2Bioethics Term coined by the oncologist Potter in 1970 in the US Definition in the Encyclopaedia of Bioethics 1978 is “ the systematic analysis of human behaviour in the field of life sciences and health, where the behaviour is examined in the light of moral values and principles”
3BackgroundResearch on the human genome and resulting applications have great potential for improving the health of individuals and humankind as a whole.UNESCO is concerned with ethical aspects of the consequences of progress in S & T in the fields of biology and genetics in the framework of respect for human rights and fundamental freedoms
4Translating human genomics to health benefits Identifying genes and metabolic pathways in disease & interaction with environmental factors.Improved genetic counseling.Prediction of drug susceptibility.Diagnostics for disease susceptibility.Genome information into therapeutic advances.
5Scientists doing frontier science Seduced by what is “technically sweet” ?Faustian urge to alter and control ?Implications of seminal discoveries are felt and discussed afterwards e.g. as admitted by Robert J. OppenheimerSimilar scenario for Dolly and human cloning??
6The Universal Declaration on the Human Genome and Human Rights Prepared by the International Bioethics Committee of UNESCOAdopted by UNESCO 1997Endorsed by the UN General Assembly in 1998
7Human Dignity and the Human Genome Article 1The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.Article 2a) Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics.b) That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity.
8Rights of the PersonsArticle 5a) Research, treatment or diagnosis affecting an individual's genome shall be undertaken only after rigorous and prior assessment of the potential risks and benefits pertaining thereto and in accordance with any other requirement of national law.b) In all cases , the prior, free and informed consent of the person concerned shall be obtained. If the latter is not in a position to consent, consent or authorization shall be obtained in the manner prescribed by law, guided by the person's best interest.
9Article 6No one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity.Article 7Genetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose must be held confidential in the conditions set by law.
10Research on the Human Genome Article 10No research or research applications concerning the human genome, in particular in the fields of biology, genetics and medicine, should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people.Article 11Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected.
11International Declaration on Human Genetic Data Prepared by the IBCAdopted by UNESCO in 2003
12BACKGROUNDHuman genetic data provides sensitive medical and personal information that is also relevant to family and community.Collection, processing, use and storage of such data is important for progress of science and medicine and may be needed for judicial purposes.However this poses potential risks for human rights, freedoms and dignity.
13CURRENT DATABASE ACTIVITIES Iceland Health Sector Database links genealogical information to DNA based genotype. Samples collected with informed consent but entry into database is by presumed consent. Single commercial company that is entitled to profits with a portion allocated for general health provision for the community.
14UK Population Biomedical Collection. 500,000 samples from adults aged 45-60y.Hopes to establish genetic and environmental factors in the aetiology of cancer, cardiovascular diseases etc.Informed consent and multiple access to companies.Database will be publicly owned but individuals cannot be identified by researchers.
15Article 1: Meaning and scope Article 2: Person's Identity General ProvisionsArticle 1: Meaning and scopeHuman genetic data are information about heritable characteristics of individuals obtained by analysis of deoxyribonucleic acid (DNA) sequences or by other means. This Declaration shall apply to human genetic data as well as to data that are derived therefrom.Article 2: Person's IdentityEach individual has a characteristic genetic make-up. Nevertheless, a person's identity should not be reduced to genetic characteristics, since it is determined by complex educational and other environmental factors as well as by emotional, social and cultural bonds with others.
16Article 3:Special Status Human genetic data constitutes a special category of information because it provides scientific, medical and personal information, and it may have both sensitive components and lifelong relevance in relation to genetic predispositions. Moreover, this information may have a significant impact on the family, extending over generations and, in some instances, on the whole group to which the person concerned belongs.Human genetic data and the biological samples used to produce them may have particular cultural significance for persons or groups and for this reason require special consideration and respect.
17Article 4:PurposesHuman genetic data may only be collected, processed, used and stored for purposes of. diagnosis and health care, medical and other scientific research, including epidemiological studies, forensic medicine, judicial purposes in civil or criminal proceedings, and any other purpose consistent with the Universal Declaration on the Human Genome and Human Rights and international human rights law.
18Article 13: Confidentiality a) Confidentiality of human genetic data linked to an identifiable person, a family or a group shall be guaranteed in accordance with national legislation or regulations and in conformity with international human rights law.b) Human genetic data linked to an identifiable person shall not be disclosed or accessible to third parties, in particular employers, insurance companies or educational institutions, except in cases provided for by national legislation or regulations and subject to the consent of the person concerned, and in compliance with international human rights law.
19Significant local developments Formation of ethics committees to approve research involving human subjects.The National Bioethics Committee at the NSFWorking groups at the National Science and Technology CommissionProliferation of assisted reproductive technologiesSexing of foetuses
20Objectives of the National Bioethics Committee at the NSF Promotion of Bioethics in the country through publicity, training and networkingExamining relevant issues and providing advice e.g. teaching of bioethics; ethical considerations of research using animalsPromotion of the International Declarations on BioethicsPromoting legislation to apply accepted bioethical principles in the country.
21Current issuesPatentability of the human genome – IBC believes WTO should clarify that the human genome is not patentable on the basis of the public interest considerations set out in Article 27(2) of the TRIPS agreement viz. public order, morality and the protection of human life and health
22Pre-implantation Genetic Diagnosis IBC takes the view that PGD for gender selection for non-medical reasons is unethicalHLA selection of embryos with the view of generating stem cells for helping a sibling survive a genetic defect is justifiable only if it is performed simultaneously with PGD for the illness concerned, and HLA incompatibility is itself a reason for eliminating an embryo that is not affected by the illness concerned.
23Development of accurate procedures for typing and selecting sperms as X or Y
24Germ-line intervention The IBC advises that technologies are not well-developed enough to justify any form of intervention at present even for medical reasonsAs distinct from somatic cell therapy
25A Universal Instrument on Bioethics UNESCO approves its development by the IBCA non-binding declaration that would serve as a reference for States wishing to adopt legislation in this areaRespect cultural diversity
26Stem cell researchEmbryonic stem cells are totipotent or pluripotent and therefore research on them can help manufacture tissues and organs for transplantation in otherwise intractable medical conditionsHowever such stem cells can only be obtained from pre-implantation embryosIBC took the position that supervision of stem cell research should be left to individual states and that the use of adult stem cells for such purposes should be examined as an alternative
27Neurosciences and Brain Research Traditional issues include privacy rights to the results of testing, optimisation of clinical trials and the use of a placebo, etc.Emerging issues are enhancement of normal functions such as mood, memory, appetite and sex; altering brain-function through court ordered rehabilitation; brain reading
28Behavioral Genetics Distinct from genetics of human disease Heritability of non-pathological variant characteristics between individuals and groupsInteraction between genes and the environmentImplications for Intelligence and other Personality traitsEugenics e.g. Nazi GermanyPGD or pre-natal selection ?
29In a broad sense Bioethics also impinges on: GM cropsTransgenic animalsPreserving BiodiversityBut many other organisations arespecifically addressing these issues