THE ETHICAL CONDUCT OF RESEARCH ON THE MENTALLY INCAPACITATED

Working Party on Research on the Mentally Incapacitated

Published December 1991- (Reprinted August 1993)

INTRODUCTION

The Working Party on Research on the Mentally Incapacitated was established by the Medical Research Council (MRC) in July 1988. The Council proposed the following terms of reference:
(i) to consider the adequacy or otherwise of existing MRC statements and the published guidance from other bodies about the conduct of non-therapeutic research investigations in the special circumstances of research on the mentally incapacitated;
(ii) to consider whether, in the light of (i), the Council should formulate new guidance, and if so prepare advice on the ethical conduct of research on the mentally incapacitated taking account of the existing guidance and supplementing, extending and modifying it where necessary;
(iii) to make recommendations to the Council.
The Working Party membership was as follows:
Mrs Renee Short (Chairman)
Dr J L T Birley
Mr I C Dodds-Smith
Professor R E Kendell
Mr W H Wells
Professor J K Wing
The Working Party submitted its report to the Council in July 1991. The Council endorsed its recommendations and agreed that its report should be published. 
 
1. BACKGROUND
1.1 The Council's general stance on ethical matters is set out in the Statement first published in the Council's Annual Report for 1962-63 (Cmnd 2382) and subsequently reprinted as a booklet 'Responsibility in Investigations on Human Subjects'.
1.2 In the years which followed publication of the Council's Statement, other bodies have taken an interest in the ethical conduct of medical research In 1984 the Council formally consulted the Royal College of Physicians of London (RCP), the then Department of Health and Social Security (DHSS) and Sir Douglas Black (as an independent adviser) and reached the view that the leadership in ethical matters had now passed, rightly and properly, to the profession. Specifically, the RCP's 1984 booklet 'Guidelines on the Practice of Ethics Committees in Medical Research' (subsequently revised in 1990) could be regarded as an up-to-date and practical expression of the principles first promulgated by the Council in its 1962-63 Statement The Council saw no pressing need to consider revising the 1962-63 Statement at that stage
1.3 In the course of a wide ranging discussion of ethical issues in 1987, Council again endorsed the general principles contained in the 1962-63 Statement but agreed that a succession of recent events had made it timely to consider whether to say more on some of the difficult issues facing those engaged in clinical research, in particular research on children and on the mentally incapacitated. Council therefore agreed to establish two Working Parties to advise on research on each of these groups. Explicit in the decision to seek this advice was the realisation that the guidance on such research given in the Council's 1962-63 Statement was now out of line with that given by other reputable bodies, and with accepted good practice in clinical research
1.4 One important development since the Council's 1962-63 Statement nas been the establishment of Local Research Ethics Committees (LRECs) Advice on the constitution and role of such Committees was published in 1973 by the RCP and subsequently updated in 1984 and 1990 (see paragraph 1 2) In 1975 the then DHSS issued a circular (HSC(15)153) urging all health authorities to ensure that research conducted under their auspices was subject to ethical review It is now accepted that any medical research project involving human subjects must be submitted for approval to the appropriate LREC, the Council's own rules governing programme and project grants have for some years required all such applications to have prior LREC approval (and that of all relevant LRECs in the case of multicentre studies). There are similar requirements in respect of directly supported research. In 1991 the Department of Health intends to issue a further circular on LRECs to Health Authorities (now published). This includes guidance on the issue of consent to research in general, and in the special circumstances of research involving mentally incapacitated people. The content of these and other relevant guidelines is discussed in section 5 below
2. METHOD OF WORKING
2.1 We met on 5 occasions; at our first meeting we agreed that as the question of consent (see 3.2.1) was central to our task, our advice might be more helpful to the Council if our proposed terms of reference were broadened to include all forms of research. We therefore deleted the term 'non-therapeutic'.
2.2 In accordance with our terms of reference we took written and oral evidence from a number of organisations and from various individuals, both in their own right and as representatives of professional bodies. We are grateful to the then President of the RCP for an early sight of drafts of the College's 1990 report on 'Research Involving Patients' and of their 1990 'Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects'. We regard both as providing valuable and up-to-date advice. We did not consider it appropriate to go over all the ground covered in these and other recent documents discussing the general ethical issues surrounding medical research, our report and recommendations should be read in the context of the advice offered by the RCP and other authoritative bodies. We recommend that the Council should continue to review its stance on ethical matters both generally and in relation to specific issues at regular intervals to ensure that it takes appropriate account of contemporary public and professional opinion.
3. The issues we considered had much in common with those being considered by the Council's Working Party on Research on Children One of our members was also a member of that Working Party and was therefore able to keep each group informed of the other's progress. Communication between the working Parties was further enhanced by the exchange of minutes and draft reports, and by discussions between the legal experts We were from the outset fully aware of the legal problems associated with research in this area; we chose to concentrate in the first instance on defining the ethical issues and only then considered the legal position. This was somewhat clarified but by no means resolved by a recent judgement by the House of Lords (see 7.2.1 below).
3. DEFINITIONS
3.1 Mental incapacity
3.1.1 We agreed that for our purposes mental incapacity should be defined as incompetence to give consent. Various categories of person are included in this definition; we are primarily concerned with the mentally ill, the mentally handicapped, the demented and the unconscious. Some of these persons will never have the capacity to give consent, some will lose it irrevocably and in some it will be present at times but not at others.
3.2 Consent
3.2.1 Seeking the consent of an individual to participation in research reflects the right of that individual to self-determination and also his fundamental right to be free from bodily interference whether physical or psychological. These are ethical principles recognised by English law as legal rights. We identified three elements to consent in its broadest sense - the information given, the capacity to understand it and the voluntariness of any decision taken.
3.2.2 At the most basic level, failure to supply information about the nature and purpose of what is proposed may lead to a claim that the interference with the research subject's body constitutes a trespass to person. Thus it should be made clear to the subject that he is being invited to participate in research even if what is proposed is part of normal treatment. If a person then freely consents that consent is real provided there has been no misrepresentation of the facts. However, additional information, for instance, on possible risks and alternatives is required in a suitable form before it can properly be said that the researcher has fully discharged his general duty to put the subject in a position to make a rational judgement about whether to participate.
3.2.3 Whether a person has the capacity to understand the information depends on the ability to comprehend the nature and purpose of any course of action and the short and long-term risks and benefits of what is proposed. An individual may be in a position to consent to take part in some studies but not others: capacity to consent will depend not only on the nature of the research itself but also on the nature of the explanation.
3.2.4 Consent must also be voluntarily given and therefore must not be obtained through either implicit or explicit coercion.
3.3 Therapeutic and non-therapeutic research*
*Note: therapeutic research is here used as an umbrella term to cover research not only on the treatment of disease but also on its prevention (eg, by vaccination) and on diagnostic procedures.
3.3.1 The primary intention of all medical research is to acquire knowledge that will be of benefit to humanity as a whole - to all who are or may become ill. Although a number of our expert witnesses used terms such as 'unproblematic and problematic' research or 'single and dual intention' research we have preferred to retain the more usual usage of therapeutic and non-therapeutic research. Therapeutic research is directly concerned with treatment and thus offers the possibility of immediate benefit to participants. Direct benefit to participants in non-therapeutic research is either unlikely or long delayed.
3.3.2 As the Council's 1962-63 Statement recognised, it may initially be difficult to make a clear distinction between innovative therapeutic procedures and research. Nevertheless, at some stage such procedures must be subjected to disciplined investigation.
4. THE POSITION SET OUT IN THE COUNCIL'S 1962-63 STATEMENT
4.1 As part of our terms of reference we considered it necessary to offer some comments on the guidance contained in the Council's 1962-63 Statement on consent, these we have appended to this report.
4.2 The Council's 1962-63 Statement does not use the term 'mental incapacity' but includes reference to the 'mentally subnormal' and the 'mentally dis ordered'. Nor does it use the terms 'therapeutic' and 'non-therapeutic' research, it does, however, make a distinction between 'procedures contributing to the benefit of the individual' end 'procedures not of direct benefit to the individual, These two categories correspond broadly to those we have defined as therapeutic and non-therapeutic research.
4.3 In relation to procedures contributing to the benefit of the individual (ie, therapeutic research) the Statement does not explicitly address the question of adults unable to consent
4.4 The Statement is clear about the requirements for the inclusion of those unable to consent in procedures which are not of direct benefit to them (ie, non-therapeutic research). Any person taking part in such procedures must volunteer 'in the full sense of the word'. The Statement reads:
"It should be clearly understood that the possibility or probability that a particular investigation will be of benefit to humanity or to posterity would afford no defence in the event of legal proceedings. The individual has rights that the law protects and nobody can infringe those rights for the public good In investigations of this type it is, therefore, always necessary to ensure that the true consent of the subject is explicitly obtained."
"When true consent cannot be obtained, procedures which are of no direct benefit and which might carry a risk of harm to the subject should not be undertaken."
5. OTHER GUIDANCE ON RESEARCH ON MENTALLY INCAPACITATED PEOPLE
5.1 The Declaration of Helsinki, drawn up by the World Medical Association in 1964 and revised by the World Medical Assembly in 1975 and 1983, states that freely given informed consent should be obtained from those participating in any medical research but that "where physical or mental incapacity makes it impossible to obtain informed consent ... permission from the responsible relative replaces that of the subject in accordance with national legislation". This statement is not of much assistance to researchers in the UK where the law does not recognise as effective the proxy consent of a relative other than in the case of consent on behalf of a minor by a parent or a legally appointed guardian, or by some other person having a care, custody or residence order.
5.2 In 1990 the Committee of Ministers of the Council of Europe issued a Recommendation (No.R(90)3) to Governments of member states to adopt legislation or measures to ensure implementation of a set of principles concerning medical research on human beings. Principle 3 includes the statement that "No medical research may be carried out without informed, free, express and specific consent of the person undergoing it." Principles 4 and 5 state:
Principle 4
A legally incapacitated person may only undergo medical research where authorised by Principle 5 and if his legal representative, or an authority or an individual authorised or designated under his national law, consents. If the legally incapacitated person is capable of understanding, his consent is also required and no research may be undertaken if he does not give his consent.
Principle 5
1. A legally incapacitated person may not undergo medical research unless it is expected to produce a direct and significant benefit to his health.
2. However, by way of exception, national law may authorise research involving a legally incapacitated person which is not of direct benefit to his health when that person offers no objection, provided that the research is to the benefit of persons in the same category and that the same scientific results cannot be obtained by research on persons who do not belong to this category."
5.3 In July 1990 the European Commission issued guidelines, prepared by the Committee for Proprietary Medicinal Products, on Good Clinical Practice for Trials on Medicinal Products in the European Community. These guidelines do not yet have statutory force in the UK, but it is proposed to require all member states to make them part of national law and it appears likely that they will represent national law by 1992 The guidelines cover a number of issues from ethics committees to consent in trials of medicinal products.
Paragraph 1.13 states:
"If the subject is incapable of giving personal consent (eg, unconsciousness or severe mental illness or disability), the inclusion of such patients may be acceptable if the ethics committee is, in principle, in agreement and if the investigator is of the opinion that participation will promote the welfare and interest of the subject. The agreement of a legally valid representative that participation will promote the welfare interest of the subject should also be recorded by a dated signature. If neither signed informed consent nor witnessed signed verbal consent are possible, this fact must be documented with reasons by the investigator"
Paragraph 1.14 states:
"Consent must always be given by the signature of the subject in a non-therapeutic study, ie, when there is no direct clinical benefit to the subject."
5.4 The RCP's 1990 report 'Research involving Patients' also emphasises that, with some exceptions such as observational research which carries no risk and is not intrusive, patients should know that they are taking part in research and that research should only be carried out with their consent.
5.5 The RCP report emphasises that many mentally handicapped and mentally ill patients will be able to give consent. It continues:
"A strong ethical case can be made out for non-therapeutic research (involving only minimal risk) in mentally handicapped patients because only through better understanding of their condition can care for such patients be improved. We think that the best guidance under these circumstances might be that there should be agreement by the close relatives or guardians and that the mentally handicapped individual seems to agree to the procedure.'
5.6 This report, together with the RCP's 1990 'Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects'*, recommends that the considerations quoted above in relation to mentally handicapped adults are relevant to therapeutic and non-therapeutic research involving mentally ill patients who cannot give consent or whose consent is in doubt. The RCP's reports emphasise, however, that no patient who refuses or resists should be included in research.
5.7 The Royal College of Psychiatrists' (RCPsych) 1990 'Guidelines for Ethics of Research Committees on Psychiatric Research involving Human Subjects' puts the case for psychiatric research as follows:
"Research is as essential in psychiatry as in any other branch of medicine. While there are ethical problems in carrying out research, it is unethical for the profession to fail to do research because this deprives present and future patients of the possibility of more informed and better treatment as well as the (more distant) prospect of prevention of psychiatric disorder."
5.8 The RCPsych Guidelines emphasise that "The majority of psychiatric patients are as capable of giving consent as are other patients". On the question of 'incompetent' patients, they point out that many suffer from conditions, such as mental handicap and dementia, in which advances are most needed and which cannot be obtained by studying other patients. The Guidelines recommend a 'common sense' approach to research in such circumstances. They do not distinguish explicitly between therapeutic and non-therapeutic research but emphasise that the LREC should decide in the usual way whether the research is acceptable in terms of the balance of benefits, discomfort and risks, and suggest that in most cases the research worker should discuss the research with one or more close relatives. If there is no relative, or the patient expresses the wish that his relatives should not be consulted (confidentiality may be an important issue in this and other contexts), they recommend consulting an independent person approved by the LREC who knows the patient well and will protect his interests. Whatever the views of third parties, the Guidelines state that no research should proceed if the patient refuses, or appears to refuse, either in words or actions.
5.9 We have had the opportunity to see in draft form the Department of Health's 1991 Circular on Local Research Ethics Committees (now published) which states at para 3.9:
"Some research proposals will draw their subjects from groups of people who may find it difficult or impossible to give their consenl, for example the OnCOn scious, the very elderly, the mentally disordered or some other vulnerable group In considering these proposals the LREC should seek appropriate specialist advice and they will' need to examine the proposal with particular care to satisfy themselves that proceeding without valid consent is ethically acceptable."
In relation to research on mentally disordered people, the Circular refers LRECs and researchers to the RCPsych's guidelines, and states at para 4.11:
"Proposals for research where capacity to consent is impaired will need particularly careful consideration by the LREC, with regard to its acceptability in terms of the balance of benefits, discomforts and risks for the individual patient and the need to advance knowledge so that people with mental disorder may benefit."
6. THE ETHICAL CASE FOR INCLUDING MENTALLY INCAPACITATED PEOPLE IN RESEARCH
General
6.1.1 Many people with mental impairment or disorder will be capable of giving or withholding consent to their inclusion in research and should be free to do so. We have given some thought to who should decide whether an individual has the capacity to consent to a particular project. When that individual is a patient in the care of a physician other than the research worker, this physician should be approached for an informed and independent judgement. When the individual concerned is not in the direct care of a physician, or that physician is the research worker, the view of a relative, friend or other person acceptable to the LREC should be sought. When there is any doubt about an individual's mental capacity to consent, an independent person should be present when consent is sought and should sign a document stating that they were present when the project
6.1.2 It is clear from the material discussed in section 5 above that there is a consensus, with which we concur, that a principled case can be made on ethical grounds for research involving people who cannot consent. There are a number of situations in which knowledge that is. badly needed for the sake of those suffering from various forms of mental handicap or mental illness can only be acquired by research on people who are themselves suffering from these conditions and as a consequence lack the mental capacity to consent
6.1.3 At the same time, there is agreement on the need for strict safeguards for such research. In particular:
•	those unable to consent should take part in research only if it relates to their condition and if the relevant knowledge could not be gained by research in persons able to consent 
•	all projects must be approved by the appropriate LREC(s) 
•	the inclusion of an individual unable to consent should be subject to the agreement of an informed, independent person acceptable to the LREC that that individual's welfare and interests have been properly safeguarded 
•	those included in the research do not object or appear to object in either words or action 
6.1.4 We are not seeking to argue that the need to seek consent for research can be waived for the mentally incapacitated or any other class of person. Rather, we believe that it is now widely accepted by authoritative individuals and bodies that there are circumstances in which it is ethically acceptable for another person to review the balance of risk and benefit (if any) associated with participation in a project and to give or withhold their agreement that the welfare and interests of a subject who is unable to consent have been properly safeguarded. The precise role of this person will depend upon the nature of the proposed research and is discussed separately below for therapeutic and non-therapeutic research. In all cases, everything possible should be done to explain the nature of, and reasons for, research procedures to mentally incapacitated people who have some measure of understanding
6.2 Therapeutic research
6.2.1 We believe that subject to the safeguards listed at 6.1.3 above there is astrong ethical case for including those who cannot consent in therapeutic research; indeed we would argue that. in circumstances where participation is in their best interests, their exclusion would be unethical.
6.2.2 The inclusion in therapeutic research of an individual who cannot consent must be subject to the agreement of a relative, friend or person acceptable to the LREC and not directly involved in the research that, weighing the likely benefits and the possible risks of harm to the individual concerned, that individual's welfare has been properly safeguarded and participation in the research is in his best interests.
6.3 Non-therapeutic research
6.3.1 Because it might infringe the rights of a group which society should take particular care to protect, the participation of people who cannot consent in non-therapeutic research raises more complex ethical issues. We do not seek to argue that a mentally incapacitated person's participation in non-therapeutic research is directly in his interests. But we recognise that there are circumstances in which it is important to gain knowledge which may be of benefit to mentally incapacitated people in general and which can only be acquired as a result of research which involves those who are unable to consent.
6.3.2 We therefore believe that there is a strong case for including those unable to consent in such research, but it is essential that the safeguards listed at 6.1.3 are observed, and that those included are placed at no more than negligible risk of harm.
6.3.3 The degree of risk involved in a project should be given particularly careful scrutiny by the LREC when mentally incapacitated people are to be included. There have been various attempts to describe and define degrees of risk. We use the term negligible risk to mean that the risks of harm anticipated in the proposed research are not greater, considering the probability and magnitude of physiological or psychological harm or discomfort, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. Examples of procedures involving negligible risk would include the observation of behaviour, non-invasive physiological monitoring, physical examinations, changes in diet and obtaining blood and urine specimens. We discuss risk in non-therapeutic research in the context of the law in para 7.3.4 below.
6.3.4 We are clear that participation in such research of an individual unable to consent can only be ethical if a relative, friend or person acceptable to the LREC and not directly involved in the research agrees that participation would place that individual at no more than negligible risk of harm and is therefore not against that individual's interests.
7. THE LEGAL POSITION
7.1 General
7.1.1 Our primary task was to advise on ethical issues; however we have considered it proper to comment on the legal position, partly because the Council's stance set out in the 1962/63 Statement derives from it and partly because it raises a number of complex issues. As was the case when the Council developed the 1962/63 Statement, one is dealing not with statute law but with common law principles as developed by judges in case law. The applicable case law focuses upon conventional medical treatment rather than treatment in the context of research or non-therapeutic research. Nevertheless, the decisions help to indicate the likely attitude of the courts.
England, Wales and Northern Ireland
7.1.2 The Mental Health Act 1983 for England and Wales and the Mental Health (Northern Ireland) Order 1986 for Northern Ireland include certain provisions relating to consent procedures relevant to the administration of particular types of treatment to mentally disordered patients for their disorder but in principle detention under these statutes does not bear upon the ability of a person to give a valid consent. The legislation does not address the question of research. However, the Department of Health and Welsh Office have issued a Code of Practice which includes guidance on the treatment of patients suffering from mental disorder. 
7.1.3 Under common law principles, research involving adults who cannot consent faces two important legal obstacles. The first is that since one has a right to determine what is done with one's body it is an unlawful act (trespass to person) for anyone, regardless of his intention, to touch or otherwise interfere with the bodily integrity of an adult without his consent. The second is that there is no provision in English law for anyone to give consent on behalf of another adult. Thus while in respect of minors (under 18) unable to consent, parents may consent to treatment on behalf of their children, or the court may exercise its wardship jurisdiction, no-one - not even the next of kin - has the  power to consent on behalf of an adult unable to consent himself through mental disability. Moreover, it is now established that no court has any jurisdiction with respect to such a person to consent on his behalf. Judges have suggested that this is an area suitable for parliamentary intervention, but in the meantime, rather than purport to give a proxy consent on behalf of the person concerned, the courts have been prepared to make binding declarations as to whether the actions of those involved in the particular proposed procedure are legal. 
Scotland
7.1.4 For Scotland the Mental Health (Scotland) Act 1984 includes provisions with regard to the administration of particular types of treatment formental disorder which are analogous, although not identical to, the Mental Health Act 1983. As in England, these treatments are unlikely to be of a type that will arise often in the research context. As in England, Wales and Northern Ireland, the Act does not deal specifically with the question of consent to treatment or research. However, the Secretary of State for Scotland has issued a Code of Practice, which deals with Medical Treatment of Patients 'therapeutic research' (see further para 7.2. below).
7.1.5 Under Scottish common law principles, research involving adults who cannot consent faces only one fundamental legal obstacle but it corresponds to the position in England, ie,, since one has a right to determine what is done with one's body, it is an unlawful act (described in Scotland as assault) for anyone, regardless of his intention to touch or otherwise interfere with the bodily integrity of an adult without his consent. 
7.1.6 In Scotland there is provision by way of a court procedure for the appointment of someone who is given, as one of his or her powers, a power to give consent on behalf of an adult. Such an appointed person is known as a 'tutor-dative'. Basically the notion is that the adult is then for these purposes, as far as the law is concerned, essentially in the position of a young child, that is in the legal position (as the law presently stands) of a girl under 12 or a boy under 14. In every case enquiry should first be made as to whether there is a 'tutor-dative' or not. If there is, the extent of power of that person to consent depends on the range of powers given in the court decree appointing them. This must be checked.
7.2 Therapeutic research
England, Wales and Northern Ireland
7.2.1 Case law in the past has established the legality of bodily interference without consent in certain circumstances, such as the physical contact of every day social activity and emergency treatment to protect life. Most recently, in a landmark decision (in Re F 1989), the House of Lords established that a doctor in England, Wales and Northern Ireland can lawfully give any treatment to an adult patient who is incapable of consenting through mental incapacity provided such treatment is performed in accordance with a responsible body of relevant professional opinion and in the best interests of the patient ie, it is carried out in order either to save life or to ensure improvement or prevent deterioration in his physical or mental health. The court also endorsed as good practice consultation with relatives and others concerned with the care of the patient. The particular case involved the sterilisation of a mentally handicapped woman: the court declared that in cases of this type involving major treatment of an irreversible nature, the public interest additionally required the express approval of the court. It has not, however, been suggested that standard curative or prophylactic treatment of the mentally incapacitated normally requires court approval (see in Re E, 1991).
7.2.2 While the judgement in Re F concerned conventional medical treatment and not research, we agree with the conclusion of the RCP 1990 Report 'Research Involving Patients', that the principle enunciated should equally apply when the treatment in question is still in the research phase. An experimental medicinal procedure may be the only appropriate therapy and provided the relevant health professional acts with proper skill and care and in the best interests of the patient, neither liability for trespass nor negligence should arise.
7.2.3 The Code of Practice issued under the Mental Health Act 1983 emphasises that patients should be informed of the nature, purpose and likely effects of the treatment proposed in a suitable manner even if they lack capacity to consent to the treatment
7.2.4 We are clear that, provided the necessary safeguards are in place, the ethical grounds for including mentally incapacitated people in therapeutic research (and indeed for not denying them the opportunity to participate in research that offers the prospect of improving their health) are so great, that it would be contrary to accepted good practice to be deterred by the comparative lack of clarity surrounding the legal position. However, it may be prudent for doctors contemplating special categories of treatment of a serious and irreversible nature in a research context to consider whether it is appropriate to seek endorsement of their actions by the court, no doubt in consultation with the relevant ethics committee.
Scotland
7.2.5 In Scotland there is no authoritative court decision on the legality of bodily interference without consent. Setting aside treatment under the Mental Health (Scotland) Act 1984, a doctor can only lawfully give treatment to an adult person who is incapable of consenting if either there is an emergency in the sense of a life threatening situation or where there is a 'tutor-dative' and he has validly consented to the treatment (see pare 7.1.6 above). As with the conclusions for England and Wales of the RCP 1990 Report, it is believed that the rules of law that apply to treatment apply as much to treatment at the research phase as to any other treatment.
7.2.6 If there is a 'tutor-dative' and the powers given in his appointment are wide enough, he can give his consent. For him the question is what is in the best interests of the patient of whom he is a 'tutor-dative'. It is important that he be in a position to make an informed decision and should be given full information about the treatment and side-effects.
The treatment must itself be an appropriate therapy It must be given against the background of Part IV of the Code of Practice issued under the Mental Health (Scotland) Act 1984. The treatment, therefore, should be the minimum necessary to restore the patient to an optimum level of health appropriate to his particular circumstances. The doctor in charge of the patient's case has a responsibility for formulating a treatment plan and the treatment proposed in the plan should be discussed with the patient at the outset in a manner appropriate to the patient's level of understanding of the issues. The fact that a particular patient is incapable in law of giving consent does not mean that the patient automatically lacks a level of understanding to have treatment discussed with him. This could be so even where there is a 'tutor-dative'.
7.3 Non-therapeutic research
England, Wales and Northern Ireland
7.3.1 In the main, the legal arguments to which the Council referred in its 1962/63 Statement (see paragraph 4.4) are still pertinent with respect to procedures involving bodily interventions or which place an individual at risk of harm. We have, however, argued on ethical grounds that a mentally incapacitated person should not be excluded from the opportunity to contribute to the welfare of other mentally incapacitated people, and possibly to his own welfare, provided no more than minimal risk of harm is involved.
7.3.2 That this is widely accepted is illustrated by the fact that the Council and other reputable funding bodies have not been paralysed by lack of clarity in the law, but have supported work of this type for some time.
7.3.3 As a legal matter, any interference with a person's body will only be lawful if it is justified on the basis of some legally recognised principle. It has been noted above that the courts in England and Wales and Northern Ireland now accept that it is in the public interest to ensure that those unable to consent should not be deprived of appropriate medical treatment but it must be stressed that the courts have not yet considered whether there is any public interest basis for allowing any form of non-therapeutic intervention in a person who, through mental incapacity, is unable to consent. In recent cases concerning issues ofconsent, the Courts have emphasised the need to establish what is in the best interests of the individual. This may suggest that health professionals will be exposed to legal action if they are responsible for allowing such a person, who has no prospect of immediate personal benefit, to be exposed to any risk purely in the interest of advancing knowledge. If this is correct, researchers should be clear that, although appropriate on ethical grounds, the approval of an ethics committee or a relative or some other independent person is unlikely to be recognised by the law as an adequate substitute for the consent of the research subject.
7.3.4 However, it seems to us that a case can be made out that it is not in the public interest for persons suffering from mental incapacity to be excluded from socially responsible behaviour purely through lack of consent competence. Where the risk attending participation in non-therapeutic research into mental disorder is minimal and a reasonable person with that disorder but able to consent is likely to accept that risk when told that such research might lead to advances in treatment, it would be strange if a person unable to consent because of that disorder should be imputed with a wholly different attitude to the welfare of the class of persons of which he is a member. It seems to us that provided the welfare of the individual in the broadest sense is properly considered by the ethics committee and, in addition, by an informed person independent of the researcher, and participation is not found to be against his best interests because the risk of harm is minimal, the subject's participation may be viewed by the courts as in the public interest and lawful. For these purposes it is difficult to define minimal risk in all the contexts that may arise but it would seem unlikely that the courts would countenance exposing a mentally incapacitated person to a risk (having regard to probability and magnitude of physical or psychological harm or discomfort) beyond what is normally encountered in daily life or in the routine medical or psychological examination of a normal person.
7.3.5 The Law Commission has undertaken a review of a variety of matters concerning the mentally incapacitated including issues of consent competence and has recently published a Consultation Paper In due course, this may lead to legislation but not in the immediate future. In the meantime, in view of the legal uncertainty, the only sure legal protection for researchers concerned about their position would be for them to seek a declaration from the court that the proposed research procedures are legal.
Scotland
7.3.6 In Scotland, in the absence of an appointment of a 'tutor-dative' with appropriate powers, at present there is no way in law that consent can legally be obtained in the situation of non-therapeutic research. A 'tutor-dative' with power to consent on the person's behalf must act in that person's best interests. By analogy with what is thought to be the legal position relating to young children (under the current law boys under 14 and girls under 12 – likely in due course to be changed to any child under 16 not capable of understanding), a 'tutor-dative' could, it is thought, consent where the risk is minimal. There has been no definition in Scottish courts of precisely what sort of risk would be viewed as minimal. Scottish and English courts are likely to take the same approach, ie, it would seem unlikely that the courts would countenance exposing a mentally incapacitated person to a risk (having regard to probability and magnitude of physical or psychological harm of discomfort) beyond what is normally encountered in daily life or in the routine medical or psychological examination of a normal person (see para 7.3.4. above).
It is important that any 'tutor-dative' be in a position to make an informed decision. He or she should be given full information including that relating to any risk, howsoever minimal. As is good practice, the matter should also be discussed with the patient at the outset in a manner appropriate to the patient's level of understanding of the issues. The fact that a particular patient is incapable in law of giving consent does not mean that the patient automatically lacks a level of understanding to have the research or other aspects of it discussed with him. The appropriate ethics committees should be consulted (see para 7.2.4).
7.3.7 The Scottish Law Commission is also undertaking a review of matters concerning the mentally incapacitated and they will also be dealing with issues of consent competence. In the light of the legal uncertainty in this area, the only sure legal protection for researchers would be for a 'tutor-dative', if there is one, to consent (see para 7.3.6 above). In the more likely position that there is none, the appropriate way to bring the question before a court would be in connection with seeking the appointment of a 'tutor-dative'.
8. SUMMARY AND RECOMMENDATIONS
8.1 Many people with mental impairment or disorder are able to consent to their inclusion in research provided care is taken to explain it to them. When there is doubt about an individual's mental capacity, we recommend that a judgement on his ability to consent should be sought from the physician responsible. When the individual is not under the care of a physician, or the physician is involved in the proposed research, a view should be sought from a relative, friend or other person acceptable to the LREC.
8.2 There is a strong case for allowing those unable to consent to participate in medical research provided safeguards are observed. We recommend that an individual unable to consent should be included in research only if it relates to his condition and the relevant knowledge could not be gained by research in persons able to consent
•	it is approved by the appropriate LREC(s) he does not object or appear to object in either words or action 
•	an informed, independent person acceptable to the LREC agrees that the individual's welfare and interests have been properly safeguarded and 
•	in the case of therapeutic research, weighing the likely benefits and the possible risk of harm to the individual concerned, participation is in that individual's best interests 
•	in the case of non-therapeutic research, that participation would place the individual at no more than negligible risk of harm and is not against that individual's interests. 
8.3 We recommend that the Council should revise its guidance on research on mentally incapacitated people so as not to exclude research satisfying these conditions.
THE ETHICAL CONDUCT OF RESEACH ON THE MENTALLY INCAPACITATED
APPENDIX
THE COUNCIL'S 1962-63 STATEMENT: CONSENT
The Council's Statement* has played an important role in the development of the discussion of the ethics of medical research. The position set out in it with respect to consent is, however, now seriously out of line with contemporary thinking. The root of the problem lies in the general statement which reads:
"In the case of procedures directly connected with the management of the condition in the particular individual, the relationship is essentially that between doctor and patient. Implicit in this relationship is the willingness on the part of the subject to be guided by the judgement of his medical attendant. Provided, therefore, that the medical attendant is satisfied that there are reasonable grounds for believing that a particular new procedure will contribute to the benefit of that particular patient, either by treatment, prevention or increased understanding of his case, he may assume the patient's consent to the same extent as he would were the procedure entirely established practice."
While we would readily accept that trust between doctor and patient continues to be central to good clinical practice, we would suggest that it can no longer be assumed that the patient will or indeed should be guided solely by the judgement of his medical attendant, or that there are any circumstances (other than some emergencies) where the doctor can assume consent.
It is now generally accepted that the doctor has a duty to explain to his patient the pros and cons of the various courses of action open to him in offering treatment or measures intended to prevent or ameliorate a given condition. If this is so for treatment, it must hold even more strongly for research. There is unanimity among those we consulted that for most classes of research the patient must understand that he is taking part in research and give his consent to his participation in that research (examples cited by the Royal College of Physicians of London of studies for which patients' consent need not be sought include the examination of anonymised specimens collected in the course of ordinary medical practice, and observational research involving no contact with or risk to patients).
* The Council has agreed that its 1962-63 Statement should be withdrawn and a revised version should be issued.