Joint Committee on the Draft Mental Incapacity Bill First Report

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 difficult area".

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."[300] 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".[301] The Royal College of Psychiatrists said that they would support the framework for research set out in Section 51 of the Scottish Incapacity Act.[302]

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".[303] 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.[304]

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 in research".[305] 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".[306] 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, fully understanding …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".[307] 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.[308]

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.[309]

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 respected.
  • 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 profession.

300   Q73 (Dr Lyons, Professor McMillan, Dr Bowden) Back

301   Q73 (Dr Lyons, Professor McMillan, Dr Bowden) Back

302   Ev 104 MIB 824b para 3.2 Back

303   Ev 104 MIB 824b para 3.2 Back

304   Ev 104 MIB 824b para 3.2 Back

305   Q247 (Dr Nathanson) Back

306   Q247 (Dr Nathanson) Back

307   Q249 (Dr Nathanson) Back

308   Ev 120 MIB 1205 para 14 Back

309   Ev 120 MIB 1205 para 17 Back

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