脆弱性のあるグループにに対しての医療倫理
Ethics on Researching vulnerable groups
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| Introduction The nature of vulnerability has been much debated (Liamputtong, 2007) and is not the primary focus of this chapter, although more will be included in Chapter 9. Instead, this chapter will concentrate on specific groups for whom particular legal rules apply, namely children, and adults who lack decision-making capacity. Vulnerability in these groups stems chiefly from their limited ability to exercise individual autonomy, either through immaturity or because of impaired mental capacity. As a consequence, people in these groups have traditionally been thought of as requiring special protection, especially in the context of research. Despite this, research involving members of groups who are viewed as vulnerable because of their inability to give a legally valid consent has been regarded as important, and ethical guidelines have been developed to support its facilitation. In 1964, for example, the World Medical Association's Declaration of Helsinki endorsed research in these populations if 'the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons'. The EU Clinical Trials Directive (2001/20/EC), preamble, para 3 states that: Persons who are incapable of giving legal consent to clinical trials should be given special protection. It is incumbent on the Member states to lay down rules to this effect. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. As previous chapters made clear, research involving human participants in the United Kingdom today is governed largely by the law pertaining to the clinical trials of medicinal products alongside the common law, and is heavily informed by ethical guidelines. In the NHS, the National Research Ethics Service (NRES) policy stipulating that the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 ('Clinical Trials Regulations') should be adopted even if the study does not involve investigational medicinal products provides a unitary starting point. However, the situation is complicated by the |
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| legal and ethical complexities
surrounding research on children and adults who
lack capacity. With regard to children and consent, the common law
revolves
largely around best interests, and has recognised circumstances whereby
minors
may be deemed competent to make their own decisions., This is at odds
with
the provisions contained in the Clinical Trials Regulations. By the
same token,
and almost perversely, the Mental Capacity Act 2005 was enacted shortly
after
the Clinical Trials Regulations, and introduces rules for the
involvement of noncompetent
adults in non-clinical trials research that operate distinctly from
those
contained in the Regulations. This chapter will be divided into two parts. The first will offer an assessment of the situation regarding the involvement of children in research, including some controversies around the status of a child's assent. The second will discuss the legal framework surrounding research involving adults who lack capacity. Following that, some general conclusions will be drawn. Children Children are rightly regarded as a particularly vulnerable population. They are often unable to make their views known, especially those of early years, and, as has been shown in Chapter 2, they have in the past been the victims of research abuses. As a result, concerns about exposing children to risks associated whh research have been cited as a reason for not involving them in clinicai' trials. However, failing to involve children in clinical research and trials of medicinal products means that reliable evidence about the efficacy and safety of interventions used in their treatment is either limited or unavailable. Similarly, failing to conduct systematic assessment of other healthcare interventions designed to be applied in the treatment of children can lead to the introduction of ineffective, or perhaps even harmful, treatment regimes (Mulhall et al, 1983). There is now a wealth of evidence to show that because of a dearth of research involving children a large proportion of treatment decisions are not supported by validated clinical evidence (Rudolf et al, 1999; Conroy, 2000; Smyth, 2001). Consequently, children may be exposed to risks every time a drug is prescribed offlabel or effectively administered 'blind' when unlicenced medications are given in everyday practice. In these circumstances sick children are subjected to potentially ineffective treatments, possibly with unknown side-effects, at a time when they are already in a weakened and vulnerable condition due to their illness. Concerns about the failure to involve children in research have been voiced increasingly over recent years (Caldwell et al, 2004), and para 3 of the preamble to the EU Clinical Trials Directive acknowledges the real need to conduct research involving children: ... there is a need for clinical trials involving children to improve the treatment available to them. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development-related research important for their benefit. |
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| With this in mind Council
Regulation (EC) 1901/2006 on medicinal products for
paediatric use came into force in January 2007. Article 1 states that
the Regulation:
. . . lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC. The central aim of the Regulation is to facilitate paediatric trials so that children have greater access to medicines that are specifically designed or adapted and licensed for their use, and 'to improve the information available on the use of medicinal products in the various paediatric populations' (preamble, para 4). The regulation of clinical research on children involving medicinal products is therefore governed by several overlapping pieces of legislation. In the United Kingdom, the Clinical Trials Regulations, which implement the EU Clinical Trials Directive, is probably the most significant. In addition, Regulation 1901/2006 operates in tandem with the Clinical Trials Regulations specifically to promote research on the paediatric population. Alongside these the common law also applies to consent arrangements and pertains to all other types of research. The regulatory environment is therefore highly complex in relation to medical research involving children. One area that might be expected to be uncomplicated concerns the definition of what it is to be a child for the purposes of medical research. There is a presumption in law that once a person attains adulthood they are entitled to make decisions on their own behalf, but socially the demarcation between adult and child is far from clear in the United Kingdom. The age of majority is 18, but a person needs only to be 17 to drive a car, 16 to consent to sexual relations, and must pay full adult ticket prices for public transport and entry to venues such as cinemas from the age of 14. With regard to healthcare in Scotland, the Age of Legal Capacity (Scotland) Act 1991 sets the age at which one attains full decision-making capacity at 16 years. In England and Wales, however, the Family Law Reform Act 1969, s 1(1) defines the age of majority as 18, but under s 8 permits those aged 16 and 17 to consent to medical treatment that is of direct benefit to the person. With regard to medical research, the legal position is further complicated by reg 2(1) of the Clinical Trials Regulations, which stipulates that "'adult" means a person who has attained the age of 16 years', and also by Art 2(1) of Regulation 1901/2006, which states that "'paediatric population" means that part of the population aged between birth and eighteen years'. Further, under the common law a minor under the age of 16 will be able to make medical treatment decisions if she is competent to do so under the rules established in Gillick v West Norfolk and Wisbech Area Health Authority (1985). The court recognised (p 421) that attaining maturity is a gradual and flexible process whose progress depends on the attributes and experience of the individual concerned: If the law should impose upon the process of growing up fixed limits where nature knew only continuous process, the price would be artificiality and a |
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| lack of realism in an area where the law must be sensitive to human development
and social change.
It will become clear from the discussion of the Gillick case below, that, in some circumstances, minors may attain the capacity to make decisions for themselves before they reach the age of 16. There is, however, a presumption in law that below this age consent for medical and other physical interventions must be given by an adult who has responsibility for the child. As with adults, legal authorisation must be obtained for the participation of minors in research before any research can be lawfully conducted. It is therefore very important to know who has the power to give consent for a minor to participate in medical research, and whether and when a minor can consent on her own behalf. In order to explain the intricacies of consent in relation to children, this discussion will begin with an analysis of the situation where the minor is not competent to decide, and then move on to discuss the position as it relates to those who have attained decisionmaking capacity. An assessment of the role of assent will also be included as this forms a major controversy in relation to the Clinical Trials Regulations. The non-competent minor Immaturity prevents very young children from exercising individual autonomy and demands that the child's welfare is protected by the adults responsible for them. Where a minor is below the age of 16, the law bestows this responsibility upon the parents, or another person with legal guardianship, or occasionally the courts. The applicable law in this regard is the Children Act 1989 in England and Wales, the Children (Scotland) Act 1995 in Scotland and the Children (Northern Ireland) Order 1995 in Northern Ireland. The law is further reinforced by Article 8 of the European Convention on Human Rights and, although the United Kingdom is not currently a signatory, it is notable that Art 6 of the European Convention on Biomedicine applies the same approach. However, each of these legal measures relates to the provision of medical treatment and is based on the presumption that the treatment concerned will be in the best interests of the child. Similarly, the right to authorise treatment under the common law exists only so far as what is proposed advances the welfare of the child. Accordingly, in Secretary of State for Health and Community Services v JWB and SMB (1992), it was asserted that in relation to surgery the right did not extend to authorising that which was perceived to be 'in the interests of those responsible foi; the care of the child or in the interests of society in general' (p 295). Consequently, concerns have been raised about the legitimacy of parental proxy consent as a means of authorising a child's participation in a research project from which the child may not benefit. In the context of research it cannot be presumed that the child's best interests will be served by participating in the study. Medical research is conducted in |
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