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Explanatory Report to the Convention on Human Rights and Biomedicine (Part 2)(See Part 1) Article 15 – General rule 95. Freedom of scientific research in the field of biology and medicine is justified not only by humanity’s right to knowledge, but also by the considerable progress its results may bring in terms of the health and well-being of patients. 96. Nevertheless, such freedom is not absolute. In medical research it is limited by the fundamental rights of individuals expressed, in particular, by the provisions of the Convention and by other legal provisions which protect the human being. In this connection, it should be pointed out that the first Article of the Convention specifies that its aim is to protect the dignity and identity of human being and guarantee to everyone, without discrimination, respect for their integrity as well as for other rights and fundamental freedoms. Any research will therefore have to observe these principles. Article 16 – Protection of persons undergoing research 97. This Article lays down the conditions for all research on human beings. These conditions were largely inspired by Recommendation No. R (90) 3 of the Committee of Ministers to member States on medical research on the human being. 98. The first condition is that there must be no alternative of comparable effectiveness to research on humans. Consequently, research will not be allowed if comparable results can be obtained by other means. Invasive methods will not be authorised if other less invasive or non-invasive methods can be used with comparable effect. 99. The second condition is that the risks which may be incurred by that person are not disproportionate to the potential benefits of the research. 100. The third condition is the need for an independent examination of the scientific merit as well as of the ethical, including legal, social and economic acceptability of the research project. The examination of the latter aspects have to be carried out by independent multi-disciplinary ethics committees. 101. Paragraph iv underlines the obligation to inform the person in advance of their legal rights and guarantees, for example their right to freely withdraw their consent at any time. 102. Paragraph v reinforces conditions set forth in Article 5 concerning consent. In the sphere of research, implicit consent is insufficient. For this reason the Article requires not only the person’s free and informed consent, but their express, specific and written consent. The words “specific consent” are to be understood here as meaning consent which is given to one particular intervention carried out in the framework of research. Article 17 – Protection of persons not able to consent to research Paragraph 1 103. In its first paragraph this Article establishes a principle with regard to research on a person who is not able to consent: the research must be potentially beneficial to the health of the person concerned. The benefit must be real and follow from the potential results of the research, and the risk must not be disproportionate to the potential benefit. 104. Moreover, to allow such research, there should be no alternative subject with full capacity. It is not sufficient that there should be no capable volunteers. Recourse to research on persons not able to consent must be, scientifically, the sole possibility. This will apply, for instance, to research aimed at improving the understanding of development in children or improving the understanding of diseases affecting these people specifically, such as infant diseases or certain psychiatric disorders such as dementia in adults. Such research can only be carried out, respectively, on children or the adults concerned. 105. Protection of the person not able to consent is also strengthened by the requirement that the necessary authorisation as provided for under Article 6 be given specifically and in writing. It is also stipulated that such authorisation may be freely withdrawn at any time. 106. The research must not be carried out if the person concerned objects. In the case of infants or very young children, it is necessary to evaluate their attitude taking account of their age and maturity. The rule prohibiting the carrying out of the research against the wish of the subject reflects concern, in research, for the autonomy and dignity of the person in all circumstances, even if the person is considered legally incapable of giving consent. This provision is also a means of guaranteeing that the burden of the research is acceptable to the person at all times. Paragraph 2 107. Under the protective conditions prescribed by domestic law, paragraph 2 provides, exceptionally, for the possibility of waiving the direct benefit rule on certain very strict conditions. Were such research to be banned altogether, progress in the battles to maintain and improve health and to combat diseases only afflicting children, mentally disabled persons or persons suffering from senile dementia would become impossible. The group of people concerned may in the end benefit from this kind of research. 108. As well as the general conditions of research on persons not able to consent, a certain number of supplementary conditions must be fulfilled. In this way the Convention enables these people to enjoy the benefits of science in the fight against disease, while guaranteeing the individual protection of the person who undergoes the research. The required conditions imply that: – in order to obtain the necessary results for the patient group concerned, there is neither an alternative method of comparable effectiveness to research on humans, nor research of comparable effectiveness on individuals capable of giving informed consent; – the research has the aim of contributing to the ultimate attainment of results capable of conferring a benefit to the person concerned or to other persons in the same age category, or afflicted with the same disease or disorder or having the same condition, through significant improvements in the scientific understanding of the individual’s conditions, disease or disorder; – the research entails only minimal risk and minimal burden for the individual concerned (for example blood sampling – see paragraphs 111 and 113 below); – the research project not only has scientific merit but is also ethically and legally acceptable and has been given prior approval by the competent bodies; – the person’s representative or an authority or a person or body provided for by law has given authorisation (adequate representation of the interests of the patient); – the person concerned does not object (the wish of the person concerned prevails and is always decisive); – authorisation for this research may be withdrawn at any time throughout a research project. 109. One of the first supplementary conditions is that this research should be likely to significantly improve the scientific understanding of a person’s health condition, disease or disorder and obtain, in the end, results benefitting the health of the person undergoing research or the health of persons in the same category. This means, for example, that a minor may participate in research on an ailment from which he or she suffers even if the minor would not benefit by the results of the research, provided that the research might be of significant benefit to other children suffering from the same disease. In the case of healthy minors undergoing research it is obvious that the result of the research might be of benefit only to other children. In cases where healthy minors participate in research, clearly it is to obtain results of benefit to other children; however such research may well be of ultimate benefit to healthy children taking part in this research. 110. The research on “the individual’s condition” might cover, with regard to research on children, not only diseases or abnormalities peculiar to childhood or certain aspects of common diseases that are specific to childhood, but also the normal development of the child where knowledge is necessary for the understanding of these diseases or abnormalities. 111. While Article 16.ii restricts research in general by establishing a criterion of risk/benefit proportionality, Article 17 lays down a more stringent requirement for research without direct benefit to persons incapable of giving consent, namely only minimal risk and minimal burden for the individual concerned. Indeed, it is only in respecting these conditions that such research may be carried out without constituting an instrumentalisation of these persons contrary to their dignity. For example, taking a single blood sample from a child would generally only present a minimal risk, and might therefore be regarded as acceptable. 112. Diagnostic and therapeutic progress for the benefit of sick children depends to a large extent on new knowledge and insight regarding the normal biology of the human organism and calls for research on the age-related functions and development of normal children before it can be applied in the treatment of sick children. Moreover, paediatric research concerns not only the diagnosis and treatment of serious pathological conditions but also the maintenance and improvement of the state of health of children who are not ill, or who are only slightly ill. In this connection mention should be made of prophylaxis through vaccination or immunisation, dietary measures or preventive treatments whose effectiveness, especially in terms of costs and possible risks, urgently requires evaluation by means of scientifically controlled studies. Any restriction based on the requirement of “potential direct benefit” for the person undergoing the test would make such studies impossible in the future. 113. As examples, the following fields of research can be mentioned, provided all conditions outlined above are met (including the condition that it is impossible to obtain the same results through research carried out on capable persons and the condition of minimal risk and minimal burden): – in respect of children : replacing X-ray examinations or invasive diagnostic measures for children by ultrasonic scanning; analyses of incidental blood samples from newborn infants without respiratory problems in order to establish the necessary oxygen content for premature infants; discovering the causes and improving treatment of leukaemia in children (for example by taking a blood sample); – in respect of adults not able to consent: research on patients in intensive care or in a coma to improve the understanding of the causes of coma or the treatment in intensive care. 114. The above-mentioned examples of medical research cannot be described as routine treatment. They are in principle without direct therapeutic benefit for the patient. However, they may be ethically acceptable if the above highly protective conditions, resulting from the combined effect of Articles 6, 7, 16 and 17, are fulfilled. Article 18 – Research on embryos in vitro 115. The first paragraph of Article 18 stresses the necessity to protect the embryo in the framework of research: where national law allows research on embryos in vitro the law must ensure adequate protection of the embryo. 116. The article does not take a stand on the admissibility of the principle of research on in vitro embryos. However, paragraph 2 of the Article prohibits the creation of human embryos with the aim to carry out research on them. |
