that cannot be performed in people who are capable.
It says in the Act that the research must be likely to be of real
and direct benefit to the adult."
However, Dr Lyons highlighted the difficulty with this legislation
stating that: "if what we were going to do was going to be
of real and direct benefit, we would be doing it, we would not
be researching it".
The Royal College of Psychiatrists said that they would support
the framework for research set out in Section 51 of the Scottish
279. The Royal College of Psychiatrists believes
legislation is needed as "common law does not strictly provide
such authority, as it cannot be argued that research is necessarily
in that incapacitated person's best interests".
We were reminded that if legal mechanisms prevented or deterred
research with such people, then the development of treatments
and the undertaking of treatment trials for disorders such as
Alzheimer's disease would be very problematic. The range of medical
research involving people with possible mental incapacity was
considerable. Other examples include investigating why people
with Down's Syndrome are at such high risk for Alzheimer's disease,
how best to treat the effects of acute brain injury, how to understand
and manage problems such as self-injurious behaviour affecting
people with autism, the causes of potentially very debilitating
mental illnesses such as schizophrenia, or the best treatment
of severe brain disorders such as new variant CJD. Research goes
beyond the medical field and includes investigating factors influencing
the quality of life of people with incapacitating disorders, or
how they can be best helped to make decisions for themselves.
In all these examples, some of the people involved will have the
capacity to consent to research but others may not.
280. We are aware that research sanctioned by
the ethics committees will vary in its invasiveness. It may extend
from no more than asking questions of informants to the direct
physical or psychological assessment of people with incapacity.
It can also include specific investigations such as blood tests
or brain scans. Such research interventions will carry with them
different levels of potential inconvenience or discomfort. Informants
are very likely to have the capacity to decide whether or not
to participate. Assessments and many investigations of people
with incapacity can only take place with their co-operation.
281. The evidence we have received has highlighted
the tension that exists between the potential benefits of research
and the potential for abuse. The well-known abuse of vulnerable
people through 'medical' experimentation led to the Helsinki Declaration
by the World Medical Association in 1964. This Declaration identified
the ethical principles that should guide research involving human
participants (including those lacking capacity to consent). These
principles have been regularly reviewed, most recently in Edinburgh
in 2000. Those engaged in medical research involving those who
may lack capacity are obliged to adhere to these principles.
282. Throughout our discussions we have considered
the moral and ethical considerations of undertaking medical research
on those with lacking capacity. Participation in medical research
should be based on informed personal consent of the individual
involved. We considered whether it is ever appropriate to involve
people in medical research who are unlikely to be able to give
such consent. We note, as described above, that research that
includes participants with specific illnesses or disorders is
essential if new treatments are to be developed and assessed for
effectiveness. This is as true for illnesses that might lead to
incapacity (such as Alzheimer's disease) as it was for usually
non-mentally incapacitating disorders such as cancer.
283. Dr Nathanson, Director of Professional Affairs,
British Medical Association, told us that the lack of such a clause
in the Bill would be "denying patients the possibility of
a real benefit if they do not have the possibility of participating
However she recognised the difficulty of implementing such legislation
and said it would have to be "extremely carefully constructed
in a way that ensures that there is no possibility that individuals
can be victimised or experimented on or exploited in any way,
but providing one tries to build a structure to avoid that, and
I think it is possible to make such a structure, then I think
there are real benefits".
When a person lacks the capacity to give consent, they should
only be involved with medical research, if it is either in their
best interests or if it is the only method of conducting research
into their particular condition and everyone involved with the
person is satisfied that this is a non-exploitative proposal which
will not harm or distress the individual involved.
284. We understand that some people with disorders
that affect decision-making capacity would be capable of deciding
whether or not to participate in research. However a proportion
would not. The legal circumstances at present whereby such a person
might be involved in research were uncertain as research could
rarely be said to be in a participant's immediate best interests
and therefore research was not covered by the principles established
through common law. We are concerned that if research were
to take place in the absence of statute or any regulation the
opportunity for abuse would be greater. It follows that the
inclusion of statutory provisions governing such research would
enable the ethical requirements that must underpin research involving
people with incapacity to be clearly enshrined in statute.
285. Our attention has also been drawn to the European
Clinical Trials Directive 2001, which seeks to implement uniform
rules on the clinical trials of medicinal products and to require
member states to draft specific legislation to do this, including
making provision for the involvement of individuals who cannot
consent. While this Directive is limited to trials of pharmaceutical
products, it is possible that future European Directives may extend
to other forms of medical research and trials of innovative treatment.
There is therefore an argument to include in the draft Bill requirements
for the authorisation and supervision of research involving people
without capacity to consent, in order to comply with the Clinical
Trials Directive and any relevant future European Directives.
286. We asked the BMA how such legislation could
ensure that incapacitated people were not exploited. Dr
Nathanson told us that "we would see the process as probably
being based upon research ethics committees looking at protocols,
that one part of their remit is to make
sure that individuals who cannot necessarily talk for themselves
or express their concerns - that it is their benefit and it is
protecting them from exploitation".
The BPS supported the existing role played by ethics committees,
but told us that the decision-making process of committees could
be enhanced by legislation. Inclusion in the draft bill would
also provide consistency of standards adhered to by the various
ethics committees in England.
287. The BPS told us that Local Research Ethics Committees
(LRECs) should be given powers to reduce the risk of exploitation
on incapacitated adults. They told us that "LRECs should
be given a formal legislative framework for their rulings in this
area. There will be occasions where the research would involve
interviewing a relative or carer and would not present unnecessary
risk or exploitation of the individual concerned. However the
BPS believe that the Mental Incapacity Bill should specifically
require LRECs to insist that individual proxy consent be obtained
for research participation by incapacitated persons.
288. We conclude that a clause should be included
in the Bill to enable strictly-controlled medical research to
explore the causes and consequences of mental incapacity and to
develop effective treatment for such conditions. This clause must
include rigorous protocols to protect incapacitated adults from
being exploited or harmed.
289. We therefore recommend that the Bill should
set out the key principles governing research, such as those enshrined
by the World Medical Association. Those key principles should
include the following:
- research involving people
who may be incapacitated must be reviewed by a properly established
and independent ethics committee and can only proceed if ethical
permission is granted.
- where a person has the capacity to consent
then his decision whether or not to partake in research must be
- considerable care should be taken to ensure
that under these circumstances consent to participate was freely
given and not a consequence of coercion.
- the inclusion of people in research, who lacked
the capacity to consent, must only occur when such research has
the potential for direct benefit to those with that particular
problem and could not have been done through the involvement of
those with capacity.
- those undertaking research involving people
lacking the capacity to consent must respect any indications that
a person did not wish to participate (i.e. was dissenting).
- any discomfort or risk involved in the research
must be, at the most, minimal.
290. We further recommend that the Codes of Practice
should set out the specific issues that ethics committees should
be obliged to consider when any research includes people who may
be incapacitated. These should include:
- Whether the involvement
of people who may be incapacitated is justified given the above.
- Whether issues of consent and consultation
with others has been properly been considered given the nature
of the research.
- Any other matters that seem relevant.
291. We also recommend that the Codes of Practice
should define the duties of research ethics committees in relation
to incapacitated adults. The Codes of Practice should state that
these committees must include people from outside the medical
300 Q73 (Dr Lyons, Professor McMillan, Dr Bowden) Back
Q73 (Dr Lyons, Professor McMillan, Dr Bowden) Back
Ev 104 MIB 824b para 3.2 Back
Ev 104 MIB 824b para 3.2 Back
Ev 104 MIB 824b para 3.2 Back
Q247 (Dr Nathanson) Back
Q247 (Dr Nathanson) Back
Q249 (Dr Nathanson) Back
Ev 120 MIB 1205 para 14 Back
Ev 120 MIB 1205 para 17 Back