Çocuklar üzerindeki tıbbi araştırmaların etik açısından değerlendirilmesi
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Date
2000
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Sağlık Bilimleri Enstitüsü
Abstract
Evaluation of Medical Researchs on Children in respect of Ethics The purpose of this thesis study is to evaluate medical researchs on children in respect of patient and subject rights under the light of basic principles of bio-ethics, by considering the differences between children and adults, to determine problem areas peculiar to Turkey and to discuss the suggestions intended to develop principles which may form basis for applications. The "scientific-experimental medicine concept", today's dominant paradigm in the evolution of the medicine, forces the scientific researches which cover animal and man subjects as well as laboratory experiments to develop the scientific knowledge in the medicine and use it for the benefit of man. Accordingly, it is necessary to conduct medical researchs also on children who show great differences from adults in regard of bio-psycho-social aspects and who can not be qualified as "miniature adults". Clinical researchs which involve children affect the development of medical concept positively, as they ensure a general increase in the knowledge on paediatrics and they contribute to rise the clinical application quality as well as they bring into question many discussion issues related with ethic problems. However, it is essential to protect and develop basic rights such as "respect for life", "human rights", "patient rights", "subject rights" and "child rights" against the necessity for the execution of researchs on children and the power of the huge technological possibilities owned by humankind today. International instruments prepared to protect patient and subject rights and to ensure the conformity of medical researchs to ethic principles and which form "the conscience of the scientific community" are of guiding quality for researchers. The concepts of "child", "respect for infant", "child rights", "health right", formed by the modern society and the system of values on which such concepts are based also form a basis to evaluate the researchs on children ethically. Children who are more defenseless in respect of being subjected to violations of patient and subject rights compared to the individuals defined as "adult" and "normal" are placed in the risk groups including old people, prisoners, psychiatric patients, HTV (+) individuals and Hepatitis B carriers. On the other hand, in respect of the treatment of a child and his/her participation in a medical research, the relationship between "the physician and the patient" or "the researcher and the subject" gains a different dimension and turns into a trio relationship in the form of "physician-child-parent/custodian" or "researcher-child-parent/ custodian". Ethic problems arising from the researchs on children due to the mentioned basic differences bring new discussion issues into question. Informed Consent is one of the basic components of the daily medical applications and an essential condition for medical research. Children self determination and capacity are the first issues of argument. Accordingly, which criteria would be used to obtain a valid approval, who would evaluate an children capacity and how it would be evaluated, problems concerning documentation, parental authority influencing on children self-determined decision making and the guidance of the physician are leading issues argument related with cleared approval in paediatric applications. There are differences between countries in the age and capacity level at which an children approval would be valid. Although 0-18 year-old individuals are legally defined as "child" and mentioned not to be able to give a legally valid approval, it is found proper for children under 18 years old to participate in decision making process in proportion to their capacity levels to accept or refuse to take part in medical treatments or researches. Age limits in different countries for the children to participate in decision making process on medical applications intended for them vary between 12-16 and proper legal arrangements are being conducted accordingly. It is a view agreed upon that children are individuals who must be protected, respected, developed and most importantly must not be hurt. However, basing on the understanding of protection children from damage, the traditional opinion which suggests not to make any researchs on them has changed today and the tendency to support the participation of children in researchs has increasingly spread out, by considering the potential benefit as well as potential damage. Depending on the subject-matter change, evaluation of benefit-harm and risk has gained a determinative significance in paediatric researchs. Accordingly, determinations of benefit-harm balance, different evaluation criteria used in this 514determination, examination of the benefit and harm in respect of intended target (child as an individual, a specific child group or all the children in general), positions of parents and/or researchers as "decision makers for children" in respect of benefit-harm, functions of ethic boards, criteria of acceptance of a proposed research project as a "valuable research" in regard of paediatrics are handled in various aspects. One of the two important criteria in the examination of the contribution of clinical researchs to the development of paediatrics is the scientific value of the study and the other is its ethic defensibility. Certain standards are required in order to conduct a research which includes both criteria which can not be evaluated separately, although they seem to be different problem areas. These standards which are most argued except "the approval capacity of a child" include the concepts of "minimal risk", "best interest of a child", "daily living risk". As the mentioned standards are minimum criteria for the acceptability of the researchs, serous discussions are maintained to determine them as "standards". Although an important portion of medical researchs in our country are conducted on children, it is rarely seen similar discussions to those mentioned above which are conducted at conceptional level. There is no doubt that this fact has cultural bases such as the perception form of the concepts of "health", "disease", "physician" and "research", the value given to children health, the thought system related with children participation in decision making processes, supposing parents and physicians as an authority. Therefore, it takes time to make changes in existing regulations accordingly; for example, there are no regulations for the children under 18 years old to take part in medical decisions and only the parents and legal custodians are decision making bodies. It is not much different in respect of physicians generally and paediatrists specially. The concepts of "child rights" and "patient rights" have been recently started to come into question in our country where a paternalistic physician-patient relationship is still dominant. The clues of a change from a paternalistic physician- patient relationship based on the principle of being useful to the patient towards a physician-patient relationship based on a mutual participation where respect for self-determination comes first have started to bee seen in our country as well. On the other hand, it may be said that first the "children health rights" should be defended, by considering that the disparity of opportunity in respect of access to and utilization of health services have been increasing day by day. All the physicians, all the employees in health services and all the parents have important duties to defend first "children health rights" then the rights of in-patient infants and "the rights of children as patients and subjects in treatment and research processes" and to ensure the participation of the children in any decision related with their health in proportion to their capacities and their development. It is expected that the informed Cousent form prepared to be used in medical researchs on children and thought to be proposed to paediatrists as well as the subject-related discussions included in the scope of this thesis should contribute to the mentioned process. Key Words: Concept of "childhood", development of child, rights of child subjects, medical researchs, medical ethics. 515
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