International Compilation of Human Research Standards 2020 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services PURPOSE The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as “standards”) that govern human subject protections in 133 countries, as well as standards from a number of international and regional organizations. First published in 2005, the Compilation is intended for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research protections around the world. Content experts from around the world, listed at the end of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. Two new countries are featured in the 2020 Edition: Nicaragua and Paraguay. ORGANIZATION The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as: 1. General, i.e., applicable to most or all types of human subjects research 2. Drugs, Biologics, and Devices 3. Clinical Trial Registries 4. Research Injury 5. Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards: https://www.hhs.gov/ohrp/international/social- behavioral-research-standards/index.html) 6. Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports) 7. Human Biological Materials 8. Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/) 9. Embryos, Stem Cells, and Cloning These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate understanding of the country’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 – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent constitutional provisions. 3. Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies. 4. Guidelines – pertain to non-binding instruments. 1 The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018. HOW TO ACCESS A DOCUMENT Documents can be accessed in four possible ways: 1. Link to the web address (URL). 2. Search for a document at the website of the agency listed in the Key Organizations column. 3. Perform an Internet search on the document title. 4. Request a local research ethics committee to provide the document. In many cases the documents are available in English. When the URL links to a non-English website or document, an online language translator usually can render an English version. TOPICS NOT COVERED In order to focus its scope, the International Compilation of Human Research Standards does not include standards from the state, provincial, or local levels. Nor does the Compilation cover: 1. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects standards, but do not direct the content of those regulations. 2. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical bioethics, product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice, bioequivalence testing, or informed consent in clinical practice. 3. Ethics codes of academic, medical, or other professional organizations – see the Ethics Codes Collection: http://ethics.iit.edu/ecodes/about 4. Working papers, drafts, commentaries, or discussion papers. NEW STANDARDS, UPDATES, AND BROKEN LINKS To request inclusion of a new standard in the Compilation or to report updates or broken links, contact OHRP@HHS.gov . DISCLAIMER Although this Compilation contains information of a legal nature, it has been developed for informational purposes only and does 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 continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to human subject protections. While in-country persons have been requested to review listings to assure their accuracy and completeness, researchers and other individuals should check with local authorities and/or research ethics committees before commencing research activities. 2 TABLE OF CONTENTS INTERNATIONAL 5 NORTH AMERICA 10 Canada 10 United States 12 EUROPE 21 Regionwide 21 Armenia 27 Austria 27 Belarus 29 Belgium 31 Bosnia and Herzegovina 33 Bulgaria 36 Croatia 39 Cyprus 41 Czech Republic 42 Denmark 43 Estonia 44 Finland 46 France 48 Georgia 50 Germany 51 Greece 55 Hungary 58 Iceland 60 Ireland 62 Italy 63 Latvia 65 Lithuania 67 Luxembourg 71 Macedonia 72 Malta 76 Moldova 77 Montenegro 79 Netherlands 81 Norway 83 Poland 86 Portugal 88 Romania 89 Russia 90 San Marino 92 Serbia 92 Slovakia 94 Slovenia 94 Spain 98 Sweden 101 Switzerland 103 Ukraine 107 United Kingdom 109 ASIA/PACIFIC 116 Australia 116 Bangladesh 119 China, People’s Republic of 119 India 123 Indonesia 126 Japan 126 Kazakhstan 129 Korea 130 Kyrgyzstan 133 Malaysia 134 Myanmar 137 Nepal 137 New Zealand 138 Pakistan 140 Philippines 141 Singapore 144 Sri Lanka 146 Taiwan 147 Tajikistan 149 Thailand 149 Uzbekistan 150 Vietnam 150 MIDDLE EAST/NORTH AFRICA 152 Egypt 152 Iran 152 Israel 152 Jordan 153 Kuwait 154 Qatar 154 3 Saudi Arabia 155 Sudan 155 Tunisia 156 Turkey 156 United Arab Emirates 158 LATIN AMERICA AND THE CARIBBEAN 159 Regionwide 159 Argentina 159 Barbados 161 Bermuda 161 Bolivia 161 Brazil 162 Chile 167 Colombia 169 Costa Rica 172 Cuba 173 Dominica 173 Dominican Republic 173 Ecuador 173 El Salvador 175 Grenada 176 Guyana 176 Guatemala 176 Haiti 177 Honduras 177 Jamaica 177 México 177 Panamá 179 Paraguay 180 Perú 180 Saint Lucia 181 Trinidad and Tobago 181 Uruguay 182 Venezuela 182 AFRICA 184 Regionwide 184 Algeria 184 Benin 184 Botswana 184 Burkina Faso 185 Cameroon 185 Congo, Democratic Republic of 186 Côte-d'Ivoire 186 Ethiopia 186 Gambia 186 Ghana 187 Guinea 187 Kenya 188 Liberia 188 Madagascar 188 Malawi 189 Mali 190 Mozambique 190 Nigeria 190 Rwanda 191 Senegal 191 Sierra Leone 191 South Africa 192 Tanzania 193 Uganda 194 Zambia 194 Zimbabwe 195 ACKNOWLEDGEMENTS 197 4 Country Key Organizations Legislation Regulations Guidelines INTERNATIONAL General Council for International Organizations of Medical Sciences (CIOMS): http://www.cioms.ch/ International Committee of the Red Cross (ICRC): www.icrc.org Office of the United Nations High Commissioner for Human Rights (OHCHR): http://www.ohchr.org/english/ TRUST Project: http://www.globalcodeofconduct.org UNAIDS: http://www.unaids.org/ 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950): https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977): http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9 International Covenant on Civil and Political Rights, Article 7 (1976): http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx 5 International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113- Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international- ethical-guidelines-for-health-related-research- involving-humans/ Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp- content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011): http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf 2. Ethical Considerations in Biomedical HIV Prevention Trials (2012): http://www.unaids.org/en/media/unaids/conten Country Key Organizations Legislation Regulations Guidelines tassets/documents/unaidspublication/2012/jc1 General Drugs, Biologics, and Devices United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO): https://en.unesco.org/ World Health Organization: http://www.who.int/en/ World Medical Association: http://www.wma.net/e/ Drugs International Conference on Harmonization (ICH): http://www.ich.org/ World Health Organization (WHO): http://www.who.int/en/ Devices International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/ 6 399_ethical_considerations_en.pdf Universal Declaration on Bioethics and Human Rights (2005): http://portal.unesco.org/en/ev.php- URL_ID=31058&URL_DO=DO_TOPIC&U RL_SECTION=201.html 1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) 2. Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013) 3. Managing Ethical Issues in Infectious Disease Outbreaks: Guidance Document (2016) 4. WHO Guidelines on Ethical Issues in Public Health Surveillance (2017) Access: http://www.who.int/ethics/publications/en/ Declaration of Helsinki (2013): https://www.wma.net/policies-post/wma- declaration-of-helsinki-ethical-principles-for- medical-research-involving-human-subjects/ Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (2016): https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4_2016_1109.pdf 1. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2005): http://whqlibdoc.who.int/publications/2005/92 4159392X_eng.pdf 2. Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005) IMDRF: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects- Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Good Clinical Practice” (2015): http://www.imdrf.org/docs/imdrf/final/proced ural/imdrf-proc-150326-statement- iso141552011.pdf Archived Documents from the Global Harmonization Task Force (GHTF), replaced by the IMDRF in 2012: 1. Clinical Evaluation (2007) 2. Clinical Evidence – Key Definitions and Concepts (2007) 3. Post-Market Clinical Follow-Up Studies (2010) 4. Clinical Investigations (2010) 5. Reportable Events During Pre-Market Clinical Investigations (2012) 6. Clinical Evidence for IVD Medical Devices (2012) 7. Scientific Validity Determination and Performance Evaluation (2012) 8. Clinical Performance Studies for IVD Medical Devices (2012) Clinical Trials Registry Research Injury International Standards Organization: http://www.iso.org/iso/home.html World Health Organization – International Clinical Trials Registry Platform: http://www.who.int/ictrp/en/ World Medical Association: http://www.wma.net/e/ International Committee of Medical Journal Editors: http://www.icmje.org/ World Medical Association: http://www.wma.net/e/ 7 Access: http://www.imdrf.org/ghtf/ghtf- archived-docs.asp Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice. Standard Number 14155:2011: http://www.iso.org/iso/iso_catalogue/catalogu e_ics/catalogue_detail_ics.htm?csnumber=455 57 Resolution WHA 58.34 (2005): http://www.wpro.who.int/health_research/poli cy_documents/ministerial_summit_on_health_ research_may2005.pdf?ua=1 Declaration of Helsinki, Article 35 (2013): http://www.wma.net/en/30publications/10poli cies/b3/index.html Clinical Trial Registration: http://icmje.org/recommendations/browse/pub lishing-and-editorial-issues/clinical-trial- registration.html Declaration of Helsinki, Paragraph 15 (2013): http://www.wma.net/en/30publications/10poli Country Key Organizations Legislation Regulations Guidelines cies/b3/index.html Research Injury Social- Behavioral Research Privacy/Data Protection Human Biological Materials International Conference on Harmonization (ICH): http://www.ich.org/ Council for International Organizations of Medical Sciences: http://www.cioms.ch/ UNESCO: http://www.unesco.org/ World Medical Association: http://www.wma.net/e/index.htm World Health Organization: http://www.who.int/en/ World Medical Association International Air Transport Association: http://www.iata.org/ International Society for Biological and Environmental Repositories: http://www.isber.org 8 Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice , Section 5.8 (2016): https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4.pdf International Ethical Guidelines for Health-related Research Involving Humans (2016), Guideline 14: https://cioms.ch/shop/product/international- ethical-guidelines-for-health-related-research- involving-humans/ Code of Conduct and Ethical Guidelines for Social Science Research: http://www.unesco.org/new/fileadmin/MULTI MEDIA/HQ/SHS/pdf/Soc_Sci_Code.pdf 1. Declaration of Helsinki, Paragraph 24 (2013): http://www.wma.net/en/30publications/10poli cies/b3/index.html 2. Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical- considerations-regarding-health-databases- and-biobanks/ 1. Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997): www.who.int/csr/emc97_3.pdf 2. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003): http://www.who.int/reproductivehealth/topics/ ethics/human_tissue_use.pdf Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical- considerations-regarding-health-databases- and-biobanks/ Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005) 1. ISBER Best Practices: Recommendations for Repositories (2018) Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Human Genome Organization: http://www.hugo-international.org/ UNESCO Bioethics Program: http://portal.unesco.org/shs/en/ev.php- URL_ID=1372&URL_DO=DO_TOPIC&URL _SECTION=201.html International Society for Stem Cell Research: http://www.isscr.org/ 2. ISBER Best Practices: Recommendations for Repositories. Fourth Edition. ADDENDUM 1: Liquid Nitrogen-Based Cryogenic Storage of Specimens (2019): https://www.isber.org/page/BPR 1. Statement on the Principled Conduct of Genetic Research (1996): http://www.eubios.info/HUGO.htm 2. Statement on DNA Sampling: Control and Access (1998): http://www.hugo- international.org/img/dna_1998.pdf 3. Statement on Gene Therapy Research (2001): http://www.hugo- international.org/img/gene_2001.pdf 4. Statement on Human Genomic Databases (2002): http://www.hugo- international.org/img/genomic_2002.pdf 1. Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998-1999 (1997): http://unesdoc.unesco.org/images/0011/00110 2/110220e.pdf#page=47 2. International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences (2003): http://unesdoc.unesco.org/images/0013/00133 1/133171e.pdf#page=45 Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/docs/default-source/hesc- guidelines/isscrhescguidelines2006.pdf 9 Country Key Organizations Legislation Regulations Guidelines NORTH AMERICA Canada Note: Several Canadian provinces and territories also have human subject research standards. General 1. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 2. National Defence and the Canadian Armed Forces: http://www.forces.gc.ca/en/index.page 3. Correctional Service of Canada: http://www.csc-scc.gc.ca/index-eng.shtml PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2018): http://www.pre.ethics.gc.ca/eng/document s/tcps2-2018-en-interactive-final.pdf National Defence and the Canadian Armed Forces: Research Involving Human Subjects (1998): http://www.forces.gc.ca/en/about- policies-standards-defence-admin-orders- directives-5000/5061-0.page Drugs, Biologics, and Devices Drugs 1. Health Canada, Therapeutic Products Directorate: http://www.hc- sc.gc.ca/ahc-asc/branch-dirgen/hpfb- dgpsa/tpd-dpt/index-eng.php 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 1. Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials) (2001): http://www.hc-sc.gc.ca/dhp- mps/alt_formats/hpfb- dgpsa/pdf/compli-conform/1024- eng.pdf Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2017): http://www.csc- scc.gc.ca/acts-and-regulations/009-cd-en.shtml Health Canada: Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2) (2017) https://www.canada.ca/content/dam/hc- sc/migration/hc-sc/dhp- mps/alt_formats/pdf/prodpharma/applic- demande/guide-ld/ich/efficac/e6r2-step4- eng.pdf Devices Health Canada, Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md- im/index-eng.php Medical Devices Regulations (SOR/98-282) (1998): http://laws- lois.justice.gc.ca/eng/regulations/sor- 98-282/FullText.html 10 PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 11: Clinical Trials (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf Country Key Organizations Legislation Regulations Guidelines Clinical Trials Registry Research Injury Social-Behavioral Research Privacy/Data Protection Note: Each of the Canadian provinces and territories also has enacted privacy legislation. Human Biological Materials Genetic Research 1. Health Canada Clinical Trial Database: http://www.hc-sc.gc.ca/dhp- mps/prodpharma/databasdonclin/index- eng.php 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 1. Office of the Privacy Commissioner of Canada (OPC): https://www.priv.gc.ca/en 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 Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 1. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index 2. Canadian Biotechnology Advisory Committee (CBAC): http://www.hc- sc.gc.ca/sr-sr/biotech/role/strateg-eng.php 3. Health Canada, Biologics and 1. Privacy Act, Sections 7-8 (1983): http://laws- lois.justice.gc.ca/PDF/P-21.pdf 2. Personal Information Protection and Electronic Documents Act, Articles 5 and 7 (2001): http://laws- lois.justice.gc.ca/PDF/P-8.6.pdf OPC: SOR/2001-6, SOR/2001-7, and SOR/2001-8 (September 29, 2014) PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Chapter 11.D. (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Article 3.2(j) (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans. Qualitative Research (Chapter 10) (2018): http://www.pre.ethics.gc.ca/eng/policy- politique/initiatives/tcps2-eptc2/Default/ PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 5: Privacy and Confidentiality (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf CIHR: CIHR Best Practices for Protecting Privacy in Health Research (2005): http://www.cihr- irsc.gc.ca/e/documents/et_pbp_nov05_sept200 5_e.pdf Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12: Human Biological Materials Including Materials Related to Human Reproduction (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 13: Human Genetic Research (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf 11 Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning United States Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/ Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO R-2007-137/index.html PRE: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last updated in 2018), and codified in the relevant section of the Code of Federal Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional subparts, such as: • 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) General Agency for International Development: www.usaid.gov/ Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety Commission: www.cpsc.gov/ Department of Agriculture: www.usda.gov/wps/portal/usdahome/ Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs /regulatory/ Department of Education: www.ed.gov/ United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects 1. Protection of Pupil Rights Amendment (1974) 2. Family Educational Rights and Privacy Act (1974) 12 22 CFR 225, Subpart A Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A 1. 7 CFR 1c, Subpart A 2. 45 CFR 46, Subparts B, C, and D 15 CFR 27, Subpart A 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011): http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf 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) Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015): https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf Country Key Organizations Legislation Regulations Guidelines General Department of Energy: http://science.energy.gov/ber/human- subjects/ Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/ Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/ Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland Security: www.dhs.gov/ Department of Housing and Urban Development: www.hud.gov/ 1. Department of Justice Office of Justice Programs: http://ojp.gov/ 2. Bureau of Prisons: www.bop.gov Department of Labor: https://www.dol.gov/ Public Health Service Act (1993): http://history.nih.gov/research/d ownloads/PL103-43.pdf Public Law 108-458, Section 8306 1. 10 CFR 745 (1991), Subpart A 2. DOE Order 443.1B 3. DOE Order 481.1 45 CFR 46, Subparts A, B, C, D, and E (2018): https://www.hhs.gov/ohrp/sites/defau lt/files/revised-common-rule-reg- text-unofficial-2018- requirements.pdf FDA is not a Common Rule agency. For studies conducted or funded by FDA: 45 CFR 46, Subparts A, D, and E: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html 1. 45 CFR 46, Subparts A-D 2. DHS Directive 026-04, Human Subjects Research (2007): https://www.dhs.gov/xlibrary/assets/f oia/mgmt-directive-026-04- protection-of-human-subjects.pdf 24 CFR 60.101, which cites 45 CFR part 46, subpart A. 1. 28 CFR 22 Privacy Regulation (1976): http://www.ecfr.gov/cgi- bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/ 28cfr22_main_02.tpl 2. 42 U.S.C. § 3789g Confidentiality of Information (1984) http://www.gpo.gov/fdsys/pkg/USC ODE-2010-title42/html/USCODE- 2010-title42-chap46-subchapVIII- sec3789g.htm 3. 28 CFR 46 (1991), Subpart A: http://www.ecfr.gov/cgi-bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/ 28cfr46_main_02.tpl 29 CFR 21 Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm 13 Country Key Organizations Legislation Regulations Guidelines General Department of Transportation: www.dot.gov/ Department of Veterans Affairs: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/ 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0 49 CFR 11, Subpart A 1. 38 FR 16 (1991), Subpart A 2. 38 CFR 17.85 (1998) 40 CFR 26 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA (Common Rule) 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women (2006) 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA (2006) 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA (2006) 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults (2013) 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who are Children or Pregnant or 14 Various: https://www.research.va.gov/resources/policies /human_research.cfm 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008): http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human- research-subjects-epa-conducted-or Country Key Organizations Legislation Regulations Guidelines Nursing Women (2013) General Drugs, Biologics, and Devices National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/ Social Security Administration: http://www.ssa.gov/ Drugs and Biologics Food and Drug Administration: https://www.fda.gov/Drugs and https://www.fda.gov/vaccines-blood- biologics Devices Food and Drug Administration, Center for Devices and Radiological 1. Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (2012): https://uscode.house.gov/browse/pre lim@title21&edition=prelim 2. Public Health Service Act, 42 USC Section 262 (1998): https://uscode.house.gov/browse/pre lim@title42&edition=prelim 3. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW- 114publ255.pdf 1. Food, Drug, and Cosmetic Act, 21 USC Section 360 15 7. Subpart M: Requirements for Submission of Information on the Ethical Conduct of Completed Human Research (2013) 8. Subpart O: Administrative Actions for Noncompliance (2013) 9. Subpart P: Review of Proposed and Completed Human Research (2013) 10. Subpart Q: Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions (2013) 14 CFR 1230, Subpart A 45 CFR 690, Subpart A 45 CFR 46, Subpart A: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html Title 21, Code of Federal Regulations: https://www.fda.gov/science- research/clinical-trials-and-human- subject-protection/regulations-good- clinical-practice-and-clinical-trials 1. 21 CFR 50 (Informed Consent) 2. 21 CFR 312 (Investigational New Drug Application) 3. 21 CFR 56 (Institutional Review Boards) 4. 21 CFR 314 (Applications for Approval to Market a New Drug) 5. 21 CFR 54 (Financial Disclosure by Clinical Investigators) 6. 21 CFR 320 (Bioavailability and Bioequivalence Requirements) Title 21, Code of Federal Regulations: General: Good Clinical Practice and Human Subject Protection in FDA-Regulated Clinical Trials: https://www.fda.gov/science- research/science-and-research-special- topics/clinical-trials-and-human-subject- protection Drugs: https://www.fda.gov/drugs/guidance- compliance-regulatory-information/guidances- drugs Biologics: https://www.fda.gov/vaccines-blood- biologics/guidance-compliance-regulatory- information-biologics Good Clinical Practice and Human Subject Protections in FDA-Regulated Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Health: https://www.fda.gov/Medical- Devices Food and Drug Administration: https://www.fda.gov/science- research/clinical-trials-and-human- subject-protection/fdas-role- clinicaltrialsgov-information National Institutes of Health ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/home (2012): https://uscode.house.gov/browse/pre lim@title21/chapter9/subchapter5& edition=prelim 2. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW- 114publ255.pdf 1. Food and Drug Administration Modernization Act, Section 113 (1997): https://www.fda.gov/regulatory- information/selected-amendments- fdc-act/food-and-drug- administration-modernization-act- fdama-1997 2. Food and Drug Administration Amendments Act, Section 801 (2007): https://www.fda.gov/regulatory- information/selected-amendments- fdc-act/food-and-drug- administration-amendments-act- fdaaa-2007 https://www.fda.gov/science- research/clinical-trials-and-human- subject-protection/regulations-good- clinical-practice-and-clinical-trials 1. 21 CFR 50 (Informed Consent) 2. 21 CFR 56 (Institutional Review Boards) 3. 21 CFR 807, Subpart E 4. 21 CFR 812 (Investigational Device Exemptions) 5. 21 CFR 814 (Premarket Approval of Medical Devices) 6. 21 CFR 54 (Financial Disclosure by Clinical Investigators) 1. Clinical Trials Regulation and Results Information Submission, 42 CFR 11 (2016): https://www.federalregister.gov/docu ments/2016/09/21/2016- 22129/clinical-trials-registration-and- results-information-submission 2. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (2016): https://www.federalregister.gov/docu ments/2016/09/21/2016- 22379/dissemination-of-nih-funded- clinical-trial-information Clinical Trials: https://www.fda.gov/science- research/science-and-research-special- topics/clinical-trials-and-human-subject- protection Other: https://www.fda.gov/medical- devices/device-advice-comprehensive- regulatory-assistance/guidance-documents- medical-devices-and-radiation-emitting- products FAQs on ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/manage- recs/faq 16 Country Key Organizations Legislation Regulations Guidelines Clinical Trials Registry Research Injury Social-Behavioral Research Privacy/Data Protection Department of Veterans Affairs: 1. Office of Research Oversight (ORO): http://www1.va.gov/oro/ 2. Office of Research and Development: www.research.va.gov Department of Defense, Regulatory Affairs: http://www.acq.osd.mil/rd/hptb/programs/ regulatory/ Department of Veterans Affairs: 1. Office of Research Oversight (ORO): www1.va.gov/oro/ 2. Office of Research and Development: www.research.va.gov All Common Rule agencies. National Science Foundation: https://www.nsf.gov/ All Common Rule agencies Department of Health and Human Services (DHHS): 1. National Institutes of Health (NIH): http://privacyruleandresearch.nih.gov/ 2. Agency for Healthcare Research and Quality (AHRQ): https://www.ahrq.gov/ 3. Office for Civil Rights (OCR): http://www.hhs.gov/ocr/hipaa/ 38 CFR 17.85: Treatment of Research-Related Injuries to Human Subjects: https://www.gpo.gov/fdsys/pkg/CF R-2013-title38-vol1/pdf/CFR-2013- title38-vol1-sec17-85.pdf 1. Privacy Act, 5 U.S.C. § 552a (1974): http://www.justice.gov/opcl/privacy act1974.htm 2. Health Insurance Portability and Accountability Act (1996): https://www.gpo.gov/fdsys/pkg/PL AW-104publ191/content-detail.html 3. Confidential Information Protection and Statistical Efficiency Act (CIPSEA) (2002): http://www.eia.gov/cipsea/cipsea.pd f 4. Health Information Technology for Economic and Clinical Health (HITECH) Act (2009): https://www.gpo.gov/fdsys/pkg/PL 17 Sections 116(a)(6) and (7) of the Common Rule: https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text- unofficial-2018-requirements.pdf DoDI 3216.02 (2011): http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf Handbook 1200.5, Appendix F, Paragraph 2a(11) Predominantly Exempt categories 1, 2, and 3, and Expedited categories 6 and 7. Common Rule 111(a)(7) (2018) 1. HIPAA Privacy Rule, 45 CFR parts 160 and 164, Subparts A and C (2002): http://www.hhs.gov/ocr/privacy/hipaa /administrative/privacyrule/index.htm l 2. HIPAA Security Rule, 45 CFR parts 160, 162, and 164 (2009): http://www.hhs.gov/ocr/privacy/hipaa /administrative/securityrule/index.ht ml 3. HIPAA Breach Notification Rule, 45 CFR §164.400-414: http://www.hhs.gov/ocr/privacy/hipaa /administrative/breachnotificationrule /index.html FAQ: http://www.research.va.gov/resources/ORD_A dmin/clinical_trials/registration-faq.pdf Frequently Asked Questions and Vignettes: https://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp NIH: 1. NIH Policy on Certificates of Confidentiality (2017): https://humansubjects.nih.gov/coc/index 2. Various: http://privacyruleandresearch.nih.gov/ AHRQ: Confidentiality in AHRQ-Supported Research (2018): https://grants.nih.gov/grants/guide/notice- files/NOT-HS-18-012.html OCR: 1. OCR 21st Century Cures Act Research Guidance on Activities Preparatory to Research (2017): https://www.hhs.gov/sites/default/files/remote- Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection AW-111publ5/pdf/PLAW- 111publ5.pdf access-research-12-15-17.pdf 2. OCR 21st Century Cures Act Research Guidance om Streamlining Authorization (2018): https://www.hhs.gov/sites/default/files/hipaa- future-research-authorization-guidance- 06122018%20v2.pdf Human Biological Materials Department of Homeland Security: www.dhs.gov/ Social Security Administration: http://www.ssa.gov/ All Common Rule agencies Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/ Food and Drug Administration: a. Office of In Vitro Diagnostic Device Evaluation and Safety: https://www.fda.gov/medical- devices/products-and-medical- procedures/vitro-diagnostics b. Center for Biologics Research and Evaluation (CBER): - Office of Cellular, Tissue and Gene Therapies - Office of Blood Research and Review: https://www.fda.gov/vaccines-blood- biologics Public Law 107-347: https://www.gpo.gov/fdsys/pkg/PL AW-107publ347/pdf/PLAW- 107publ347.pdf Privacy Act (1974): http://www.hhs.gov/foia/privacy/ind ex.html 18 Predominantly Exempt categories 4, 7, and 8, and Expedited categories 2, 3, and 5 in the Common Rule (2018): https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text- unofficial-2018-requirements.pdf Various: https://www.hhs.gov/hipaa/for- professionals/special- topics/research/index.html and https://www.hhs.gov/hipaa/for- professionals/faq/research-uses-and-disclosures Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/biological-materials-and- data/index.html 1. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable (2006): https://www.fda.gov/regulatory- information/search-fda-guidance- documents/guidance-informed-consent-vitro- diagnostic-device-studies-using-leftover- human-specimens-are-not 2. In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (2010) : https://www.fda.gov/regulatory- information/search-fda-guidance- documents/vitro-diagnostic-ivd-device-studies- Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning All Common Rule agencies 1. DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/ 2. DHHS National Institutes of Health, Office of Science Policy, Biosafety, Biosecurity, and Emerging Biotechnology Policy Division: https://osp.od.nih.gov/biosafety- biosecurity-and-emerging-biotechnology/ 3. DHHS Office for Civil Rights (OCR): https://www.hhs.gov/hipaa/for- professionals/special-topics/genetic- information/index.html Food and Drug Administration, Center for Biologics Evaluation and Research: https://www.fda.gov/vaccines- blood-biologics National Academy of Sciences (NAS): http://www.nationalacademies.org/nrc/ National Institutes of Health: http://stemcells.nih.gov/ 1. Research on Transplantation of Fetal Tissue, Public Law 103- 43 (1993): http://www.hhs.gov/ohrp/regulation s-and-policy/guidance/public-law- 103-43/index.html 2. Genetic Information Nondiscrimination Act (2008): https://www.gpo.gov/fdsys/pkg/PL AW-110publ233/content-detail.html Research on Transplantation of Fetal Tissue. Public Law 103-43 19 Common Rule 116(c)(9) (2018) HIPAA Privacy Rule Provisions Implementing GINA Requirements at 45 CFR 160.103; 45 CFR 164.502(a)(5)(i); 45 CFR 164.514(g); and 45 CFR 164.520(b)(1)(iii)(C) frequently-asked-questions 3. CBER-Specific: Various: https://www.fda.gov/vaccines-blood- biologics/other-recommendations-biologics- manufacturers/references-regulatory-process- office-tissues-and-advanced-therapies OHRP: Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards (2009): http://www.hhs.gov/ohrp/regulations-and- policy/guidance/guidance-on-genetic- information-nondiscrimination-act/index.html NIH: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016): https://osp.od.nih.gov/wp- content/uploads/2013/06/NIH_Guidelines.pdf Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products. October 14, 1993. 58 FR 53248: https://www.fda.gov/media/76647/download 1. Guidelines for Human Embryonic Stem Cell Research (2005): http://www.nap.edu/catalog.php?record_id=11 278 2. 2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research: http://books.nap.edu/catalog.php?record_id=12 260 3. 2010 Final Report of the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research: http://www.nap.edu/catalog.php?record_id=12 923 1. Removing Barriers to Responsible Scientific Research Involving Human Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning (1993): https://history.nih.gov/research/dow nloads/PL103-43.pdf Stem Cells, Executive Order 13505 (2009): https://www.gpo.gov/fdsys/pkg/DCPD- 200900136/pdf/DCPD-200900136.pdf 2. NIH Guidelines on Human Stem Cell Research (2009): http://stemcells.nih.gov/policy/2009- guidelines.htm 3. NIH Human Embryonic Stem Cell Registry (2016): https://grants.nih.gov/stem_cells/registry/curre nt.htm Access: http://stemcells.nih.gov/ 20 Country Key Organizations Legislation Regulations Guidelines EUROPE Regionwide General Drugs, Biologics, and Devices European Commission: 1. European Group on Ethics in Science and New Technologies (EGE): https://ec.europa.eu/research/ege/index.cf m 2. Directorate-General for Research and Innovation: http://ec.europa.eu/research/participants/d ocs/h2020-funding-guide/cross-cutting- issues/ethics_en.htm Council of Europe, Bioethics Unit: http://www.coe.int/bioethics Drugs European Commission: DG SANTE: Directorate-General for Health and Food Safety: http://ec.europa.eu/health/index_en.htm 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (1997): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, CETS No. 195 (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG 1. Directive 2001/20/EC on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use: http://ec.europa.eu/health/files/eudra lex/vol- 1/dir_2001_20/dir_2001_20_en.pdf 2. Directive 2005/28/EC Laying 21 EGE: 1. Ethical Aspects of Clinical Research in Developing Countries (2003): http://ec.europa.eu/bepa/european-group- ethics/docs/avis17_en.pdf 2. Horizon 2020: How to Complete your Ethics Self –Assessment (2015): http://ec.europa.eu/research/participants/portal/ doc/call/h2020/h2020-msca-if-2015/1645175- h2020_-_guidance_ethics_self_assess_en.pdf EudraLex Volume 10: Clinical Trials: http://ec.europa.eu/health/documents/eudralex/ vol-10/ Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices European Medicines Agency: http://www.ema.europa.eu/ Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorization of the Manufacturing or Importation of Such Products: http://ec.europa.eu/health/files/eudra lex/vol- 1/dir_2005_28/dir_2005_28_en.pdf 3. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, Repealing Directive 2001/20/EC: http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2014_536/reg_2014_536_en. pdf 4. Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the Detailed Arrangements for the Good Clinical Practice Inspection Procedures Pursuant to Regulation (EU) No 536/2014 of the European Parliament and Council: https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CEL EX:32017R0556&from=EN 22 1. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) (1997): https://ec.europa.eu/health/sites/health/file s/files/eudralex/vol-10/3cc1aen_en.pdf 2. Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products for Human Use Conducted Outside of the EU/EEA and Submitted in Marketing Authorization Applications to the EU Regulatory Authorities (2012): http://www.ema.europa.eu/docs/en_GB/docum Country Key Organizations Legislation Regulations Guidelines ent_library/Regulatory_and_procedural_guideli Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Devices DG GROWTH: Internal Market, Industry, Entrepreneurship, SMEs: https://ec.europa.eu/growth/sectors/medic al-devices_en EU Clinical Trials Register: https://www.clinicaltrialsregister.eu/ European Commission: DG SANTE: Directorate-General for Health and Food Safety: http://ec.europa.eu/health/index_en.htm 1. Directive 93/42/EEC Concerning Medical Devices: http://eur- lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=CONSLEG:1993L0042:2 0071011:en:PDF 2. Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVD): https://ec.europa.eu/growth/single- market/european- standards/harmonised-standards/iv- diagnostic-medical-devices_en 3. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive 90/385/EEC on Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX :32007L0047&from=EN 1. Clinical Trials Directive 2001/20/EC: http://ec.europa.eu/health/human- use/clinical- trials/directive/index_en.htm 2. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, Repealing Directive 2001/20/EC: ne/2012/04/WC500125437.pdf 3. Guideline for Good Clinical Practice E6(R2) (2016): http://www.ema.europa.eu/docs/en_GB/docum ent_library/Scientific_guideline/2009/09/WC5 00002874.pdf Various: http://ec.europa.eu/consumers/sectors/medical- devices/documents/guidelines/index_en.htm FAQs: https://www.clinicaltrialsregister.eu/doc/EU_C TR_FAQ.pdf 23 Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Council of Europe, Bioethics Unit: http://www.coe.int/bioethics European Data Protection Board (EDPB): https://edpb.europa.eu/ http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2014_536/reg_2014_536_en. pdf 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (1997): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Article 13, CETS No. 195 (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation): http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX :32016R0679&from=EN EDPB: 1. Guidelines on consent under Regulation 2016/679, WP259 rev.01: http://ec.europa.eu/newsroom/article29/item- detail.cfm?item_id=623051 2. Transfers of Personal Data to Third Countries: Applying Articles 25 and 26 of the EU Data Protection Directive (1998): Consent (2018): http://ec.europa.eu/justice/article- 29/documentation/opinion- recommendation/files/1998/wp12_en.pdf 3. Adequacy Referential (2018): http://ec.europa.eu/newsroom/article29/docume nt.cfm?action=display&doc_id=49724 4. Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (2019): https://edpb.europa.eu/our-work-tools/our- documents/opinion-art-70/opinion-32019- concerning-questions-and-answers- interplay_en 24 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Samples European Medicines Agency (EMA): http://www.ema.europa.eu/ Council of Europe: Data Protection and Cybercrime Division: http://www.coe.int/t/dghl/standardsetting/ dataprotection/default_EN.asp European Commission: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m Council of Europe, Bioethics Unit: http://www.coe.int/bioethics Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1981): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=10 8&CL=ENG 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://eur- lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=CELEX:32004L0023:EN :HTML Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22, ETS No. 164 (1997): 25 1. European Medicines Agency policy on publication of clinical data for medicinal products for human use https://www.ema.europa.eu/documents/other/e uropean-medicines-agency-policy-publication- clinical-data-medicinal-products-human- use_en.pdf 2. Questions and Answers on the European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products for Human Use (2015): http://www.ema.europa.eu/docs/en_GB/docum ent_library/Report/2014/10/WC500174378.pdf 3. External Guidance on the Implementation of the European Medicines Agency Policy on the Publication of Clinical Data for Medicinal Products for Human Use (2016): https://www.ema.europa.eu/documents/regulat ory-procedural-guideline/external-guidance- implementation-european-medicines-agency- policy-publication-clinical-data_en-1.pdf 1. Recommendation No. R (97) 5 on the Protection of Medical Data (1997): https://wcd.coe.int/ViewDoc.jsp?id=571075&S ite=CM&BackColorInternet=C3C3C3&BackC olorIntranet=EDB021&BackColorLogged=F5 D383 2. Article 29 Working Party Documentation: http://ec.europa.eu/justice/data- protection/article-29/index_en.htm Guidelines on Good Clinical Practice Specific to Advanced Therapy Medicinal Products: https://ec.europa.eu/health/sites/health/files/file s/eudralex/vol-10/atmp_guidelines_en.pdf Recommendation Rec (2016) 6 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin: Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning European Medicines Agency: http://www.ema.europa.eu/ Council of Europe, Bioethics Unit: http://www.coe.int/bioethics European Commission: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No. 726/2004: http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2007_1394/reg_2007_1394_e n.pdf 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14, ETS No. 164 (1997): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, CETS No. 195 (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG 1. Statements by the Commission Re: Article 6 (2006): http://www.uv.es/operuv/docs_7pm/ FP7ECStatementsComm_Ethical.pd f 2. Statement of the Commission Related to Research Activities Involving Human Embryonic Stem Cells (2013): http://eur- lex.europa.eu/LexUriServ/LexUriSe 26 https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff 1. Recommendation No. R (92) on Genetic Testing and Screening for Health Care Purposes (1992): http://wcd.coe.int/ViewDoc.jsp?id=612007&Si te=CM&BackColorInternet=9999CC&BackCo lorIntranet=FFBB55&BackColorLogged=FFA C75 2. Recommendation Rec (2006)4 of the Committee of Ministers to Members States on Research on Biological Materials of Human Origin (2016): https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff 3. Recommendation Rec(2016)8 of the Committee of Ministers to Member States on the Processing of Personal Health- Related Data for Insurance Purposes, Including Data Resulting from Genetic Tests (2016): https://search.coe.int/cm/Pages/result_details.as px?ObjectId=09000016806b2c5f 1. Commission Staff Working Paper Report on Human Embryonic Stem Cell Research (2003): https://ec.europa.eu/research/press/2003/pdf/se c2003-441report_en.pdf 2. Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007): http://bookshop.europa.eu/ga/recommendations -on-the-ethical-review-of-hesc-fp7-research- projects-pbKAAJ07022/downloads/KA-AJ-07- 022-EN- C/KAAJ07022ENC_002.pdf;pgid=y8dIS7GU Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Armenia Council of Europe, Bioethics Unit: http://www.coe.int/bioethics rv.do?uri=OJ:C:2013:373:0012:001 5:EN:PDF 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Additional Protocol on Prohibition of Human Cloning, ETS No. 168 (1998): http://conventions.coe.int/Treaty/Comm un/QueVoulezVous.asp?NT=168&CM= 7&DF=9/15/2008&CL=ENG WMdSR0EAlMEUUsWb0000dz- kvfzb;sid=Iexx3tq0IOFxyokBvtfvebiRJj93DZf XP54=?FileName=KAAJ07022ENC_002.pdf &SKU=KAAJ07022ENC_PDF&CatalogueNu mber=KA-AJ-07-022-EN-C Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 1: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf Note: All websites and documents are in Armenian. Drugs, Biologics, and Devices Human Biological Materials Austria General 1. Drug and Medical Technology Agency: http://www.pharm.am/ 2. Ethics Committee of the Ministry of Health Ethical Committee of the National Center for AIDS Prevention: http://www.armaids.am/main/index.php?l ng=1 1. Ministry of Health: http://www.bmg.gv.at 2. Forum of Austrian Ethics Committees: http://www.ethikkommissionen.at 3. Bioethics Commission: 1. Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21: http://www.arlis.am/DocumentView .aspx?DocID=71619 2. Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Medications in Armenia: http://www.arlis.am/DocumentView .aspx?docID=9154 RA Law on Prevention of Disease Caused by HIV (2012): http://www.arlis.am/DocumentView .aspx?DocID=78616 1. University Act (2011): http://www.ris.bka.gv.at/Dokumente /Erv/ERV_2002_1_120/ERV_2002 _1_120.pdf 2. Hospitals Act (2014): http://www.ris.bka.gv.at/GeltendeFa 27 Regulation on Leading Ethics Committees (2004): http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen& Gesetzesnummer=20003352&ShowP rintPreview=True Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2013) Bioethics Commission: 1. Codification of Legislation on Medical Research (2011) 2. Research on Persons without the Capacity to Consent (2013) Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Note: The Austrian states also have privacy/data protection laws http://www.bundeskanzleramt.at/site/3575 /default.aspx Drugs 1. Ministry of Health: http://www.bmg.gv.at 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian- agency-for-health-and-food-safety/ 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian- federal-office-for-safety-in-health-care/ Devices 1. Ministry of Health: http://www.bmg.gv.at 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian- agency-for-health-and-food-safety/ 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian- federal-office-for-safety-in-health-care/ 1. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian- agency-for-health-and-food-safety/ 2. Austrian Federal Office for Safety in Health Care: http://www.basg.at/en/austrian-federal- office-for-safety-in-health-care/ Austrian Data Protection Authority: https://www.dsb.gv.at/DesktopDefault.asp x?alias=dsken ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010285&Sho wPrintPreview=True Austrian Drug Law (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010441&Sho wPrintPreview=True Medical Devices Act (2014): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003 1. Austrian Drug Law, Article 32 (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010441&Sho wPrintPreview=True 2. Austrian Medical Devices Law, Article 47 (2017): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003&Sho wPrintPreview=True 1. Data Protection Act No. 165/1999: https://www.ris.bka.gv.at/GeltendeF assung.wxe?Abfrage=Bundesnorme n&Gesetzesnummer=10001597 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 28 Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx Various: http://www.basg.at/arzneimittel/vor-der- zulassung/klinische-pruefungen/ Various: http://www.basg.at/medizinprodukte/formulare /klinische-pruefung/ Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Belarus 1. Ministry of Health: http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/3575 /default.aspx 1. Ministry of Health: http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/3575 /default.aspx 1. Ministry of Health: http://www.bmg.gv.at 2. Bioethics Commission: http://www.bundeskanzleramt.at/site/3575 /default.aspx 1. Law on Safety of Blood (2009): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011145&Sho wPrintPreview=True 2. Law on Quality and Safety of Human Tissue and Cells (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=20005698&Sho wPrintPreview=True Gene Technology Act (2012): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010826&Sho wPrintPreview=True Reproductive Medicine Act (2010): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10003046&Sho wPrintPreview=True Regulation on Tissue Banks (2014): http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen& Gesetzesnummer=20005848&ShowP rintPreview=True Bioethics Commission: 1. Opinion of the Bioethics Commission at the Federal Chancellery: Biobanks for Medical Research (2007) 2. Biobanks for Medical Research - Amendments to the Bioethics Commission Report of May 2007 (2011) Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx Bioethics Commission: 1. Stem Cell Research in the Context of the EU’s Sixth Framework Programme Research (2002) 2. Research on Human Embryonic Stem Cells (2009): http://www.bundeskanzleramt.at/DocView.axd ?CobId=34240 For an overview of human subject protections in Belarus, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 3: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf General Drugs, Biologics, and Devices 1. Ministry of Health (MOH): http://minzdrav.by/en/ 2. National Bioethics Committee Drugs 1. Ministry of Health (MOH): http://minzdrav.by/en/ 2. State Pharmacological Committee 3. Centre for Expertise and Testing in Health Care: http://rceth.by/ 1. Constitution of the Republic of Belarus, Article 25 (2004): http://www.pravo.by/WEBNPA/text .asp?RN=v19402875 2. Law on Health Care System, Articles 40, 46 (2010): http://pravo.by/webnpa/text.asp?RN =v19302435 1. Law on Drugs, Articles 15,16 (2009): http://pravo.by/webnpa/text.asp?RN =h10600161 2. Law on Health Care System, Article 40 (2010): 29 MOH: 1. Ordinance No. 274 on Establishing the National Bioethics Committee (2006) 2. Decree No. No. 55 on Ethics Committees (2008) (Russian): http://www.levonevski.net/pravo/nor m2009/num05/d05639.html MOH: 1. Ordinance No. 254 on Clinical Drug Trials and Good Clinical Practice (1999): http://www.levonevski.net/pravo/nor m2009/num36/d36922/index.html MOH: 1. Code of Medical Ethics (1999): http://www.levonevski.net/pravo/norm2009/nu m37/d37726.html 2. Guidelines for Ethics Committees on Standard Operational Proceedings (No. 55-0004, 2000): http://www.levonevski.net/pravo/norm2009/nu m35/d35896/index.html 3. Methodological Guidelines of Health Ministry (2000) MOH: Instruction on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical Trials of Drugs and Medical Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Privacy/Data Protection Human Biological Materials Devices 1. Ministry of Health (MOH): http://minzdrav.by/en/ 2. Centre for Expertise and Testing in Health Care: http://rceth.by/ 1. Ministry of Health: http://minzdrav.by/en/ 2. National Bioethics Committee 1. Ministry of Health (MOH): http://minzdrav.by/en/ 2. National Bioethics Committee 3. State Service of Forensic Medicine http://pravo.by/webnpa/text.asp?RN =v19302435 Law on Health Care System, Article 40 (2010): http://pravo.by/webnpa/text.asp?RN =v19302435 1. Constitution of the Republic of Belarus, Article 28 (2004): http://www.pravo.by/WEBNPA/text .asp?RN=v19402875 2. Law on Health Care System, Article 46 (2010): http://pravo.by/webnpa/text.asp?RN =v19302435 Law on Health Care System, Articles 40 and 46 (2010): http://pravo.by/webnpa/text.asp?RN =v19302435 30 2. Ordinance No. 161 on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical Trials of Drugs and Medical devices (1999): http://www.levonevski.net/pravo/nor m2009/num37/d37336.html 3. Decree No. 55 on Ethics Committees (2008): http://www.levonevski.net/pravo/nor m2009/num05/d05639.html 4. Decree No. 50 on Certain Aspects of Clinical Drug Trials (2009) MOH: 1. Ordinance No. 161 on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical Trials of Drugs and Medical devices (1999): http://www.levonevski.net/pravo/nor m2009/num37/d37336.html 2. Decree No. 216 on Certain Aspects of Clinical Trials of Medical Devices (2008) (Russian): http://86.57.250.247/data/pravo/ipb_p rikazmz/N216_2008.htm MOH: Ordinance No. 111 on Further Development of National Pathology Service (1993): Devices (No. 55-0504, 2004) (Russian): http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html MOH: Instruction on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical Trials of Drugs and Medical Devices (No. 55-0504, 2004): http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Belgium (SSFM) http://86.57.250.247/data/pravo/ipb_p rikaznew/N111_1993(1994).doc SSFM: Ordinance No. 38-c on Rules for Conducting Morphological Examinations (1999) For an overview of human subject standards in Belgium, see The Ethics Committees: https://www.famhp.be/en/human_use/medicines/medicines/research_development/ethic_committee General 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian -advisory-committee-bioethics Law Relating to Experimentation on Humans (2004): http://www.ejustice.just.fgov.be/cgi _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi FAMHP: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee BACB: 1. Opinion No. 13: Experimentation on Humans (2001) 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004) 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006) 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007) 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012) 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical Trial (2015) 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017) Access: https://www.health.belgium.be/en/list- opinions 31 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials 1. Federal Agency for Medicines and Health Products (FAMHP): Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian -advisory-committee-bioethics 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative- bodies/ct-college-clinical-trial-college Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines Belgian Data Protection Authority: https://www.dataprotectionauthority.be/ 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines 2. Belgian Advisory Committee on Bioethics (BACB): http://www.health.belgium.be/en 3. Superior Health Council (CSS): http://www.health.belgium.be/eportal/Abo utus/relatedinstitutions/SuperiorHealthCo uncil/index.htm Law Relating to Experimentation on Humans (2004): http://www.ejustice.just.fgov.be/cgi _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i Law Relating to Experimentation on Humans, Chapter XVII (Responsibility and Insurance) Article 29 (2004): https://www.famhp.be/en/human_us e/medicines/medicines/research_dev elopment/ethic_committee 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 3. Act on the Protection of Natural Persons with Regard to the Processing of Personal Data (30 July 2018): https://www.dataprotectionauthority .be/legislation-and-standards Law Relating to the Use of Human Biological Materials (19 December 2008): https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor el_humain/legislation/apres_le_01_ 12_2009 32 1. Royal Decrees to Experimentation on Humans: https://www.famhp.be/en/human_use/ medicines/medicines/research_develo pment/ethic_committee 2. Royal Decrees on Clinical Trials: https://consultativebodies.health.belgi um.be/en/advisory-and-consultative- bodies/ct-college-clinical-trial-college Decree of February 13, 2001 Implementing the Law of December 8, 1999: http://www.privacycommission.be/sit es/privacycommission/files/document s/Royal_Decree_2001.pdf Royal Decrees to the Use of Human Biological Materials: https://www.afmps.be/fr/humain/prod uits_de_sante/materiel_corporel_hum ain/banques_de_materiel_corporel_h umain/legislation/apres_le_01_12_20 09 BACB: 1. Opinion No. 58: Financing Expensive Medication: https://www.health.belgium.be/sites/default/file s/uploads/fields/fpshealth_theme_file/opinion_ 58_web.pdf 1. Legal Basis (2018): https://www.autoriteprotectiondonnees.be/fond ement-legal-pour-le-traitement-de-donnees-a- caractere-personnel 2. Consent (2018): https://www.autoriteprotectiondonnees.be/cons entement 3. International Data Transfer (2018): https://www.autoriteprotectiondonnees.be/inter national-0 BACB: 1. Opinion No. 42: Umbilical Cord Blood Banks (2007) 2. Opinion No. 43: Commercialization of Human Body Parts (2007) 3. Opinion No. 45: Human Biological Material Banks Intended for Research (2009) 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine Country Key Organizations Legislation Regulations Guidelines Human Biological Materials (2012) 5. Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applications or for Scientific Research Purposes (2012) Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics Embryos, Stem Cells, and Cloning 1. Federal Commission for Medical and Scientific Research on Embryos in Vitro: http://health.belgium.be/eportal/Healthcar e/Consultativebodies/Commissions/Embr yoinvitro/19076630?ie2Term=research&i e2section=83 2. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines 3. Belgian Advisory Committee on Bioethics: https://www.health.belgium.be/en/belgian -advisory-committee-bioethics 1. Act on Research on Embryos in Vitro (2003): https://organesdeconcertation.sante. belgique.be/fr/organe-d'avis-et-de- concertation/commission-federale- embryons 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007): https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor el_humain/legislation/apres_le_01_ 12_2009 Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15 February 1999): https://organesdeconcertation.sante.be lgique.be/fr/organe-d'avis-et-de- concertation/commission-federale- embryons CSS: Various: https://www.health.belgium.be/en/superior- health- council?f%5B0%5D=field_shc_doc%3A1145 BACB: 1. Opinion No. 10: Reproductive Human Cloning (1999) 2. Opinion No. 18: Research on Human Embryos in Vitro (2002) 3. Opinion No. 33: Somatic and Germinal Line Gene Modification (2005) 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012) Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics Bosnia and Herzegovina Note: All websites and documents are in Bosnian. General 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (2007): 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2007) 3. Law on Health Protection, MoH Republic of Srpska (2015): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20zdravstven 33 Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Federation of Bosnia and Herzegovina 1. Ministry of Health: http://www.fmoh.gov.ba/ 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/ Republic of Srpska 1. Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa ges/Splash.aspx 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/ oj%20zastiti%20sa%20izmjenama %20106-99%20%2044-15.pdf 4. Law on Health Protection, MoH Federation of Bosnia and Herzegovina, No 46/10: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- zdravstvenoj-zastiti 1. Law on Drugs No. 58/08: http://www.almbih.gov.ba/_doc/reg ulative/medicinal_products_and_me dical_devices_act.pdf 2. Law on Changes and Amendments of the Law on Drugs No. 29/05: http://www.almbih.gov.ba/_doc/reg ulative/fbih/Zakon_o_lijekovima- sluzbene_novine_FBiH_broj_29- 05.pdf 3. Law on Drugs Federation of Bosnia and Herzegovina, No 109/2012: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- lijekovima-fbih 1. Law on Drugs No. 58/08: http://www.almbih.gov.ba/_doc/reg ulative/medicinal_products_and_me dical_devices_act.pdf 2. Law on Changes and Amendments of Law on Drugs No. 34/08: http://www.almbih.gov.ba/_doc/reg ulative/rs/ID_Zakona_o_lijekovima _34_08.pdf 34 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak se-bo.pdf 4. Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016): http://www.almbih.gov.ba/_doc/upust va- vodici/uputstvo_o_nacinu_izvjestava nja_o_sigurnosti.pdf 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak se-bo.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Embryos, Stem Cells Federation of Bosnia and Herzegovina Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/ Republic of Srpska Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa ges/Splash.aspx Personal Data Protection Agency of Bosnia and Herzegovina: http://www.azlp.gov.ba/Default.aspx?lang Tag=en- US&template_id=147&pageIndex=1 Federation of Bosnia and Herzegovina 1. Medicinal Products and Medicinal Devices Act, Articles 52 and 116 (2008): http://www.almbih.gov.ba/_doc/reg ulative/medicinal_products_and_me dical_devices_act.pdf 2. Law on Health Insurance of the Federation of Bosnia and Herzegovina, Official Gazette No. 46/10 1. Medicinal Products and Medicinal Devices Act, Article 52 and 116 2. Law on Health Insurance of the Republic of Srpska, Official Gazette Republic of Srpska No. 106/09: http://www.farmaceutska- komora.org/images/stories/5Zakon_ o_zdravstvenoj_zastiti.pdf 1. Law on the Protection of Personal Data in Bosnia and Herzegovina (2005): http://www.azlp.gov.ba/propisi/Def ault.aspx?id=5&langTag=en- US&pageIndex=1 2. Law on Amendments to the Law on the Protection of Personal Data in Bosnia and Herzegovina, Official Gazette of Bosnia and Herzegovina No. 76/11 (2011): http://www.azlp.gov.ba/Default.asp x?langTag=en- US&template_id=147&pageIndex= 1 4. Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016): http://www.almbih.gov.ba/_doc/upust va- vodici/uputstvo_o_nacinu_izvjestava nja_o_sigurnosti.pdf Regulation about Clinical Testing of IMP and Medical Devices, 4/10: http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf Regulation about Clinical Testing of IMP and Medical Devices, 4/10: http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf Regulation on the Manner of Keeping the Records of Personal Data Filing Systems and the Pertinent Records Form (2009): http://www.azlp.gov.ba/propisi/defaul t.aspx?id=1321&langTag=bs-BA 35 Country Key Organizations Legislation Regulations Guidelines and Cloning Bulgaria General Ministry of Health: http://www.fmoh.gov.ba/ Republic of Srpska Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa ges/Splash.aspx Ministry of Healthcare: http://www.mh.government.bg/ 1. Law on Transplantation of Organs and Tissues, Official Gazette of Bosnia and Herzegovina No. 75/09: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- transplantaciji-organa-i-tkiva-u- svrhu-lijecenja 2. Law on Blood and Blood Products, Official Gazette of Bosnia and Herzegovina No. 09/10: http://www.fbihvlada.gov.ba/bosans ki/zakoni/2010/zakoni/8bos.htm 1. Law on Transplantation of Organs (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20transplanta ciji%20ljudskih%20organa.pdf 2. Law on Transplantation of Human Tissues and Cells (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20transplanta ciji%20ljudskih%20tkiva%20i%20c elija.pdf 1. Constitution of the Republic of Bulgaria, Amendment SG. 18/25, Article 29 (2015): http://www.parliament.bg/bg/const 2. Oviedo Convention on Human Rights and Biomedicine (2003) 3. Law Ratifying the Additional Protocol on Biomedical Research (2006): https://www.mh.government.bg/me dia/filer_public/c6/12/c612c85a- 36 Rulebook about Testing Procedure for Donor of Transplant Organs in Terms of Diseases Which can be Transmitted by Transplantation (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Documents/%d 0%9f%d1%80%d0%b0%d0%b2%d0%b8%d0 %bb%d0%bd%d0%b8%d0%ba_%d0%be_%d 0%ba%d1%80%d0%b8%d1%82%d0%b5%d1 %80%d0%b8%d1%98%d1%83%d0%bc%d0% b8%d0%bc%d0%b0_%d0%b7%d0%b0_%d1 %82%d0%b5%d1%81%d1%82%d0%b8%d1 %80%d0%b0%d1%9a%d0%b5_%d0%b4%d0 %b0%d0%b2%d0%b0%d0%bb%d0%b0%d1 %86%d0%b0_%d1%99%d1%83%d0%b4%d1 %81%d0%ba%d0%b8%d1%85_%d0%be%d1 %80%d0%b3%d0%b0%d0%bd%d0%b0_64_1 0.pdf Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Drugs 1. Ministry of Healthcare (MOH): http://www.mh.government.bg/ 2. Bulgarian Drug Agency (BDA): http://www.bda.bg/en/ Devices Bulgarian Drug Agency (BDA): http://www.bda.bg/en/ Bulgarian Drug Agency (BDA): http://www.bda.bg/en/ 519f-4a22-b390- 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf 4. Medicinal Products in Human Medicine Act (2017): http://www.bda.bg/images/stories/d ocuments/regulations/zakoni/ZLPH M_28122017.pdf 5. Healthcare Act, Articles 197- 206 (2018): http://www.mh.government.bg/medi a/filer_public/2018/02/27/zakon-za- zdraveto.pdf Medicinal Products in Human Medicine Act, Chapter 4 (2018): https://www.lex.bg/laws/ldoc/21355 49536 Medical Devices Act (2016): http://www.bda.bg/images/stories/d ocuments/legal_acts/ZMI_en_20160 308.pdf Medicinal Products in Human Medicine Act, Chapter 4, Articles 91 and 92 (2016): http://www.bda.bg/images/stories/d ocuments/legal_acts/ZLPHM_en.pd f 37 Regulation No. 31 from 12 August 2007 for Determining the Principles of Good Clinical Practice (2012): http://www.bda.bg/images/stories/doc uments/regulations/naredbi/20180320 _Naredda_31.pdf Ordinance No. 10 of 2008 on the Documents Required from the Principal/Coordinating Investigator or Sponsor for Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices During Clinical Investigations and Assessment of the Clinical Data Collected During such Investigations (2010): http://www.bda.bg/images/stories/doc uments/legal_acts/Ordinance_Clinical _investigations_MD_EN.pdf Regulation 31 from 12 August 2007 for Determining the Principles of Good Clinical Practice, Section 5.8 (2012) (Bulgarian): http://www.bda.bg/images/stories/doc uments/regulations/naredbi/20180320 Various: http://www.bda.bg/en/114-information-for- companies-section/medical-devices-category Country Key Organizations Legislation Regulations Guidelines _Naredda_31.pdf Privacy/Data Protection Human Biological Materials: Embryos, Stem Cells, and Cloning 1. Bulgarian Commission for Personal Data Protection: https://www.cpdp.bg/en/index.php?p=rubr ic&aid=2 2. Ombudsman: www.ombudsman.bg 1. Executive Agency for Transplantation: http://www2.bgtransplant.bg/bg 2. Council of Ministers, Ethics Committee for Transplantation Ministry of Healthcare: http://www.mh.government.bg/ 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Law for Protection of Personal Data (2018): https://www.cpdp.bg/en/index.php? p=element&aid=373 1. Law Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (2006): https://www.mh.government.bg/me dia/filer_public/c6/12/c612c85a- 519f-4a22-b390- 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf 2. Law on Transplantation of Organs, Tissues, and Cells (2013): http://bgtransplant.bg/iat/docs/Zako ni_ZTOTK.doc 1. Law Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (2006): https://www.mh.government.bg/me dia/filer_public/c6/12/c612c85a- 519f-4a22-b390- 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf 2. Law on Transplantation of Organs, Tissues, and Cells (2013): http://bgtransplant.bg/iat/docs/Zako ni_ZTOTK.doc Regulation No. 13 of 4 April 2007 for the Terms and Conditions of Informing Bulgarian Citizens on the Activities regarding the Transplantation of Organs, Tissues and Cells: http://www2.bgtransplant.bg/sites/def ault/files/docs/naredbi/Naredba_no13 _ot_04_april_2007_g.rtf 1. General (2018): https://www.cpdp.bg/index.php?p=element&ai d=1163 2. Research (2018): https://www.cpdp.bg/en/index.php?p=element &aid=1162 3. Consent (2018): https://www.cpdp.bg/en/index.php?p=element &aid=1162 38 Country Key Organizations Legislation Regulations Guidelines Croatia Note: All websites and documents are in Croatian. General Drugs, Biologics, and Devices Research Injury Central Ethics Committee: http://www.halmed.hr/en/O-HALMED- u/Sredisnje-eticko-povjerenstvo-SEP/ Drugs 1. Ministry of Health: https://zdravlje.gov.hr/ 2. Agency for Medicinal Products and Medical Devices: http://www.halmed.hr/ Devices 1. Ministry of Health: https://zdravlje.gov.hr/ 2. Agency for Medicinal Products and Medical Devices: http://www.halmed.hr/ 1. Agency for Medicinal Products and Medical Devices of Croatia: http://www.halmed.hr/ 2. Ministry of Health: https://zdravlje.gov.hr/ 3. Croatian Health Insurance Fund: http://www.hzzo.hr/en/ 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (1997): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Patient Protection Act, Article 20 (2008): http://www.zakon.hr/z/255/Zakon- o-za%C5%A1titi-prava-pacijenata 1. Medicinal Product Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1522.html 2. Rule Book on Amendments to Medicinal Product Act (2014): http://narodne- novine.nn.hr/clanci/sluzbeni/2014_0 7_90_1809.html Medical Devices Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1521.html 1. Law on Mandatory Health Insurance (2013): http://www.hzzo.hr/wp- content/uploads/2013/10/ZOZO_PR OCISCENI_TEKSTv2.pdf?6d8ad4 2. Medicinal Product Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1522.html 3. Rule Book on Amendments to Medicinal Product Act (2014): http://narodne- novine.nn.hr/clanci/sluzbeni/2014_0 39 1. Ordinance on Clinical Trials and Good Clinical Practice (2015): http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03 _25_534.html 2. Ordinance on Amendments to the Ordinance on Clinical Trials and Good Clinical Practice (2015): https://narodne- novine.nn.hr/clanci/sluzbeni/2014_07 _90_1809.html Ordnance on Clinical Trials and Good Clinical Practice, Articles 11 and 16, Act 5.8., 6.8. and 8.2.5 (2015): http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03 _25_534.html Country Key Organizations Legislation Regulations Guidelines 7_90_1809.html Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Croatian Personal Data Protection Agency: http://www.azop.hr/ Ministry of Health: https://zdravlje.gov.hr/ Ministry of Health: https://zdravlje.gov.hr/ 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Implementation Act of the General Data Protection Act (NN 42/18) (2018): https://narodne- novine.nn.hr/clanci/sluzbeni/2018_0 5_42_805.html 1. Law about Blood and Blood Products (2006): http://narodne- novine.nn.hr/clanci/sluzbeni/2006_0 7_79_1916.html 2. Rule Book on Amendments to Law about Blood and Blood Products (2011): http://narodne- novine.nn.hr/clanci/sluzbeni/2011_1 1_124_2476.html 3. Law on the Implementation of Human Tissues and Cells (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1 2_144_3070.html 4. Law on Transplantation of Human Organs for the Purpose of Treatment (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1 2_144_3071.html 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): http://zakon.poslovna.hr/public/Kon vencija-o-zastiti-ljudskih-prava-i- dostojanstva-ljudskog-bica-u- pogledu-primjene-biologije-i- medicine-u-vezi-presadivanja- organa-i-tkiva-ljudskog- porijekla/243337/zakoni.aspx Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for Collection, Retrieval, Testing, Processing, Preservation, Storage, and Allocation of Human Tissues and Cells (2013): http://www.propisi.hr/print.php?id=9 354 Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for Collection, Retrieval, Testing, Processing, Preservation, Storage and Allocation of Human Tissues and Cells (2013): http://www.propisi.hr/print.php?id=9 354 General (2018): http://azop.hr/info- servis/detaljnije/smjernice 40 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Cyprus General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection 1. Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/Moh/phs/phs.nsf/ dmlindex_en/dmlindex_en?opendocument 2. Ministry of Health, National Bioethics Committee: http://www.bioethics.gov.cy/moh/cnbc/cn bc.nsf/index_en/index_en?OpenDocumen t Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/moh/moh.nsf/ind ex_en/index_en?OpenDocument Commissioner's Office for the Protection of Personal Data: http://www.dataprotection.gov.cy/dataprot ection/dataprotection.nsf/index_en/index_ en?opendocument 2. Medical Fertilization Act, Article 32: (2012): http://www.hzzo- net.hr/dload/zakoni/20_01.pdf 3. Law on the Implementation of Human Tissues and Cells (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1 2_144_3070.html 1. Law No. 31 (III)/2001: Oviedo Convention on Human Rights and Biomedicine 2. The Safeguarding and Protection of Patients’ Rights Law (2004): http://www.bioethics.gov.cy/Moh/c nbc/cnbc.nsf/All/745717D26F0685 82C2257CCA003B350F/$file/Patie nts%20Rights%20Law- English%20translation.pdf Law for Good Clinical Practice (2004): http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C F%84%CE%BF%CF%85%202004. pdf?OpenElement Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8): http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C F%84%CE%BF%CF%85%202004. pdf?OpenElement 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Protection of Natural Persons Against the Processing of Personal Data and the Free 41 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Embryos, Stem Cells, and Cloning Czech Republic General Drugs, Biologics, and Devices Ministry of Health, Central Ethics Committee: http://www.mzcr.cz Drugs 1. Ministry of Health (MOH): http://www.mzcr.cz 2. State Institute for Drug Control (SUKL): http://www.sukl.cz/index.php?lchan=1&lr ed=1 Devices State Institute for Drug Control (SUKL): http://www.sukl.cz/index.php?lchan=1&lr ed=1 Circulation of such Data Act of 2018 (Law 125 (I)): http://www.dataprotection.gov.cy/d ataprotection/dataprotection.nsf/all/ DE97F6F59835A03AC22582DD00 3D895E/$file/%CE%9D%CF%8C %CE%BC%CE%BF%CF%82%201 25(%CE%99)_2018.pdf?openeleme nt 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) 1. Oviedo Convention on Human Rights and Biomedicine (2001) 2. Act No. 130/2002 Collection on Research and Development Support, as Amended (2018) 3. Act No. 372/2011 on Healthcare Services, As Amended (2019) 4. Act. No. 373/2011 on Specific Healthcare Services, As Amended (2018) Act No. 378/2007 Collection on Pharmaceuticals, As Amended (2019) 1. Act No 268/2014 Coll., on Medical Devices and on Amendment to Act. 634/2004 Coll., on Administrative Fees, As Amended (2017) 2. Decree No 62/2015 Coll. Implementing Certain Provisions of the Act on 42 MOH: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products Various: http://www.sukl.cz/medical- devices?highlightWords=501%2F200 0 SUKL: Various: http://www.sukl.cz/medicinal-products- clinical-trials-guidelines-1 Various: http://www.sukl.cz/medical-devices-guidelines Country Key Organizations Legislation Regulations Guidelines Medical Devices Research Injury 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2001) 2. Law No. 89/2012 Coll. Civil Code: http://www.czechlegislation.com/en /89-2012-sb Privacy/Data Protection Embryos, Stem Cells, and Cloning Denmark General Drugs, Biologics, and Devices Research Injury Office for Personal Data Protection: https://www.uoou.cz/en/ 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.aspx? idsekce=15908 National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english Danish Medicines Agency: https://laegemiddelstyrelsen.dk/en/ Patient Compensation Association: http://pebl.dk/en.aspx 1. Act No. 110/2019 Coll., On Personal Data Processing: https://www.uoou.cz/en/assets/File. ashx?id_org=200156&id_dokument y=1837 2. General Data Protection Regulation (2018): https://gdpr-info.eu/ Act of 26 April 2006 on Research on Human Embryonic Stem Cells No. 227/2006 Sb. (Coll.), as amended (2017) Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For ms/R0710.aspx?id=192671 2013 version (English): http://www.nvk.dk/english/act-on- research Act No. 620 on Clinical trials on Medical Products No. 620 (2016): https://www.retsinformation.dk/For ms/r0710.aspx?id=180117 1. Liability for Damages Act (2007): https://protect2.fireeye.com/url?k=8 312f002-df47f9d2-8312c13d- 43 Executive Order No. 1464 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2018) (Danish): https://www.retsinformation.dk/Form s/R0710.aspx?id=201254 Executive Order No. 295 on Clinical Trials of Medicinal Products on Humans (2006): https://www.retsinformation.dk/Form s/R0710.aspx?id=9891 1. General (2018): https://www.uoou.cz/gdpr-strucne/ds- 4843/p1=4843 2. International Data Transfer (2018): https://www.uoou.cz/en/vismo/zobraz_dok.asp ?id_org=200156&id_ktg=1165&p1=1165 Guidelines about Notification (Checklist) (2017): http://www.nvk.dk/forsker/forskervejledning Guidelines for Applications for Authorisation of Clinical Trials of Medical Products in Humans (2017): https://laegemiddelstyrelsen.dk/en/licensing/cli nical-trials/trials-in-humans/guideline-for- applications-for-authorisation-of-clinical-trials- of-medicinal-products-in-humans/ Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Estonia General Danish Data Protection Agency (DPA): https://www.datatilsynet.dk/english/ National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english Danish Council of Ethics: http://www.etiskraad.dk/english Estonian Council on Bioethics: http://www.eetikakeskus.ut.ee/en 0cc47a6a52de- 8126763cf8cbd825&u=https://www .retsinformation.dk/forms/R0710.as px?id=202098 2. Act No. 1022 on the Right to Complain and Receive Compensation within the Health Service (2017): https://www.retsinformation.dk/For ms/R0710.aspx?id=192623 1. Act No. 429 on Processing of Personal Data (2007): https://www.datatilsynet.dk/med ia/6894/danish-data-protection- act.pdf 2. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 1. Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For ms/R0710.aspx?id=192671 2. Data Protection Act 2018: https://www.datatilsynet.dk/media/6 894/danish-data-protection-act.pdf Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For ms/R0710.aspx?id=192671 2013 version (English): http://www.nvk.dk/english/act-on- research Act No. 440 on Danish Council of Ethics (2004): https://www.retsinformation.dk/for ms/r0710.aspx?id=9909 1. Oviedo Convention on Human Rights and Biomedicine (2002) 2. Constitution of the Republic 44 Executive Order No. 903 on Health Law, Chapter 9 (2019): https://www.retsinformation.dk/Form s/R0710.aspx?id=210110#id56770de c-1ec6-44de-9fb0-8fabec8f4a62 Health Law (2019): https://www.retsinformation.dk/Form s/R0710.aspx?id=210110 Executive Order No. 902 on Medically Assisted Procreation (2019): https://www.retsinformation.dk/Form s/R0710.aspx?id=210080 Guidelines on the Use of Biological Material in Health Research Projects (2017): http://www.nvk.dk/emner/biobanker/vejledning -om-bio-mat Guidelines on Health Research Projects Involving Genome Research (2018): http://www.nvk.dk/emner/genomer/vejledning- om-genomer Code of Ethics of Estonian Scientists: http://www.akadeemia.ee/_repository/File/AL USDOKUD/Code-ethics.pdf Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Genetic Research Embryos, Stem Cells, and Cloning Drugs: 1. State Agency of Medicines: http://www.sam.ee/en/clinical-trials- medicinal-products-estonia 2. Minister of Social Affairs (MSA): https://www.sm.ee/en Devices: Estonian Health Board: http://www.terviseamet.ee/en/medical- devices.html 1. Minister of Social Affairs (MSA): https://www.sm.ee/en 2. Estonian Health Insurance Fund: https://www.haigekassa.ee/en Estonian Data Protection Inspectorate: http://www.aki.ee/en/inspectorate of Estonia, Paragraph 18 (2016): https://www.riigiteataja.ee/en/eli/52 1052015001/consolide Medicinal Products Act, Chapter 5 (2015): https://www.riigiteataja.ee/en/eli/ee/ 525112013005/consolide/current Medical Devices Act (2004): https://www.riigiteataja.ee/en/eli/ee/ 509012015001/consolide/current Medicinal Products Act, Section 90: https://www.riigiteataja.ee/en/eli/ee/ 525112013005/consolide/current 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Personal Data Protection Act (2016): https://www.riigiteataja.ee/en/eli/ee/ 512112013011/consolide/current Human Genes Research Act (RT I 2000, 104, 685) (2014): https://www.riigiteataja.ee/en/eli/ee/ 518062014005/consolide 1. Additional Protocol to the Convention for the Protection of 45 MSA: 1. 1 RTL 2005, 22, 298: Rules of Procedure of Medical Ethics Committee for Clinical Trials, a List of Data to be Submitted for Obtaining Approval, Procedure for Adoption of Resolutions and Format of Application for Obtaining Approval (2005): https://www.riigiteataja.ee/en/eli/502 052017001/consolide 2. Conditions and Procedure for Conducting Clinical Trials of Medicinal Products. Regulation No. 23 (2005): https://www.riigiteataja.ee/en/eli/502 052017002/consolide Regulation No 86: 2010 of the Minister of Social Affairs on the Conditions and Procedures for the Clinical Investigation of Medical Devices Conditions and Procedure for Conducting Clinical Trials of Medicinal Products. Regulation No. 23 of the Minister of Social Affairs of (2005): https://www.riigiteataja.ee/en/eli/502 052017002/consolide 1. Research (2018) 2. International Data Transfer (2018): http://www.aki.ee/en/guidelines/transfer- personal-data-foreign-country Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Finland General Drugs, Biologics, and Devices 1. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi/en/frontpage 2. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en Drugs 1. Finnish Medicines Agency (FIMEA): https://www.fimea.fi/web/en/frontpage 2. Ministry of Social Affairs and Health (MSAH): http://stm.fi/en/frontpage 3. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en Devices National Supervisory Authority for Welfare and Health (VALVIRA): http://www.valvira.fi/en/licensing/medical _devices 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) (Estonian): https://www.riigiteataja.ee/akt/7856 9 2. Artificial Insemination and Embryo Protection Act, RT I 1997, 51, 824 (2011): https://www.riigiteataja.ee/en/eli/ee/ 530102013057/consolide/current Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok set/1999/en19990488 1. Medicines Act No. 395/1987: http://www.finlex.fi/fi/laki/smur/19 87/19870395 2. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok set/1999/en19990488 Medical Devices Act No. 629/2010 (Finnish): http://www.finlex.fi/fi/laki/kokoelm a/2010/20100085.pdf 46 1. Decree of the National Research Ethics Council of Finland No. 1347/1991 2. Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016 3. Decrees on the National Committee on Medical Research Ethics No. 820/2010 and 788/2018 4. Decree on Fees, No. 1287/2018 1. Decree on Clinical Trials on Medicinal Products No. 841/2010 2. Other Decrees: http://www.finlex.fi/fi/laki/smur/1987 /19870395#nojalla FIMEA: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2012: http://www.fimea.fi/download/22302 _Maarays_2- 2012_kliiniset_laaketutkimukset.pdf 1. Decree (Decision) on Clinical Investigations (2010): http://www.finlex.fi/data/normit/3964 4- TUKIJA: 1. Report on Children in Medical Research (2003) 2. Operating Procedures of the National Committee on Medical Research Ethics (2019) Access: http://tukija.fi/en/publications1 TUKIJA: Templates for Clinical Trial Information Leaflet and Consent Form (2018) Access: http://tukija.fi/en/publications1 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Social-Behavioral Research Privacy/Data Protection Human Biological Materials Genetic Research 1. Finnish Patient Insurance Centre: https://www.pvk.fi/fi/ 2. Pharmaceutical Injuries Insurance http://www.laakevahinko.fi/in-english/ Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/ Office of the Data Protection Ombudsman: https://tietosuoja.fi/en/home National Supervisory Authority for Welfare and Health (Valvira): http://www.valvira.fi/web/en 1. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en EU Regulations: Medical Device Regulation 2017/745: http://eur- lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX :32017R0745&from=EN In Vitro Diagnostic Medical Devices Regulation 2017/746: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX :32017R0746&from=EN Patient Injuries Act No. 585/1986: http://www.finlex.fi/fi/laki/ajantasa/ 1986/19860585 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Data Protection Act (1050/2018): https://www.finlex.fi/en/laki/kaanno kset/2018/20181050 1. Act on the Medical Use of Human Organs, Tissues, and Cells No. 101/2001 (Finnish and Swedish): http://www.finlex.fi/fi/laki/ajantasa/ 2001/20010101 2. Law on Biobanks, No 688/2012 (Finnish and Swedish): http://www.finlex.fi/fi/laki/ajantasa/ 2012/20120688 1. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): 47 maarays_3_2010_kliininen_laitetutki mus.pdf 2. Various: http://www.valvira.fi/en/licensing/me dical_devices/legislation 1. Decree on Consent for Biobank No. 643/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130643 2. Decree on information on Biobank No. 649/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130649 3. Government Decree on Medical Use of Human Organs, Tissues, and Cells No. 594/2007 4. Ministry Decree on Medical Use of Human Organs, Tissues, and Cells No. 1302/2007 Pharmaceutical Injuries Insurance: General Terms and Conditions (2017): https://www.laakevahinko.fi/en/potilaille/vaku utusehdot/ The Ethical Principles of Research with Human Participants and Ethical Review in the Human Sciences in Finland (2019): https://www.tenk.fi/en/ethical-review-in- finland Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning France General Drugs, Biologics, and Devices 2. Board for Gene Technology: http://www.geenitekniikanlautakunta.fi/en 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/ 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/ 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/ http://www.finlex.fi/en/laki/kaannok set/1999/en19990488 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa /1995/19950377 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning (2002) 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok set/1999/en19990488 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf 1. Law No. 2012-300 of 5 March 2012 on Research Involving Human Persons: https://www.legifrance.gouv.fr/affic hTexte.do?cidTexte=JORFTEXT00 0025441587 2. Law No. 2011-814 of 7 July 2011 on Bioethics Medications for Human Use, Articles 5111-1 and Subsequent Sections for Drugs and Medical Devices: https://www.legifrance.gouv.fr/affic hCode.do?cidTexte=LEGITEXT00 0006072665 Public Health Code Articles R1121-1 and subsequent sections: http://legifrance.gouv.fr/ Decision on Good Clinical Practices: http://www.legifrance.gouv.fr/affichT exte.do?cidTexte=JORFTEXT00000 0819256 TUKIJA: Report on Stem Cells, Cloning, and Research (2005): http://tukija.fi/documents/1481661/1546647/20 05cells.pdf/c14b7dd0-11b4-428d-bdae- 539566ade614 CCNE: Various: http://www.ccne- ethique.fr/en/type_publication/avis CCNE: Phase I Trials in Cancer (2002) Access: http://www.ccne- ethique.fr/en/type_publication/avis 48 Country Key Organizations Legislation Regulations Guidelines Social-Behavioral Research Privacy/Data Protection Human Biological Materials National Consultative Ethics Committee 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 1. Protection of Persons Committee (CPP) 2. Ministry of Higher Education, Research, and Innovation: http://www.enseignementsup- recherche.gouv.fr/ 3. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- 1. Act N° 78-17 of 6 January 1978 on Information Technology, Data Files, and Civil Liberties (2018): https://www.cnil.fr/fr/la-loi- informatique-et-libertes 2. Law No. 2016-1321 of 7 October 2016 for a Numeric Republic: https://www.legifrance.gouv.fr/affic hLoiPubliee.do?idDocument=JORF DOLE000031589829&type=genera l&legislature=14 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 4. Data Protection Act (2018): https://www.legifrance.gouv.fr/affic hLoiPreparation.do;jsessionid=AD5 660270AD9F70B94275AC8233216 80.tplgfr22s_3?idDocument=JORF DOLE000036195293&type=conten u&id=2&typeLoi=proj&legislature =15 1. Donation and Use of the Components and Products of the Human Body, Articles L1211-1 to L1274-3 (2004): http://www.legifrance.gouv.fr/ 2. Public Health Code Articles L1243-3 and following sections: (2012): http://www.legifrance.gouv.fr/initR 49 CNIL: Decree N° 2019-536 of 29 May 2019 Enacted for the Application of Act No. 78-17 of 6 January 1978 on Data Processing, Data Files, and Civil Liberties: https://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT0000 38528420&categorieLien=id Decree No. 2017-1549 of 8 November 2017 on the Conservation and Preparation for Scientific Purposes of Elements of the Human Body and Amending the Public Health Code Opinion on the Ethics of Research in the Sciences of Human Behavior No. 38 (1993): http://www.ccne- ethique.fr/en/publications/opinion-ethics- research-sciences-human- behaviour#.WNkybNfytEY CNIL: 1. Health Research: CNIL Adopts New Simplification Measures (2018): https://www.cnil.fr/fr/recherches-dans-le- domaine-de-la-sante-la-cnil-adopte-de- nouvelles-mesures-de-simplification 2. Health Research with Consent (2018): https://www.cnil.fr/fr/declaration/mr-001- recherches-dans-le-domaine-de-la-sante-avec- recueil-du-consentement 3. Health Research without Consent (2018): https://www.cnil.fr/fr/declaration/mr- 003-recherches-dans-le-domaine-de-la-sante- sans-recueil-du-consentement 4. Practical Guide on the Protection of Personal Data: What Framework Applies to Research? (2018): https://www.cnil.fr/sites/default/files/atoms/file s/guide-cnom-cnil.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) Access: http://www.ccne- ethique.fr/en/type_publication/avis 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) Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Georgia ethique.fr 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 2. Biomedicine Agency: https://www.agence- biomedecine.fr/About-us 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr 2. Biomedicine Agency: http://www.enseignementsup- recherche.gouv.fr/ echCodeArticle.do Civil Code Articles 16-10 to 16- 13: http://www.legifrance.gouv.fr/affich Code.do;jsessionid=D2DE0231944 83D3384DE19DE8959BDDA.tpdjo 17v_3?idSectionTA=LEGISCTA00 0006136513&cidTexte=LEGITEX T000006070721&dateTexte=20131 006 Law No. 2013-715 of 6th August 2013: http://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT000 027811435&dateTexte=&categorie Lien=id Article R1131-1 and Subsequent Sections of the Public Health Code: https://www.legifrance.gouv.fr/affich Code.do?idArticle=LEGIARTI00001 8615563&idSectionTA=LEGISCTA0 00006196158&cidTexte=LEGITEXT 000006072665&dateTexte=20191011 Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following Sections: http://legifrance.gouv.fr/affichCode.d o?idArticle=LEGIARTI00003023346 9&idSectionTA=LEGISCTA0000061 90409&cidTexte=LEGITEXT000006 072665&dateTexte=20151015 Access: http://www.ccne- ethique.fr/en/type_publication/avis 1. Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood (2013) 2. Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing (2016) Access: http://www.ccne- ethique.fr/en/type_publication/avis 1. Commercialization of Human Stem Cells and Other Cell Lines (2006) 2. Opinion on the Ethical Reflection Concerning Research on Human Embryonic Cells and on Human Embryos in Vitro (2010) Access: http://www.ccne- ethique.fr/en/type_publication/avis For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 4: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf General Drugs, Biologics, and Devices Bioethics and Health Law Studies Society: http://www.patientsrights.ge/index.php?pa ge=385&lang=geo State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs: http://rama.moh.gov.ge/ 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001) 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195 (2010) 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37 Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015): https://matsne.gov.ge/en/document/ view/29836?impose=translateEn 50 Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005): http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996) including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf Country Key Organizations Legislation Regulations Guidelines Research Injury Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2001) Privacy/Data Protection Embryos, Stem Cells, and Cloning Germany General Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/weite re-sprachen/english/german-medical- association/ 2. Central Ethics Committee of the German Medical Association (ZEKO): http://www.zentrale-ethikkommission.de/ 3. Permanent Working Party of Research Ethics Committees in Germany: http://www.ak-med-ethik-komm.de/ 4. German Ethics Council: https://www.ethikrat.org/en/ 5. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html 6. German Research Foundation (DFG), Permanent Senate Commission on Key Questions in Clinical Research (SCCR): http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/clinical_research/index.ht 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Law on Data Protection (2018): https://matsne.gov.ge/en/document/ view/1561437?publication=15 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human Cloning ETS No. 168 (2001) 2. Law on Health Care, Article 142 (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37 51 BÄK: (Model) Professional Code for Physicians in Germany, Article 15 (2018): http://www.bundesaerztekammer.de/fileadmin/ user_upload/downloads/pdf- Ordner/MBO/MBO-AE_EN_2018.pdf Country Key Organizations Legislation Regulations Guidelines ml Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Privacy/Data Protection Note: The 16 German states also have data protection Drugs 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html 2. Paul-Ehrlich-Institut (PEI): http://www.pei.de/EN/home/node.html4 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html Devices 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html 2. Paul-Ehrlich-Institut (PEI): http://www.pei.de/EN/home/node.html4 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html German Clinical Trials Register (DRKS): https://www.drks.de/drks_web/setLocale_ EN.do 1. Federal Commissioner for Data Protection and Freedom of Information: https://www.bfdi.bund.de/EN/ 2. Datenschutzkonferenz (DSK): https://www.datenschutzkonferenz- online.de/ Medicinal Products Act, Sixth Chapter (2019): http://www.gesetze-im- internet.de/amg_1976/ 2016 English version, without amendments: Medicinal Products Act, Sixth Chapter (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a mg.html#p0925 Act on Medical Devices, Fourth Chapter (2019): http://www.gesetze-im- internet.de/mpg/ 1. Medicinal Products Act, Section 40(3) (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a mg.html#p0926 2. Act on Medical Devices, Section 20(3) (2019): http://www.gesetze-im- internet.de/mpg/ 20.html 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Federal Data Protection Act (BDSG) (2017): https://www.gesetze-im- internet.de/englisch_bdsg/index.htm 52 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 on the Application of Good Clinical Practice in the Conduct of Clinical Trials of Medicinal Products for Human Use (2012): http://www.gesetze-im- internet.de/gcp-v/ Regulation on Clinical Trials of Medical Devices (2014): http://www.gesetze-im- internet.de/mpkpv/ BfArM and PEI: Third Notification on the Clinical Trials of Medicinal Products for Humans (2006): http://www.pei.de/SharedDocs/Downloads/EN/ pu/clinical-trials/3rd-notification-clinical-trials- 2006-08-10.pdf? blob=publicationFile&v=1 FAQs: https://www.drks.de/drks_web/navigate.do?nav igationId=faq&messageEN=FAQ DSK: Short Paper No. 4: Data Transmission to Third Countries: https://www.bfdi.bund.de/SharedDocs/Downlo ads/DE/Datenschutz/Kurzpapier_Drittlaender.p df? blob=publicationFile&v=3 Country Key Organizations Legislation Regulations Guidelines laws: http://www.datenschut z- bayern.de/infoquel/ds- inst/deutschland.html Human Biological Materials Genetic Research German Ethics Council: https://www.ethikrat.org/en/ Central Ethics Committee of the German Medical Association (ZEKO) (German): http://www.zentrale-ethikkommission.de/ German Society of Surgery (DGCH): http://www.dgch.de/index.php?id=118 l 1. Act of Quality and Security of Human Tissue and Cells (2019): https://www.buzer.de/s1.htm?g=Ge webegesetz&f=1 2. Transfusion Law (2019): http://www.gesetze-im- internet.de/tfg/ 3. Transplantation Law (2019): http://www.gesetze-im- internet.de/tpg/ 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/ Opinion on Human Biobanks for Research (2010): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/DER_StnBiob_En gl_Online_mitKennwort.pdf 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf- Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_ menschlicher_Gewebe.pdf 53 Country Key Organizations Legislation Regulations Guidelines 2. Genetic Engineering Act Genetic Research Embryos, Stem Cells, and Cloning German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/ German Research Foundation (DFG), Permanent Senate Commission on Genetic Research: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php German Ethics Council: https://www.ethikrat.org/en/ (2017): http://www.gesetze-im- internet.de/gentg/ 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/ 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/ 54 Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell Act (2017): http://www.gesetze-im- internet.de/zesv/ 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004): http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_ gfh_positionspapier.pdf Statements: http://www.dfg.de/en/dfg_profile/statutory_bod ies/senate/genetic_research/publications/index. html 1. The Import of Human Embryonic Stem Cells (2001): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stellungnahme_Sta mmzellimport.pdf 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stellungnahme_Klo nen.pdf 3. Should the Stem Cell Law be Amended? (2007): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stn_Stammzellgese tz.pdf 4. Human-Animal Mixtures in Research (2011): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/opinion-human- Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Greece General Central Ethics Committee of the German Medical Association (ZEKO): http://www.zentrale-ethikkommission.de/ German Research Foundation (DFG): http://www.dfg.de/en/ Central Ethics Committee for Stem Cell Research (ZES): http://www.rki.de/EN/Content/Institute/C ommittees/StemCell/StemCell_content.ht ml National Bioethics Commission (NBC): http://www.bioethics.gr/ 55 animal-mixtures-in-research.pdf 5. Stem Cell Research - New Challenges for the Ban on Cloning and Treatment of Artificially Created Germ Cells? (2014): https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc- Empfehlungen/englisch/recommendation-stem- cell-research.pdf 6. Germline Intervention in the Human Embryo (2017): https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc- Empfehlungen/englisch/recommendation- germline-intervention-in-the-human- embryo.pdf 7. Intervening in the Human Germline (2019): https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/opinion- intervening-in-the-human-germline- summary.pdf Opinion on Stem Cell Research (2002): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Stammzell.pdf Opinion on Stem Cell Research (2006): http://www.dfg.de/download/pdf/dfg_magazin/ forschungspolitik/stammzellforschung/stammz ellforschung_deutschland_lang_0610.pdf 1. Research Ethics for Biological Sciences (2008): http://www.bioethics.gr/index.php/en/gnomes/ 86-research-ethics-in-biological-sciences 2. A Guide for Research Ethics Committees for Biological Research (2008): http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/guide.pdf 3. Conflict of Interest in Biomedical Research (2014): Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection 1. National Organization for Medicines (NOM): http://www.eof.gr/web/guest/home, then click on “EN” in upper left hand section for English 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3 National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3 Hellenic Data Protection Authority: http://www.dpa.gr/ 1. 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) 2. Act 3418/2005 Code on Medical Ethics 1. 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) 2. Act 3418/2005 Code on Medical Ethics 1. Greek Constitution 1975/1986/2001 Article 9.1 2. Act 2619/98 (Biomedicine Convention of the Council of Europe) (1998) 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws 2819/2000 and 2915/2000): http://www.dpa.gr/portal/page?_pag eid=33,19052&_dad=portal&_sche ma=PORTAL 4. Act 3418/2005 Code on Medical Ethics 5. General Data Protection 56 1. Ministerial Decision ΔΥΓ3 89292/2003: Harmonization of the Greek Legislation with EU Legislation, According to the Directive 2001/20/EC 2. Ministerial Decision ΔΥΓ 3 α/79602/2007: Harmonization of the Greek Legislation with EU Legislation, according to the Directive 2005/28/EC 1. Ministerial Decision ΔΥΓ3 89292/2003: Harmonization of the Greek Legislation with EU Legislation, According to the Directive 2001/20/EC 2. Ministerial Decision ΔΥΓ 3 α/79602/2007 Harmonization of the Greek Legislation with EU Legislation, According to the Directive 2005/28/EC: http://www.bioethics.gr/images/pdf/EKDOSEI S/OPINIONS_AND_REPORTS_2008- 2013_EN.pdf 4. Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/index.php/en/gnomes/ 983-incidental-findings-in-research-and- clinical-practice NBC: 1. Recommendation on Clinical Trials: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/recom_clinical_trials_ en.pdf 2. Control of Non-Invasive Clinical Trials for Drugs (2013): http://www.bioethics.gr/index.php/en/gnomes/ 532-control-of-non-invasive-clinical-trials-for- drugs Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Genetic Research Embryos, Stem Cells, and Cloning National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3 1. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3 2. National Authority for Medically Assisted Reproduction Regulation (2016): https://www.lawspot.gr/nomikes- plirofories/nomothesia/genikos- kanonismos-gia-tin-prostasia- dedomenon?lspt_context=gdpr 1. Greek Constitution 1975/1986/2001, Article 5.5 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. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws 2819/2000 and 2915/2000): http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF 4. Act 3418/2005 Code on Medical Ethics 1. 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) 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction) 3. Act 3305/2005 Application of Medically Assisted 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/recom_genetic_data_e ng.pdf 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/ 91-direct-to-consumer-dtc-genetic-testing 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION_Incidental_Findings_FINAL_.pdf 6. Opinion on Advances in Human Genome Editing (2016): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION gene%20editing_Final_EN.pdf NBC: 1. Recommendation on the Use of Stem Cells in Biomedicine and Clinical Medicine 2. Recommendation on Human Reproductive Cloning 3. Opinion on Prenatal and Pre- implantation Diagnosis and Embryo Treatment 57 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Hungary Note: All webpages and documents are in Hungarian. Reproduction Access: http://www.bioethics.gr/index.php/gnomes General Drugs, Biologics, and Devices 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/ Drugs 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/ 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953 2. Act CLIV of 1997 on Health Care, Chapters VIII and IX: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=30903.339193 3. Act VI. of 2002 on the Promulgation of the Oviedo Convention on Human Rights and Biomedicine: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=64201.264663 4. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research 5. Act C of 2012 on the Criminal Code, Chapter XVI Medical Procedures and Criminal Offenses Against the Order of Research, Sections 168-175 Clinical Trials: Act XCV of 2005 on Medicinal Products for Human Use, Section 3: http://net.jogtar.hu/jr/gen/getdoc.cgi ?docid=a0500095.tv&dbnum=62 Non-Interventional Trials: Act CLIV of 1997 on Health Care, Chapter VIII, Section 164/A: http://net.jogtar.hu/jr/gen/hjegy_doc 58 1. Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam 2. Decree 35/2005 (VIII.26.) of the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the Application of Good Clinical Practice: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0500035.EUM 3. Decree No. 235/2009 (X.20.) from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam Clinical Trials: 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://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0500035.EUM&celpara= #xcelparam Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Devices 1. Authority for Medical Devices, National Healthcare Service System: http://www.enkk.hu/index.php/hun/ 2. Medical Research Council, Ethics Committee for Clinical Pharmacology: https://ett.aeek.hu/kfeb/ National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu Hungarian National Authority for Data Protection and Freedom of .cgi?docid=99700154.TV Act CLIV of 1997 on Health Care, Chapter VIII, Section 159: http://net.jogtar.hu/jr/gen/hjegy_doc .cgi?docid=99700154.TV Act XCV of 2005 on Medicinal Products for Human Use, Section 3, Paragraph 5: http://net.jogtar.hu/jr/gen/getdoc.cgi ?docid=a0500095.tv&dbnum=62 1. Act XLVII of 1997 on the Handling of Medical and Other 59 Non-Interventional Trials: Decree 23/2002. (V. 9) of the Minister of Health on Biomedical Research on Human Beings: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam Clinical Trials: Decree 4/2009. (III. 17.) of the Minister of Health on Medical Devices: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900004.EUM&celpara= #xcelparam Non-Interventional Trials: 1. Decree 23/2002. (V. 9.) of the Minister of Health on Biomedical Research on Human Beings http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam 2. Government Decree 235/2009. (X.20.) on the Regulations of Giving Permission for Human Medical Experiments, for Clinical Studies of Experimental Medicinal Products and for the Clinical Studies of the Medical Devices: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam 3. Government Decree 27/2015 (II.25.) About the National Health Care Service System: http://njt.hu/cgi_bin/njt_doc.cgi?doci d=174246.343548 Preparing to Apply the Privacy Policy in 12 Steps: Guidance for Data Controllers Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Iceland General Information: http://www.naih.hu/general- information.html Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma 2. Medical Research Council, Committee for Human Reproduction (HRB): https://ett.aeek.hu/hrb/ 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/hrb/ 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/ 2. National Bioethics Committee Related Data: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=99700047.TV&celp ara=#xcelparam 2. Act CXII of 2011 on Right of Informational Self- Determination and Freedom of Information: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=A1100112.TV&cel para=#xcelparam 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 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: http://net.jogtar.hu/jr/gen/hjegy_doc .cgi?docid=A0600080.TV&celpara =#xcelparam Act XXI of 2008 on the Rules of Protection of Human Genetic Data, of Human Genetic Examinations and Research and of the Operation of Biobanks: http://net.jogtar.hu/jr/gen/hjegy_doc .cgi?docid=A0800021.TV&celpara =#xcelparam 1. Act CLIV of 1997 on Health Care, Chapter IX 2. Act VI of 2002 on the Promulgation of the Convention on Human Rights and Medicine and the Additional Protocol on Cloning: http://net.jogtar.hu/jr/gen/hjegy_doc .cgi?docid=A0200006.TV&celpara =#xcelparam 1. Act on Scientific Research in the Health Sector No. 44/2014: https://www.government.is/media/v elferdarraduneyti- 60 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: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=99800018.EUM&celpara=# xcelparam Decree 30/1998. (VI. 24.) of the Minister of Welfare on Regulations on Specific Procedures for Human Reproduction: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=99800030.NM&celpara=#x celparam Regulation on the Structure of Research Projects in the Health Sector, Including Research Protocol, Internal Monitoring, and and Data Processors (2018): http://www.naih.hu/felkeszueles-az- adatvedelmi-rendelet-alkalmazasara.html Decree 60/2003. (X. 20.) of the Minister of Health, Social and Family Affairs on the Minimum Professional Requirements Necessary for Providing Health Services: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid =A0300060.ESC&celpara=#xcelparam Decree 18/1998. (XII. 27.) of the Minister of Health on Implementing Act CLIV of 1997 on Health Care Regarding Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid =99800018.EUM&celpara=#xcelparam NBC: 1. Vulnerable Groups Including Children: http://www.vsn.is/en/content/vulnerable- groups-including-children Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury (NBC): http://www.vsn.is/en Drugs 1. Icelandic Medicines Agency (MCA): http://www.ima.is/ 2. National Bioethics Committee (NBC): www.visindasidanefnd.is Devices Ministry of Health: https://www.government.is/ministries/min istry-of-health/ Icelandic Health Insurance Agency (MCA): http://www.sjukra.is/english media/media/acrobat- enskar_sidur/Health-Sector- Research-Act-No-44-2014.pdf 3. Oviedo Convention on Human Rights and Biomedicine (2004) Medicinal Products Act No. 93/1994 (2013): http://eng.velferdarraduneyti.is/acts- of-Parliament/nr/20128 Act on Medical Devices No 16/2001 (2011): https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Medicinal-Products- Act-NoMedicinal-Products-Act-No- 93-1994-as-amended.pdf 1. Act on Patient Insurance No. 111/2000 (2011): https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Act-on-Patient- Insurance-as-amended.pdf 61 the Responsibilities of the Principal Investigator No. 520/2018: https://www.reglugerd.is/reglugerdir/ eftir- raduneytum/velferdarraduneyti/nr/21 073 MCA: Regulation on Clinical Trials of Medicinal Products in Humans No. 443/2004 (2010): http://eng.velferdarraduneyti.is/media /acrobat-enskar_sidur/Medicinal- Products-Act-NoMedicinal-Products- Act-No-93-1994-as-amended.pdf 1. Regulation on Medical Devices No. 934/2010 (2010): http://eng.velferdarraduneyti.is/media /acrobat-enskar_sidur/16012012_Act- on-Medical-Devices-No-16-2001-as- amended.pdf 2. Regulation on Active Implantable Medical Devices No. 320/2011: http://www.stjornartidindi.is/Advert.a spx?ID=c50d676c-4651-46c2-83b5- ad946f3deeaa 3. Regulation on In Vitro Diagnostic Medical Devices No. 936/2011: http://stjornartidindi.is/Advert.asp x?ID=f20b3e4e-ab25-44d3-8e32- e5f42a7b02f0 Regulation on Clinical Trials of Medicinal Products in Humans No 443/2004 (2010): https://www.government.is/media/vel ferdarraduneyti- media/media/Reglugerdir- enska/Regulation-on-clinical-trials- 2. Informed Consent: http://www.vsn.is/en/content/informed-consent 3. Withdrawal of Consent: http://www.vsn.is/en/content/withdrawal- consent 4. Duty to Report Unexpected Events: http://www.vsn.is/en/content/duty-report- unexpected-events 5. Advertising to Recruit Participants: http://www.vsn.is/en/content/advertising- recruit-participants NBC: Various: http://www.vsn.is/en/content/clinical-trials Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Ireland Data Protection Authority: http://www.personuvernd.is/information- in-english/ 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/ 2. National Bioethics Committee (NBC): www.visindasidanefnd.is/en 2. Act on Health Insurance No. 112/2008 (2012): https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Act-on-Health- Insurance-No-112-2008-16.pdf 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Act No. 90/2018 on Data Protection and the Processing of Personal Data: https://www.althingi.is/altext/148/s/ 1296.html Biobanks Act No. 110/2000 (2015): https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Biobanks-Act-as- amended-2015.pdf 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. Act on Artificial Fertilisation and Use of Human Gametes and Embryos for Stem-Cell Research, No. 55/1996 (2010): http://eng.velferdarraduneyti.is/medi a/acrobat- enskar_sidur/Act_No_55_1996_on_ Artificial_Fertilisation_etc_as_amen ded.pdf of-medicinal-products-in-humans-no- 443-2004-as-amended.pdf Regulations on the Keeping and Utilization of Biological Samples in Biobanks No. 1146/2010: https://www.reglugerd.is/reglugerdir/ eftir- raduneytum/heilbrigdisraduneyti/nr/1 6910 Regulation on Artificial Fertilization No. 144/2009: https://www.reglugerd.is/reglugerdir/ eftir-raduneytum/heilbrigdis/nr/10797 NBC: 1. Access to and Utilisation of Health Data and Bio-Samples: http://www.vsn.is/en/content/access-and- utilisation-health-data-and-bio-samples 2. Biobanks: http://www.vsn.is/en/content/biobanks See this summary on Clinical Trials Involving Medical Products: http://health.gov.ie/blog/policy/clinical-trials-involving-medicinal-products/ General Department of Health: http://health.gov.ie/ 62 1. Operational Procedures for Research Ethics Committees: Guidance 2004: http://health.gov.ie/wp- content/uploads/2014/07/Operational_Procedur es1.pdf 2. Health Service Executive National Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials Genetic Research Italy General 1. Department of Health: http://health.gov.ie/ 2. Health Products and Regulatory Authority: https://www.hpra.ie/ Health Products and Regulatory Authority: https://www.hpra.ie/ Data Protection Commissioner (DPC): http://www.dataprotection.ie/docs/Home/ 4.htm Health Research Board (HRB): http://www.hrb.ie/ Health Products and Regulatory Authority: https://www.hpra.ie/ Health Products and Regulatory Authority: https://www.hpra.ie/ 1. National Bioethics Committee (CNB): http://www.governo.it/bioetica/eng/index. html 2. National Monitoring Center for Clinical Trials (OSS): European Communities (Clinical Trials on Medicinal Products for Human Use) Amendment 2004 (S.I. No. 190 of 2004): http://www.irishstatutebook.ie/eli/2 004/si/878/made/en/print 1. Data Protection Act (1988), as Amended (2003): http://www.irishstatutebook.ie/2003 /en/act/pub/0006/index.html 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 3. Data Protection Act 2018: https://www.oireachtas.ie/en/bills/bi ll/2018/10/ 63 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004): http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, Section 13(6)(k) and Schedule 1, Part 2, Paragraph 4 (S.I. No. 190 of 2004): http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018: http://www.hrb.ie/funding/gdpr- guidance-for-researchers/gdpr-and- health-research/health-research- regulations-2018/ OSS: Ministerial Decree of 12 May 2006: Terms of Reference for the Establishment and the Functioning of Ethics Committees Consent Policy, Part 3: http://www.hse.ie/eng/about/Who/qualityandpa tientsafety/National_Consent_Policy/ Various: https://www.hpra.ie/homepage/site- tools/search?query=clinical%20trials DPC: 1. 12 Steps to Being Prepared (2018): http://gdprandyou.ie/organisations/ 2. Transfers Abroad (2018): https://www.dataprotection.ie/docs/Transfers- Abroad/y/37.htm HRB: Health Research Regulations 2018 FAQ: http://www.hrb.ie/funding/gdpr-guidance-for- researchers/general-gdpr-faq/ Human Biological Material: Recommendations for Collection, Use, and Storage in Research (2005): http://health.gov.ie/wp- content/uploads/2014/07/Human_Biological_ Material1.pdf Guidelines for Pharmacogenetic Research (2006): http://lenus.ie/hse/bitstream/10147/96983/1/Ph armacogenetic06.pdf CNB: Various: http://www.governo.it/bioetica/eng/opinions.ht ml Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices http://oss-sper-clin.agenziafarmaco.it/ Drugs 1. National Monitoring Center for Clinical Trials: http://www.agenziafarmaco.com/en/conte nt/national-monitoring-centre-clinical- trials 2. Italian Medicines Agency: http://www.agenziafarmaco.it/ 3. Ministry of Health (MOH): 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) 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) 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/dlgs_ 200-6nov2007.pdf 1. Ministerial Decree of 21 December 2007: Directions for Submitting the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authority, for Communicating Substantial Amendments, for Declaring the End of the Trial and for the Request of an Opinion to the Ethics Committee 2. Ministerial Decree of 31 March 2008: Definition of the Minimum Requirements that Contract Research Organisations (CROs) Shall Satisfy in Order to Work within Clinical Trials on Medicinal Products Research Injury Privacy/Data Protection Devices Ministry of Health, Directorate General for Medicines and Medical Devices: http://www.ministerosalute.it Ministry of Labour and Social Policy: www.lavoro.gov.it Italian Data Protection Independent Authority: http://www.garanteprivacy.it/garante/navi 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 64 Ministerial Decree 2 of August 2005: Procedures for the Presentation of Documentation to Notify about Clinical Investigations with Medical Devices Ministerial Decree 14 of July 2009: Minimum Requirements for Insurance Policies Which Safeguard Participants to Clinical Trials of Medicinal Products 1. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical Administrative Procedures Concerning the Conduction of Clinical Investigations with CE-Marked Medical Devices (2007) General Principles of Processing Personal Data (2018): https://www.garanteprivacy.it/home/doveri#2 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Genetic Research g/jsp/index.jsp?solotesto=N 1. Instituto Superiore di Sanita (ISS): http://www.iss.it/chis/?lang=2 2. Italian Society of Human Genetics (SIGU): http://www.sigu.net/ 2. Italian Personal Data Protection Code, Legislative Decree No. 196 of June 30, 2003: http://www.garanteprivacy.it/garant e/navig/jsp/index.jsp?folderpath=No rmativa%2FItaliana%2FIl+Codice+ in+materia+di+protezione+dei+dati +personali Experimentation (May 25, 2000) 2. Regulation for the Implementation of Articles No. 20 and 21 of the Legislative Decree No. 196 of June 30, 2003 3. Ministerial Decree No. 277 (2007) ISS: Guidelines for Phase I Clinical Trials with Investigational Medicinal Products Employed in Gene Somatic Therapy (2004): http://www.iss.it/binary/publ/publi/0478.11066 53420.pdf Embryos, Stem Cells, and Cloning Latvia General Drugs, Biologics, and Devices Central Medical Ethics Committee Drugs 1. State Agency of Medicines: http://www.zva.gov.lv/?setlang=en&large 2. Central Medical Ethics Committee Regulation of Medically Assisted Reproduction, Law No. 40, Article 13 (2004) Law on Pharmacy, Section 26 (2013): https://likumi.lv/ta/en/en/id/43127- pharmaceutical-law 65 Statutes of Central Medical Ethics Committees (1998): http://likumi.lv/doc.php?id=46597 Cabinet Regulation No. 289: Regulations Regarding the Procedures for Conduct of Clinical Trials and Non- interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice: https://likumi.lv/ta/en/en/id/207398- regulations-regarding-the-procedures- for-conduct-of-clinical-trials-and- SIGU: Various: http://www.sigu.net/show/documenti/5/1/linee %20guida Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Devices State Agency of Medicines: http://www.zva.gov.lv/?setlang=en&large = State Agency of Medicines: http://www.zva.gov.lv/?setlang=en&large = Medical Treatment Law, Section 34 (2014): https://likumi.lv/ta/en/en/id/44108- medical-treatment-law non-interventional-trials-of- medicinal-products-labelling-of- investigational-medicinal-products- and-the-procedures-for-assessment- of-conformity-of-clinical-trial-of- medicinal-products-with-the- requirements-of-good-clinical- practice Cabinet Regulation No. 891: Procedures for the Clinical Trial of Medical Devices Intended for Human Use (2010): https://likumi.lv/ta/en/en/id/218764- procedures-for-the-clinical-trial-of- medical-devices-intended-for-human- use Drugs: Cabinet Regulation No. 289: Regulations Regarding the Procedures for Conduct of Clinical Trials and Non- interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice, Sections 22, 31.6, 54.10, 55.9, and 61.14 (2010): https://likumi.lv/ta/en/en/id/207398- regulations-regarding-the-procedures- for-conduct-of-clinical-trials-and- non-interventional-trials-of- medicinal-products-labelling-of- investigational-medicinal-products- and-the-procedures-for-assessment- of-conformity-of-clinical-trial-of- medicinal-products-with-the- requirements-of-good-clinical- practice Devices: Cabinet Regulation No. 891: 66 Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Lithuania Data State Inspectorate: http://www.dvi.gov.lv/en/ Central Medical Ethics Committee 1. Ministry of Health: http://www.vm.gov.lv/en/ 2. Data State Inspectorate: http://www.dvi.gov.lv/en/ 3. Central Medical Ethics Committee 1. Ministry of Health: http://www.vm.gov.lv/en/ 2. Central Medical Ethics Committee 1. Personal Data Processing Law (2014): https://likumi.lv/ta/en/en/id/300099- personal-data-processing-law 2. Law on the Rights of Patients, Section 10 (2013): https://likumi.lv/ta/en/en/id/203008- law-on-the-rights-of-patients 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law on the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine (2008): https://likumi.lv/ta/en/en/id/62843- on-the-protection-of-the-body-of- deceased-human-beings-and-the- use-of-human-tissues-and-organs- in-medicine 1. Human Genome Research Law (2005): https://likumi.lv/ta/en/en/id/64093- human-genome-research-law 2. Law on the Development and Use of the National DNA Database (2006): https://likumi.lv/ta/en/en/id/90819- law-on-development-and-use-of- the-national-dna-database Sexual and Reproductive Health Law, Sections 15-20 (2004): https://likumi.lv/ta/en/en/id/58982- sexual-and-reproductive-health-law Procedures for the Clinical Trial of Medical Devices Intended for Human Use, Sections 42.7 and 62.5 (2010): https://likumi.lv/ta/en/en/id/218764- procedures-for-the-clinical-trial-of- medical-devices-intended-for-human- use Cabinet Regulation No. 446: Procedures for Using Patient Data in a Specific Research Study (2015): https://likumi.lv/ta/en/en/id/275747- procedures-for-using-the-patient- data-in-a-specific-research Cabinet Regulation No. 1176 (2013) Procedures for Use of Human Tissues and Cells: http://likumi.lv/ta/id/261810-cilveka- audu-un-sunu-izmantosanas-kartiba Regulation of the Cabinet of Ministers: “Procedures for Genetic Research” (2004): http://likumi.lv/doc.php?id=92330 Cabinet Regulation No. 1176 (2013) Procedures for Use of Human Tissues and Cells: http://likumi.lv/ta/id/261810-cilveka- audu-un-sunu-izmantosanas-kartiba Note: All websites and documents are in Lithuanian. 67 Country Key Organizations Legislation Regulations Guidelines General Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG 1. Oviedo Convention on Human Rights and Biomedicine (2002): http://conventions.coe.int/treaty/en/t reaties/html/164.htm 2. Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL 3. Changes of Law on Ethics of Biomedical Research No. 536/2014 (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0 5f11e7910a89ac20768b0f 68 1. V-405, Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage, and Providing Information on Biomedical Research (2010): https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.372121 2. Government of the Republic of Lithuania: Decree No. 1458 on State Fees (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.E3A145 C8DD49/adJtSaHbRM 3. V-15, Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation in Biomedical Research and the Time Spent (2018): https://www.e- tar.lt/portal/lt/legalAct/2a0242a0b5fe 11e5a6588fb85a3cc84b/ILdhwknYP P 4.V-28, Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent (2018): https://www.e- tar.lt/portal/lt/legalAct/0f2f1b70b9db 11e5a6588fb85a3cc84b/asr 5. V-1483, Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health (2018): https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/828d5 3e095ef11e4b92e9028929aad91/asr 6. V-235/A1-83, Decree on the Country Key Organizations Legislation Regulations Guidelines General Lithuanian Bioethics Committee (LBEC): http://bioetika.sam.lt/index.php?23518515 30 Procedure for a Minor’s Participation in Biomedical Research (2018): https://www.e- tar.lt/portal/lt/legalAct/104c2540d3e7 11e583a295d9366c7ab3 1. V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28 (2011): https://www.e- tar.lt/portal/lt/legalAct/TAR.480CDD 584ADB 2. V-7, Decree on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol and the CV of Investigator (2017): https://www.e- tar.lt/portal/lt/legalAct/352d55b0c441 11e583a295d9366c7ab3/Maiuzzfyns 3. V-24, Decree on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favorable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/3790a050be7e 11e5a6588fb85a3cc84b 4. V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical Research Ethical Assessment Form (2016): https://www.e- tar.lt/portal/lt/legalAct/27a3460090f0 11e4bb408baba2bdddf3/UqgJXDRU qi Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical Research of the LBEC (2018): http://bioetika.sam.lt/get_file.php?file=bmNlV 3pKeWhhWjJlcW1xZ2xxQnNrWlprbXM2VW tKblJ5Wlp1ekptZG1hV2V5c3JXbUdGa3IzR2 NrNkNab1pxVng2aVprR2ZIWk0yWG81ekxr MnlYY21tV3lwSEtvbWFjbkp4bWNwcCUyQ mNZT2FlMjdUWThacno4ZW1iTlBHbWNlb mJzbVZ4SjJWYWFHZW9HYW1tNmhvajVo bmFwR1ZrbW1jbFdSd2xwdGxsR1pzbHB5W nlXQmdxRzZhWVozRmNKMXJuZyUzRCUz RA==&view=1 69 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Drugs 1. Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG 2. State Medicines Control Agency (SMCA): http://www.vvkt.lt/lit/English Lithuanian Bioethics Committee (LBEC): http://bioetika.sam.lt/index.php?23518515 30 Devices Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG State Health Care Accreditation Agency Under the Ministry of Health (SHCA): http://www.vaspvt.gov.lt/en Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG 1. Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL 2. Law on Pharmacy (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.FF33B 3BF23DD/asr 1. Law on Ethics of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/dReKXfNQaQ 2. Changes of Law on Ethics of Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0 5f11e7910a89ac20768b0f Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL 70 1. Decree No. 320 on the Rules of Good Clinical Practice (2006): https://www.e- tar.lt/portal/lt/legalAct/TAR.EF5F8A 32B830/WkRbILGNxF 2. Decree No. 435 on the Procedure for Issuing a Favorable Opinion to Conduct Clinical Trials on Medicinal Product, Approval for Clinical Trials on Medicinal Product, and Conducting and Controlling Clinical Trials (2017): https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.277308/QPLLKpOUKw Decree No. V-6 on the Sample Form of the Request to Issue Favorable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form (2016): https://www.e- tar.lt/portal/lt/legalAct/b65b5ca0c440 11e583a295d9366c7ab3/qcrDrSCSCJ Decree No. V-2 on the Procedure to Issue Approvals to Conduct Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.47B2353 93D3A/zpczrvbOOR MOH: Decree No. 745 on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor Guidelines to Advertise Clinical Trials, Adopted by the Group of Experts on Biomedical Research of the LBEC (2018): http://bioetika.sam.lt/index.php?3396441505 Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Luxembourg State Data Protection Inspectorate: https://www.ada.lt/go.php/eng Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Law on Legal Protection of Personal Data (2018): https://www.e- tar.lt/portal/lt/legalAct/TAR.5368B5 92234C/VCRurdZydD Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL 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 (2002): http://www.coe.int/en/web/conventi ons/full-list/-/conventions/treaty/168 2. Law on Ethics of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL 3. Changes of Law on Ethics of Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0 5f11e7910a89ac20768b0f (2016): https://www.e- tar.lt/portal/lt/legalAct/c86cf490b3be 11e598c4c7724bda031b/IaIhDiebov 1. Decree No. V-660 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 (2007): https://www.e- tar.lt/portal/lt/legalAct/TAR.8A75E7 9827FD 2. Decree No. V-659 on the Procedure for Importing of the Stem Cells Taken from the Umbilical Cord or Placenta after the Birth of a Child and the Samples Taken for Genetic Research into the Territory of the Republic of Lithuania and Exporting Therefrom (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.E2473B1 958CA/gEtbNSRzzc Note: All websites and documents are available in French. General National Ethics Commission: http://www.cne.lu Various: http://www.cne.public.lu/fr/publications/a vis.html Drugs, Biologics, and Devices 1. Ministry of Health: http://www.ms.public.lu and Hospitals Act of 1998 (2010): http://legilux.public.lu/eli/etat/leg/lo 71 Grand-Ducal Decree of May 30, 2005 on the Conduct of Clinical CNER: 1. Guidance Regarding Elements to Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Privacy/Data Protection Genetic Research Macedonia http://www.sante.lu 2. National Research Ethics Committee (CNER): http://www.cner.lu 3. Division of Pharmacy and Medicines of the Ministry of Health: http://www.sante.public.lu/fr/politique- sante/ministere-sante/direction-sante/div- pharmacie-medicaments/index.html National Data Protection Commission: http://www.cnpd.public.lu/fr/index.html National Research Ethics Committee (CNER): http://www.cner.lu i/2018/03/08/a222/jo 1. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Act of 1 August 2018 on the Organisation of the National Data Protection Commission, Articles 63-65: https://cnpd.public.lu/dam- assets/fr/legislation/droit-lux/Act- of-1-August-2018-on-the- organisation-of-the-National-Data- Protection-Commission-and-the- general-data-protection- framework.pdf Trials on Medicinal Products for Human Use: http://www.legilux.public.lu/leg/a/arc hives/2005/0084/2005A15161.html Include in the Participant Information Sheet and Informed Consent Form 2. Secondary Use of Samples Collected in the Framework of a Research Project 3. Incidental Findings Access: https://www.cner.lu/en- gb/Publications Guidelines Regarding Incidental Findings and Informed Consent Management in the Framework of Whole Genome Sequencing Research Projects: https://www.cner.lu/fr- fr/Publications Notes: Effective February 12, 2019, the name of the country was officially changed to the Republic of North Macedonia. All websites and documents are available in Macedonian. Drugs and Devices Drugs 1. Ministry of Health of Republic of Macedonia: http://moh.gov.mk/ 2. Drug and Devices Register: https://lekovi.zdravstvo.gov.mk/ 1. Law on Medicinal Products and Medical Devices (Official Gazette No.106/2007) and Laws Amending and Supplementing the Law (2010-2018, according 72 1. Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents (2009): https://lekovi.zdravstvo.gov.mk/docu 1. Guideline for the Clinical Trial Applicant (Annex 3) (Sub-folder 23.2) (2012): https://lekovi.zdravstvo.gov.mk/documents/1/1 2.Guideline for Good Clinical Practice, Country Key Organizations Legislation Regulations Guidelines Drugs and Devices 3. Drug Agency http://malmed.gov.mk/ to year of amendment): Click on file folder 1., then open sub-folders: https://lekovi.zdravstvo.gov.mk/doc uments/2 2. Health Care Law (Official Gazette No. 43/2012) and Laws Amending and Supplementing the Law, Article 275: http://www.fzo.org.mk/default.asp?I temID=37115BDC6DEF524D877A 8C36F95A85F6 ments.documentcomponent:download file/817325622?t:ac=1/1 1.1. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents (2010): https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/879452170?t:ac=1/1 1.2. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents (2012): https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/880033320?t:ac=1/1 1.3. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents and Annex No.3 (Guideline for the Clinical Trial Applicant ) (Document No. 23.3) (2012): https://lekovi.zdravstvo.gov.mk/docu ments/1/1 1.4. Rulebook on Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents (2016) (Document No. 23.4): https://lekovi.zdravstvo.gov.mk/docu ments/1/1 2. Regulation on the Manner of Reporting, Contents of the Reporting Form for Adverse Reactions to Medicinal Products and the Manner of Organisation of Pharmacovigilance System Official Gazette No.62/2009, Document No. 19: https://lekovi.zdravstvo.gov.mk/documents/1/1 73 Country Key Organizations Legislation Regulations Guidelines Drugs and Devices Research Injury Privacy/Data Protection Devices 1. Ministry of Health of Republic of Macedonia: http://moh.gov.mk/ 2. Drug and Devices Register: https://lekovi.zdravstvo.gov.mk/ 3. Drug Agency http://malmed.gov.mk/ 1. Ministry of Health of Republic of Macedonia: http://moh.gov.mk/ 2. Drug Agency: http://malmed.gov.mk/ Directorate for Personal Data Protection: www.dzlp.mk Law on Medicinal Products and Medical Devices (Official Gazette No.106/2007) and Laws Amending and Supplementing the Law (2010-2018): Click on file folder 1., then open sub-folders: https://lekovi.zdravstvo.gov.mk/doc uments/2 1. Law on Ratification on Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2005): http://www.dzlp.mk/sites/default/fil es/pdf/Zakon_za_ratifikacija_na_Ko nvencijata_108.pdf 2. Law on Ratification on Additional Protocol to the (2012): https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/880287913?t:ac=1/1 1. Rulebook for the Required Documentation and the Method of Application for Clinical Trials on Medical Devices and the Amendments, and Reporting of Drug Adverse Reactions and Events (Official Gazette No. 62/2010): https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/844338380?t:ac=1/2 2. Rulebook on the Manner of Reporting Adverse Effects During the Use of Medical Devices, Types of Reactions they Cause, the Actions of Health Workers and Suppliers, As Well as the Manner of Organizing the System of Monitoring Adverse Effects and Reactions to Medical Devices (Official Gazette No.100/2016) (Document No.8): https://lekovi.zdravstvo.gov.mk/docu ments/1/2 Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and Documentation Contents (2009): https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/817325622?t:ac=1/1 Regulations on Protection of Personal Data: http://www.dzlp.mk/mk/podzakonski _akti 74 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials 1. Ministry of Health of the Republic of Macedonia: http://moh.gov.mk/ 2. Health Insurance Fund of Republic of Macedonia: http://www.fzo.org.mk Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2008): http://www.dzlp.mk/sites/default/fil es/pdf/Dopolnitelen_protokol_Konv encija_108.pdf 3. Law on Personal Data Protection, Consolidated (2016): http://www.dzlp.mk/sites/default/fil es/u4/ZZLP_konsolidiran_tekst_201 6.pdf 1. Law on 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, With Additional Protocol on the Prohibition of Cloning Human Beings and Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2009): http://www.pravo.org.mk/document Detail.php?id=5543 2. Law on Health Protection: (Official Gazette No. 43/2012) and Laws Amending and Supplementing the Law (2012- 2016): http://zdravstvo.gov.mk/zakon-za- zdravstvenata-zashtita/ 3. Law on Taking and Transplanting of Human Body Organs (Official Gazette No. 47/2011) and Laws Amending and Supplementing the Law (2011-2016): http://zdravstvo.gov.mk/zakon-za- zemanje-i-presaduvanje-na-delovi- na-chovechkoto-telo-zaradi- lekuvanje/ 4. Sub-Law Acts : http://www.fzo.org.mk/default.asp?I temID=6541AC10FFC3C5498F088 75 Regulations for Transplantation of Tissues and Organs (13 regulations): http://www.fzo.org.mk/default.asp?It emID=6541AC10FFC3C5498F0887 C57131D996 Regulation on Criteria Relating to Space, Personnel and Equipment for Collection, Transplantation and Exchange of Organs and Tissues, the Necessary Space, Equipment and Staff Required to be Provided by the Health Institution for the Collection, Transfer, Exchange and Storage of Organs and Tissues from Human Body for Treatment Purposes (2012): http://zdravstvo.gov.mk/wp- content/uploads/2012/12/za_pobliskite_kriteriu mi_vo_odnos_na_prostorot_kadarot_i_opremat a_za_zemawe_presaduvawe_i_razmenuvawe_ na_organite_i_tkivata_za_potrebniot_pr.pdf Country Key Organizations Legislation Regulations Guidelines 7C57131D996 Genetic Research Embryos, Stem Cells, and Cloning Malta General Drugs, Biologics, and Devices Ministry of Health of the Republic of Macedonia: http://moh.gov.mk/ Ministry of Health of the Republic of Macedonia: http://moh.gov.mk/ Bioethics Committee: http://health.gov.mt/en/regcounc/Bioethic s- Committee/Pages/CommitteeMembers.as px Drugs Medicines Authority: http://medicinesauthority.gov.mt/ Law on Patient Rights Protections, Article 21: Action on Human Genome (2012): http://zdravstvo.gov.mk/wp- content/uploads/2012/12/zakon-za- zastita-na-pravata-na-pacientite- precisten.pdf Law on 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, With Additional Protocol on the Prohibition of Cloning Human Beings and Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2009): http://www.pravo.org.mk/document Detail.php?id=5543 1. Medicines Act, 2003: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8924&l=1 2. Subsidiary Legislation, 458.43, Clinical Trials Regulations, 2004: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=11281&l=1 3. Subsidiary Legislation, 458.47, Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of Investigational Medicinal Products (Human Various: http://health.gov.mt/en/regcounc/Bioethics- Committee/Pages/Opinions.aspx Guidance Notes on Good Clinical Practice (2010): http://medicinesauthority.gov.mt/clinicaltrials.h tm 76 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Privacy/Data Protection Moldova Devices 1. Medicines Authority: http://medicinesauthority.gov.mt/ 2. Malta Competition and Consumer Affairs Authority, Technical Regulations Division, Regulatory Affairs Directorate: http://www.mccaa.org.mt/en/regulatory- affairs-directorate Office of the Information and Data Protection Commissioner: http://idpc.gov.mt/index.aspx Use) Regulations, 2004: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=11285&l=1 1. Product Safety Act, 2001: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8893&l=1 2. Subsidiary Legislation, 427.16, In Vitro Diagnostic Medical Devices Regulations, 2003 http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10756&l=1 3. Subsidiary Legislation, 427.44, Medical Devices Regulations, 2010: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10781&l=1 4. Subsidiary Legislation, 427.10, Active Implantable Medical Devices Regulations, 2010: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10753&l=1 1. Data Protection Act, 2002: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8906&l=1 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj For an overview of human subject protections in Moldova, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 7: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf Note: All websites and documents are in Moldovian. General Ministry of Health, National Committee for Ethical Expertise of Clinical Trials: http://ms.gov.md/?q=comitetul-national- etica Oviedo Convention on Human Rights and Biomedicine (2002) 77 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection 1. Ministry of Health , National Committee for Ethical Expertise of Clinical Trials: http://ms.gov.md/?q=comitetul-national- etica 2. Medicines and Medical Devices Agency: http://www.amed.md/ Ministry of Health (MOH): http://www.ms.gov.md/ National Center for Personal Data Protection of the Republic of Moldova: http://www.datepersonale.md/en/start/ 1. Law No. 1409 Dated 17.12.1997 on Medicines, Articles 11 and 12: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=31 1586 2. Law No. 263 Dated 27.10.2005 on Patients’ Rights and Responsibilities. Articles 9, 10, 11, 12, 13, and 14: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=31 3060 Law No. 411-XIII Dated 28.03.1995 on Health: http://lex.justice.md/viewdoc.php?a ction=view&view=doc&id=312823 &lang=1 1. Convention No. 108 for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1981): http://datepersonale.md/en/internati onal003/ 2. Decision of Parliament No. 483-XIV Dated 02.07.1999 on Ratification of Convention No. 108: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=30 9121 3. Law No. 982 Dated 11.05.2000 on Access to Information: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=31 1759 MOH: 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trial: http://lex.justice.md/md/362783/ 2. Order No.648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul %20MS%20nr.%20648.pdf 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trials: http://lex.justice.md/md/362783/ 2. Order No. 648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul %20MS%20nr.%20648.pdf Decision of Government No. 1123 Dated 14.12.2010 on the Approval of the Requirements for the Assurance of Personal Data Security at their Processing within the Information Systems of Personal Data: http://www.datepersonale.md/file/hot ariri/cerinte_securitate%20eng_10122 8.pdf 78 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Montenegro Drugs, Biologics, and Devices 1. Ministry of Health (MOH): http://www.ms.gov.md/ 2. Transplant Agency http://lex.justice.md/md/334622 1. Ministry of Health (MOH): http://www.ms.gov.md/ 2. National Commission on Biological Security: http://lex.justice.md/index.php?action=vie w&view=doc&lang=1&id=303353 1. Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat 2. Agency for Medicines and Medical Devices: https://www.calims.me/Portal/faces/glavn a?_adf.ctrl-state=rsbe35pln_83 4. Law No.133 Dated 08.07.2011 on the Protection of Personal Data: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=34 0495 5. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 6. LP143 Din 19.07.18, MO309- 320/17.08.18 Article 482 1. Law No. 42 Dated 06.03.2008 on Transplantation of Organs, Tissues and Human Cells: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=32 7709 2. LP79 Din 24.05.18, MO195- 209/15.06.18 Article 338 1. 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) 2. Law No. 42 Dated 06.03.2008 on Transplantation of Organs, Tissues and Human Cells: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=32 7709 3. LP79 Din 24.05.18, MO195- 209/15.06.18 Article 338 1. Law on Medicines (“Official Gazette of Montenegro”, No. 56/2011 and 06/13): https://www.calims.me/Portal/faces/ servlet1?putanja=CG_Zakon_o_ljek ovima.pdf&_afrWindowMode=0&_ afrLoop=3654755254077715&_adf. ctrl-state=13nzchbscd_171 2. Law on Medical Devices (“Official Gazette of 79 MOH: Order No.648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of Clinical Trials in Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul %20MS%20nr.%20648.pdf Rulebook on More Detailed Conditions and Documentation Required for Approval and Conduct of Clinical Trials of Medicines for Human Use (2013): https://www.calims.me/Portal/faces/ser vlet1?_afrLoop=26656243505641585& _afrWindowMode=0&putanja=Ruleboo k%2520on%2520Clinial%2520trials.pd f&_adf.ctrl-state=wdqo8wvwo_214 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials 1. Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat 2. Agency for Medicines and Medical Devices: https://www.calims.me/Portal/faces/glavn a?_adf.ctrl-state=rsbe35pln_83 National Security Agency: http://www.anb.gov.me/en/Home?alphabe t=lat Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat Montenegro” No. 79/2004, 53/09, and 40/11): https://www.calims.me/Portal/faces/ servlet1?putanja=CG- Zakon%2520o%2520medicinskim %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181 1. Law on Medicines (“Official Gazette of Montenegro”, No. 56/2011 and 06/13): https://www.calims.me/Portal/faces/ servlet1?putanja=CG_Zakon_o_ljek ovima.pdf&_afrWindowMode=0&_ afrLoop=3654755254077715&_adf. ctrl-state=13nzchbscd_171 2. Law on Medical Devices (“Official Gazette of Montenegro” No. 79/2004, 53/09, and 40/11): https://www.calims.me/Portal/faces/ servlet1?putanja=CG- Zakon%2520o%2520medicinskim %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181 Law on the Protection of Personal Data (Official Gazette of Montenegro No. 79/08, 70/09, 44/12): http://www.azlp.me/docs/zajednicka /zakoni/zakon-o-zastiti-podataka-o- licnosti.pdf Law on the Collection and Use of Biological Samples (Official Gazette of Montenegro No. 14/2010): http://www.mzdravlja.gov.me/Reso urceManager/FileDownload.aspx?ri d=57491&rType=2&file=ZAKON %20O%20UZIMANJU%20I%20K ORI%C5%A0%C4%86ENJU%20B IOLO%C5%A0KIH%20UZORAK A.pdf 80 Country Key Organizations Legislation Regulations Guidelines Genetics Embryos, Stem Cells, and Cloning Netherlands General Drugs, Biologics, and Devices Clinical Trials Registry Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/ 1. Ministry of Health, Welfare, and Sport (VWS): http://www.government.nl/ministries/vws #ref-minvws 2. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/ 3. Medicines Evaluation Board (MEB): http://english.cbg-meb.nl/ 1. Netherlands Trial Register: http://www.trialregister.nl/trialreg/index.a sp 2. Central Committee Register Law on the Protection of Genetic Data (Official Gazette of Montenegro No. 25/2010): http://www.mzdravlja.gov.me/Reso urceManager/FileDownload.aspx?ri d=57566&rType=2&file=ZAKON %20O%20ZA%C5%A0TITI%20G ENETI%C4%8CKIH%20PODATA KA%20.pdf 1. Population Screening Act (1996): http://wetten.overheid.nl/BWBR000 5699/geldigheidsdatum_24-09-2015 2. Medical Research Involving Human Subjects Act (2012) 2006 English version: http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7- 2013-afkomstig-van-vws.pdf Medicines Act (2007): http://wetten.overheid.nl/BWBR002 1505 81 Rulebook on the Collection, Storage, and Use of Stem Cells (2012): http://www.mzdravlja.gov.me/Resour ceManager/FileDownload.aspx?rid=2 22783&rType=2&file=Pravilnik%20 o%20postupku%20prikupljanja,%20 %C4%8Duvanja%20i%20upotrebe% 20mati%C4%8Dnih%20%C4%87elij a%2056-2012.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) VWS: 1. Medicines Act Decree (2007): http://www.ccmo.nl/attachments/files /eng-decree-on-scientific-research- with-medicinal-products.pdf 2. Medicines Act Regulation (2007): http://wetten.overheid.nl/BWBR0022 160 Various: http://www.ccmo.nl/en/publications-of-the- ccmo CCMO: Clinical Research with Medicinal Products in the Netherlands: Instructional Manual (2005): http://www.vumc.nl/afdelingen- themas/1646433/7876770/7876776/7955410/C linical_research_with_medi1.pdf Country Key Organizations Legislation Regulations Guidelines Clinical Trials Registry Research Injury Social-Behavioral Research Privacy/Data Protection Human Biological Materials Genetic Research (Dutch): https://www.toetsingonline.nl/to/ccmo_se arch.nsf/Searchform?OpenForm Ministry of Health, Welfare and Sport: http://www.government.nl/ministries/vws #ref-minvws National Ethics Council for Social and Behavioural Sciences: http://www.nethics.nl/ 1. Dutch Data Protection Authority: https://cbpweb.nl/en 2. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/ 3. Federation of Biomedical Scientific Societies (FMWV): http://www.federa.org/ Federation of Biomedical Scientific Societies (FMWV): http://www.federa.org/ 1. Ministry of Infrastructure and the Environment (IenM): http://www.government.nl/ministries/ien m 2. Dutch Health Care Inspectorate (IGZ): http://www.igz.nl/english/ 3. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/ Medical Research Involving Human Subjects Act, Article 7 (2006): http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7- 2013-afkomstig-van-vws.pdf 1. Personal Data Protection Act (2004): http://wetten.overheid.nl/BWBR001 1468 2. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Civil Code, Article 467 (1994): http://www.ccmo.nl/attachments/file s/wgbo-pdf.pdf Medical Research Involving Human Subjects Act (2006): http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7- 2013-afkomstig-van-vws.pdf Regulation on Mandatory Insurance Regarding Medical Research Involving Human Subjects (2003): https://zoek.officielebekendmakingen .nl/stb-2014-477.html Ethical Code (2018): http://www.nethics.nl/Gedragscode-Ethical- Code/ CCMO: 1. General Data Protection Regulation (2018): http://www.ccmo.nl/en/algemene- verordening-gegevensbescherming?5ad0a79c- a970-44d7-8c78-6de7c35ff8ba 2. Adaptations to the Trial Information Form Due to New European Privacy Legislation (2018) FMWV: 1. Code for Adequate Secondary Use of Data (2004): http://www.federa.org/sites/default/files/bijlage n/coreon/code_of_conduct_for_medical_resear ch_1.pdf 2. Explanatory Report Accompanying the Code (2004): http://www.federa.org/sites/default/files/bijlage n/coreon/explanatory_report1.pdf Code for Proper Secondary Use of Human Tissue in the Netherlands (2002): http://www.federa.org/sites/default/files/bijlage n/coreon/codepropersecondaryuseofhumantissu e1_0.pdf IenM, VWS, and CCMO: Guidelines for Researchers and Sponsors with Regard to the Assessment by Official Bodies of Clinical Research Involving Gene Therapeutics in the Netherlands (2012): http://www.ggo- vergunningverlening.nl/dsresource?type=pdf& objectid=rivmp:193539&versionid=&subobjec tname= 82 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Norway General Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/ National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/ National Committee for Research Ethics in the Social Sciences and the Humanities (NESH): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-in-the-social-sciences- and-the-humanities-nesh/ National Committee for Research Ethics in Science and Technology (NENT): https://www.etikkom.no/en/our- 1. Foetal Tissue Act (2001) (Dutch): http://wetten.overheid.nl/BWBR001 2983/ 2. Embryos Act (2002): http://www.ccmo.nl/attachments/file s/embryos-act.pdf 1. Oviedo Convention on Human Rights and Biomedicine (2006) 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovdata/ lov-20060630-056-eng.pdf 3. Act on Health Care Research (2008): http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov *&& 83 1. Organization of Health Research: https://lovdata.no/dokument/SF/forsk rift/2009-07-01-955 2. Population-Based Health Survey: https://lovdata.no/dokument/SF/forsk rift/2018-04-27-645 3. Right of Children Between 12- 16 Years to Consent to Participate in Health Research: https://lovdata.no/dokument/SF/forsk rift/2017-06-28-1000 1. Guidelines for Research on Persons with Impaired Informed Consent Capacity (2005) 2. Payment for Research Participants in Medical and Health Research (2009) 3. Guidelines for Research Ethical and Scientific Evaluation of Qualitative Research Projects in Medical and Health Research (2009): https://www.etikkom.no/forskningsetiske- retningslinjer/Medisin-og-helse/Kvalitativ- forskning/ 4. Guidelines for Ethical Evaluation and Post-marketing Studies (2003) 5. Guidelines for Genetic Research of Humans (2016) (Norwegian): https://www.etikkom.no/forskningsetiske- retningslinjer/Medisin-og- helse/retningslinjer-for-bruk-av-genetiske- undersokelser-av-mennesker-i-medisinsk- og-helsefaglig-forskning/ 1. Guidelines for Research Ethics in the Social Sciences, Humanities, Law and Theology (2016): https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research-ethics-in- the-social-sciences--humanities-law-and- theology/ 2. A Guide to Internet Research Ethics (2019): https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/ Research Ethics Guidelines for Science and Technology (2016): https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research-ethics-in- science-and-technology/ Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Research Injury Social-Behavioral Research work/about-us/the-national-committee- for-research-ethics-in-science-and- technology-nent/ National Committee for Research Ethics on Human Remains: https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-on-human-remains/ Drugs Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx Devices Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx Norwegian System of Patient Injury Compensation: https://www.npe.no/en/information- compensation-claimants/drug- injury/clinical-trials/ 1. National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) 2. National Committee for Research Ethics on Human Remains (NCEHR): 1.Medicines Act: https://lovdata.no/dokument/NL/lov /1992-12-04- 132?q=lov%20om%20legemidler 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov /2008-06-20- 44?q=helseforskningsloven Act of 12 January 1995 No. 6 Relating to Medical Devices (1995): http://lovdata.no/dokument/NL/lov/ 1995-01-12- 6?q=lov+om+medisinsk+utstyr 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov /2008-06-20- 44?q=helseforskningsloven 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2007) 2. Act on Patient Injury Compensation (2001): https://lovdata.no/dokument/NL/ lov/2001-06-15-53 3. Act on Product Liability, Chapter 3: https://lovdata.no/dokument/NL/lov /1988-12-23- 104?q=produktansvarsloven Research Ethics Act (2017): https://lovdata.no/dokument/NL/lov /2017-04-28-23?q=forskningsetikk 2. Act of Cultural Heritage (1978): 84 Regulation Relating to Clinical Trials on Medicinal Products for Human Use (2009): http://lovdata.no/dokument/SF/forskri ft/2009-10-30- 1321?q=forskrift+om+kliniske+utpr %C3%B8vning Regulation of December 15th 2005 No. 1690 Relating to Medical Devices (2005): http://lovdata.no/dokument/SF/forskri ft/2005-12-15- 1690?q=forskrift+medisinsk+utstyr Guidelines for Research Ethics on Human Remains: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research--ethics-on- human-remains/ Guidelines for the Regulations Concerning Clinical Trials of Human Drugs (1999): http://www.legemiddelverket.no/Godkjenning_ og_regelverk/Klinisk- utproving/Regelverk%20og%20veiledninger/D ocuments/Veiledning%20- %20revidert%20versjon%202.2%2006.11.201 2.pdf Various: https://legemiddelverket.no/english/medical- devices/regulatory-information-regarding- medical-devices NESH: 1. Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2016): https://www.etikkom.no/en/ethical- guidelines-for-research/guidelines-for- Country Key Organizations Legislation Regulations Guidelines Social- Behavioral Research https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-on-human-remains/ https://lovdata.no/dokument/NL/lov /1978-06-09-50 research-ethics-in-the-social-sciences-- humanities-law-and-theology/ 2. Guide to Internet Research Ethics (2018): https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/ Privacy/Data Protection Human Biological Materials Genetic Research Norwegian Data Protection Authority: https://www.datatilsynet.no/en/ 1. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/ 2. Regional Committees for Medical Research Ethics (REK): https://rekportalen.no/#home/REK 1. Norwegian Directorate of Health: https://www.helsedirektoratet.no/tema/gen teknologi 2. Norwegian Biotechnology Advisory Board: http://www.bion.no/english/ 3. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-medical-and-health-research-ethics- 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Personal Data Act (2018): https://lovdata.no/dokument/NL/lov /2018-06-15- 38?q=personopplysningsloven 1. Act Relating to the Application of Biotechnology in Human Medicine, etc. (Biotechnology Act) (December 5, 2003, No. 100): https://lovdata.no/dokument/NL/lov /2003-12-05- 100?q=humanmedisinsk%20bruk 2. Act on Health Care Research (2008): http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov *&& 1. Act Relating to the Application of Biotechnology in Human Medicine, Etc. (December 5, 2003, No. 100): https://lovdata.no/dokument/NL/lov /2008-06-20- 44?q=helseforskningsloven 2. Gene Technology Act: https://lovdata.no/dokument/NL/lov /1993-04-02-38?q=genteknologi 3. Act on Health Care Research: 85 NCEHR: Guidelines for Research Ethics on Human Remains: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research--ethics-on- human-remains/ 1. Guidelines for Genetic Research in Humans (Norwegian): https://www.etikkom.no/forskningsetiske- retningslinjer/Medisin-og-helse/retningslinjer- for-bruk-av-genetiske-undersokelser-av- mennesker-i-medisinsk-og-helsefaglig- forskning/ 2. Guidelines for Research Ethics in Science and Technology (2016): https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research-ethics-in- Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning Poland General Drugs, Biologics, and Devices nem/ 4. Regional Committees for Medical Research Ethics (REK): https://www.etikkom.no/en/In- English/Committee-for-Medical-and- Health-Research/ 5. National Committee for Research Ethics in Science and Technology (NENT): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-in-science-and- technology-nent/ 1. Norwegian Directorate of Health: https://www.helsedirektoratet.no/tema/gen teknologi 2. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/ 3. Regional Committees for Medical Research Ethics (REK): https://www.etikkom.no/en/In- English/Committee-for-Medical-and- Health-Research/ 1. Ministry of Health, Bioethics Appeals Commission (MOH) Bioethics Appeals Commission (MOH): https://www.gov.pl/zdrowie/odwolawcza- komisja-bioetyczna 2. Center of Bioethics, Polish Chamber of Physicians and Dentists (NIL): http://www.nil.org.pl/dzialalnosc/orodek- bioetyki Drugs Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products: http://www.urpl.gov.pl/en https://lovdata.no/dokument/NL/lov /2008-06-20- 44?q=helseforskningsloven 1. Act Relating to the Application of Biotechnology in Human Medicine, etc. (Biotechnology Act) (December 5, 2003, No. 100): https://lovdata.no/dokument/NL/lov /2003-12-05- 100?q=humanmedisinsk%20bruk 2. Act on Health Care Research: https://lovdata.no/dokument/NL/lov /2008-06-20- 44?q=helseforskningsloven 1. Constitution of the Republic of Poland, Article 39 (1997): http://www.sejm.gov.pl/prawo/kons t/polski/kon1.htm 2. Medical Profession Act, Articles 21-29 (1996): http://isap.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20190000537 Pharmaceutical Law (2017): http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000499 MOH: Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics Committees (1999): http://isap.sejm.gov.pl/DetailsServlet ?id=WDU19990470480 Decree of the Minister of Health on Clinical Trials on Minors (2004): http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20041041108 science-and-technology/ NIL: Code of Medical Ethics, Chapter II (2003): http://www.nil.org.pl/dokumenty/kodeks-etyki- lekarskiej 86 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Devices Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products: http://www.urpl.gov.pl/en/medical- devices Act on Medical Devices: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000175 1. Regulation of the Minister of Health on Detailed Conditions to be Met for Clinical Evaluation of Medical Devices or Active Implantable Medical Devices (2011): http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20110630331 Research Injury Privacy/Data Protection Human Biological Materials Personal Data Protection Office: https://uodo.gov.pl/en Pharmaceutical Law, Chapter 36b: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000499 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 2. Act on the Protection of Personal Data (2018): https://uodo.gov.pl/pl/131/262 1. Act of 22 August 1997 on the Public Blood Service: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190001222 Various: http://www.urpl.gov.pl/pl/wyroby- medyczne/akty-prawne/przepisy-rp 1. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors (2004): http://isap.sejm.gov.pl/DetailsServlet ?id=WDU20041011034 2. Order of the Minister of Finance Amending the Regulation Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors (2005): http://isap.sejm.gov.pl/DetailsServlet ?id=WDU20051010845 3. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors in Clinical Trials of Medicinal Products (2010): http://isap.sejm.gov.pl/DetailsServlet ?id=WDU20101941290 87 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Portugal General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection National Council of Ethics for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/ Drugs 1. National Institute of Pharmacy and Medicines: http://www.infarmed.pt/portal/page/portal/ INFARMED/ENGLISH 2. Ethics Commission for Clinical Research (CEIC): http://www.infarmed.pt/portal/page/portal/ INFARMED/MEDICAMENTOS_USO_H UMANO/CEIC Devices National Institute of Pharmacy and Medicines: http://www.infarmed.pt/portal/page/portal/ INFARMED/DISPOSITIVOS_MEDICOS National Data Protection Commission: http://www.cnpd.pt/english/index_en.htm 2. July 1, 2005 Act Regarding Sampling, Storage, and Transplanting of Cells, Tissues, and Organs: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20170001000 Oviedo Convention on Human Rights and Biomedicine (2001) 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: http://www.infarmed.pt/portal/page/ portal/INFARMED/LEGISLACAO/ LEGISLACAO_FARMACEUTICA _COMPILADA/TITULO_III/TITU LO_III_CAPITULO_I/portaria_57- 2005.pdf Various: http://www.infarmed.pt/portal/page/ portal/INFARMED/LEGISLACAO/ LEGISLACAO_FARMACEUTICA _COMPILADA/TITULO_V/TITU LO_V_CAPITULO_II Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2001) 1. Constitution, Article 35 (1997) 2. Act on the Protection of Personal Data, No. 67/98 (1998): http://www.cnpd.pt/english/bin/legis lation/Law6798EN.HTM Decree-Law No. 102/2007 of April 2 Various: http://www.cnecv.gov.pt/cnecv/en/opinions/ Various: http://www.infarmed.pt/portal/page/portal/INF ARMED/DISPOSITIVOS_MEDICOS/NOTAS _INFORMATIVAS FAQs: Consent (2018): https://www.cnpd.pt/bin/faqs/faqs.htm#consenti mento 88 Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Genetic Research Embryos, Stem Cells, and Cloning Romania General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Ministry of Health: http://www.portugal.gov.pt/en/the- ministries/ministry-of-health.aspx National Council of Ethics for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/ Ministry of Health (MOH): http://www.ms.ro/ 1. Ministry of Health (MOH): http://www.ms.ro/ 2. National Agency for Medicines and Medical Devices: https://www.anm.ro/en/ 3. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/ 1. National Agency for Medicines and Medical Devices: http://www.anm.ro/anmdm/en/index.html 2. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/ National Supervisory Authority for Personal Data Processing: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law 12/2005 1. 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) Oviedo Convention on Human Rights and Biomedicine (2001) Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2001) 1. Law No. 667/2001 On the Protection of Individuals with 89 Ordinance No. 57/16.08.2002 (2002): http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie MOH: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive Access: https://www.anm.ro/en/medicamente -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/ 1. Opinion 15/CNECV/95 on Embryo Research (1995) 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC- 419999D9B693/0/47CNECV2005.pdf 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D- D70A7E9AD961/0/p048_en.pdf MOH: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999) The New General Data Protection Regulation (2018): Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Russia http://www.dataprotection.ro/index.jsp?pa ge=documents&lang=en Ministry of Health (MOH): http://www.ms.ro/ Regard to the Processing of Personal Data and on the Free Movement of Such Data: http://www.dataprotection.ro/servlet /ViewDocument?id=174 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law No. 95/2006 Regarding the Reform in Health Field. Title VI. Performing of Sampling and Transplant of Organs, Tissues and Human Origin Cells with Therapeutic Purpose: http://www.transplant.ro/Lege/Lege -2006-95.pdf 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. Law No. 301 from 2004 Penal Code – Chapter IV – Crimes and Felonies Regarding Genetic Manipulation: http://www.codpenal.ro/legislatie/do cument/lege-301-din-2004-codul- penal-capitol-4-crime-si-delicte- privind-manipularea-genetica-1260- 63259.html Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Quality and Safety of Human Organs Intended for Transplantation: http://europa.eu/legislation_summari es/public_health/threats_to_health/sp 0008_ro.htm http://www.dataprotection.ro/?page=Regulame ntul_nr_679_2016 For an overview of human subject protections in Russia, see http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf General 1. Ministry of Healthcare of the Russian Federation (MOH): http://www.rosminzdrav.ru 2. Federal Service on Surveillance in Healthcare (Roszdravnadzor): http://www.roszdravnadzor.ru/ 3. Russian Committee for Bioethics: http://www.bioethics.ru/eng/ 1. Constitution of the Russian Federation, Article 21 (1993): http://www.constitution.ru/en/10003 000-03.htm 2. Federal Law #FZ 323 “On Foundations of Protection of Citizen’s Health in the Russian Federation” (2011): 90 MOH: 1. Ministry of Health Order 433n (July 10, 2015) “On Adoption of the Regulations on Organization of Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation (Including Order of Patients’ Assignment for Administering Such Medical Help), Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices 1. Council of Ethics of the Ministry of Healthcare of the Russian Federation (MOH): http://www.grls.rosminzdrav.ru/ 2. Association of Clinical Trials Organizations: http://acto-russia.org/en/ 3. Federal Agency for Technical Regulation and Metrology (GOST): http://www.gost.ru/wps/portal/pages.en.M ain http://acto- russia.org/en/index.php?option=co m_content&task=view&id=105 3. Federal Law #FZ55 “On Introduction of Changes in FZ “On Foundations of Protection of Citizens’ Health in the Russian Federation” with Regard to Questions of Organization of Medical Aid Administered in the Course of Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation” (2015): http://www.consultant.ru/document/ cons_doc_LAW_176159 Federal Law #61FZ “On Circulation of Medicines” (2011): http://acto- russia.org/files/zakon_ob_obr_ls_en .docx MOH: 1. Ministry of Health Order No. 753n (August 26, 2010) “On Assertion of Order of Organization and Carrying out of Ethical Review…” (Russian): http://base.garant.ru/12178437/ 2. Ministry of Health Order No. 774n (August 31, 2010) “On Council of Ethics” (Russian): http://www.rg.ru/2013/02/22/etika- dok.html 3. Ministry of Health Order of April 1, 2016 No. 200н "On Approval of the Rules of Good Clinical Practice:” http://acto- russia.org/files/prikaz_200n.docx Standard Form of Protocol for Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment, and Rehabilitation”: http://base.consultant.ru/cons/cgi/online.cgi?req =doc;base=LAW;n=183847 2. Ministry of Health Order 435h “On Ethics Committee of the Ministry of Health of the Russian Federation” (July 10, 2015): http://base.consultant.ru/cons/cgi/online.cgi?req =doc;base=LAW;n=183677 Research Injury Federal Law #61FZ “On Circulation of Medicines” (2011), Art. 38-44: GOST: Good Clinical Practice. GOST-R 52379-2005 (September 27, 2005): http://acto- russia.org/index.php?option=com_co ntent&task=view&id=17 91 Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Genetic Embryos, Stem Cells, and Cloning San Marino General Research Injury Serbia Drugs, Biologics, and Devices Interdepartmental Commission on Genetic-Engineering Activity San Marino Bioethics Committee (Italian): http://www.sanita.sm/on- line/home/comitato-bioetica/comitato- sammarinese-di-bioetica.html 1. Ministry of Health (MOH): http://www.zdravlje.gov.rs/ 2. Serbian Drug Agency http://www.alims.gov.rs/eng/ http://acto- russia.org/files/zakon_ob_obr_ls_en .docx 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/ 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:” http://base.garant.ru/10135402/ Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010): http://base.garant.ru/184467/ Oviedo Convention on Human Rights and Biomedicine (1998) Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998) Law on Medicines and Medical Devices, Official Gazette of RS No. 30/2010, 107/2012, 113/2017, and 105/2017: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf 92 Order of the Ministry of Education and Science of the Russian Federation #154: “Statute of the Inter- Departmental Commission on Genetic-Engineering Activity” (2005): http://www.zakonprost.ru/content/ba se/part/438157 MOH: Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical Trials, Official Gazette of RS, 64/2011, 91/2013, Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Genetics Embryos, Stem Cells, and Cloning 1. Ministry of Health (MOH): http://www.zdravlje.gov.rs/index.php? 2. Serbian Drug Agency http://www.alims.gov.rs Commissioner for Information of Public Importance and Personal Data Protection: https://www.poverenik.rs/en/ Ministry of Health (MOH): http://www.zdravlje.gov.rs/index.php? National Health Insurance Fund: http://www.rfzo.rs/ Law on Medicines and Medical Devices, Article 72: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf Law on the Protection of Personal Data, Official Gazette 87/2018: https://www.paragraf.rs/propisi/zak on-o-zastiti-podataka-o- licnosti.html Law on the Prevention and Diagnosis of Genetically Conditioned Diseases, Genetically Caused Anomalies and Rare Diseases, Official Gazette 8/2015: https://www.paragraf.rs/propisi/zak on_o_prevenciji_i_dijagnostici_gen etickih_bolesti_geneticki_uslovljeni h_anomalija_i_retkih_bolesti.html 1. Law on Organ Transplantation, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do wnload/zakon-o-presadjivanju- ljudskih-organa.pdf 2. Law on Human Cells and Tissues, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do 93 60/2016, and 9/2018: https://www.alims.gov.rs/ciril/files/2 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf MOH: 1. Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical Trials, Official Gazette of RS, 64/2011, 91/2013, 60/2016, and 9/2018: https://www.alims.gov.rs/ciril/files/2 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf 2. Law on Patients' Rights, Article 25 Official Gazette of RS, 45/2013 and 25/2019: https://www.paragraf.rs/propisi/zako n_o_pravima_pacijenata.html Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Slovakia General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Slovenia 1. Ministry of Health (Slovak): http://www.health.gov.sk/ 2. Institute of Medical Ethics and Bioethics: http://www.bioethics.sk/ State Institute for Drug Control: http://www.sukl.sk/en Office for Personal Data Protection: https://dataprotection.gov.sk/uoou/en wnload/zakon-o-ljudskim-celijama- i-tkivima.pdf 1. Oviedo Convention on Human Rights and Biomedicine (1998) 2. Additional Protocol on Biomedical Research (2005) 3. Act No. 576/2004 Coll on Health Care, As Amended by Acts No. 350/2005, 282/2006, 662/2007, 345/2009 Coll. Act No. 140/1998 Coll. on Drugs and Medical Devices, as amended by Acts No. 9/2004 and 542/2006, 489/2008, and 402/2009 Coll. Law 277/1994 on Health Care, Section 44 1. Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll. 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 1. Act No. 576/2004 Coll. on Health Care, Sections 35-39. 2. Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b). 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 No. 576/2004 Coll. on Health Care, Section 26.10.a. Ministerial Regulation No. 239/2004 Coll. on Requirements for Clinical Trials and Good Clinical Practice, as Amended by Ministerial Regulation No. 148/2009 Coll. Governmental Regulation No. 20/2007 Coll. on Tissue and Cell Collection GDPR Regulation (2018): https://dataprotection.gov.sk/uoou/sk/main- content/nariadenie-gdpr Note: All websites and documents are in Slovenian. General Republic of Slovenia National 1. Health Services Act Code of Medical Ethics (2016): 94 Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ Drugs 1. Ministry of Health of the Republic of Slovenia http://www.mz.gov.si/ 2. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/ Devices 1. Ministry of Health of the Republic of Slovenia: http://www.mz.gov.si/ 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/ 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO214 2. Decree Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005): http://pisrs.si/Pis.web/pregledPredpi sa?id=URED3728 3. Patient Rights Act, Official Gazette No. 15/2008 55/2017: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO4281 and https://www.uradni-list.si/glasilo-uradni- list-rs/vsebina/2017-01-2526?sop=2017- 01-2526 4. Mental Health Act, Official Gazette Nos. 77/2008 and 46/2015: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO2157 1. Medicinal Products Act, Official Gazette No. 17/2014: http://www.uradni- list.si/1/objava.jsp?sop=2014-01- 0539 2. EU Clinical Trials Regulation No. 536/2014: http://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL EX:32014R0536&from=EN 1. Medical Devices Act, Official Gazette No. 98/2009: http://www.pisrs.si/Pis.web/pregled Predpisa?id=ZAKO5503 1. Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV6611 2. Rules on the Composition, Duties, Responsibilities, and Working Methods of the Commission for Medical Ethics, Official Gazette No. 21/2018: http://pisrs.si/Pis.web/pregledPre dpisa?id=PRAV13345 Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV9508 https://www.zdravniskazbornica.si/docs/default -source/zbornicni-akti/kodeks- 2016.pdf?sfvrsn=2 95 Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Human Biological Materials 1. Ministry of Health of the Republic of Slovenia: http://www.mz.gov.si/ 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/ 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ Information Commissioner of the Republic of Slovenia: http://www.ip-rs.si/ 1. Ministry of Health of the Republic of Slovenia: http://www.mz.gov.si/ 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/ 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ 4. Institute for transplantation of Organs and Tissues of the Republic of Slovenia: http://www.slovenija- transplant.si/index.php?id=predstavitev&L =2 1. Medicinal Products Act, Official Gazette No. 17/2014: http://www.uradni- list.si/1/objava.jsp?sop=2014-01- 0539 2. Medical devices Act Official Gazette No. 98/2009 http://www.pisrs.si/Pis.web/pregled Predpisa?id=ZAKO5503 3. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (1999) 4. Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005) Decree ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research: http://pisrs.si/Pis.web/pregledPredpi sa?id=URED3728 1. Personal Data Protection Act No. 94/2007: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO3906 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 1. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Transplantation of Organs and Tissues of Human Origin (2006) 2. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No. 61/2007: http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297 3. Rules on Donation and Procurement of Human Tissues 96 1. Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV6611 2. Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV9508 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999) 2. On Interventions into the Human Corpse Which are Not Part of the Routine Autopsy and on Handling with Biologic Material of Human Origin (2004): http://bswww.mf.uni- lj.si/pls/bs/BS_full_rec?lang=SLO&c_docid=1 05859 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Embryos, Stem Cells, and Cloning 5. Institute Service of Slovenia for Transfusion Medicine: http://www.ztm.si/en/ Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ 1. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/ 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/ and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014 4. Act Regulating the Collection and Transplantation of Human Body Parts for the Purposes of Medical Treatment, Official Gazette No. 56/2015: http://www.uradni- list.si/1/objava.jsp?sop=2015-01- 2357 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (2009) 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. Infertility Treatment and Procedures of Biomedically- Assisted Procreation Act, Official Gazette No. 70/2000, Section 9 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2000-01- 3307 3. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No. 61/2007 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297 4. Rules on Donation and Procurement of Human Tissues and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014 97 Country Key Organizations Legislation Regulations Guidelines Spain Note: Many of the 17 Spanish autonomous regions have their own laws and regulations on human subject protections. General Drugs, Biologics, and Devices 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/farmacia/ ceic/home.htm 3. Institute of Health Carlos III, Ministry of Science and Innovation http://www.isciii.es/htdocs/en/index.jsp Drugs Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion Clinica/medicamentos/home.htm 1. Oviedo Convention on Human Rights and Biomedicine (1999): http://www.coe.int/t/dg3/healthbioet hic/texts_and_documents/ETS164S panish.pdf 2. Law 14/2007 on Biomedical Research: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf 98 1. Order SCO/362/2008 that Modifies Order SCO/256/2007: http://www.aemps.gob.es/legislacion /espana/investigacionClinica/docs/rc l_2008_410.pdf 2. Order SAS/3470/2009 on Drugs Post Authorization Research: http://www.aemps.gob.es/legislacion /espana/medicamentosUsoHumano/d ocs/farmacovigilancia/rcl_2009_257 7.pdf 3. Royal Decree 1015/2009: Drug Availability for Special Purposes: http://www.boe.es/boe/dias/2009/07/ 20/pdfs/BOE-A-2009-12002.pdf 4. Royal Decree 577/2013 Regulating Pharmacovigilance in Human Use Medicines: http://www.boe.es/diario_boe/txt.ph p?id=BOE-A-2013-8191 5. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with Medicinal Products and the Spanish Clinical Studies Registry: http://noticias.juridicas.com/base_da tos/Admin/565124-rd-1090-2015- Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Devices Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion Clinica/productosSanitarios/home.htm Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/home.htm 1. Spanish Data Protection Authority: https://www.agpd.es/portalweb/index-ides- idphp.php 2. Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/en/investigacion Clinica/medicamentos/home.htm Royal Decree 1591/2009, Regulating Sanitary Devices: http://www.ont.es/infesp/Legislacin/ RD_1591_2009.pdf 1. Law 14/2007 on Biomedical Research, Article 18: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf 2. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, Repealing Directive 2001/20/EC: http://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL EX:32014R0536&from=EN 3. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with Medicinal Products and the Spanish Clinical Studies Registry: https://www.aemps.gob.es/legislaci on/espana/investigacionClinica/docs /Royal-Decree-1090-2015_4- December.pdf 1. Law 14/2007 on Biomedical Research, Title I, Article 5: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf 2. EU General Data Protection Regulation (2018): https://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL EX:32016R0679&from=EN 3. Organic Law 3/2018 of 99 de-4-dic-regula-los-ensayos- clinicos-con-medicamentos-los- comites.html Various: http://www.aemps.es/actividad/psch b/implantables1.htm#circulares 1. Royal Decree 1720/2007: http://www.davara.com/documentos/ relacionados/proteccion/RD_1720- 2007_english.pdf 2. Royal Decree of 19 January 2008 AEMPS: Revised Instructions for Updating the Section “Protection of Personal Data in the Subject Information Sheet (HIP /CI) Regarding the Regulation (EU) No. 2016/679 General Data Protection (2018): https://www.aemps.gob.es/investigacionClinica /medicamentos/docs/anexo8c-Ins-AEMPS- EC.pdf Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Genetic Ministry of Health, Consumer Affairs, and Social Welfare: http://www.msssi.gob.es/en/home.htm Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US December 5 on the Protection of Personal Data and Guaranteeing Digital Rights: https://www.boe.es/biblioteca_juridi ca/codigos/codigo.php?id=055_Prot eccion_de_Datos_de_Caracter_Pers onal&modo=1 Law 14/2007 of July 3 on Biomedical Research, Title I, Article 11; Title III, Article 37; Title V: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf 1. Royal Decree 65/2006 of Requirements for the Import and Export of Biological Samples: http://www.boe.es/boe/dias/2006/02/ 07/pdfs/A04626-04636.pdf 2. Royal Decree 1723/2012 Regarding Activities of Collection, Clinical Use and Territorial Coordination of Human Organs for Transplants and Establishing Their Quality and Safety Requirements: http://noticias.juridicas.com/base_da tos/Admin/rd1716-2011.html 3. Royal Decree 1716/2011 on Biobanks: http://www.comitedebioetica.es/nor mativa/docs/RD%201716_2011_de %20autorizacion%20y%20funciona miento%20de%20los%20biobancos. pdf 4. Royal Decree 9/2014 on Quality and Security Rules Regarding Donating, Gathering, Evaluation, Processing, Storage, Preservation, and Distribution of Human Cells and Tissues and Rules Regarding Coordination and Functioning of their Use in Human Beings: http://www.boe.es/buscar/doc.php?id =BOE-A-2014-7065 100 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Sweden 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US 2. National Commission for the Donation and Use of Embryos, Cells, and Human Tissues for Biomedical Research: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml 3. National Biobank Register: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml 4. National Stem Cell Bank: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/fd-organizacion/fd- estructura-directiva/fd-subdireccion- general-investigacion-terapia-celular- medicina-regenerativa/fd-centros- unidades/banco-nacional-lineas- celulares.shtml 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 3. Law 14/2007 of July 3 on Biomedical Research, Title III: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf Royal Decree 1527/2010 By Which the Guarantees Commission for the Donation and Use of Human Cells and Tissues and Registration Research Projects is Regulated: http://www.boe.es/diario_boe/txt.ph p?id=BOE-A-2010-18654 For an overview of human subject protections in Sweden, see CODEX: Rules and Guidelines for Research: http://www.codex.uu.se/en/index.shtml General 1. Swedish Ethical Review Authority: https://etikprovningsmyndigheten.se/ 2. Ethics Review Appeal Board: https://www.onep.se/en/start/ Swedish Research Council: http://www.vr.se/english Act No. 460 on the Ethical Review of Research Involving Humans (2003): https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk- forfattningssamling/lag-2003460- om-etikprovning-av-forskning- som_sfs-2003-460 101 1. Ordinance No. 615 Concerning the Ethical Vetting of Research Involving Humans (2003): https://www.riksdagen.se/sv/dokume nt-lagar/dokument/svensk- forfattningssamling/forordning- 2003615-om-etikprovning-av_sfs- 2003-615 2. Statute with Instructions for the Swedish Ethical Review Authority (2018:1879) https://svenskforfattningssamling.se/ sites/default/files/sfs/2018- 11/SFS2018-1879.pdf 3. Statute with Instructions for the Ethics Review Appeals Board (2007:1068) http://rkrattsbaser.gov.se/sfst?bet=20 07:1068 Good Research Practice (2017): https://www.vr.se/english/analysis-and- assignments/we-analyse-and-evaluate/all- publications/publications/2017-08-31-good- research-practice.html Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Drugs Medical Products Agency: https://lakemedelsverket.se/english/ Devices Medical Products Agency: http://www.lakemedelsverket.se/english/pr oduct/Medical-devices/Clinical- Investigations/ 1. Pharmaceuticals Act No. No 2015:315: https://open.karnovgroup.se/halso- och-sjukvard/lakemedelslagen 1. Swedish Medical Devices Act (SFS 1993:584): http://www.notisum.se/rnp/sls/lag/1 9930584.htm 2. Medical Devices Ordinance (SFS1993:876): http://www.riksdagen.se/sv/dokume nt-lagar/dokument/svensk- forfattningssamling/forordning- 1993876-om-medicintekniska_sfs- 1993-876 MPA Regulations on Clinical Trials in Humans -- LVFS 2011:19: http://www.lakemedelsverket.se/upl oad/lvfs/LVFS_2011_19.pdf Swedish Implementation of Directive 93/42/EEC -- LVFS 2003:11: https://lakemedelsverket.se/uploa d/lvfs/LVFS_2003-11.pdf Social-Behavioral Research Privacy/Data Protection Swedish Research Council Swedish Data Protection Agency (SDPA): http://www.datainspektionen.se/in-english/ 1. Patient Data Act: SFS 2008:355: http://www.notisum.se/rnp/sls/lag/2 0080355.htm 2. SFS 2009:400 - Public Access to Information and Secrecy Act: http://www.notisum.se/rnp/sls/lag/2 0090400.htm 3. Act on Certain Health Research Registers, SFS 2013:794: http://www.notisum.se/Pub/Doc.asp x?url=/rnp/sls/lag/20130794.htm 4. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj 5. Act (2018:218) Complement to the GDPR: https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk- forfattningssamling/lag-2018218- 102 SFS 2009:641 - Public Access to Information and Secrecy Ordinance: http://www.notisum.se/rnp/sls/lag/20 090641.htm Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2017): https://www.vr.se/english/analysis-and- assignments/we-analyse-and-evaluate/all- publications/publications/2017-08-31-good- research-practice.html 1. General Data Protection Regulation (2018): https://www.datainspektionen.se/lagar- -regler/dataskyddsforordningen/ 2. Transmission to Third Countries (2018): https://www.datainspektionen.se/lagar-- regler/dataskyddsforordningen/tredjelandsoverf oring/ Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Switzerland 1. Health and Social Care Inspectorate (IVO): https://www.ivo.se/om-ivo/other- languages/english/ 2. Biobank Sweden: http://biobanksverige.se/ 1. Medical Products Agency: https://lakemedelsverket.se/english/ 2. The Swedish Gene Technology Advisory Board (SGTAB): https://www.genteknik.se/ National Board of Health and Welfare (SOS): http://www.socialstyrelsen.se/english med-kompletterande- bestammelser_sfs-2018-218 1. Biobanks in Medical Care Act No. 297 (2002): https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk- forfattningssamling/lag-2002297- om-biobanker-i-halso--och_sfs- 2002-297 2. Regulation No. 746 (2002): http://www.notisum.se/rnp/sls/lag/2 0020746.htm Act on Genetic Integrity (2006:351): http://www.notisum.se/rnp/sls/lag/2 0060351.htm Act on Genetic Integrity (2006:351): http://www.notisum.se/rnp/sls/lag/2 0060351.htm Drug Administration Regulations and Guidelines (LVFS 2004:10) on the Intentional Release of Clinical Trials of Medicinal Products Containing or Consisting of Genetically Modified Organisms: http://www.lakemedelsverket.se/upl oad/lvfs/LVFS_2004-10.pdf 1. Legal Regulation of Stem Cell Research 2002:119: http://www.regeringen.se/sb/d/108/a/ 2717 2. Regulations and Guidelines for the Use of Tissues and Cells in Healthcare and Clinical Research - SOSFS 2009:32: http://www.socialstyrelsen.se/sosfs/2 009-32 SGTAB: Advice for Ethical Assessments: https://www.genteknik.se/wp- content/uploads/2017/09/072_2010-Etisk- v%C3%A4gledning.pdf For an overview of human subject protections in Switzerland, see: http://kofam.ch/en/home/ General 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang =en 2. Federal Office of Public Health, Portal for Human Research (FOPH): http://kofam.ch/en/home/ 3. National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/ 3. Swiss Ethics Committees on Research Involving Humans: http://www.swissethics.ch/index_e.html 1. Council of Europe Convention on Human Rights and Biomedicine of 4 April 1997, ETS No. 164, Articles 15- 18: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G 2. Federal Constitution of the Swiss Confederation of 18 April, 1999, RS 101, Article 118b: 103 1. Ordinance of 20 September 2013 on Clinical Trials in Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305: https://www.admin.ch/opc/en/classif Swiss Clinical Trial Organisation, Guidelines for Good Operational Practice (GGOP) (2017): https://www.scto.ch/en/publications/guidel ines.html Access: http://www.scto.ch/en/News.html Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Drugs 1. Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en 2. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang =en Devices Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en http://www.admin.ch/opc/en/classifi ed- compilation/19995395/index.html 3. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html 1. Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA), RS 812.21, Articles 53- 54: http://www.admin.ch/opc/en/classifi ed- compilation/20002716/index.html 2. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html 1. Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA), RS 812.21, Articles 1-2, 45-67: https://www.admin.ch/opc/en/classif ied- compilation/20002716/index.html 2. Federal Act of 30 September 104 ied- compilation/20121176/index.html 3. Ordinance of 20 September 2013 on Organizational Aspects of the Human Research Act (HRA Organisational Ordinance, OrgO-HRA), RS 810.308: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance HRO), RS 810.301, Article 7 (2014): http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html 3. Ordinance of 20 September 2013 on Organisational Aspects of the Human Research Act (HRA Organisational Ordinance, OrgO-HRA), RS 810.308, Articles 6-7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance HRO), RS 810.301, Article 7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html 2. Ordinance of 20 September 2013 Swissmedic Guide to the Regulation of Medical Devices: https://www.swissmedic.ch/medizinprodukte/0 0287/index.html?lang=en Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Privacy/Data Protection Note: Most Swiss cantons have enacted laws Swiss National Clinical Trials Portal: http://kofam.ch/en/swiss-clinical-trials- portal/ 1. Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en 2. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang =en Federal Data Protection and Information Commissioner (FDPIC): http://www.edoeb.admin.ch/index.html?la ng=en 2011on Research involving Human Beings, (Human Research Act, HRA), RS. 810.30: https://www.admin.ch/opc/en/classif ied- compilation/20061313/index.html Federal Act on Research Involving Human Beings, Articles 56, 64, 65, and 67 (2014): https://www.admin.ch/opc/en/classif ied- compilation/20061313/index.html Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 19-20: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html 1. Federal Act of 19 June 1992 on Data Protection (FADP), RS 235.1: http://www.admin.ch/opc/en/classifi ed- compilation/19920153/index.html 2. Federal Act of 30 September 105 on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305 articles 20, 32, 37, 42-45 and Annexes 1, 3 and 4: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html 3. Ordinance of 20 September 2013 on Organisation Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO- HRA), RS 810.308, Articles 6-7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance HRO), RS 810.301, Articles 8, 12, 13, and 15, and Annexes 1-2: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance ClinO), RS 810.305, Articles 7, 10-13, 25, and 71, and Annexes 2-3: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 5 - 8, 10, 15, 21, 24-34, 37-39, 41, Country Key Organizations Legislation Regulations Guidelines regarding data collection in the public sector that are similar to the Federal Act on Data Protection. Human Biological Materials Genetic Research 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang =en 2. Swiss Academy of Medical Sciences (SAMS): http://www.samw.ch/en/News/News.html Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang =en 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2, 3, 8, 16-18, 31-35, 41-45, 47, 49, 58-60, and 63: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2, 3, 17, 18, 31, 32 - 35, 41-43, 45, 47, 49, and 63: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html 1. Federal Constitution of the Swiss Confederation of 18 April 1999, RS 101, Article 119: http://www.admin.ch/opc/en/classifi ed- compilation/19995395/index.html 2. Federal Act of 8 October 2004 on Human Genetic Testing (HGTA), RS 810.12: http://www.admin.ch/opc/en/classifi ed- compilation/20011087/index.html 106 and 44-45, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305 Articles 5, 7, 9, 12, 16-18, and 25, and Annexes 2-3: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html 1. Ordinance of 14 February 2007 on Human Genetic Testing, RS 810.122.1: http://www.admin.ch/opc/fr/classifie d-compilation/20051790/index.html 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301 Articles 5 - 8, 10, 15, 21, 24-30, 33-34, 37 - 39, 41, 44-45 and Annex 2): http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305, Articles 7, 9, 12, 16 - 18 and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html 1. Ordinance of 14 February 2007 on Human Genetic Testing, RS 810.122.1 (French): http://www.admin.ch/opc/fr/classifie d-compilation/20051790/index.html 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 28 - 32: http://www.admin.ch/opc/en/classifi SAMS: Biobanks: Obtainment, Preservation and Utilization of Human Biological Material (2006): http://www.samw.ch/en/Ethics/Guidelines/Arch ive.html Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning Ukraine General Drugs, Biologics, and Devices Swiss National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/ Ukrainian Ministry of Health: http://www.moz.gov.ua/en/ 1. Ministry of Health of Ukraine State Expert Center: http://www.dec.gov.ua 2. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index- 3. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 3, 32 - 35, 42, and 49: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html Embryos in Vivo: Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30 Articles 2, 25 - 27, 39, 40, 44, and 62: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html Others: Federal Act of 19 December 2003 on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA), RS 810.31: http://www.admin.ch/opc/en/classifi ed- compilation/20022165/index.html 1. Constitution of Ukraine Art. 28 (1996) 2. Health Care Law, Article 45 (1992) 3. Criminal Code of Ukraine 2001, Article 141 and 142 1. Ministry of Health Act On Procedure of Clinical Trials and Basic Statute of Ethics Commission 23.09/2009 No. 690 (2014): http://zakon5.rada.gov.ua/laws/sho 107 ed-compilation/20121177/index.html 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305 Articles 22 and 35, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305, Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines (2009): http://zakon5.rada.gov.ua/rada/show/ NEK-CNE: 1. Pre-Implantation Genetic Diagnosis, 2007/9: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/embryonen _en.pdf 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/PID_II_d.pdf Access: http://www.nek-cne.ch/en/topics/opinions/ Bioethics Committee: 1. Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006) 2. Ethics Expertise of Clinical Trials Medicines (2007) Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials en/bioethics-committee Ukrainian Ministry of Health: http://www.moz.gov.ua/en/ 1. State Service of Ukraine on Personal Data Protection 2. Ukrainian Parliament Commissioner for Human Rights: www.ombudsman.gov.ua Ukrainian Ministry of Health: http://www.moz.gov.ua/en/ w/z1010-09 2. On Medicines, Articles 7 and 8 No. 123/96ВР (2014): http://zakon4.rada.gov.ua/laws/sho w/123/96-%D0%B2%D1%80 On Medicines, Article 8 No. 123/96ВР (2014): http://zakon4.rada.gov.ua/laws/sho w/123/96-%D0%B2%D1%80 1. Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2010) 2. On Protection of Personal Data Act, 01.06.2010 with changes from 19.10.2017: http://zakon3.rada.gov.ua/laws/sho w/2297-17 1. Cabinet Ministry of Ukraine Act No. 286 on 02.03.2016 License Conditions on Providing Activities of Banks of Cord Blood and Other Human Tissues and Cells: http://zakon2.rada.gov.ua/laws/sho w/286-2016-%D0%BF 2. Ministry of Health Act 20.04.12 No. 276 On Approving the List of Human Tissues and Cells, Allowing the Use of Banks of Cord Blood and Other Human Tissues and Cells: http://zakon3.rada.gov.ua/laws/sho w/z1124-12 v0095282-09 2. Ministry of Health Act 14.12.2009 N 944 on Approval of the Clinical Trial and Expertise of Clinical Trials: http://zakon4.rada.gov.ua/laws/show /z0053-10 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) with Changes from 23.09.2009 No. 690: http://zakon1.rada.gov.ua/laws/show /z1206-07 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) Ministry of Health: Guidelines for Pre-Clinical and Clinical Trials: http://www.dec.gov.ua/index.php/ekspertiza- materialiv-doklinichnikh-ta-klinichnikh- viprobuvan/metodichni-rekomendatsiji- shchodo-provedennya-doklinichnikh-ta- klinichnikh-viprobuvan 108 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning United Kingdom 1. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index- en/bioethics-committee 2. Ukrainian Ministry of Health: http://www.moz.gov.ua/en/ 1. Act on the Banning of Human Reproductive Clonin g (2004): http://zakon0.rada.gov.ua/laws/sho w/2231-15 2. Act on the Transplantation on Human Using Anatomic Materials (2019): http://zakon.rada.gov.ua/laws/show/ 2427-19 1. 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): http://zakon1.rada.gov.ua/laws/show /z1206-07 2. Ukrainian Ministry of Health Order No. 787 on Approval of the Use of Reproductive Technologies in Ukraine 09.09.2013: http://zakon4.rada.gov.ua/laws/show /z1697-13 Unless otherwise noted, all laws, regulations, and guidelines listed for England also apply to the entire United Kingdom. For an overview of clinical research regulations in the United Kingdom, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=226 General England: Health Research Authority (HRA): http://www.hra.nhs.uk/ Department of Health and Social Care (DHSC): https://www.gov.uk/government/organisati ons/department-of-health-and-social-care 1. Mental Capacity Act (2005) (England and Wales only): http://www.legislation.gov.uk/ukpg a/2005/9/contents 2. Health and Social Care Act (2012): http://www.legislation.gov.uk/ukpg a/2012/7/contents/enacted 109 1. Research Governance Framework for Health and Social Care UK Policy Framework for Health and Social Care Research (2018): https://www.hra.nhs.uk/planning- and-improving-research/policies- standards-legislation/uk-policy- framework-health-social-care- research/ 2. Governance Arrangements for Research Ethics Committees (2018): https://www.hra.nhs.uk/planning- and-improving-research/policies- standards-legislation/governance- arrangement-research-ethics- committees/ 1. HRA Guidance: https://www.hra.nhs.uk/planning-and- improving-research/ 2. Integrated Research Application System: https://www.myresearchproject.org.uk/ Country Key Organizations Legislation Regulations Guidelines General Medical Research Council (MRC): https://www.mrc.ac.uk/ Scotland: 1. NHSScotland, Chief Scientist Office (CSO): http://www.cso.scot.nhs.uk/ 2. NHS Research Scotland: http://www.nhsresearchscotland.org.uk/ Wales: Health and Care Research Wales: http://www.healthandcareresearch.gov.wal es/ Northern Ireland: 1. Department of Health, Social Services and Public Safety: http://www.dhsspsni.gov.uk/ 2. Office for Research Ethics. Committees Northern Ireland: http://www.hscbusiness.hscni.net/orecni.ht m 3. Care Act (2014): http://www.legislation.gov.uk/ukpg a/2014/23/contents/enacted/data.ht m 4. Ionising Radiation (Medical Exposure) Regulations (2017): http://www.legislation.gov.uk/uksi/ 2017/1322/contents/made Adults with Incapacity (Scotland) Act 2000, Section 51: http://www.scotland.gov.uk/Topics/ Justice/law/awi/legislation Ionising Radiation (Medical Exposure) (Northern Ireland) Regulations (2018): http://www.legislation.gov.uk/nisr/2 018/17/contents/made 110 Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002): http://www.scotland- legislation.hmso.gov.uk/legislation/s cotland/ssi2002/20020190.htm 1. Research Involving Human Participants in Developing Societies (2004): https://mrc.ukri.org/publications/browse/researc h-involving-human-participants-in-developing- societies/ 2. Medical Research Involving Children (2004): https://mrc.ukri.org/documents/pdf/medical- research-involving-children/ 3. Medical Research Involving Adults Who Cannot Consent (2007): https://mrc.ukri.org/documents/pdf/medical- research-involving-adults-who-cannot-consent/ 4. Good Research Practice: Principles and Guidelines (2012): https://mrc.ukri.org/publications/browse/good- research-practice-principles-and-guidelines/ CSO: Research Governance Framework for Health and Community Care (2006): http://www.cso.scot.nhs.uk/wp- content/uploads/2013/02/RGF-Second-Edition- February-06.pdf Research Governance Framework for Health and Social Care in Wales Second Edition (2009): http://www.wales.nhs.uk/sites3/Documents/952/Rese arch%20Governance%20Framework%202009%20% 28English%291.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Drugs 1. Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/organisati ons/medicines-and-healthcare-products- regulatory-agency 2. Administration of Radioactive Substances Advisory Committee (ARSAC) (UK): https://www.gov.uk/government/organisati ons/administration-of-radioactive- substances-advisory-committee 3. Department of Environment, Food & Rural affairs (DEFRA) https://www.gov.uk/government/organisati ons/department-for-environment-food- rural-affairs 4. Health and Safety Executive (HSE) http://www.hse.gov.uk/ Medicines Act (1968): http://www.legislation.gov.uk/ukpg a/1968/67/contents 1. Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031 (2004): http://www.legislation.gov.uk/uksi/2 004/1031/contents/made 2. Amendment Regulations (SI 2006/1928) http://www.legislation.gov.uk/uk si/2006/1928/contents/made 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.legislation.gov.uk/uksi/2 006/2984/pdfs/uksi_20062984_en.pd f 4. SI 2008 No.941 The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment Regulations 2008: http://www.legislation.gov.uk/uksi/2 008/941/contents/made 5. Genetically Modified Organisms (Deliberate Release) Regulations 2002: http://www.legislation.gov.uk/uksi/2 002/2443/contents/made 6. Genetically Modified Organisms (Contained Use) Regulations 2014 (England, Scotland and Wales): http://www.legislation.gov.uk/uksi/2 014/1663/part/1/made 7. Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015: http://www.legislation.gov.uk/nisr/2 015/339/contents/made 111 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk National Institute for Health Research: http://www.nihr.ac.uk/ Health Research Authority (HRA): http://www.hra.nhs.uk/ Devices Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/collection s/regulatory-guidance-for-medical-devices Health Research Authority (HRA): http://www.hra.nhs.uk/ 1. ISRCTN: http://www.isrctn.com/ 2. Health Research Authority (HRA): http://www.hra.nhs.uk/ Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/organisati ons/medicines-and-healthcare-products- regulatory-agency Department of Health (DH): https://www.gov.uk/government/organisati ons/department-of-health 112 1. Medical Devices Regulations (2002): http://www.opsi.gov.uk/si/si2002/20 020618.htm 2. Medical Devices (Amendment) Regulations 2008 No 2936: http://www.legislation.gov.uk/uksi/2 008/2936/contents/made Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031, Regulation 15(5)(i)(j)(k) and Schedule 3 Part 1, Paragraphs 1(g) and 3(c) (2004): http://www.legislation.gov.uk/uksi/2 004/1031/contents/made Guidelines for Phase I Clinical Trials (2012): http://www.abpi.org.uk/our- work/library/guidelines/Pages/phase-1-trials- 2012.aspx Clinical Trials Toolkit: http://www.ct-toolkit.ac.uk/ Clinical Trials of Investigational Medicinal Products (CTIMPs) – Resource page: http://www.hra.nhs.uk/resources/before-you- apply/types-of-study/clinical-trials-of- investigational-medicinal-products/ 1. Clinical Trials for Medical Devices: https://www.gov.uk/government/collections/reg ulatory-guidance-for-medical-devices 2. Notify MHRA About a Clinical Investigation for a Medical Device: https://www.gov.uk/guidance/notify-mhra- about-a-clinical-investigation-for-a-medical- device Medical Devices Guidance: http://www.hra.nhs.uk/resources/before-you- apply/types-of-study/medical-devices-research- 2/ ISRCTN: FAQs: http://www.isrctn.com/page/faqs HRA: Transparency: Researchers’ Responsibilities: https://www.hra.nhs.uk/planning-and- improving-research/research-planning/research- registration-and-research-project-identifiers/ NHS Indemnity Arrangements for Clinical Negligence Claims in the NHS: www.nhsla.com/claims/Documents/NHS%20In Country Key Organizations Legislation Regulations Guidelines Research Injury Social-Behavioral Research Privacy/Data Protection Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk Association of the British Healthcare Industry (ABHI): http://www.abhi.org.uk/ Economic and Social Research Council UK Research Integrity Office United Kingdom: Information Commissioner’s Office: https://ico.org.uk/ Health Research Authority: https://www.hra.nhs.uk Data Protection Act (2018): http://www.legislation.gov.uk/ukpg a/2018/12/contents/enacted 113 demnity.pdf 1. Insurance and Compensation in the Event of Injury in Phase I Clinical Trials (2012): http://www.abpi.org.uk/our- work/library/guidelines/Pages/clinical-trials- insurance.aspx 2. Clinical Trial Compensation Guidelines (2014): http://www.abpi.org.uk/our- work/library/guidelines/Pages/ct- compensation.aspx Clinical Investigations Compensation Guidelines (2014): http://www.abhi.org.uk/multimedia/groups/clini cal- investigations/ci_compensationguidelines.doc ESRC Framework for Research Ethics (2015): http://www.esrc.ac.uk/files/funding/guidance- for-applicants/esrc-framework-for-research- ethics-2015/ Good Practice in Research: Internet- Mediated Research (2016): http://ukrio.org/wp-content/uploads/UKRIO- Guidance-Note-Internet-Mediated-Research- v1.0.pdf 1. Guide to the General Data Protection Regulation (2018): https://ico.org.uk/for- organisations/guide-to-the-general-data- protection-regulation-gdpr/ 2. International Transfers (2018): https://ico.org.uk/for-organisations/guide-to- the-general-data-protection-regulation- gdpr/international-transfers/ 1. GDPR Guidance: https://www.hra.nhs.uk/planning-and- improving-research/policies-standards- legislation/data-protection-and-information- governance/gdpr-guidance/ 2. Consent in Research (2018): https://www.hra.nhs.uk/planning-and- improving-research/policies-standards- legislation/data-protection-and-information- governance/gdpr-guidance/what-law- says/consent-research/ Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Medical Research Council (MRC): http://www.mrc.ac.uk/ England and Wales: 1. Health Research Authority (HRA) (England): http://www.hra.nhs.uk/ 2. Confidentiality Advisory Group (CAG): http://www.hra.nhs.uk/about-the-hra/our- committees/section-251 United Kingdom: Human Tissue Authority (HTA): http://www.hta.gov.uk/ Medical Research Council (MRC): https://www.mrc.ac.uk/ Health Service (Control of Patient Information) Regulations 2002 (HS (CPI) Regs): http://www.legislation.gov.uk/uksi/ 2002/1438/made?view=plain 1. Human Tissue Act (2004): http://www.legislation.gov.uk/ukpg a/2004/30/contents (Applies to England, Wales, and Northern Ireland. Section 45 also applies in Scotland.) 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.legislation.gov.uk/uksi/ 2006/1260/contents/made (Applies to England, Wales, and Northern Ireland.) 3. Statutory Instrument 2006 No. 1659: The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (Different provisions apply to England, Wales, Northern Ireland, and/or Scotland.): http://www.legislation.gov.uk/uksi/ 2006/1659/contents/made 114 Using Information About People in Health Research (2017): https://mrc.ukri.org/documents/pdf/using- information-about-people-in-health-research- 2017/ 1. Research Data and Tissue Resources: https://www.hra.nhs.uk/planning-and- improving-research/research-planning/research- data-and-tissue-resources/ 2. Section 251 and the Confidentiality Advisory Group (CAG): http://www.hra.nhs.uk/about-the-hra/our- committees/section-251/ Guidance for Professionals: https://www.hta.gov.uk/guidance-professionals Human Tissue and Biological Samples for Use in Research (2014): https://mrc.ukri.org/publications/browse/human -tissue-and-biological-samples-for-use-in- research/ Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetics Research Embryos, Stem Cells, and Cloning Scotland: Healthcare Improvement Scotland: http://www.healthcareimprovementscotlan d.org/our_work/governance_and_assuranc e/human_tissue_banks.aspx 1. Public Health Genetics Foundation: http://www.phgfoundation.org/ 2. Gene Therapy Advisory Committee: http://www.hra.nhs.uk/resources/applying- to-recs/gene-therapy-advisory-committee- gtac/ 3. Genomics England: https://www.genomicsengland.co.uk/ 1. Human Fertilisation and Embryology Authority: http://www.hfea.gov.uk/ 2. Human Tissue Authority (HTA): https://www.hta.gov.uk/regulated-sectors Human Tissue (Scotland) Act 2006: http://www.legislation.gov.uk/asp/2 006/4/contents 1. Human Fertilisation and Embryology Act (1990): http://www.legislation.gov.uk/ukpg a/1990/37/contents 2. HFE Act (2008): http://www.legislation.gov.uk/ukpg a/2008/22/contents Human Fertilisation and Embryology Regulation and Chronology: https://www.hfea.gov.uk/about- us/how-we-regulate/ HFEA Code of Practice 9th Edition (2018): https://www.hfea.gov.uk/media/2609/june- 2018-code-of-practice-9th-edition-draft.pdf 115 Country Key Organizations Legislation Regulations Guidelines ASIA/PACIFIC Australia General Drugs, Biologics, and Devices 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/ 2. Australian Research Council (ARC): http://www.arc.gov.au Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS): http://aiatsis.gov.au/ Drugs Therapeutic Goods Administration (TGA): http://www.tga.gov.au National Health and Medical Research Council Act 1992 (2014): http://www.comlaw.gov.au/Details/ C2014C00364 Therapeutic Goods Act 1989 (2019): https://www.legislation.go v.au/Details/C2019C00066 National Health and Medical Research Regulation 2016: https://www.legislation.gov.au/Detail s/F2016L00682 Therapeutic Goods Regulations 1990 (2019): https://www.legislation.gov.au/Detail s/F2019C00575 NHMRC: 1. Ethical conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018): https://nhmrc.gov.au/about- us/publications/ethical-conduct-research- aboriginal-and-torres-strait-islander-peoples- and-communities 2. Keeping Research on Track II (2018): https://nhmrc.gov.au/about- us/publications/keeping-research-track-ii NHMRC, ARC, and Universities Australia: 1. Australian Code for the Responsible Conduct of Research (2018): https://www.nhmrc.gov.au/about- us/publications/australian-code-responsible- conduct-research-2018 2. National Statement on Ethical Conduct in Human Research, 2007 (2018): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 Guidelines for Ethical Research in Australian Indigenous Studies (2012): http://www.aiatsis.gov.au/research/ethics/GER AIS.html TGA: Australian Clinical Trial Handbook (2018): https://www.tga.gov.au/publication/australian- clinical-trial-handbook Australian States and Territories: National Mutual Acceptance of Scientific and Ethical Review of Multi-Centre Human Research (2017): https://www.australianclinicaltrials.gov.au/ethi cal-review-process-each-australian-state-and- 116 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Social-Behavioral Research Privacy/Data Protection Note: All Australian states and territories Devices Therapeutic Goods Administration: http://www.tga.gov.au/industry/devices.ht m 1. National Health and Medical Research Council and the Department of Industry, Innovation, and Science: https://www.australianclinicaltrials.gov.au 2. Australian New Zealand Clinical Trials Registry: http://www.anzctr.org.au/ 1. Therapeutic Goods Administration (TGA): http://www.tga.gov.au/ 2. Medicines Australia https://medicinesaustralia.com.au 3. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au Office of the Australian Information Commissioner: https://www.oaic.gov.au/ Therapeutic Goods Act 1989 (2016): https://www.legislation.go v.au/Details/C2016C00269 Privacy Act 1988 (2019): https://www.legislation.gov.au/Deta ils/C2019C00241 117 Therapeutic Goods (Medical Devices) Regulations 2002 (2016): https://www.legislation.gov.au/Detail s/F2016C00801 1. Australian Privacy Principles Guidelines (2019): https://www.oaic.gov.au/privacy/aust ralian-privacy-principles-guidelines/ 2. Guidelines under Section 95 of territory Australian Regulatory Guidelines for Medical Devices (ARGMD) (2011): http://www.tga.gov.au/industry/devices- argmd.htm 1. National Statement on Ethical Conduct in Human Research, 3.1.7 (2018): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 2. FAQs: http://www.anzctr.org.au/Faq.aspx TGA: Guidance on Good Clinical Practice (CPMP/ICH-135/95). Paragraphs 5.8.1, 5.11.1, 8.2.5 , 8.2.7 (2018): https://www.tga.gov.au/publication/note- guidance-good-clinical-practice Medicines Australia: Industry Standard Compensation Guidelines (2012): https://medicinesaustralia.com.au/policy/clinica l-trials/indemity-and-compensation-guidelines/ NHMRC, ARC, and UA: National Statement on Ethical Conduct in Human Research. Paragraphs 5.1.38 and 5.1.39 (2018): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 National Statement on Ethical Conduct in Human Research, Chapter 3.1 (2019): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated- 2018 1. Australian Privacy Principles Guidelines (2019): https://www.oaic.gov.au/privacy/australian- privacy-principles-guidelines/ 2. Guidelines under Section 95 of the Country Key Organizations Legislation Regulations Guidelines have privacy/data protection laws: https://www.oaic.gov.a u/privacy/privacy-in- your-state/ Human Biological Materials Note: All Australian states and territories also have laws on human biological materials. Genetic Research Embryos, Stem Cells, and Cloning 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/ 2. Therapeutic Goods Administration (TGA): http://www.tga.gov.au/ 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/ 2. Office of the Gene Technology Regulator: http://www.ogtr.gov.au/ 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/ 2. National Health and Medical Research Council: Embryo Research Licensing Committee: https://nhmrc.gov.au/embryo-research- Gene Technology Act 2000 (2016): https://www.legislation.gov.au/Deta ils/C2016C00792 1. Prohibition of Human Cloning for Reproduction Act 2002 (2017): https://www.legislation.gov.au/Deta ils/C2017C00306 2. Research Involving Human Embryos Act 2002 (2016): 118 the Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under- section-95-privacy-act-1988 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2015): https://nhmrc.gov.au/about- us/publications/guidelines-approved- under-section-95a-privacy-act-1988 4. Guidelines Approved under Section 95AA of the Privacy Act 1988 (2014): https://www.nhmrc.gov.au/about- us/publications/guidelines-approved- under-section-95aa-privacy-act-1988- cth 5. Privacy Regulation 2013 (2019): https://www.legislation.gov.au/Detail s/F2019C00361 Gene Technology Regulations 2001 (2016): https://www.legislation.gov.au/Detail s/F2016C00615 Research Involving Human Embryos Regulations (2017): https://www.legislation.gov.au/Detail s/F2017L01213 Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under-section-95- privacy-act-1988 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2019): https://nhmrc.gov.au/about- us/publications/guidelines-approved-under- section-95a-privacy-act-1988 4. Guidelines Approved under Section 95AA of the Privacy Act 1988 (2014): https://www.nhmrc.gov.au/about- us/publications/guidelines-approved-under- section-95aa-privacy-act-1988-cth NHMRC, ARC, and UA: National Statement on Ethical Conduct in Human Research (2018): Chapter 3.2: https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 TGA: Australian Regulatory Guidelines for Biologicals (2018): http://www.tga.gov.au/industry/biologicals- argb.htm NHMRC, ARC, and UA: National Statement on Ethical Conduct in Human Research, Chapter 3.3 (2018): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 NHMRC, ARC, and UA: National Statement on Ethical Conduct in Human Research, Chapter 3.2 (2018): https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Bangladesh General Drugs, Biologics, and Devices Human Biological Materials licensing-committee Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org Bangladesh Directorate of Drug Administration: http://www.dgda.gov.bd/ Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org https://www.legislation.gov.au/Deta ils/C2016C00968 1. The Drugs Act (1964) 2. Drugs (Control) Ordinance 1982, Ordinance No. VIII: http://bdlaws.minlaw.gov.bd/pdf_pa rt.php?id=623 NHMRC: Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2017): https://nhmrc.gov.au/about- us/publications/ethical-guidelines-use-assisted- reproductive-technology 1. Ethical Guidelines for Conducting Research Studies Involving Human Subjects: https://www.bmrcbd.org/application_form/Ethi calGideline 2. Standard Operating Procedures (SOPs): https://www.bmrcbd.org/application_form/SOP s Good Clinical Practice (GCP) Guidelines: http://www.dgda.gov.bd/index.php/2013-03- 31-05-16-29/registered-medical-device-list- 4/129-good-clinical-practice-gcp- guidelines/file Guidelines for Transfer of Human Biological Materials Abroad for Research Purposes (2004) China, People’s Republic of For an overview of clinical research regulations in China, see the ClinRegs report: https://clinregs.niaid.nih.gov/country/china General 1. National Health Commission of the People’s Republic of China (NHC): http://en.nhc.gov.cn/ 2. State Administration for Market Regulation: http://www.samr.gov.cn/ 3. National Medical Products Administration: http://www.nmpa.gov.cn Law on Practicing Doctors (June 26, 1998), Articles 26 and 37: http://www.gov.cn/banshi/2005- 08/01/content_18970.htm People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2 019-06/10/content_5398829.htm NHFPC: Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016): http://www.gov.cn/gongbao/content/2017/ content_5227817.htm NHFPC, CFDA, and State Administration of TCM: Management Guidelines for Conducting Clinical Research at Medical/Health Institutions (Mandarin) (2014): http://www.nhc.gov.cn/yzygj/s3593g/2014 10/9bd03858c3aa41ed8aed17467645fb68. shtml 119 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Drugs National Medical Products Administration: http://www.nmpa.gov.cn Devices National Medical Products Administration: http://www.nmpa.gov.cn Drug Administration Law of the People's Republic of China (2019): http://www.npc.gov.cn/npc/c30834/ 201908/26a6b28dd83546d79d17f90 c62e59461.shtml 2. Vaccine Management Law of the People’s Republic of China (2019): http://www.npc.gov.cn/npc/c30834/ 201907/11447c85e05840b9b12c62b 5b645fe9d.shtml 120 1. Regulations for Implementation of the Drug Administration Law of the People's Republic of China (2016): http://www.nmpa.gov.cn/WS04/CL2 076/300567.html 2. Chinese Good Clinical Practice (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html 3. Measures for the Administration of Drug Registration (2007): http://www.nmpa.gov.cn/WS04/CL2 174/300629.html 4. Interim Measures for the Confirmation of Clinical Trial Sites/Institutions (2004): http://www.nmpa.gov.cn/WS04/CL2 079/337621.html 5. Rules on the Administration of Report and Supervision of Adverse Drug Reactions (2011): http://samr.cfda.gov.cn/WS01/CL103 1/62621.html 6. Administrative Measures for the Signing and Issuing of Biological Product (2017): http://www.nmpa.gov.cn/WS04/CL2 077/300708.html 1. Good Clinical Practice on Medical Device Clinical Trials (2016): http://www.nmpa.gov.cn/WS04/CL2 077/300685.html 2. Regulations on the Supervision and Administration of Medical Devices (revised 2017): http://www.nmpa.gov.cn/WS04/CL2 076/331389.html 3. Measures for the Registration and Administration of In Vitro Diagnostic Reagents (2014): 1. Guideline for HIV Vaccine Research Technology (2003): http://samr.cfda.gov.cn/WS01/CL0237/15705.h tml 2. Guideline for Vaccine Research Technology (2004): http://samr.cfda.gov.cn/WS01/CL0055/10307.h tml 3. Guidelines on Ethical Review of Drug Clinical Trials (2010): http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml 4. Interim Guidelines on International Multi-Regional Drug Clinical Trials (2015): http://samr.cfda.gov.cn/WS01/CL0087/114002. html 5. Interim Guidelines for Reporting and Supervision of Adverse Drug Reactions (2015): http://www.nmpa.gov.cn/WS04/CL2196/32411 8.html 1. Guiding Principles of the Clinical Trail Technology on In Vitro Diagnostic (IVD) Reagents (2014): http://www.nmpa.gov.cn/WS04/CL2138/29998 8.html 2. Management Measures for the Monitoring and Re-evaluation of Adverse Events on Medical Devices (2019): http://www.nmpa.gov.cn/WS04/CL2077/33007 1.html 3. Templates for Medical Device Clinical Trials – Ethical Application and Approval (2016): Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Privacy/Data Protection Research Injury Chinese Clinical Trial Registry: http://www.chictr.org.cn/enIndex.aspx Mainland: 1. Ministry of Industry and Information Technology of People’s Republic of China: http://www.miit.gov.cn/ 2. Office of the Central Cyberspace Affairs Commission: http://www.cac.gov.cn/ 3. National Information Security Standardization Technical Committee: https://www.tc260.org.cn/ Hong Kong: 1. Privacy Commissioner for Personal Data, Hong Kong: http://www.pcpd.org.hk 2. eHealth Electronic Health Record Sharing System: https://www.ehealth.gov.hk/en/home/inde x.html 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/ 2. National Medical Products Administration: http://www.nmpa.gov.cn 1. People's Republic of China Cyber Security Law (2016): http://www.cac.gov.cn/2016- 11/07/c_1119867116.htm 2. People's Republic of China Electronic Commerce Law, Articles 23-25 and 32 (2018): http://www.cac.gov.cn/2018- 09/01/c_1123362506.htm Personal Data (Privacy) Ordinance (2018): https://www.elegislation.gov.hk/hk/ cap486!en-zh-Hant- HK.pdf?FROMCAPINDEX=Y Tort Liability law of the People's Republic of China, Chapter 7 (2009): http://www.gov.cn/flfg/2009- 12/26/content_1497435.htm http://www.nmpa.gov.cn/WS04/CL2 077/300661.html 4. Amendment of Measures for the Registration and Administration of In Vitro Diagnostic Reagents (updated Art.20 in 2017): http://www.nmpa.gov.cn/WS04/CL2 077/300690.html 5. Administrative Measures for Recall of Medical Devices (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html 1. Chinese Good Clinical Practice, Article 43 (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html 2. Administrative Measures for Recall of Medical Devices, 1. Ethical Review Application And Review Form 2. Informed Consent Form 3. CRF Template 4. Protocol Template 5. Clinical Trial Report Template 6. Required Documents List for Archiving Access: http://samr.cfda.gov.cn/WS01/CL0087/148126. html FAQs: http://www.chictr.org.cn/questionen.aspx Information Security Technology-Personal Information Security Specification (2017, GB/T 35273-2017): https://www.tc260.org.cn/front/postDetail.html ?id=20180124211617 1. Code of Practice on the Identity Card Number and Other Personal Identifiers (2016): https://www.pcpd.org.hk/english/data_privacy_ law/code_of_practices/files/picode_en.pdf 2. Code of Practice on Human Resource Management (2016): https://www.pcpd.org.hk/english/data_privacy_ law/code_of_practices/files/PCPD_HR_Bookle t_Eng_AW07_Web.pdf 1. Guideline on Vaccine Clinical Trials, Part 6 (2004): http://samr.cfda.gov.cn/WS01/CL0844/10307.h tml 2. Guideline on Ethical Review of Drug Clinical Trials, Appendix 1, Section 6.10 121 Country Key Organizations Legislation Regulations Guidelines Research Injury Genetic Research Embryos, Stem Cells, and Cloning 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/ 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/ Mainland: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/ 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/ Article 36 (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html 3. Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016), Articles 18.5, 20.8, 36.6, and 37: http://www.gov.cn/gongbao/content/2 017/content_5227817.htm 4. Good Clinical Practice on Medical Device Clinical Trials (2016), Articles 10, 22, 33, and 48: http://www.nmpa.gov.cn/WS04/CL2 077/300685.html People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2 019-06/10/content_5398829.htm 1. Ethical Principles and Conduct Norms for Human Assisted Reproductive Technologies. (2003): http://www.moh.gov.cn/qjjys/s3581/2 00805/f69a925d55b44be2a9b4ada7fc dec835.shtml 2. Administrative Measures for Clinical Application of Medical Technology (2018): http://www.jzswjw.gov.cn/upfile/201 809/2018092558392053.pdf 3. Interim Measures for the Administrative Measures of Stem Cell Clinical Research (2015): http://www.nmpa.gov.cn/WS04/CL2 077/300673.html (2010): http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml 1. Service Guidelines for the Collection, Selling, Export. and Admission Application of Human Genetic Resources (2015): http://www.most.gov.cn/tztg/201507/t2015070 3_120547.htm 2. Service Guideline for the Approval of Administrative Licensing Items for Exporting Human Genetic Resources Outside of China: https://fuwu.most.gov.cn/r/cms/zwpt/web/asset s/pdf/4.rlyczycjspfwzn.pdf NHC and MOST: 1. Ethical Guidelines for Research on Human Embryo Stem Cells (2003): http://www.most.gov.cn/fggw/zfwj/zfwj2003/2 00512/t20051214_54948.htm 2. Interim Guidelines for the Quality Control of Stem Cell Preparations and Preclinical Research (2015): http://www.nmpa.gov.cn/WS04/CL2196/32412 4.html 122 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning India Hong Kong: Legislative Council of the Hong Kong Special Administrative Region of the People’s Republic of China: http://www.legco.gov.hk/index.html Human Reproductive Technology (Amendment) Ordinance 2016: https://www.legco.gov.hk/yr15- 16/english/ord/ord020-2016-e.pdf For an overview of the clinical research regulations in India, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=100 General Drugs, Biologics, and Devices Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ 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/ Schedule Y of the Drugs and Cosmetics Act (2016): http://www.cdsco.nic.in/writereadda ta/2016Drugs%20and%20Cosmetic s%20Act%201940%20&%20Rules %201945.pdf 123 DCGI: 1. Good Clinical Practices for Clinical Research in India (2001): http://rgcb.res.in/wp- content/uploads/2014/07/Good- Clinical-Practice-Guideline.pdf 2. Permission for Clinical Trials: General Statutory Rules 63(E) (2013) 3. Ethics Committee Registration: General Statutory Rules 72(E) (2013) 4. A/V Consent – General Statutory Rules 611 (E) (2015) 5. Phytopharmaceutical Drug: General Statutory Rules 918(E) (2015) 6. Exemption for Academic Research and Animal Toxicity: General Statutory Rules 313(E) (2016) 7. New Drugs and Clinical Trials Rules (2019): https://cdsco.gov.in/opencms/opencm s/system/modules/CDSCO.WEB/ele 1. National Ethical Guidelines For Biomedical and Health Research Involving Human Participants (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf 2. National Ethical Guidelines for Biomedical Research Involving Children (2017): http://icmr.nic.in/guidelines/National_Ethical_ Guidelines_for_BioMedical_Research_Involvi ng_Children.pdf ICMR: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Section 7 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Devices 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/ 1. Clinical Trials Registry – India: http://ctri.nic.in/ 2. Office of Drugs Controller General 1. Central Drugs Standard Control Organization (CDSCO): https://cdsco.gov.in/opencms/opencm s/en/Home/ 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ Drugs & Cosmetics Act, 1940 (2005): https://cdsco.gov.in/opencms/op encms/en/Notifications/Gazette- Notifications/ Drugs & Cosmetics Act, 1940 (2005): http://www.cdsco.nic.in/writereadda ta/Drugs&CosmeticAct.pdf 124 ments/download_file_division.jsp?nu m_id=NDI2MQ== CDSCO: 1. Medical Devices Rules, 2017. 2. General Statutory Rules 78(E) http://134t7045rwgf19lpbh29libk9d3. wpengine.netdna-cdn.com/wp- content/uploads/sites/11/2017/07/Indi a-Medical-Device-Rules.pdf DCGI: CDSCO: 1. Compensation: General Statutory Rules 53 (E): http://www.manupatra.com/manufeed /contents/PDF/634969625902580076. pdf 2. Compensation and Reporting of SAE timelines GSR 889 (E) 2014 (scroll down to see English version): http://www.cdsco.nic.in/writereaddat a/Notificatiohn%20on%20Compensat ion%20on%20clincial%20trial%20(1 ).pdf 3. Compensation in Case of Injury or Death During Clinical Trial, Schedule Y, Appendix XII (2013) (Scroll down to see English version): http://www.pharmamedtechbi.com/~/ media/Supporting%20Documents/Ph armasia%20News/2013/February/Cli nical%20Trials%20Compensation%2 0Guidelines.pdf 4. Compensation Formula for Clinical Trial Injury Other than Death (2014) : ICMR: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 7.7 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf Clinical Trials Registry – India: FAQs: http://ctri.nic.in/Clinicaltrials/faq.php Office of Drugs Controller General: Registration of Clinical Trial in ICMR Clinical Trial Registry: http://www.cdsco.nic.in/writereaddata/CTRegi stration.doc ICMR: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 2.6 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf Country Key Organizations Legislation Regulations Guidelines Research Injury Social-Behavioral Research Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ Ministry of Health and Family Welfare: https://mohfw.gov.in 1. Department of Biotechnology (DBT): http://dbtindia.nic.in/ 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ 1. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/ 2. Central Drugs Standard Control Organization, Office of Drugs Environmental Protection Act (1986) http://www.cdsco.nic.in/writereaddat a/ORDER%20and%20Formula%20to %20Determine%20the%20quantum% 20of%20compensation%20in%20the %20cases%20of%20Clinical%20Tria l%20related%20serious%20Adverse %20Events(SAEs)%20of%20Injury% 20other%20than%20Death.pdf Govt. of India Office Memorandum (O.M. No.19015/53/1997 - IH Pt.) 19th November, 1997 on Exchange of Human Biological Material for Biomedical Research Purposes National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 9 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Sections 2 and 11 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 11 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf DBT: 1. Recombinant DNA Safety Guidelines (1990) 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002) ICMR: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 10 (2017): http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf National Guidelines for Stem Cell Research (2017): http://icmr.nic.in/guidelines/Guidelines_fo r_stem_cell_research_2017.pdf 125 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Indonesia Controller General of India (DCGI): https://cdsco.gov.in For an overview of health research ethics, see: http://www.fercap-sidcer.org/newsletter/2013/12/PPT/04%20Suriadi%20Guwanan-PPT.pdf General Drugs, Biologics, and Devices Human Biological Materials Japan General Drugs, Biologics, and Devices Ministry of Health, National Institute of Health Research and Development: http://indonesia.go.id/en National Agency of Drug and Food Control: http://www.pom.go.id/index.php/home/en 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.htm l Drugs 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l Devices 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l Indonesian Health Act No. 23/1992 Section on Health Research, Article 69 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e- gov.go.jp/htmldata/S35/S35HO145. html 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e- gov.go.jp/htmldata/S35/S35HO145. html 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- 126 1. Regulation No. 39/1995 on Health Research and Development 2. Presidential Decree No. 100/1993: Research by Foreigners 1. Ministry of Health Decree No. 56/2000: Guidelines on Clinical Trials of Traditional Drugs 2. Guidelines on Good Clinical Practice (2001) National Guidelines on Use of Stored Biological Materials (2005) MHLW: Ministerial Ordinance on Good Clinical Practice for Drugs (2016): http://elaws.e- gov.go.jp/search/elawsSearch/elaws_ search/lsg0500/detail?lawId=409M50 000100028&openerCode=1 MHLW: Ministerial Ordinance on Good Clinical Practice for Medical Devices (2016): http://law.e- gov.go.jp/htmldata/H17/H17F190010 00036.html National Guidelines on Ethics in Health Research (2003) MEXT and MHLW: Ethics Guidelines for Medical and Health Research Involving Human Subjects (2017): https://www.lifescience.mext.go.jp/files/pdf/n2 181_01.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Privacy/Data Protection Research Injury Human Biological Materials 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index .html 2. National Institute of Public Health: https://www.niph.go.jp/index_en.html 3. Japan Registry of Clinical Trials: https://jrct.niph.go.jp/ 1. Personal Information Protection Commission: http://www.ppc.go.jp/en/ 2. Office of Healthcare Policy of the Cabinet Secretariat: http://www.kantei.go.jp/jp/singi/kenkouir you/en/ Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l Seisakujouhou-10800000- Iseikyoku/0000213334.pdf Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf 1. Amended Act on the Protection of Personal Information (2017): https://www.ppc.go.jp/files/pdf/Act _on_the_Protection_of_Personal_In formation.pdf 2. Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field (2017): http://www.kantei.go.jp/jp/singi/ken kouiryou/jisedai_kiban/pdf/170310_ shiryou3.pdf 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e- gov.go.jp/htmldata/S35/S35HO145. html 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf 127 2009 version (English): https://www.pmda.go.jp/files/000153 732.pdf 1. Amendment to the Cabinet Order to Enforce the Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/Cabin et_Order.pdf 2. Enforcement Rules for the Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/PPC_ rules.pdf 3. Regulation for Enforcement of the Clinical Trials Act, Article 20 (2018): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000195391.pdf 1. Ministerial Ordinance on Good Clinical Practice for Drugs, Article 14 (2016): http://law.e- gov.go.jp/htmldata/H09/H09F036010 00028.html 2. Ministerial Ordinance on Good Clinical Practice for Medical Devices, Article 14 and 23 (2016): http://law.e- gov.go.jp/htmldata/H17/H17F190010 00036.html NIPH Clinical Trials Search: http://rctportal.niph.go.jp/en/ Guidelines for Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/guidelines01.p df https://www.ppc.go.jp/files/pdf/guidelines02.p df https://www.ppc.go.jp/files/pdf/guidelines03.p df https://www.ppc.go.jp/files/pdf/guidelines04.p df Ethics Guidelines for Medical and Health Research Involving Human Subjects, Chapter 2, No. 5, 1-(3) and No. 6, 2-(2) (2017): http://www.lifescience.mext.go.jp/files/pdf/n1859_01 .pdf On Research and Development Utilizing Human Tissues Removed by Surgery and Other Procedures (1998) (Japanese): https://www.mhlw.go.jp/www1/shingi/s9812/s 1216-2_10.html Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. 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.htm l 4. Ministry of Economy, Trade, and Industry (METI): http://www.meti.go.jp/english/ 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. 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.htm l 1. Act on Regulation of Human Cloning Techniques (2014): http://law.e- gov.go.jp/htmldata/H12/H12HO146 .html 2000 version (English): http://www.cas.go.jp/jp/seisaku/hou rei/data/htc.pdf 2. Act on Safety of Regenerative Medicine (2013): http://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000030847.pdf 128 1. Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2009): http://www.lifescience.mext.go.jp/file s/pdf/n1564_01.pdf 2. Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019): https://www.lifescience.mext.go.jp/fil es/pdf/n2163_01.pdf 3. Rules for Enforcement of Act on Safety of Regenerative Medicine (2018): https://www.mhlw.go.jp/content/0004 52630.pdf CSTI: Fundamental Principles of Research on the Human Genome (2000) MEXT, MHLW, and METI: Ethics Guidelines for Human Genome/Gene Analysis Research (2017): http://www.lifescience.mext.go.jp/files/pdf/n18 59_03r2.pdf 2008 version (English): http://www.lifescience.mext.go.jp/files/pdf/n79 6_00.pdf MHLW: Guidelines for Clinical Research in Gene Therapy and Others (2019): https://www.neurology- jp.org/news/pdf/news_20190307_02_02.pdf CSTP: Fundamental Philosophy on Handling of Human Embryo (2004): http://www.lifescience.mext.go.jp/files/pdf/6_2 8.pdf MEXT: 1. Guidelines on the Derivation of Human Embryonic Stem Cells (2014): http://www.lifescience.mext.go.jp/files/pdf/n15 53_01.pdf 2. Guidelines on Research on Producing Germ Cells from Human Induced Pluripotent Stem Cells or Human Tissue Stem Cells (2015): http://www.lifescience.mext.go.jp/files/pdf/n14 92_01r2.pdf 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_02r2.pdf 3. Guidelines on the Handling of a Specified Embryo (2019): https://www.lifescience.mext.go.jp/files/pdf/n2 163_07.pdf 4. Guidelines on the Distribution of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE SCdistributionguideline2019.pdf Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Kazakhstan 5. Guidelines on the Utilization of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE SCutilizationguideline2019.pdf MEXT and MHLW: 1. Ethical Guidelines for Research on Assisted Reproductive Technology to Develop Human Fertilized Embryos (2017): http://www.lifescience.mext.go.jp/files/pdf/n18 59_05.pdf 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_01r2.pdf 2. Guidelines for Research Using Gene- altering Technologies on Human Fertilized Embryos (2019): https://www.lifescience.mext.go.jp/files/pdf/Ov erview_Human_embryo_geneome- editing_guideline2019En.pdf Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 5: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf General Drugs, Biologics, and Devices Ministry of Healthcare and Social Development, Central Commission on Research Ethics: http://www.mzsr.gov.kz/en Ministry of Healthcare and Social Development, Control Committee of Medical and Pharmacy Activity: https://www.mzsr.gov.kz/en/taxonomy/ter m/674 Code of the Republic of Kazakhstan "On People's Health and the Health Care System" (18.09.2009 No.193-IV), Articles 74 and 180 (2015): http://online.zakon.kz/Document/?d oc_id=30479065#pos=1;-8 129 1. Order of the MHSD of the RK Dated 12.11.2009 No. 697 on the Approval of Regulations on the Medical-Biological Experiments, Preclinical (Non-Clinical) and Clinical Trials 2. Order of the MHSD of the RK dated 19.11.2009 No. 744 on the Approval of Regulations on the Conduct of Clinical Trials and/or Trials on Pharmaceutical and Drug Products, Medical Devices, and Medical Equipment 3. Order of the MHSD Dated 20.05.2014 No.272 on the 1. Guidelines on Ethics in Health Research. (2007) 2. Local Ethics Committees: Policy, Rules and Procedures ( 2014) 3. Guidelines on Ethics in Biomedical Research (2015) Guidelines on Clinical Trials in Kazakhstan (2003) Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Privacy/Data protection Korea Ministry of Healthcare and Social Development: http://www.mzsr.gov.kz/en Code of the Republic of Kazakhstan “On People's Health and the Health Care System” (18.09.2009 No.193-IV), Article 28 (2015): http://online.zakon.kz/Document/?d oc_id=30479065#pos=1;-8 Approval of Regulations on the Implementation of the New Methods of Diagnostic, Treatment, and Rehabilitation Note: All documents are in Korean. General Ministry of Health and Welfare: http://www.mohw.go.kr/eng/index.jsp Bioethics and Safety Act No. No. 15188 (2017.12): http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG 1. Enforcement Decree of Pharmaceutical Affairs Act No. 28821 (2017.7): http://www.law.go.kr/LSW/ lsInfoP.do?lsiSeq=195703&url Mode=engLsInfoR&viewCls=engLsI nfoR#0000 Drugs, Biologics, and Devices Drugs Ministry of Food and Drug Safety (MFDS) (2013): http://www.mfds.go.kr/eng/index.do Medical Device Act No. 15486 (2018.3): http://elaw.klri.re.kr/kor_service/la wView.do?hseq=48691&lang=ENG 130 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/lsInfoP.d o?lsiSeq=98198&urlMode=engLsI nfoR&viewCls=engLsInfoR#0000 1. Enforcement Decree of Pharmaceutical Affairs Act No. 27673 (2016.12): http://elaw.klri.re.kr/kor_service/law View.do?hseq=40268&lang=ENG 2. Regulation on Safety of Medicinal Products, etc. No. 1089(2014.8): http://www.mfds.go.kr/eng/brd/m_18 /view.do?seq=69740&srchFr=&srchT o=&srchWord=&srchTp=&itm_seq_ 1=0&itm_seq_2=0&multi_itm_seq=0 &company_cd=&company_nm=&pa ge=3 3. Regulations for Clinical Trial Personnel Education and Certification for the Educational MFDS: 1. Guidelines on Human Research Protection Program 0053-01 (2014.3) 2017-.5.30 고시: http://www.mfds.go.kr/brd/m_210/view.do?seq =12203 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Institution Notice No.2019-3 (2019.01. 17.) http://www.law.go.kr/admRulLsIn foP.do?admRulSeq=2100000175429 4. Regulation on Approval for Investigational New Drug Application of Drugs, Notice No.2018-42 (2018. 06.04) https://www.mfds.go.kr/eng/brd/m_18/ view.do?seq=71451 Clinical Trials Registry Research Injury Privacy/Data Protection Devices Ministry of Food and Drug Safety: http://www.mfds.go.kr/eng/index.do Korea Centers for Disease Control and Prevention (KCDC), Clinical Research Information Service: https://cris.nih.go.kr/cris/en/index.jsp?mo bile= Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do 1. Ministry of the Interior and Safety (MOIS): http://www.mois.go.kr/eng/a01/engMain. Medical Device Act No. 15486 (2018.03.13): http:// www.law.go.kr/LSW/eng/ engLsSc.do? menuId=2§ion=lawNm&quer y=medical+device +act&x=27&y=26#liBgcolor6 MFDS: Pharmaceutical Affairs Act No.14328 (2016.12.02) https://elaw.klri.re.kr/kor_service/ lawView.do?hseq=40196&lang=ENG MOIS: Personal Information Protection Act No. 14839 (2017): 131 1. Enforcement Decree of the Medical Device Act No. 27209 (2016.05.31): http://www.law.go.kr/LSW/eng/ engLsSc.domenuId=2&s ection=lawNm&query=medical+ device+act&x=23&y=20#liBgcolor2 2. 2. Enforcement Regulations of the Medical Device Act No. 18 (2010.9): http://www.law.go.kr/LSW/lsInfoP.do lsiSeq=107498&urlMode=engLsInfo R&viewCls=engLsInfoR#0000 Regulation on Safety of Pharmaceuticals, etc. No. 1455 (2018.04.25) https://www.mfds.go.kr/eng/brd/ m_18/view.do? seq=71447&srchFr=&srchTo=&srch Word=&srchTp=&itm_seq_1=0&it m_seq_2=0&multi_itm_seq=0&com pany_cd=&company_nm=&page=2 Enforcement Regulations of the Medical Device Act No.1354 (2017.01. 04) https://mfds.go.kr/eng/brd/m_40/ view.do?seq=69732 MOIS: 1. Enforcement Decrees to Personal Information Protection Guidelines for Clinical Trial Indemnity and Its Process 0053-01 (2013.10) 2017.6.1 고시: http://www.mfds.go.kr/brd/m_210/view.do?seq =13069&srchFr=&srchTo=&srchWord=%EB %B3%B4%EC%83%81&srchTp=0&itm_seq_ 1=0&itm_seq_2=0&multi_itm_seq=0&compa ny_cd=&company_nm=&page=1 2. Guidance for Sponsors; Safety Reporting Requirements 0785-01 (2017.8) 2017.8.31 고시: http://www.mfds.go.kr/brd/m_210/view.do?seq =13317&srchFr=&srchTo=&srchWord=%EC %95%88%EC%A0%84%EC%84%B1&srchT p=0&itm_seq_1=0&itm_seq_2=0&multi_itm_ seq=0&company_cd=&company_nm=&page= 1 MOIS: Guidelines for De-identification of Personal Data (2016.06.30): Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning do 2. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46731&lang=ENG MOHW: Bioethics and Safety Act No. 15188 (2017.12): http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG MOHW: Bioethics and Safety Act No. 15188 (2017.12): http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG MOHW: Bioethics and Safety Act No. 15188 (2017.12): http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG MOHW: Bioethics and Safety Act No. 15188 (2017.12): http://elaw.klri.re.kr/kor_service/la 132 Act No. 28355 (2017.10): http://elaw.klri.re.kr/kor_service/law View.do?hseq=45683&lang=ENG 2. Enforcement Rules to Personal Information Protection Act No. 1 (2013.3): http://www.law.go.kr/LSW/eng/eng LsSc.do?menuId=1&query=pers onal&x=0&y=0#liBgcolor21 MOHW: Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11 1. Enforcement Decree of Bioethics and Safety Act No. 28211 (2017): http://elaw.klri.re.kr/kor_service/law View.do?hseq=45482&lang=ENG 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11 MOHW: 1. Enforcement Decree of Bioethics and Safety Act No. 28211 (2017): http://elaw.klri.re.kr/kor_service/law View.do?hseq=45482&lang=ENG 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11 MOHW: 1. Enforcement Decree of Bioethics and Safety Act No. https://www.privacy.go.kr/eng/ news_event_view.do?nttId=7585 MFDS: Guidelines on the Evaluation of Quality, Safety, and Efficacy of Recombinant Protein Products 0324-01 (2014.12) 2017.6.1 고시: http://www.mfds.go.kr/brd/m_210/view.do?seq =12542&srchFr=&srchTo=&srchWord=%EC %9E%AC%EC%A1%B0%ED%95%A9&srch Tp=0&itm_seq_1=0&itm_seq_2=0&multi_itm _seq=0&company_cd=&company_nm=&page =1 MFDS: 1. Guideline on Sponsor-Investigator Trials of Cell Therapy Products for Academic Purpose 0307-01 (2014.12) 2014.12.30 고시: Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Kyrgyzstan 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do wView.do?hseq=46341&lang=ENG 28211 (2017): http://elaw.klri.re.kr/kor_service/law View.do?hseq=45482&lang=ENG 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11 http://www.mfds.go.kr/brd/m_210/view.do? seq=12490&srchFr=&srchTo=&srchWord=%EC% 84%B8%ED%8F%AC%EC%B9%98%EB%A3% 8C&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_ itm_seq=0&company_cd=&company_nm=&page=1 2.Guideline on the Design of Early-Phase Clinical Trials of Cell Therapy and Gene Therapy Products 안내서0309-01 (2015.11): https://www.mfds.go.kr/brd/m_210/view.do?seq=12501 3.Guideline on Tumorigenicity Assessment of Stem Cell Therapy Products (2016.05.) https:// www.mfds.go.kr/eng/brd/m_27/view.do?seq=70469 Note: All websites and documents are in Russian. General 1. Government of the Kyrgyz Republic: http://www.gov.kg 2. Ministry of Health: http://www.med.kg 3. Ministry of Justice of the Kyrgyz Republic: http://cbd.minjust.gov.kg 1. Constitution of Kyrgyz Republic, Chapter II, Article 22 (2010): http://www.gov.kg/?page_id=263&l ang=ru 2. Law on Health Protection of the Kyrgyz Republic (Sept. 1, 2005, No. 6): Articles 34 and 72: http://www.pharm.kg/ru/legislation 1. Code of Professional Ethics of Medical Worker of the Kyrgyz Republic (2004): http://old.med.kg/index.php/ru/doku menty-2/kodex-prof-etiki-2.html 2. Сode of Administrative Responsibility of the Kyrgyz Republic №114 from 04.08.1998г. (Updated June 11, 2008 N 115 and June 23, 2008 N 136) Chapters 7 and 10: http://www.pharm.kg/ru/legislation/ Drugs, Biologics, and Devices Research Injury 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg 2. Ministry of Health, National Bioethics Committee 3. Pharmaceutical Union of Kyrgyzstan, Ethics Committee: http://farmunion.kg/o-nas/eticheskij- komitet/ 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg 2. Ministry of Health, National Bioethics Committee Law on the Circulation of Medicinal Products of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles 24-25: http://cbd.minjust.gov.kg/act/view/r u-ru/111672 Law on the Circulation of Medicinal Products of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles 24-25: http://cbd.minjust.gov.kg/act/view/r u-ru/111672 DDMDP: 1. National Standard KMC 1195:2010: Medical Devices: Rules for Clinical Trials (2010): http://www.pharm.kg/ru/legislation/ 2. Technical Regulations on the Safety of Medical Products for Medical Application, Approved by the Governmental Order # 74 from February 1, 2012: http://www.pharm.kg/ru/legislation/ DDMDP: National Standard KMC 1195:2010: Medical Devices, Rules for Clinical Trials, Paragraphs 3, 4, and 6 (2010): http://www.pharm.kg/ru/legislation/ 133 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Social-Behavioral Research Privacy/Data Protection Malaysia General Drugs, Biologics, and Devices 1. Ministry of Health, Department of Drug and Medical Devices Provision: http://www.pharm.kg 2. Ministry of Health, National Bioethics Committee Ministry of Justice of the Kyrgyz Republic: http://minjust.gov.kg/ru/ 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg 2. Ministry of Health, National Bioethics Committee 1. Ministry of Health Malaysia, Medical Review and Ethics Committee (MREC) 2. Malaysian Industry-Government Group For High Technology (MIGHT), National Science Council: https://www.might.org.my/download/the- malaysian-code-of-responsible-conduct- in-research/ 1. Society of Clinical Research Professionals Malaysia (SCRPM): https://scrpm.ucoz.com/ 2. Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA): https://npra.gov.my/index.php/en/ Law on Health Protection of the Kyrgyz Republic (09.01.2005 No. 6): Article 39: http://www.pharm.kg/ru/legislation Law On the Protection of Traditional Knowledge, as amended by the Law of the Kyrgyz Republic of July 18, 2014 No. 144): http://cbd.minjust.gov.kg/act/view/r u-ru/202149/20?cl=ru-ru Law on Health Protection of the Kyrgyz Republic (09.01.2005 No. 6): Article 91: http://www.pharm.kg/ru/legislation 134 Technical Regulations on the Safety of Medical Products for Medical Application, Approved by the Governmental Order #74 from February 1, 2012: http://www.pharm.kg/ru/legislation/ DDMDP: 1. National Standard KMC 1195:2010: Medical Devices, Rules for Clinical Trials, Paragraphs 3, 4, and 6 (2010): http://www.pharm.kg/ru/legislation/ 2. Technical Regulations on the Safety of Medical Products for Medical Application, Approved by the Governmental Order #74 from February 1, 2012: http://www.pharm.kg/ru/legislation/ MREC: Guidelines for Ethical Review of Clinical Research or Research Involving Human Subjects (2006): http://www.nccr.gov.my/view_file.cfm?fileid= 16 MIGHT: The Malaysian Code of Responsible Conduct in Research: https://uitmethics.uitm.edu.my/v1/images/stori es/guidelines/my_code.pdf SCRPM: Guide to Conducting Clinical Trials in Malaysia: http://www.clinicalresearch.my/wp- content/uploads/2017/03/A-Guide-to-Conduct- Clinical-Trials-in-Malaysia.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trial Registry Research Injury Social-Behavioral Research 3. National Committee for Clinical Research: http://www.nccr.gov.my/ 4. Ministry of Health, National Institutes of Health (NIH): http://www.nih.gov.my/ National Medical Research Register: https://www.nmrr.gov.my/fwbLoginPage. jsp 1. Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA): https://npra.gov.my/index.php/en/ 2. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p hp?r=portal2 1. Malaysian Industry-Government Group For High Technology (MIGHT), National Science Council: https://www.might.org.my/download/the- malaysian-code-of-responsible-conduct- in-research/ 2. Ministry of Health Malaysia, Institute for Health Behavioural Research (IPTK): AGC: Occupational Safety and Health Act 1994, Section 35: http://www.dosh.gov.my/index.php/ en/legislation/acts/23-02- occupational-safety-and-health-act- 1994-act-514/file 135 NPRA: 1. Malaysian Guidelines of Good Clinical Practice (2011): https://mrc.ukri.org/documents/pdf/malaysian- guidelines-for-good-clinical-practice/ 2. Malaysian Guideline for Phase I Unit Inspection and Accreditation Program: https://www.npra.gov.my/images/Guidelines_ Central/Guidelines_on_Clinical_Trial/MALAY SIANGUIDELINEFORPHASEIUNITINSPEC TION.pdf CRC: Malaysian Phase I Clinical Trial Guidelines: https://clinicalresearch.my/mp1g/ NIH: Guidelines for Conducting Research in Ministry of Health Institutions and Facilities (2015): https://www.pharmacy.gov.my/v2/sites/default/ files/document-upload/nih-guidelines- conducting-research-moh-institutions-facilities- revision-01-2015.pdf Frequently Asked Questions: https://www.nmrr.gov.my/doc/FREQUENTLY _ASKED_QUESTIONS_FAQ.pdf NPRA: Malaysian Guideline for Good Clinical Practice, Section 5.8: Compensation to Subjects and Investigators https://www.crc.gov.my/wp- content/uploads/2018/03/Malaysian_gcp_4th_ Edition28Final_29.pdf MIGHT: Malaysian Code of Responsible Conduct, Section 8: https://uitmethics.uitm.edu.my/v1/images/stori es/guidelines/my_code.pdf Country Key Organizations Legislation Regulations Guidelines Social-Behavioral Research Privacy/Data Protection Human Biological Materials Genetic Research Embryos, Stem Cells and Cloning http://iptk.moh.gov.my/iptk/index.php/ho me 1. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p hp?r=portal2 2. Ministry of Communications and Multimedia (KKMM), Personal Data Protection Commissioner Malaysia. http://www.pdp.gov.my/index.php/en/ 3. Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA): https://npra.gov.my/index.php/en 1. National Committee for Clinical Research: http://www.nccr.gov.my/ 2. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p hp?r=portal2 1. Malaysian Medical Council: http://mmc.gov.my/ 2. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p hp?r=portal2 1. Ministry of Health, National Pharmaceutical Control Bureau (NPCB): https://npra.gov.my/index.php/en/ 2. Ministry of Health, Medical Act 709: Personal Data Protection Act 2010, Sections 39 and 40: http://www.pdp.gov.my/images/LA WS_OF_MALAYSIA_PDPA.pdf 1. Act 130: Human Tissues Act (1974): Section 2 Removal of parts of bodies for therapeutc purpose http://www.agc.gov.my/agcportal/u ploads/files/Publications/LOM/EN/ Act%20130.pdf 2. Act 699: DNA Identification Act 2009. Malaysian Government Gazette of 3 September 2009: http://www.agc.gov.my/agcportal/u ploads/files/Publications/LOM/EN/ Act%20699%209_7_2015.pdf AGC: Act 678. Biosafety Act 2007: http://bch.cbd.int/database/attachme nt/?id=17640 136 DNA Identification Regulations 2012. Malaysian Government Gazette of 30 Aug 2012. Biosafety (Approval and Notification) Regulations 2010: http://bch.cbd.int/database/attachment /?id=17640 KKMM: Compliance to Personal Data Protection Act (PDPA): A Quick Guide: http://www.pdp.gov.my/images/slaid- seminar/PDPA-Compliance---Jan-2019.pdf NPRA: Malaysian Guideline for Good Clinical Practice, Confidential Information: https://www.crc.gov.my/wp- content/uploads/2018/03/Malaysian_gcp_4th_ Edition28Final_29.pdf NCCR: Guideline on the Use of Human Biological Tissues for Research (2016): https://www.nmrr.gov.my/doc/Guideline-on- Human-Tissue-in-Clinical-Research.pdf MMC: Medical Genetics and Genetic Services. MMC Guidelines 010/2006: http://www.npra.gov.my/images/Guidelines_C entral/Guidelines_on_Regulatory/CGTP_guide lines.doc NBB: Guidelines for Institutional Biosafety Committees: https://um.edu.my/docs/default- source/institutional-biosafety-committee- (ibc)/ibc-guidelines.pdf?sfvrsn=2 1. Checklist for Research on Stem Cell and Cell-Based Therapies (2014): http://www.nih.gov.my/mrec/documents/Research_O n_Stem_cell_and_Cell_based_Therapies.pdf 2. Guidance Document and Guidelines for Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Myanmar General Drugs, Biologics, and Devices Human Biological Materials Nepal General Development Division: http://www.moh.gov.my/index.php?mid= 5 1. Department of Medical Research (DMR): http://www.dmrlm.gov.mm/ 2. Ministry of Health National Ethics Committee on Clinical Research: www.moh.gov.mm Ministry of Health, Food and Drug Administration: http://www.fdamyanmar.gov.mm/index.p hp/en/ Nepal Health Research Council, Ethical Review Board: http://www.nhrc.org.np/ National Drug Law (1992) 1. Blood and Blood Products Law (2003) (Burmese): http://www.moh.gov.mm/file/Law/ Blood%20and%20Blood%20Produc t%20Law%20(2003).pdf 2. Body Organ Donation Law (2004) Nepal Health Research Council Act, 1991, Section 3(1): http://www.lawcommission.gov.np/ en/documents/2015/08/nepal-health- research-council-act-2047-1991.pdf 137 Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia (2016): https://www.npra.gov.my/images/00NPRA/bio logic/guidelines/CGTP_guidelinesbio.pdf 3. Medical Development Division: Guidelines for Stem Cell Research and Gene Therapy (2009): http://www.moh.gov.my/moh/resources/auto% 20download%20images/586f38d1c77ed.pdf 4. National Organ, Tissue and Cell Transplantation Policy: http://www.mst.org.my/articles/MALAYSIA% 20TRANSPLANT%20POLICY.pdf 5. National Standards for Cord Blood Banking and Transplantation: http://www.moh.gov.my/moh/resources/auto% 20download%20images/589d78e8689af.pdf 6. National Standards for Stem Cell Transplantation: http://www.moh.gov.my/moh/resources/Arkib/ National_Standards_For_Stem_cell_Transplata tion.pdf DMR: Guideline for Submission to Ethics Review Committee (2016) 1. National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure (2011): http://nhrc.org.np/guidelines 2. Guidelines for Institutional Review Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices New Zealand General Nepal Health Research Council: http://www.nhrc.org.np/ 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.ethics.health.govt.nz/ 6. Ministry of Business, Innovation and Employment: http://www.mbie.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. Accident Compensation Act 2001 Access: All New Zealand acts, bills, and regulations can be found here: http://www.legislation.govt.nz/ HDC: The Code of Health and Disability Services Consumers’ Rights (the Code of Rights) (2004): http://www.hdc.org.nz/the-act-- code/the-code-of-rights Committees (IRCs) for Health Research in Nepal (2016): http://nhrc.org.np/guidelines National Guidelines on Clinical Trials with the Use of Pharmaceutical Products (2005): http://nhrc.org.np/guidelines HRC: 1. Guidelines for Researchers on Health Research Involving Māori (2010) 2. Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members (2010) 3. HRC Research Ethics Guidelines (2017) 4. Pacific Health Research Guidelines (2014) Access: http://www.hrc.govt.nz/ethics-and- regulatory/applying-ethical-approval 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 (2012) 3. Ethical Guidelines for Intervention Studies (2012) Access: http://www.neac.health.govt.nz/moh.nsf/indexc m/neac-resources-publications Drugs, Biologics, and Devices Drugs 1. New Zealand Medicines and Medical Devices Safety Authority 1. Accident Compensation Act 2001, Section 32 (2010) 138 Medsafe: Medicines Regulations 1984 http://www.legislation.govt.nz/regulat MOH: Standard Operating Procedures for Health and Disability Ethics Committees (2012): http://www.ethics.health.govt.nz/operating- procedures Medsafe: Good Clinical Research Practice and Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Privacy/Data Protection Human Biological Materials (Medsafe): http://www.medsafe.govt.nz 2. Medicines New Zealand: http://www.medicinesnz.co.nz/ 3. Health Research Council (HRC), Standing Committee on Therapeutic Trials: http://www.hrc.govt.nz/about- us/committees/standing-committee- therapeutic-trials-scott Devices New Zealand Medicines and Medical Devices Safety Authority (Medsafe): http://www.medsafe.govt.nz Australian New Zealand Clinical Trials Registry: http://www.anzctr.org.au/ Privacy Commissioner: http://www.privacy.org.nz/ 1. Ministry of Health (MOH): http://www.moh.govt.nz/ 2. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/ethics-and- regulatory/applying-ethical-approval 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 Business, Innovation and Employment: http://www.mbie.govt.nz/ 2. Medicines Act 1981(2012) 1. Official Information Act 1982 (2012) 2. Public Records Act (2005) 3. Privacy Act 1993 (2012) 1. Health Act 1956 (2012) 2. Human Tissue Act 2008 ion/public/1984/0143/latest/DLM956 68.html Medicines (Database of Medical Devices) Regulations (2003): http://www.legislation.govt.nz/regulat ion/public/2003/0325/latest/DLM224 223.html Health Information Privacy Code 1994: http://www.privacy.org.nz/assets/File s/Codes-of-Practice-materials/Health- Information-Privacy-Code-1994- including-Amendment.pdf Obtaining Approval for Clinical Trials (2013): http://www.medsafe.govt.nz/medicines/clinical -trials.asp Medicines New Zealand: Guidelines on Clinical Trials Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial (2015): https://ethics.health.govt.nz/system/files/docum ents/pages/2015-medicines-new-zealand- compensation-guidelines.pdf 1. Standard Operating Procedures for Health and Disability Ethics Committees (2012): http://www.ethics.health.govt.nz/operating- procedures 2. Various: http://medsafe.govt.nz/regulatory/DevicesNew/ 13ConductingClinicalTrials.asp FAQs: http://www.anzctr.org.au/Faq.aspx MOH: Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007): http://www.health.govt.nz/publication/guidelin es-use-human-tissue-future-unspecified- research-purposes 139 Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning Pakistan General Drugs, Biologics, and Devices Human Biological Materials 1. Environmental Protection Authority: http://www.epa.govt.nz/ 2. Health Research Council (HRC), Gene Technology Advisory Committee: http://www.hrc.govt.nz/about- us/committees/gene-technology-advisory- committee-gtac 1. Advisory Committee on Assisted Reproductive Technology (ACART): http://acart.health.govt.nz/ 2. Ethics Committee on Assisted Reproductive Technology (ECART): http://ecart.health.govt.nz/ 3. Ministry of Health: http://www.moh.govt.nz/ National Bioethics Committee: http://nbcpakistan.org.pk/ National Bioethics Committee: http://nbcpakistan.org.pk/ National Bioethics Committee: http://nbcpakistan.org.pk/ Hazardous Substances and New Organisms Act 1996 (2012) Human Assisted Reproductive Technology Act 2004 (2009) 140 Human Assisted Reproductive Technology (HART) Order (2005): http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html ACART: 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000) 2. Guidelines for Research on Gametes and Non-viable Embryos (2005) 3. Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005) 4. Guidelines on Embryo Donation for Reproductive Purposes (2008) 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012) 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013) 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013) 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014) Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart Various: http://nbcpakistan.org.pk/guidelines.html Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines): http://nbcpakistan.org.pk/?page_id=61 Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM): Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Embryos, Stem Cells, and Cloning Philippines General National Bioethics Committee: http://nbcpakistan.org.pk/ 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/ 3. Department of Health (DOH): http://www.doh.gov.ph/ 4. Commission of Higher Education (CHED): www.ched.gov.ph/ 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph Republic Act No. 10532: An Act Institutionalizing the Philippine National Health Research System (2013): http://www.gov.ph/2013/05/07/repu blic-act-no-10532/ PHREB: 1. PNHRS Act Implementing Rules and Regulations: http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/2 -uncategorised/214-implementing- rules-of-pnhrs 2. Memorandum: Registration and Accreditation of all Ethics Review Committees in the Philippines (2015): http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/226-phreb-memo http://nbcpakistan.org.pk/assets/hbm-nbc- guidelines-final-18june-2016.pdf Protocol/Guidelines for Stem Cell Research/Regulation in Pakistan: http://nbcpakistan.org.pk/?page_id=61 PHREB: National Ethical Guidelines for Health and Health-Related Research (2017): http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical- guidelines-for-health-and-health-related- research DOST: 1. Administrative Order 001 Series 2007: Requirement for Review of All Research Involving Human Subjects/Participants (2007): http://ethics.healthresearch.ph/index.p hp/component/content/article/2- uncategorised/112-ao-001-2007 2. Administrative Order 001 Series 2008: Registration of All Ethics Review Committee at the PHREB (2008): http://ethics.healthresearch.ph/index.p hp/component/content/article/2- uncategorised/111-ao-001 3. PCHRD Special Order No. 146 Series of 2013: Reactivation and Amendment of Functions of the National Ethics Committee http://nec.pchrd.dost.gov.ph/compone nts/com_ethics/pdf_files/nec_so.pdf 141 Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Drugs Food and Drug Administration (FDA): http://www.fda.gov.ph/ 142 DOH: Department Circular No. 2015- 0059: Research Ethics Review Committees Registration and Accreditation: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/217-doh-circular CHED: 1. Memo 34 Series 2007: Policy Requirement in the Conduct of Health Research involving Human Subjects: http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/2 -uncategorised/130-ched- memorandum 2. Memorandum from the CHED Chairperson: Philippine Health Research Ethics Board – Registration and Accreditation of All Ethics Review Committees: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/225-ched-memo NCIP: NCIP AO No. 3 Series 2012: Revised Guidelines on Free and Prior Informed Consent (FPIC) and Related Processes of 2012: http://www.wipo.int/wipolex/en/text.j sp?file_id=414691 FDA: 1. Rules and Regulations on the 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) National Ethical Guidelines for Health and Health-Related Research, Page 70 (2017): http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical- guidelines-for-health-and-health-related- research Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices 2. FDA Circular 2015-026: Adoption of the ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C: http://www.fda.gov.ph/attachments/ar ticle/118205/FC2013-026.pdf DOST, DOH, CHED, and UPM: Joint Memorandum Order 001 Series of 2012: http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/1 0-orders-and-memos/215-joint- memo-01 Clinical Trials Registry Research Injury Devices Food and Drug Administration: http://www.fda.gov.ph/ Philippine Health Research Registry: http://registry.healthresearch.ph/ 1. Department of Science and Technology (DOST): http://www.dost.gov.ph/ 2. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph 143 DOST, DOH, CHED, and UPM: Joint Administrative Order No. 001: The Implementing Rules and Regulations of Republic Act 10532 Otherwise Known as “The Philippine National Health Research System Act of 2013:” http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/2 -uncategorised/214-implementing- rules-of-pnhrs FDA Guidelines: Regulation of Clinical Trials in the Philippines http://www.pcrp.org.ph/pdf/Guidelinesversion LR.PDF FAQs: http://registry.healthresearch.ph/index.php?opti on=com_content&view=article&id=7&Itemid= 185 PHREB: National Ethical Guidelines for Health and Health-Related Research (2017): http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical- guidelines-for-health-and-health-related- research Country Key Organizations Legislation Regulations Guidelines Social-Behavioral Research Privacy/Data Protection Embryos, Stem Cells, and Cloning Singapore General 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph 2. Philippine Social Science Council (PSSC): http://pssc.org.ph/ Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org Republic Act No. 10173: Data Privacy Act of 2012: http://www.officialgazette.gov.ph/2 012/08/15/republic-act-no-10173/ Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15 Data Privacy Act Implementing Rules and Regulations (2016): https://privacy.gov.ph/implementing- rules-and-regulations-of-republic-act- no-10173-known-as-the-data-privacy- act-of-2012/ MOH: Human Biomedical Research Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015 -S621-2017 National Ethical Guidelines for Health and Health-Related Research, Pages 108-118. (2017): http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4-neg National Ethical Guidelines for Health and Health-Related Research, Pages 91, 157 and 163 (2017): http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical- guidelines-for-health-and-health-related- research MOH: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and- legislation/human-biomedical-research-act Drugs, Biologics, and Devices Drugs Health Sciences Authority of Singapore (HSA): http://www.hsa.gov.sg 1. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007 2. Medicines Act (Cap 176): https://sso.agc.gov.sg/Act/MA1975 144 1. Health Products (Clinical Trials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S331-2016 2. Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S332-2016 3. Medicines (Clinical Trials) Regulations 2016: BAC: Ethics Guidelines for Human Biomedical Research (2015): http://www.bioethics- singapore.org/index/publications/reports/86- reports/ethics-guidelines-for-human- biomedical-research.html HSA: Singapore Guideline for Good Clinical Practice (2016): http://www.ich.org/fileadmin/Public_Web_Site /ICH_Products/Guidelines/Efficacy/E6/E6_R2 Step_4_2016_1109.pdf Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials Devices 1. Health Sciences Authority (HSA): http://www.hsa.gov.sg 2. National Environment Agency (NEA), Centre For Radiation Protection And Nuclear Science: http://www.nea.gov.sg/anti-pollution- radiation-protection/radiation-protection 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Health Sciences Authority: http://www.hsa.gov.sg 1. Personal Data Protection Commission (PDPC): https://www.pdpc.gov.sg 2. Bioethics Advisory Committee (BAC): https://www.bioethics- singapore.org 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org 1. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007 2. Radiation Protection Act (2007): https://sso.agc.gov.sg/Act/RPA2007 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15 2. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007 Personal Data Protection Act (2012): https://sso.agc.gov.sg/Act/PDPA20 12 1. Medical (Therapy, Education, and Research) Act (1973): https://sso.agc.gov.sg/Act/MTERA1 972 2. Human Biomedical Research 145 https://sso.agc.gov.sg/SL/MA1975- S335-2016 4. Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016: https://sso.agc.gov.sg/SL/MA1975- S336-2016 1. Health Products (Medical Device) Regulations (2010): http://sso.gov.sg/SL/HPA2007-S436- 2010 2. Radiation Protection (Non- Ionising Radiation) Regulations (Cap 262 Rg 1): http://sso.gov.sg/SL/RPA1991-RG1 1. Human Biomedical Research Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015 -S621-2017 2. Health Products (Clinical Trials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S331-2016 Medicines (Clinical Trials) Regulations (2016): https://sso.agc.gov.sg/SL/MA1975- S335-2016 Medicines (Clinical Trials) Regulations (2000): http://statutes.agc.gov.sg/aol/search/d isplay/view.w3p;orderBy=date- rev,loadTime;page=0;query=Id%3A7 e3c748b-8089-4699-a4b2- HSA: Singapore Guideline for Good Clinical Practice (2016): http://www.ich.org/fileadmin/Public_Web_Site /ICH_Products/Guidelines/Efficacy/E6/E6_R2 Step_4_2016_1109.pdf PDPC: Sector Specific Guidelines Promulgated by PDPC: https://www.pdpc.gov.sg/Legislation-and- Guidelines/Guidelines BAC: Personal Information in Biomedical Research (2007): http://www.bioethics- singapore.org/index/publications/reports/170- personal-information-in-biomedical- research.html MOH: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and- legislation/human-biomedical-research-act Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning Sri Lanka Drugs and Devices Clinical Trials Registry Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org 1. Ministry of Health (MOH): http://www.moh.gov.sg/ 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org/ Cosmetics, Devices, and Drugs Regulatory Authority, Subcommittee on Clinical Trials: http://www.cdda.gov.lk/index.php?option =com_content&view=article&id=78&Ite mid=115&lang=en Sri Lanka Clinical Trials Registry: http://www.slctr.lk/ Bill No. 25/2015, Part 6: https://sso.agc.gov.sg/Act/HBRA20 15 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15 2. Human Cloning and Other Prohibited Practices Act (Cap 131B): https://sso.agc.gov.sg/Act/HCOPPA 2004 National Medicines Regulatory Authority Act of 2015: http://www.cdda.gov.lk/images/stori es/new/pdf/legislations/5e_nmdra.p df 9f66af6f7820;rec=0 Human Biomedical Research (Restricted Research) Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015 -S622-2017 BAC: Human Tissue Research (2002): http://www.bioethics- singapore.org/index/publications/reports/173- human-tissue-research.html BAC: Genetic Testing and Genetic Research (2005): http://www.bioethics- singapore.org/index/publications/reports/171- genetic-testing-and-genetic-research.html MOH: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and- legislation/human-biomedical-research-act BAC: 1. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (2002): http://www.bioethics- singapore.org/index/publications/reports/86- reports/174-stem-cell-research.html 2. Donation of Human Eggs for Research (2008): http://www.bioethics- singapore.org/index/publications/reports/86- reports/168-donation-of-human-eggs-for- research.html 3. Human-Animal Combinations in Stem- Cell Research (2010): http://www.bioethics- singapore.org/index/publications/reports/86- reports/167-human-animal-combinations-in- stem-cell-research.html Guidelines for the Conduct of Clinical Trials in Sri Lanka (2014): http://www.cdda.gov.lk/images/pdf/clinical%2 0trials%20guidelines_oct2014.pdf FAQs: http://slctr.lk/faq 146 Country Key Organizations Legislation Regulations Guidelines Taiwan General Drugs, Biologics, and Devices Ministry of Health and Welfare: http://www.mohw.gov.tw/EN/Ministry/In dex.aspx 1. Ministry of Health and Welfare (MOHW): http://www.mohw.gov.tw/EN/Ministry/In dex.aspx 2. Taiwan Food and Drug Administration (FDA): http://www.fda.gov.tw/EN/index.aspx 1. Human Subjects Research Act (2019) (Chinese): https://law.moj.gov.tw/LawClass/La wAll.aspx?pcode=L0020176 2. Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021 MOHW: Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021 ‘ FDA: Pharmaceutical Affairs Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0030001 147 1. Regulations on Human Trials (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020162 2. Enforcement Rules of the Medical Care Act (2017) (Chinese): http://law.moj.gov.tw/LawClass/Law Content.aspx?PCODE=L0020023 3. Regulations for the Organization and Operation of Human Research Ethics Review Boards (2018): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020179 4. Exempt Review Categories for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54295 5. Informed Consent Exemptions for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54273 6. Expedited Review Categories for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54277 MOHW: 1. Regulations on Human Trials (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020162 2. Pharmaceutical Affairs Act Enforcement Rules (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030002 3. Regulations for Drug Safety Monitoring (2013) https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030050 4. Regulations for Good Clinical Practice (2014): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030056 5. Regulations for Governing the Regulations Governing the Organization and Operation of the Human Research Ethics Review Board (2018): http://law.moj.gov.tw/Eng/LawClass/LawCont ent.aspx?PCODE=L0020179 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Social-Behavioral Research Privacy/Data Protection Human Biological Materials Genetic Research 1. Ministry of Health and Welfare (MOHW): https://www.mohw.gov.tw/mp-2.html 2. Food and Drug Administration (FDA), MOHW: http://www.fda.gov.tw/EN/index.aspx Ministry of Health and Welfare: https://www.mohw.gov.tw/mp-2.html Ministry of Justice: http://www.moj.gov.tw/mp095.html Ministry of Health and Welfare: https://www.mohw.gov.tw/mp-2.html 1. Ministry of Health and Welfare (MOHW): https://www.mohw.gov.tw/mp-2.html 2. Food and Drug Administration (FDA): http://www.fda.gov.tw/EN/index.aspx 3. Ministry of Science and Technology: https://www.most.gov.tw/en/public Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021 Personal Information Protection Act (2015): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=I0050021 Human Biobank Management Act (2012): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020164 3. Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021 MOHW: Human Biobank Management Act (2012): http://law.moj.gov.tw/Eng//LawClas s/LawContent.aspx?pcode=L00201 64 148 Management of Medical Devices (2014): http://mohwlaw.mohw.gov.tw/Chi/En gContent.asp?msgid=528&KeyWord = 6. Regulation on Bioavailability and Bioequivalence Studies (2015): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030065 FDA: Regulation for Good Clinical Practice (2014): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030056 Exempt Review Categories for Human Research (2012) https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54295 Enforcement Rules of the Personal Data Protection Act (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=I0050022 1. Regulations on Human Trials (2009): http://law.moj.gov.tw/Eng/LawClass/ LawContent.aspx?pcode=L0020162 2. Administrative Regulations on the Establishment of Human Biobanks (2011) https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020173 MOHW: 1. Regulations on Commercial Benefit Feedback of Human Biobanks (2010) (Chinese): https://law.moj.gov.tw/LawClass/La wAll.aspx?pcode=L0020170 2. Administrative Regulations on the Establishment of Human Biobanks (2011): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020173 1. Good Tissue Practice (2002) (Chinese): http://www.fda.gov.tw/TC/includes/GetFile.ash x?id=1153&chk=342a5c73-c206-4756-ade9- 9c63265c859d&mid=46&name=fdContent 2. Guidelines for the Collection and Use of Human Specimens for Research (2006) (Chinese): http://www.fda.gov.tw/TC/includes/GetFile.ash x?id=1598&chk=6056f7dd-eb0a-48bf-ae7e- 8a2a5875e6e0&mid=46&name=fdContent MOHW: Guidance for Information Safety of Human Biobank (2010) (Chinese): http://regulation.cde.org.tw/doc_data_display?s id=1929&doctype2= Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Tajikistan Ministry of Health and Welfare (MOHW): https://www.mohw.gov.tw/mp-2.html Artificial Reproduction Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0070024 Note: For an overview of human subject protections in Tajikistan, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 9: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf Note: All websites and documents are in Russian. General Thailand Ministry of Public Health: http://www.health.tj/ Order of the Ministry of Public Health of the Republic Tajikistan of 10 March, 2005 No. 118: About the Assertion of the Normative Documents of Republic Committee on Medical Ethics For an overview of the clinical research regulations in Thailand, see: https://clinregs.niaid.nih.gov/single_country.php?c_id=213 General Drugs, Biologics, and Devices 1. National Research Council of Thailand (NCRT): http://en.nrct.go.th/en/home.aspx 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php 3. Forum for Ethical Review Committees in Thailand (FERCIT): http://www.fercit.org/ Drugs 1. Food and Drug Administration, Drug Control Division: http://www.fda.moph.go.th/eng/index.stm 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php Devices Food and Drug Administration, Medical Device Control Division: http://www.fda.moph.go.th/eng/medical/p re.stm Medical Professions Act (2009), Articles 47-50: http://www.fercit.org/SIDCER- FERCAP/Handout_10/4.%20Accre ditation- update_surveyor_aj.Sopit.pdf Consumer Protection Act (2007) 1988 Medical Device Act: http://www2.fda.moph.go.th/Export ers/law/Document/Mdc/36- MEDICAL%20DEVICE%20ACT.h tm NCRT: Regulation on the Permission of Foreign Researchers (1982): http://www.dnp.go.th/otec/eng_laws_ regs/NRCT_Reg2525E.pdf MCT: Rule of the Medical Council on the Observance of Medical Ethics (1983): http://thailaws.com/law/t_laws/tlaw0 510.pdf MCT: National Guideline for Ethical Research on Human Subjects (2002) FERCIT: Ethical Guidelines for Research on Human Subject in Thailand (2007): http://www.fercit.org/file/Guideline_English_v ersion.pdf FDA: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (2018) MCT: Thailand Good Clinical Practice Guidelines (2002) 149 Country Key Organizations Legislation Regulations Guidelines Clinical Trials Registry Privacy/Data Protection Uzbekistan Thai Clinical Trials Registry: http://www.clinicaltrials.in.th/ Office of the Information Commission: http://www.oic.go.th/content_eng/default_ eng.asp Official Information Act, B.E. 2540 (1997): http://www.oic.go.th/content_eng/ac t.htm FAQs: http://www.clinicaltrials.in.th/index.php?meun =home&smenu=4&task=home&task1=openpa ge&task2=view&topid=4 Note: All websites and documents are in Uzbek and Russian. General 1. Government of the Republic of Uzbekistan: http://www.gov.uz 2. Ministry of Health: http://www.minzdrav.uz 1. Constitution of Republic of Uzbekistan, Articles 24, 26, 40, 44 (1992): http://www.gov.uz 2. Law on Protection of Citizens’ Health (1997): http://www.minzdrav.uz Drugs, Biologics, and Devices Human Biological Materials Vietnam 1. Ministry of Health, Pharmacological Committee of the Central Department for Quality Control of Pharmaceuticals and Medical Equipment: http://www.minzdrav.uz 2. Ministry of Health, National Ethics Committee 3. Scientific Boards of Medical Institutes 1. Ministry of Health, Pharmacological Committee of the Central Department for Quality Control of Pharmaceuticals and Medical Equipment: http://www.minzdrav.uz 2. Ministry of Health, National Ethics Committee 3. Scientific Boards of Medical Institutes 1. Law on Protection of Citizens’ Health (1997): http://www.minzdrav.uz 2. Law on Drugs and Pharmaceutical Activity (1997) 3. Law on Narcotic and Psychoactive Drugs (2000) 1. Guidelines on Conducting Clinical Trials and Determining Clinical Sites (2001) 2. National Standard of Uzbekistan: Good Clinical Practice (2013) 1. Guidelines on Conducting Clinical Trials and Determining Clinical Sites (2001) 2. National Standard of Uzbekistan: Good Clinical Practice (2013) For an overview of the clinical research regulations in Vietnam, see the ClinRegs report: https://clinregs.niaid.nih.gov/single_country.php?c_id=233 General 1. Ministry of Health (MOH): http://www.moh.gov.vn/homebyt/en/porta l/index.jsp 2. Ministry of Health, Independent Ethics Committee (MOH): http://iecmoh.vn MOH: Decision No. 111/QD-BYT – On Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass- 150 MOH: Decision No. 460/QD-BYT – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of the 1. Circular No. 45/2017/TT-BYT – Regulation on the Establishment, Functions, Tasks, and Powers of the Ethics Committee in Biomedical Research (2017) (Vietnamese): https://thuvienphapluat.vn/van-ban/The-thao- Y-te/Thong-tu-45-2017-TT-BYT-nhiem-vu- Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Ministry of Health: http://www.moh.gov.vn/homebyt/en/porta l/index.jsp Roots Level, Chapter I (Articles 3 and 4), Chapter II, and Chapter III (2013): http://clinregs.niaid.nih.gov/docume nts/vietnam/DecisionNo111-QD- BYT.pdf 1. Law on Pharmacy (No. 34/2005/QH11), Chapter II (Section III, Article 20), Chapter VIII (Articles 54 and 59) (2005): http://www.vertic.org/media/Nation al%20Legislation/Vietnam/VN_La w_on_Pharmacy.pdf 2. Decision No. 799/QD-BYT on the Issuance of Guideline on Good Clinical Practice, Chapter III, Articles 1 and 2 (2008): http://clinregs.niaid.nih.gov/doc uments/vietnam/DecisionNo799 -QD-BYT.pdf Ministry of Health, Period 2012- 2017, Chapters I-III (2012): http://clinregs.niaid.nih.gov/documen ts/vietnam/DecisionNo460-QD- BYT.pdf 1. Decision No. 799/QD-BYT of the Minister of Health on the Promulgation of the Guidelines on Good Clinical Practice of Clinical Trials (2008): http://clinregs.niaid.nih.gov/documen ts/vietnam/DecisionNo799-QD- BYT.pdf 2. Circular – Guidelines for Clinical Trials on Drugs (C- ClinDrugTrial), Articles 2, 4, 5, 9, 17, 18, 31, and 39 (2012): http://clinregs.niaid.nih.gov/documen ts/vietnam/C-ClinDrugTrial.pdf quyen-han-Hoi-dong-dao-duc-nghien-cuu-y- sinh-hoc-354849.aspx 2. Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in Biomedical Research of the Ministry of Health, Period 2018-2023: http://crc.pasteurhcm.gov.vn/upload/files/1122 _2018.pdf Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17 (2012): https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van- ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx 151 Country Key Organizations Legislation Regulations Guidelines MIDDLE EAST/NORTH AFRICA Egypt General Drugs, Biologics, and Devices Iran General Clinical Trials Registry Israel General Drugs, Biologics, and Devices Privacy/Data Protection Genetic Research Medical Professionals Union Egyptian Drug Authority: http://www.eda.mohp.gov.eg/ 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/ Iranian Registry of Clinical Trials: http://www.irct.ir/ Ministry of Health: http://www.health.gov.il/english/ Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/English/Ministry Units/HealthDivision/MedicalTechnologi es/Drugs/Pages/default.aspx Israeli Law, Information, and Technology Authority: http://www.justice.gov.il/MOJEng/ILITA/ Ministry of Health: http://www.health.gov.il/english/ Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dusto r-en001.pdf Public Health Order (1940) 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007- 5FD6A6B8E0A5/18334/Protectiono fPrivacyLaw57411981unofficialtran slatio.pdf 2. Protection of Privacy Law No. 5741, as Amended by Law No. 5745 (1985) Genetic Information Law (2000): http://www.moital.gov.il/NR/exeres /66F4DD4E-FA4A-4B76-94BC- DC29543471DE.htm Professional Ethics Regulations: Conducting Medical Research on Human Beings, Articles 52-61 (2003) Protection Code for Human Subjects in Medical Research (1999) Public Health Regulations (Medical Experiments Involving Human Subjects) (1999) 1. Public Health Regulations (Clinical Studies in Human Subjects) – 1980 2. 1990 Amendment 3. 1992 Amendment 4. 2005 Amendment FAQs: http://www.irct.ir/faq.php Guidelines for Clinical Trials in Human Subjects (2006): https://firstclinical.com/regdocs/doc/?db=INT_ Israel_Clinical_Trials 1. Instruction of the Supreme Committee for Clinical Studies on Humans Regarding Establishment and Usage of Genetic Samples Reservoir (2005) 2. Amendment (2007) 152 Country Key Organizations Legislation Regulations Guidelines Embryos, Stem Cells, and Cloning Jordan Note: All documents are in Arabic. Genetic Intervention Prohibition Law (Human Cloning and Genetic Changes in Reproduction Cells) (1999) Drugs, Biologics, and Devices Research Injury 1. Ministry of Health: http://www.moh.gov.jo/en/Pages/default.a spx 2. Jordan Food and Drug Administration: http://www.jfda.jo/Default.aspx 1. Law of Clinical Studies, Law No. 2 (2011) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws AndRegulation/Drug/Pharmaceu ticalStudies/50_211.pdf 2. Drug and Pharmacy Law No. 12 (2013) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws AndRegulation/Drug/DrugDirec torate/%D9%82%D8%A7%D9 %86%D9%88%D9%86%20%D 8%A7%D9%84%D8%AF%D9 %88%D8%A7%D8%A1%20% D9%88%D8%A7%D9%84%D8 %B5%D9%8A%D8%AF%D9% 84%D8%A9.pdf 3. Narcotic and Psychotropic Law No. 23 (2016) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws AndRegulation/Drug/DrugsAnd PsychotropicSubstances/%D9% 82%D8%A7%D9%86%D9%88 %D9%86%20%D8%A7%D9% 84%D9%85%D8%AE%D8%A F%D8%B1%D8%A7%D8%AA %20%D9%88%D8%A7%D9% 84%D9%85%D8%A4%D8%A B%D8%B1%D8%A7%D8%AA %20%D8%A7%D9%84%D8% B9%D9%82%D9%84%D9%8A %D8%A9.pdf 153 Regulations for Insurance on Research-Related Injury (2013): http://www.jfda.jo/EchoBusV3.0/Syst emAssets/PDF/AR/LawsAndRegulati Country Key Organizations Legislation Regulations Guidelines Research Injury Embryos, Stem Cells, and Cloning Kuwait General Qatar General Social/Behavioral Research Human Biological Materials Genetic Research Ministry of Health, Kuwait Institute for Medical Specialization: http://www.kims.org.kw/ Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en /Pages/Regulations.aspx Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en /Pages/Regulations.aspx Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en /Pages/Regulations.aspx Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en /Pages/Regulations.aspx Stem Cell By-law No. 10 (2014) 154 on/Drug/PharmaceuticalStudies/22_2 52.pdf Protection of Human Subjects Involved in Research: https://researchwebadmin.moph.gov. qa//DepartmentalDocuments/Policies, %20Regulations%20and%20Guidelin es%20for%20Research%20Involving %20Human.pdf Ethical Guidelines for Biomedical Research: http://www.kims.org.kw/Ethical%202.doc 1. IRB - IEC Registration Application: https://researchwebadmin.moph.gov.qa/en/Pag es/IRB.aspx 2. Guidelines on Reviewing and Reporting Adverse Events: https://researchportal.moph.gov.qa/_layouts/15 /ResearchPortal/RDLogin.aspx?ReturnUrl=%2 f_layouts%2f15%2fAuthenticate.aspx%3fSour ce%3d%252F&Source=%2F 3. GCP Conduct of Clinical Trials: https://researchwebadmin.moph.gov.qa//D epartmentalDocuments/Standards%20of% 20Good%20Clinical%20Practice.pdf 1. Protection of Human Subjects, Exempt Research: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf 2. Protection of Human Subjects, Expedited Research: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf Guidance for the Use of Stored Data and Biological Specimens in Human Research: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20the%2 0Use%20of%20Stored%20Data%20and%20Bi ological%20Specimens%20in%20Human%20 Research.pdf 1. Guidance for the Design, Ethical Review, and Conduct of Genomic Research in Qatar: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20the%2 Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning Saudi Arabia General Social-Behavioral Research Sudan General Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en /Pages/Regulations.aspx National Committee of BioEthics: http://bioethics.kacst.edu.sa/?lang=en-US National Committee of BioEthics Federal Ministry of Health: http://www.fmoh.gov.sd/ Law of Ethics of Research on Living Creatures: http://bioethics.kacst.edu.sa/getattac hment/4bd0d4e2-1b93-4c32-b483- 57902227fae2/Bioethic-Rgl-fin- bks.aspx 155 Implementing Regulations of the Law of Ethics of Research on Living Creatures (2016): http://prod.kau.edu.sa/Med/ali/files/P ublications/Guide/National_Committ e_of_BioEthics- Regulations_of_the_Law_of_Ethics_ of_Research_on_Living_Creatures.pd f Implementing Regulations of the Law of Ethics of Research on Living Creatures, Expedited Research (Article 10.18g) and Categories of Social-Behavioral Research That do not Require Continuing Review (Article 10.32) (2016): http://prod.kau.edu.sa/Med/ali/files/P ublications/Guide/National_Committ e_of_BioEthics- Regulations_of_the_Law_of_Ethics_ of_Research_on_Living_Creatures.pd f 0Design,%20Ethical%20Review,%20and%20 Conduct%20of%20Genomic%20Research%20 in%20Qatar.pdf 2. Guidelines for Gene Transfer Research in Humans: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidelines%20for%20Gene %20Transfer%20Research%20in%20Humans. pdf Guidance for Research Involving Humans: Guidance for Research Involving Human Stem Cells, Germ Cells, and Cells Obtained from Cord Blood: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20Resear ch%20Involving%20Human%20%20Stem%20 Cells.pdf 1. National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008): http://sites.google.com/site/healthresearchlibrar y/national-guidelines Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Human Biological Materials Genetic Research Tunisia Drugs, Biologics, and Devices Turkey General National Medicines and Poisons Board: http://www.nmpb.gov.sd/en/ 1. Federal Ministry of Health: http://www.fmoh.gov.sd/ 2. National Council on Biosafety University of Khartoum, Institute of Endemic Diseases: http://iend.uofk.edu/index.php?lang=en Ministry of Public Health, Institut Pasteur: www.pasteur.tn Ministry of Health (Turkish): http://www.saglik.gov.tr/ Act on Pharmaceuticals and Poisons (2009) (Arabic): http://www.nmpb.gov.sd/index.php/ 2015-08-05-11-05- 04/regulations/113-laws2009 1. Human Organs and Tissues Transplant Legislation, Chapter 2, Articles 3 and 4 (1978) Act on Biosafety (2010) 1. Turkish Constitution, Article 17 2. Health Services Basic Law No. 3359 (1987) 3. Oviedo Convention on Human Rights and Biomedicine (2004) 4. Update on the Law of the Support of Research and Development Activities (2016). Official Gazette (Turkish): http://www.resmigazete.gov.tr/eskil er/2016/02/20160226-1.pdf Conditions of Contract and Specifications Related to Medical or Scientific Experimentation of Medicines Intended for Humans 1. Regulation on Medical Deontology, Article 11 (1960) 2. Bylaw on Patient Rights No. 23420 (1998) 2. Accreditation Guidelines for Research Ethics Committees In Sudan (2017): http://snrec.sd/wp- content/uploads/2017/05/Accredition- guidelines.pdf 3. Operation Guidelines, Functions, and Procedures (2016) 4. NHREC protocol application form http://snrec.sd/wp- content/uploads/2017/05/NHREC- PROTOCOL-APPLICATION-FORM.pdf Guidelines for Genetics Research on Sudanese Subjects (2005) Disposals and Director’s Principles Related to Good Practices in Clinical Trials 156 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Drugs 1. Turkey Pharmaceuticals and Medical Devices Agency (Turkish) (TITCK): http://www.titck.gov.tr 2. Clinical Research Association (CRA): www.klinikarastirmalar.org Devices Turkey Pharmaceuticals and Medical Devices Agency (TITCK): http://www.titck.gov.tr Turkey Pharmaceuticals and Medical Devices Agency (TITCK): http://www.titck.gov.tr Turkish Penal Law, Article 90 (2005) Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 157 1. Fundamental Law #3359 on Health Services, Supplemental Article 10 (2011): 2. Regulation on Clinical Trials with Drugs and Biological Products (2015): An Update of 2014 Clinical Trials Regulation: http://www.klinikarastirmalar.org/Det ail/1992/ilac-ve-biyolojik-urunlerin- klinik-arastirmalari-hakkinda- yonetmelikte-degisiklik-yapilmasina- dair-yonetmelik-2015 3. Regulation on Efficacy, Safety, and Clinical Trials of Cosmetic Products (2015): http://www.klinikarastirmalar.org.tr/d oc/file_346.pdf 4. Update on the Regulation of the Management and Inspection of the Support of Research and Development Activities (2016). Official Gazette: http://www.resmigazete.gov.tr/eskiler /2016/08/20160810-7.htm 5. Bylaw on Clinical Research of Traditional and Complementary Medicine (2019): http://www.klinikarastirmalar.org/Det ail/2631/geleneksel-ve-tamamlayici- tip-uygulamalarinin-klinik- arastirmalari-hakkinda-yonetmelik- 2019 7. Guideline on Phase 1 Clinical Research Centers (2019) https://titck.gov.tr/storage/Archive/20 19/legislation/ad316d19-8b9e-420c- 86db-3946c56add1d.pdf Regulation on Research on Medical Devices (2014): http://www.klinikarastirmalar.org.tr/d oc/file_318.pdf CRA: 1. GCP Guideline (2015): http://www.klinikarastirmalar.org.tr/doku man.php?id=374 2. Guideline on the Audit of Pharmacovigilance: https://titck.gov.tr/storage/Archive/2019/l egislation/05ef1188-6756-4165-b0d5- bb0a28bbebb3.pdf 3. Various: http://www.klinikarastirmalar.org.tr/en/do cuments.php?dok_cat=0 Guidance on Insuring Volunteers in a Clinical Trial (2011) Country Key Organizations Legislation Regulations Guidelines Research Injury Human Biological Materials Genetic Research Embryos, Stem Cells, and Cloning United Arab Emirates 164 (2004) 1. Law on Procurement, 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) Regulation on Centers for Diagnosis and Genetic Diseases, No. 23368 (1998) 1. Regulation on Centers for Medically Assisted Procreation, No. 19551 (1987) 2. Regulation on Organ and Tissue Transplantation Services (2005) 3. Regulation on Cordon Blood Banks (2005) 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999) 2. Good Clinical Practice Guidelines for Advanced Therapy Medicinal Products (2011) Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999) 1. Circular on Research of Embryonic Stem Cells (2005) 2. Guideline on Clinical Research of Non- Embryonic Stem Cells (2006) General Health Authority - Abu Dhabi: http://www.haad.ae/haad/ Standard Operating Procedures for Research Ethics Committees (2012): http://www.haad.ae/HAAD/LinkClick.aspx?fil eticket=UL7o8f5mukc%3D&tabid=820 158 Country Key Organizations Legislation Regulations Guidelines LATIN AMERICA and the CARIBBEAN Regionwide General Caribbean Public Health Agency: http://carpha.org/What-We-Do/Research- Training-and-Policy-Development Drugs, Biologics, and Devices Argentina Drugs Pan American Health Organization: http://www.paho.org/ Devices Pan American Health Organization: http://www.paho.org/ Good Clinical Practices: Document for the Americas (2005): http://www.paho.org/english/ad/ths/ev/GCP- Eng-doct.pdf A Model Regulatory Program for Medical Devices: An International Guide (2001): http://www.paho.org/English/HSP/HSE/medica l_devices.pdf Note: Several provinces have their own regulations pertaining to human subjects research. General Drugs, Biologics, and Devices Ministry of Health: https://www.argentina.gob.ar/salud Drugs National Administration of Drugs, Foods, and Medical Devices (ANMAT): https://www.argentina.gob.ar/anmat Civil and Commercial Code, Articles 26, 58, and 59 (2015): http://servicios.infoleg.gob.ar/infole gInternet/anexos/235000- 239999/235975/norma.htm 159 Ministerial Resolution 1480/2011 Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm 1. Provision ANMAT 6677/10: Regulatory Guideline for Good Clinical Practices in Clinical Pharmacological Studies (2010): http://www.anmat.gov.ar/Comunicad os/Dispo_6677-10_en.pdf 2. Provision ANMAT 12.792/2016: Request for Import of Medication /Treatment and Materials – Procedure (2016): http://www.anmat.gov.ar/boletin_an mat/Noviembre_2016/Dispo_12792- 16.pdf 3. Provision ANMAT 828/2017: Authorization of Expanded Access Programs: http://www.anmat.gov.ar/boletin_an mat/enero_2017/Dispo_0828-17.pdf Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research: http://servicios.infoleg.gob.ar/infolegInternet/a nexos/185000-189999/187206/norma.htm Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trial Registries Privacy/Data Protection Devices National Administration of Drugs, Foods, and Medical Devices (ANMAT): https://www.argentina.gob.ar/anmat National Registry of Health Research: https://www.argentina.gob.ar/salud/registr oinvestigaciones National Directorate for the Protection of Personal Data: https://www.argentina.gob.ar/aaip/datospe rsonales 1. Personal Data Protection Act No. 25.326 (2000): http://www.protecciondedatos.com. ar/law25326.htm 2. Decree 1558/2001. Regulation of the Personal Data Protection Act: http://servicios.infoleg.gob.ar/infole gInternet/anexos/70000- 74999/70368/norma.htm 4. Provision ANMAT 4008/2017: Substitution of Article 2° of Provision ANMAT N° 6677/10: http://www.anmat.gov.ar/boletin_an mat/Abril_2017/Dispo_4008-17.pdf 5. Provision ANMAT 4009/2017: Health Care Institutions: Requirements and Conditions of Authorization for Conducting Phase I and/or Bioequivalence Clinical Pharmacology Studies: http://www.anmat.gov.ar/boletin_an mat/Abril_2017/Dispo_4009-17.pdf 6. Provision 10017-E/2017 ANMAT: Promoting Cooperation Between ANMAT and Jurisdictional Health Authorities for the Evaluation and Oversight of Clinical Research Sites and Investigators: http://servicios.infoleg.gob.ar/infolegI nternet/verNorma.do?id=279820 Provision ANMAT No. 969/97 on the Regulation of Good Clinical Practice with Medical Devices (1997): http://www.anmat.gov.ar/webanmat/ Legislacion/Medicamentos/Disp_969 -97_actualizada.pdf Resolution 1480/2011 Approving a Guide for Human Subjects Research: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm FAQs: https://sisa.msal.gov.ar/sisa/#Renis 160 Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Barbados Bermuda General Bolivia General Drugs, Biologics, and Devices Ministry of Health: https://www.argentina.gob.ar/salud University of the West Indies – Cave Hill / Ministry of Health: http://www.cavehill.uwi.edu/researchethic s/home.aspx Department of Health: https://www.gov.bm/department/health 1. Ministry of Health and Sport (MHS): http://www.sns.gob.bo 2. National Bioethics Committee (NBC) 1. Ministry of Health and Sport, National Pharmacological Commission (MHS): http://www.sns.gob.bo 2. National Bioethics Committee (NBC) 1. Legal Decree No. 15.629 of July 18, 1978, Articles 147 and 148. 2. New Political Constitution of the State, Article 44 (2009): https://www.constituteproject.org/co nstitution/Bolivia_2009.pdf 1. Resolution 1789/2006: Authorization for Import and Export of Biological Material for Diagnosis, Research and Surveillance Purposes: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/120000- 124999/122199/norma.htm 2. Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health Research, Section A3: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm 1. Regulations on Public Health Research, Chapter V (1978) 2. Rules and Regulations of the National Bioethics Committee Research Ethics Policy and Guidelines Research Governance Framework (2008): http://citeseerx.ist.psu.edu/viewdoc/download? doi=10.1.1.592.8671&rep=rep1&type=pdf MHS: Guidelines for the Development of Health Research and Ethical Norms (2002) NBC: 1. Requirements for the Evaluation of Research Projects 2. Code of Ethics and Medical Deontology MHS: Rule on Clinical Studies with Medicines or Products in the Clinical Investigation Stage (2005) NBC: Projects that Involve Drugs or Therapeutic Products 161 Country Key Organizations Legislation Regulations Guidelines Brazil For an overview of clinical research regulations in Brazil, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=30 General 1. National Health Council (CNS): http://www.conselho.saude.gov.br/ 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep 162 CNS/CONEP: 1. Resolution CNS No. 240/97 - Defining "Participating User" According to IRB: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_240_- _1997 - _Define_representao_de_usurio_CEP .pdf 2. Resolution CNS No. 292/99 on Research with Foreign Cooperation: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_292_- _1997 -_Cooperao_estrangeira.pdf 3. Resolution CNS No. 304/2000: Rules on Research Involving Human Beings – Area of Indigenous Peoples: http://conselho.saude.gov.br/resoluco es/2000/Res304_en.pdf 4. Internal CONEP Regulation (2001): http://conselho.saude.gov.br/comissa o/conep/regimento.doc 5. Resolution CNS No. 346/2005 on Multicenter Research: http://conselho.saude.gov.br/resoluco es/2005/Res346_en.pdf 6. Resolution CNS No. 370/07 on Registration and Accreditation or Renewal of Registration and Accreditation of CEP: http://conselho.saude.gov.br/resoluco es/2007/Reso370.doc 7. Resolution CNS No. 446/2011on Composition of the National Commission on Research Ethics: http://conselho.saude.gov.br/images/c CNS/CONEP: 1. Operating Normative 001/2013 Organization and Operation of CEP/CONEP System: http://conselho.saude.gov.br/images/comissoes/ conep/documentos/NORMAS- RESOLUCOES/Norma_Operacional_n_001- 2013_Procedimento_Submisso_de_Projeto.pdf 2. Various: http://plataformabrasil.saude.gov.br/login.jsf Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Drugs and Biologics 1. National Health Council (CNS): http://www.conselho.saude.gov.br/ 2. Brazilian Health Surveillance Agency (ANVISA): http://portal.anvisa.gov.br/english 3. Federal Council of Medicine (CFM): http://portal.cfm.org.br/ 4. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep Law Nº 9782/99 Defining the National Health Surveillance System: http://www.planalto.gov.br/ccivil_0 3/leis/L9782.htm 163 omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_446_- _2011_- Sobre_composio_da_CONEP.pdf 8. Resolution CNS No. 466/2012 on Guidelines and Rules for Research Involving humans Subjects: http://conselho.saude.gov.br/resoluco es/2012/466_english.pdf 9. Resolution CNS Nº 506/2016 Accreditation of CEP: http://conselho.saude.gov.br/resoluco es/2016/Reso_506.pdf 10. Resolution CNS No 563/2017 on Research Participant's Right in Ultra-rare Diseases: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_563_- _2017_- _Regulamenta_direito_participante_d e_pesquisa_com_doenas_ultrarraras.p df 11. Resolution CNS No 580/2018 on Research of Strategic Interest for the Unified Health System (SUS): http://conselho.saude.gov.br/resoluco es/2018/Reso580.pdf CNS: 1. Resolution CNS No. 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests: http://conselho.saude.gov.br/resoluco es/1997/Res251_en.pdf 2. Resolution CNS No. 301, 16th March 2002: Regarding Placebos: http://conselho.saude.gov.br/resoluco es/2000/Res301_en.pdf ANVISA: 1. Manual for Submission of “Drug Clinical Development Dossier” (DDCM) (2017): http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+para+Submiss%C3%A3o+de+ Dossi%C3%AA+de+Desenvolvimento+Cl%C 3%ADnico+de+Medicamento+%28DDCM%2 9+e+Dossi%C3%AA+Espec%C3%ADfico+de +Ensaio+Cl%C3%ADnico+- +3%C2%AA+edi%C3%A7%C3%A3o/29e9c5 b1-2942-4bb9-a4dd-4fccc6fccda3 2. Manual for Submission of Modifications, Amendments, Suspensions Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Clinical Trials Registry Research Injury Devices Brazilian Health Surveillance Agency (ANVISA): http://portal.anvisa.gov.br/english Brazilian Clinical Trials Registry: http://www.ensaiosclinicos.gov.br/ 1. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english ANVISA: Law Nº 6360/76: http://www.planalto.gov.br/ccivil_0 164 CFM: 1. Resolution CFM Nº 1.885, 2008 – about placebo: http://www.portalmedico.org.br/resol ucoes/cfm/2008/1885_2008.htm ANVISA: 1. Resolution ANVISA 09/15 - Regulations for Clinical Trials with Drugs: https://clinregs.niaid.nih.gov/docume nts/brazil/ResolutionNo9-English.pdf 2. Resolution RDC No. 9, 20 February 2015 Regarding Regulation for Realization of Clinical Trials of Medication in Brazil: https://clinregs.niaid.nih.gov/docume nts/brazil/ResolutionNo9-English.pdf 3. Resolution RDC No. 260, 21 December 2018: Regulation for Conducting Clinical Trials with Investigational Advanced Therapy Product in Brazil, and Makes Other Arrangements: http://portal.anvisa.gov.br/documents/ 10181/2718376/RDC_260_2018_.pdf /dd889184-bd4a-40ea-ae1c- b93155b20ea1 Resolution ANVISA 10/15 - Regulations for Clinical Trials with Medical Devices: http://pesquisa.in.gov.br/imprensa/jsp /visualiza/index.jsp?data=03/03/2015 &jornal=1&pagina=73&totalArquivo s=140 CNS/CONEP: 1. Standards Survey of New Drugs, Medicines, Vaccines, and and Cancellations on DDCM (2018): http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+Para+Submiss%C3%A3o+de+ Modifica%C3%A7%C3%B5es%2C+Emendas %2C+Suspens%C3%B5es+e+Cancelamentos+ - +4%C2%AA+edi%C3%A7%C3%A3o/85672f fa-db76-4869-b286-ff59bc3fcf60 ANVISA: Manual for Submission of Modifications, Amendments, Suspensions, and Cancellations on DICD (2015): http://portal.anvisa.gov.br/documents/33912/27 85629/Manual+Para+Submiss%C3%A3o+de+ Modifica%C3%A7%C3%B5es%2C+Emendas %2C+Suspens%C3%B5es+e+Cancelamentos/ 431fa7ef-24e6-4b14-80b9-ce68bccc24d8 FAQs: http://www.ensaiosclinicos.gov.br/assistance/fa q/ CNS/CONEP: Orientation of Adverse Event Reporting in Clinical Trials (008/2011): Country Key Organizations Legislation Regulations Guidelines Research Injury Social-Behavioral Research Privacy/Data Protection Human Biological Materials 2. National Health Council (CNS): http://www.conselho.saude.gov.br/ 3. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep 1. National Health Council (CNS): http://www.conselho.saude.gov.br/ 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep 3. Federal Council of Medicine (CFM): http://portal.cfm.org.br 1. National Health Council (CNS): http://www.conselho.saude.gov.br/ 2. National Commission on Research Ethics (CONEP): 3/leis/l6360.htm General Data Protection Law (2018): http://www.planalto.gov.br/ccivil_0 3/_Ato2015- 2018/2018/Lei/L13709.htm Ordinance No. 2.201/11: Establishing the National Guidelines for Biobanks of Human Biological Material for 165 Diagnostic Tests Involving Human Beings - Resolution CNS No. 251/97: http://conselho.saude.gov.br/resoluco es/1997/Res251_en.pdf 2. Resolution CNS No. 346/2005 on Multicenter Research: http://conselho.saude.gov.br/resoluco es/2005/Res346_en.pdf 3. Resolution MS/CNS No. 466/2012 - Guidelines and Rules for Research Involving Human Subjects: http://conselho.saude.gov.br/resoluco es/2012/466_english.pdf Resolution No. 510 of April 7, 2016: http://conselho.saude.gov.br/resoluco es/2016/Reso510.pdf CNS/CONEP: Circular Letter No. 039/2011 - Use of Medical Record Data for Research Purposes: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/CARTA S/CartaCircular039.pdf CFM: Resolution CFM Nº 1.821, 23 November 2007: http://www.portalmedico.org.br/resol ucoes/cfm/2007/1821_2007.htm CONEP: 1. Resolution CNS No. 441 of 12 May 2011: Storage of Human Biological Material or Use of http://conselho.saude.gov.br/images/comissoes/ conep/documentos/CARTAS/Carta_Circular_0 08.pdf ANVISA: 1. Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Drugs (2016): http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+para+Notifica%C3%A7%C3% A3o+de+Eventos+Adversos+e+Monitorament o+de+Seguran%C3%A7a+em+Ensaios+Cl%C 3%ADnicos+- +1%C2%AA+Edi%C3%A7%C3%A3o/04a68 574-8aac-43c9-b0b2-7b7cd80831c4 2. Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Medical Devices (2016): http://portal.anvisa.gov.br/documents/33912/27 85629/MANUAL+PARA+NOTIFICA%C3%8 7%C3%83O+DE+EVENTOS+ADVERSOS+E +MONITORAMENTO+DE+SEGURAN%C3 %87A+EM+ENSAIOS+CL%C3%8DNICOS+ ENVOLVENDO+DISPOSITIVOS+M%C3%8 9DICOS+EM+INVESTIGA%C3%87%C3%8 3O/df22b9ac-688d-4e6a-8207-faf862a05994 CONEP/CNS: Circular Letter No. 014/2014 - Regularization of biobanks: http://conselho.saude.gov.br/images/comissoes/ Country Key Organizations Legislation Regulations Guidelines Human Biological Materials http://conselho.saude.gov.br/comissoes- cns/conep 3. Ministry of Health (MS) – National Institute of Cancer (INCA): https://www.inca.gov.br/en 4. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english Research Purposes (2011): https://www.inca.gov.br/sites/ufu.sti .inca.local/files//media/document//p ortaria-ms-gm-2201-11.pdf Material Stored in Previous Research: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_441_- _2011_- _Armazenamento_de_Material_Biolg ico.pdf 2. Decree CNS No. 2201 of 14 Sep 2001 - The National Bio- Repository and Biobank Guideline: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Portaria_MS_n%C2 %BA_2.201_de_2011.pdf conep/documentos/CARTAS/CartaCircular014 .pdf Genetic Research 1. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep 2. National Biosafety Technical Commission (CTNBio): http://ctnbio.mcti.gov.br/inicio 3. National Health Council (CNS): http://www.conselho.saude.gov.br/ 1. Biosafety Law 11.105/05 (2005): http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/lei/l11105.htm 2. Decree No. 5,591, of November 22, 2005: http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/Decreto/D5591.htm 3. Law 13.123/2015 (2015): Brazilian Legislation on Biodiversity Access (Genetic Heritage): http://www.planalto.gov.br/ccivil_0 3/_Ato2015- 2018/2015/Lei/L13123.htm 4. Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015: http://www.planalto.gov.br/ccivil_0 166 ANVISA: Resolution – RDC No. 20 of 10 April 2014: http://www.saude.pr.gov.br/arquivos/ File/RDC_20_de_10_de_abril_2014_ Transporte_de_material_Biologico.pd f CTNBio: 1. Instruction CTNBio No. 8 of 9 July 1997: http://ctnbio.mcti.gov.br/instrucoes- normativas/- /asset_publisher/3dOuwS2h7LU6/con tent/instrucao-normativa-ctnbio- n%C2%BA-8-de-09-07-97 2. Instruction CTNBio No. 9 of 10 October 1997: http://www.agrobiobrasil.org.br/wp- content/uploads/2014/06/CTNBio- Normative-Instruction-n%C2%BA-9- of-October-10-1997.pdf CNS/CONEP: Resolution CNS No. 340/2004: On Research on Human Genetics (2004): http://conselho.saude.gov.br/resoluco es/2004/Res340_en.pdf CNS/CONEP: 1. Guidance to Researchers and Ethics Committees about the Item V.1.a of CNS Resolution 340 2004: http://conselho.saude.gov.br/images/comissoes/ conep/documentos/CARTAS/CartaCircular041 -15.pdf 2. Statement on Pharmacogenetic Studies in Brazil N/° 011/2012/CONEP, 12 January 2012: http://www.fcm.unicamp.br/fcm/sites/default/fi les/11_- _Comunicado_sobre_estudos_farmacogenetico s_no_Brasil.pdf Country Key Organizations Legislation Regulations Guidelines Genetic Research Embryos, Stem Cells, and Cloning Chile 1. National Biosafety Technical Commission: http://ctnbio.mcti.gov.br/inicio 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep 3. National Health Council (CNS): http://www.conselho.saude.gov.br/ 3/_ato2015- 2018/2016/decreto/D8772.htm 1. Biosafety Law 11.105/05 (2005): http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/lei/l11105.htm 2. Decree No. 5,591, of November 22, 2005: http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/Decreto/D5591.htm ANVISA: 1. Resolution RDC No. 9, 14 March 2011: http://bvsms.saude.gov.br/bvs/saudele gis/anvisa/2011/prt0009_14_03_2011 .html 2. Resolution RDC No. 29, 12 May 2008: http://bvsms.saude.gov.br/bvs/saudele gis/anvisa/2008/rdc0029_12_05_200 8.html 3. Resolution RDC No.260, 21 December 2018: Regulation for Conducting Clinical Trials with Investigational Advanced Therapy Product in Brazil, and Makes Other Arrangements: http://portal.anvisa.gov.br/documents/ 10181/2718376/RDC_260_2018_.pdf /dd889184-bd4a-40ea-ae1c- b93155b20ea1 Note: All websites and documents are in Spanish. General 1. Ministry of Health: http://www.minsal.cl 2. Institute of Public Health: http://www.ispch.cl 1. Law No. 20.120 Regarding Scientific Research in Human Beings, their Genome, and the Prohibition of Human Cloning (2006): http://www.leychile.cl/Navegar?idN orma=253478 2. Law No. 20584. Regulating the Rights and Duties Incumbent upon Persons in Connection with Actions Linked to their Health Care (2012): http://www.leychile.cl/Navegar?idN orma=1039348 3. Law No. 20.724 Modifying the Health Code in the Area of the Regulation of Pharmacies and Medications (2014): http://www.leychile.cl/Navegar?idN orma=1058373 1. Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo rma=1032919 2. Supreme Decree Nº 30/2013 Regulation on Law Nº20.120 Modifying Supreme decree Nº114/2010, Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning Official Diary January 14, 2013: http://www.leychile.cl/Navegar?idNo rma=1048008& 167 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury 1. Ministry of Health : http://www.minsal.cl 2. Institute of Public Health: http://www.ispch.cl 1. Ministry of Health: http://www.minsal.cl 2. Institute of Public Health: http://www.ispch.cl Law No. 20.724 Modifying the Health Code in the Area of the Regulation of Pharmacies and Medications (2014): http://www.leychile.cl/Navegar?idN orma=1058373 Law No. 20.120 Regarding Scientific Research in Human Beings, their Genome, and the Prohibition of Human Cloning (2006): http://www.leychile.cl/Navegar?idN orma=253478 168 1. Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo rma=1032919 2. Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use. Official Diary of June 25, 2011: http://www.ispch.cl/ley20285/t_activ a/marco_normativo/7c/ds_minsal_3_ 2010.pdf 3. Exempt Resolution 2263, July 30th 2015 Modifying Resolution Nº 403 Ex. February 5, 2015 that Approves the Guidelines for Use Control of Pharmaceuticals Products in Scientific Research: http://www.leychile.cl/Navegar?i dNorma=1080011 1. Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use. Official Diary of Jun 25, 2011: http://www.ispch.cl/ley20285/t_activ a/marco_normativo/7c/ds_minsal_3_ 2010.pdf 2. General Technical Rule No. 140 Regarding the National System of Pharmacovigilance of Pharmaceutical Products for Human Use. June 20, 2012: http://web.minsal.cl/portal/url/item/c4 a31ad6db50e085e040010165017a39. pdf 3. Resolution No. 441, Notification of Adverse events in Clinical Research in Chile, February13, 2012: Country Key Organizations Legislation Regulations Guidelines Research Injury Privacy/Data Protection Genetic Research Embryos, Stem Cells, and Cloning Colombia 1. Ministry of Health: http://www.minsal.cl 2. Ministry of the Secretary General of the Government: http://www.msgg.gob.cl Ministry of Health: http://www.minsal.cl Ministry of Health: http://www.minsal.cl 1. Law for the Protection of Private Life No. 19.628 (1999): http://www.bcn.cl/leyes/141599 2. Law No. 20584. Regulating the Rights and Duties Incumbent upon Persons in Connection with Actions Linked to their Health Care (2012): http://www.leychile.cl/Navegar?idN orma=1039348 Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006): http://www.leychile.cl./Navegar?id Norma=253478 Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006): http://www.leychile.cl./Navegar?id Norma=253478 http://www.ispch.cl/sites/default/files/ res_441.pdf Supreme Decree No. 41 of 2012: Regulation Regarding Clinical Records of December 15, 2012: http://www.leychile.cl/Navegar?idNo rma=1046753 Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo rma=1032919 Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo rma=1032919 Note: All websites and documents are in Spanish. General 1. Ministry of Health and Social Protection: http://www.minsalud.gov.co 2. National Institute of Drug and Food Surveillance (INVIMA): https://www.invima.gov.co/ 3. Administrative Department of Science, Technology, and Innovation (COLCIENCIAS): http://www.colciencias.gov.co/ 169 Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 8430 (1993): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF INVIMA: 1. Guide for Research Ethics Committees. Code: ASS-RSA-GU040 Version: 00 (2015): https://www.invima.gov.co/documents/20143/4 53029/ASS-RSA-GU040.pdf/96ea752d-2639- 3024-4287- 4527589fb26b?version=1.0&t=155050830781 4 2. Guide for Assessing and Monitoring of Research Protocols. Code: ASS-RSA- GU039 Version: 03 (2018): https://www.invima.gov.co/documents/20143/1 Country Key Organizations Legislation Regulations Guidelines General 208783/Gui%CC%81a+para+la+evaluacio%C C%81n+y+seguimiento+de+protocolos+de+in vestigacio%CC%81n+ASS-RSA- GU039v1.pdf/004a03e7-ee7d-9fe0-89af- 55a43de7a37d?version=1.0&t=156079110732 6 3. Guide for the Presentation of Amendments, New Centers, New Researchers, and Informed Consent of Research Protocols. Version: 01 2018: https://www.invima.gov.co/documents/20143/4 53029/ASS-RSA-GU031.pdf/2130f364-0b2a- 8af3-7672- e9f5e89b6217?version=1.0&t=1540842235665 Drugs, Biologics, and Devices Drugs National Institute of Drug and Food Surveillance (INVIMA): http://www.invima.gov.co/ 170 1. Resolution No. 2378 of 2008, Adapting Good Clinical Practices for Institutions that Conduct Research with Medicines in Human Beings: https://www.invima.gov.co/document s/20143/1024715/RESOLUCION+N o+2378+DE+2008.pdf/e71f5227- 68fe-a85b-bb5c- fae31a5254ff?version=1.0&t=155495 5058893 2. Resolution No. 2011020764 of June 10th, 2011: Regulation Related to the Content and Frequency of Adverse Event Reports in Clinical Investigation in Humans: https://www.invima.gov.co/document s/20143/453029/Resoluci%C3%B3n+ 2011020764+de+2011.pdf/e4d84d9e- 3df4-8155-0eef- f50d81e621f4?version=1.0&t=15408 30094266 COLCIENCIAS: Policy on Ethical Research, Bioethics, and Scientific Integrity (2018): http://www.colciencias.gov.co/sites/default/file s/ckeditor_files/PDF%20Pol%C3%ADtica.pdf 1. ABC Good Clinical Practice (2009) https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/ABCBPCultima_ver sion.pdf 2. Circular No 600-5776-14: Processes of Good Clinical Practice (2014): https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/normatividad/CIRC ULAR_600-5776-14-2.pdf 3. Guide of Medications and Supplies for Clinical Research, Version 1 (2018): https://www.invima.gov.co/images/stories/for matotramite/ASS-RSA-GU045.pdf 4. Guide for the Evaluation and Follow-up of Research Protocols, Version 3 (2018): https://www.invima.gov.co/images/stories/for matotramite/ASS-RSA-GU039.pdf 5. External Circular No. 600-2006-16: National Reporting Serious Adverse Events (2016): https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/normatividad/Circula r-600-1081-16-Reporte-de-Eventos-adversos- serios-Nacionales-Febrero2016.pdf 6. External Circular No. 600-1414-16: Notification of Deviations (2016): Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials Devices National Institute of Drug and Food Surveillance: http://www.invima.gov.co/ Ministry of Health and Social Protection: http://www.minsalud.gov.co Ministry of Health and Social Protection: http://www.minsalud.gov.co Ministry of Health and Social Protection: http://www.minsalud.gov.co 1. Constitution of Colombia, Article 15 (2003): http://www.corteconstitucional.gov. co/inicio/Constitucion%20politica% 20de%20Colombia%20- %202015.pdf 2. Law 1581 of 2012: General Regimen of Protection of Personal Data: https://www.mintic.gov.co/portal/60 4/articles-4274_documento.pdf 171 Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title III, Chapters I and III (1993): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter I, Art. 13 (1993): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter I, Article 8 (1993) 1. Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter VI (1993): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF 2. Requirements for the Use of Unclaimed Cadavers for Research Purposes, Resolution No. 002640, https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/normatividad/Circula r_600-2006-16_Alcance-Circular-600-1081- 16_Abril2016.pdf Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Genetic Research Costa Rica Ministry of Health and Social Protection: http://www.minsalud.gov.co Article 21 (2005): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/Resolución_2640_de_2005.pdf Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title III, Chapter II (1993): https://www.minsalud.gov.co/sites/rid /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF Note: All websites and documents are in Spanish. General Ministry of Health: http://www.misalud.go.cr Reform Regulation to the Biomedical Research Regulatory Law: http://www.pgrweb.go.cr/scij/Busque da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor 1=1&nValor2=81213&nValor3=103 450&strTipM=TC Drugs, Biologics, and Devices Clinical Trials Registry National Health Research Council: http://www.ministeriodesalud.go.cr/index. php/consejos/conis National Health Research Council (Spanish): http://www.ministeriodesalud.go.cr/index. php/consejos/conis (scroll to bottom of page to Investigaciones Registradas) Regulatory Law of Biomedical Research No. 9234 (2014): http://www.pgrweb.go.cr/scij/Busqu eda/Normativa/Normas/nrm_texto_ completo.aspx?param1=NRTC&nV alor1=1&nValor2=77070&nValor3 =96424&strTipM=TC 172 1. Regulatory Decree N° 39061-S (2016) on the Regulatory Law of Biomedical Research N° 39533- S: http://www.pgrweb.go.cr/scij/Busque da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor 1=1&nValor2=81213&nValor3=103 450&strTipM=TC 2. Reforms to the Regulatory Decree No. 39533-S (2016) Regulatory Law of Biomedical Research No. 9234: http://www.pgrweb.go.cr/scij/Busque da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor 1=1&nValor2=81213&nValor3=103 450&strTipM=TC Various: http://www.ministeriodesalud.go.cr/index.php/ consejos/conis Country Key Organizations Legislation Regulations Guidelines Cuba Note: All websites and documents are in Spanish. Drugs, Biologics, and Devices Clinical Trials Registry Dominica General Center for State Control of Medications: http://www.cecmed.cu/ Public Cuban Registry of Clinical Trials: http://registroclinico.sld.cu/en/home Ministry of Health: http://www.dominica.gov.dm/cms/index.p hp?q=node/21 Various: http://www.cecmed.cu/ensayos- clinicos/autorizos Guidelines for the Conduct of Research on Human Subjects (2005) Dominican Republic General National Council on Health Bioethics: http://conabios.gob.do/ National Health Law 42-01, Chapter VI: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf Regulation for Evaluation Request for a Clinical Investigation Project: http://conabios.gob.do/index.php/regl amentos Biological Materials Ecuador Note: All websites and documents are in Spanish. National Health Law 42-01, Book Five: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf General Ministry of Public Health : http://www.salud.gob.ec/ 1. Constitution of the Republic: http://www.asambleanacional.gob.e c/sites/default/files/documents/old/c onstitucion_de_bolsillo.pdf 2. Organic Health Law of 22 December 2006, Articles 207- 208 (2018) 3. Code on Childhood and Adolescence. Law 100 Official Register 737 of January 3, 2003 (2019) 173 1. Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292 (March 11, 2008): https://www.controlsanitario.gob.ec/ wp- content/uploads/downloads/2017/01/ A.M.-66-REGLAMENTO-DE- PROYECTOS-EN- INVESTIGACION-DE-SALUD.pdf 2. Regulation for the Approval of Ethics Committees (2014): https://www.salud.gob.ec/aprobac ion-de-comites-de-etica/ 4. Regulation on Health Research Ethics Committees (2014): https://www.controlsanitario.gob.ec/ wp- content/uploads/downloads/2016/12/ A-4889-Reglamento-para-la- aprobaci%C3%B3n-y-seguimiento- 1. National Policy on Scientific Research. Ministerial Agreement 209, Public Registry No. 87 of August 23, 2005 2. Approval of Ethics Committees: https://www.salud.gob.ec/aprobacion-de- comites-de-etica/ 3. Approval of Health Research: https://www.salud.gob.ec/autorizacion-de- investigaciones-en-salud/ Country Key Organizations Legislation Regulations Guidelines de-CEISH-y-CEAS-L.pdf Drugs, Biologics, and Devices Privacy/Data Protection Biological Materials 1. Ministry of Public Health: http://www.salud.gob.ec/ 2. National Health Agency for Regulation, Control, and Oversight: http://www.controlsanitario.gob.ec/ensayo s-clinicos/ Ministry of Public Health: http://www.salud.gob.ec/ National Institute on Donation and Transplantation of Organs, Tissues, and Cells: http://www.donaciontrasplante.gob.ec/ind ot/ Constitution of the Republic of Ecuador 2008 (Article: 92): http://www.asambleanacional.gob.e c/sites/default/files/documents/old/c onstitucion_de_bolsillo.pdf 1. Organic Health Law of December 22, 2006, Articles 81- 86 (2018) 2. Organic Law on the Donation and Transplantation of Organs, Tissues, and Cells (2017) 174 1. Regulation for the Approval, Development, Oversight, and Control of Clinical Trials (2017): http://www.controlsanitario.gob.e c/wp- content/uploads/downloads/2017/ 08/Normativa-Ensayos- Cli%CC%81nicos-Registro- Oficial.pdf 2. Regulation for the Approval of Ethics Committees (2014): http://instituciones.msp.gob.ec/i mages/Documentos/CNBS/1%20 normativa/Registro%20Oficial% 20Comites%20de%20Etica%20j ulio%202014.pdf 3. Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292 (March 11, 2008): https://www.controlsanitario.gob. ec/wp- content/uploads/downloads/2017/ 01/A.M.-66-REGLAMENTO- DE-PROYECTOS-EN- INVESTIGACION-DE- SALUD.pdf Ministerial Agreement No. 005216, Public Registry No. 427, Confidential Information in National Health System (January, 29, 2015): http://instituciones.msp.gob.ec/cz6/im ages/lotaip/Enero2015/Acuerdo%20 Ministerial%205216.pdf 1. Executive Order 1205, July 13, 2012: Regulation for the Organic Law on the Donation and Transplantation of Organs, Tissues, and Cells: http://181.211.7.45/legal_sis_v2/f iles/externa/Reglamento_General _a_la_Ley_Organica_Donacion_ y_Trasplantes.pdf 2. Import and Export of Human Biological Samples for research. Approval of Clinical Trials: https://www.controlsanitario.gob.ec/ensayos- clinicos/ Country Key Organizations Legislation Regulations Guidelines Biological Materials Genetic Research Embryos, Stem Cells, and Cloning El Salvador General Ministry of Public Health: http://www.salud.gob.ec/ 1. Ministry of Public Health: http://www.salud.gob.ec/ 2. National Institute of Donation and Transplantation of Organs, Tissues, and Cells: http://www.donaciontrasplante.gob.ec/ind ot/ National Health Research Ethics Committee: http://www.cneis.org.sv/ Organic Health Law, December 22, 2006, Articles 209-210 (2011) Organic Health Law of 22 December 2006, Article 214 (2018) 1. Law on Duties and Rights of Patients and Healthcare Providers, Articles 9 and 16 (2016): https://www.asamblea.gob.sv/sites/d efault/files/documents/decretos/171 117_073651293_archivo_document o_legislativo.pdf 2. Law on the Comprehensive Protection of Childhood and Adolescence, Article 19 (2009): https://www.asamblea.gob.sv/sites/d 175 Ministerial Agreement No. 0088, Public Registry No. 34, (July 12, 2017): http://www.controlsanitario.gob.ec/w p- content/uploads/downloads/2017/08/ Acuerdo-Ministerial-0088- 2017_Autorizaci%C3%B3n-de- importaci%C3%B3n-y- exportaci%C3%B3n-de-muestras- biol%C3%B3gicas.pdf 4. External Instruction Authorization of Import and Export of Human Biological Samples for Research and Health Care Purposes: https://www.controlsanitario.gob.ec/ wp- content/uploads/downloads/2017/10/I E-B.3.3.2-EC-01-Instructivo- Externo-Autorizaci%C3%B3n- Muestras-Biol%C3%B3gicas..pdf Regulation for the Organic Law on the Donation and Transplantation of Organs, Tissues, and Cells. Executive Order 1205, July 13, 2012: http://181.211.7.45/legal_sis_v2/files/e xterna/Reglamento_General_a_la_Ley _Organica_Donacion_y_Trasplantes.p df Regulation on the Law on Duties and Rights of Patients and Healthcare Providers, Article 12 (2018): http://cssp.gob.sv/wp- content/uploads/2016/05/Reglamento -de-la-ley-de-Deberes-y-Derechos- de-los-Pacientes-y-prestadores-de- Servicios-de-Salud.pdf 1. Standard Operating Procedures for the Ethical Evaluation of Health Research (2015): http://cssp.gob.sv/wp- content/uploads/2016/06/MANUAL-CNEIS- 2017-03-15.pdf 2. Manual on the Functioning of the National Health Research Ethics Committee (2017): http://cssp.gob.sv/wp- content/uploads/2016/06/manual_funcionamien to_comite_nacional_etica_investigacion_en_sa lud.pdf Country Key Organizations Legislation Regulations Guidelines General Drugs and Devices Grenada General Guyana General Guatemala National Directorate of Medications: http://www.medicamentos.gob.sv/index.p hp/es/ St. George’s University/Windward Islands Research and Education Foundation: http://www.sgu.edu/school-of- medicine/institutional-review-board.html efault/files/documents/decretos/F31 2B814-45C5-48EB-A71D- 0DFC612FF135.pdf 3. Law on the Integrated National System of Health, Article 28 (2019): https://www.diariooficial.gob.sv/dia rios/do-2019/05-mayo/17-05- 2019.pdf Medication Law, Articles 29 and 66 (2012): https://www.asamblea.gob.sv/sites/d efault/files/documents/decretos/171 117_073104135_archivo_document o_legislativo.pdf Medical Research Involving Human Subjects Regulations (2007) User’s Guide for the Application of Clinical Investigation Protocols: http://www.medicamentos.gob.sv/index.php/es/ servicios-m/descargables/ensayos-clinicos 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guida nce/45cfr46.html Note: All websites and documents are in Spanish. General Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/ 1. Regulation on Clinical Research on Humans (2015) 2. Internal Regulations of the National Committee on Health Ethics (2018): http://www.mspas.gob.gt/images/files /acuerdosministeriales/2018/Acuerdo Ministerial1392018NormativaCNES. pdf Drugs, Biologics, and Devices Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/ 176 1. Governmental Agreement 712- 99, Articles 91-94 (1999): http://asisehace.gt/media/ag_712_99. pdf 2. Rules for the Regulation of Human Clinical Trials. Ministerial Accord 82-2019: https://medicamentos.mspas.gob.gt/p hocadownload/Acuerdo%20Ministeri Drug Surveillance -- Clinical Trials: http://www.mspas.gob.gt/index.php/servicios/f armacovigilancia Country Key Organizations Legislation Regulations Guidelines al%2082-2019.pdf Haiti General Ministry of Public Health and Population: http://mspp.gouv.ht/newsite/ Internal Regulations (2010) Honduras Note: All websites and documents are in Spanish. General Secretariat of Health: http://www.salud.gob.hn/ Code, Decree No. 65-91, Articles 175 and 176 (1996): https://www.acnur.org/fileadmin/Do cumentos/BDL/2016/10636.pdf Health Code, Decree No. 65-91, Articles 175 and 176 Drugs, Biologics, and Devices Human Biological Materials Embryos, Stem Cells, and Cloning Jamaica General Drugs, Biologics, and Devices México Secretariat of Health: http://www.salud.gob.hn/ Ministry of Health, Ethics and Medico-Legal Affairs Panel: http://moh.gov.jm/ Ministry of Health, Standards and Regulation Division: http://moh.gov.jm/divisions- agencies/divisions/standards-and- regulation-division/ Law of Donation and Transplantation of Anatomical Organs in Human Beings (2014): http://www.tsc.gob.hn/leyes/Ley_do nacion_transp_organos_2014.pdf n. 329-2013 Penal Code Decree No. 130- 2017 (2019): https://criterio.hn/wp- content/uploads/2019/05/C%C3 %B3digo-Penal-1.pdf Food and Drugs Act (1975): http://www.moj.gov.jm/sites/default /files/laws/Food%20and%20Drugs %20Act%20LN%2065%20of%207 5.pdf Regulation for the Health Control of Products, Services, and Health Establishments (2015): https://honduras.eregulations.org/med ia/Acuerdo-06-2005- REGLAMENTO-PARA-EL- CONTROL-SANITARIO.pdf Food and Drugs Regulations (1975): http://www.moj.gov.jm/sites/default/f iles/laws/Food%20and%20Drugs%20 Act%20LN%2065%20of%2075.pdf Ministry of Health Guidelines for the Conduct of Research on Human Subjects (2010): http://moh.gov.jm/guidelines/guidelines-for- the-conduct-of-research-on-human-subjects/ Note: All websites and documents are in Spanish. General 1. Secretariat of Health: https://www.gob.mx/salud 2. General Health Council: General Health Law, Title V, Chapter 1, Articles 96-103: 177 1. Rule NOM-012-SSA3-2012 Establishing Criteria for the CONBIOETICA: National Guidelines on the Composition Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Privacy/Data Protection Human Biological Materials Genetic Research http://www.csg.gob.mx/ 3. National Bioethics Commission (CONBIOETICA): https://www.gob.mx/salud/conbioetica 4. Federal Commission for Protection Against Health Risks (COFEPRIS): https://www.gob.mx/cofepris Federal Commission for Protection Against Health Risks (COFEPRIS): https://www.gob.mx/cofepris Federal Institute on Access to Public Information: www.inai.org.mx/ Secretariat of Health: https://www.gob.mx/salud National Institute of Genomic Medicine: http://www.inmegen.gob.mx/ Health Research (2018): http://www.diputados.gob.mx/Leyes Biblio/pdf/142_241218.pdf General Health Law, Title V, Chapter I, Articles 96-103: Health Research (2014) 1. Federal Law for the Protection of Personal Data in the Possession of Private Individuals (2017): http://www.dof.gob.mx/nota_detalle .php?codigo=5469949&fecha=26/0 1/2017 2. Federal Law on Transparency and Access to Public Information (2017): http://www.diputados.gob.mx/Leyes Biblio/pdf/LFTAIP_270117.pdf General Health Law, Title XIV, Articles 313-342 (2018): http://www.salud.gob.mx/unidades/ cdi/legis/lgs/index-t14.htm 1. Biosafety Law on Genetically Modified Organisms (2017): http://www.dof.gob.mx/nota_detalle .php?codigo=5468449&fecha=03/0 1/2017 178 Conduct of Health Research Projects (2013): http://www.salud.gob.mx/unidades/cd i/nom/compi/rlgsmpsam.html 2. Regulation on the General Health Law in the Matter of Health Research (2014): http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LGS_MIS.pdf Regulation on the General Health Law in the Matter of Health Research (2014): http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LGS_MIS.pdf Regulation of the General Law of Health in Matter of Transplants (2014): http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LGS_MT.pdf Regulation on the General Health Law in the Matter of Health Research, Title Four, Chapter Two (2014): http://www.diputados.gob.mx/Leyes and Functioning of Research Ethics Committees (2018): https://www.gob.mx/cms/uploads/attachment/fi le/460756/7_Guia_CEI_2018_6a.pdf 1. Guidelines to Fulfill Good Clinical Practice in Health Research (2012): http://www.imss.gob.mx/sites/all/statics/profesi onalesSalud/investigacionSalud/normativaNac/ 6_Lineamientos_BPC.pdf 2. Guide for the Submission of Human Research Protocols – Observational Studies (2016) 3. Guide for the Submission of Human Research Protocol Amendments – Requirements for Applicant Information Changes (2016): https://www.gob.mx/cms/uploads/attachment/fi le/149028/Gu_a_de_Sometimiento_COFEPRI S-09-012_MODIFICACI_N.pdf Country Key Organizations Legislation Regulations Guidelines Genetic Research Nicaragua Note: All websites and documents are in Spanish. 1. Ministry of Health (MINSA) Nicaragua: http://www.minsa.gob.ni 2. Institutional Ethical Review Committee (CIRE) Panamá Note: All websites and documents are in Spanish. 2. Regulation of the Biosafety Law on Genetically Modified Organisms (2009) http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LBOGM.pdf 3. Modifications to the General Health Law to Protect Genomic Sovereignty (2008) 4. Modifications to the General Health Law to Protect Genomic Sovereignty (2008) Ley General de Salud, No 423 Republica de Nicaragua: http://www.vertic.org/media/Nation al%20Legislation/Nicaragua/NI_Le y_423_General_de_Salud_2002.pdf Biblio/regley/Reg_LGS_MIS.pdf General Drugs, Biologics, and Devices Privacy/Data Protection 1. Ministry of Health (MINSA): http://www.minsa.gob.pa/ 2. National Committee of Research Bioethics: https://cnbi.senacyt.gob.pa Law Nº 84 on Research with Human Beings (2019): https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Ley-N°84- del-14-de-mayo-de-2019-Ley-de- investigación.pdf Law 1 of 2001, Official Gazette 24,218: http://www.perezcarrera.com/leyes/l ey-registro-sanitario-panama.pdf 1. Law Nº 68, November 20, 2003: https://cnbi.senacyt.gob.pa/wp- 179 MINSA: 1. Executive Decree Nº1, January 21, 2013: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto- Ejecutivo-N°1-del-21-de-Enero- de-2013.pdf 2. Executive Decree N°1843 on the National Research Ethics Committee of Panama (2014): https://www.gacetaoficial.gob.pa/.../G acetaNo_27716_20150206.pdf 3. Executive Decree N° 6 on the National Research Ethics Committee of Panama (2015): https://www.gacetaoficial.gob.pa/pdf Temp/27716/GacetaNo_27716_2015 0206.pdf Executive Directive No. 1458 of 6 November 2012: https://www.gacetaoficial.gob.pa/pdf Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Human Biological Materials Embryos, Stem Cells, and Cloning Paraguay Note: All websites and documents are in Spanish. content/uploads/2019/07/Ley-68- del-20-de-noviembre-de-2003.pdf 2. Law Nº81, March 26, 2019: https://www.gacetaoficial.gob.pa/pd fTemp/28743_A/GacetaNo_28743a _20190329.pdf Law 3 of 2010, Official Gazette 26,468-B on Transplant of Organs and Tissues: https://www.gacetaoficial.gob.pa/pd fTemp/26468_B/GacetaNo_26468b _20100210.pdf Law No. 3, 15 January 2004: https://docs.panama.justia.com/fede rales/leyes/3-de-2004-jan-19- 2004.pdf Temp/27160_A/39630.pdf Executive Directive No. 179 of 8 June 2018: https://www.gacetaoficial.gob.pa/pdf Temp/28546_A/68013.pdf Executive Decree Nº179, June 8, 2018: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto-Ejecutivo- N°-179-del-8-de-junio-de-2018.pdf General Drugs, Biologics, and Devices Perú National Institute of Health, Research Ethics Committee: http://www.ins.gov.py/ Ministry of Public Health and Social Welfare: https://www.mspbs.gov.py/index.php Law 1119/97 Regarding Health Products and Other Products, Article 30: https://www.mspbs.gov.py/depende ncias/dnvs/adjunto/1d0e83- LEYN11191997DEPRODUCTOSP ARALASALUDYOTROS.pdf Statute and Operating Procedures (2017) (Spanish): https://www.mspbs.gov.py/dependen cias/cnbioetica/adjunto/a03ba4- CEIINS.VersionFinal.pdf For an overview of clinical research regulations in Peru, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=170 General Drugs, Biologics, and Devices National Institute of Health: http://www.ins.gob.pe/ 1. National Institute of Health (INS) General Office on Research and Technology Transfer (OGITT): http://www.ins.gob.pe/ 2. National Directorate of Drugs and Medical Devices (MINSA): www.digemid.minsa.gob.pe General Health Law No. 26842, Article 28 (1997): https://www.gob.pe/institucion/mins a/normas-legales/256661-26842 180 INS: Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials (2017): https://www.gob.pe/institucion/minsa /normas-legales/189280-021-2017-sa 2. Errata - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (2017): https://busquedas.elperuano.pe/norma OGITT: Procedures Manual for Clinical Trials (2017) Country Key Organizations Legislation Regulations Guidelines Privacy/Data Protection Clinical Trials Registry Research Injury Privacy/Data Protection Saint Lucia Drugs, Biologics, and Devices Peruvian Registry of Clinical Trials: http://www.ensayosclinicos- repec.ins.gob.pe/en/about-repec/clinical- trial-search National Institute of Health: http://www.ins.gob.pe/ National Directorate of Drugs and Medical Devices: www.digemid.minsa.gob.pe 1. Law 29733 for the Protection of Personal Information (2011): http://www.minjus.gob.pe/legislacio n/ 2. Law for Electronic Medical Charts (2013): http://elperuanolegal.blogspot.com/ 2013/05/ley-30024-ley-que-crea-el- registro.html Clinical Trials Act (2016): http://slugovprintery.com/template/f iles/document_for_sale/laws/3742/ Act%2010%20of%202016.pdf slegales/-fe-de-errata-ds-n-021-2017- sa-1542992-1/ MINSA: Ministerial Resolution N° 655- 2019/MINSA (2019): https://www.gob.pe/institucion/minsa /normas-legales/286523-655-2019- minsa Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials, Articles 102-103 (2017): https://www.gob.pe/institucion/minsa /normas-legales/189280-021-2017-sa Regulation on Clinical Trials in Peru: Articles 27-29: http://www.ins.gob.pe/portal/jerarqui a/2/990/reglamento-de-ensayos- clinicos/jer.990 1. Supreme Decree No. 003- 2013-JUS, Regulation of Law No. 29733 for the protection of personal information (2013): https://www.minjus.gob.pe/wp- content/uploads/2013/04/DS-3-2013- JUS.REGLAMENTO.LPDP_.pdf 2. Supreme Decree No. 009-2017- SA, Regulation of Law No. 30024 for Electronic Medical Charts (2017): https://busquedas.elperuano.pe/norma slegales/aprueban-el-reglamento-de- la-ley-n-30024-ley-que-crea-el-r- decreto-supremo-n-009-2017-sa- 1500555-3/ Trinidad and Tobago 1. Ministry of Health http://www.health.gov.tt/ 2. University of the West Indies (UWI), St. Augustine: https://sta.uwi.edu/research/ethics.asp 181 UWI: 1. UWI Policy on Research Ethics 2. Application Guidelines 3. Ethics Committee Protocols Country Key Organizations Legislation Regulations Guidelines Trinidad and Tobago Uruguay Note: All websites and documents are in Spanish. Access: https://sta.uwi.edu/research/ethics.asp General Drugs, Biologics, and Devices Research Injury Privacy/Data Protection Human Biological Materials Venezuela Ministry of Public Health: http://www.msp.gub.uy/ Ministry of Public Health: http://www.msp.gub.uy/ Ministry of Public Health: http://www.msp.gub.uy/ Ministry of Public Health: http://www.msp.gub.uy/ 1. Ministry of Public Health: http://www.msp.gub.uy/ 2. National Institute on Donation and Transplantation: www.indt.edu.uy 1. Decree 189/998 http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/ GMC_RES_1996- 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF 2. Decree 379/008: http://www.elderechodigital.com.uy /smu/legisla/D0800379.html Decree 189/998: http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/ GMC_RES_1996- 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF 1. Decree 189/998 http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/ GMC_RES_1996- 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF 2. Decree 379/008: http://www.elderechodigital.com.uy /smu/legisla/D0800379.html 1. Law 18.331: http://www0.parlamento.gub.uy/ley es/AccesoTextoLey.asp?Ley=18331 2. Decree 379/008: http://www.elderechodigital.com.uy /smu/legisla/D0800379.html Decree 160/006: http://www.indt.edu.uy/documentos /documentacion_legal/decreto_160- 006.pdf Decree No. 370/2008: Regulation Concerning Research with Humans Note: All websites and documents are in Spanish. General 1. National Fund on Science and Technology, Commission on Bioethics and Biosecurity (FONACIT): www.fonacit.gov.ve/ 2. Venezuelan Institute of Scientific Research, Bioethics Commission Constitution, Article 46 (3): http://www.venezuelaemb.or.kr/eng lish/ConstitutionoftheBolivarianingl es.pdf 182 Resolution No. 48 (1998): http://www.ivic.gob.ve/bioetica/?mod =bioeticahome.php FONACIT: Code on Bioethics and Biosecurity (2002) IVIC: 1. Annex 1: General Ethical Issues in Research Involving Living Persons: Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Genetic Research (IVIC): http://www.ivic.gob.ve/bioetica/?mod=ho me.php National Institute of Hygiene “Rafael Rangel”: http://www.inhrr.gob.ve/ Venezuelan Institute of Scientific Research, Bioethics Commission: http://www.ivic.gob.ve/bioetica/?mod=ho me.php Medicines Act, Title III, Chapter II: http://www.ginecoweb.com/PDF/Le y-del-Ejercicio-de-la-Medicina.pdf http://www.ivic.gob.ve/bioetica/?mod=Anexo. php 2. Annex 2: Necessity of Establishing a Clear and Precise Study Protocol Before Starting Research: http://www.ivic.gob.ve/bioetica/?mod=Anexo. php 3. Informed Consent: http://www.ivic.gob.ve/bioetica/?mod=manual. php 1. Contract for Accessing Genetic Resources (2003): http://www.ivic.gob.ve/bioetica/contrato.pdf 2. Revised Outline of the International Declaration of Human Genetic Data (2003): http://www.ivic.gob.ve/bioetica/chapter3.pdf 183 Country Key Organizations Legislation Regulations Guidelines AFRICA Regionwide Clinical Trials Registry Algeria Drugs, Biologics, and Devices Benin General Botswana General Pan African Clinical Trials Registry: http://www.pactr.org/ Directorate of Pharmacy and Medicine: http://www.ands.dz/ Ministry of Health, Research and Development Committee: http://www.moh.gov.bw/ Law No. 2010-40 of 8 December, 2010 Regarding the Ethical Code and Duties in Health Research in the Republic of Benin: http://ethique- sante.org/pdf/loi-portant-code- ethique.pdf Anthropological Research Act 45 (1967): http://www.elaws.gov.bw/docs/statu tes/Botswana%20Statute%20Law% 201967.pdf 184 1. Order No. 387 of July 31, 2006 Regarding Clinical Trials: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2 %B0387-388_31_juil_2006.pdf 2. Order No. 00200 of July 25, 2009 Modifying Order No. 112 of October 22, 1995 Establishing Rules on Good Clinical Practice: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2 %B0200%20_25_Juil_2009.pdf 1. Order No. 387 of 31 July 2006 Relating to Clinical Trials: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2 %B0387-388_31_juil_2006.pdf 2. Order No. 00200 of 25 July 2009 Amending Order No. 112 of 22 October 1995 Setting the Rules of Good Clinical Practice: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2 %B0200%20_25_Juil_2009.pdf FAQs: http://www.pactr.org/ATMWeb/appmanager/at m/atmregistry?_nfpb=true&_pageLabel=atmpo rtal_page_FAQ 1. Guidelines for Application for Research Permit (2004): http://www.gov.bw/Global/OP%20Ministry/R ESEARCH%20PERMIT%20GUIDELINES.pd f 2. Guide for a Consent Form (2005) 3. Guidelines for the Review of Research Proposals (2005) Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Social-Behavioral Research Burkina Faso Ministry of Health, Drug Regulatory Unit: http://www.moh.gov.bw/ Ministry of Health and Wellness, Research and Development Committee Anthropological Research Act 45 (1967): http://webcache.googleusercontent.c om/search?q=cache:A7aea2ZEMhk J:static1.1.sqspcdn.com/static/f/723 732/25889598/1422112465653/ch5 9- 02%2BANTHROPOLOGICAL%2 BRESEARCH.pdf%3Ftoken%3DT SMJNydkWHdUJ7iPvvm7Qkzk4u U%253D+&cd=1&hl=en&ct=clnk &gl=us Drugs and Related Substances Regulations (1993) 1. SADC Guidelines for Regulating Clinical Trials in Human Subjects (2006) 2. Guideline for Regulating the Conduct of Clinical Trials Using Medicines in Human Participants (2012): http://www.moh.gov.bw/Publications/drug_reg ulation/CLINICAL%20TRIAL%20GUIDELIN ES%20botswana%20v4-060312.pdf Note: All websites and documents are in French. General Ethics Committee for Health Research Drugs, Biologics, and Devices Cameroon Joint Order 2004-147 / MS / MESSE of 11 May 2004 on the Organization and Functioning of the Ethics Committee for Health Research in Burkina Faso Order No. 2010-292/MS /CAB of 1 October 2010 on the Conditions for Granting Authorizations for Clinical Trials: http://elearning.trree.org/pluginfile.ph p/34806/mod_folder/content/0/19_Ar rete_autorisations_essais_cliniques.p df?forcedownload=1 For an overview of human subject protections in Cameroon, see: http://elearning.trree.org/mod/nationalsupplement/view.php?id=227 General Cameroon Bioethics Initiative: www.cambin.org Ministerial Order No. 079/A/MSP/DS of MINSANTE (1987): http://elearning.trree.org/pluginfile.ph p/34735/mod_folder/content/0/cm- arrete-079-MSP- CreationComiteEthique- 1987.pdf?forcedownload=1 Operational Guidelines for Ethics Committees in Charge of the Evaluation of Biomedical Research 185 Country Key Organizations Legislation Regulations Guidelines Congo, Democratic Republic of General Drugs, Biologics, and Devices Côte-d'Ivoire Decree-Law Framework on Public Health, Title VII: Regarding the National Medical Ethics Committee, Biomedical Research, Transplantation of Organs and Tissues, Genetic Treatment, and Cloning: https://www.mindbank.info/item/25 43 1. Proposal for Ministerial Order No. 1250 Establishing the National Advisory Committee on Ethics Health (2004): https://healthresearchweb.org/?action=downloa d&file=DRCPOlicy.pdf 2. Guidelines for the Ethical Evaluation of Research Involving Human Subjects in the Democratic Republic of Congo (2011) (Fench): https://clinregs.niaid.nih.gov/sites/default/files/ documents/DRC/G-EthicalEval.pdf For an overview of human subject protections in Côte-d'Ivoire, see: http://elearning.trree.org/course/view.php?id=19 Note: All websites and documents are in French. Drugs, Biologics, and Devices Ethiopia General Drugs and Devices Human Biological Materials Gambia Genetic Research National Committee on Ethics and Research Ethiopian Science and Technology Commission, Health Department: http://www.most.gov.et/ Food, Medicine, and Health Administration and Control Authority: www.fmhaca.gov.et Ethiopian Science and Technology Commission, Health Department: http://www.most.gov.et/ MRC: Gambia Unit: http://www.mrc.gm/ Proclamation 60/1999, Section 21 Decree No 317 / SP / DSPH of 14 July 1987 on the Regulation of Drugs Before and After Marketing in Ivory Coast: http://elearning.trree.org/pluginfile.ph p/34816/mod_folder/content/0/20_Ar rete_Regl_exp_clinique_des_substan ces_med.pdf?forcedownload=1 Drug Administration and Control Proclamation No. 176/1999, Article 21 National Health Research Ethics Review Guideline, Fourth Edition (2014): http://www.ccghr.ca/wp- content/uploads/2013/11/national-research- ethics-review-guidline.pdf National Health Research Ethics Review Guideline, Fourth Edition, Chapter 9 (2005): http://www.ccghr.ca/wp- content/uploads/2013/11/national-research- ethics-review-guidline.pdf Guidelines of the National DNA Bank (2001) 186 Country Key Organizations Legislation Regulations Guidelines Ghana For an overview of the clinical trial information in Ghana, see: http://www.fdaghana.gov.gh/index.php?option=com_content&view=article&id=71&Itemid=55 Drugs, Biologics, and Devices Guinea Food and Drugs Authority: http://www.fdaghana.gov.gh Public Health Act, 2012 Act 851, Sections 150-166: http://www.fdaghana.gov.gh/images/s tories/pdfs/Clinical%20Trials/REGU LATION%20OF%20CLINICAL%20 TRIALS%20IN%20GHANA.pdf 1. Guidelines for Good Clinical Practice in Ghana (2015): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20ON%20GOOD%20C LINICAL%20PRACTICE%20IN%20GHANA .pdf 2. Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices (2015): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20FOR%20AUTHORI ZATION%20OF%20CLINICAL%20TRIALS %20OF%20MEDICINES,%20GHANA.pdf 3. Guidelines for Conduct of Clinical Trials in Paediatric Population (2016): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20FOR%20CONDUCT %20OF%20CLINICAL%20TRIALS%20WIT H%20PAEDIATRIC%20POPULATION%20I N%20GHANA.pdf 4. Guidelines for Conduct of Clinical Trials During Emergencies (2016): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/GUIDELINE S%20FOR%20TRIALS%20IN%20EMERGE NCIES1.pdf For an overview of the clinical research regulations in Guinea, see the ClinRegs report: https://clinregs.niaid.nih.gov/single_country.php?c_id=90 Note: All websites and documents are in French. General Research Injury National Ethics Committee on Health Research (CNERS): http://cners- guinee.org/ National Ethics Committee on Health Research: http://cners-guinee.org/ Public Health Code, Articles 237-316 (1997): http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code _Sante_Publique.pdf Public Health Code, Articles 301-302 (1997): http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code 187 Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS), Chapters I and II (1998): http://cners-guinee.org/wp- content/uploads/2014/02/Decret-.pdf CNERS: Frequently Asked Questions: http://cners- guinee.org/faq/ Country Key Organizations Legislation Regulations Guidelines Research Injury Kenya _Sante_Publique.pdf For an overview of the clinical research regulations in Kenya, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=111 General Drugs, Biologics, and Devices Human Biological Materials Liberia 1. National Council for Science and Technology (NCST): http://www.nacosti.go.ke/ 2. Ministry of Health (MOH): www.health.go.ke/ Pharmacy and Poisons Board: http://www.pharmacyboardkenya.org/ Ministry of Health (MOH): www.health.go.ke/ 1. Science and Technology Act (2001) 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006) Pharmacy and Poisons Act, Chapter 244 (2009): http://apps.who.int/medicinedocs/do cuments/s18245en/s18245en.pdf MOH: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005) Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, page 44 (2005) MOH: National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008): https://healthresearchweb.org/?action=downloa d&file=Final%20national%20ethical%20guidel ines-last%20draft.pdf Guidelines for Applications to Conduct Clinical Trials in Kenya (2014): http://pharmacyboardkenya.org/downloads/?fil e=Clinical%20Trial%20Guidelines%202014.p df For an overview of the clinical research regulations in Liberia, see the ClinRegs report: https://clinregs.niaid.nih.gov/single_country.php?c_id=122 General Drugs, Biologics, and Devices Madagascar Drugs and Devices Ministry of Health and Social Welfare: http://www.mohsw.gov.lr/ Liberia Medicines and Health Products Regulatory Authority Law No. 2011-002, Article 122 Regarding Clinical Trials: https://www.ilo.org/dyn/natlex/docs /ELECTRONIC/97799/116199/F10 71917999/MDG-97799.pdf 1. Institutional Review Board (IRB) Policies and Procedures Handbook (2008): http://www.ul-acre.org/wp- content/uploads/2013/03/UL-IRB- Policy-Handbook.pdf 2. Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011): http://clinregs.niaid.nih.gov/documen ts/liberia/G-LIBR-NHSREC.pdf Operational Guidelines of the National Research Ethics Board (2019): https://clinregs.niaid.nih.gov/sites/default/files/ documents/liberia/G-NREB-revised.pdf Guideline for Application to Conduct Clinical Trials in Liberia (2014): https://clinregs.niaid.nih.gov/documents/liberia /G-LibClinTrial.pdf 188 Country Key Organizations Legislation Regulations Guidelines Malawi For an overview of the clinical research regulations in Malawi, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=129 General Drugs, Biologics, and Devices Social-Behavioral Research 1. National Commission for Science and Technology (NCST): http://www.ncst.mw/ 2. National Health Sciences Research Committee (NHSRC): http://www.ncst.mw/national-health- science-research-committee-nhsrc/ 3. College of Medicine Research and Ethics Committee (COMREC): http://www.medcol.mw/ 4. Ministry of Health: www.malawi.gov.mw Pharmacy, Medicines, and Poisons Board of Malawi National Committee on Research in the Social Sciences and Humanities 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) 1. Pharmacy, Medicines, and Poisons Act, Act 15 of 1988: http://www.google.com/url?sa=t&rc t=j&q=&esrc=s&source=web&cd= 1&cad=rja&uact=8&ved=0CB0QFj AAahUKEwi3qf2P2vLIAhUEqh4K HfyNBvw&url=http%3A%2F%2F www.malawilii.org%2Ffiles%2Fm w%2Flegislation%2Fconsolidated- act%2F35%3A01%2Fpharmacy_me dicines_poisons_act_pdf_19885.pdf &usg=AFQjCNFJR- Y4F7y3eoC6DV0H7Jr77s5Msg 2. Section 42(1) of PMPB Act, 2003 Supplement 189 NCST: 1. The Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi (2011) 2. Policy Requirements, Procedures and Guidelines for the Conduct and Review of Research (2012) 3. National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (2012) 4. National Policy Requirements and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi (2012) NHSRC: 1. Operational Guidelines (2001) 2. Summary Guidelines for Writing Research Proposals (2001) COMREC: General Guidelines on Health Research (2014): http://www.medcol.mw/comrec/wp- content/uploads/2014/07/comrec_guidelines.pd f Framework of Guidelines for Research in the Social Sciences and Humanities in Country Key Organizations Legislation Regulations Guidelines Social-Behavioral Research Human Biological Materials Genetic Research Mali National Commission for Science and Technology: www.ncst.mw National Research Council of Malawi (NRCM): www.sdnp.org.mw/nrcm/ National Regulatory Requirement and Position on Accessing, Collection, Storage, and Use of Human Biological Specimens for Research (2014): https://www.ncst.mw/wp- content/uploads/2014/03/National- regulatory-requirement-on-human- samples.pdf Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi (2002) Malawi (2011): http://www.ncst.mw/wp- content/uploads/2014/03/NATIONAL- FRAMEWORK-OF-GUIDELINES-IN- SSH.pdf Circular on Human Biological Samples and Participants Recompense in Research Involving Human Subjects (2019): https://clinregs.niaid.nih.gov/sites/default/files/ documents/malawi/CIRCULAR.ON_.SAMPL ES.AND_.RECOMPENSE-RECs.pdf For an overview of human subject protections in Mali, see: https://clinregs.niaid.nih.gov/single_country.php?c_id=132&utm_medium=GovDelivery&utm_source=ClinRegs&utm_campaign=MaliP ublication#_top Drugs, Biologics, and Devices Mozambique Directorate of Pharmacy and Medicine Law No. 09-059 of 28 December 2009 Governing Biomedical Research on Humans: https://clinregs.niaid.nih.gov/docum ents/LawNo09-059.pdf Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (2017) (French): https://clinregs.niaid.nih.gov/sites/def ault/files/documents/mali/DecreeNo2 017-0245.pdf For an overview of human subject protections in Mozambique, see: http://elearning.trree.org/course/view.php?id=14&lang=en General Science and Technology Ethics Code (2007): http://elearning.trree.org/pluginfile.php/34764/ mod_folder/content/0/02- CodigoDeEtica.pdf?forcedownload=1 Nigeria For an overview of human subject protections in Nigeria, see: http://elearning.trree.org/mod/page/view.php?id=142 General National Health Research Ethics Committee: http://nhrec.net/ National Health Act 2014 1. Nigerian Code of Health Research Ethics (2007): http://nhrec.net/nhrec/wp- content/uploads/2018/10/NCHRE_Aug_07.zip 2. Policy Statement Regarding Enrollment of Children in Research in Nigeria (2016): http://nhrec.net/nhrec/Final%20NHREC%20Po licy%20Statement%20on%20Enrollment%20o f%20Children%20in%20Research.pdf 190 Country Key Organizations Legislation Regulations Guidelines General Drugs, Biologics, and Devices Clinical Trial Registries Social-Behavioral Research Human Biological Materials Rwanda General Senegal General Sierra Leone National Agency for Food, Drug Administration and Control (NAFDAC): http://www.nafdac.gov.ng/ National Health Research Ethics Committee: http://nhrec.net/ National Health Research Ethics Committee National Health Research Ethics Committee: http://nhrec.net/ Ministry of Health, National Ethics Committee: http://www.moh.gov.rw/index.php?id=2 National Committee on Health Research Ethics Decree No. 15 of 1993 Law Supporting the Code of Ethics for Health Research (2009) Various: http://nhrec.net/download-guides-and- forms/ Good Clinical Practice Guidelines (2016): http://www.nafdac.gov.ng/images/GUIDELIN ES/DRUG%20GUIDELINES/NAFDAC%20G OOD%20CLINICAL%20PRACTICE%20GUI DELINES%202016%20V%2013.pdf Frequently Asked Questions: http://nctr.nhrec.net Nigerian Code of Health Research Ethics (2007): http://nhrec.net/nhrec/wp- content/uploads/2018/10/NCHRE_Aug_07.zip Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria (2013): http://nhrec.net/nhrec/NHREC_Policy_Stateme nt_on_Biobanks_FINAL.pdf Standard Operating Procedures (2009): http://www.moh.gov.rw/index.php?option=co m_docman&task=doc_download&gid=126&It emid=81 For an overview of the clinical research regulations in Sierra Leone, see the ClinRegs report: https://clinregs.niaid.nih.gov/single_country.php?c_id=193 General Drugs, Biologics, and Devices Sierra Leone Ethics and Scientific Review Committee 1. Ministry of Health: http://www.sante.gov.bf/ 2. Pharmacy Board of Sierra Leone: http://pharmacyboard.gov.sl/ 191 Application Guidelines (2017): https://mohs2017.files.wordpress.com/2017/03/ guidelines-and-checklist-for-ethical-clearance- 2017.pdf 1. Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone, Sections: 3.1.7 and 3.2 (2014): http://pharmacyboard.gov.sl/site/LinkClick.asp x?fileticket=9jeTGC2WIZ8%3d&tabid=316& portalid=1&mid=934 2. Guideline for Good Clinical Practice (GCP) in Sierra Leone, Sections 3.2 and 3.3 (2018): https://clinregs.niaid.nih.gov/sites/default/files/ documents/sierra_leone/PBSL-GCP-Guideline- Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices V2.pdf 3. Guideline for Conducting Clinical Trials: http://pharmacyboard.gov.sl/site/LinkClick.asp x?fileticket=YrGQkXzfLP8%3d&tabid=316& portalid=1&mid=934&forcedownload=true South Africa For an overview of human subject protections in South Africa, see: http://elearning.trree.org/course/view.php?id=9&lang=en For an overview of the clinical research regulations, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=199 Forms: http://pharmacyboard.gov.sl/site/Downloads/Fo rms.aspx General Drugs, Biologics, and Devices Clinical Trials Registry Social-Behavioral Research Human Biological 1. Department of Health (DH): http://www.doh.gov.za 2. National Health Research Ethics Council: http://www.nhrec.org.za/ 3. Medical Research Council of South Africa (MRC): http://www.mrc.ac.za 4. Human Sciences Research Council (HSRC): http://www.hsrc.ac.za/index.phtml 1. Department of Health (DH): http://www.doh.gov.za 2. Health Products Regulatory Authority: https://www.sahpra.org.za/ South African National Clinical Trials Register: http://www.sanctr.gov.za/ Department of Health Department of Health (DH): http://www.doh.gov.za 1. Constitution of South Africa, Section 12 (2) (1996) 2. National Health Act No. 61, Chapter 9 (2003): http://www.saflii.org/za/legis/consol _act/nha2003147.pdf Medicines and Related Substances Control Act, 101 of 1965 http://www.hpcsa.co.za/Uploads/edi tor/UserFiles/downloads/legislations /acts/medicines_and_related_sub_ac t_101_of_1965.pdf National Health Act No. 61, 192 Regulations Relating to Research with Human Participants No. R719 (2014): http://www.google.co.za/url?url=http: //www.lawsofsouthafrica.up.ac.za/ind ex.php/browse/medical-and- health/national-health-act-61-of- 2003/regulations-and-notices/61-of- 2003-national-health-act-regs-gnr- 719-19-sept-2014-to-date- pdf/download&rct=j&frm=1&q=&es rc=s&sa=U&ei=W6UtVOOvLa6S7A a34YDwAg&ved=0CBUQFjAA&us g=AFQjCNFpKA9W0jNyeWhk0n0l 0Q-WxazBtg General Regulations Made in Terms of the Medicines and Related Substances Act, 1965 (2003): http://www.hpcsa.co.za/Uploads/edit or/UserFiles/downloads/legislations/a cts/medicines_and_related_sub_act_1 01_of_1965.pdf 1. Regulations Relating to the Use DH: Ethics in Health Research: Principles, Structures, and Processes (2015): http://www.nhrec.org.za/docs/Documents/Ethic sHealthResearchFinalAused.pdf MRC: 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) DH: Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2016): http://www.nhrec.org.za/docs/trainingrequ irements/gcp.pdf FAQs: http://www.sanctr.gov.za/InvestigatorbrnbspInf ormation/FAQ/tabid/200/Default.aspx Ethics in Health Research: Principles, Processes, and Structures, Section 3.3.7(i) (2015): http://www.commerce.uct.ac.za/Downloads/Et hics%20in%20Health%20Research%20Final% 20A%20used.pdf Country Key Organizations Legislation Regulations Guidelines Materials Genetic Research Embryos, Stem Cells, and Cloning Tanzania Medical Research Council of South Africa (MRC): http://www.mrc.ac.za Medical Research Council of South Africa (MRC): http://www.mrc.ac.za Chapter 8, Sections 53-68 (2003): http://www0.sun.ac.za/ruralhealth/u kwandahome/rudasaresources2009/ DOH/ethics/app5.pdf National Health Act No. 61, Chapter 8, Section 57 (2003): http://www0.sun.ac.za/ruralhealth/u kwandahome/rudasaresources2009/ DOH/ethics/app5.pdf of Human Biological Material, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf 2. Regulations Regarding General Control of Human Bodies, Tissues, Blood Products and Gametes, 2 March 2012 3. Regulations Relating to Blood and Blood Products, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf 4. Regulations Relating to Artificial Insemination of Persons, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf Regulations relating to Stem Cell Banks, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf Guidelines on Ethics in Reproductive Biology and Genetic Research (2002): http://www.sahealthinfo.org/ethics/book2.htm Guidelines on Ethics in Reproductive Biology and Genetic Research (2002): http://www.kznhealth.gov.za/research/ethics2.p df For an overview of human subject protections in Tanzania, see: http://elearning.trree.org/mod/resource/view.php?id=41&lang=en For an overview of the clinical research regulations in Tanzania, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=212 General Drugs, Biologics, and Devices 1. Ministry of Health (MOH) 2. National Institute for Medical Research (NIMR), National Health Research Ethics Committee (NHREC): http://www.nimr.or.tz/ 3. Tanzania Commission for Science and Technology (COSTECH): www.costech.or.tz Drugs Tanzania Food and Drugs Authority: 1. National Institute for Medical Research, Act of Parliament No. 23, of 1979: http://www.parliament.go.tz/Polis/P AMS/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 Tanzania Food, Drugs, and 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. Brochure for Health Researchers in Tanzania (2006) 2. Guidelines on Ethics for Health Research in Tanzania (2009): https://clinregs.niaid.nih.gov/documents/tanzan ia/G-EthicsHR.pdf COSTECH: COSTECH Guidelines on Research Permits and Clearance (2006) https://protect2.fireeye.com/url?k=df97c3b9 Cosmetics Act, Sections 61, 66, -83c3dac5-df97f286-0cc47adc5fa2-9df96a 6e749380d6&u=https://www.tmda.go.tz/ 67, and 69 (2003): http://www.tfda.or.tz/index.php?opti 193 Country Key Organizations Legislation Regulations Guidelines Drugs, Biologics, and Devices Devices Tanzania Food and Drugs Authority: http://www.tfda.or.tz/ on=com_phocadownload&view=cat egory&download=44:tfdc-acts- 2003&id=52:tfdc-acts- 2003&Itemid=417 Medical Device Act (1988) Clinical Trials Registry Uganda Tanzania Clinical Trial Registry: http://www.tzctr.or.tz/ FAQs: http://www.tzctr.or.tz/faq.php For an overview of the clinical research regulations in Uganda, see the ClinRegs report: http://clinregs.niaid.nih.gov/single_country.php?c_id=223 General Drugs, Biologics, and Devices Zambia General Drugs, Biologics, and Devices Uganda National Council for Science and Technology (UNCST): http://www.uncst.go.ug/ National Drug Authority: http://www.nda.or.ug/ Ministry of Health: http://www.moh.gov.zm/ Zambia Medicines Regulatory Authority: http://www.zamra.co.zm/ Uganda National Council for Science and Technology Act of 1990 (CAP 209): https://ulii.org/ug/legislation/consoli dated-act/209 Drug Conduct of Clinical Trials Regulation (2014): https://www.nda.or.ug/files/downlo ads/Drug%20Conduct%20of%20Cli nical%20trials%20Regulation.pdf National Health Research Act (2013): http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health %20%20Research%20%20Act%20 2013.pdf Medicines and Allied Substances Act, Part VI: Regulation of Clinical Trials, 2013: http://www.zamra.co.zm/wp- content/uploads/2016/10/MASA- No-3-2013.pdf 194 National Drug Policy and Authority Act Regulations: https://www.nda.or.ug/ndpa-act- regulations/ 1. National Guidelines for Research Involving Humans as Research Participants (2014): https://uncst.go.ug/guidelines-and-forms/ 2. Research Registration and Clearance Policy and Guidelines (2016) 3. Research Guidelines and Forms: https://www.uncst.go.ug/guidelines-and-forms/ 4. Accredited Research Ethics Committees: https://www.uncst.go.ug/research-ethics- committee-accreditation/ 1. Human Medicine Guidelines: https://www.nda.or.ug/human-medicine- guidelines/ 2. Clinical Trial Application Forms: https://www.nda.or.ug/application-forms/ 3. Guidelines for the Conduct of Drug Related Clinical Trials (2019) Guidelines on Regulating the Conduct of Clinical Trials in Human Participants: http://www.zamra.co.zm/wp- content/uploads/2016/10/Guidelines-on- Application-for-Clincal-Trial- Authorisation.pdf Country Key Organizations Legislation Regulations Guidelines Human Biological Materials Zimbabwe General Drugs, Biologics, and Devices Privacy/Data Protection Human Biological Materials Medical Research Council of Zimbabwe: http://www.mrcz.org.zw Drugs Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/ Devices Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/devices.html Registrar General: http://www.rg.gov.zw/ Zimbabwe National Statistics Agency: http://www.zimstat.co.zw/ Research Council of Zimbabwe: www.rcz.ac.zw National Health Research Act, Part VI (2013): http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health %20%20Research%20%20Act%20 2013.pdf 1. Medical Research Government Notice Act (1974) 2. Research Act (1986) Medicines and Allied Substances Control Act, Chapter 15:03 (1997) Medicines and Allied Substances Control Act, Chapter 15:03 (1997): https://www.unodc.org/res/cld/docu ment/zwe/medicines-and-allied- substances-control- act_html/Zimbabwe_Medicines_and _Allied_Substances_Control_Act.p df 1. Constitution of Zimbabwe of 2013, Section 57: https://www.constituteproject.org/co nstitution/Zimbabwe_2013.pdf 2. Access to Information and Protection of Privacy Act, Chapter 10:27: www.fesmedia- africa.org/uploads/media/Acess_to_ Information_Zimbabwe Research Act (2001): http://faolex.fao.org/docs/pdf/zim93 551.pdf 1. Medicines and Allied Substances Control Act, General Regulations (1991) 2. Statutory Instrument 150 of 1991 Medicines and Allied Substances Control (Condom) Regulations (2005): http://www.mcaz.co.zw/index.php/do wnloads/category/15-regulations-and- guidelines?download=29:condom- regulations Various: http://www.mrcz.org.zw/faqs/ 1. Guidelines for Good Clinical Practice (2012): http://www.medbox.org/guidelines- for-good-clinical-trial-practice-in-zimbabwe- 2012/download.pdf 2. Pharmacy Guidelines for Investigational Drugs (2016): http://www.mcaz.co.zw/index.php/downloads/f ile/114-pharmacy-guidelines-for- investigational-drugs-draft-1 Various: http://www.rcz.ac.zw/research- registration/ 195 Country Key Organizations Legislation Regulations Guidelines Genetic Research National Biotechnology Authority of Zimbabwe: http://www.nba.ac.zw/ National Biotechnology Authority Act, Chapter 14:31 (2006): http://www.nba.ac.zw/index.php/our -resources/finish/1-national- biotechnology-association/2- national-biotechnolgy-authority-act 196 ACKNOWLEDGEMENTS The DHHS Office for Human Research Protections thanks the following individuals for providing updates or confirmations of accuracy for the 2020 edition of the International Compilation of Human Research Standards. We are particularly grateful for the assistance provided by Carla Saenz of the Pan American Health Organization, Washington DC. International: CIOMS: Sue le Roux International Society for Biological and Environmental Repositories: Daniel Simeon-Dubach TRUST Project: Doris Schroeder UNAIDS: Peter Godfrey-Faussett World Health Organization: Andreas Reis North America: United States: • Consumer Product Safety Commission: Alice Thaler • Department of Commerce: Anne Andrews • Department of Veterans Affairs: Kristina Borror • DHHS Agency for Healthcare Quality and Research: Hope Hongzhu He • DHHS Food and Drug Administration: Carolyn Hommel • DHHS Office for Civil Rights: Devi Mehta • Department of Justice, Bureau of Prisons: Jody Klein-Saffran • United States Department of Agriculture: David Klurfeld • Social Security Administration: Leola Brooks Europe: European Medicines Agency: Maria Antonietta Antonelli Belgium: Sophie Bertrand Czech Republic: Alice Nemcova Denmark: Ann-Sofie Lydiksen Nygaard Finland: Outi Konttinen France: Emmanuelle Rial-Sebbag Germany: Claudia Leuker Iceland: Rögnvaldur G. Gunnarsson Latvia: Signe Mezinska Lithuania: Vilma Lukaseviciene Luxembourg: Malika Pailhes Macedonia: Marija Todorovska Norway: Camilla Bø Standal Poland: Marek Czarkowski and Agnieszka Seweryniak Serbia: Jelena Rakobradović Slovenia: Marija Lap Sweden: Stefan Eriksson Switzerland: Brigitte Meier and Rosine Muchlow Spain: Iñigo de Miguel Beriain Asia/Pacific: Australia: Jeremy Kenner China, People’s Republic of: Yali Cong and Haihong Zhang Japan: Shimon Tashiro Korea: B.I. Choe, Hye Ryung Lee, Jin Myeong Hwang, Hoseob Ji. Areum Choi, Sang-Min Park, Yoon Joung Chang and Kyoungtae Park 197 Malaysia: Chirk Jenn Ng Pakistan: Saima Iqbal Taiwan: Benjamin Kuo Middle East/North Africa: Jordan: Amal Al Omari Sudan: Lamis Beshir and Faiza Osman Turkey: Hamdi Akan Qatar: Eman Sadoun Latin America and the Caribbean: Argentina: Susana Carreño, Ana Palmero, and Diana Salmún Brazil: Sergio Rego, Marisa Palacios, and Marcelo Nóbile Franco Chile: Juan Pablo Beca Colombia: Claudia Ayala Leal and Maria Consuelo Miranda Costa Rica: Yohana Díaz de Valle Ecuador: Adriana Granizo M. Guatemala: Sofia Fabian Grenada: Cheryl Cox Macpherson Honduras: Mireya Matamoros Zelaya and Jackeline Alger Mexico: María de la Luz Casas Martínez PhD Nicaragua: Alberto Montoya Panama: Claude Vergès and Jesica Eileen Candanedo Pérez Paraguay: Enrique de Mestral Peru: Sarah Carracedo Africa: Sierra Leone: Eddie Foday Sudan: Faiza Osman and Lamis Beshir Uganda: Winfred Badanga Nazziwa and John Barugahare Zambia: Maureen Mupeta Kombe Updated November 5, 2019 198