THE ETHICAL CONDUCT OF RESEARCH ON CHILDREN

WORKING PARTY ON RESEARCH ON CHILDREN

Published December 1991 (reprinted August 1993)

INTRODUCTION

The Working Party on Research on Children 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 children;
(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 children taking account of the existing guidance and supplementing, extending and modif ying it where necessary;
(iii) to make recommendations to the Council.
The Working Party's membership was as follows:
Lady Howe (Chairman)
Professor A L Diamond
Professor G R Dunstan
Professor June Lloyd
Professor R D G Milner
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. Since then there have been some developments. In the present reprinting of the report, the opportunity has been taken to refer to them through footnotes. In particular the Council's 1962-3 general statement on human ethical issues has been replaced and the Scottish legal position clarified.
1. BACKGROUND
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'*.
* This statement has now been withdrawn and replaced by a new guidance book/et 'Responsibility in Investigations on Human Participants and Material and on Personal information, (MRC November 1992).
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 somewhat out of line with that given by other reputable bodies, and with accepted good practice in clinical research.
One important development since the Council's 1962-63 Statement has 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 their 1984 'Guidelines on the Practice of Ethics Committees in Medical Research' (itself updated in 1990). 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**. This will include guidance on the issue of consent to research in general, and in the special circumstances of research involving children. The content of these and other relevant guidelines is discussed in section 5 below.
** This statement and a complementary statement by the SOHHD, has now been published
2. METHOD OF WORKING
2.1 We met on 6 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 individuals and professional bodies, 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 recently published report on 'Research involving Patients' (January 1990) and of their 'Guidelines on the Practice of Ethics Committees in Medical Research involving Human Subjects' (January 1990). We regard both as providing valuable and upto-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 conjunction with 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.
2.3 The issues we considered had much in common with those being considered by the Council's Working Party on the Mentally Incapacitated. 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 on each group.
2.4 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 considering the legal position.
3. DEFINITIONS
3.1 Children
3.1.1 We agreed that we should consider all live-born children up to the age of 18 years including those with mental handicap or illness
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*
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. 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.
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.
* 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
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.
4.2 The Council's 1962-63 Statement does not refer to 'therapeutic' and 'non-therapeutic' research; it does however make a distinction between 'procedures contributing to the benefit of the individual' and '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 therapeutic research in children the Statement is explicit:
"It is clearly within the competence of a parent or guardian of a child to give permission for procedures intended to benefit that child when he is not old or intelligent enough to be able himself to give a valid 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, nontherapeutic 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."
"In the strict view of the law parents and guardians of minors cannot give consent on their behalf to any procedures which are of no particular benefit to them and which may carry some risk of harm."
The Statement goes on to consider what constitutes consent in the case of minors, and concludes that when this 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.
"Even when true consent has been given by a minor ..., considerations of ethics and prudence still require that, if possible, the assent of parents or guardians ... should be obtained."
5. OTHER GUIDANCE ON RESEARCH ON CHILDREN
5.1 The Declaration of Helsinki, drawn up by the World Health 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 "when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation; whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian ".
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." The recommendations do not refer specifically to children (other than those of nursing mothers), but 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 English law by 1992. The guidelines cover a number of issues from ethics committees to consent in trials of medicinal products. They do not refer specifically to children, but 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 or intrusiveness, patients should know that they are taking part in research, and research should only be carried out with the patient's consent.
5.5 In relation to children the RCP report stipulates that "research which could equally well be done on adults should never be done on children". The report points out that a child's ability to consent depends upon his having sufficient understanding and intelligence to make that decision; it does not depend upon a fixed age limit. However, when a child under 16 years of age is judged able to consent, parental approval should always be sought, and this may also be useful with older children. For children unable to give consent, the report sees no difficulties in a parent or guardian giving consent for a child's inclusion in therapeutic research. In the case of non-therapeutic research, the report states that "the law is unclear, but the prevailing view appears to be that the duty of the parents to act in the best interests of the child can reasonably be interpreted as an obligation not to do anything clearly against the interests of the child." It therefore concludes that a child unable to consent may be included in non-therapeutic research with the parents' consent, provided the child does not object and that the research is limited to that which carries no greater than minimal risk.
5.6 The RCP's 1990 'Guidelines on the Practice of Ethics Committees in Medical Research involving Human Subjects' takes a similar line on non-therapeutic research on children not competent to consent.
5.7 The RCP's recommendations have much in common with those contained in the report* of an Institute of Medical Ethics Working Group on the Ethics of Clinical Research Investigations on Children. This group considered in detail the ethical, legal and practical issues raised by research on children. Amongst their recommendations are:
•	research requiring children as subjects should not be undertaken unless there is a specific and demonstrable need to perform the research on children, and no other route to the relevant knowledge is available; 
•	parents and guardians should be considered as trustees of a child's interests, rather than as having rights over the child. The prime consideration in any research involving children should be that it be not against the interests of any individual child; proxy consent by parents or guardians to a non-therapeutic research procedure on their child is legally valid and ethically acceptable only when the risk to the child subject is no more than minimal; 
•	consent should be sought of a parent or guardian whatever the child's age and ability to consent; and 
•	research should not be undertaken if a parent or guardian withholds consent, or if a child over 14 years of age withholds consent or agreement.
* Medical Research with Children; Ethics, Law and Practice. (Ed R H Nicholson) OUP, 1986 
We understand that the British Paediatric Association (BPA) is reviewing its position on the ethics of research on children**. The Association's 1980 'Guidelines to Aid Ethical Committees Considering Research Involving Children' propose that therapeutic and non-therapeutic research may be undertaken on children provided that the same investigation could not be done on adults and that the benefit resulting from the research justifies the risk of disturbance, discomfort or pain to those participating.
** This advice has now been published (December 1992).
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 consent, for example the unconscious, 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."
It also contains the following guidance on research on children:
4.1 Research proposals should only involve children where it is absolutely essential to do so and the information required cannot be obtained using adult subjects.
4.2 When seeking consent to examination or treatment (which may include research which is intended to benefit the patient ie therapeutic research) young people aged 16 and 17 are presumed (in the absence of indications to the contrary) to be able to give their full consent independently of their parents or guardians. Children who are under 16 years of age may also be able to give full consent providing they have a sufficient understanding of what is proposed, as judged by the doctor attending them. Even for therapeutic research purposes it would however be unacceptable not to have the consent of the parent or guardian [there is footnote here referring to other persons legally in a position to give consent on behalf of a child to medical treatment] where the child isunder 16. Where the child is over 16 and under 18 generally parental consent should also be required - unless it is clearly in the child's best interests that the parents should not be informed. 
4.3 Where the proposal is for non-therapeutic research all of the above applies but in addition the child must be subject to no more than minimal risk as a result of his/her participation.
4.4 The LREC should note that those acting for the child can only legally give their consent provided that the intervention is for the benefit of the child. If they are responsible for allowing the child to be subjected to any risk (other than one so insignificant as to be negligible) which is not for the benefit of that child, it could be said they were acting illegally. It should also be noted that the giving of consent by a parent or guardian cannot override the refusal of consent by a child who is competent to make that decision."
6. THE ETHICAL CASE FOR INCLUDING CHILDREN IN RESEARCH
6.1 General
6.1.1 There is thus a broad consensus, with which we concur, that a principled case can be made on ethical grounds for research on children. There are a number of situations in which knowledge that is badly needed for the sake of children suffering from various conditions can only be acquired by research on children.
6.1.2 At the same time, there is agreement on the need for strict safeguards for such research. In particular:
•	children should take part in research only if the relevant knowledge could not be gained by research in adults
•	all projects must be approved by the appropriate LREC(s)
•	either those included have given consent, or consent has been given on their behalf by a parent or guardian and those included do not object or appear to object in either words or action.
6.1.3 When a child has sufficient understanding to consent, his consent should of course be sought. The advisability from a legal standpoint of seeking parental consent in addition to that of a child who is able to consent is discussed in section 7 below. From an ethical standpoint, research workers and LRECs should consider carefully the maturity and independence of the children to be approached and the likely expectations of their parents. For example, an LREC may agree that it would be inappropriate to approach the parents of children who are living independently of them. them.
6.1.4 When a child lacks sufficient understanding to consent, his willing cooperation should be sought. The ethical grounds for including such children with parental consent in therapeutic and non-therapeutic research are discussed in sections 6.2 and 6.3 below. Section 7 discusses the legal considerations.
6.2 Therapeutic research
6.2.1 We believe that subject to the safeguards listed at 6.1.2 above there is a strong ethical case for including children who cannot consent in therapeutic research; indeed we would argue that in circumstances where participation would be in their best interests their exclusion would be unethical.
6.2.2 When a child lacks sufficient understanding to consent, his inclusion in therapeutic research should be subject to his parents' or guardians' judgement that the benefits likely to accrue to him outweigh the possible risks of harm, and that participation is therefore 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 children in non-therapeutic research raises more complex ethical issues. We do not seek to argue that a child's participation in non-therapeutic research is in his best interests. But we recognise that there are circumstances in which it is important to gain knowledge which may be of benefit to children in general and which can only be acquired as a result of research which involves children.
6.3.2 We therefore believe that there is a strong case for including children unable to consent in such research, but it is essential that the safeguards listed at 6.1.2 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 particular project should be given particularly careful scrutiny by the LREC when children 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, developmental assessments and 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 7.2.10 below.
6.3.4 We are clear that a child's participation in such research can only be ethical if his parents or guardians agree that it would place him at no more than negligible risk of harm and is therefore not against his interests.
7. THE LEGAL POSITION
7.1 General
7.1.1 This is an area in which there are important differences between the laws of England and Wales, and Northern Ireland, on the one hand, and the law of Scotland, on the other.
7.2 England, Wales and Northern Ireland
7.2.1 We deal first with the law of England and Wales. This discussion also covers the legal position in Northern Ireland.
7.2.2 The specific issue of a child's competence to consent to medical research has not been considered by the courts but is we believe probably covered by the wider principle that a minor's capacity to make his own decisions depends upon his having sufficient understanding and intelligence to make that decision rather than upon any judicially fixed age limit. When a child under 16 years of age is competent to consent it is usually considered wise to complement this with the approval of his parents or guardian, although there may be circumstances where this is impracticable, inappropriate or unnecessary (see para 6.1.3 above).
7.2.3 When a child lacks sufficient understanding to be competent to consent, the question arises whether a parent or guardian may consent on behalf of the child. This we consider further below.
Therapeutic research
7.2.4 Where the child is of the age of 16 or over, we believe the legal position in relation to therapeutic research to be relatively straightforward. Under the Family Law Reform Act 1969 a person of the age of 16 has full power to consent to medical treatment, and since therapeutic research is a form of medical treatment there is little doubt that the child can consent to participate in the research. Such consent from a child does not in law demand a parallel consent from a parent or guardian, and a child of 16 who consents may be treated without regard to the wishes of the parents. In some circumstances, however, particularly where there is some doubt as to the degree of understanding shown by the child, it may be thought to be a matter of good professional practice to seek the child's permission to explain the research proposals to parents and, if they object, to give these objections considerable weight.
7.2.5 Where the child is under 16, the 1969 Act does not apply, and the position is as described in paragraph 7.2.2 above: a child with sufficient understanding and intelligence can consent to medical treatment, and the physical age is not of importance. However, research workers are likely to be reluctant to proceed without the approval of a parent or guardian, even if confident that the child fully understands, and should certainly not do so without the prior agreement of the LREC.
7.2.6 Where a child lacks sufficient understanding to be competent to consent, a parent or guardian can give a valid consent to medical treatment. This is one of the few situations in law where a 'proxy' consent is recognised. Since the intention is to benefit the child, there is no reason to think that therapeutic research differs from any other form of medical treatment in this regard.
Non-therapeutic research
7.2.7 In relation to non-therapeutic research there is no precise age below 18 at which a child acquires legal capacity to consent; the 1969 Act (paragraph 7.2.4 above) applies to medical treatment, and not to non-therapeutic research. The general rule, already explained, will be that the validity of consent by the child will depend on the child's understanding and intelligence. If a child fully understands the research proposal and gives consent then, although the law has never been authoritatively formulated, it is believed that that consent is valid.
7.2.8 Where this is so, there would appear to be no legal reason why the consent of an understanding and sufficiently intelligent child should not be acted on. There is no clear legal requirement to inform or consult with parents or obtain their consent. But the prudent course of conduct where non-therapeutic research is contemplated would be to seek the consent of a parent or guardian where this is available, though where obtaining parental consent might impede the research the approval of the LREC to dispensing with parental consent could be sought. Needless to say, the younger the child, the more desirable it would be to seek parental consent.
7.2.9 Where a child does not have sufficient understanding or intelligence to consent, it is necessary to consider whether parental consent to nontherapeutic research can be obtained. Parents or guardians cannot in law consent to any treatment or procedure that is against the interests of the child, and it is not only unethical for a researcher to undertake research that is against the child's interests, it leaves him exposed to possible legal proceedings. Neither Act of Parliament nor court decision has laid down any principle relating to parental consent to non-therapeutic research.
7.2.10 In one sense all research carries an element of risk: babies have been dropped when being bathed, children have slipped and fallen when stepping on the scales, the taking of a blood sample has led to injury. Although there has been no authoritative legal decision involving research, and although there is no unanimity among lawyers as to the strict legal position, there is a respectable body of legal opinion which takes the view that there is no obstacle to the consent by a parent to a procedure which carries no greater risk for the child than the risks that reasonable parents commonly expose their children to in everyday life. This is, we think, the same idea sometimes expressed by saying that nontherapeutic research involving children must not involve greater than 'minimal' or 'negligible risk'. We cannot visualise any circumstances where non-therapeutic research which placed a child unable to consent on his or her own behalf to greater risk than that described at paragraph 6.3.3 above would be ethically justifiable.
7.2.11 It is understood that the Lord Chancellor has asked the Law Commission to undertake a review of a variety of matters concerning the mentally incapacitated and that issues of consent competence will be dealt with. In due course, this may lead to legislation which may have a bearing on research on children.
7.3 Scotland
7.3.1 The position depends on whether the child has reached the age of 12 in the case of a girl or 14 in the case of a boy. Below these respective ages children (known in law as 'pupils') fundamentally cannot themselves give valid consent. It must be given on their behalf by a parent or guardian. Above these ages up to the age of 18 the child is a 'minor' and the child's ability to give a valid consent depends on whether he or she has sufficient understanding to consent. Reaching the age of 16 in Scotland is not of any significance in connection with medical procedures, whether in the form of treatment or otherwise.
2.	If proposals contained in the Age of Legal Capacity (Scotland) Bill, currently before Parliament become law the situation will to some extent be simplified*.
* The Age of Legal Capacity (Scot/and) Act 1991, which came into force in September 1992, has abolished the previous concepts of pupillanty and minority and replaced them with a single tier of children under the age of 1fi It has expressly clarified a child's capacity to consent to medical treatment as follows:
"A person under the age of 16 years shall have legal capacity to consent on his own behalf to any surgical, medical or dental procedure or treatment where, In the opinion of a qualified medical practitioner attending him, he is capeable of understanding the nature and possible consequences of procedure or treatment
 
Therapeutic Research
7.3.3 Girls under 12 and boys under 14: the parent(s)/guardian(s) must consent. The position is no different from any other activity involving the body of the child. A possible right to carry out 'simple treatment', such as putting sticking plaster on a child's cut may perhaps be possible in law without their consent, although this has never been clarified. The parent(s)/guardian(s) have to act in the best interests of the child and should be appropriately informed of the nature of the treatment and its risks.
7.3.4 Girls of 12 or over and under 18 living independently, and boys between of 14 or over and under 18 living independently: if the someone has set up living independently on his or her own the question is whether that adolescent has, in the light of the information given to himor her, sufficient maturity and understanding to consent. There is no question of the parents being involved at all. If such an adolescent were not capable of understanding he or she would have to be considered in the same way as a person of 18 or over who does not have sufficient understanding to consent (See Section 7).
7.3.5 Girls of 12 or over and under 18, capable of understanding and not living independently and boys between of 14 or over and under 18, capable of understanding and not living independently: if the adolescent in question has sufficient maturity and understanding in the light of the information given to him or her that person can consent. In such a situation parent(s)/guardian(s) certainly cannot give proxy consent. However, although the law is unclear, the parent(s)/guardian(s), at least if they have custody of the adolescent in question, may have a legal right to be informed so as to be able to advise rather than so as to take the decision or veto the decision of the adolescent.
7.3.6 Girls of 12 or over but under 18, not capable of understanding and not living independently, and boys of 14 or over and under 18 not capable of understanding and not living independently: there is some unclarity in the law as to whether parent(s)/guardian(s) can give consent in this situation, although it has been suggested that they in practice often do. Certainly if the lack of understanding is simply that normally associated with the child's age it is unlikely there would be any adverse legal consequences if parent(s)/guardian(s) give consent in a situation that is in the best interests of the child. They could bring the matter before a court, either by way of an application to be appointed 'tutor' to put them into the same position as if the child were still a boy under 14 or a girl under 12 (see pare 7.3.3) or perhaps by an application under section of the Law Reform (Parent and Child) (Scotland) Act 1986. There are still some doubts about the procedure.
Non-Therapeutic Research
7.3.7 With girls of 12 or over or boys of 14 or over the position is the same as it is with therapeutic research, except in the case where the child or adolescent does not have sufficient maturity and understanding to consent. With this latter group there exists unclarity about the parents' role (see para 7.3.6 above). With this group and likewise with boys under 14 and girls under 12 there is also the question (as there is in England and Wales with children or adolescents who are incapable of understanding) as to how a person who in law has power to consent ought to exercise it in the context of proposed non-therapeutic research. The position is as discussed in the English context in para 7.2.2.
8. SUMMARY AND RECOMMENDATIONS
8.1 There is a strong case for allowing children to be included in medical research provided certain safeguards are observed. We recommend that children should only be included in research if the relevant knowledge could not be gained by research in adults
•	it is approved by the appropriate LREC(s)
•	either those included have given consent, or consent has been given on their behalf by a parent or guardian and those included do not object or appear to object in either words or action
•	in the case of therapeutic research, the benefits likely to accrue to a child participating outweigh the possible risk of harm
•	in the case of non-therapeutic research, participation places a child at no more than negligible risk of harm.
8.2 We recommend that the Council should revise its guidance on research on children so as not to exclude research satisfying these conditions.