Research on the human genome - human rights perspective
| Autor | Anna Bialek |
| Páginas | 27-40 |
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Contemporary development of biotechnology is revolutionizing modern medicine. The cornerstone in medical research on human beings was sequencing the human genome1. Undoubtedly, there are considerable advantages in supporting progress in research in the field of genomics, like the possibility of making conscious preventative decisions, concerning health condition or development of personalized medicine, which may lead to de-crease in spending on application of an inadequate treatment, not to mention the possible benefits for whole populations. Achieving above-mentioned out-comes is possible due to, among others, closer cooperation between national biobanks and exchanging biological material and genetic data.
Nevertheless, the new possibilities bring new threats to human rights2.
The following article will focus on chosen problems concerning the right to informed consent, which is embedded in the right to self-determination and the right to privacy. The problem of informed consent will be discussed in two aspects – as the right to consent to biological material donation and as the right to consent to carry out research on donated material. Regarding
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the first aspect, there will be discussed how to balance free movement of biological material between biobanks and patient autonomy. Then, there will be critiqued different concepts of consent to conduct research in the light of the right to self-determination. At the end, there will be presented threats to the human right to privacy, which may lead to discriminatory practices and postulated legal standards, which should be implemented in order to ensure an adequate level of protection of the right to privacy.
The doctor’s obligation to obtain patient’s informed consent to any medical procedure is widely accepted as a fundamental rule governing the doctor – patient relationship, which guarantee respect for patient autonomy and the right to self-determination3. The importance of informed consent is expressed in several international, European and national acts. For example, the first universal and accepted by the international community regulation on bioethics – the Universal Declaration on the Human Genome and Human Rights4– focuses on chosen bioethical problems with special regard to the human genome5. The Declaration establishes three conditions which must be met for informed consent to be valid. According to this act consent must be given before the procedure (prior consent), independently without pressure (free consent). Moreover, the patient must be informed of the purpose and methods of the procedure and prognosis (in-formed consent)6.
One of the most complex regulation on informed consent is established in the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (hereinafter referred to as
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Convention or European Convention)7. According to the article 5 of the Convention “[a]n intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.”8The Explanatory Report to the Convention9, highlights that patients should be informed about relevant facts regarding the intervention and “this information must include the purpose, nature and consequences of the intervention and the risks involved”. Moreover, the Convention establishes additional conditions concerning informed consent under which a research on human beings may be carried out (article 16). Firstly, the person under-going research should be informed of his rights and safeguards prescribed by law for his protection and the consent should be given expressly, specifically and it should be documented. According to the Explanatory Report implicit consent described in the article 5 of the Convention is insufficient in the area of medical research. This is why it is claimed that consent to participation in research must be given to “one particular intervention carried out in the framework of research.”10The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (hereinafter referred to as Additional Protocol) specifies types of information that patient should be given before the intervention. The article 13 of the Additional Protocol states that patients shall be informed, among others, about “arrangements to ensure respect for private life and ensure the confidentiality of personal data, arrangements for access to information relevant to the participant arising from the research and to its overall results and about any foreseen potential further uses, including commercial uses, of the research results, data or biological materials.”11
Described regulation, which is applicable in case of performing medical research on persons, does not solve all problematic matters, such as con-
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ducting studies after a patient’s death or re-using donated material12. What is more, as a matter in principle, this informed consent standards do not refer to already donated biological material stored in biobanks13. Undoubtedly, biological material donation for research purposes, which usually involves violation of human physical and psychological integrity, falls within the meaning of the term “research on human beings”14. Nevertheless, it should be borne in mind that the significant number of research may be conducted on biological material acquired form treatment undertaken for other purposes15. Because of the fact that research on biological material do not cause similar threat to human integrity as research on individuals do, some argue that in this case researchers’ obligation to obtain informed consent is not justifiable and research should be conducted freely for common good16.
Important, but not binding regulation regarding donated material is ex-pressed in the Recommendation Rec (2006)4 of the Committee of Ministers to member states on research on biological materials of human origin17, which partially refers to the Additional Protocol of the European Convention. According to the article 10 of the Recommendation, informed consent for the future use of samples should be as precise as possible, but does not have to meet the standards of specific consent. Having in mind that in the next article the Recommendation states that the donation on biological material should not breach the regulations of the Additional Protocol to European Convention18, above-mention regulation expressed in Recommendation raises doubts. The most reasonable solution seems to be joint application of both acts as far as it is possible19. If the research project presume obtaining biological material for storing and the future use, consent should be explicit, precise, freely expressed and documented. Joint interpretation of the article 13 of the Protocol and the article 11 of Recommendation leads to conclusion that the donor should be informed as precisely as it is possible about the possible future use of the research results, biological material and derived data. Nevertheless, when the pur-
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pose, possible risks and benefits of the study are unknown, patient should be given information known at the time of material extraction. Finally, it is worth mentioning that according to the Recommendation’s regulations on the problem of residual biological materials “[b]iological materials removed for purposes other than storage for research should only be made available for research activities with appropriate consent or authorisation, or in accordance with the provisions of Article 22 paragraph 1. Whenever possible, information should be given and consent or authorisation requested before biological materials are removed”.
The problem of informed consent to research on biological material gained significant importance due to the development of biobanks, where biological material and data (e.g. genetic, clinical, genealogical data) is collected in order to conduct scientific research on genetic and environmental causes of diseases and which are designed for finding new methods of diagnosis of illnesses and treatment20. Biobanks foster closer cooperation by participating in research within biobanking networks. Closer cooperation leads to broader access to samples of biological material and genetic data, and as a result to carrying out research more effectively (faster and with more accuracy). Moreover, development of biobanks brings considerable advantages for individuals and whole populations, but also generates new threats to human rights. The problematic nature of biobanks raises the question about the need of change of existing – and slightly out-dated – legal framework on biomedical research.
The most important ethical, legal and social problems connected with biobanking are obtaining informed consent and protection of privacy (the problem of privacy will be discussed in the next chapter)21. The difficulties in application existing legal regulation regarding informed consent to...
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