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Bioethics in Genetic Research: Concepts and Applications

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Created by: Batch 4 of Genetic Counseling Concentration, Magister of Biomedical Science Diponegoro University, 2010.

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Bioethics in Genetic Research: Concepts and Applications

  1. 1. BIOethics in genetic research:Concepts and applications<br />1<br />Magister of Biomedical Science/ Genetic Counseling<br />Faculty of MedicineDiponegoro University, 2010<br />
  2. 2. Outline<br />Introduction<br />Societal concerns<br />Responding to genomic advances<br />Focus of moral and bioethical debate<br />Key issues in ethical implications <br />Stem cell research<br />Answers to social concerns<br />2<br />
  3. 3. Introduction<br />Consequences of advances in genetic research:<br />Large, comprehensive sets of genetic data<br />New powerful technologies<br />Ethical, legal and social implications (ELSI)<br />Collins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. A vision for the future of genomics research. Nature. 2003 Apr 24;422(6934):835-47. <br />3<br />
  4. 4. Societal concerns<br />Some examples:<br />Who should have access to personal genetic information, and how will it be used?<br /> How do we prepare the public to make informed consent/ choices?<br />How do we prepare healthcare professionals for the new genetics? <br />4<br />
  5. 5. Responding to genomic advances<br />We need to:<br />Understand the consequences of genetic advances in individual and society<br />Eg. Allowing to predict individual “fate”, adapt life plans, intervene <br />Assess how to define the ethical boundaries for uses of genomics<br />Discuss science and ethical, legal and social factors of genomic advance to make effective policies<br />Collins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. A vision for the future of genomics research. Nature. 2003 Apr 24;422(6934):835-47. <br />5<br />
  6. 6. Focus of moral and bioethical debate<br />Respect for autonomy of individuals<br />Appropriate use? Based on moral, rights, rules<br />Redefining concept of disease:<br />Focusing not just on clinical symptoms but also on increased risk and consequences of individual and society<br />Purpose of comprehensive debate<br />Develop guidelines<br />Standards for appropriate use of gene technology<br />Biomedicine should be associated with bio-criticism<br />Ten Have HA. Genetic advances require comprehensive bioethical debate.<br />Croat Med J. 2003 Oct;44(5):533-7.<br />6<br />
  7. 7. GWAS<br />Genome wide association studies (GWAS) seek to establish associations between genomic variants and disease or traits. <br />GWAS provide detailed genotype information at high resolution<br />“Genetic libraries”<br />Information from DNA is a personal identifier and can provide information not just on individual but family and group identity.<br />Data is used multiple times by multiple researchers<br />Kaye J, Boddington P, de Vries J, Hawkins N, Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet. 2009 Nov 4. <br />7<br />
  8. 8. Key issues in ethical implications <br />Informed consent<br />Individuals have knowledge in advance and choose how personal information is used<br />Potential harm from violation of privacy and misuse of information<br />Data is repeatedly used by multiple researchers, withdrawal from research is difficult and costly<br />Broad consent? Controversial!<br />Feedback of finding<br />When there is serious condition: research team have moral obligation to inform participants<br />8<br />
  9. 9. Key issues in ethical implications<br />Privacy of participants<br />Diagnosis of disease -> family, insurance company, employers?<br />De-identifying is difficult for detailed information!<br />Supervision of research<br />Most supervision is at national level<br />enforcement power?<br />9<br />
  10. 10. Stem cells? <br />Definition<br />Stem cells are cells that can divide to produce either cells like themselves (self renewal),or cells of one or several specific differentiated types. <br />Origin<br />Animal tissues (Xenotransplantation)<br />Adult stem cells<br />Stem cells of foetal origin<br />Haematopoetic stem cells<br />Foetal tissue<br />Stem cells of embryonic origin<br />iPS<br />10<br />
  11. 11. Embryonic Stem Cells<br />Europe: <br />“to ensure adequate protection of the embryo” <br />to prohibit “the creation of human embryos for research purposes”<br />US: Research on human ESC can be if:<br />the cells must be taken from frozen spare embryos from fertility clinics and already destined to be discarded; <br />Federal funds could not be used to destroy the embryos to obtain the cells<br />China: Even if just research, a human embryo should not be destroyed at will<br />Singapore: The concerns over sacrificing embryos are not sufficient to outweigh the advantage of pluripotent<br />Indonesia ??<br />11<br />
  12. 12. Human Stem Cells<br /><ul><li>Free and informed consent
  13. 13. Risk benefit assesment (safety and precaution)
  14. 14. Protection of health of persons involved in clinical trials
  15. 15. Scientific evaluation of stem cell use for therapeutic purposes
  16. 16. Anonymity of the donation (donor and recipient)
  17. 17. Commercialization should be avoided (NO BUSINESS for embryo, fetal, cadaveric tissues)</li></ul>12<br />
  18. 18. Xenotransplantation<br />Xenografting and xenotransplantation raise no unique ethical problems as long as the principle of voluntary agreement to treatment is observed. <br />Sale and commercial supply of stem cells should preferably be DISALLOWED<br />There is widespread public concern over issues of genetic modification generally. It would be advisable to limit cross-species experimentation except in cases where a clear anticipated benefit is unattainable by other means<br />13<br />
  19. 19. Societal Concerns<br />Who should have access to personal genetic information, and how will it be used?<br />How do we prepare the public to make informed consent/choices?<br />How do we prepare healthcare professionals for the new genetics? <br />
  20. 20. Who Should Have Access to Personal Genetic Information, and How Will It Be Used?<br />1. Researchers have an obligation to protect the confidentiality of genetic information.<br />a.Universal Declaration on the Human Genome and Human Rights of the UNESCO (1997) : <br /> “Genetic 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.”<br />
  21. 21. b. WHO (1998) :<br /> “Genetic data is only used to advantage and empower an individual or family, and for better treatment or prevention of disease.”<br />c. Human Genetic Commission (2002) :<br /> “Private genetic information should generally not be obtained, held or communicated without the free and informed consent of the individual.”<br />
  22. 22. 3. Human genetic research is not conducted with the aim of providing research participants with specific information about their genetic status or health.<br />4. A difficult situation may arise when an individual refuses to disclose a test result which may be medically beneficial to a genetic relative. <br />e.g high risk of developing ca colon<br />
  23. 23. 5. Genetic Information Nondiscrimination Act (US,2008):<br />a. prohibits US insurance companies and employers from discriminating on the basis of information derived from genetic test.<br />b. Insurers and employers are not allowed under the law to request or demand a genetic test<br />
  24. 24. 5.Exceptional conditions when genetic information may be disclosed despite the individual’s right to confidentiality.<br />NMEC of Singapore (2001) : <br /><ul><li>separate efforts by 2 physicians have failed, despite patient fully understanding
  25. 25. High probability both that harm will occur to individuals or society
  26. 26. The harm that individual would suffer would be serious
  27. 27. Only the genetic information needed for diagnosis &/ treatment of the disease</li></li></ul><li>How Do We Prepare The Public to Make Informed Consent/Choices?<br />1. Researchers should provide research participants with sufficient information in an understandable form to make an informed decision (purpose, benefits, why he/she, procedure, risks, etc).<br />2. If the research involves the use of stored tissue samples or genetic information, consent is required from the person from whom the tissue was derived or to whom the information relates. <br />3. Tissue donors should be free to choose between making a general gift or restricted gift<br />
  28. 28. 4. Participation in genetic research is voluntary. Researchers need to seek the informed consent of prospective research participants, whether or not they are also patients :<br /><ul><li>An attending physician is also the researcher
  29. 29. Tissue samples provided for clinical use are also intended for research
  30. 30. Intention to store the tissue for other future research
  31. 31. Children -> their informed consent from parents</li></li></ul><li>How Do We Prepare Healthcare Professionals for The New Genetics? <br />It is hoped that human genetic research will enable or facilitate the development of new or more reliable ways of diagnosing, preventing and treating genetic disorders effectively.<br />Education of doctors and other health service providers, patients, and the general public in genetic capabilities, scientific limitations & social risks<br />Help doctors catch problems early, perhaps leading to preventive treatment and lower costs<br />
  32. 32. References<br />Collins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. A vision for the future of genomics research. Nature. 2003 Apr 24;422(6934):835-47. <br />Kaye J, Boddington P, de Vries J, Hawkins N, Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet. 2009 Nov 4. <br />Ten Have HA. Genetic advances require comprehensive bioethical debate. Croat Med J. 2003 Oct;44(5):533-7.<br />The Bioethics Advisory Committee of Singapore. Genetic Testing and Genetic Research. 2005. <br />The Ethical, Legal and Social Implications (ELSI) Research Program. http://www.genome.gov/10001618<br />U.S. Department of Energy Office of Science, Office of Biological and Environmental Research, Human Genome Program. http://www.ornl.gov/sci/techresources/Human_Genome/elsi/elsi.shtml<br />23<br />

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