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References and official documents

Laws

• Act on Biobanks no. 110/2000
• Act on the Medical Use of Human Organs and Tissues
• Act relating to biobanks
• Biobanks in Medical Care Act
• Bundesdatenschutzgesetz (F. R. Germany)
• Human Genes Research Act
• Human Tissue Act 2004
• Personal Data Protection Act

Regulations

• Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings
• Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
• Belmont Report
• CHARTER OF FUNDAMENTAL RIGHTS OF THE EUROPEAN UNION
• COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
• 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, Explanatory Report
• 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, Oviedo 4.IV.1997
• Convention for the Protection of Human Rights and Fundamental Freedoms
• DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• DIRECTIVE 2002/58/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications)
• Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
• 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
• Draft additional Protocol to the Convention on Human Rights and Biomedicine, on biomedical research
• International Declaration on Human Genetic Data
• REGULATION (EC) No 45/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 18 December2000. on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data
• Universal Declaration on the Human Genome and Human Rights

Recommendations

• 25 Recommendations on the ethical, legal and social implications of genetic testing by Eryl McNally (chair) and Anne Cambon-Thomsen (rapporteur)
• CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects
• CIOMS: International Guidelines for Ethical Review of Epidemiological Studies
• Code of Conduct: "Proper Secondary Use of Human Tissue" by the Dutch Federation of Biomedical Scientific Societies
• Code of Conduct: "Use of Data in Health Research" by the Dutch Federation of Biomedical Scientific Societies
• Comité Consultatif National d'Ethique: Opinion and Recommendations on 'Genetics and Medicine: from Prediction to Prevention'
• Draft Recommendation on Research on Biological materials of Human Origin
• European Epidemiology Federation: Good Epidemiological Practice (GEP) Proper Conduct in Epidemiologic Research
• HUGO Ethics Committee: STATEMENT ON BENEFIT-SHARING
• HUGO ETHICS COMMITTEE: STATEMENT ON DNA SAMPLING: CONTROL AND ACCESS
• HUGO ETHICS COMMITTEE: STATEMENT ON HUMAN GENOMIC DATABASES December 2002
• HUGO ETHICS COMMITTEE: Statement on the Principled Conduct of Genetics Research
• Human Medical Genetic Testing. A EuropaBio Position Paper
• International Ethical Guidelines for Epidemiological Studies - Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
• Medical Research Council: Human Tissue and Biological Samples for use in Research - Operational and Ethical guidelines
• Operational Guidelines forEthics Committees That Review Biomedical Research
• Proposal for an instrument on the use of archived human biological materials in biomedical research
• RECOMMENDATION 1160 (1991) on the preparation of a convention on bioethics
• RECOMMENDATION No. R (92) 3 OF THE COMMITTEE OF MINISTERS TO MEMBER STATES ON GENETIC TESTING AND SCREENING FOR HEALTH CARE PURPOSES
• Recommendation No.R(97) 5 on the protection of medical data (13 February 1997)
• Recommendation on research on human biological materials
• Research ethics guidelines for using biobanks, especially projects involving genome research
• Statement of the WHO Expert Consultation on New Developments in Human Genetics
• THE BARCELONA DECLARATION POLICY PROPOSALS to the European Commission November 1998 by Partners in the BIOMED-II Project Basic Ethical Principles in Bioethics and Biolaw
• The Nuremberg Code (1949) - International Principles for Human Experimentation
• THE WORLD MEDICAL ASSOCIATION DECLARATION ON ETHICAL CONSIDERATIONS REGARDING HEALTH DATABASES
• World Health Organization: Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services, Geneva, 15-16 December 1997.
• WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI - Ethical Principles for Medical Research Involving Human Subjects
• World Medical Association: Declaration on the Human Genome Project

Scientific publications

• ACCESS TO COLLECTIONS OF DATA AND MATERIALS FOR HEALTH RESEARCH - A report to the Medical Research Council and the Wellcome Trust
• Ashkenazi Jews and Breast Cancer: The Consequences of Linking Ethnic Identity to Genetic Disease
• Biobanks for research
• Chaoqiang Jiang, G et al: Cohort Profile: The Guangzhou Biobank Cohort Study, a Guangzhou-Hong Kong-Birmingham collaboration
• Die (Weiter-)Verwendung von menschlichen Körpermaterialien für Zwecke medizinischer Forschung, Stellungnahme der Zentralen Ethikkommission
• Draft Report on Collection, Treatment, Storage and Use of Genetic Data
• Ethical issues and GenomEUtwin. (PubMed citation)
• Ethical, legal and social aspects of genetic testing: research, development and clinical applications by Eryl McNally (chair) and Anne Cambon-Thomsen (rapporteur)
• Knoppers BM et al, The emergence of an ethical duty to disclose genetic research results: international perspectives
• Laurie G et al: Genetic databases. Assessing the benefits and the impact on human and patient rights
• National ethics councils - Their backgrounds, functions and modes of operation compared
• Nuffield Council on Bioethics: Pharmacogenetics: Ethical Issues
• Obtaining Informed Consent for Genetic Studies - The Multiethnic Study of Atherosclerosis
• Parliamentary Office of Science and Technology, January 2005 Number 235 Data protection and medical research
• Parliamentary Office of Science and Technology, July 2002 Number 180: THE UK BIOBANK
• Pharmacogenetics Working Group: Returning Genetic Research Results to Individuals: Points-to-Consider
• Predictive genetic diagnosis, Scientific background, practical and social implementation Memorandum by the Senate Commission on Genetic Research
• Predictive health information in the conclusion of insurance contracts - OPINION
• Research Ethics Recommendations for Whole-Genome Research: Consensus Statement
• UNESCO (Working group of the International Bioethics Committee (IBC) on Confidentiality and Genetic Data): Report on Confidentiality and Genetic Data. Paris, 30 June 2000. BIO-503/99/CIB-6/GT-2/3
• Voluntary Participation and Informed Consent to International Genetic Research