Table 1.
Normative documents
| Year | Author | Title |
|---|---|---|
| International | ||
| 2002 | Council for International Organizations of Medical Sciences (CIOMS) 14 | International Ethical Guidelines for Biomedical Research Involving Human Subjects |
| 2003 | United Nations Educational Scientific and Cultural Organization (UNESCO) 13 | International Declaration on Human Genetic Data |
| 2003 | World Health Organization (WHO) 12 | Genetic Databases: Assessing the Benefits and the Impact on Human and Patients Rights |
| 2006 | Pharmacogenomics Working Group (PWG) 17 | Returning Genetic Research Results to Individuals: Points-to-Consider |
| 2007 | International Epidemiological Association (IEA) 16 | Good Epidemiological Practice (GEP)—IEA Guidelines for Proper Conduct in Epidemiological Research |
| 2008 | Council for International Organizations of Medical Sciences (CIOMS) 15 | Ethical Guidelines for Epidemiological Studies |
| 2009 | Organization for Economic Cooperation and Development (OECD) 18 | OECD Guidelines on Human Biobanks and Genetic Research Databases |
| Regional | ||
| 1997 | Council of Europe (COE) 20 | Convention on Human Rights and Biomedicine |
| 2005 | Council of Europe (COE) 19 | Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research |
| National | ||
| 1999 | National Bioethics Advisory Committee (NBAC) (US) 29 | Research Involving Human Biological Materials: Ethical Issues and Policy Guidance |
| 2000 | Government of Estonia 21 | Human Genes Research Act |
| 2001 | Japan Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare; Ministry of Economy, Trade and Industry 22 | Ethical Guidelines for Analytical Research on the Human Genome/Genes |
| 2001 | Medical Research Council (MRC) (UK) 30 | Human Tissue and Biological Samples for use in Research—Operational and Ethical Guidelines |
| 2003 | Nuffield Council on Bioethics (Nuffield) (UK) 31 | Pharmacogenetics: Ethical Issues |
| 2007 | Government of Spain 23 | Law 14/2007, of 3 July, on Biomedical Research |
| 2007 | National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors’ Committee (NHMRC) 24 | National Statement on Ethical Conduct in Human Research |
| 2008 | Canadian College of Medical Geneticists, Canadian Association of Genetic Counsellors (CCMG/CAGC) 32 | Joint Statement on the Process of Informed Consent for Genetic Research |
| 2010 | Canadian Institutes of Health Research; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada (CIHR) 3 | Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans |
| 2010 | Government of Western Australia Department of Health 25 | Guidelines for Human Biobanks, Genetic Research Databases and Associated Data |
| 2010 | National Heart Lung Blood Institute (Fabsitz et al) (NHLBI) (US) 28 | Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group |
| 2010 | Office of Biorepositories and Biospecimen Research, National Cancer Institute, National Institutes of Health (NCI/NIH) (US) 26 | Workshop Summary. Workshop on Release of Research Results to Participants in Biospecimen Studies |
| 2012 | Presidential Commission for the Study of Bioethical Issues 33 | Privacy and Progress in Whole Genome Sequencing |
| N/A | National Human Genome Research Institute (NHGRI) (US) 27 | Federal Policy Recommendations Including HIPAA |