Protection of Human Research Subjects Especially Children and Other Related Ethical Questions

One of the consequences of the Nazi medical crimes on psychiatric patients, mentally retarded people and sick children was the Nuremberg Code. Following this tradition, the Helsinki Declaration and the Convention on Human Rights and Biomedicine of the European Council have also been enacted. Protection of human research subjects has become imperative, especially for interventions in children and the human psyche. In this chapter, therefore, we will focus on the developmental aspect of intervening in critical phases of development in the discussion of psychopharmacotherapy.

While psychopharmacotherapy is widely used especially in most First and Second World countries where there are high levels of prescription, there is still a lack of research on the developmental aspects of psychophar-maceutical interventions in the developing brain. Children who are treated with psychotropic agents often show age-specific reactions and side effects. Efficacy and safety issues are not the same over the age span. The earlier in a child's life a therapeutic intervention starts, the more likely it will be to influence brain development and modify plasticity and capacity (Carlezon and Konradi 2004) and therefore the more likely long-term consequences might be. These long-term consequences may be beneficial, but they could also consist of late onset side effects leading to drug dependencies or late impairments such as tardive dyskinesia, which is related to neuroleptic treatment, especially with the classical neuroleptics. By focusing on developmental aspects of psychopharmacology, we will describe in this chapter the use of pharmaceutical agents in different developmental stages to prevent or treat psychiatric illness, and to enhance cognitive and/or emotional functioning in human beings, particularly in children and adolescents but also during the life span. Some classes of substances will be used to illustrate the classic questions as well as conflicts that might arise in the future, related with the introduction of new possibilities of intervening in the brain dealt with in the other chapters like deep brain simulation. These general questions of ethical importance are the standard questions of efficacy and effectiveness as well as the combination of different forms of interventions and safety issues. The use of an intervention against a patient's will is also taken into consideration with the example of chemical restraint.

These days, questions of health resource allocation, determining who gets access to what form of treatment, are relevant to the ethical discussion on medical innovations. If we refer here to the principles which have been introduced into medical ethics by Beauchamp and Childress (2001)4, ques

4 The first edition of their "Principles of Biomedical Ethics" dates back to 1977. In 1979 a similar set of principles formed the basis of the so-called "Belmont Report" issued by the National Commission for the Protection of Human Subjects of Biomedical Research.

tions of justice and autonomy should be of prime importance in ethical discussion of psychopharmacology. In contrast, however, it is the primary questions of nonmaleficence (primum non nocere) and beneficence which seem to be the aspects which are particularly well studied in psychopharmacolog-ical interventions.

One might presume that ethical debates on novel interventions in the brain would focus first on the dangers to the first research subjects and patients (nonmaleficence), before focusing on the question whether there are scientific proofs of an overall beneficence and a positive cost benefit relationship of a new intervention. Questions of justice like access to care, access to new interventions are usually discussed later in the development of novel and often very expensive technologies - unfortunately, the differences of medical development in different regions of the world mean that only a small group of patients in first world countries obtains access to new forms of intervention.

The developmental focus underlines the importance of the concept of autonomy and the difficulties associated with this. In the treatment of children, but in a different way also in the treatment of mentally retarded people or people suffering from dementia, questions of patients' rights will become increasingly important. Who can and should consent to treatment? How important is the assent of the person who has to tolerate the treatment? Can parents decide on preventive interventions or enhancement in children whilst the children are too young to articulate their will or do not recognise the problems the parents have with their behaviour? Who defines the problems? Who decides about the cure and who has to take the pill? These are the standard questions in the triangle of parent, child and doctor or legal guardian, patient and doctor.

Regarding autonomy, another dimension is quite important: that of society. One of the historical tasks of psychiatry has always been the restraint of aggressive or dangerous psychiatrically ill patients. From the beginning of modern psychiatry in the 19th century this aspect was regulated in police law. In the context of intervening in the psyche, the interests of society can conflict with the personal interests of a subject. For example: is so-called "chemical restraint" acceptable to avoid harm to self or others? Individual rights of freedom and autonomy are sometimes overruled by mechanical or chemical interventions in psychiatrically ill patients. These classic ethical questions will be discussed in this chapter against the background of some examples from different classes of psy-chopharmacological agents. This will lay the groundwork of possible future discussions that will accompany the introductions of new forms of interventions in the psyche.

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