Websites

Keyword: Organisations

  1. BBMRI - a pan-European and internationally broadly accessible research infrastructure and a network of existing and de novo biobanks and biomolecular resources.
  2. Council of Europe http://conventions.coe.int
  3. European Group on Ethics (EGE) http://europa.eu.int/comm/european_group_ethics
  4. French National Consultative Ethics Committee for Health and Life Sciences (CCNE) http://www.ccne-ethique.fr
  5. Generation Scotland http://129.215.140.49/gs/
  6. Genetic Interest Group (GIG) www.gig.org.uk
  7. German National Ethics Commission www.ethikrat.org
  8. Human Genetics Commission (HGC), UK http://www.hgc.gov.uk
  9. Human Genome Organisation (HUGO) Ethics Committee http://www.hugo-international.org
  10. International Institute for Research Ethics and Biomedicine http://www.iireb.org/en/index.cfm
  11. Norwegian University of Science and Technology (NTNO) www.ntnu.no/medtek
  12. UK Biobank Ethics and Governance Council www.egcukbiobank.org.uk
  13. UK Biobank Ethics and Governance, www.ukbiobank.ac.uk/ethics/egf.php

Keyword: Web resources

  1. Centre for Law and Genetics http://www.lawgenecentre.org/
  2. hSERN Human Sample Exchange Regulation  Navigator http://www.hsern.eu/
  3. HumGen “Ethical, Legal and Social Issues in Human Genetics” www.humgen.umontreal.ca/int/
  4. Privacy International “DNA and Genetic Privacy” www.privacyinternational.org
  5. US Office for Human Research Protections  The International Compliation of Human Subject Research Protections (2009 version), http://www.hhs.gov/ohrp/international/HSPCompilation.pdf
  6. WHO International Digest of Health Legislation http://apps.who.int/idhl-rils/frame.cfm?language=english

Keyword: Projects

  1. ARCTIC (Assessment of Risk for Colorectal Tumours in Canada) Project , GE3LS (genomic, ethical environmental, economic, and legal issues) portion Genetic Information, Privacy and Biobanks, 2006.
  2. ELSAGEN Project: Ethical, Legal and Social Aspects of Human Genetic Databases. A European Comparison (2002-2004) www.elsagen.net
  3. EuroGenBank 1998-2000 (Banking of Genetic Material Data in Europe: Legal, Ethical and Economical Issues). See Hirtzlin et al “An empirical survey on biobanking of human genetic material and data in six EU countries” Eur J Hum Genet (2003) 11: 475-488;
  4. EuroGenTest “Harmonising Genetic Testing Across Europe” http://www.eurogentest.org/
  5. FIDIS (Future of IDentity in the Information Society)
  6. Forskningsbiobanker (Mapping the language of research biobanks and health registries - From traditional biobanking to research biobanking) 01/01/04-31/12/07, Norway.
  7. GenBenefit 2006-2009 (Genomics and Benefit Sharing with Developing Countries – From Biodiversity to Human Genomics)
  8. Genes Without Borders? Towards Global Genomic Governance Project, Austria.
  9. GeneBanC Project - Genetic Bio and Databanking: Confidentiality and Protection of Data www.genebanc.eu
  10. Genetic Discrimination Project http://www.gdproject.org/
  11. Governing Genetic Databases Project http://ggd.org.uk
  12. Hide Project - Homeland Security, Biometric Identification & Personal Detection Ethics http://www.hideproject.org/
  13. Human Genetic Testing: What Implications? Conference based on 25 recommendations on the ethical, legal and social implications of genetic testing made by an EC expert group (2004)
  14. INES (Institutionalisation of ethics in science policy) project
  15. Law, Ethics and Genetic Discrimination (legend)
  16. P3G Observatory Internet repository aimed at facilitating the development, realization and harmonization of population genomic research projects, www.p3gobservatory.org
  17. PRIME (Privacy and Identity Management for Europe) Project and the follow-up, PRIME-Life (Bringing sustainable privacy and identity management to future networks and services) Project.
  18. PRISE Project - Privacy enhancing shaping of security research and technology
  19. PRIVIREAL - Privacy in Research Ethics and Law (2005) www.privireal.org
  20. Tiss.EU “Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis” http://www.tisseu.uni-hannover.de/
  21. WHO Human genetic databases: towards a global ethical framework

Keywords: International Regulations and Recommendations

  1. Article 29 Working Party
    1. Opinion 4/2007 on the Concept of Personal Data
    2. Working Document on Genetic Data (17/03/2004)
    3. Opinion 6/2000 on the Human Genome and Privacy
  2. CIOMS & WHO
    1. International Ethical Guidelines for Epidemiological Studies (1991, updated in 2009)
    2. International Ethical Guidance for Biomedical Research Involving Human Subjects (2002)
  3. Council of Europe
    1. Recommendation R2006(4) on Research on Biological Materials of Human Origin
    2. Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005)
    3. Protection of the Human Genome by the Council of Europe (Opinion, 2001)
    4. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997)
    5. Recommendation R 97(5) on the Protection of Medical Data
    6. Recommendation No R94(1) on Human Tissue Banks
    7. Recommendation R 90(3) on Medical Research on Human Beings
    8. Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1981)
    9. Convention for the Protection of Human Rights and Fundamental Freedoms, as amended (1950)
  4. EMEA - European Medicines Agency
    1. Draft concept paper on the development of a guideline on biobanks issues relevant to pharmacogenetics (2005)
  5. European Commission
    1. Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice.
    2. EC Directive (31/03/04) on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells
    3. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality of safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
    4. Directive 2001/20/EC of the European Parliament and the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the context of clinical trials.
    5. Charter of Fundamental Rights of the European Union 2000
    6. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
  6. European Group on Ethics in Science and New Technologies
    1. Ethical Aspects of Clinical Research in Developing Countries, Opinion 17 (04/03/2003)
    2. Ethical Aspects of Human Tissue Banking, Opinion 11 (21/07/1998)
  7. European Society of Human Genetics
    1. Data Storage and DNA Banking for Biomedical Research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics. European Journal of Human Genetics (2003) 11 Suppl 2, S8-10.
  8. Human Genetics Organisation (HUGO) Ethics Committee
    1. Statement on Human Genomic Databases, 2002
    2. Statement on Benefit Sharing, 2000
    3. Statement on DNA Sampling: Control and Access, 1998
    4. Statement on the Principled Conduct of Genetics Research, 1995
  9. ICH-GCP
    1. Guideline for Good Clinical Practice (1996)
  10. International Conference of Data Protection and Privacy Commissioners
    1. Montreux Declaration - The Protection of Personal Data and Privacy in a Globalised World: A Universal Right Respecting Diversites, 2005 (27th International Conference)
  11. International Society for Biological and Environmental Repositories (ISBER)
    1. Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research. Cell Preservation Technology Vol. 3, No. 1, 2005
  12. OECD
    1. Draft Guidelines for Human Biobanks and Genetic Research Databases (2008)
    2. Recommendation concerning guidelines covering the protection of privacy and transborder flows of personal data (1980)
  13. P3G
    1. Model framework for the governance of biobanks (2008)
    2. Model consent forms and information sheets available, see www.p3gobservatory.org
  14. UN
    1. International Covenant on Civil and Political Rights 1966
    2. Universal Declaration of Human Rights 1948
  15. UNESCO
    1. Declaration on Bioethics and Human Rights  (2005)
    2. Resolution on Genetic Privacy and Non-discrimination (2004/9)
    3. International Declaration on Human Genetic Data (2003)
    4. Universal Declaration on the Human Genome and Human Rights (1997)
  16. World Health Organisation
    1. World Health Assembly Resolution 58.34 Ministerial Summit on Health Research (2005)
    2. World Health Assembly Resolution 57.13 Genomics and World Health (2004)
    3. Advisory Committee on Health Research (ACHR) recommendations on ELSI of human genetics (2002)
    4. Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
    5. WHO SERG Guidelines for obtaining informed consent for the procurement and use of human tissues, cells and fluids in research (2000)
  17. World Medical Association
    1. Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, as amended 2008
    2. Statement on Genetics and Medicine (2005)
    3. Declaration on the Rights of the Patient, updated 2005
    4. Declaration on Ethical Considerations Regarding Health Databases (2002)