Table 1.
Comparative review of international laws, guidelines and regulations on biobank-based research and consent requirements
| Organization or country | Laws (L), guidelines (G) and regulations (R) | Informed consent requirements |
|---|---|---|
| World Health Organization | (G) Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells and Fluids in Research (2003) (G) Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services (1997) | Specific informed consent Partially restricted consent Broad consent |
| Council for International Organizations of Medical Sciences | (G) International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) | Specific informed consent |
| United Nations Educational, Scientific and Cultural Organization | (G) International Declaration on Human Genetic Data (2003) | Partially restricted consent |
| Human Genome Organization | (G) Statement on DNA Sampling: Access and Control (1998) | Broad consent |
| Council of Europe | (L) Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (1997) (L) Treaty Series No. 195, Human Rights and Biomedicine. Protocol on Biomedical Research (2005) (G) Recommendation (2006) 4 on Research on Biological Materials of Human Origin (2006) | Specific informed consent |
| National Bioethics Advisory Commission | (G) Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999) | Multi-layered consent |
| Australia | (G) National Statement on Ethical Conduct in Human Research (2007) | Specific informed consent Partially restricted consent Broad consent |
| Estonia | (L) Human Genes Research Act (2001) | Broad consent |
| France | (G) Ethical Issues Raised by Collections of Biological Materials and Associated Data: ‘Biobanks', ‘Biolibraries'—National Consultative Bioethics Committee for Health and Life Sciences (2003) | Specific informed consent |
| Germany | (G) Biobanks for Research—National Ethics Council Opinion (2004) | Broad consent |
| Italy | (G) Biobanks and Research on Human Biological Material—National Bioethics Committee Opinion (2006) (G) Guideline for Clinical Protocols of Genetic Research—Italian Society of Human Genetics (2006) | Partially restricted consent |
| (G) Guideline for Clinical Protocols of Genetic Research—Italian Society of Human Genetics (2006) | Specific informed consent | |
| (G) Guideline for Genetic Biobanks—Telethon (2003) | Specific informed consent | |
| (G) Guideline for the Establishment and Accreditation of Biobanks (2006) | Specific informed consent | |
| Japan | (G) Ethical Guidelines for Analytical Research on the Human Genome/ Genes (2001) | Broad consent |
| Switzerland | (G) Biobanks: Obtainment, Preservation and Utilization of Human Biological Material (2006) | Broad consent Specific informed consent |
| Spain | (R) Royal Decree 411/1996, by which Activities Regarding the Use of Human Tissues are Regulated (1996) | Informed expressed consent |
| United Kingdom | (L) Human Tissue Act (2004) (G) Human Tissue and Biological Samples for Use in Research—Medical Research Council (2001) | Broad consent |
| The Netherlands | (L) Civil code, article 467 (1994) (G) Code for Proper Secondary Use of Human Tissue in The Netherlands (2002) | Informed expressed consent |
| Iceland | (L) Act on Biobanks No. 110 (2000) | Broad consent |
| Denmark | (L) Law on Biobanks No. 312 (2003) | Informed expressed consent |
| Sweden | (L) Law No. 297 (2005) | Specific informed consent |
| Norway | (L) Act on Biobanks (2003) | Informed expressed consent |