Compilação de Leis e Diretrizes de 79 diferentes países em

1 International Compilation of Human Research Protections 2010 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services FINAL VERSION PURPOSE This Compilation lists the approximately 1,100 laws, regulations, an d guidelines that govern human subjects research in 96 coun tries, as well as standards from a number of international and regional organizations. This Compilation was developed for IRBs/Research Ethics Committees, researchers, spon sors, and others who are involved in international research. Its purpose is to help these groups fami liarize themselves with the laws, regulations, and guidelines w here the research will be conducted, to assure these standards are followed appropriately.

The 2010 Edition includes numerous additions and updates to the 20 09 Edition, and features the laws, regulations, and/or guidel ines for five new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar. Srpska is one of the two political-territorial di visions of Bosnia and Herzegovina, and is now listed under that country. ORGANIZATION The Table of Contents is found on page 3. Under each country, the rows categorize the standards as: 1. General, i.e., applicable to most or all types of human subjects research 2. Drugs 3. Privacy/Data Protection (Note: Further information can be found at the website of Privacy Laws and Business: http://www.privacylaws.com/ ) 4.

Human Biological Materials 5. Genetic (Note: Further information can be found in the HumGen International database at http://www.humgen.umontreal.ca/int/ ) 6. Embryos, Stem Cells, and Cloning These six categories often overlap, so it may be necessary to re view all standards to obtain a full understanding of the countr y’s requirements. The information is then organized into four columns: 1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research. 2. Legislation – includes statutes, statutory instruments, and le gislative decrees, as well as constitutional provisions that rela te to human subject protections.

3. Regulations – refer to instruments that are created and issued under the name of governmental administrative bodies. 2 4. Guidelines – pertain to non-binding instruments. The year of the document’s initial approval or most recent modification is indicated in parenthesis (w hen that information is a vailable), unless the date is part of the document’s actual title. For example, Law 46/2006 indicates the law was enacted in 2006. Note that there may be other applicable laws that are not necessarily labeled as pertaining to research. HOW TO ACCESS A DESIRED DOCUMENT Documents can be accessed in five ways: 1.

Link to the web address (URL) when provided. 2. Perform an Internet search on the document title. 3. Go to the website of the agency listed in the Key Organizations column and look for the sub-page labeled “guidance,” “regulatio ns,” or similar terms. 4. Go to the website of the corresponding ag ency and e-mail a request for the document. 5. Request the local research ethics committee to provide the document. In most cases the documents are available in English. Sometimes the English translation is a non-official version. When the lin k is to a non-English language website or document, the language is indicated in parenthesis, e.g., (Spanish).

TOPICS NOT COVERED In order to focus its scope, the Compilation does not include standards from the state or local levels. Nor does the Compilatio n cover: 1. Laws, regulations, or guidelines specific to clinical bioethics, medical devices, adve rse event reporting, insurance requiremen ts, product liability, clinical trial inspection procedures, intellectual property, or in formed consent in clinical practice. 2. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects regulations, but do not direct the conte nt of those regulations. 3. Ethics codes of academic, medical, or other professional organizations.

4. Working papers, drafts, commentaries, or discussion papers. Updates and Broken Links Updates and broken links should be reported to the attention of Edward E. Bartlett, PhD, Office for Human Research Protections, International Activities Program, at: edward.bartlett@hhs.gov . Disclaimer Although this Compilation contains information of a legal nature , it has been developed for informational purposes only and doe s not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a cont inuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to human subject protections.

While reasonable effo rts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities. 3 7 7 91 INTERNATIONAL 4 NORTH AMERICA Canada 10 United States EUROPE 17 European-wide 17 20 Confederation of Independent States Armenia 21 Austria 21 Belgium 23 26 Bosnia and Herzegovina Bulgaria 27 Croatia 28 Cyprus 29 30 Czech Republic Denmark 31 Estonia 33 Finland 34 France 36 Georgia 38 Germany 39 Greece 44 Hungary 45 Iceland 47 Ireland 49 Italy 51 Latvia 54 Lithuania 55 Luxembourg 57 Macedonia 58 Malta 59 Moldova 59 Montenegro 60 Netherlands 60 Norway 62 Poland 64 Portugal 65 Romania 67 Russia 68 69 San Marino Serbia 70 70 Slovak Republic Slovenia 71 Spain 73 Sweden 76 Switzerland 77 Turkey 79 Ukraine 81 84 United Kingdom England 84 88 Northern Ireland: Scotland: 88 Wales: 88 89 ASIA/PACIFIC/MIDDLE EAST Australia 89 Bangladesh 90 91 Burma (Myanmar) China, People’s Republic of 93 Hong Kong India 93 Indonesia 94 Iran 95 Israel 95 Japan 97 Jordan 99 Kazakhstan 100 10 Korea, South1 Kuwait 102 Kyrgyzstan 102 Nepal 103 10 New Zealand4 Philippines 108 Qatar 109 Singapore 109 Taiwan 111 Tajikistan 113 Thailand 114 Vietnam 114 LATIN AMERICA and the CARIBBEAN 115 11 Pan American Health Organization5 Argentina 115 Bolivia 116 Brazil 117 Chile 119 Colombia 120 12 Costa Rica1 Dominica 122 Guatemala 122 Honduras 122 Jamaica 122 Mexico 123 Panama 124 Peru 124 Uruguay 125 Venezuela 125 AFRICA 126 Botswana 126 Egypt 126 Ethiopia 127 Gambia 127 Kenya 127 Malawi 128 Nigeria 128 12 South Africa9 Sudan 130 Tanzania 131 Uganda 131 Zimbabwe 132 4INTERNATIONAL Country Key Organizations Legislation Regulations Guidelines General 1.

International Committee of the Red Cross (ICRC): www.icrc.org 2. Office of the United Nations High Commissioner for Human Rights (OHCHR): http://www.ohchr.org/english/ 3. World Health Organization (WHO): http://www.who.int/en/ 4. Council for International Organizations of Medical Sciences (CIOMS): http://www.cioms.ch/ 5. United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO): http://portal.unesco.org/shs/en/ev.php -URL_ID=1372&URL_DO=DO_TOP IC&URL_SECTION=201.html 6. UNAIDS: http://www.unaids.org/en/default.asp 7. World Medical Association (WMA): http://www.wma.net/e/ ICRC: 1.

Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950): http://www.icrc.org/Web/Eng/si teeng0.nsf/html/genevaconventi ons#a1 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977): http://www.icrc.org/ihl.nsf/7c4d 08d9b287a42141256739003e63 6b/f6c8b9fee14a77fdc125641e0 052b079 OHCHR: International Covenant on Civil and Political Rights, Articles 4 and 7 (1976) WHO: Operational Guidelines for Ethics Committees that Review Biomedical Research (2000): http://whqlibdoc.who.int/hq/2000/TDR_P RD_ETHICS_2000.1.pdf CIOMS: 1.

International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) 2. International Guidelines for Ethical Review of Epidemiological Studies (2009) UNESCO: Universal Declaration on Bioethics and Human Rights (2005) UNAIDS: Ethical Considerations in Biomedical HIV Prevention Trials (2007): http://data.unaids.org/pub/Report/2007/JC 1399_ethical_considerations_en.pdf WMA: Declaration of Helsinki (2008) 5 Country Key Organizations Legislation Regulations Guidelines Drugs 1. International Conference on Harmonization (ICH): http://www.ich.org/ 2. World Health Organization (WHO): http://www.who.int/en/ E6 Good Clinical Practice: Consolidated Guidance (1996): http://www.ich.org/cache/compo/475-272- 1.html#E6 WHO: 1.

Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2002): http://whqlibdoc.who.int/publications/200 5/924159392X_eng.pdf 2. Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005) Privacy/Data Protection World Medical Association: http://www.wma.net/e/index.htm Regarding Health Databases (2002): http://www.wma.net/en/30publications/10 policies/d1/index.html Human Biological Materials 1. World Health Organization: http://www.who.int/en/ 2. International Air Transport Association (IATA): http://www.iata.org/ 3. International Soci ety for Biological and Environmental Repositories (ISBER): http://www.isber.org Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003): http://www.who.int/reproductive- health/hrp/tissue.pdf IATA: Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005) ISBER: Best Practices for Repositories I: Collection, Storage and Retrieval of Human Biological Materials for Research (2005) 6 Country Key Organizations Legislation Regulations Guidelines Genetic Research 1.

Human Genome Organization (HUGO): http://www.hugo- international.org/ 2. UNESCO Bioethics Program: http://portal.unesco.org/shs/en/ev.php -URL_ID=1372&URL_DO=DO_TOP IC&URL_SECTION=201.html 1. Statement on the Pr incipled Conduct of Genetic Research (1996) 2. Statement on DNA Sampling: Control and Access (1998) 3. Statement on Gene Therapy Research (2001) 4. Statement on Human Genomic Databases (2002) UNESCO: 1. Universal Declaration on the Human Genome and Human Rights (1997) 2. International Declaration on Human Genetic Data (2003) Embryos, Stem Cells, and Cloning International Society for Stem Cell Research: http://www.isscr.org/ Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/gu idelines/ISSCRhE SCguidelines2006.pdf 7NORTH AMERICA Canada Country Key Organizations Legislation Regulations Guidelines General Note: Several Canadian provinces and territories also have standards on human subjects research.

1. National Defence 2. Correctional Service of Canada 3. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 4. National Council on Ethics in Human Research: http://www.ncehr- cnerh.org/english/home.php Research Involving Human Subjects (1998): http://www.admfincs.forces.gc.ca/admfinc s/subjects/daod/5061/0_e.asp Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2004): http://www.csc- scc.gc.ca/text/plcy/cdshtm/009- cde_e.shtml PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2005): http://www.pre.ethics.gc.ca/eng/policy- politique/tcps-eptc/ Drugs Health Canada, Therapeutic Products Directorate: http://www.hc- sc.gc.ca/ahc-asc/branch-dirgen/hpfb- dgpsa/tpd-dpt/index-eng.php Consolidated Guideline (1997): http://www.hc-sc.gc.ca/dhp- mps/prodpharma/applic- demande/guide-ld/ich/efficac/e6- eng.php 2.

Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials) (2004): http://www.hc-sc.gc.ca/dhp- mps/compli-conform/clini-pract- prat/reg/1024-eng.php 8 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Note: Each of the Canadian provinces and territories has also enacted privacy legislation. 1. Office of the Privacy Commissioner of Canada (OPC): http://www.privcom.gc.ca/index_e.as p 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 3. Canadian Institutes of Health Research (CIHR): http://www.cihr- irsc.gc.ca/e/193.html 1.

Privacy Act, Sections 7-8 (1983): http://www.privcom.gc.ca/legisl ation/02_07_01_e.asp 2. Personal Information Protection and Electronic Documents Act, Articles 5 and 7 (2001): http://www.privcom.gc.ca/legisl ation/02_06_01_e.asp OPC: SOR/2001-6, SOR/2001-7, and SOR/2001-8 (December 13, 2000) PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Section 3: Privacy and Confidentiality (2005) CIHR: CIHR Best Practices for Protecting Privacy in Health Research (2005): http://www.cihr- irsc.gc.ca/e/documents/pbp_sept2005_e.p df Human Biological Materials Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Section 10: Human Tissue (2005) Genetic Research 1.

Canadian Biotechnology Advisory Committee (CBAC): http://cbac- cccb.ca/epic/internet/incbac- cccb.nsf/en/Home 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 3. Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc- asc/branch-dirgen/hpfb-dgpsa/bgtd- dpbtg/index-eng.php Genetic Research and Privacy (2004) PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Section 8: Human Genetic Research (2005) 9 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 2.

Canadian Institutes of Health Research (CIHR): http://www.cihr- irsc.gc.ca/e/193.html Assisted Human Reproduction Act (2004): http://www.hc- sc.gc.ca/hl-vs/reprod/hc- sc/legislation/index_e.html Assisted Human Reproduction (Section 8 Consent) Regulations (2007) PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Section 9: Research Involving Human Gametes, Embryos, or Foetuses (2005) CIHR: Updated Guidelines for Human Pluripotent Stem Cell Research (2007): http://www.cihr-irsc.gc.ca/e/34460.html 10United States Note: All of the following departments and agencies subscribe to the Common Rule, which is subpart A (last updated in 2005) of the relevant section of the Code of Federal Regulations.

As indicated below, some department s and agencies subscribe to additional subparts:  Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)  Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (1978)  Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)  Subpart E: Institutional Review Board Registration Requirements (2009) Country Key Organizations General Agency for International Development: www.usaid.gov/ Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2006): http://www.usaid.gov/policy/ads/200/200 mbe.pdf Central Intelligence Agency: www.odci.gov/ A, B, C, and D Consumer Product Safety Commission: www.cpsc.gov/ Department of Agriculture: www.usda.gov/wps/portal/usdahome/ Department of Commerce: www.commerce.gov/ 11 Country Key Organizations Legislation Regulations Guidelines Department of Defense, Regulatory Affairs: www.dtic.mil/biosys/org/regulatory.h tml United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects 1.

32 CFR 219, Subpart A 2. DoD Directive 3216.02 (2002) Army: 1. AR 70-25 2. AR 40-38 Navy: SECNAVINST 3900.39 series Air Force: AFI 40-402 (2005) Office of the Under Secretary of Defense for Personnel and Readiness: USUHS Instruction 3201 Defense Threat Reduction Agency: 1. DTRA Directive 3216.1 2. DTRA Instruction 3216.2 Department of Education: www.ed.gov/ 1. Protection of Pupil Rights Amendment (1974) 2. Family Educational Rights and Privacy Act (1974) 1. 34 CFR 97 subparts A (1991) and D (1997) 2. 34 CFR 98 (1984) 3. 34 CFR 99 (2000) 4. 34 CFR 350.4(c) (1991) 5. 34 CFR 356.3(c) (1991) Department of Energy: www.energy.gov/engine/content.do/ 2.

Order 1300.3 3. Order 481.1 Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/ Public Health Service Act (1993): http://www.hhs.gov/ohrp/human subjects/guidance/statute.htm 45 CFR 46, Subparts A, B, C, D, and E Various: http://www.hhs.gov/ohrp/policy/index.ht ml#topics 12 Country Key Organizations Legislation Regulations Guidelines Department of Homeland Security: www.dhs.gov/ Public Law 108-458, Section 8306 Department of Housing and Urban Development: www.hud.gov/ Department of Justice: www.usdoj.gov/ 2. 28 CFR 46 (1991), Subpart A 3. 28 CFR 512 (1994) Department of Transportation: www.dot.gov/ 49 CFR 11, Subpart A Department of Veterans Affairs 1.

Office of Research Oversight (ORO): www1.va.gov/oro/ 2. Office of Research and Development: www.research.va.gov 1. 38 FR 16 (1991), Subpart A 2. 38 CFR 17.85 (1998) 13 Country Key Organizations Legislation Regulations Guidelines Environmental Protection Agency, Program in Human Research Ethics: http://www.epa.gov/osa/phre/ 40 CFR 26 1. Subpart A: Common Rule 2. Subpart B: Prohibition of Intentional Exposure Research Conducted or Supported by EPA in Children and Pregnant or Nursing Women (2006) 3. Subpart C: Additional Protections for Observational Research Conducted or Supported by EPA in Pregnant Women and Fetuses (2006) 4.

Subpart D: Additional Protections for Observational Research Conducted or Supported by EPA in Children (2006) 5. Subpart K: Regulation of Third-Party Intentional Exposure Research for Pesticides in Non- Pregnant, Non-Nursing Adults (2006) 6. Subpart L: Prohibition of Third-Party Intentional Exposure Research for Pesticides in Children and Pregnant or Nursing Women (2006) Scientific and Ethical Approaches for Observational Exposure Studies (2008): http://www.epa.gov/nerl/sots/SEAOES_d oc20080707.pdf National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov / 14 Country Key Organizations Legislation Regulations Guidelines Drugs Food and Drug Administration: www.fda.gov 1.

Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (Device coverage – Section 360) (2004): http://www.fda.gov/RegulatoryI nformation/Legislation/FederalF oodDrugandCosmeticActFDCA ct/default.htm 2. Public Health Service Act, 42 USC Section 262 (1944): http://www.fda.gov/RegulatoryI nformation/Legislation/ucm148 717.htm 1. 21 CFR 50 (1980) 2. 21 CFR 312 (1987) 3. 21 CFR 56 (2001) 4. 21 CFR 812 (2007) 1. Good Clinical Practice and Human Subject Protections in FDA-Regulated Clinical Trials: http://www.fda.gov/ScienceResearch/Spec ialTopics/RunningClinicalTrials/default.ht m 2. Other: http://www.fda.gov/ScienceResearch/Spec ialTopics/RunningClinicalTrials/Guidance sInformationSheetsandNotices/ucm11370 9.htm Privacy/Data Protection 1.

Department of Health and Human Services, National Institutes of Health (NIH): http://privacyruleandresearch.nih.gov / 2. Department of Health and Human Services, Office for Civil Rights (OCR): http://www.hhs.gov/ocr/hipaa/ 1. Privacy Act, 5 U.S.C. § 552a (1974): http://www.usdoj.gov/oip/04_7_ 1.html 2. Health Insurance Portability and Accountability Act (1996): http://www.hhs.gov/ocr/hipaa/pr ivrulepd.pdf 3. Confidential Information Protection and Statistical Efficiency Act (2002): http://www.whitehouse.gov/om b/inforeg/cipsea/cipsea_statute.p df 1. HIPAA Privacy Rule: Standards for Privacy of Individually Identifiable Health Information, Final Rule, 45 CFR parts 160 and 164 (2002): http://www.hhs.gov/ocr/hipaa/pri vrulepd.pdf 2.

HIPAA Security Rule, 45 CFR parts 160, 162, and 164: http://www.hhs.gov/ocr/hipaa/ NIH: 1. Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (2004) http://privacyruleandresearch.nih.gov/pr_0 2.asp 2. Research Repositories, Databases, and the HIPAA Privacy Rule (2004): http://privacyruleandresearch.nih.gov/rese arch_repositories.asp 3. Institutional Review Boards and the HIPAA Privacy Rule (2004): http://privacyruleandresearch.nih.gov/irba ndprivacyrule.asp 15 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials 1. Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/ 2.

Food and Drug Administration Office of In Vitro Diagnostic Device Evaluation and Safety: http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/InVit roDiagnostics/default.htm 1. Issues to Consider in the Research Use of Stored Data or Tissues (1997) 2. Guidance on Research Involving Coded Private Information or Biological Specimens (2008) FDA: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable (2006): http://www.fda.gov/MedicalDevices/Devi ceRegulationandGuidance/GuidanceDocu ments/ucm078384.htm Genetic Research National Institutes of Health, Office of Biotechnology Activities: http://www4.od.nih.gov/oba/ Research on Transplantation of Fetal Tissue, Public Law 103-43 Recombinant DNA Molecules, Appendix M (2009): http://www4.od.nih.gov/oba/RAC/guideli nes_02/NIH_Guidelines_Apr_02.htm 16 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Food and Drug Administration, Center for Biologics Evaluation and Research: http://www.fda.gov/BiologicsBloodV accines/default.htm 2. National Academy of Sciences (NAS): http://www.nationalacademies.org/nr c/ 3. National Institutes of Health: http://stemcells.nih.gov/index.asp Research on Transplantation of Fetal Tissue. Public Law 103-43 FDA: Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products. October 14, 1993. 58 FR 53248 NAS: 1. Guidelines for Human Embryonic Stem Cell Research (2005): http://www.nap.edu/catalog.php?record_i d=11278 2.

2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research: http://books.nap.edu/catalog.php?record_i d=11871 3. 2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research: http://books.nap.edu/catalog.php?record_i d=12260 NIH: http://stemcells.nih.gov/policy : 1. Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, Executive Order 13505 (2009) 2. NIH Guidelines on Human Stem Cell Research (2009) 3. NIH Human Embryonic Stem Cell Registry (2009) 17EUROPE European-wide Country Key Organizations Legislation Regulations Guidelines General 1.

Council of Europe, Bioethics Division (CoE): http://www.coe.int/bioethics 2. European Group on Ethics in Science and New Technologies (EGE): http://europa.eu.int/comm/european_ group_ethics/index_en.htm CoE: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (1997): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=164&CM=7&DF=9/15/200 8&CL=ENG 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2005): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=195&CM=1&DF=10/24/20 07&CL=ENG EGE: Ethical Aspects of Clinical Research in Developing Countries (2003): http://ec.europa.eu/european_group_ethics /docs/avis17_en.pdf Drugs 1.

European Commission, Enterprise Directorate-General, Pharmaceuticals Unit (EC): http://europa.eu.int/comm/enterprise/ pharmaceuticals/index_en.htm 2. European Medicines Agency (EMEA): http://www.emea.europa.eu/ EC: 1. Directive 2001/20/EC: http://europa.eu/eur- lex/pri/en/oj/dat/2001/l_121/l_1 2120010501en00340044.pdf 2. Directive 2005/28/EC: http://eur- lex.europa.eu/LexUriServ/site/e n/oj/2005/l_091/l_09120050409 en00130019.pdf EC: See EudraLex Volume 10: Clinical Trials: http://ec.europa.eu/enterprise/pha rmaceuticals/eudralex/vol10_en.h tm EMEA: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) (1997) EC: See EudraLex Volume 10: Clinical Trials: http://ec.europa.eu/enterprise/pharmaceuti cals/eudralex/vol10_en.htm 18 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection 1.

European Commission (EC): http://europa.eu.int/ 2. Council of Europe, Bioethics Division (CoE): http://www.coe.int/T/E/Legal_affairs/ Legal_co-operation/Bioethics/ EC: Data Protection Directive 95/46/EC of the European Parliament and of the Council (1995): http://europa.eu.int/smartapi/cgi/ sga_doc?smartapi!celexapi!prod !CELEXnumdoc&lg=EN&num doc=31995L0046&model=guic hett CoE: 1. Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1985) 2. Recommendation No. R (97) 5 on the Protection of Medical Data (1997) Human Biological Samples 1. European Commission (EC): http://europa.eu.int/ 2.

Council of Europe, Bioethics Division (CoE): http://www.coe.int/bioethics 3. European Group on Ethics in Science and New Technologies (EGE): http://europa.eu.int/comm/european_ group_ethics/index_en.htm 4. European Medicines Agency (EMEA): http://www.emea.europa.eu/ EC: Directive 2004/23/EC on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage, and Distribution of Human Tissues and Cells: http://europa.eu/eur- lex/pri/en/oj/dat/2004/l_102/l_1 0220040407en00480058.pdf CoE: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22, ETS No.

164 (1997): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=164&CM=7&DF=9/15/200 8&CL=ENG EGE: Ethical Aspects of Human Tissue Banking (1998) EMEA: Concept Paper on the Development of a Guideline on Biobanks Issues Relevant to Pharmacogenetics (2005) CoE: Recommendation Rec (2006) 4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin (2006): http://wcd.coe.int/ViewDoc.jsp?id=97785 9&Site=CM&BackColorInternet=9999CC &BackColorIntranet=FFBB55&BackColo rLogged=FFAC75 19 Country Key Organizations Legislation Regulations Guidelines Genetic Research Council of Europe, Bioethics Division: http://www.coe.int/bioethics 1.

Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14, ETS No. 164 (1997): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=164&CM=7&DF=9/15/200 8&CL=ENG 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2005): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=195&CM=1&DF=10/24/20 07&CL=ENG Genetic Testing and Screening for Health Care Purposes (1992): http://wcd.coe.int/ViewDoc.jsp?id=61200 7&Site=CM&BackColorInternet=9999CC &BackColorIntranet=FFBB55&BackColo rLogged=FFAC75 2. Recommendation Rec(2006)4 of the Committee of Ministers to Members States on Research on Biomedical Materials of Human Origin (2006): http://wcd.coe.int/ViewDoc.jsp?id=97785 9&Site=CM&BackColorInternet=9999CC &BackColorIntranet=FFBB55&BackColo rLogged=FFAC75 20 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Council of Europe, Bioethics Division (CoE): http://www.coe.int/bioethics 2. European Commission (EC), Directorate-General for Research: http://ec.europa.eu/research/science- society/index.cfm?fuseaction=public. topic&id=22 3. European Group on Ethics in Science and New Technologies (EGE): http://ec.europa.eu/european_group_e thics/index_en.htm CoE: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=164&CM=7&DF=9/15/200 8&CL=ENG 2. Additional Protocol on Prohibition of Human Cloning, ETS No.

168 (1998): http://conventions.coe.int/Treaty /Commun/QueVoulezVous.asp? NT=168&CM=7&DF=9/15/200 8&CL=ENG EC: Decision No. 1982/2006/EC: http://eur- lex.europa.eu/LexUriServ/site/e n/oj/2006/l_412/l_41220061230 en00010041.pdf EGE: Opinion No. 15 - Ethical Aspects of Human Stem Cell Research and Use (2000) 2. Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007) Confederation of Independent States Country Key Organizations Legislation Regulations Guidelines General Interparliamentary Assembly: http://www.iacis.ru/html/index- eng.php Rights and Dignity in Biomedical Research in the CIS Member States (2005): http://www.iacis.ru/html/index- eng.php?id=54&pag=596&nid=9 21Armenia Note: For an overview of human subject protections in Armenia, s ee “Ethical Review of Biomedical Research in the CIS Countries, ” Chapter 3, Section 1: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.p d f Country Key Organizations Drugs 1.

Drug and Medical Technology Agency 2. National Ethics Committee 1. Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21 2. Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Medications in Armenia Austria Country Key Organizations Legislation Regulations Guidelines General 1. Forum of Austrian Ethics Committees (German): http://www.ethikkommissionen.at 2. Ministry of Health (German): http://www.bmg.gv.at 3. Bioethics Commission: http://www.bundeskanzleramt.at/site/ 3575/default.aspx 1. University Act (2002): http://www.ris.bka.gv.at/Dokum ent.wxe?Abfrage=Erv&Dokume ntnummer=ERV_2002_1_120& ResultFunctionToken=7323e17 4-9167-4ce6-b47d- 2bbfb8982d55&Titel=&Quelle= &ImRisSeit=Undefined&Result PageSize=50&Suchworte=* 2.

Hospitals Act (2002) (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=10 010285&ShowPrintPreview=Tr ue Forum of Austrian Ethics Committees: Various guidelines. 22 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Health (German): http://www.bmg.gv.at 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/ueber- uns/english-what-is-ages/ Austrian Drug Law (2005) (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=10 010441&ShowPrintPreview=Tr ue Regulation on Leading Ethics Committees (German): http://www.ris.bka.gv.at/Geltende Fassung.wxe?Abfrage=Bundesno rmen&Gesetzesnummer=200033 52&ShowPrintPreview=True Forum of Austrian Ethics Committees: Various guidelines.

Privacy/Data Protection Note: A number of Austrian states have privacy/data protection laws (German):http://ww w.dsk.gv.at/site/620 2/default.aspx Austrian Data Protection Commission: http://www.dsk.gv.at/DesktopDefault .aspx?alias=dsken 1. Federal Act Concerning the Protection of Personal Data (2007): http://www.ris.bka.gv.at/Dokum ent.wxe?Abfrage=Erv&Dokume ntnummer=ERV_1999_1_165& ResultFunctionToken=7323e17 4-9167-4ce6-b47d- 2bbfb8982d55&Titel=&Quelle= &ImRisSeit=Undefined&Result PageSize=50&Suchworte=* Human Biological Materials 1. Ministry of Health (German): http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/ 3575/default.aspx 1.

Law on Safety of Blood (2009) (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=10 011145&ShowPrintPreview=Tr ue 2. Law on Quality and Safety of Human Tissue and Cells (2009) (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=20 005698&ShowPrintPreview=Tr ue Regulation on Tissue Banks (German): http://www.ris.bka.gv.at/Geltende Fassung.wxe?Abfrage=Bundesno rmen&Gesetzesnummer=200058 48&ShowPrintPreview=True Bioethics Commission: 1. Opinion of the Bioethics Commission at the Federal Chancellery: Biobanks for Medical Research (2007): http://www.bundeskanzleramt.at/DocVie w.axd?CobId=25510 2.

Ruling of the Bioethics Commission: Cord Blood Banking (2008): http://www.bundeskanzleramt.at/DocVie w.axd?CobId=31001 23 Country Key Organizations Legislation Regulations Guidelines Genetic Research 1. Ministry of Health (German): http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/ 3575/default.aspx Gene Technology Act (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=10 010826&ShowPrintPreview=Tr ue Embryos, Stem Cells, and Cloning 1. Ministry of Health (German): http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/ 3575/default.aspx 1.

Reproductive Medicine Act (2009) (German): http://www.ris.bka.gv.at/Gelten deFassung.wxe?Abfrage=Bunde snormen&Gesetzesnummer=10 003046&ShowPrintPreview=Tr ue 2. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) Bioethics Commission: Research on Human Embryonic Stem Cells (2009) (German): http://www.bundeskanzleramt.at/ DocView.axd?CobId=34240 Belgium Country Key Organizations Legislation Regulations Guidelines General Belgium Advisory Committee on Bioethics: https://portal.health.fgov.be/portal/pa ge?_pageid=56,512676&_dad=portal &_schema=PORTAL Law Relating to Experimentation on Humans (2004) Experimentation on Man (2001) 2.

Opinion No. 31: Regarding Experimentation Involving Pregnant and Breastfeeding Women (2004) 24 Country Key Organizations Legislation Regulations Guidelines Drugs Medicines Directorate-General (French): https://portal.health.fgov.be/portal/pa ge?_pageid=56,512460&_dad=portal &_schema=PORTAL 1994. 2. Royal Decree of June 30, 2004 Determining the Implementation Measures of the Law 3. Royal Decree of June 30, 2004 Modifying the Royal Decree of June 6, 1960 4. Royal Decree of July 15, 2004 Determining Payments for Ethical Opinions or Authorization for the Conduct of a Clinical Trial or Experiment. 5.

Application of the Law of May 7, 2004 Relating to Experiments on Human Volunteers who Participate in Phase I Trials (2004) 6. Explanations Concerning the Submission of a Request for an Ethical Opinion or Authorization for the Conduct of a Clinical Trial (2004) Privacy/Data Protection Commission for the Protection of Privacy (French and Flemish): http://www.privacy.fgov.be/ Law of December 8, 1992 on Privacy Protection in Relation to the Processing of Personal Data as Modified by the Law of December 11, 1998 Implementing Directive 95/46/EC : http://www.law.kuleuven.ac.be/i cri/itl/12privacylaw.php Decree of February 13, 2001 Implementing the Law of December 8, 1999 25 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials 1.

Conseil Supérieur de la Santé/Hoge Gezondheidsraad (CSS) (French and Dutch): http://www.health.fgov.be/CSS_HGR 2. Federal Public Service: www.health.fgov.be 1. Royal Decree (1987), Regarding the Expression of Consent for the Removal of Organs and Tissues on Living Donors 2. Royal Decree (1997) Regarding the Removal and Allocation of Organs of Human Origin 3. Act on the Removal and Transplantation of Organs (2006) (French): http://www.staatsbladclip.be/loi s/2006/08/28/loi- 2006022815.html 4. 2007 Amendment (French): http://www.staatsbladclip.be/loi s/2007/04/13/loi- 2007022504.html CSS: Common Quality Standards for All Tissues and Cells of Human Origin Intended for Human Application (2007) (French): https://portal.health.fgov.be/pls/portal/doc s/PAGE/INTERNET_PG/HOMEPAGE_ MENU/ABOUTUS1_MENU/INSTITUTI ONSAPPARENTEES1_MENU/HOGEG EZONDHEIDSRAAD1_MENU/ADVIEZ ENENAANBEVELINGEN1_MENU/AD VIEZENENAANBEVELINGEN1_DOCS /7691_SQ_COMMUNS_2007_FR.PDF Embryos, Stem Cells, and Cloning 1.

Federal Public Service: www.health.fgov.be 2. Federal Commission for Medical and Scientific Research on Embryos in Vitro 1. Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15/02/1999) 2. Act on Research on Embryos in Vitro (2003): http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Belgium/page.as px/164 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007) (French): http://www.staatsbladclip.be/loi s/2007/07/17/loi- 2007023090.html 26Bosnia and Herzegovina Country Key Organizations Legislation Regulations Guidelines Drugs Federation of Bosnia and Herzegovina: Ministry of Health: http://www.fmoh.gov.ba/ 1.

Law on Drugs No. 51/01 2. Law on Changes and Amendments of the Law on Drugs No. 29/05 1. Regulation on Good Clinical Practice and Clinical Trials No. 61/04 2. Regulation Amending the Regulation of Good Clinical Practice and Clinical Trials No. 56/05 Republic of Srpska: Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMi n/Pages/Splash.aspx 1. Law on Drugs No. 19/01 2. Law on Changes and Amendments of Law on Drugs No. 34/08 1. Regulation of Clinical Trials No. 64/05 2. Regulation on Changes and Amending the Regulation of Clinical Trials No.

23/07 Privacy/Data Protection Personal Data Protection Agency of Bosnia and Herzegovina Law on the Protection of Personal Data in Bosnia and Herzegovina (2001): http://www.privacyinternational. org/article.shtml?cmd[347]=x- 347-63545 27Bulgaria Note: For an overview of human subject protections in Bulgaria, see “National Regulations on Ethi cs and Research in Bulgaria:” http://ec.europa.eu/research/science- society/pdf/bg_eng_lr.p d f Country Key Organizations General Ministry of Healthcare (Bulgarian): http://www.mh.government.bg/ 1. Constitution of the Republic of Bulgaria, Article 29 (1991) 2.

Oviedo Convention on Human Rights and Biomedicine (2001) 3. Law Ratifying the Additional Protocol on Biomedical Research (2005) 4. Law on Medicinal Products in Human Medicine (2007) 5. Healthcare Act, Articles 199 and 200 (2007) Drugs 1. Ministry of Healthcare (MOH) (Bulgarian): http://www.mh.government.bg/ 2. Bulgarian Drug Agency (BDA): http://www.bda.bg/?lang=en Law for Medicinal Products in Human Medicine (2007), Chapter 4 MOH: Regulation No. 31 on the Rules for GCP (2007) Privacy/Data Protection 1. Bulgarian Commission for Personal Data Protection: http://www.ceecprivacy.org/main.php ?s=2&k=bulgaria 2.

Ombudsman: www.ombudsman.bg Personal Data Protection Act (2006): http://www.ceecprivacy.org/pdf/ law_bulgaria.pdf Human Biological Materials: 1. Executive Agency for Transplantation (Bulgarian): http://bgtransplant.bg/ 2. Council of Ministers, Ethics Committee for Transplantation Law on Transplantation of Organs, Tissues, and Cells (2006) Regulation No. 13 of 04 April 2007 for the Terms and Conditions of Informing Bulgarian Citizens on the Activities regarding the Transplantation of Organs, Tissues and Cells 28 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Ministry of Healthcare (Bulgarian): http://www.mh.government.bg/ Law Ratifying the Convention for Human Rights (2007) 2.

SG No. 13/8, Article 134 (2008) Croatia Country Key Organizations Legislation Regulations Guidelines General Rights and Biomedicine (2003) Drugs 1. Ministry of Health and Social Welfare (MZSS): http://www.mzss.hr/ 2. Agency for Medicinal Products and Medical Devices: http://www.almp.hr/ Law on Drugs (2007) Ordinance on Clinical Trials and Good Clinical Practice (2007) (Croatian): http://narodne- novine.nn.hr/clanci/sluzbeni/3297 74.html Privacy/Data Protection Croatian Personal Data Protection Agency (Croatian): http://www.azop.hr/d efault.asp Personal Data Protection Act (2008): http://www.legal500.com/c/croa tia/developments/4908 Embryos, Stem Cells, and Cloning 1.

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 (2003) 2. Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2007) 29Cyprus Country Key Organizations Legislation Regulations Guidelines General Law No. 31 (III)/2001 (Oviedo Convention on Human Rights and Biomedicine) Drugs 1. National Health Authority (Medicines Council): http://www.moh.gov.cy/moh/moh.nsf /index_en/index_en# 2. Ministry of Health, National Bioethics Committee: http://www.moh.gov.cy Law for Good Clinical Practice (2004) Privacy/Data Protection Commissioner for Personal Data Protection: http://www.dataprotection.gov.cy/dat aprotection/dataprotection.nsf/index_ en/index_en?opendocument 1.

Processing of Personal Data (Protection of Individuals) Law 138 (1) 2001: http://www.dataprotection.gov.c y/dataprotection/dataprotection. nsf/697e70c0046f7759c2256e8c 004a0a49/f8e24ef90a27f34fc22 56eb4002854e7/$FILE/138(I)- 2001_en.pdf 2. Amended in 2003: http://www.dataprotection.gov.c y/dataprotection/dataprotection. nsf/697e70c0046f7759c2256e8c 004a0a49/f8e24ef90a27f34fc22 56eb4002854e7/$FILE/37(I)- 2003_en.pdf Embryos, Stem Cells, and Cloning 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 (2002) 30Czech Republic Country Key Organizations Legislation Regulations Guidelines General Ministry of Health, Central Ethics Committee (Czech): http://www.mzcr.cz 1.

Act No. 20/1996 on the Care for the Health of People 2. Oviedo Convention on Human Rights and Biomedicine (2001) 3. Act No. 130/2002 Collection on the Research and Development Support as Amended Drugs 1. Ministry of Health (MOH) (Czech): http://www.mzcr.cz 2. State Institute for Drug Control (SUKL): http://www.sukl.cz/in dex.php?lchan= 1&lred=1 Act No. 378/2007 Collection on Pharmaceuticals MOH: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products SUKL: 1. KHL-8: Clinical Trial Protocol and Protocol Amendments (1998) 2. KLH-10: Terminology and Principles of Good Clinical Practice (1998) 3.

KLH-11: Ethics Committees (1998) 4. KLH-10: Terminology and Principles of Good Clinical Practice (1998) 5. KLH-19: Documentation Required for an Approval of a Clinical Trial on a Human Pharmaceutical (2001) 6. KLH-20: Application for Approval/ Notification of a Clinical Trial (2004) Privacy/Data Protection Office for Personal Data Protection: http://www.uoou.cz/uoou.aspx Act on the Protection of Personal Data and on Amendment to Some Related Acts (No. 101 of April 4, 2000): http://www.uoou.cz/uoou.aspx? menu=4&submenu=5 Position No. 3/2004 Personal Data Processing in the Context of Clinical Testing of Drugs and Other Medical Substances 31 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Ministry of Education, Youth, and Sport: http://www.msmt.cz/index.php?lchan =1&lred=1 2. Research and Development Council, Bioethical Commission: http://www.vyzkum.cz/FrontClanek.a spx?idsekce=15908 1. 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 (2001) 2. Act of 26 April 2006 on Research on Human Embryonic Stem Cells Access: http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Czech- Rep/page.aspx/165 Denmark Note: For an overview of human subject protections in Denmark, see http://www.cvk.sum.dk/cvk/site.aspx?p=119 .

Country Key Organizations General Danish National Committee on Biomedical Research Ethics (CVK): http://www.cvk.sum.dk/CVK/Home/ English.aspx 1. Oviedo Convention on Human Rights and Biomedicine (1999) 2. Act on the Biomedical Research Ethics Committee System (2003): http://www.cvk.sum.dk/English/ actonabiomedicalresearch.aspx 3. Act Amending the Act on the Biomedical Research Ethics Committee System (2006) http://www.cvk.sum.dk/English/ actamending.aspx Ministerial Order No. 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2004): http://www.cvk.sum.dk/English/ ministerialorder806.aspx CVK: 1.

Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics (2008) 2. Appendices (2008) 32 Country Key Organizations Legislation Regulations Guidelines Drugs Danish Medicines Agency: http://www.dkma.dk Medicinal Product Act No. 382 (2003) 1. Executive Order No. 935 on Informed Consent from Patients in Biomedical Trials (2000) 2. Executive Order on Clinical Trials on Medicinal Products, Human Use (2004) 3. Danish Guideline on Notification of Clinical Trials of Medicinal Products in Humans (2004) Guideline on Informed Consent from Patients in Biomedical Trials (2000) Privacy/Data Protection Danish Data Protection Agency (DPA): http://www.datatilsynet.dk/english/ The Act on Processing of Personal Data (Act No.

429) (2007): http://www.datatilsynet.dk/engli sh/the-act-on-processing-of- personal-data/ Protection of Sensitive Personal Information http://www.etiskraad.dk/sw314.asp Other guidelines can be accessed at: http://www.privireal.group.shef.ac.uk/cont ent/dp/denmark.php Human Biological Materials Danish National Committee on Biomedical Research Ethics (CVK): http://www.cvk.sum.dk/CVK/Home/ English.aspx Health Law, Chapter 7 (2005) Embryos, Stem Cells, and Cloning Danish Council of Ethics (DCE): http://www.etiskraad.dk/sw293.asp 1. Act on Medically Assisted Procreation (1997) 2. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) 3.

Law No. 535, Chapter 7, Sections 25 and 28 (2008): http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Denmark/page.a spx/365 DCE: 1. Cloning (2001) 2. Research in Human Gametes, Fertilized Ova, Embryos and Fetuses (2004) 33Estonia Note: For an overview of human subject protections in Estonia, see “National Regulations on Ethics and Research in Estonia:” http://ec.europa.eu/research/science- society/pdf/et_eng_lr.pdf Country Key Organizations General Estonian Council of Bioethics: http://www.eetikakeskus.ut.ee/index. aw/set_lang_id=2 1. Constitution of the Republic of Estonia, Paragraph 18 (1992) 2.

Oviedo Convention on Human Rights and Biomedicine (2002) http://www.akadeemia.ee/_repository/File /ALUSDOKUD/Code-ethics.pdf Drugs 1. State Agency of Medicines: http://www.sam.ee/index.aw?set_lang _id=2 2. Minister of Social Affairs (MSA): http://www.sm.ee/eng.html Medicinal Products Act, Chapter 5 (2005): http://www.ravimiamet.ee/orb.a w/class=file/action=preview/id= 5118/EstonianAct- 10May2005.doc MSA: 1. RTL 2001, 90, 1258: Requirements for Membership of Medical Ethics Committees for Clinical Trials, Rules of Procedures for Committee, Rate of Fee for Evaluation of Clinical Trials, and List of Information to be Submitted in Order to Obtain Approval (2001) 2.

Conditions and Procedure for Conducting Clinical Trials of Medicinal Products. Regulation No. 23 (2005): http://www.sam.ee/627 Privacy/Data Protection Estonian Data Protection Inspectorate: http://www.aki.ee/eng/ 1. Databases Act (1997) 2. Personal Data Protection Act (2003): http://www.legaltext.ee/en/andm ebaas/tekst.asp?loc=text&dok= X70030&keel=en&pg=1&ptyyp =RT&tyyp=X&query=data%2B protectionLink Genetic Research (RT I 2000, 104, 685) (2000): http://www.geenivaramu.ee/inde x.php?id=98 34 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 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 (2002) http://conventions.coe.int/Treaty /en/Treaties/Html/168.htm 2.

Artificial Insemination and Embryo Protection Act (2003) Finland Country Key Organizations Legislation Regulations Guidelines General 1. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi/en/frontpage 2. Sub-Committee on Medical Research Ethics (TUKIJA): http://www.etene.org/e/tukija/index.s html 3. National Advisory Board on Research Ethics (TENK): http://pro.tsv.fi/tenk/english1.htm Medical Research Act No. 295/2004: http://www.finlex.fi/en/laki/kaa nnokset/1999/en19990488 MSAH: 1. Decree on the National Advisory Board on Health Care Ethics No. 494/1998 2. Decree on the National Research Ethics Council of Finland No.

1347/2002 3. Decree on Medical Research and Subsidiary Regulations Issued in Pursuance Hereof, No. 313/2004 4. Decree on Clinical Trials on Medicinal Products No. 316/2005 TUKIJA: 1. Checklist for Researchers and Members of Ethics Committees (2009) (Finnish): http://www.etene.org/tukija/dokumentit/T UKIJAn-muistilista-170409.pdf 2. Operating Procedures (2009) (2005 English translation): http://www.etene.org/tukija/dokumentit/T UKIJA_eng_1307.pdf Drugs 1. National Agency for Medicines (NAM): http://www.nam.fi/index.html 2. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi Medicines Act and Decree No.

296/2004 NAM: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2004 MSAH: Decree on Clinical Trials No. 316/2005 35 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Office of the Data Protection Ombudsman: http://www.tietosuoja.fi/1560.htm 1. Personal Data Act No. 523/1999: http://www.tietosuoja.fi/uploads /hopxtvf.HTM 2. Act on the Amendment of the Personal Data Act No. 986/2000: http://www.tietosuoja.fi/uploads /p9qzq7zr3xxmm9j.rtf Human Biological Materials Human Organs and Tissues No. 101/2001: http://www.finlex.fi/pdf/saadkaa n/E0010101.PDF Genetic Research 377/1995 Embryos, Stem Cells, and Cloning National Advisory Board on Research Ethics: http://www.tenk.fi/ENG/function.htm 1.

Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) 2. Medical Research Act No. 295/2004: http://www.finlex.fi/en/laki/kaa nnokset/1999/en19990488 Human Stem Cells, Cloning, and Research (2005) (Finnish): http://videnskabsministeriet.dk/site/forside /publikationer/2000/guidelines-on- biomedical- experiments/html/guidelines.pdf 36France Country Key Organizations Legislation Regulations Guidelines General 1. Ministry of Health and Sport (MHS) (French): http://www.sante- sports.gouv.fr/ 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/?langue=2 3.

National Conference of CPPRB (French): http://cncp.med.univ- tours.fr/html/index.php 1. Decree No. 97-555 Concerning the National Consultative Ethics Committee for Health and Life Sciences (1997): http://www.ccne- ethique.fr/decree_n_97555.php 2. Biomedical Research (Loi Huriet-Sérusclat), Articles L1121-1 to L1126-7 (2004) Access: The laws can be found at the following web site (French): http://www.legifrance.gouv.fr/ From there, go to “Les Codes en Vigeur.” Go to the “Recherche d'un article au sein d'un code” box. In the “Nom de code” box select “Code de la Santé Publique” and in the “Numéro d'article” box enter the number of the desired article.

MHS: 1. Protection of Persons who Participate in Biomedical Research (Public Health Code, Regulatory Section, Additional Book II, Articles R.2001 to R.2053) 2. Decision of August 20, 2002 CCNE - Various: http://www.ccne-ethiqu e.fr/opinions.php Drugs 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 2. French Health Products Safety Agency (AFSSAPS): http://agmed.sante.gouv.fr/ang/ indang.htm Medications for Human Use, Articles L5121-11, L5124-1, and L5126-1) (2004) http://www.legifrance.gouv.fr/ CCNE: 1. Phase I Trials in Cancer (2002) 2.

Transposition into French Law of the European Directive Relating to Clinical Trials on Medicinal Products: A New Ethical Framework for Human Research (2003) 37 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection 1. National Commission of Information and Liberty (CNIL): http://www.cnil.fr/index.php?id=4 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr Law 2004-801 of August 6, 2004 Modifying Law 78-17 of January 6, 1978 Relating to the Protection of Data Subjects as Regards the Processing of Personal Data : http://www.cnil.fr/fileadmin/doc uments/uk/Decree_20_October_ 2005_English_version.pdf CCNE: 1.

Ethical Questions Arising from the Transmission of Scientific Information Concerning Research in Biology and Medicine (1995) 2. Biometrics, Identifying Data and Human Rights (2007) Human Biological Materials National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr Donation and Use of the Components and Products of the Human Body, Articles L1211-1 to L1274-3 (2004) (French): http://www.legifrance.gouv.fr/ CCNE: 1. Umbilical Cord Blood Banks for Autologous Use for Research (2002) 2. Ethical Issues Raised by Collections of Biological Material and Associated Information Data: “Biobanks,” “Biolibraries” (2003) Genetic Research National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 1.

Opinion on Gene Therapy (1990) 2. Opinion regarding the Application of Genetic Testing to Individual Studies, Family Studies and Population Studies. (Problems related to DNA "Banks," Cell "Banks," and Computerization) (1991) 3. Opinion that the Human Genome should not be Used for Commercial Purposes. Report. Thoughts Relating to Ethical Problems of Human Genome Research (1991) 4. Opinion on the Use of Somatic Gene Therapy Procedures. Report (1993) 38 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 1.

Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) 2. Law No. 2004-800 (2004) 3. Biomedical Research, Articles L2151-1, L2151-2, L2151-6, and L2151.7: http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/France/page.asp x/166 CCNE: Commercialisation of Human Stem Cells and Other Cell Line (2006) Georgia Note: For an overview of human subject protections in Georgia, se e “Ethical Review of Biomedical Research in the CIS Countries, ” Chapter 3, Section 4: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.p d f Country Key Organizations General Rights and Biomedicine (2000) Drugs Drug Agency of the Ministry of Labor, Health, and Social Affairs: http://www.healthministry.ge/eng/ind ex.php 1.

Drug and Pharmacy Law No. 659 (1997) 2. Licenses and Approvals Law (2005) Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005) Embryos, Stem Cells, and Cloning and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2000) 39Germany Note: For an overview of human s ubject protections in Germany, see http://www.eurecnet.org/information/germany.html Country Key Organizations General 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/ page.asp?his=4.3569 2. Central Ethics Commission of the BÄK (German): www.zentrale-ethikkommission.de/ 3.

Working Group of the Medical Ethics Committees in Germany (German): http://www.ak-med-ethik-komm.de/ 4. German Ethics Council (NER): http://www.ethikrat.org/en_index.php 5. Federal Ministry of Health (BMG): http://www.bmg.bund.de/cln_041/nn _600110/EN/Home/homepage__node ,param=.html__nnn=true (Model) Professional Code of Conduct, Section 15 (2006) (German): http://www.bundesaerztekammer.de/page. asp?his=1.100.1143 40 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/cln_029/EN/Ho me/homepage__node.html__nnn=true 2.

Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php 3. Paul Ehrlich Institute (PEI) (German): http://www.pei.de/cln_048/DE/home/ de-node.html?__nnn=true 4. Federal Ministry of Health (BMG): http://www.bmg.bund.de/cln_041/nn _600110/EN/Home/homepage__node ,param=.html__nnn=true Medicinal Products Act, Sections 40-42 (2008): http://www.bfarm.de/cln_028/n n_424928/EN/BfArM/BfArMSe rvice/AMG__en/amg-node- en.html__nnn=true BfArM : 1. Promulgation on the Principles of the Conduct of Clinical Trials of Drugs According to the Rules (1987) 2. Second Promulgation on the Clinical Trial of Drugs in Human (1997) 3.

Regulation for the Application of Good Clinical Practice of Clinical Medications for Human Use (2006) BMBF: Principles and Responsibilities Related to Clinical Studies (2003): http://www.bmbf.de/en/1173.php http://www.bmbf.de/en/4861.php BfArM: Third Announcement on Clinical Trials of Medicinal Products in Humans (2006): http://www.bfarm.de/cln_012/nn_119978 0/SharedDocs/Bekanntmachungen/EN/dru gs/clinTrials/bm-KlinPr-20060810-klinPr- pdf- en,templateId=raw,property=publicationFi le.pdf/bm-KlinPr-20060810-klinPr-pdf- en.pdf http://www.bfarm.de/cln_012/nn_119971 6/EN/drugs/1__befAuth/clinTrials/clintria ls-node-en.html__nnn=true Privacy/Data Protection Note: The 16 German states also have data protection laws (German): http://www.datensch utz- bayern.de/infoquel/d s- inst/deutschland.htm l Federal Commissioner for Data Protection and Freedom of Information: http://www.bfdi.bund.de/cln_030/nn_ 533554/EN/Home/homepage__node. html__nnn=true Federal Data Protection Act, as Amended (2003): http://www.bfdi.bund.de/cln_02 9/nn_535764/EN/DataProtectio nActs/DataProtectionActs__nod e.html__nnn=true 41 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials 1.

German Society of Surgery (DGCH) (German): http://www.dgch.de/ 2. German Medical Association (BÄK): http://www.bundesaerztekammer.de/ page.asp?his=4.3569 3. German Ethics Council (NER): http://www.ethikrat.org/en_index.php 4. Central Ethics Commission of the German Medical Association (ZEKO) (German): http://www.zentrale- ethikkommission.de/ 5. German Institute for Cell and Tissue Replacement (DIZG) (German): http://www.dizg.de 1. Transplantation Law (2007) (German): http://www.bmg.bund.de/cln_11 0/nn_1200474/SharedDocs/Dow nloads/DE/GV/GT/Organspende /TransplantationsG,templateId=r aw,property=publicationFile.pdf /TransplantationsG.pdf 2.

Transfusion Law (2007) (German): http://www.bmg.bund.de/cln_11 0/nn_1200364/SharedDocs/Dow nloads/DE/GV/GT/Blutprodukte /3-Gesetz-zur-Regelung-des- Trans- ,templateId=raw,property=publi cationFile.pdf/3-Gesetz-zur- Regelung-des-Trans-.pdf 3. Act of Quality and Security of Human Tissue and Cells (2007) (German): http://www.bmg.bund.de/cln_04 1/nn_600110/SharedDocs/Geset zestexte/Arzneimittel/Gewebege setz,templateId=raw,property=p ublicationFile.pdf/Gewebegeset z.pdf DGCH Rule for the Production of Human Tissues (German) BÄK: http://www.bundesaerztekammer.de/page. asp?his=0.7.45&all=true NER: Opinion on Biobanks for Research (2004): http://www.ethikrat.org/_english/publicati ons/Opinion_Biobanks-for-research.pdf ZEKO (German): http://www.zentrale- ethikkommission.de/downloads/Koerperm at.pdf DIZG: 1.

Ethical Code (2000) 2. Common Standards: Tissues and Cell Banking (2004) 42 Country Key Organizations Legislation Regulations Guidelines Genetic Research 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/ page.asp?his=4.3569 2. German Society of Human Genetics (GFHEV): http://www.gfhev.de/en/gfh/ 3. Paul-Ehrlich-Institut (PEI) (English): http://www.pei.de/cln_048/nn_15903 0/EN/institute-en/institut-node- en.html?__nnn=true Law of 20 June 1990/16.12.1993 to Regulate Matters Related to Gene Technology (2006) BÄK: Guideline on Gene Transfer (1995) (German) http://www.bundesaerztekammer.de/30/Ri chtlinien/Richtidx/Gentransferpdf.pdf GFHEV: 1.

Position Paper of the German Society of Human Genetics (1996) 2. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004) PEI – Various: http://www.pei.de/cln_048/nn_162568/EN /infos-en/fachkreise-en/genther-fach- en/genther-fach-node-en.html?__nnn=true 43 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1. Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php 2. German Ethics Council (NER): http://www.ethikrat.org/en_index.php 3. Central Ethics Commission of the German Medical Association (ZEKO) (German): http://www.zentrale- ethikkommission.de/ 4.

German Research Foundation (DFG): http://www.dfg.de/en/ 5. Central Ethics Committee for Stem-Cell Research (ZES): http://www.rki.de/cln_048/nn_21678 2/EN/Content/Institute/DepartmentsU nits/StemCell/StemCel__node.html?_ _nnn=true 1. Embryo Protection Act (1990): http://www.bmj.bund.de/enid/P ublications/Embryo_Protection_ Act_19u.html 2. Stem Cell Act (2008): English translation of 2002 version: http://www.bmj.bund.de/files/- /1146/Stammzellgesetz%20engl isch.pdf BMBF: Law Allowing the Import of Embryonic Stem Cells (2002): http://www.bmbf.de/en/1056.ph p Implementation Regulation for the Stem Cell Act (German): http://bundesrecht.juris.de/zesv/in dex.html NER: 1.

On the Import of Human Embryonic Stem Cells (2001): http://www.ethikrat.org/_english/publicati ons/stem_cells/Opinion_Import- HESC.pdf 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004): http://www.ethikrat.org/_english/publicati ons/Opinion_Cloning.pdf 3. Should the Stem Cell Law be Amended? (2007): http://www.ethikrat.org/_english/publicati ons/Opinion_Should_the_Stem_Cell_Law _be_amended.pdf ZEKO: 1. Stem Cell Research (2002) (German): http://www.zentrale- ethikkommission.de/downloads/Stammzel l.pdf 2. Cloning (2006) (German): http://www.zentrale- ethikkommission.de/downloads/TherapKl onen.pdf DFG: Opinion on Stem Cell Research (2006) (German): http://www.dfg.de/aktuelles_presse/red en _stellungnahmen/2006/download/stammz ellforschung_deutschland_lang_0610.pdf 44Greece Country Key Organizations Legislation Regulations Guidelines Drugs 1.

National Organization for Medicines (NOM): http://www.eof.gr/web/guest/home , then click on flag icon in upper left hand section for English 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?ca tegory_id=3 1. A6/10983/1 (1984) 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (1998) 3. Greek Republic Gazette No. 1973 (2003) 4. Act 3418/2005 Code of Medical Ethics NOM: 1. Ministerial Decision A6/10983/1/12-20.12.1984 on Clinical Trials and Protection of the Human Being (1984) 2.

Ministerial Decision DYG3/89292/31.12.2003 (2003) NBC: 1. Report on Biomedical Experimentations Involving Human Subjects and Clinical Trials of Medicinal Products (2005) 2. Code of Medical Ethics (2005) 3. Clinical Trials (2005) 4. A Guide for Research Ethics Committees for Biological Research (2009) Access: Enter the name of the guideline in the Search box in the upper right-hand corner of the NBC home page. Privacy/Data Protection 1. Hellenic Data Protection Authority (Greek): http://www.dpa.gr/ 1. Greek Constitution 1975/1986/2001 Article 9.1 2. Act 2619/98 (Biomedicine Convention of the Council of Europe) (1998) 3.

Law 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws 2819/2000 and 2915/2000) (Greek): http://www.dpa.gr/Documents/E ng/2472engl_all.doc 4. Act 3418/2005 Code of Medical Ethics Genetic Research 1. Hellenic Data Protection Authority (HDPA) (Greek): http://www.dpa.gr/ 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?ca tegory_id=3 1. Greek Constitution 1975/1986/2001, Article 5.5 2. Act 2619/98 (Biomedicine Convention of the Council of Europe) (1998) HDPA: Opinion No. 15/2001 NBC: 1. On the Collection and Use of Genetic Data (2002) 45 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?ca tegory_id=3 2. National Authority for Medically Assisted Reproduction (Greek): http://www.iya.gr 1. 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 (1998) 2. Act 3089/2002 on Medically Assisted Human Reproduction 3. Act 3305/2005 NBC: 1. On the Use of Stem Cells in Biomedical Research and Clinical Medicine (2002) 2. On Prenatal and Pre-implantation Diagnostic Tests and the Question of Choice of Embryo (2007) Hungary Note: For an overview of human subject protections in Hungary, see “National Regulations on Ethics and Research in Hungary:” http://ec.europa.eu/research/science- society/pdf/hu_eng_lr.p d f Country Key Organizations General 1.

Ministry of Health (EüM): http://www.eum.hu/?akt_menu=2&se t_lang=2 2. Medical Research Council, Scientific and Research Ethics Committee 1. Act XX of 1949 on the Constitution of the Republic of Hungary, Article 54. 2. Act CLIV of 1997 on Health Care, Chapter VIII 3. Act IV of 1978 on the Criminal Code Title II of Chapter XII. Crimes Against the Order of Medical Interventions and Medical Research and Against Self-Determination Related to Health Issues 4. Act VI. of 2002 on the promulgation of the Oviedo Convention on Human Rights and Biomedicine 5. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research EüM: Decree 23/2002 (V.

9.) EüM on Biomedical Research on Human Beings 46 Country Key Organizations Legislation Regulations Guidelines Drugs 1. National Institute of Pharmacy: http://www.ogyi.hu/main_page 2. Medical Research Council, Ethics Committee for Clinical Pharmacology: http://www.ett.hu/kfeb/kfeb.htm Act XCV of 2005 on Medicinal Products for Human Use: http://net.jogtar.hu/jr/gen/getdoc .cgi?docid=a0500095.tv&dbnu m=62 EüM: Decree 35/2005 (VIII. 26) of the Minister of Health on the Clinical Trial and Application of Correct Clinical Practices of Investigational Medicinal Products Intended for Use in Humans: http://www.ogyi.hu/dynamic/Dec ree35_2005.doc Privacy/Data Protection Parliamentary Commissioner for Data Protection and Freedom of Information: http://www.obh.hu/indexen.htm 1.

Act LXIII of 1992 on Protection of Personal Data and Disclosure of Data of Public Interest, Amended by the Parliamentary Act No XLVIII of 2003 : http://abiweb.obh.hu/dpc/index. php?menu=gyoker/relevant/nati onal/1992_LXIII 2. Act XLVII of 1997 on the Handling of Medical and Other Related Data: http://abiweb.obh.hu/dpc/index. php?menu=gyoker/relevant/nati onal/1997_XLVII Human Biological Materials Ministry of Health (EüM): http://www.eum.hu/english Act LXXX of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Transplantation of Organs and Tissues of Human Origin Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as regards Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations Genetic Research of Protection of Human Genetic Data, of Human Genetic Examinations and Research and of the Operation of Biobanks Professional Requirements Necessary for Providing Health Services 47 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Ministry of Health (EüM): http://www.eum.hu/english 2. Medical Research Council 1. Act CLIV of 1997 on Health Care, Articles 180-182: http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Hungary/page.as px/557 2. Act VI of 2002 on the Promulgation of the Convention on Human Rights and Medicine and the Additional Protocol on Cloning Decree 30/1998 (VI. 24.) NM on Regulations on Specific Procedures for Human Reproduction Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as regards Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations Iceland Country Key Organizations Legislation Regulations Guidelines General 1.

Ministry of Health and Social Security (MOH): http://ministryofhealth.is 2. National Bioethics Committee (NBC): www.visindasidanefnd.is (Select “English” in the upper-right hand corner.) 1. Act on the Rights of Patients No. 74 (1997): http://ministryofhealth.is/laws- and-regulations//nr/34 2. Oviedo Convention on Human Rights and Biomedicine (2004) MOH: Regulation on Scientific Research in the Biomedical field, No. 286 (2008) http://eng.heilbrigdisraduneyti.is/l aws-and- regulations/Regulations//nr/2847 NBC: 1. Research Projects 2. Withdrawal Drugs 1. Icelandic Medicines Control Agency (MCA): http://www.imca.is/ 2.

National Bioethics Committee (NBC): www.visindasidanefnd.is Medicinal Products Act No. 93 (1994): http://ministryofhealth.is/media/ Laws%20in%20english/The_M edicinal_Products_Act_No_93- 1994.pdf MCA: Regulation on Clinical Trials of Medicinal Products in Humans No. 443 (2004): http://eng.heilbrigdisraduneyti.is/ media/Reglugerdir- enska/Regulation_on_clinical_tri als_of_medicinal_products_in_hu mans_No443-2004.pdf 48 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Data Protection Authority: http://www.personuvernd.is/informati on-in-english/ 1. Judgment by the Supreme Court of Iceland Concerning the Health Sector Database (2003): http://www.personuvernd.is/info rmation-in-english/ 2.

Act on the Protection of Privacy as Regards the Processing of Personal Data, No. 77/2000, as Amended (2003): http://www.personuvernd.is/info rmation-in-english/ Government Regulation on a Health Sector Database No. 32 (2000): http://eng.heilbrigdisraduneyti.is/l aws-and-regulations/nr/670 Human Biological Materials 1. Ministry of Health: http://ministryofhealth.is 2. National Bioethics Committee (NBC): www.visindasidanefnd.is Act on Biobanks No. 110 (2000): http://ministryofhealth.is/laws- and-regulations/nr/31 Regulations on the Keeping and Utilization of Biological Samples in Biobanks No. 134 (2001): http://eng.heilbrigdisraduneyti.is/l aws-and-regulations/nr/684 NBC: 1.

Biological Samples (2001) 2. Research Services (no date) Embryos, Stem Cells, and Cloning 1. 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 (2004) 2. Artificial Fertilization Act No. 55/1996 as Amended by Laws No. 65/2006, 27/2008, and 54/2008 (Icelandic): http://althingi.is/lagas/nuna/199 6055.html English translation of 1996 law: http://eng.heilbrigdisraduneyti.is /laws-and-regulations/nr/685 49Ireland Country Key Organizations Legislation Regulations Guidelines General 1.

Irish Council for Bioethics (ICB): http://www.bioethics.ie 2. Irish Medicines Board (IMB): http://www.imb.ie/ Operational Procedures for Research Ethics Committees: Guidance 2004 IMB: Guide to Clinical Trials (2004) 50 Country Key Organizations Legislation Regulations Guidelines Drugs Irish Medicines Board: http://www.imb.ie/ 1. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004 http://www.dohc.ie/legislation/st atutory_instruments/pdf/si20040 190.pdf 2. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No.

878 of 2004) http://www.dohc.ie/issues/clinic al_trials_2004/Commission_Dir ective_2003_94_EC.pdf 3. European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006 (S.I. 374 of 2006) http://www.dohc.ie/issues/clinic al_trials_2004/CT_EC_No2_Re gulations_2006.pdf 4. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2006 (Informal Codification Text) http://www.dohc.ie/issues/clinic al_trials_2004/Final_Consolidat ed_Regulations_2007.pdf Access: These Statutory Instruments can be viewed at: http://www.dohc.ie/issues/clinic al_trials/ Privacy/Data Protection Data Protection Commissioner: http://www.dataprotection.ie/docs/Ho me/4.htm Data Protection Act (1988), as amended (2003): http://www.irishstatutebook.ie/2 003/en/act/pub/0006/index.html 51 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Irish Council for Bioethics: http://www.bioethics.ie Recommendations for Collection, Use, and Storage in Research (2005): http://www.bioethics.ie/pdfs/BioEthics_fi n.pdf Genetic Research Irish Medicines Board: http://www.imb.ie/ (2006): http://www.imb.ie/images/uploaded/docu ments/AUT- G0003_Guidelines_for_pharmacogenetic_ research_v1.pdf Embryos, Stem Cells, and Cloning and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) Italy Country Key Organizations Legislation Regulations Guidelines General 1.

National Federation of Ethics Committees (FNACE) (Italian): http://www.unich.it/fnace/ 2. National Monitoring Center for Clinical Trials (OSS): https://oss-sper- clin.agenziafarmaco.it/index_ingl.htm 3. National Bioethics Committee (NBC): http://www.governo.it/bioetica/eng/in dex.html 4. Ministry of Health (Italian): http://www.ministerosalute.it Statute on the National Federation of Ethics Committees (1995) (Italian): http://www.unich .it/fnace/stat ut o.htm FNACE: Regulation Implementing the Statute on the National Federal of Ethics Committees (1995) OSS: Ministerial Decree: Terms of Reference for the Establishment and the Functioning of Ethics Committees (May 12, 2006) NBC: Opinion of the National Bioethics Committee on the European Protocol on Biomedical Research (1999) 52 Country Key Organizations Legislation Regulations Guidelines Drugs 1.

National Monitoring Center for Clinical Trials: https://oss-sper- clin.agenziafarmaco.it/index_ingl.htm 2. Italian Medicines Agency (Italian): http://www.agenziafarmaco.it/ 3. Ministry of Health (MOH) (Italian): http://www.ministerosalute.it 1. Decree of the President of the Republic: Regulations to Simplify the Procedures and to Verify and Check New Systems and Experimental Therapeutic Protocols (September 21, 2001) (Italian): http://oss-sper- clin.agenziafarmaco.it/normativ a/ , then select document in the left column. 2. Legislative Decree No. 211: Transposition of Directive 2001/20/EC Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Clinical Use (2003): https://oss-sper- clin.agenziafarmaco.it/normativ a/decreto_24062003_inglese.pdf 3.

Legislative Decree No. 200: Transposition of Directive 2005/28 EC Laying down Principles and Detailed Guidelines as Regards Investigational Medical Products for Human Use, as well as the Requirements for Authorizing of Manufacturing or Importing of such Products (2007) (Italian): http://www.aifa.gov.it/allegati/d lgs_200-6nov2007.pdf Italy has numerous regulations that govern drug research (Italian): http://oss-sper- clin.agenziafarmaco.it/normativa/ The following are the most important: 1. Ministerial Decree 21 December 2007: Modalities of Submission of the Application to the Competent Authority, for Communication of Substantial Changes and Declaration of Conclusion of the Clinical Trial, and for Request of an Ethics Committee Opinion 2.

Ministerial Decree 31 March 2008: Definition of the Minimum Requirements that Contract Research Organisations (CROs) Shall Satisfy in Order to Work on Clinical Trials on Medicinal Products 3. Ministerial Decree 14 of July 2009: Minimal Insurance Requirements for Subjects Involved in Clinical Trials 53 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Italian Data Protection Independent Authority Italian Personal Data Protection Code, Legislative Decree No. 196 of June 30, 2003: http://www.garanteprivacy.it/gar ante/doc.jsp?ID=1030925 1. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical Experimentation (May 25, 2000) 2.

Ministerial Decree No. 277 (2007) Regulation for the Implementation of Articles No. 20 and 21 of the Legislative Decree No. 196 of June 30, 2003 Genetic Research 1. Instituto Superiore di Sanita (ISS): http://www.iss.it/chis/?lang=2 2. Italian Society of Human Genetics (SIGU): http://www.sigu.net/news.php Guidelines for Phase I Clinical Trials with Investigational Medicinal Products Employed in Gene Somatic Therapy (2004) (Italian): http://www.iss.it/binary/publ/publi/0478.1 106653420.pdf SIGU: Guidelines for Genetic Biobanks (2004): http://www.gaslini.org/DPPM/BIOBANK _GUIDELINES.pdf Embryos, Stem Cells, and Cloning Assisted Reproduction, Law No.

40, Article 13 (2004): http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Italy/page.aspx/1 67 54Latvia Note: For an overview of human subject protections in Latvia, see the report “National Regulations on Ethics and Research in La tvia:” http://ec.europa.eu/research/science- society/pdf/lv_eng_lr.pdf Country Key Organizations Drugs 1. State Agency of Medicines: http://www.vza.gov.lv/index.php?setl ang=en&large = 2. Central Medical Ethics Committee Pharmaceutical Law, Amended April 24, 2008 (Latvian): http://www.vza.gov.lv/index.ph p?id=355&sa=355&top=333 1.

Cabinet Regulation No. 172, Regulations Regarding the Conduct of Clinical Trials and Non-interventional Trials, the Procedures for the Labeling of Investigational Medicinal Products, and the Procedures for Inspection of Conformity with the Requirements of Good Clinical Practice, February 28, 2006: http://www.vza.gov.lv/doc_upl/M K-172-28022006-ENGv3.pdf 2. Amended January 15, 2008: http://www.vza.gov.lv/doc_upl/M K_172_groz_15012008-Eng.pdf Privacy/Data Protection 1. Data State Inspectorate: http://www.dvi.gov.lv/eng/ 2. Central Medical Ethics Committee 1. Medical Treatment Law, Amended May 8, 2008 2.

Personal Data Protection Law, Amended February 21, 2008: http://www.dvi.gov.lv/eng/legisl ation/pdp/ Human Biological Materials Central Medical Ethics Committee Human Beings and Use of Human Organs and Tissue, Amended February 6, 2004 Cabinet of Ministers Regulation No. 208 (2007): Order of Use of Human Biological Materials Genetic Research 1. Ministry of Health: http://www.vm.gov.lv /index.php?setl ang=en 2. Data State Inspectorate: http://www.dvi.gov.lv/eng/ 3. Central Medical Ethics Committee 1. Human Genome Research Law, Amended January 3, 2005 2. Law on the Development and Use of the National DNA Database, Amended March 9, 2006 Regulation of the Cabinet of Ministers, “Procedures for Genetic Research” (2004) 55 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Ministry of Health: http://www.vm.gov.lv /index.php?setl ang=en 2. Central Medical Ethics Committee Sexual and Reproductive Health Law, amended March 29, 2007: http://www.ttc.lv/New/lv/tulkoj umi/E0750.doc Cabinet Regulation No. 716 (2003.16.12): Order of Medically-Assisted Procreation, Donor Registry, and Donor Bank Lithuania Note: For an overview of human subject protections in Lithuania, see the report “National Regulations on Ethics and Research in Lithuania:” http://ec.europa.eu/research/science- society/pdf/lt_eng_lr.p d f http://www.eurecnet.org/in formation/lithuania.html Country Key Organizations General 1.

Ministry of Health (MOH): http://www.sam.lt/en/ 2. Lithuanian Bioethics Committee (LBEC): http://bioetika.sam.lt/index.php?- 1702632112 1. Oviedo Convention on Human Rights and Biomedicine (2002): http://conventions.coe.int/treaty/ en/treaties/html/164.htm 2. Law on Ethics of Biomedical Research, No. VIII-1679 (2007): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=32605 7 MOH: 1. Decree on the Procedure for the Estimation and Covering of Expenses Incurred by Research Subjects, No. 677 (2000) 2. Decree on the List of the Documents to be Presented by the Sponsor of Biomedical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Research, No.

29 (2001) 3. Decree on the Procedure to Issue Approvals to Conduct Biomedical Research, No. V-2 (2008) LBEC: Decree on the List of Documents to be Presented by the Sponsor of Medical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Trial No. V-21 (2004) 56 Country Key Organizations Legislation Regulations Guidelines Drugs 1. State Medicines Control Agency (SMCA): http://www.vvkt.lt/index.php?332772 3903 2. Lithuanian Bioethics Committee (LBEC): http://bioetika.sam.lt/index.php?- 1876243809 3. Ministry of Health (MOH): http://www.sam.lt/en/ 1. Law on Ethics of Biomedical Research, No.

VIII-1679 (2000): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=32605 7 2. Law on Pharmacy, No. X-709 (2008): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=33813 9 SMCA: 1. Decree on Pediatric Clinical Trials No. 70 (2002) 2. Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments, and Declaration of the End of the Trial (2006) http://www.vvkt.lt/index.php?305 3919977 LBEC: Decree on the Regulation for the Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favourable Opinion to Conduct a Clinical Trial on Medicinal Products No.

V-11 (2004) MOH: Health Care Ministry Decree on the Procedure to Issue Approvals to Conduct Clinical Trial on Medicinal Product, No. V-435 (2006) LBEC - Various: http://bioetika.sam.lt/index.php?- 82619484 Privacy/Data Protection State Data Protection Protector ate Legal Protection of Personal Data, No. X-1444 (2008): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=31563 3 57 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Transplantation of Human Tissues, Cells and Organs (2006): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=31439 6 Embryos, Stem Cells, and Cloning Ministry of Health (MOH): http://www.sam.lt/en/ 1.

Law on Ethics of Biomedical Research, No. VIII-1679, Article 3 (2000): http://www3.lrs.lt/pls/inter3/dok paieska.showdoc_l?p_id=32605 7 2. 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 No. IX- 1085 (2002): http://conventions.coe.int/Treaty /EN/Treaties/Html/168.htm MOH: Decree on the Procedure to Issue Authorization for the Transit of Tissues of Human Embryonic Tissue, Embryonic Stem Cells and their Lines, Fetal Tissue, and Fetal Stem Cells throughout the Territory of the Republic of Lithuania, No.

V-660 (2007) Luxembourg Country Key Organizations Legislation Regulations Guidelines General 25 (French): http://www.legilux.public.lu/leg /a/archives/1998/0078/a078.pdf #page=2 58 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Health (French): http://www.ms.public.lu and http://www.sante.lu 2. National Committee on Ethics in Research (CNER) (French): http://www.cne.lu 3. Division of Pharmacy and Medicines (French) http://www.ms.public.lu/fr/direction/ divisions-services/pharmacie- medicaments/index.html May, 2005 on Good Clinical Practice (French): http://www.legilux.public.lu/leg/a /archives/2005/0084/2005A15161 .html Privacy/Data Protection National Commission for Data Protection: http://www.cnpd.lu/en/index.html Law of August 2, 2002 on the Protection of Persons with Regard to the Processing of Personal Data as amended by a law of July 27, 2007: http://www.cnpd.lu/objets/en/do c_loi02082002mod_en.pdf#zoo m=125,0,0 Grand-Ducal Decree of October 2nd, 1992 on the Use of Personal Medical Data in IT Processing (French): http://www.legilux.public.lu/leg/a /archives/1992/0074/a074.pdf#pa ge=12 Macedonia Country Key Organizations Legislation Regulations Guidelines Drugs Macedonian Drug Agency http://moh.gov.mk/index.php?categor y=39 http://www.reglek.com.mk / 1.

Law for Drugs and Medical Devices (2007) 2. Pharmaco-Vigilance Law (2008) Regulations on Clinical Trials of Medicinal Products on Human Subjects (2009) Privacy/Data Protection Directorate for Personal Data Protection (Macedonian): http://www.dpdp.gov.mk/ Law on Personal Data Protection (2005): http://www.ceecprivacy.org/pdf/ Law%20on%20Personal%20Da ta%20Protection.pdf 59Malta Note: For an overview of human subject protections in Malta, see “National Regulations on Et hics and Research in Malta:” http://ec.europa.eu/research/science- society/pdf/mt_eng_lr.pdf Country Key Organizations Legislation Regulations Guidelines General Health Ethics Committee: http://sahha.gov.mt/pages.aspx?page= 134 Drugs Medicines Authority: http://medicinesauthority.gov.mt/ Medicines Act, 2003 (English translation begins on page 66): http://www.doi.gov.mt/EN/parli amentacts/2003/Act%203.pdf As amended by Act No.

III of 2004: http://www.doi.gov.mt/EN/parli amentacts/2004/ACTIIIe.pdf Legal Notice 490: Clinical Trials Regulations, 2004 (English translation begins half way through document): http://www.doi.gov.mt/EN/legaln otices/2004/11/LN490.pdf Guidance Notes on Good Clinical Practice (2005) Privacy/Data Protection Office of the Data Protection Commissioner: http://www.dataprotection.gov.mt/ Data Protection Act (2006): http://www.dataprotection.gov. mt/dbfile.aspx/DPA.pdf Moldova Note: For an overview of human subject protections in Moldova, se e “Ethical Review of Biomedical Research in the CIS Countries, ” Chapter 3, Section 7: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.pdf Country Key Organizations General Rights and Biomedicine (2002) Drugs Ministry of Public Health, National Ethics Committee Moldova Republic Law on Medicines of December 17, 1997, Articles 11 and 12 Ordnance No.

10: On Performance of Clinical Trials in the Republic of Moldova (2002) Embryos, Stem Cells, and Cloning Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being, on the Prohibition of Cloning Human Beings (2002) 60Montenegro Country Key Organizations Legislation Regulations Guidelines Drugs Ministry of Health of Montenegro: www.mz.cg.yu Law for Drugs and Pharmacies of Montenegro, Articles 37-39 Netherlands Country Key Organizations Legislation Regulations Guidelines General Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl 1.

Population Screening Act (1996): http://www.gr.nl/wbo.php?phpL ang=en 2. Medical Research Involving Human Subjects Act (2006): http://www.ccmo- online.nl/hipe/uploads/downloa ds_catw/Medical%20Research %20involving%20Human%20S ubjects%20Act%20March%200 1%202006.pdf 3. Medical Research (Human Subjects) Compulsory Insurance Decree (2003): http://www.ccmo- online.nl/hipe/uploads/downloa ds/Verzekeringsbesluit_2003- ENG(1).pdf 1. Concerning the Use of a Special Form (2002) 2. Concerning Requirements of Expertise of Accredited Review Board Members (2002) 3. Concerning the Organization and Working Method of Accredited Review Board Members (2003) 4.

External Review Guideline (2004) 5. Research Contract Review Guideline (2009) Manual for the Review of Medical Research Involving Human Subjects (2002) 61 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Health, Welfare, and Sport (MHWS): http://www.minvws.nl/en/ 2. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl 3. Medicines Evaluation Board (MEB): http://www.cbg- meb.nl/cbg/en/default.htm Medicines Act (2007) (Dutch): http://wetten.overheid.nl/cgi- bin/deeplink/law1/title=Genees middelenwet MHWS: 1. Medicines Act Decree (2007) (Dutch): http://wetten.overheid.nl/cgi- bin/deeplink/law1/title=Besluit% 20Geneesmiddelenwet 2.

Medicines Act Regulation (2007) (Dutch): http://wetten.overheid.nl/cgi- bin/deeplink/law1/title=Regeling %20Geneesmiddelenwet CCMO: Clinical Research with Medicinal Products in the Netherlands: Instructional Manual (2005): http://www.ccmo- online.nl/hipe/uploads/downloads_cati/Ins truction%20manual%20versie%202.pdf Privacy/Data Protection 1. Federation of Biomedical Scientific Societies (FMWV) (Dutch): http://www.federa.org/ 2. Dutch Data Protection Authority: http://www.dutchdpa.nl/index.stm Personal Data Protection Act (2004) (Dutch): http://www.cbpweb.nl/downloa ds_wetten/WBP.PDF English translation of 2002 version: http://www.dutchdpa.nl/downlo ads_wetten/wbp.pdf?refer=true &theme=purple FMWV: Code for Adequate Secondary Use of Data (2004): http://www.federa.org/DB_FILES/product ie/general/1_78_301/Code%20of%20cond uct%20for%20medical%20research%20.p df Human Biological Materials Federation of Biomedical Scientific Societies (Dutch): http://www.federa.org/ Civil Code, Article 467 (1994) (Dutch): http://www.healthlaw.nl/wgboe ng.html Tissue in the Netherlands (2002): http://www.federa.org/?s=1&m=78&p=& v=4 Genetic Research 1.

Ministry of Housing, Spatial Planning, and Environment (VROM): www.vrom.nl 2. Dutch Health Care Inspectorate (IGZ): http://www.igz.nl/ 3. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/ Medical Research Involving Human Subjects Act (2006): http://www.ccmo- online.nl/hipe/uploads/downloa ds_catw/Medical%20Research %20involving%20Human%20S ubjects%20Act%20March%200 1%202006.pdf Researchers and Sponsors with Regard to the Assessment by Official Bodies of Clinical Research Involving Gene Therapeutics in the Netherlands (2007): http://213.154.234.72/Documenten/Docu menten%20IM/Guidelines%20gene%20th erapy%20applications.pdf 62 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl 1.

Foetal Tissue Act (2001): http://www.minvws.nl/includes/ dl/openbestand.asp?File=/image s/Foetal%20act_tcm20- 107821.pdf 2. Embryos Act (2002) http://www.minvws.nl/includes/ dl/openbestand.asp?File=/image s/eng-embryowettekst_tcm20- 107819.pdf (no date): http://www.minvws.nl/includes/dl/openbe stand.asp?File=/images/explanatory- notes-to-the-embryos-bill_tcm20- 108037.pdf Norway Country Key Organizations Legislation Regulations Guidelines General 1. Regional Committees for Medical Research Ethics (REK): http://www.etikkom.no/English/NEM /REK 2. National Committee for Medical Research Ethics (NEM): http://www.etikkom.no/English 3.

National Committee for Research Ethics in the Social Sciences and the Humanities (NESH): http://www.etikkom.no/English/NES H 4. National Committee for Research Ethics in Science and Technology (NENT): http://www.etikkom.no/English/NEN T 1. Oviedo Convention on Human Rights and Biomedicine (2006) 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovd ata/lov-20060630-056-eng.pdf 3. Act on Health Care Research (2008) (Norwegian): http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lo vdata/all/nl-20080620- 044.html&emne=helseforskning slov*&& REK: Terms of Reference for the Regional Committees for Medical Research Ethics, Norway (2003) http://www.etikkom.no/English/N EM/REK/reference NEM: 1.

Research Ethical Review in Norway (1998) 2. NEM: Standard Operating Procedures for the Regional Committees for Medical Research Ethics (2002) NESH: Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2001) NENT: Research Ethics Guidelines for Science and Technology (2007) (Norwegian): www.etikkom.no/retningslinjer/nent Drugs Norwegian Medicines Agency: http://www.regjeringen.no/en/dep/ho d/About-the-Ministry/Subordinate- institutions/The-Norwegian- Medicines-Agency.html?id=279753 Regulation Relating to Clinical Trials on Medicinal Products for Human Use (2003) 1. Guidelines for the Regulations Concerning Clinical Trials of Human Drugs (1999) 2.

Guidance to the Regulation (2004) (Norwegian): www.legemiddelverket.no/upload/78182/ Endelig%20veiledning%202004.doc 63 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Data Inspectorate: http://www.datatilsynet.no/templates/ Page____194.aspx Personal Data Act No. 31 (2000): http://www.datatilsynet.no.htest. osl.basefarm.net/upload/Dokum enter/regelverk/lov_forskrift/lov -20000414-031-eng.pdf Regulations on the Processing of Personal Data (2003): http://www.datatilsynet.no.htest.o sl.basefarm.net/upload/Dokument er/regelverk/lov_forskrift/lov- 20000414-031-eng.pdf Human Biological Materials 1.

Ministry of Health and Care Services (MHCS): http://www.odin.no/hod/english/bn.ht ml 2. Ministry of Education and Research (MER): http://www.odin.no/kd/english/bn.ht ml 1. Act on Biobanks (February 21, 2003, No. 12): http://www.regjeringen.no/uploa d/kilde/hod/red/2005/0078/ddd/ pdfv/242629- act_relating_to_biobanks_bioba nkloven_.pdf 2. Act Relating to the Application of Biotechnology in Human Medicine, etc. (December 5, 2003, No. 100) 3. Act on Health Care Research (2008) (Norwegian): http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lo vdata/all/nl-20080620- 044.html&emne=helseforskning slov*&& MHCS: Guidelines for the Norwegian Act on Biobanks (2003) (Norwegian): http://odin.dep.no/hod/norsk/publ /rundskriv/042051-990014/ Genetic Research 1.

Ministry of Health and Care Services (MHCS): http://www.odin.no/hod/english/bn.ht ml 2. Norwegian Biotechnology Advisory Board: http://www.bion.no/index_eng.shtml 3. Regional Committees for Medical Research Ethics (REK): http://www.etikkom.no/English/NEM /REK Act Relating to the Application of Biotechnology in Human Medicine, etc. (December 5, 2003, No. 100): http://www.odin.no/hod/english/ doc/legislation/acts/048051- 990012/dok-bn.html 64 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Directorate for Health and Social Affairs: http://www.helsedirektoratet.no/porta l/page?_pageid=134,112387&_dad=p ortal&_schema=PORTAL&language =english 1.

Revised Act Relating to the Application of Biotechnology in Human Medicine (June 15, 2007) Regarding Changes in the Act Related to Stem Cell Research and Pre-implantation Diagnostics (2007) 2. Norwegian Law on the Human-Medical Use of Biotechnology, Chapter 3: http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Norway/page.as px/168 Poland Note: For an overview of human subject protections in Poland, see “National Regulations on Ethics and Research in Poland:” http://ec.europa.eu/research/science- society/pdf/pl_eng_lr.pdf Country Key Organizations General 1.

Ministry of Health, Bioethics Appeals Commission (MOH): http://www.kb.mz.gov.pl/index_en.ht ml 2. Polish Chamber of Physicians and Dentists (NIL): http://www.nil.org.pl/xml/nil/wladze/ nil_eng 1. Constitution of the Republic of Poland, Article 39 (1997) 2. Medical Profession Act, Articles 21-29 (1997) MOH: Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics Committees (1999) NIL: Code of Medical Ethics, Chapter II (2003) 65 Country Key Organizations Legislation Regulations Guidelines Drugs Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products: http://www.urpl.gov.pl/english/index. htm 1.

Pharmaceutical Law, Act of Sept. 6, 2001, Article 6 2. Law of 20/04/2004 on Amendment of the Pharmaceutical Law, Law on the Profession of Medical Doctor, and Regulations Introducing the Pharmaceutical Law, Law on Medical Devices, and Law on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Journal of Laws No. 92, Item 882) 1. Order of the Minister of Health in the Matter of Central Register of Clinical Trials (2004) 2. Decree of the Minister of Health on Clinical Trials on Minors (2004) 3. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors (2004) 4.

March 11, 2005 Order of the Minister of Health Concerning Detailed Requirements of Good Clinical Practice (2005) Privacy/Data Protection Inspector General for the Protection of Personal Data: http://www.giodo.gov.pl/168/j/en/ Act on the Protection of Personal Data (2006): http://www.giodo.gov.pl/data/fil emanager_en/61.doc Human Biological Materials the Collection and Transplantation of Cells 2. Act of 22 August 1997 on the Public Blood Service Portugal Country Key Organizations Legislation Regulations Guidelines General National Council of Ethics for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/ Oviedo Convention on Human Rights and Biomedicine (2001) (1993) 2.

Opinion 9/CNE/94 on Ethics Commissions (1994) 3. Doc. 13/CNECV/95 on Legislation on Clinical Trials and Ethics Committees (1995) 4. Doc. 34/CNECV/2001 on the Helsinki Declaration (2001) 66 Country Key Organizations Legislation Regulations Guidelines Drugs 1. National Institute of Pharmacy and Medicines: http://www.infarmed.pt/portal/page/p ortal/INFARMED/ENGLISH 2. Ethics Commission for Clinical Research (CEIC): http://www.infarmed.pt/portal/page/p ortal/INFARMED/MEDICAMENTO S_USO_HUMANO/CEIC 1. Approval of the Applicable Legal Standards for the Conduct of Clinical Trials of Medicines for Human Use, Law No.

46/2004 2. Approval of the Composition, Operations, and Financing of the Ethics Commission for Clinical Research, Decree No. 57/2005 (Portuguese): http://www.infarmed.pt/portal/p age/portal/INFARMED/LEGIS LACAO/LEGISLACAO_FAR MACEUTICA_COMPILADA/ TITULO_III/TITULO_III_CAP ITULO_I/portaria_57-2005.pdf Decree-Law No. 102/2007 of April 2 Privacy/Data Protection National Data Protection Commission: http://www.cnpd.pt/english/index_en. htm 1. Constitution, Article 35 (1997) 2. Act on the Protection of Personal Data, No. 67/98 (1998): http://www.cnpd.pt/english/bin/l egislation/Law6798EN.HTM Genetic Research Ministry of Health Embryos, Stem Cells, and Cloning National Council of Ethics for the Life Sciences http://www.cnecv.gov.pt/cnecv/en/ Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001) 2.

Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006) http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Portugal/page.as px/473 Research (1995) 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F1 3B34FD-F9F7-4C9D-96DC- 419999D9B693/0/47CNECV2005.pdf 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/77 0EA390-9326-4FF9-B28D- D70A7E9AD961/0/p048_en.pdf 67Romania Note: For an overview of human subject protections in Romania, see “National Regulations on Ethics and Research in Romania:” http://ec.europa.eu/research/science- society/pdf/ro_eng_lr.p d f Country Key Organizations General Ministry of Health (MOH) (Romanian): http://www.ms.ro/ 1.

Law 336/2002 2. Oviedo Convention on Human Rights and Biomedicine (2001) Ordinance No. 57/16.08.2002 (2002) Drugs 1. Ministry of Health (MOH) (Romanian): http://www.ms.ro/ 2. National Medicines Agency: http://www.anm.ro/en/home.html MOH: 1. Emergency Ordinance 152/1999 on Medicinal Products for Human Use 2. Order of MOH No. 1300/2004: Detailed Guidance on the Application Format and Documentation to be Submitted in an Application for an Ethics Committee Opinion on the Clinical Trial on Medicinal Products for Human Use (2004) 3. Order of MOH No. 1117/2004: Detailed Guidance for the Request for Authorization of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Approval of Substantial Amendments and Declaration of the End of the Trial (2004) 4.

Order of MOH No. 904/25.07.2006 Transposing Directive 2001/20/EC of the European Parliament and of the Council (2006) MOH: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999) 68 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection National Supervisory Authority for Personal Data Processing: http://www.dataprotection.ro/index.js p?page=documents&lang=en Law No. 667/2001 On the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data: http://www.dataprotection.ro/ser vlet/ViewDocument?id=174 Embryos, Stem Cells, and Cloning 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 (2001) Russia Note: For an overview of human subject protections in Russia, s ee “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 8: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.pdf Country Key Organizations General 1.

Federal Service on Surveillance in Healthcare and Social Development (FSSHSD) (Russian): http://www.roszdravnadzor.ru/ 2. Ethics Committee of the Federal Service on Surveillance in Healthcare and Social Development (Russian): http://www.roszdravnadzor.ru/etika/e t/norm Constitution of the Russian Federation, Article 21 (1993): http://www.constitution.ru/en/10 003000-03.htm FSSHSD: Order No. 2314-Pr/07 17 on August 2007 About the Ethics Committee (Russian): http://www.roszdravnadzor.ru/ab out/news/11698 69 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Health (MOH) (Russian): http://www.minzdrav- rf.ru/ 2.

Federal Agency for Technical Regulation and Metrology (GOST): http://www.gost.ru/wps/portal/pages. en.Main 3. Ethics Committee of the Federal Service on Surveillance in Healthcare and Social Development (Russian): http://www.roszdravnadzor.ru/etika/e t/norm 4. Scientific Center for Expertise of the Remedies for Medicinal Use (Russian): http://www.regmed.ru/ On Medicinal Products, Federal Law No. 86-FZ, Articles 35-41 (2006) (1998 version in Russian): http://www.medtran.ru/rus/trials /gov/zakon_86.htm MOH: 1. Ministry of Health Order No. 103 (March 24, 2000) 2. Clinical Practice Rules in the Russian Federation, Minister’s Decree #266 (2003) GOST: Good Clinical Practice.

GOST-R 52379-2005 (September 27, 2005) Privacy/Data Protection Federation on Information, Information Technologies, and Protection of Information (2006) 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://www.hunton.com/files/tbl _s47Details/FileUpload265/162 5/Privacy_Russia_White_Paper. pdf Genetic OF 8'-FZ “About the Government Control in the Area of Genetic-Engineering Activity” (With changes of July 12, 2000) San Marino Country Key Organizations Legislation Regulations Guidelines General Rights and Biomedicine (1998) 70Serbia Country Key Organizations Legislation Regulations Guidelines Drugs 1.

Ministry of Health (MOH): http://www.zdravlje.gov.rs/ 2. Serbian Drug Agency http://www.alims.sr.gov.yu/ Law on Medicines and Medical Devices No. 84/2004 and 85/2005: http://www.alims.sr.gov.yu/eng/ regulativa/zakon.php MOH: 1. Regulation on the Conditions and Manner of Clinical Testing of Medicinal Products, Procedure and Contents of Documentation for Authorizing Clinical Trials of Medicinal Products No. 19/2007: http://www.alims.sr.gov.yu/eng/r egulativa/pravilnici_l.php 2. Regulation on Changes of the Regulation on Conditions and Manner of Clinical Testing of Medicinal Products, Procedure and Contents of Documentation for Authorizing Clinical Trials of Medicinal Products No.

44/2009 Slovak Republic Note: For an overview of human subject protections in the Slovak Republic, see “National Regulations on Ethics and Research in Slovak Republic:” http://ec.europa.eu/research/sci ence-society/pdf/sk_eng_lr.pdf http://www.eurecnet.org/information/slovakia.html Country Key Organizations General 1. Ministry of Health (Slovak): http://www.health.gov.sk/ 2. Institute of Medical Ethics and Bioethics: http://www.bioethics.sk/ 1. Act No. 576/2004 Coll., as amended by Act No. 282/2006 Coll. 2004 law: http://www.privireal.org/content /rec/documents/Slovakia_ActNo 576_Healthcare_2004.pdf 2.

Oviedo Convention on Human Rights and Biomedicine (1998) 3. Additional Protocol on Biomedical Research (2005) 71 Country Key Organizations Legislation Regulations Guidelines Drugs State Institute for Drug Control (Slovak): http://www.sukl.sk/ Act on Drugs and Medical Devices No. 140/1998, Coll., as amended by Act No. 545/2006 Ministerial Regulation No. 239/2004 Coll. on Requirements for Clinical Trials and Good Clinical Practice (2004) Privacy/Data Protection Office for Personal Data Protection: http://www.dataprotection.gov.sk/bux us/generate_page.php3?page_id=413 Act No. 428/2002 Coll. on Protection of Personal Data, as Amended (2005): http://www.privireal.org/content /dp/documents/SlovakiaAct428_ 2002%20_2005_PersonalData.p df Human Biological Materials Sections 35-39.

Embryos, Stem Cells, and Cloning 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 (1998) Slovenia Note: For an overview of human subject protections in Slovenia, see “National Regulations on Ethics and Research in Slovenia:” http://ec.europa.eu/research/science- society/pdf/sl_eng_lr.pdf Country Key Organizations General Human Rights and Biomedicine (1998) 2. Additional Protocol on Biomedical Research (2006) Articles 47-50 (1992) 72 Country Key Organizations Legislation Regulations Guidelines Drugs 1.

National Medical Ethics Committee (NMEC) 2. Agency for Medicinal Products and Medical Devices (Slovenian): http://www.jazmp.si/index.php?id=56 NMEC: 1. Ministerial Decree No. 30 (1995) 2. Statutory Notes (1998) 3. Slovenian Directive on Clinical Drug Testing No. 67.8372-8385 (2000) 4. On the Ethical Review of Phase IV Clinical Studies (2003) (Slovenian): http://www.mf.uni- lj.si/kme- nmec/Docu/Ocenjevanje_klin_stu dij_IV_faze.pdf Privacy/Data Protection Inspectorate for Personal Data Protection (Slovenian): http://www.ip-rs.si/ 1. Personal Data Protection Act No. 59 (1999) 2. Act Amending the Personal Data Protection Act No.

57/2001 Human Biological Materials National Medical Ethics Committee (NMEC) Corpse Which are not Part of the Routine Autopsy and on Handling with Biologic Material of Human Origin (2004) Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999) Embryos, Stem Cells, and Cloning 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 (2002) http://conventions.coe.int/Treaty /en/Treaties/Html/168.htm 2. Law on Biomedically Assisted Fertilization No.

70 (2000) 73Spain Note: For an overview of human subject protections in Spain, see “National Information – Spain”: http://www.eurecnet.org/information/spain.html Country Key Organizations General 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang =en_US 2. Coordinating Center for Ethical Committees on Clinical Research (Spanish): http://www.msc.es/profesionales/far macia/ceic/home.htm 1. Oviedo Convention on Human Rights and Biomedicine (1999) 2. Law 14/2007 on Biomedical Research: http://www.catedraderechoygen omahumano.es/images/novedad es/SpanishLawonBiomedicalRe searchEnglish.pdf Drugs Note: Many of the Spanish autonomous communities have their own laws and regulations pertaining to drug research.

Spanish Agency for Medications and Health Products, Clinical Trials (Spanish): http://www.agemed.es/profHumana/e nsayosClinicos/home.htm Royal Decree 223/2004: Regulation of Medication Clinical Trials (Spanish): http://www.agemed.es/actividad /legislacion/espana/ensayos.htm 1. Order SCO/256/2007 That Establishes the Principles and Detailed Directives on Good Clinical Practice, and the Requirements to Approve the Manufacture and Import of Research Medications for Human Use (Spanish): http://www.agemed.es/actividad/l egislacion/espana/ensayos.htm 2. Order SCO/362/2008 that Modifies Order SCO/256/2007 (Spanish): http://www.agemed.es/actividad/l egislacion/espana/ensayos.htm Privacy/Data Protection Note: Many of the Spanish autonomous communities have their own laws and regulations on privacy/data protection.

Spanish Data Protection Authority (Spanish): https://www.agpd.es/po rtalweb/index -ides-idphp.php 1. Organic Law 15/1999 of December 13 on the Protection of Personal Data: https://www.agpd.es/upload/Ley %20Org%E1nica%2015- 99_ingles.pdf 2. Law 14/2007 on Biomedical Research, Title I, Article 5: http://www.catedraderechoygen omahumano.es/images/novedad es/SpanishLawonBiomedicalRe searchEnglish.pdf 74 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Ministry of Health and Consumption: http://www.msc.es/en/home.htm 1. Royal Decree 1301/2006 of November 10 Regarding the Use of Cells and Human Tissue: http://www.ont.es/legislacion/fic herosPDF/RD1301.pdf 2.

Royal Decree 2070/1999 of December 30, Regarding Activities of Collection and Clinical Use of Human Organs for Organ Transplants and Tissues 3. Law 14/2007 of July 3 on Biomedical Research, Title I, Article 11; Title III, Article 37; Title V: http://www.catedraderechoygen omahumano.es/images/novedad es/SpanishLawonBiomedicalRe searchEnglish.pdf Royal Decree 65/2006 of Requirements for the Import and Export of Biological Samples (2006) Genetic Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang =en_US Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V: http://www.catedraderechoygen omahumano.es/images/novedad es/SpanishLawonBiomedicalRe searchEnglish.pdf 75 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang =en_US 1.

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 (2000) 2. Law 14/2006 on Methods of Assisted Human Reproduction, Chapters IV and V: http://www.eshre.com/ESHRE/ English/Legal-Matters-and- Guidelines/Legal- documentation/Spain/page.aspx/ 170 3. Law 14/2007 of July 3 on Biomedical Research, Title III: http://www.catedraderechoygen omahumano.es/images/novedad es/SpanishLawonBiomedicalRe searchEnglish.pdf 76Sweden Note: For an overview of human subject protections in Sweden, see “CODEX: Rules and Guidelines for Research:” http://www.codex.uu.se/en/index.shtml Country Key Organizations General 1.

Central Ethical Review Board (CEPN): http://www.epn.se/start/startpage.asp x 2. Swedish Research Council (SRC): http://www.vr.se/english Law No. 460 on the Ethical Review of Research Involving Humans (2003) CEPN: 1. Ordinance No. 615 Concerning the Ethical Vetting of Research Involving Humans (2003) 2. Statute No. 2007:1069 Containing Instructions for Regional Ethical Review Boards (2007) 3. Statute No. 2007:1068 Containing Instructions for the Central Ethical Review Boards (2007) CEPN: Information for Research Participants SRC: 1. Ethical Guidelines of Epidemiological Research (1994) 2. Guidelines for Good Medical Research (1996) 3.

Guidelines for the Ethical Evaluation of Medical Research on Humans (2003) 4. Policy Statement Regarding the Assessment of Scientific Studies in which Patients or Healthy Subjects are to Undergo Invasive Operations (2003) Drugs Medical Products Agency: http://www.lakemedelsverket.se/Tpl/ StartPage____395.aspx Pharmaceuticals Act No. 1992: 859 (Swedish): http://www.notisum.se/rnp/SLS/ LAG/19920859.HTM 1. Medical Products Agency’s Provisions and Guidelines on the Clinical Trials of Medicinal Products (1996): http://www.lakemedelsverket.se/u pload/foretag/humanlakemedel/K linisk%20pr%c3%b6vning/Provis ions%20and%20guidelines%20o n%20clinical%20trials%201996- 17.pdf 2.

Medical Product Agency’s Provisions and Guidelines on Clinical Trials of Medicinal Products for Human Use (2003): http://www.lakemedelsverket.se/u pload/foretag/humanlakemedel/K linisk%20pr%c3%b6vning/Provis ions%20and%20guidelines%20o n%20clinical%20trials%202003- 11.pdf 77 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Swedish Data Inspection Board: http://www.datainspektionen.se/in- english/ 1. Personal Data Act No. 204 (1998): http://www.datainspektionen.se/ pdf/ovrigt/pul-eng.pdf 2004:2 Human Biological Materials 1. National Board of Health and Welfare (SOS): http://www.socialstyrelsen.se/english 2.

Swedish Research Council (SRC): http://www.vr.se/english 3. Swedish National Biobank Program: http://www.biobanks.se/ 2. Biobanks in Medical Care Act No. 297 (2002): http://www.sweden.gov.se/conte nt/1/c6/02/31/26/f69e36fd.pdf SOS: 1. Regulation No. 746 (2002) 2. SOSFS No. 11 (2002) 3. SOSFS No. 2 (2004) SRC: Research Ethics Guidelines for Using Biobanks (2003) Genetic Research 1. Ministry of Health and Social Affairs: http://www.sweden.gov.se/sb/d/2061 2. National Board of Health and Welfare: http://www.socialstyrelsen.se/english Act on Genetic Integrity (2006:351) (Swedish): http://www.notisum.se/rnp/sls/la g/20060351.htm Health Care: State of the Art and Guidelines for Ethical Considerations (1999) Embryos, Stem Cells, and Cloning (2006:351) (Swedish): http://www.notisum.se/rnp/sls/la g/20060351.htm Legal Regulation of Stem Cell Research 2002:119: http://www.regeringen.se/sb/d/10 8/a/2717 Switzerland Note: For an overview of human subject protections in Switzerland, see “National Information – Switzerland:” http://www.eurecnet.org/in form ation/switzerland.html Country Key Organizations General Note: Many Swiss cantons have implemented pertinent regulations (French): http://www.swisseth ics.ch/fileadmin/user _upload/Dokumente/ f_RegelungenKant.d oc 1.

Swiss Academy of Medical Sciences (SAMS): http://www.samw.ch/ 2. Swiss National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek- cne.ch/?langId=2 3. Swiss Ethics Committees for Research: http://www.swissethics.ch/fileadmin/ se/swissethics_en.htm 1. Guidelines on Human Research (1997) 2. Memorandum Concerning Research on Human Beings (2009) 78 Country Key Organizations Legislation Regulations Guidelines Drugs Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html ?lang=en Federal Law on Medicinal Products and Medical Devices (2002) Ordinance on Clinical Trials of Therapeutic Products, RS 812.214.2 (2004): http://www.swissmedic.ch/files/p df/VKlin%20_e_%202005-03- 14.pdf Privacy/Data Protection Note: Many Swiss cantons have enacted laws regarding data collection in the public sector.

Federal Data Protection Commissioner: http://www.edoeb.admin.ch/index.ht ml?lang=en 1. Federal Law on Data Protection (1992) (French): http://www.admin.ch/ch/f/rs/c23 5_1.html 2. Regulation of June 14, 1993 Regarding the Release of Professional Secrets in the Area of Medical Research, RS 235.154 (French): http://www.admin.ch/ch/f/rs/235 _154/index.html 3. Confidentiality in Medical Research (2006) (French): http://www.admin.ch/ch/f/rs/311 _0/a321bis.html Human Biological Materials Swiss Academy of Medical Sciences (SAMS): http://www.samw.ch/ Utilization of Human Biological Material (2006) Genetic Research 1.

Swiss Academy of Medical Sciences: http://www.samw.ch/ 2. Swiss Society of Medical Genetics: http://www.ssgm.ch/ Swiss Federal Constitution, Article 119 (2006): http://www.oefre.unibe.ch/law/i cl/sz00000_.html Ordinance on Clinical Trials of Therapeutic Products RS 812.214.2, Section 2 (2004): http://www.swissmedic.ch/files/p df/VKlin%20_e_%202005-03- 14.pdf 79 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Swiss National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.bag.admin.ch/nek- cne/04236/index.html?lang=en 1. Pre-Implantation Genetic Diagnosis, Opinion No.

10/2005 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007: http://www.bag.admin.ch/nek- cne/04229/04232/index.html?lang=en Turkey Note: For an overview of human subject protections in Turkey, see “National Regulations on Ethics and Research in Turkey:” http://ec.europa.eu/research/science- society/pdf/tr_eng_lr.pdf Country Key Organizations General Ministry of Health (Turkish): http://www.saglik.gov.tr/ 1. Turkish Constitution, Article 17 2. Health Services Basic Law No. 3359 (1987) 3. Oviedo Convention on Human Rights and Biomedicine (2004) 1.

Regulation on Medical Deontology, Article 11 (1960) 2. Bylaw on Patient Rights No. 23420 (1998) Drugs Ministry of Health (Turkish): http://www.saglik.gov.tr/ Turkish Penal Law, Article 90 (2005) 1. Bylaw on the Evaluation and Monitoring of the Safety of Medical Products (2005) 2. Regulation Regarding the Implementation and Inspection of the Support for Research and Development Activities (2008) 3. Regulation Regarding Clinical Trials (2008) Access: Many of these documents are available on the website of the Turkish Clinical Research Association: http://www.clinicstr.org/ GCP Guideline (2009) Access: http://www.clinicstr.org/ 80 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Preservation, Grafting, and Transplantation of Organs and Tissues, No.

2238 (1979) 2. Law on Blood and Blood Products, No. 2857 (1983) Regulation on Blood and Blood Products, No. 7314 (1983) Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999) Genetic Research Diagnosis and Genetic Diseases, No. 23368 (1998) Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999) Embryos, Stem Cells, and Cloning Medically Assisted Procreation, No. 19551 (1987) 2. Regulation on Organ and Tissue Transplantation Services (2005) 3. Regulation on Cordon Blood Banks (2005) 1. Circular on Research of Embryonic Stem Cells (2005) 2.

Guideline on Clini cal Research of Non- Embryonic Stem Cells (2006) 81Ukraine Note: For an overview of human subject protections in the Ukraine, see “Ethical Review of Biomed ical Research in the CIS Countr ies,” Chapter 3, Section 10: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.p d f Country Key Organizations General 1. Ethical Commission with the Higher Education Committee (EC- HEC) 2. Ukrainian Ministry of Health: http://www.moz.gov.ua/en/ EC-HEC: Order of this Committee for Requirements of Ethical Review of All Dissertation Theses on Science, Degree in Biology, Medicine, and Veterinary Medicine (2005) MOH: 1.

Order No. 485 About Creation and Composition of Central Ethics Committee of Ministry of Health of the Ukraine (2006) (Ukrainian): http://www.moz.gov.ua/ua/main/ docs/?docID=6893 2. Order No. 142 About Optimization of Work of Central Ethics Committee of Ministry of Health of the Ukraine (2007) (Ukrainian): http://www.moz.gov.ua/ua/main/ docs/?docID=7989 82 Country Key Organizations Legislation Regulations Guidelines Drugs 1. State Pharmacological Center: http://www.pharma- center.kiev.ua/view/all_information 2. Ukrainian Ministry of Health, Central Ethics Committee: http://www.moz.gov.ua/en/main/siter ubr/ On Medicines, Articles 7 and 8 No.

123/96 ВР (1996): http://www.pharma- center.kiev.ua/site/file_uploads// en/new_doc/law_en.doc 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines (2009) (Ukrainian): http://www.moz.gov.ua/ua/main/ docs/?docID=12796 2. Ukrainian Ministry of Health Order No. 66 About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committee (2006): http://www.pharma- center.kiev.ua/site/file_uploads//e n/new_doc/66_p.doc MOH Central Ethics Committee: 1.

Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006) 2. Ethics Expertise of Clinical Trials Medicines (2007) 3. Methodological Aspects of Central EC Activity of Ukrainian Ministry of Health (2007) 4. Ethical Aspects of Placebo Controlled Clinical Trials in Patients with MS (2008) 5. Optimization of Local Ethics Committee Activities (2009) Privacy/Data Protection Cabinet of Ministers of the Ukraine (2002) Human Biological Materials Ukrainian Ministry of Health: http://www.moz.gov.ua/en/main/siter ubr/ Ukrainian Ministry of Health Order No. 630 About Approval of Procedure for Conduction Clinical Trials of Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007) (Ukrainian): http://www.moz.gov.ua/ua/main/ docs/?docID=8767 Genetic Research Academy of Medical Sciences of the Ukraine Genetic Investigations in Humans 83 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

National Bioethics Committee of the National Academy of Sciences of the Ukraine (NBC) 2. Ukrainian Ministry of Health: http://www.moz.gov.ua/en/main/siter ubr/ 1. About the Ban of Human Reproductive Cloning (2004) 2. About Organs and Other Human Materials Transplantology No. 1007-XIV (2007) 1. Recommendation No. 1046, Use of the Human Fetus for the Purpose of Diagnosis, Therapy, Research, Industrial Purchase, and Trading (1986) 2. Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007) (Ukrainian): http://www.moz.gov.ua/ua/main/ docs/?docID=8767 NBC: Ethical Regulations and Problems of Embryo-Tissue Storage (Recommendations) 84United Kingdom Note: Unless otherwise noted, all laws, regulations, and guidelines listed for England apply to the entire United Kingdom.

England Country Legislation Regulations General 1. Department of Health (DH): http://www.dh.gov.uk/Home/fs/en 2. National Research Ethics Service (NRES): http://www.nres.npsa.nhs.uk/home 3. Medical Research Council (MRC): http://www.mrc.ac.uk/PolicyGuidanc e/EthicsAndGovernance/index.htm 4. Royal College of Physicians: http://www.rcplondon.ac.uk/ 5. Association of Research Ethics Committees: http://www.arec.org.uk/ 6. Appointing Authority for Phase 1 Ethics Committees (AAPEC) http://www.aapec.org.uk/ 7. Economic and Social Research Council (ESRC): http://www.esrc.ac.uk/ Mental Capacity Act 2005, Sections 30-34 (England and Wales): http://www.opsi.gov.uk/acts/act s2005/20050009.htm DH: 1.

Governance Arrangements for NHS Research Ethics Committees (2001) http://www.dh.gov.uk/en/Publicationsands tatistics/Publications/PublicationsPolicyA ndGuidance/DH_4005727 2. Research Governance Framework for Health and Social Care (2005) http://www.dh.gov.uk/en/Publicationsands tatistics/Publications/PublicationsPolicyA ndGuidance/DH_4108962 85 Country Legislation Regulations Guidelines General 1. NRES Guidance on Information Sheets and Consent Forms (2007) 2. NRES Guidance on Research Involving Adults Unable to Consent for Themselves (Including Guidance on the Mental Capacity Act 2005) (2007) 3.

Guidance for Applicants to NRES (2007) 4. Standard Operating Procedures for Research Ethics Committees in the United Kingdom (2008) 5. NRES Leaflets (2008):  Building on Improvement  Research Ethics Timeline  Defining Research  Explaining Research Integrated Research Application System (2008): https://www.myresearch project.org.uk/ MRC: 1. MRC Guidelines for Good Clinical Practice in Clinical Trials (1998) 2. Good Research Practice (2000) 3. Personal Information in Medical Research (2000) 4. Research Involving Human Participants in Developing Societies (2004) 5. Medical Research Involving Children (2004) RCP: Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants (2007) ESRC: Research Ethic s Fram ework 86 Country Legislation Regulations Guidelines Drugs 1.

Medicines and Healthcare Products Regulatory Agency (MHRA): http://www.mhra.gov.uk 2. Medical Research Council (MRC): http://www.mrc.ac.uk/index.htm 3. National Research Ethics Service (NRES): http://www.nres.npsa.nhs.uk/home Medicines Act (1968): http://www.legislation.gov.uk/R evisedStatutes/Acts/ukpga/1968/ cukpga_19680067_en_1 MHRA: 1. The Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031 (2004): http://www.uk- legislation.hmso.gov.uk/si/si2004 /20041031.htm 2. Amendment Regulations (SI 2006/1928) http://www.opsi.gov.uk /si/si2006/ 20061928.htm 3. Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and Adults with Incapacity (Scotland) Act 2000 to Facilitate Clinical Research in Emergency Settings (SI 2006/2984): http://www.opsi.gov.uk /si/si2006/ 20062984.htm MHRA: Consultation Letter on the Medicines for Human Use (Clinical Trials) Regulations (2003) MRC: 1.

MRC Guidelines for Good Clinical Practice in Clinical Trials (1998) 2. MRC Policy on Antiretroviral Therapy for People Infected with HIV and Involved in AIDS Research in Developing Countries (2003) NRES: Memorandum of Understanding between MHRA, COREC, an d GTAC (2006) http://www.nres.npsa.nhs.uk/rec- community/guidance/ Privacy/Data Collection 1. Medical Research Council (MRC): http://www.mrc.ac.uk/index.htm 2. Information Commissioner Office: http://www.informationcommissioner .gov.uk/ 3. National Research Ethics Service (NRES): http://www.nres.npsa.nhs.uk/home Data Protection Act (1998): http://www.opsi.gov.uk/acts/act s1998/19980029.htm A number of Statutory Instruments have been developed to implement the Data Protection Act: http://www.dca.gov.uk/ccpd/dps ubleg.htm MRC: Personal Information in Medical Research (2000) NRES: Ethical Review of Research Databases (2008): http://www.nres.npsa.nhs.uk/rec- community/guidance/#useofpersonaldata NHS Information Governance: Security of NHS Patient Data Shared for Research Purposes (2008): http://www.connectingforhealth.nhs.uk/sy stemsandservices/infogov/whatsnew 87 Country Legislation Regulations Guidelines Human Biological Materials 1.

Royal College of Physicians (RCP): http://www.rcplondon.ac.uk/index.as p 2. Medical Research Council (MRC): http://www.mrc.ac.uk/index.htm 3. Department of Health (DH): http://www.dh.gov.uk/Home/fs/en 4. Human Tissue Authority (HTA): http://www.hta.gov.uk/ 1. Human Tissue Act (2004): http://www.opsi.gov.uk/acts/act s2004/20040030.htm 2. Statutory Instrument 2006 No. 1260: The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006: http://www.opsi.go v.uk/si/si200 6/20061260.htm 3. Statutory Instrument 2006 No. 1659: The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006: http://www.opsi.go v.uk/si/si200 6/20061659.htm RCP: Research Based on Archived Information and Samples (1999) MRC: Human Tissue and Biological Samples for Use in Research (2001) + Annex (2004) DH: The Use of Human Organs and Tissue: An Interim Statement (2003): http://www.nres.npsa.nhs.uk/docs/guidanc e/MoU.pdf HTA: Codes of Practice 2006 Genetics Research 1.

Advisory Committee on Genetic Testing (ACGT): http://www.advisorybodies.doh.gov.u k/genetics/acgt/ 2. Public Health Genetics Unit: http://www.phgu.org.uk/index.php Advice to Research Ethics Committees (1998) Embryos, Stem Cells, and Cloning Human Fertilisation and Embryology Authority: http://www.hfea.gov.uk/ Human Fertilisation and Embryology Act (1990): http://www.opsi.gov.uk/acts/act s1990/Ukpga_19900037_en_1.h tm Human Fertilisation and Embryology (Research Purposes) Regulation (2001) 88Northern Ireland: Country Key Organizations Legislation Regulations Guidelines General Northern Ireland Health and Personal Social Services: http://www.dhsspsni.gov.uk/ Health and Social Care (2002) Scotland: Country Key Organizations Legislation Regulations Guidelines General NHSScotland, Chief Scientist Office: http://www.show.scot.nhs.uk/cso/ Adults with Incapacity (Scotland) Act 2000, Section 51: http://www.opsi.gov.uk/legislati on/scotland/acts2000/20000004. htm Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002): http://www.scotland- legislation.hmso.gov.uk/legislatio n/scotland/ssi2002/20020190.htm Research Governance Framework for Health and Community Care (2006) Privacy/Data Collection NHSScotland: http://www.show.scot.nhs.uk/ Wales: Country Key Organizations Legislation Regulations Guidelines General Wales Office of Research and Development for Health and Social Care: http://wales.gov.uk/topics/health/rese arch/word/?lang=en Health and Social Care in Wales (2001) 89ASIA/PACIFIC/MIDDLE EAST Australia Country Key Organizations Legislation Regulations Guidelines General National Health and Medical Research Council, Australian Health Ethics Committee: http://www.nhmrc.gov.au/about/com mittees/ahec/index.htm Australian Research Council http://www.arc.gov.au/ National Health and Medical Research Council Act (1992): http://www.comlaw.gov.au/Co mLaw/Legislation/ActCompilati on1.nsf/all/search/4AFACF8FA AF9ED97CA25719C0081EF9F National Health and Medical Research Regulations (2006): http://www.comlaw.gov.au/Com Law/Legislation/LegislativeInstru ment1.nsf/all/search/CD6C81A81 3A14BCCCA257211000E4F9D 1.

Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003) 2. Keeping Research on Track: A Guide for Aboriginal and Torres Strait Islander Peoples about Health Research Ethics (2006) 3. National Statement on Ethical Conduct in Human Research (2007) 4. Australian Code for the Responsible Conduct of Research (2007) Drugs Therapeutic Goods Administration: http://www.tga.gov.au/ct/index.htm Therapeutic Goods Act (2009): http://www.comlaw.gov.au/Co mLaw/Legislation/ActCompilati on1.nsf/all/search/89DC85FBD 2CF7799CA25762C000A762F Therapeutic Goods Regulations (1991) http://www.comlaw.gov.au/Com Law/Legislation/LegislativeInstru mentCompilation1.nsf/all/search/ AC1C41C98B71506ACA257631 002F4B15 1.

Human Research Ethics Committees and the Therapeutic Goods Administration (2001) 2. Australian Clinical Trial Handbook (2006) http://www.tga.gov.au/ct/cthandbook.htm Privacy/Data Protection Note: All the Australian states and territories have privacy/data protection laws: http://www.austlii.ed u.au/au/other/alrc/pu blications/reports/10 8/vol_3_full.pdf Office of the Privacy Commissioner: http://www.privacy.gov.au/ Privacy Act No. 119 (2009): http://www.comlaw.gov.au/com law/Legislation/ActCompilation 1.nsf/all/search/8039E7AB4B89 A16ACA25760700060E24 Privacy (Private Sector) Regulations (2001): http://www.comlaw.gov.au/Com Law/Legislation/LegislativeInstru mentCompilation1.nsf/all/search/ C46A983B1C8AA3DFCA25760 A00097BFE 90 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Note: All the Australian states and territories have laws on the use of human biological materials.

National Health and Medical Research Council, Australian Health Ethics Committee: http://www.nhmrc.gov.au/about/com mittees/ahec/index.htm Human Research (2007): Chapters 3.2 and 3.4 Genetic Research 1. National Health and Medical Research Council, Australian Health Ethics Committee (AHEC): http://www.nhmrc.gov.au/about/com mittees/ahec/index.htm 2. Office of the Gene Technology Regulator: http://www.ogtr.gov.au/ Gene Technology Act (2000): http://www.comlaw.gov.au/Co mLaw/Legislation/ActCompilati on1.nsf/all/search/51A2449A3E BB9A1CCA257475001ECD9C AHEC: National Statement on Ethical Conduct in Human Research, Chapter 3.5 (2007) Embryos, Stem Cells, and Cloning 1.

National Health and Medical Research Council, Australian Health Ethics Committee (AHEC): http://www.nhmrc.gov.au/about/com mittees/ahec/index.htm 2. National Health and Medical Research Council: Embryo Research Licensing Committee http://www.nhmrc.gov.au/about/com mittees/lc/index.htm 1. Prohibition of Human Cloning Act (2008): http://www.comlaw.gov.au/Co mLaw/Legislation/ActCompilati on1.nsf/all/search/ED63FF59CF EBB728CA2575280008CFC5 2. Research Involving Human Embryos Act (2008): http://www.comlaw.gov.au/Co mLaw/Legislation/ActCompilati on1.nsf/all/search/535F95A0A6 D118AACA25752700811D2E Research Involving Human Embryos Regulations (2003): http://www.comlaw.gov.au/Com Law/Legislation/LegislativeInstru mentCompilation1.nsf/all/search/ 53B9DAE14F396A2CCA25744E 0005E313 AHEC: 1.

National Statement on Ethical Conduct in Human Research, Chapter 3.6 (2007) 2. Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007) Bangladesh Country Key Organizations Legislation Regulations Guidelines General Bangladesh Medical Research Council, Ethics Review Committee: http://www.bmrcbd.org Drugs Bangladesh Directorate of Drug Administration: http://www.ddabd.org 1. The Drugs Act (1964) 2. Drugs (Control) Ordinance 1982, Ordinance No. VIII: http://www.ddabd.org/ordinance _1982.htm 91 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Bangladesh Medical Research Council, Ethics Review Committee: http://www.bmrcbd.org Biological Materials Abroad for Research Purposes (2004) Burma (Myanmar) Country Key Organizations Legislation Regulations Guidelines General 1.

Ministry of Health National Ethics Committee on Clinical Research: www.moh.gov.mm 2. Department of Medical Research (DMR) DMR: Operational Guidelines for Institutional Ethical Review Committee (2005) China, People’s Republic of Country Key Organizations Legislation Regulations Guidelines General 1. Ministry of Health (MOH) (Mandarin): http://www.moh.gov.cn/ 2. Chinese Association for Science and Technology (CAST) 3. Ministry of Science and Technology Law on Practicing Doctors (June 26, 1998), Articles 26 and 37 MOH: Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2007) (Mandarin): http://www.moh.gov.cn/publicfiles/busine ss/htmlfiles/mohkjjys/s3581/200804/1881 6.htm CAST: Moral Standards for Scientists (2007) 92 Country Key Organizations Legislation Regulations Guidelines Drugs State Food and Drug Administration: http://www.sfda.gov.cn/ Drug Administration Law (2001) 1.

Implementation Bylaws for the Drug Administration Law (2002) (Mandarin) http://www.moh.gov.cn/publicfile s/business/htmlfiles/mohyzs/s357 2/200804/18293.htm 2. Chinese Good Clinical Practice (2003) (Mandarin): http://www.sfda.gov.cn/WS01/C L0053/24473.html 3. Regulation on Drug Registration (2007) (Chinese): http://www.sda.gov.cn/WS01/CL 0053/24529.html 4. Qualification and Evaluation of Clinical Trial Sites (2008) (Chinese): http://www.sfda.gov.cn/WS01/C L0121/29571.html 1. Guideline for HIV Vaccine Research Technology (2003) (Mandarin): http://www.sfda.gov.cn/WS01/CL0237/15 705.html 2. Guideline for Vaccine Research Technology (2004) (Mandarin): http://www.sfda.gov.cn/WS01/CL0055/10 307.html Human Biological Materials Ministry of Health (Mandarin): http://www.moh.gov.cn/ Genetic Research 1.

Ministry of Health (MOH) (Mandarin): http://www.moh.gov.cn/ 2. Ministry of Science and Technology (MOST) Interim Measures for the Administration of Human Genetic Resources (1998) 93 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1. Ministry of Health (MOH) (Mandarin): http://www.moh.gov.cn/ 2. Ministry of Science and Technology (MOST) MOH: 1. Ethical Principles and Conduct Norms for Human Assisted Reproductive Technologies. (2003) 2. Regulation on Medical Technique (2009) http://www.moh.gov.cn/publicfile s/business/htmlfiles/zwgkzt/pyzgl /200903/39511.htm MOH and MOST: Ethical Guideline for Research on Human Embryo Stem Cells (2004) Hong Kong Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Privacy Commissioner for Personal Data: www.pco.org.hk Personal Data (Privacy) Ordinance (1996): http://www.pco.org.hk/english/o rdinance/ordfull.html Embryos, Stem Cells, and Cloning Government of the Hong Kong Special Administrative Region Ordinance, Chapter 561 (2002): http://www.hklii.org.hk/hk/legis/o rd/561/ India Country Key Organizations Legislation Regulations Guidelines General 1.

National Committee for Ethics in Social Science Research in Health (NCESSRH) 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/human_ethics. htm Ethical Guidelines for Social Science Research (2000) ICMR: Ethical Guidelines for Biomedical Research on Human Participants (2006) 94 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/human_ethics. htm Drugs and Cosmetics Act, Schedule Y (2005) DCGI: Good Clinical Practices for Clinical Research in India (2001): http://cdsco.nic.in/html/GCP.htm ICMR: Ethical Guidelines for Biomedical Research on Human Subjects: Statement of Specific Principles for Clinical Evaluation of Drugs/Devices/Diagnostics/ Vaccines/Herbal Remedies (2006) Genetic Research 1.

Department of Biotechnology (DBT): http://dbtindia.nic.in/ 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/human_ethics. htm Environmental Protection Act 1. Recombinant DNA Safety Guidelines (1990) 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002) ICMR: Ethical Guidelines for Biomedical Research on Human Subjects: Statement of Specific Principles for Human Genetics and Genomics Research (2006) Embryos, Stem Cells, and Cloning 1. Department of Biotechnology (DBT): http://dbtindia.nic.in/ 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/human_ethics. htm Guidelines for Stem Cell Research and Therapy (2007): http://icmr.nic.in/stem_cell/Stem_cell_gui delines.pdf Indonesia Country Key Organizations Legislation Regulations Guidelines General Ministry of Health, National Institute of Health Research and Development Indonesian Health Act No.

23/1992 Section on Health Research, Article 69 Regulation No. 39/1995 on Health Research & Development National Guidelines on Ethics in Health Research (2003) Drugs Indonesian FDA Practice (2001) 95 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Stored Biological Materials (2005) Iran Country Key Organizations Legislation Regulations Guidelines General Ministry of Health and Medical Education, Office for the Study of Humanistic and Islamic Science in Medicine and Medical Ethics: http://www.mohme.gov.ir/ Subjects in Medical Research (1999) Israel Country Key Organizations Legislation Regulations Guidelines General Ministry of Health: http://www.health.gov.il/english/ Public Health Regulations (Medical Experiments Involving Human Subjects) (1999) (Hebrew): http://www.health.gov.il/pages/de fault.asp?maincat=11&catid=301 &pageid=2203 96 Country Key Organizations Legislation Regulations Guidelines Drugs Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/english/Page s_E/default.asp?maincat=10 Public Health Order (1940) (Clinical Studies in Human Subjects) – 1980 (Hebrew): http://www.health.gov.il/downloa d/forms/a365_si12r_81.pdf 2.

1990 Amendment (Hebrew): http://www.health.gov.il/downloa d/forms/a1962_mr98_90.pdf 3. 1992 Amendment (Hebrew): http://www.health.gov.il/downloa d/forms/a2117_mr23_92.pdf 4. 2005 Amendment (Hebrew): http://www.health.gov.il/downloa d/forms/a2672_mk07_05.pdf Guidelines for Clinical Trials in Human Subjects (2006) (English): http://www.health.gov.il/Download/pages/ GuidelinesforClinicalTrials.doc Privacy/Data Protection Israeli Law and Information Technologies Authority 1. Privacy Protection Act No. 5741 (1981) (Hebrew): http://www.itpolicy.gov.il/topics _security/privacy.htm 2. Protection of Privacy Law No.

5741, as Amended by Law No. 5745 (1985) Genetic Research Ministry of Health: http://www.health.gov.il/english/ Genetic Information Law (2000) (Hebrew): http://www.moital.gov.il/NR/ex eres/66F4DD4E-FA4A-4B76- 94BC-DC29543471DE.htm 1. The Instruction of the Supreme Committee for Clinical Studies on Humans Regarding Establishment and Usage of Genetic Samples Reservoir (2005) (Hebrew): http://www.health.gov.il/download/forms/ a2658_mk01_05.pdf 2. Amendment (2007) (Hebrew): http://www.health.gov.il/download/forms/ a3037_mk17_07.pdf Embryos, Stem Cells, and Cloning Genetic Intervention Prohibition Law (Human Cloning and Genetic Changes in Reproduction Cells) (1999) 97Japan Country Key Organizations Legislation Regulations Guidelines General 1.

Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/ 2. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index .html Ethics Guidelines for Epidemiological Research (2007) MHLW: Ethical Guidelines for Clinical Research (2008) (Japanese): http://www.mhlw.go.jp/general/seido/kou sei/i-kenkyu/index.html Drugs 1. Ministry of Health, Labor, and Welfare (MHLW) 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index. html Pharmaceutical Affairs Law, Article 80-2 (2006) MHLW: Good Clinical Practice Guidelines (2008) Privacy/Data Protection Consumer Affairs Agency (Japanese): http://www.caa.go.jp/index.html Personal Information Protection Act (2003) Human Biological Materials Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index .html Utilizing Human Tissues Removed by Surgery and Other Procedures (1998) (Japanese) http://www1.mhlw.go. j p/shingi/s9812/s12 16-2_10.html 2.

Guidelines for Quality Assurance and Safety of Medicines Manufactured from Human Cells and Tissues (2008) (Japanese): http://www.kuhp.kyoto- u.ac.jp/~ccmt/files/20080208.pdf 98 Country Key Organizations Legislation Regulations Guidelines Genetic Research 1. Council for Science and Technology (CST) 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT) 3. Ministry of Health, Labor, and Welfare (MHLW) 4. Ministry of Economy, Trade, and Industry (METI) CST: Fundamental Principles of Research on the Human Genome (2000): http://www.mext.go.jp/b_menu/shingi/kag aku/rinri/pri00614.htm MEXT, MHLW, and METI: Ethical Guidelines for Human Genome/Gene Analysis Research (2008) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/40_126.pdf MEXT and MHLW: Guidelines for Clinical Research in Gene Therapy (2008) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/6_7.pdf 99 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Council for Science and Technology Policy (CSTP): http://www8.cao.go.jp/cstp/english/in dex.html 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/ 3. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index .html Act on Regulation of Human Cloning Techniques (2000): http://www.cas.go.jp/jp/seisaku/ hourei/data/htc.pdf Rules for Enforcement of Act on Regulation of Human Cloning Techniques (2009) (Japanese): http://www.lifescience.mext.go.jp /files/pdf/29_224.pdf CSTP: Fundamental Philosophy on Handling of Human Embryo (2004) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/6_28.pdf MEXT: 1.

Guidelines for Handling of a Specified Embryo (2009) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/30_226.pdf 2. Guidelines for Derivation and Distribution of Human Embryonic Stem Cells (2009) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/56_229.pdf 3. Guidelines for Utilization of Human Embryonic Stem Cells (2009) (Japanese): http://www.lifescience.mext.go.jp/files/pd f/57_232.pdf Jordan Country Key Organizations Legislation Regulations Guidelines Drugs Jordan Food and Drug Administration: http://www.jfda.jo/en/default/ 1. Narcotic and Psychotropic Law No. 11 (1988) 2. Clinical Trial Law No.

67 (2001) 3. Pharmacy and Drug Law No. 80 (2001) 100Kazakhstan Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomed ical Research in the CIS Countri es,” Chapter 3, Section 5: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.pdf Country Key Organizations General Ministry of Health, Central Bioethics Commission (2007) Drugs Ministry of Health, Committee of Pharmacy (Kazakh): http://www.mz.gov.kz/ Drug Law (13.01.2004 No. 522- 2), Articles 19 and 20 (2004) (Kazakh): http://www.zakon.kz/ 1. Order 14.02.2005 No.

53 Instruction on the Conduct of Clinical Trials in Kazakhstan (2005) 2. Order 25.06.2007 # 442 Rules on Preclinical, Medico- Biological Experiments, and Clinical Trials in Kazakhstan (2007) Guidelines on Clinical Trials in Kazakhstan (2003) Privacy/Data protection Ministry of Health (Kazakh): http://www.mz.gov.kz/ Law on the Health Care System (4.06.2003 # 430-II) (2003) (Kazakh): http://www.zakon.kz/ 101Korea, South Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Public Administration and Security (MPAS): http://www.mopas.go.kr 2. Korea Food and Drug Administration (KFDA) (Korean): www.kfda.go.kr/ Pharmaceutical Affairs Act (No.

91235) Articles 10 and 31-34 (2008) MPAS: Enforcement Rule of Pharmaceutical Affairs Act No. 122, Articles 12, 22, 24, 29, 31- 34, 49, 62, 75, 76, and 94 (2009) KFDA: 1. Korean Good Clinical Practice. Public Notification of Food and Drug Administration, No. 2008- 39 (2008): Translation of 1999 version: http://www.lskglobal.com/english _htm/regulation/kgcp_00.htm 2. Guideline for Investigational New Drug Application: Public Notification No. 2008-32 (2008) Privacy/Data Protection Ministry of Public Administration and Security: http://www.mopas.go.kr Act on the Protection of Personal Information Maintained by Public Agencies No.

8871 (2008) Enforcement Rule of the Protection of Personal Information Maintained by Public Agencies No. 1 (2008) Genetic Research Ministry of Health, Welfare, and Family Affairs: http://english.mw.go.kr/ Bioethics and Safety Act, Articles 2, 6, 9, 24-43, 47, 48, 51-55 (2008) 1. Regulation for Human Risk Assessment of Genetically Modified Organisms. No. 2006- 81 (2006) 2. Enforcement Decree of Bioethics and Safety Act, Articles 2, 3, 13, 14-21, 27, and 28 (2008) 3. Guidance for Genetic Recombination Research No. 2009-150 (2009) Guidelines for Research Involving Recombinant DNA Molecules (1997) 102 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Ministry of Health, Welfare, and Family Affairs: http://english.mw.go.kr/ Bioethics and Safety Act, Articles 2, 18-21, 38, 41, and 45 (2008) 1.

Enforcement Decree of Bioethics and Safety Act, Articles 3, 12, and 19-2 (2008) 2. Enforcement Regulation of Bioethics and Safety Act, Articles 2, 7, and 13 (2008) Kuwait Country Key Organizations Legislation Regulations Guidelines General Ministry of Health, Kuwait Institute for Medical Specialization: http://www.kims.org.kw/ Ethical Guidelines for Biomedical Research (no date): http://www.kims.org.kw/Ethical%202.doc Kyrgyzstan Country Key Organizations Legislation Regulations Guidelines General 1. Ministry of Health (Russian): http://www.med.kg 2. National Bioethics Committee 1. Constitution of Kyrgyz Republic Chapter II, Article 19 (2007) 2.

Law on Protection of Citizens Health (09.01.2005 No. 6): Articles 34 and 73 (Russian): http://www.med.kg/MyFiles/Зак оны/Закон%20КР%20%20Об %20охране%20здоровья %20гр аждан%20в%20Кыргызской% 20Республике %20_1.rtf Drugs 1. Ministry of Health (Russian): http://www.med.kg / 2. Department of Drug and Medical Devices Provision (Russian): http://pharm.med.kg/ 3. National Bioethics Committee Drug Law of Kyrgyz Republic (30.04.2003 No. 91) Chapter VII, Articles 25-29 (2003) (Russian): http://www.med.kg/MyFiles/Зак оны/Закон%20КР%20%20О% 20лекарственных%20средства х%20.rtf Order of the Ministry of Health 16.03.2004 No.

120 on the Conduct of Medical Trials (2004) (Russian): http://pharm.med.kg/Docs/spisok. shtml?m=134&sm=134126 103 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials 1. Ministry of Health (Russian): http://www.med.kg / 2. National Bioethics Committee Law on Protection of Citizens Health in the Kyrgyz Republic (09.01.2005 No. 6): Article 39 Privacy/Data Protection 1. Ministry of Health (Russian): http://www.med.kg / 2. National Bioethics Committee Law on Protection of Citizens Health in the Kyrgyz Republic (09.01.2005 No. 6): Article 91 Nepal Country Key Organizations Legislation Regulations Guidelines General Nepal Health Research Council: http://www.nhrc.org.np/ Research in Nepal (2001): http://www.nhrc.org.np/guidelines/nhrc_et hicalguidelines_2001.pdf Drugs Nepal Health Research Council: http://www.nhrc.org.np/ with the Use of Pharmaceutical Products (2005): https://webapps.sph.harvard.edu/live/grem ap/files/np_pharmaceutical_trial_guidelin es.pdf 104New Zealand Country Key Organizations Legislation Regulations Guidelines General 1.

Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/ 2. National Ethics Advisory Committee (NEAC): http://www.neac.health.govt.nz/ 3. Ministry of Health (MOH): http://www.moh.govt.nz/ 4. Health and Disability Commissioner (HDC): http://www.hdc.org.nz/ 5. Health and Disability Ethics Committees: http://www.ethicscommittees.health.g ovt.nz/ 6. Ministry of Science, Research, and Technology (MoRST): http://www.morst.govt.nz/ 1. Health Research Council Act 1990, Sections 24 and 25 2. New Zealand Bill of Rights Act, Article 10 (1990) 3. Health and Disability Commissioner Act 1994 4.

New Zealand Public Health and Disability Act 2000, Section 16 5. Injury Prevention, Rehabilitation, and Compensation Act 2001 Access: All New Zealand laws can be found at: http://www.legislation.govt.nz/a ct/searchquick.aspx Then search for the name of the law under “Statutes of New Zealand.” HDC: The Code of Health and Disability Services Consumers’ Rights (the Code of Rights) (2004): http://www.hdc.org.nz/files/hdc/c ode-leaflet.pdf HRC: http://www.hrc.govt.nz/root/Publications/ Ethics_Reports_and_Guidelines.html : 1. Guidelines for Re searchers on Health Research Involving Māori (1998) 2. Guidelines on Ethics in Health Research (2005) 3.

Guidelines on Pacific Health Research (2005) NEAC: 1. Goals, Objectives, and Desired Outcomes of an Ethical Review System (2003) 2. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2006) MOH: Operational Standard for Ethics Committees (2006): http://www.moh.govt.nz/moh.nsf/pagesm h/4703/$File/operational-standard-for- ethics-committees-updated-edition.pdf 105 Country Key Organizations Legislation Regulations Guidelines Drugs 1. New Zealand Medicines and Medical Devices Safety Authority (Medsafe): http://www.medsafe.govt.nz 2. Researched Medicines Industry (RMI): http://www.rmianz.co.nz 3.

Health Research Council (HRC), Standing Committee on Therapeutic Trials: http://www.hrc.govt.nz/root/pages_re gulatory/Standing_Committee_on_Th erapeutic_Trials.html 1. Medicines Act 1981(2005) 2. Injury Prevention, Rehabilitation, and Compensation Act 2001, Section 32 (2008): Medsafe: New Zealand Regulatory Guidelines for Medicines, Vol. 3: Interim Good Clinical Research Practice Gu idelines (1998): http://www.medsafe.govt.nz/regulatory/G uideline/NZRGM%20Volume%203.asp RMI: Guidelines on Clinical Trials Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial (2008): http://www.rmianz.co.nz/compensation% 20guidelines%200808%20final.pdf Privacy/Data Protection Privacy Commissioner: http://www.privacy.org.nz/ 1.

Official Information Act 1982 (2009) 2. Public Records Act (2005) 3. Privacy Act 1993 (2006): http://www.legislation.govt.nz/a ct/public/1993/0028/latest/view pdf.aspx Health Information Privacy Code 1994: http://www.privacy.org.nz/assets/ Files/Codes-of-Practice- materials/Health-Information- Privacy-Code-1994-including- Amendment.pdf 106 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials 1. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/root/Ethics/Et hics%20Overview/HRC_Ethics_Com mittee.html 2. Human Specimen Ethical Guidelines Committee (HPEGC) 3.

Te Puni Kokiri (TPK): http://www.tpk.govt.nz/ 4. Office of the Health and Disability Commissioner (HDC): http://www.hdc.org.nz 5. Ministry of Research Science and Technology: http://www.morst.govt.nz/wayfinder/i ndex.asp 1. Health Act 1956 (2005) 2. Human Tissue Act 2008 Standards New Zealand: New Zealand Standard 8135: 2009: Non-Therapeutic Use of Human Tissue: http://www.standards.co.nz/web- shop/?action=basicShopSearch& mod=search&SearchBox1_txtSho pName=non+therapeutic+use+of +human+tissue&selStatus=CUR RENTANDDRAFT&catalog=NZ HPEGC: Ethical Guidelines for Human Specimen Collection, Storage, Use and Disposal: A Report to the New Zealand Department of Health (1992) TPK: Guidelines for the Removal, Retention, Return, and Disposal of Maori Body Parts.

(1999) MOH: Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007): http://www.moh.govt.nz/moh.nsf/pagesm h/6135/$File/guidelines-use-of-human- tissue-may07.pdf Genetic Research 1. Environmental Risk Management Authority: http://www.ermanz.govt.nz/ 2. Health Research Council (HRC), Gene Technology Advisory Committee: http://www.hrc.govt.nz/root/pages_re gulatory/Gene_Technology_Advisory _Committee.html Hazardous Substances and New Organisms Act 1996 (2008) HRC: Ethical Considerations Relating to Research in Human Genetics (2000): http://www.hrc.govt.nz/assets/pdfs/public ations/ethumangen.pdf 107 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning 1.

Advisory Committee on Assisted Reproductive Technology (ACART) http://www.acart.health.govt.nz/ 2. Ministry of Health http://www.moh.govt.nz/ 3. Ethics Committee on Assisted Reproductive Technology (ECART) http://www.ecart.health.govt.nz/ 4. Health and Disability Ethics Committees http://www.newhealth.gov t.nz/ethicsc ommittees/ Human Assisted Reproductive Technology Act 2004 (2009) ACART: http://www.acart.health.govt.nz/moh.nsf/i ndexcm/acart-resources-guidelines : 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000) 2. Guidelines on Preimplantation Genetic Diagnosis (2005) 3.

Guidelines on IVF Surrogacy (2005) 4. Guidelines on Within-Family Gamete Donation (2005) 5. Embryo Donation for Reproductive Purposes (2005) 6. Guidelines for Research on Gametes and Non-viable Embryos (Interim) MOH: Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005): http://www.moh.govt.nz/moh.nsf/0/DF32 587ABFCA33C5CC2570C800708A24/$F ile/GuidelinesUsingCells.pdf 108Philippines Country Key Organizations Legislation Regulations Guidelines General 1. Philippine Health Research Ethics Board (PHREB): http://www.pchrd.dost.gov.ph/index.p hp?option=com_frontpage&Itemid=1 2.

National Ethics Committee (NEC) 3. Department of Science and Technology: http://www.dost.gov.ph/ NEC: National Ethical Guidelines for Health Research (2006): https://webapps.sph.harvard.edu/live/grem ap/files/ph_natl_ethical_gdlns.pdf This document includes the following: Ethical Guidelines for International Collaborative Research Ethical Guidelines fo r Herbal Research Ethical Guidelines for Complementary and Alternative Medicine Research Ethical Guidelines for Epidemiological Research Ethical Guidelines for Social and Behavioral Research Ethical Guidelines for the Conduct of Research on Populations Traumatized in Emergencies and Disasters Ethical Guidelines for HIV/AIDS Research Ethical Guidelines for Research on Assisted Reproductive Technology Drugs Bureau of Food and Drugs: http://www.bfad.gov.ph/ Registration, Including Approval and Conduct of Clinical Trials, and Lot or Batch Release Certification of Vaccines and Biologic Products (Administrative Order No.

47-a) (2001) Ethical Guidelines for Clinical Trials on Drugs, Devices, and Diagnostics (2006): https://webapps.sph.harvard.edu/live/grem ap/files/ph_natl_ethical_gdlns.pdf 109 Country Key Organizations Legislation Regulations Guidelines Genetic Research National Ethics Committee (NEC) with a Section on Stem Cell Research (2006): https://webapps.sph.harvard.edu/live/grem ap/files/ph_natl_ethical_gdlns.pdf Embryos, Stem Cells, and Cloning National Ethics Committee (NEC) with a Section on Stem Cell Research (2006): https://webapps.sph.harvard.edu/live/grem ap/files/ph_natl_ethical_gdlns.pdf Qatar Country Key Organizations Legislation Regulations Guidelines General Health Research Ethics Committee Research Involving Human Subjects (2009): http://qatar- weill.cornell.edu/res earch/pdf/Ministry%2 0Guidelines.doc Singapore Country Key Organizations Legislation Regulations Guidelines General 1.

Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Ministry of Health National Medical Ethics Committee (NMEC) 3. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org 4. Singapore Medical Council (SMC): http://www.smc.gov.sg Medical Registration Act (Cap. 174) (1985): http://statutes.agc.gov.sg/ MOH: Directive of June 25, 1998: Hospital Ethics Committees NMEC: Ethical Guidelines on Research Involving Human Subjects (1997) BAC: Research Involving Human Subjects: Guidelines for IRBs (2004) MOH: 1. Governance Framework for Human Biomedical Research (2007) 2. Operational Guidelines for IRBs (2007) 3.

Code of Ethical Practice in Human Biomedical Research (2009) 110 Country Key Organizations Legislation Regulations Guidelines Drugs 1. Ministry of Health National Medical Ethics Committee (NMEC) 2. Health Sciences Authority of Singapore (HSA): http://www.hsa.gov.sg 1. Medicines Act Section 74 (Cap. 176) (1975): 2. Medicines (Clinical Trials) Regulations (2000) 3. Health Products Act (2007) Access: http://statutes.agc.gov.sg/ Singapore Guideline for Good Clinical Practice (1998) NMEC: Recommendations On Clinical Trials: Update Focusing On Phase I Trials (2007) Privacy/Data Protection 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2.

Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org Computer Misuse Act (Cap. 50A) (1993): http://statutes.agc.gov.sg/ MOH: Advisory on Data Protection Standards for Electronic Medical Records (EMR) Systems (2002) BAC: Personal Information in Biomedical Research (2007) Human Biological Materials 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org Medical (Therapy, Education, and Research) Act (1973): http://statutes.agc.gov.sg/ BAC: Human Tissue Research (2002) Genetic Research 1. Ministry of Health National Medical Ethics Committee (NMEC) 2.

Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org Ethical Guidelines for Gene Technology (2001) BAC: Genetic Testing and Genetic Research (2005): http://www.bioethics- singapore.org/uploadfile/55211%20PMG T%20Research.pdf Embryos, Stem Cells, and Cloning 1. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org/ 2. Ministry of Health (MOH): http://www.moh.gov.sg/ Human Cloning and Other Prohibited Practices Act (2004): http://statutes.agc.gov.sg/ Directives for Private Healthcare Institutions Providing Assisted Reproduction Services: Regulation 4 of the Private Hospitals and Medical Clinics Act (2006) BAC: 1.

Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (2002) 2. Donation of Eggs for Research (2008) 111Taiwan Country Key Organizations Legislation Regulations Guidelines General Department of Health: http://www.doh.gov.tw/EN2006/inde x_EN.aspx Medical Care Act, Articles 8, 78, 79, 80, and 98 (2009): http://www.doh.gov.tw/ufile/do c/Medical_Care_Act98.pdf Enforcement Rules of the Medical Care Act (2006) (Chinese): http://dohlaw.doh.gov.tw/Chi/FL AW/FLAWDAT0202.asp 1. Ethical Guidelines for the Announcement of New Medical Knowledge or Research Report by Medical Institutes or Members (2001) http://www.doh.gov.tw/ufile/doc/ 2.

Healthcare Institution Institutional Review Board Organization and Operations (2003): http://www.doh.gov.tw/EN2006/DM/DM 2_p01.aspx?class_no=386&now_fod_list_ no=9064&level_no=1&doc_no=43274 3. Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through Expedited Review (2006) (Chinese): http://www.doh.gov.tw/CHT2006/DM/D M2_p01.aspx?class_no=1&now_fod_list_ no=4356&level_no=3&doc_no=43680 4. Human Research Ethics Policy Guidelines (2007): http://www.doh.gov.tw/ufile/doc/Human %20Research%20Ethics%20Policy%20G uidelines.pdf 112 Country Key Organizations Legislation Regulations Guidelines Drugs 1.

Department of Health: http://www.doh.gov.tw/EN2006/inde x_EN.aspx 2. Taiwan Food and Drug Administration DOH: Pharmaceutical Affairs Act (2005): http://www.doh.gov.tw/EN2006 /DM/DM1_p01.aspx?class_no= 247&now_fod_list_no=247&lev el_no=1&doc_no=39739 DOH: 1. Guideline for Good Clinical Practice (2005) (Chinese): http://www.doh.gov.tw/CHT2006 /DM/DM2_p01.aspx?class_no=2 &now_fod_list_no=6726&level_ no=3&doc_no=39852 2. Enforcement Rules of the Pharmaceutical Affairs Act (2006) (Chinese): http://www.doh.gov.tw/CHT2006 /DM/DM2_p01.aspx?class_no=2 &now_fod_list_no=8108&level_ no=3&doc_no=454 DOH: 1.

Operational Guidelines for Drug Clinical Trials (2002) 2. Guidelines for Informed Consent in Clinical Trials (2007) (Chinese): http://www.doh.gov.tw/ufile/doc/%e5%8f %97%e8%a9%a6%e8%80%85%e5%90% 8c%e6%84%8f%e6%9b%b8%e5%85%a7 %e5%ae%b9%e5%8f%83%e8%80%83% e7%af%84%e6%9c%ac.pdf 3. Principles for Clinical Trial Subject Recruitment (2007) (Chinese): http://www.doh.gov.tw/CHT2006/DM/D M2_p01.aspx?class_no=2&now_fod_list_ no=6726&level_no=3&doc_no=501727 Privacy/Data Protection Ministry of Justice: http://www.moj.gov.tw/mp095.html Computer-Processed Personal Data Protection Law (1995): http://www.privacyexchange.or g/legal/nat/omni/taiwan.html Human Biological Materials Department of Health: http://www.doh.gov.tw/EN2006/inde x_EN.aspx Medical Care Act (2009): http://www.doh.gov.tw/ufile/do c/Medical_Care_Act98.pdf 1.Good Tissue Practice (2002) (Chinese): http://www.doh.gov.tw/CHT2006/DM/D M2_p01.aspx?class_no=1&now_fod_list_ no=4356&level_no=3&doc_no=40875 2.

Guidelines for Collection and Use of Human Specimens for Research (2006): http://www.doh.gov.tw/ufile/doc/Human %20Research%20Ethics%20Policy%20G uidelines.pdf 113 Country Key Organizations Legislation Regulations Guidelines Genetic Research 1. Department of Health: http://www.doh.gov.tw/EN2006/inde x_EN.aspx 2. National Science Council: http://web.nsc.gov.tw/default.asp?mp =7 1. Guidance for Informed Consent Forms for Pharmacogenetic Research (2005) (Chinese): http://www.doh.gov.tw/ufile/doc/200511_ %e8%97%a5%e7%89%a9%e5%9f%ba% e5%9b%a0%e5%ad%b8%e7%a0%94%e7 %a9%b6%e4%b9%8b%e5%8f%97%e6% aa%a2%e8%80%85%e5%90%8c%e6%84 %8f%e6%9b%b8%e5%85%a7%e5%ae% b9%e5%8f%83%e8%80%83%e6%8c%87 %e5%bc%95.pdf Embryos, Stem Cells, and Cloning Department of Health: http://www.doh.gov.tw/EN2006/inde x_EN.aspx Human Embryo and Embryonic Stem Cell Research (2007): http://www.doh.gov.tw/ufile/doc/Policy% 20Instructions%20on%20the%20Ethics% 20of%20Human%20Embryos.pdf Tajikistan Note: For an overview of human subject protections in Tajikistan , see “Ethical Review of Biomed ical Research in the CIS Countri es,” Chapter 3, Section 9: http://www.unesco.ru/files/docs/shs/2007/publica tions/ethical_review_cis_book_kubar_english.pdf Country Key Organizations General 1.

Ministry of Public Health 2. Republic Committee on Medical Ethics Health of the Republic Tajikistan of 10 March, 2005 No. 118: About the Assertion of the Normative Documents of Republic Committee on Medical Ethics (Russian) 2. Position of the Republic Committee on Medical Ethics, Affirmed by the Order of the Ministry of Public Health of Republic Tajikistan of March 10, 2005, No. 118 (Russian) 114Thailand Country Key Organizations Legislation Regulations Guidelines General 1. National Research Council of Thailand (NCRT) (Thai): http://nrct.go.th/ 2. Medical Council of Thailand (MCT) (Thai): http://www.tmc.or.th NCRT: Regulation on the Permission of Foreign Researchers (1982) MCT: Rule of the Medical Council on the Observance of Medical Ethics (2006) MCT: 1.

National Guideline for Ethical Research on Human Subjects (2002) 2. The Ethical Guidelines for Research on Human Subject in Thailand (2007) Drugs Food and Drug Administration, Drug Control Division: http://www.fda.moph.go.th/eng/index .stm/ Consumer Protection Act (2007) Guidelines (2002) Privacy/Data Protection Office of the Information Commission 1. Official Information Act, B.E. 2540 (1997) 2. National Health Act, B.E. 2549 (2006) Vietnam Country Key Organizations Legislation Regulations Guidelines General Ministry of Health: http://www.moh.gov.vn/homebyt/en/ portal/index.jsp Promulgation of the “Procedure of Organizing and Functioning Ethical Committee for Bio- Medical research, Mission 2008 – 2012” (2008) (Vietnamese) 115 Country Key Organizations Legislation Regulations Guidelines Drugs Ministry of Health: http://www.moh.gov.vn/homebyt/en/ portal/index.jsp (2007) 2.

Decision No. 799/QD-BYT of the Minister of Health on the Promulgation of the “Guidelines on Good Clinical Practice of Clinical Trials” (2008) 3. Decision No. 23 /2008/QD- BYT of the Minister of Health on the Promulgation of the “Regulations on Utilization of Vaccine and Medical Immuno- Biological Products in Prevention and Treatment” (2008) Guidelines on Good Clinical Practice of Clinical Trials (2008) LATIN AMERICA and the CARIBBEAN Pan American Health Organization Country Key Organizations Legislation Regulations Guidelines Drugs Pan American Health Organization: http://www.paho.org/ Americas (2004): http://www.paho.org/english/ad/ths/ev/GC P-Eng-doct.pdf Argentina Country Key Organizations Legislation Regulations Guidelines General Note: Several provinces have their own regulations pertaining to human subjects research.

Ministry of Health: http://www.msal.gov.ar MOH: Ministerial Resolution 1490/2007 Approving the Good Clinical Practice Guideline for Clinical Research with Human Beings 116 Country Key Organizations Legislation Regulations Guidelines Drugs Note: Several provinces have their own regulations pertaining to drug research. National Administration of Medications, Foods, and Medical Technology (ANMAT) (Spanish): http://www.anmat.gov.ar/index.asp ANMAT: Provision 5330/97 on Good Research Practices in Clinical Pharmaceutical Studies (1997) (Spanish): http://infoleg.mecon.gov.ar/infole gInternet/anexos/45000- 49999/46745/norma.htm Privacy/Data Protection National Personal Data Protection Authority (Spanish): http://www.jus.gov.ar/datospersonale s/index.html Personal Data Protection Act No.

25.326 (2000): http://www.protecciondedatos.c om.ar/law25326.htm Bolivia Country Key Organizations Legislation Regulations Guidelines General 1. Ministry of Health and Sport: http://www.sns.gov.bo/ 2. National Bioethics Committee 1. Legal Decree No. 15629 of July 18, 1978 2. New Political Constitution of the State, Article 44 (2009): http://www.repac.org.bo /docum entos/NUEVA%20CPE.pdf Regulations on Public Health Research, Chapter V (1978) Guidelines for the Development of Health Research and Ethical Norms (2002) Drugs Ministry of Health and Sport: http://www.sns.gov.bo/ or Products in the Clinical Investigation Stage (2005) 117Brazil Country Key Organizations Legislation Regulations Guidelines General 1.

National Health Council (CNS) (Portuguese): http://www.conselho.saude.gov.br/ 2. National Commission on Research Ethics (CONEP) (Portuguese): http://www.conselho.saude.gov.br/co missao/eticapesq.htm CNS: Decree 98 830: Collection by Foreigners of Data and Scientific Materials in Brazil (1990) (Portuguese): http://ibama2.ibama.gov.br/cnia 2/renima/cnia/lema/lema_texto/ HTM-ANTIGOS/98830- 90.HTM CONEP: 1. Resolution 196/96: Rules on Research Involving Human Subjects (1996): http://www.conselho.saude.gov.b r/resolucoes/1996/Reso196.doc http://www.conselho.saude.gov.b r/docs/Resolucoes/reso_196_engl ish.doc 2.

Resolution 304/2000: On Complimentary Rules for Research Involving Indigenous People (2000): http://www.conselho.saude.gov.b r/resolucoes/2000/Reso304.doc 3. Internal CONEP Regulation (2001) (Portuguese): http://www.conselho.saude.gov.b r/Web_comissoes/conep/aquivos/ conep/regimento.doc 4. Regulation of Resolution CNS 292/99 on Research with Foreign Cooperation (2002) (Portuguese): http://www.conselho.saude.gov.b r/resolucoes/1999/Reso292.doc http://www.ensp.fiocruz.br/etica/ docs/cns/Res292i.pdf 5. Resolution 346/2005: On Multicenter Research (2005) (Portuguese): http://www.conselho.saude.gov.b r/docs/Resolucoes/Reso346.doc 118 Country Key Organizations Legislation Regulations Guidelines Drugs 1.

National Health Council (CNS) (Portuguese): http://www.conselho.saude.gov.br/ 2. National Healthcare Surveillance Agency (Portuguese): http://www.anvisa.gov.br CNS: Resolution 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests (1997): http://www.ensp.fiocruz.br/etica/ docs/cns/Res251i.pdf Human Biological Materials National Commission on Research Ethics (CONEP) (Portuguese): http://www.conselho.saude.gov.br/co missao/eticapesq.htm CONEP: CNS Resolution 347/05 Approval Guidelines for Ethical Analysis of Research Projects Involving Storage of Materials or Use of Materials Stored by Previous Research (Portugese): http://conselho.saude.gov.br/docs/ Reso347.doc CONEP: Approval Guidelines for Ethical Analysis of Research Projects Involving Storage of Materials or Use of Materials Stored by Previous Research: Resolution 347/05 (2005) Genetic Research 1.

National Commission on Research Ethics (CONEP) (Portuguese): http://www.conselho.saude.gov.br/W eb_comissoes/conep/index.html 2. National Biosafety Technical Commission (CTNBio) (Portuguese): http://www.ctnbio.gov.br Biosafety Law 11.105/05 (2005): http://www.ctnbio.gov.br/index. php/content/view/12847.html CONEP: Resolution 340/2004 : On Research on Human Genetics (2004) (Portuguese): http://conselho.saude.gov.br/resol ucoes/2004/Reso340.doc CTNBio: Decree No. 5,591, of November 22, 2005: http://www.ctnbio.gov.br/index.p hp/content/view/3670.html CONEP: Approval Guidelines for Ethical Analysis and Conduct of Research Projects in the Special Thematic Area of Human Genetics: Resolution 340/04 (2004) Embryos, Stem Cells, and Cloning National Biosafety Technical Commission (Portuguese): http://www.ctnbio.gov.br Biosafety Law 11.105/05 (2005): http://www.ctnbio.gov.br/index. php/content/view/12847.html CTNBio: Decree No.

5,591, of November 22, 2005: http://www.ctnbio.gov.br/index.p hp/content/view/12848.html 119Chile Country Key Organizations Legislation Regulations Guidelines General Ministry of Health (Spanish): http://www.minsal.cl 2. Supreme Decree No. 1.935 (1993) 3. General Technical Rule No. 2 of the Ministry of Health (1993) 4. Exemption Resolution No. 134 (1994) 5. Supreme Decree No. 494 (1999) 6. Exemption Resolution No. 1.856 (1999) 7. Resolution No. 2.085 of the Ministry of Health (2001) Drugs Ministry of Health (Spanish): http://www.minsal.cl Regulation of the Conduct of Clinical Trials that Use Pharmaceutical Products in Human Beings (2001): http://www.ispch.cl/formularios/n orma_tec/norm_tec_n_57.pdf Ethical Guidelines for Clinical Trials with Pharmaceutical and Biological Products (2001) Privacy/Data Protection Private Life No.

19.628 (1999) (Spanish): http://www.bcn.cl/leyes/141599 Genetic Research http://www.lyd.com/programas/l egislativo/proyecto_ley_genoma _humano.pdf 2. Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2007) 120 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2007) Colombia Country Key Organizations Legislation Regulations Guidelines General Ministry of Social Protection (Spanish): www.minproteccionsocial.gov.co/ Scientific, Technical, and Administrative Regulations for Health Research, Resolution No.

008430 (1993): http://www.unal.edu.co/dib/norm as/etica_res_8430_1993.pdf Drugs National Institute of Drug and Food Surveillance (Spanish): http://www.invima.gov.co/ Adapting Good Clinical Practices for Institutions that Conduct Research with Medicines in Human Beings: http://www.minproteccionsocial.g ov.co/VBeContent/library/docum ents/DocNewsNo17655Documen tNo7224.PDF Privacy/Data Protection Constitution of Colombia, Article 15 (2003) Human Biological Materials Ministry of Health, National Institute of Health (Spanish): http://www.ins.gov.co/ Administrative Regulations for Health Research, Resolution No.

008430, Title II, Chapter VI (1993) Genetic Research Ministry of Health, National Institute of Health (Spanish): http://www.ins.gov.co/ Administrative Regulations for Health Research, Resolution No. 008430, Title III, Chapter II (1993) 121Costa Rica Country Key Organizations Legislation Regulations Guidelines General 1. National Council on Health Research (CONIS) Network of Scientific Ethics Committees 2. Social Security Fund (CCSS), Research and Bioethics Subarea: http://www.cendeisss.sa.cr/etica/01- PRESENaa.html 3. Ministry of Health: http://www.ministeriodesalud.go.cr/ Law 5395, General Health Law, Articles 64-68 (1973) (Spanish): http://www.ministeriodesalud.g o.cr/leyes/leygeneraldesalud.pdf CONIS: Executive Decree No.

31078-S (2003) (Spanish): http://www.ministeriodesalud.go. cr/reglamentos/31078-s.pdf CCSS: Regulation of Clinical Investigation in the Assistance Services of the Social Security Fund (2005) http://www.cendeisss.sa.cr/etica/r eglamentobiomedica.pdf CONIS: 1. Ethical and Legal Principles 2. Duties and Responsibilities of the National Council on Health Research, of Investigators, and of the Sponsor 3. Structure and Functioning of the Committee Network 4. Design of the Research Protocol 5. Requirements for the Submission of a Research Protocol 6. Informed Consent 7. Approval and Follow-up of a Research Project 8.

Sanctions Drugs 1. National Council on Health Research (CONIS) Network of Scientific Ethics Committees (Spanish): http://www.ministeriodesalud.go.cr/c omconis.htm 2. Ministry of Health (Spanish): www.ministeriodesalud.go.cr Executive Decree 21085-S: Good Clinical Practice for Pharmaceutical Products CONIS: 1. Guidelines for Good Clinical Practice (1996) 2. Protocol for Clinical Trials Human Biological Materials National Council on Health Research Network (CONIS) of Scientific Ethics Committees (Spanish): http://www.ministeriodesalud.go.cr/c omconis.htm search that Requires Biobanks 122Dominica Country Key Organizations Legislation Regulations Guidelines General Ministry of Health and Environment: http://www.dominica.gov.dm/cms/ind ex.php?q=node/21 Human Subjects (2005) Guatemala Country Key Organizations Legislation Regulations Guidelines Drugs Ministry of Public Health and Social Assistance Ministerial Accord SP-M-466- 2007, For the Regulation of Clinical Trials in Humans (2007) Honduras Country Key Organizations Legislation Regulations Guidelines General Articles 175 and 176 Jamaica Country Key Organizations Legislation Regulations Guidelines General Ministry of Health: http://www.moh.gov.jm Ministry of Health Guidelines for the Conduct of Research on Human Subjects (2002) 123Mexico Country Key Organizations Legislation Regulations Guidelines General Secretariat of Health: http://www.salud.gob.mx/ General Health Council: www.csg.salud.gob.mx/ General Health Law, Title V, Chapter 1, Articles 96-103: Health Research (2007): www.consejomexicano.org.mx/ documents/lgs.pdf As amended (2008): http://www.diputados.gob.mx/L eyesBiblio/ref/lgs/LGS_ref36_1 4jul08.pdf Regulation on the General Health Law in the Matter of Health Research (1984) (Spanish): www.salud.gob.mx/unidades/cdi/ nom/compi/rlgsmis.html Drugs Federal Commission for Protection Against Health Risks: www.cofepris.gob.mx/ General Health Law, Title V, Chapter 1, Articles 96-103: Health Research (2005): www.consejomexicano.org.mx/ documents/lgs.pdf Regulation on the General Health Law in the Matter of Health Research, Title Three (1984) (Spanish): www.salud.gob.mx/unidades/cdi/ nom/compi/rlgsmis.html Privacy/Data Protection Federal Institute on Access to Public Information (Spanish): www.ifai.org.mx/ Human Biological Materials Secretariat of Health: http://www.salud.gob.mx/ General Health Law, Title XIV, Articles 313-342 (2005): www.consejomexicano.org.mx/ documents/lgs.pdf Genetic Research National Institute of Genomic Medicine: http://www.inmegen.gob.mx/ 1.

Biosafety Law on Genetically Modified Organisms (2008 (Spanish): http://www.inmegen.gob.mx/im ages/stories/noticias/2008/pdf/so berania_genomica.pdf 2. Modifications to the General Health Law to Protect Genomic Sovereignty (2008): http://www.inmegen.gob.mx/ind ex.php?option=com_content&ta sk=view&id=816&Itemid=155 Regulation on the General Health Law in the Matter of Health Research, Title Four, Chapter Two (1984) (Spanish): www.salud.gob.mx/unidades/cdi/ nom/compi/rlgsmis.html 124Panama Country Key Organizations Legislation Regulations Guidelines General National Research Bioethics Committee (Spanish): http://www.gorgas.gob.pa/index.php? option=com_content&task=view&id =15&Itemid=43 No.

390 Adopting the Operational Guide for Research Bioethics, Official Gazette 24,938 (2003) (Spanish): http://www.gorgas.gob.pa/images /Gaceta%20Nº%2024%20938%2 0%20Resolucion390.doc Informed Consent (2006) (Spanish): http://www.gorgas.gob.pa/images/bioetica /Elementos%20del%20Consentimiento%2 0Informado.pdf Human Biological Materials Gazette 22,929 Embryos, Stem Cells, and Cloning 24,969 Peru Country Key Organizations Legislation Regulations Guidelines General 1. National Institute of Health (Spanish): http://www.ins.gob.pe/ 2. National Network of Research Ethics Committees: http://www.ins.gob.pe/gxpsites/hgxpp 001.aspx?2,13,59,O,S,0,MNU;C;1;14 ;20;5;MNU General Health Law No.

26842, Article 28 (1997) (Spanish) Drugs 1. National Institute of Health (Spanish): http://www.ins.gob.pe/gxpsites/hgxpp 001.aspx?2,13,326,O,S,0,MNU;E;1;1 4;20;10;MNU 2. National Directorate of Drugs and Medical Devices: www.digemid.minsa.gob.pe 2006-SA: Regulation on Clinical Trials in Peru (2006): http://www.digemid.minsa.gob.pe /normatividad/DS017- 2006SA.pdf 2. Supreme Decree No. 006- 2007-SA: Modification of the Regulation on Clinical Trials in Peru (2007): http://www.digemid.minsa.gob.pe /normatividad/DS006- 2007EP.pdf 125 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection National Directorate of Drugs and Medical Devices: www.digemid.minsa.gob.pe SA: Regulation on Legislative Decree No.

1072, Data Protection http://www.digemid.minsa.gob.pe /normatividad/DS%20002-2009- SA09.pdf Uruguay Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Ministry of Public Health (Spanish): http://www.msp.gub.uy/index_1.html Circular No. 40/95 Establishing Rules Regarding the Donation of Organs and Tissues for Scientific and Therapeutic Purposes (1995) Venezuela Country Key Organizations Legislation Regulations Guidelines General 1. National Fund on Science and Technology, Commission on Bioethics and Biosecurity (FONACIT) (Spanish): http://www.fonacit.gov.ve/bioetica.as p 2.

Venezuelan Institute of Scientific Research, Bioethics Commission (IVIC) Constitution, Article 46 (Spanish) Resolution No. 48 (1998) Code on Bioethics and Biosecurity (2002) IVIC: 1. Annex 1: General Ethical Issues in Research Involving Living Persons 2. Annex 2: Necessity of Establishing a Clear and Precise Study Protocol Before Starting Research 3. Informed Consent Drugs National Institute of Hygiene “Rafael Rangel” (Spanish): http://www.inhrr.gov.ve Medicines Act, Articles 72 and 73 Genetic Research Venezuelan Institute of Scientific Research, Bioethics Commission (Spanish) Resources (2003) (Spanish) 2.

Revised Outline of the International Declaration of Human Genetic Data (2003) 126AFRICA Botswana Country Key Organizations Legislation Regulations Guidelines General Ministry of Health, Research and Development Committee: http://www.moh.gov.bw/ Anthropological Research Act 45 (1967) 2. Guidelines for the Review of Research Proposals (2005) Drugs Ministry of Health, Drug Regulatory Unit: http://www.moh.gov.bw/ Regulations (1993) SADC Guidelines for Regulating Clinical Trials in Human Subjects (2006) Privacy/Data Protection Botswana Telecommunications Authority: http://www.bta.org.bw/background.ht ml Egypt Country Key Organizations Legislation Regulations Guidelines General Medical Profession Union Republic of Egypt, Article 43: http://www.sis.gov.eg/En/Politic s/Constitution/Text/0407030000 00000001.htm Professional Ethics Regulations: Conducting Medical Research on Human Beings Articles 52-61 (2003) Access: Scroll to bottom of page, click Download Code of Ethics: http://www.ems.org.eg/2_4/2_4_ 4/2_4_4.htm Drugs Egyptian Drug Authority: http://www.eda.mohp.gov.eg/ Human Biological Materials Conducting Medical Research on Human Beings Articles 49-51 (2003): http://www.ems.org.eg/2_4/2_4_ 4/2_4_4.htm 127Ethiopia Country Key Organizations Legislation Regulations Guidelines General Ethiopian Science and Technology Commission, Health Department: http://www.estc.gov.et/ Proclamation 60/1999, Section 21 Guideline, Fourth Edition (2005): http://www.estc.gov.et/Ethics%20Guideli ne.pdf Human Biological Materials Ethiopian Science and Technology Commission, Health Department: http://www.estc.gov.et/ Guideline, Fourth Edition, Section 8 (2005) Gambia Country Key Organizations Legislation Regulations Guidelines Genetic Research Medical Research Council (UK) The Gambia: http://www.mrc.gm/ (2001) Kenya Country Key Organizations Legislation Regulations Guidelines General 1.

National Council for Science and Technology (NCST) 2. Ministry of Health (MOH): http://www.health.go.ke/index.html 1. Science and Technology Act (2001) 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006) NCST: Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (2004): https://webapps.sph.harvard.edu/l ive/gremap/files/ke_NCST_guide lines.pdf MOH: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005) Drugs Pharmacy and Poisons Board: http://www.pharmacyboardkenya.org / Pharmacy and Poisons Act, Chapter 244 (2001) Human Biological Materials Ministry of Health (MOH): http://www.health.go.ke/index.html Research and Development of HIV/AIDS Vaccines, page 44 (2005) 128Malawi Country Key Organizations Legislation Regulations Guidelines General 1.

National Research Council of Malawi (NRCM) 2. National Health Sciences Research Committee (NHSRC) 3. College of Medicine Research and Ethics Committee (COMREC) 4. Ministry of Health 1. Presidential Decree on 30th March 1974 2. Malawi Government Gazette, June 11, 1976, General Notice No. 398 3. Constitution of Malawi, Article 19(5) (1994) NRCM: Procedures and Guidelines for the Conduct of Research in Malawi (2002) NHSRC: 1. Operational Guidelines (2001) 2. Summary Guidelines for Writing Research Proposals (2001) COMREC: Research Guidelines (2004): http://www.medcol.mw/comrec/res.guidel ines.php Drugs Pharmacy, Medicines, and Poisons Board of Malawi Pharmacy, Medicines, and Poisons Act, Act 15 of 1988) Genetic Research National Research Council of Malawi (NRCM) Access and Collection of Genetic Resources in Malawi (2002) Nigeria Country Key Organizations Legislation Regulations Guidelines General National Health Research Ethics Committee: http://nhrec.net/ National Health Bill 2009 (2006) Drugs National Agency for Food, Drug Administration and Control (NAFDAC): http://www.nafdac.gov.ng/ Decree No.

15 of 1993 Good Clinical Practice Regulations (2009): http://www.nafdac.gov.ng/index. php?option=com_docman&task= doc_download&gid=18&Itemid= 80 129South Africa Country Key Organizations Legislation Regulations Guidelines General 1. Department of Health (DH): http://www.doh.gov.za 2. Medical Research Council of South Africa (MRC): http://www.mrc.ac.za 3. National Health Research Ethics Council: http://www.doh.gov.za/nhrec/ 1. Constitution of South Africa, Article 12(2) (1996) 2. National Health Act No. 61, Chapter 9 (2003): http://www.doh.gov.za/docs/legi slation-f.html DH: Ethics in Health Research: Principles, Structures, and Processes (2004): http://www.doh.gov.za/nhrec/norms/ethics .pdf MRC: http://www.sahealthinfo.org/ethics/index. htm 1.

Guidelines on Ethics in Medical Research: General Principles (2002) 2. Guidelines on Ethics in the Use of Biohazards and Radiation (2003) 3. Guidelines on Ethics in HIV Vaccine Trials (2003) Drugs 1. Department of Health (DH): http://www.doh.gov.za 2. Medicines Control Council: http://www.mccza.com DH: 1. Medicines and Related Substances Control Act, 101 of 1965 http://www.info.gov.za/view/Do wnloadFileAction?id=68096 2. Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2006): http://www.doh.gov.za/nhrec/nor ms/gcp.pdf Human Biological Materials Department of Health (DH): http://www.doh.gov.za National Health Act No.

61, Chapter 8, Sections 53-68 (2003): http://www.doh.gov.za/docs/legi slation-f.html 130 Country Key Organizations Legislation Regulations Guidelines Genetic Research Medical Research Council of South Africa (MRC): http://www.mrc.ac.za Guidelines on Ethics in Reproductive Biology and Genetic Research (2002): http://www.sahealthinfo.org/ethics/book2. htm Embryos, Stem Cells, and Cloning Medical Research Council of South Africa (MRC): http://www.mrc.ac.za National Health Act No. 61, Chapter 8, Section 57 (2003): http://www.doh.gov.za/docs/legi slation-f.html MRC: Guidelines on Ethics in Reproductive Biology and Genetic Research (2002): http://www.sahealthinfo.org/ethics/book2. htm Sudan Country Key Organizations Legislation Regulations Guidelines General Federal Ministry of Health: http://www.fmoh.gov.sd/ Ethics (2002) Drugs Federal Ministry of Health: http://www.fmoh.gov.sd/ Act on Pharmaceuticals and Poisons (2001) Human Biological Materials Federal Ministry of Health: http://www.fmoh.gov.sd/ Human Organs and Tissues Transplant Legislation, Chapter 2, Articles 3 and 4 (1978) Genetic Research University of Khartoum, Institute of Endemic Diseases Sudanese Subjects (2005) 131Tanzania Country Key Organizations Legislation Regulations Guidelines General 1.

Ministry of Health (MOH) 2. National Institute for Medical Research (NIMR), National Health Research Ethics Committee (NHREC): http://www.nimr.or.tz/index.php?opti on=com_content&task=view&id=26 &Itemid=34 3. Tanzania Commission for Science and Technology (COSTECH): www.costech.or.tz 1. National Institute for Medical Research, Act of Parliament No. 23, of 1979: http://www.parliament.go.tz/Pol is/PAMS/Docs/23-1979.pdf 2. Tanzania Commission for Science and Technology, Act No. 7 of 1986 3. Amendment of NIMR Act 1997, Tanzania Government Gazette, No. 675 NIMR: 1. Coordination of Health Research in Tanzania 2.

Coordination of Formation of Institutional Health Research Committees to Formally Approve for Local Health Research 3. Coordination of Research in Tanzania NHREC: 1. Guidelines on Ethics for Health Research in Tanzania (2001) 2. Brochure for Health Researchers in Tanzania (2006) COSTECH: COSTECH Guidelines on Research Permits and Clearance (2006) Drugs Tanzania Food and Drugs Authority: http://www.tfda.or.tz/ Tanzania Food, Drugs, and Cosmetics Act, Sections 61, 66, 67, and 69 (2003): http://www.tfda.or.tz/tfdaact.pdf Uganda Country Key Organizations Legislation Regulations Guidelines General Uganda National Council on Science and Technology (UNCST): http://www.uncst.go.ug/ Involving Humans as Research Participants (2007) Drugs National Drug Authority: http://www.nda.or.ug/ National Drug Authority Statute (1993) 132Zimbabwe Country Key Organizations Legislation Regulations Guidelines General Medical Research Council of Zimbabwe: http://www.mrcz.org.zw 1.

Government Notice Act (1974) 2. Research Act (1986) 1. Guidelines for Re searchers and Ethics Review Committees in Zimbabwe (2004): http://www.mrcz.org.zw/ docs/MRCZ%20 guidelines%20for%20researchers%20200 4.pdf 2. Conducting Health Research in Zimbabwe: What Researchers Need to Know (2004): http://www.mrcz.org.zw/ docs/conducting _health_research_in_zim.pdf Drugs Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/ Medicines and Allied Substances Control Act, Chapter 15:03 (1997) 1. Medicines and Allied Substances Control Act, General Regulations (1991) 2. Statutory Instrument 150 of 1991 Guidelines for Good Clinical Practice (2002): http://www.mcaz.co.zw/trials/Guidelines %20for%20Good%20Clinical%20Trial% 20Practice%20in%20Zimbabwe.pdf Human Biological Materials Medical Research Council of Zimbabwe: http://www.mrcz.org.zw Blood Samples for Research (1999): http://www.mrcz.org.zw/ docs/blood%20c ollection%20guidelines%201999.pdf