697317C5A19D2D82EE28783676D2186B
International Compilation of Human Research Standards
https://www.hhs.gov/ohrp/sites/default/files/2020-international-compilation-of-human-research-standards.pdf
http://leaux.net/URLS/ConvertAPI Text Files/9AA4DC92D210DD04B66653C3BDA028FA.en.txt
Examining the file media/Synopses/9AA4DC92D210DD04B66653C3BDA028FA.html:
This file was generated: 2020-11-03 19:18:59
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000003: Zambia 194
p.000003: Zimbabwe 195
p.000003: ACKNOWLEDGEMENTS 197
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p.000004: 4
p.000004:
p.000004: Country Key Organizations Legislation
p.000004: Regulations Guidelines
p.000004:
p.000004:
p.000004: INTERNATIONAL
p.000004: General Council for International Organizations of
p.000004: Medical Sciences (CIOMS):
p.000004: http://www.cioms.ch/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: International Committee of the Red Cross (ICRC): www.icrc.org
p.000004:
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p.000004:
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p.000004: Office of the United Nations High Commissioner for Human Rights (OHCHR): http://www.ohchr.org/english/
p.000004:
p.000004: TRUST Project:
p.000004: http://www.globalcodeofconduct.org
p.000004:
p.000004:
p.000004:
p.000004: UNAIDS:
p.000004: http://www.unaids.org/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950):
p.000004: https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68
p.000004: 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977):
p.000004: http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9
p.000004: International Covenant on Civil and Political Rights, Article 7 (1976):
p.000004: http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx
p.000004:
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p.000005: 5
p.000005:
p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
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p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
...
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
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p.000011:
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p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
...
Political / Illegal Activity
Searching for indicator crime:
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p.000089:
p.000089: Privacy/Data Protection
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Human Biological Materials
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Embryos, Stem Cells, and Cloning
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p.000089: Russia
p.000089: http://www.dataprotection.ro/index.jsp?pa ge=documents&lang=en
p.000089:
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p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ministry of Health (MOH):
p.000089: http://www.ms.ro/
p.000089: Regard to the Processing of Personal Data and on the Free Movement of Such Data: http://www.dataprotection.ro/servlet
p.000089: /ViewDocument?id=174
p.000089: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law No. 95/2006
p.000089: Regarding the Reform in Health Field. Title
p.000089: VI. Performing of Sampling and Transplant of Organs, Tissues and Human Origin Cells with Therapeutic Purpose:
p.000089: http://www.transplant.ro/Lege/Lege
p.000089: -2006-95.pdf
p.000089:
p.000089: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard
p.000089: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2001)
p.000089: 2. Law No. 301 from 2004 Penal Code – Chapter IV – Crimes and Felonies Regarding Genetic Manipulation:
p.000089: http://www.codpenal.ro/legislatie/do cument/lege-301-din-2004-codul- penal-capitol-4-crime-si-delicte-
p.000089: privind-manipularea-genetica-1260- 63259.html
p.000089:
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p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Quality and Safety of
p.000089: Human Organs Intended for Transplantation: http://europa.eu/legislation_summari es/public_health/threats_to_health/sp
p.000089: 0008_ro.htm
p.000089: http://www.dataprotection.ro/?page=Regulame ntul_nr_679_2016
p.000089: For an overview of human subject protections in Russia, see
p.000089: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000089:
p.000089: General
p.000089: 1. Ministry of Healthcare of the Russian Federation (MOH): http://www.rosminzdrav.ru
p.000089: 2. Federal Service on Surveillance in Healthcare (Roszdravnadzor): http://www.roszdravnadzor.ru/
p.000089: 3. Russian Committee for Bioethics:
p.000089: http://www.bioethics.ru/eng/
p.000089: 1. Constitution of the Russian Federation, Article 21 (1993): http://www.constitution.ru/en/10003 000-03.htm
p.000089: 2. Federal Law #FZ 323 “On Foundations of Protection of Citizen’s Health in the Russian Federation” (2011):
p.000090: 90
p.000090: MOH:
p.000090: 1. Ministry of Health Order 433n (July 10, 2015) “On Adoption of the Regulations on Organization of Clinical
p.000090: Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation (Including Order of Patients’
p.000090: Assignment for Administering Such Medical Help),
p.000090:
p.000090: Country Key Organizations Legislation
p.000090: Regulations Guidelines
p.000090:
p.000090: General
p.000090:
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Political / Indigenous
Searching for indicator indigenous:
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p.000115:
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p.000115: Therapeutic Goods Act 1989 (2019): https://www.legislation.go v.au/Details/C2019C00066
p.000115: National Health and Medical Research Regulation 2016: https://www.legislation.gov.au/Detail s/F2016L00682
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p.000115:
p.000115: Therapeutic Goods Regulations 1990 (2019):
p.000115: https://www.legislation.gov.au/Detail s/F2019C00575
p.000115: NHMRC:
p.000115: 1. Ethical conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for
p.000115: Researchers and Stakeholders (2018): https://nhmrc.gov.au/about- us/publications/ethical-conduct-research-
p.000115: aboriginal-and-torres-strait-islander-peoples- and-communities
p.000115: 2. Keeping Research on Track II (2018): https://nhmrc.gov.au/about- us/publications/keeping-research-track-ii
p.000115:
p.000115: NHMRC, ARC, and Universities Australia:
p.000115: 1. Australian Code for the Responsible Conduct of Research (2018): https://www.nhmrc.gov.au/about-
p.000115: us/publications/australian-code-responsible- conduct-research-2018
p.000115: 2. National Statement on Ethical Conduct in Human Research, 2007 (2018): https://www.nhmrc.gov.au/about-
p.000115: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 Guidelines for Ethical Research in
p.000115: Australian Indigenous Studies (2012): http://www.aiatsis.gov.au/research/ethics/GER AIS.html
p.000115:
p.000115: TGA:
p.000115: Australian Clinical Trial Handbook (2018):
p.000115: https://www.tga.gov.au/publication/australian- clinical-trial-handbook
p.000115:
p.000115: Australian States and Territories: National Mutual Acceptance of Scientific and Ethical Review of Multi-Centre Human
p.000115: Research (2017): https://www.australianclinicaltrials.gov.au/ethi cal-review-process-each-australian-state-and-
p.000115:
p.000116: 116
p.000116:
p.000116: Country Key Organizations Legislation
p.000116: Regulations Guidelines
p.000116:
p.000116: Drugs, Biologics, and Devices
p.000116:
p.000116:
p.000116:
p.000116: Clinical Trials Registry
p.000116:
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p.000116:
p.000116: Research Injury
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p.000116:
p.000116: Social-Behavioral Research
p.000116:
p.000116:
p.000116:
p.000116: Privacy/Data Protection
p.000116:
p.000116: Note: All Australian states and territories
p.000116:
p.000116: Devices
p.000116: Therapeutic Goods Administration: http://www.tga.gov.au/industry/devices.ht m
p.000116:
p.000116:
p.000116: 1. National Health and Medical Research Council and the Department of Industry, Innovation, and Science:
p.000116: https://www.australianclinicaltrials.gov.au
p.000116: 2. Australian New Zealand Clinical Trials Registry: http://www.anzctr.org.au/
p.000116: 1. Therapeutic Goods Administration (TGA): http://www.tga.gov.au/
p.000116: 2. Medicines Australia
p.000116: https://medicinesaustralia.com.au
...
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
p.000140: 4. Commission of Higher Education (CHED): www.ched.gov.ph/
p.000140: 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Republic Act No. 10532: An Act Institutionalizing the Philippine National Health Research System (2013):
p.000140: http://www.gov.ph/2013/05/07/repu blic-act-no-10532/
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: PHREB:
p.000140: 1. PNHRS Act Implementing Rules and Regulations: http://www.ethics.healthresearch.ph/i
p.000140: ndex.php/component/content/article/2
p.000140: -uncategorised/214-implementing- rules-of-pnhrs
p.000140: 2. Memorandum: Registration and Accreditation of all Ethics Review Committees in the Philippines (2015):
p.000140: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/226-phreb-memo
p.000140: http://nbcpakistan.org.pk/assets/hbm-nbc- guidelines-final-18june-2016.pdf Protocol/Guidelines for Stem Cell
p.000140: Research/Regulation in Pakistan: http://nbcpakistan.org.pk/?page_id=61
p.000140:
p.000140: PHREB:
p.000140: National Ethical Guidelines for Health and Health-Related Research (2017):
p.000140: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
p.000140: guidelines-for-health-and-health-related- research
p.000140:
p.000140: DOST:
p.000140: 1. Administrative Order 001 Series 2007: Requirement for Review of All Research Involving Human Subjects/Participants
p.000140: (2007): http://ethics.healthresearch.ph/index.p hp/component/content/article/2- uncategorised/112-ao-001-2007
...
p.000160:
p.000160: NBC:
p.000160: Projects that Involve Drugs or Therapeutic Products
p.000160:
p.000160:
p.000161: 161
p.000161:
p.000161: Country Key Organizations Legislation
p.000161: Regulations Guidelines Brazil
p.000161: For an overview of clinical research regulations in Brazil, see the ClinRegs report:
p.000161: http://clinregs.niaid.nih.gov/single_country.php?c_id=30
p.000161:
p.000161: General
p.000161: 1. National Health Council (CNS):
p.000161: http://www.conselho.saude.gov.br/
p.000161: 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000161:
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p.000162: 162
p.000162: CNS/CONEP:
p.000162: 1. Resolution CNS No. 240/97 - Defining "Participating User" According to IRB: http://conselho.saude.gov.br/images/c
p.000162: omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_240_-
p.000162: _1997 -
p.000162: _Define_representao_de_usurio_CEP
p.000162: .pdf
p.000162: 2. Resolution CNS No. 292/99 on Research with Foreign Cooperation: http://conselho.saude.gov.br/images/c
p.000162: omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_292_-
p.000162: _1997 -_Cooperao_estrangeira.pdf
p.000162: 3. Resolution CNS No. 304/2000: Rules on Research Involving Human Beings – Area of Indigenous Peoples:
p.000162: http://conselho.saude.gov.br/resoluco es/2000/Res304_en.pdf
p.000162: 4. Internal CONEP Regulation (2001): http://conselho.saude.gov.br/comissa o/conep/regimento.doc
p.000162: 5. Resolution CNS No. 346/2005 on Multicenter Research: http://conselho.saude.gov.br/resoluco es/2005/Res346_en.pdf
p.000162: 6. Resolution CNS No. 370/07 on Registration and Accreditation or Renewal of Registration and Accreditation of CEP:
p.000162: http://conselho.saude.gov.br/resoluco es/2007/Reso370.doc
p.000162: 7. Resolution CNS No. 446/2011on Composition of the National Commission on Research Ethics:
p.000162: http://conselho.saude.gov.br/images/c
p.000162: CNS/CONEP:
p.000162: 1. Operating Normative 001/2013 Organization and Operation of CEP/CONEP System:
p.000162: http://conselho.saude.gov.br/images/comissoes/ conep/documentos/NORMAS- RESOLUCOES/Norma_Operacional_n_001-
p.000162: 2013_Procedimento_Submisso_de_Projeto.pdf
p.000162: 2. Various:
p.000162: http://plataformabrasil.saude.gov.br/login.jsf
p.000162:
p.000162: Country Key Organizations Legislation
p.000162: Regulations Guidelines
p.000162:
p.000162: General
p.000162:
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p.000162:
p.000162: Drugs, Biologics, and Devices
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p.000162:
p.000162:
p.000162:
p.000162:
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000047: 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa
p.000047: /1995/19950377
p.000047: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
p.000047: 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden:
p.000047: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf
p.000047:
p.000047:
p.000047: 1. Law No. 2012-300 of 5
...
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953
p.000057: 2. Act CLIV of 1997 on Health Care, Chapters VIII and IX: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=30903.339193
p.000057: 3. Act VI. of 2002 on the Promulgation of the Oviedo Convention on Human Rights and Biomedicine:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=64201.264663
p.000057: 4. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine,
p.000057: Concerning Biomedical Research
p.000057: 5. Act C of 2012 on the Criminal Code, Chapter XVI Medical Procedures and Criminal Offenses Against the Order of
p.000057: Research, Sections 168-175
p.000057:
p.000057: Clinical Trials:
p.000057: Act XCV of 2005 on Medicinal Products for Human Use, Section 3: http://net.jogtar.hu/jr/gen/getdoc.cgi
p.000057: ?docid=a0500095.tv&dbnum=62
p.000057:
p.000057: Non-Interventional Trials: Act CLIV of 1997 on Health Care, Chapter VIII, Section 164/A:
p.000057: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000058: 58
p.000058: 1. Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings:
p.000058: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam
p.000058: 2. Decree 35/2005 (VIII.26.) of
p.000058: the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the
p.000058: Application of Good Clinical Practice: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0500035.EUM
p.000058: 3. Decree No. 235/2009 (X.20.)
p.000058: from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical
p.000058: Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices:
p.000058: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Clinical Trials:
p.000058: Decree 35/2005 (VIII. 26) of the Minister of Health on the Clinical Trial and Application of Correct Clinical Practices
p.000058: of Investigational Medicinal Products Intended for Use in Humans: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000058: gi?docid=A0500035.EUM&celpara= #xcelparam
p.000058:
p.000058: Country Key Organizations Legislation
p.000058: Regulations Guidelines
p.000058:
p.000058: Drugs, Biologics, and Devices
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
...
p.000106: Ukraine
p.000106: General
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Drugs, Biologics, and Devices
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Swiss National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Ukrainian Ministry of Health:
p.000106: http://www.moz.gov.ua/en/
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: 1. Ministry of Health of Ukraine State Expert Center: http://www.dec.gov.ua
p.000106: 2. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index-
p.000106: 3. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles
p.000106: 3, 32 - 35, 42, and 49: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html Embryos in Vivo:
p.000106: Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30 Articles 2, 25
p.000106: - 27, 39, 40, 44,
p.000106: and 62: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000106:
p.000106: Others:
p.000106: Federal Act of 19 December 2003 on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA), RS 810.31:
p.000106: http://www.admin.ch/opc/en/classifi ed- compilation/20022165/index.html
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: 1. Constitution of Ukraine Art. 28 (1996)
p.000106: 2. Health Care Law, Article 45 (1992)
p.000106: 3. Criminal Code of Ukraine 2001, Article 141 and 142
p.000106: 1. Ministry of Health Act On Procedure of Clinical Trials and Basic Statute of Ethics Commission 23.09/2009 No. 690
p.000106: (2014): http://zakon5.rada.gov.ua/laws/sho
p.000107: 107
p.000107: ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305
p.000107: Articles 22 and 35, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html
p.000107: 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS
p.000107: 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html
p.000107: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000107: HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000107: Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi
p.000107: ed-compilation/20121176/index.html
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines
p.000107: (2009): http://zakon5.rada.gov.ua/rada/show/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: NEK-CNE:
p.000107: 1. Pre-Implantation Genetic Diagnosis, 2007/9:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
p.000014: General
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Drugs, Biologics, and Devices
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/
p.000014: Social Security Administration:
p.000014: http://www.ssa.gov/
p.000014:
p.000014: Drugs and Biologics
...
p.000024: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=10 8&CL=ENG
p.000024:
p.000024:
p.000024: Directive 2004/23/EC on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing,
p.000024: Preservation, Storage, and Distribution of Human Tissues and Cells: http://eur- lex.europa.eu/LexUriServ/LexUriSe
p.000024: rv.do?uri=CELEX:32004L0023:EN
p.000024: :HTML
p.000024: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22, ETS No. 164 (1997):
p.000025: 25
p.000025: 1. European Medicines Agency policy on publication of clinical data for medicinal products for human use
p.000025: https://www.ema.europa.eu/documents/other/e uropean-medicines-agency-policy-publication-
p.000025: clinical-data-medicinal-products-human- use_en.pdf
p.000025: 2. Questions and Answers on the European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products
p.000025: for Human Use (2015): http://www.ema.europa.eu/docs/en_GB/docum ent_library/Report/2014/10/WC500174378.pdf
p.000025: 3. External Guidance on the Implementation of the European Medicines Agency Policy on the Publication of Clinical Data
p.000025: for Medicinal Products for Human Use (2016): https://www.ema.europa.eu/documents/regulat
p.000025: ory-procedural-guideline/external-guidance- implementation-european-medicines-agency-
p.000025: policy-publication-clinical-data_en-1.pdf
p.000025: 1. Recommendation No. R (97) 5 on the Protection of Medical Data (1997): https://wcd.coe.int/ViewDoc.jsp?id=571075&S
p.000025: ite=CM&BackColorInternet=C3C3C3&BackC olorIntranet=EDB021&BackColorLogged=F5 D383
p.000025: 2. Article 29 Working Party Documentation: http://ec.europa.eu/justice/data- protection/article-29/index_en.htm
p.000025: Guidelines on Good Clinical Practice Specific to Advanced Therapy Medicinal Products:
p.000025: https://ec.europa.eu/health/sites/health/files/file s/eudralex/vol-10/atmp_guidelines_en.pdf
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Recommendation Rec (2016) 6 of the Committee of Ministers to Member States on Research on Biological Materials of Human
p.000025: Origin:
p.000025:
p.000025: Country Key Organizations Legislation
p.000025: Regulations Guidelines
p.000025:
p.000025: Human Biological Materials
p.000025:
p.000025: Genetic Research
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Embryos, Stem Cells, and Cloning
p.000025:
p.000025:
p.000025:
p.000025: European Medicines Agency:
p.000025: http://www.ema.europa.eu/
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Council of Europe, Bioethics Unit:
p.000025: http://www.coe.int/bioethics
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: European Commission:
p.000025: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m
...
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996)
p.000050: including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf
p.000050:
p.000050: Country Key Organizations Legislation
p.000050: Regulations Guidelines
p.000050: Research Injury Convention on Human Rights
p.000050: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000050: 164 (2001)
p.000050:
p.000050: Privacy/Data Protection
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Embryos, Stem Cells, and Cloning
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Germany
p.000050: General
p.000050: Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/weite re-sprachen/english/german-medical-
p.000050: association/
p.000050: 2. Central Ethics Committee of the German Medical Association (ZEKO):
p.000050: http://www.zentrale-ethikkommission.de/
p.000050: 3. Permanent Working Party of Research Ethics Committees in Germany:
p.000050: http://www.ak-med-ethik-komm.de/
p.000050: 4. German Ethics Council:
p.000050: https://www.ethikrat.org/en/
p.000050: 5. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000050: 6. German Research Foundation (DFG), Permanent Senate Commission on Key Questions in Clinical Research (SCCR):
p.000050: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/clinical_research/index.ht
p.000050: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000050: 2. Law on Data Protection (2018): https://matsne.gov.ge/en/document/ view/1561437?publication=15
p.000050: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000050: Cloning ETS No. 168 (2001)
p.000050: 2. Law on Health Care, Article 142 (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: BÄK:
p.000051: (Model) Professional Code for Physicians in Germany, Article 15 (2018): http://www.bundesaerztekammer.de/fileadmin/
p.000051: user_upload/downloads/pdf- Ordner/MBO/MBO-AE_EN_2018.pdf
...
Searching for indicator political:
(return to top)
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Country Key Organizations Legislation
p.000004: Regulations Guidelines
p.000004:
p.000004:
p.000004: INTERNATIONAL
p.000004: General Council for International Organizations of
p.000004: Medical Sciences (CIOMS):
p.000004: http://www.cioms.ch/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: International Committee of the Red Cross (ICRC): www.icrc.org
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Office of the United Nations High Commissioner for Human Rights (OHCHR): http://www.ohchr.org/english/
p.000004:
p.000004: TRUST Project:
p.000004: http://www.globalcodeofconduct.org
p.000004:
p.000004:
p.000004:
p.000004: UNAIDS:
p.000004: http://www.unaids.org/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950):
p.000004: https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68
p.000004: 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977):
p.000004: http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9
p.000004: International Covenant on Civil and Political Rights, Article 7 (1976):
p.000004: http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
p.000005: 2. Ethical Considerations
p.000005: in Biomedical HIV Prevention Trials (2012):
p.000005: http://www.unaids.org/en/media/unaids/conten
p.000005:
p.000005: Country Key Organizations Legislation
p.000005: Regulations Guidelines
p.000005: tassets/documents/unaidspublication/2012/jc1
p.000005:
p.000005: General
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
p.000160: 160
p.000160:
p.000160: Country Key Organizations Legislation
p.000160: Regulations Guidelines
p.000160:
p.000160: Human Biological Materials
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Barbados
p.000160:
p.000160:
p.000160:
p.000160: Bermuda
p.000160: General
p.000160:
p.000160: Bolivia
p.000160: General
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Drugs, Biologics, and Devices
p.000160: Ministry of Health:
p.000160: https://www.argentina.gob.ar/salud
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: University of the West Indies – Cave Hill / Ministry of Health: http://www.cavehill.uwi.edu/researchethic s/home.aspx
p.000160:
p.000160: Department of Health:
p.000160: https://www.gov.bm/department/health
p.000160:
p.000160:
p.000160: 1. Ministry of Health and Sport (MHS): http://www.sns.gob.bo
p.000160: 2. National Bioethics Committee (NBC)
p.000160:
p.000160:
p.000160:
p.000160: 1. Ministry of Health and Sport, National Pharmacological Commission (MHS): http://www.sns.gob.bo
p.000160: 2. National Bioethics Committee (NBC)
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: 1. Legal Decree No. 15.629 of July 18, 1978, Articles 147 and 148.
p.000160: 2. New Political Constitution of the State, Article 44 (2009): https://www.constituteproject.org/co
p.000160: nstitution/Bolivia_2009.pdf
p.000160: 1. Resolution 1789/2006: Authorization for Import and Export of Biological Material for Diagnosis, Research and
p.000160: Surveillance Purposes: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/120000- 124999/122199/norma.htm
p.000160: 2. Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of
p.000160: Health Research, Section A3: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: 1. Regulations on Public Health Research, Chapter V (1978)
p.000160: 2. Rules and Regulations of the National Bioethics Committee
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Research Ethics Policy and Guidelines
p.000160:
p.000160:
p.000160:
p.000160: Research Governance Framework (2008): http://citeseerx.ist.psu.edu/viewdoc/download?
p.000160: doi=10.1.1.592.8671&rep=rep1&type=pdf
p.000160:
p.000160: MHS:
p.000160: Guidelines for the Development of Health Research and Ethical Norms (2002)
p.000160:
p.000160: NBC:
p.000160: 1. Requirements for the Evaluation of Research Projects
p.000160: 2. Code of Ethics and Medical Deontology MHS:
p.000160: Rule on Clinical Studies with Medicines or Products in the Clinical Investigation Stage (2005)
p.000160:
p.000160: NBC:
p.000160: Projects that Involve Drugs or Therapeutic Products
p.000160:
p.000160:
p.000161: 161
p.000161:
...
Political / stateless persons
Searching for indicator nation:
(return to top)
p.000149:
p.000149: General
p.000149: 1. Ministry of Health (MOH): http://www.moh.gov.vn/homebyt/en/porta l/index.jsp
p.000149: 2. Ministry of Health, Independent Ethics Committee (MOH): http://iecmoh.vn
p.000149: MOH:
p.000149: Decision No. 111/QD-BYT – On Promulgation of Regulation on Organization and Operation of Council of Ethics in
p.000149: Biomedical Research at Grass-
p.000150: 150
p.000150: MOH:
p.000150: Decision No. 460/QD-BYT – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation
p.000150: Committee in Biomedical Research of the
p.000150: 1. Circular No. 45/2017/TT-BYT – Regulation on the Establishment, Functions, Tasks, and Powers of the Ethics Committee
p.000150: in Biomedical Research (2017) (Vietnamese): https://thuvienphapluat.vn/van-ban/The-thao-
p.000150: Y-te/Thong-tu-45-2017-TT-BYT-nhiem-vu-
p.000150:
p.000150: Country Key Organizations Legislation
p.000150: Regulations Guidelines
p.000150:
p.000150: General
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150: Drugs, Biologics, and Devices
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150: Ministry of Health: http://www.moh.gov.vn/homebyt/en/porta l/index.jsp
p.000150: Roots Level, Chapter I (Articles 3 and 4), Chapter II, and
p.000150: Chapter III (2013): http://clinregs.niaid.nih.gov/docume nts/vietnam/DecisionNo111-QD- BYT.pdf
p.000150:
p.000150:
p.000150: 1. Law on Pharmacy (No. 34/2005/QH11), Chapter II (Section III, Article 20), Chapter VIII (Articles 54 and 59) (2005):
p.000150: http://www.vertic.org/media/Nation al%20Legislation/Vietnam/VN_La w_on_Pharmacy.pdf
p.000150: 2. Decision No. 799/QD-BYT on the Issuance of Guideline on Good Clinical Practice, Chapter III, Articles 1 and 2
p.000150: (2008): http://clinregs.niaid.nih.gov/doc uments/vietnam/DecisionNo799
p.000150: -QD-BYT.pdf
p.000150: Ministry of Health, Period 2012- 2017, Chapters I-III (2012):
p.000150: http://clinregs.niaid.nih.gov/documen ts/vietnam/DecisionNo460-QD- BYT.pdf
p.000150:
p.000150:
p.000150:
p.000150: 1. Decision No. 799/QD-BYT of the Minister of Health on the Promulgation of the Guidelines on Good Clinical Practice of
p.000150: Clinical Trials (2008): http://clinregs.niaid.nih.gov/documen ts/vietnam/DecisionNo799-QD- BYT.pdf
p.000150: 2. Circular – Guidelines for Clinical Trials on Drugs (C- ClinDrugTrial), Articles 2, 4, 5, 9, 17, 18, 31, and 39
p.000150: (2012): http://clinregs.niaid.nih.gov/documen ts/vietnam/C-ClinDrugTrial.pdf
p.000150: quyen-han-Hoi-dong-dao-duc-nghien-cuu-y- sinh-hoc-354849.aspx
p.000150: 2. Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in Biomedical Research of the Ministry of
p.000150: Health, Period 2018-2023: http://crc.pasteurhcm.gov.vn/upload/files/1122
p.000150: _2018.pdf
p.000150: Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17
p.000150: (2012):
p.000150: https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf
p.000150: 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van-
p.000150: ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
...
p.000178: le/460756/7_Guia_CEI_2018_6a.pdf
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: 1. Guidelines to Fulfill Good Clinical Practice in Health Research (2012):
p.000178: http://www.imss.gob.mx/sites/all/statics/profesi onalesSalud/investigacionSalud/normativaNac/ 6_Lineamientos_BPC.pdf
p.000178: 2. Guide for the Submission of Human Research Protocols – Observational Studies (2016)
p.000178: 3. Guide for the Submission of Human Research Protocol Amendments – Requirements for Applicant Information Changes
p.000178: (2016): https://www.gob.mx/cms/uploads/attachment/fi le/149028/Gu_a_de_Sometimiento_COFEPRI S-09-012_MODIFICACI_N.pdf
p.000178:
p.000178: Country Key Organizations Legislation
p.000178: Regulations Guidelines
p.000178:
p.000178: Genetic Research
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: Nicaragua
p.000178: Note: All websites and documents are in Spanish.
p.000178: 1. Ministry of Health (MINSA) Nicaragua: http://www.minsa.gob.ni
p.000178: 2. Institutional Ethical Review Committee (CIRE)
p.000178: Panamá
p.000178: Note: All websites and documents are in Spanish.
p.000178: 2. Regulation of the Biosafety Law on Genetically Modified Organisms (2009) http://www.diputados.gob.mx/Leyes
p.000178: Biblio/regley/Reg_LBOGM.pdf
p.000178: 3. Modifications to the General Health Law to Protect Genomic Sovereignty (2008)
p.000178: 4. Modifications to the General Health Law to Protect Genomic Sovereignty (2008)
p.000178:
p.000178:
p.000178: Ley General de Salud, No 423 Republica de Nicaragua: http://www.vertic.org/media/Nation
p.000178: al%20Legislation/Nicaragua/NI_Le y_423_General_de_Salud_2002.pdf
p.000178: Biblio/regley/Reg_LGS_MIS.pdf
p.000178:
p.000178: General
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: Drugs, Biologics, and Devices
p.000178:
p.000178: Privacy/Data Protection
p.000178: 1. Ministry of Health (MINSA):
p.000178: http://www.minsa.gob.pa/
p.000178: 2. National Committee of Research Bioethics: https://cnbi.senacyt.gob.pa
p.000178: Law Nº 84 on Research with Human Beings (2019): https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Ley-N°84-
p.000178: del-14-de-mayo-de-2019-Ley-de- investigación.pdf
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: Law 1 of 2001, Official Gazette
p.000178: 24,218:
p.000178: http://www.perezcarrera.com/leyes/l ey-registro-sanitario-panama.pdf
p.000178: 1. Law Nº 68, November 20, 2003: https://cnbi.senacyt.gob.pa/wp-
p.000179: 179
p.000179: MINSA:
p.000179: 1. Executive Decree Nº1, January 21, 2013: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto-
p.000179: Ejecutivo-N°1-del-21-de-Enero- de-2013.pdf
p.000179: 2. Executive Decree N°1843 on the National Research Ethics Committee of Panama (2014):
p.000179: https://www.gacetaoficial.gob.pa/.../G acetaNo_27716_20150206.pdf
p.000179: 3. Executive Decree N° 6 on the National Research Ethics Committee of Panama (2015):
p.000179: https://www.gacetaoficial.gob.pa/pdf Temp/27716/GacetaNo_27716_2015 0206.pdf
p.000179:
p.000179:
p.000179:
p.000179:
...
p.000186: s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20ON%20GOOD%20C LINICAL%20PRACTICE%20IN%20GHANA
p.000186: .pdf
p.000186: 2. Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices
p.000186: (2015): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20AUTHORI ZATION%20OF%20CLINICAL%20TRIALS
p.000186: %20OF%20MEDICINES,%20GHANA.pdf
p.000186: 3. Guidelines for Conduct of Clinical Trials in Paediatric Population (2016):
p.000186: http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20CONDUCT
p.000186: %20OF%20CLINICAL%20TRIALS%20WIT H%20PAEDIATRIC%20POPULATION%20I N%20GHANA.pdf
p.000186: 4. Guidelines for Conduct of Clinical Trials During Emergencies (2016): http://www.fdaghana.gov.gh/images/stories/pdf
p.000186: s/downloads/drugs%20guidelines/GUIDELINE S%20FOR%20TRIALS%20IN%20EMERGE NCIES1.pdf
p.000186: For an overview of the clinical research regulations in Guinea, see the ClinRegs report:
p.000186: https://clinregs.niaid.nih.gov/single_country.php?c_id=90 Note: All websites and documents are in French.
p.000186:
p.000186: General
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: Research Injury
p.000186: National Ethics Committee on Health Research (CNERS): http://cners- guinee.org/
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: National Ethics Committee on Health Research: http://cners-guinee.org/
p.000186: Public Health Code, Articles 237-316 (1997):
p.000186: http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code
p.000186: _Sante_Publique.pdf
p.000186:
p.000186:
p.000186:
p.000186: Public Health Code, Articles 301-302 (1997):
p.000186: http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code
p.000187: 187
p.000187: Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for
p.000187: Research in Health (CNERS), Chapters I and II (1998):
p.000187: http://cners-guinee.org/wp- content/uploads/2014/02/Decret-.pdf
p.000187: CNERS:
p.000187: Frequently Asked Questions: http://cners- guinee.org/faq/
p.000187:
p.000187: Country Key Organizations Legislation
p.000187: Regulations Guidelines
p.000187:
p.000187: Research Injury
p.000187: Kenya
p.000187: _Sante_Publique.pdf
p.000187: For an overview of the clinical research regulations in Kenya, see the ClinRegs report:
p.000187: http://clinregs.niaid.nih.gov/single_country.php?c_id=111
p.000187:
p.000187: General
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Drugs, Biologics, and Devices
p.000187:
p.000187:
p.000187: Human Biological Materials
p.000187:
p.000187:
p.000187: Liberia
p.000187: 1. National Council for Science and Technology (NCST): http://www.nacosti.go.ke/
p.000187: 2. Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187:
p.000187:
p.000187: Pharmacy and Poisons Board:
p.000187: http://www.pharmacyboardkenya.org/
p.000187:
p.000187:
p.000187:
p.000187: Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187: 1. Science and Technology Act (2001)
p.000187: 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
p.000187:
p.000187: Pharmacy and Poisons Act, Chapter 244 (2009): http://apps.who.int/medicinedocs/do cuments/s18245en/s18245en.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: MOH:
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000060: Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as Regards Transplantation and Storage of
p.000060: Organs and Tissues and Certain Histopathology Examinations: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000060: gi?docid=99800018.EUM&celpara=# xcelparam
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 30/1998. (VI. 24.) of the Minister of Welfare on Regulations on Specific Procedures for Human Reproduction:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=99800030.NM&celpara=#x celparam
p.000060:
p.000060: Regulation on the Structure of Research Projects in the Health Sector, Including Research Protocol, Internal
p.000060: Monitoring, and
p.000060: and Data Processors (2018): http://www.naih.hu/felkeszueles-az- adatvedelmi-rendelet-alkalmazasara.html
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 60/2003. (X. 20.) of the Minister of Health, Social and Family Affairs on the Minimum Professional Requirements
p.000060: Necessary for Providing Health Services: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =A0300060.ESC&celpara=#xcelparam
p.000060:
p.000060:
p.000060: Decree 18/1998. (XII. 27.) of the Minister of Health on Implementing Act CLIV of 1997 on Health Care Regarding
p.000060: Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =99800018.EUM&celpara=#xcelparam
p.000060:
p.000060: NBC:
p.000060: 1. Vulnerable Groups Including Children: http://www.vsn.is/en/content/vulnerable- groups-including-children
p.000060:
p.000060: Country Key Organizations Legislation
p.000060: Regulations Guidelines
p.000060:
p.000060: General
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs, Biologics, and Devices
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Research Injury
p.000060: (NBC):
p.000060: http://www.vsn.is/en
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs
p.000060: 1. Icelandic Medicines Agency (MCA):
p.000060: http://www.ima.is/
p.000060: 2. National Bioethics Committee (NBC):
p.000060: www.visindasidanefnd.is
p.000060:
p.000060:
p.000060: Devices
p.000060: Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Icelandic Health Insurance Agency (MCA):
p.000060: http://www.sjukra.is/english
p.000060: media/media/acrobat- enskar_sidur/Health-Sector- Research-Act-No-44-2014.pdf
p.000060: 3. Oviedo Convention on Human Rights and Biomedicine (2004)
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Medicinal Products Act No. 93/1994 (2013):
p.000060: http://eng.velferdarraduneyti.is/acts- of-Parliament/nr/20128
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Act on Medical Devices No 16/2001 (2011):
...
Health / Cadavers
Searching for indicator cadavers:
(return to top)
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: 1. Constitution of Colombia, Article 15 (2003): http://www.corteconstitucional.gov. co/inicio/Constitucion%20politica%
p.000170: 20de%20Colombia%20-
p.000170: %202015.pdf
p.000170: 2. Law 1581 of 2012: General Regimen of Protection of Personal Data: https://www.mintic.gov.co/portal/60
p.000170: 4/articles-4274_documento.pdf
p.000170:
p.000170:
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p.000170:
p.000171: 171
p.000171:
p.000171:
p.000171:
p.000171:
p.000171: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title III, Chapters I
p.000171: and III (1993):
p.000171: https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000171: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter I,
p.000171: Art. 13 (1993):
p.000171: https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000171: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter I,
p.000171: Article 8 (1993)
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171: 1. Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter
p.000171: VI (1993): https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000171: 2. Requirements for the Use of Unclaimed Cadavers for Research Purposes, Resolution No. 002640,
p.000171: https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/normatividad/Circula
p.000171: r_600-2006-16_Alcance-Circular-600-1081- 16_Abril2016.pdf
p.000171:
p.000171: Country Key Organizations Legislation
p.000171: Regulations Guidelines
p.000171:
p.000171: Human Biological Materials
p.000171: Genetic Research
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171: Costa Rica
p.000171:
p.000171:
p.000171:
p.000171: Ministry of Health and Social Protection: http://www.minsalud.gov.co
p.000171: Article 21 (2005):
p.000171: https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/Resolución_2640_de_2005.pdf Scientific, Technical, and Administrative Regulations
p.000171: for Health Research, Resolution No. 008430, Title III, Chapter II (1993):
p.000171: https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000171:
p.000171: Note: All websites and documents are in Spanish.
p.000171: General Ministry of Health:
p.000171: http://www.misalud.go.cr
p.000171:
p.000171: Reform Regulation to the Biomedical Research Regulatory Law: http://www.pgrweb.go.cr/scij/Busque
p.000171: da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor 1=1&nValor2=81213&nValor3=103 450&strTipM=TC
p.000171:
p.000171: Drugs, Biologics, and Devices
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171: Clinical Trials Registry
p.000171: National Health Research Council: http://www.ministeriodesalud.go.cr/index. php/consejos/conis
p.000171:
p.000171:
...
Health / Cognitive Impairment
Searching for indicator impaired:
(return to top)
p.000082:
p.000082:
p.000082: National Committee for Research Ethics in Science and Technology (NENT):
p.000082: https://www.etikkom.no/en/our-
p.000082: 1. Foetal Tissue Act (2001) (Dutch): http://wetten.overheid.nl/BWBR001 2983/
p.000082: 2. Embryos Act (2002): http://www.ccmo.nl/attachments/file s/embryos-act.pdf
p.000082:
p.000082: 1. Oviedo Convention on Human Rights and Biomedicine (2006)
p.000082: 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovdata/ lov-20060630-056-eng.pdf
p.000082: 3. Act on Health Care Research (2008): http://www.lovdata.no/cgi-
p.000082: wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov
p.000082: *&&
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p.000083: 83
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. Organization of Health Research: https://lovdata.no/dokument/SF/forsk rift/2009-07-01-955
p.000083: 2. Population-Based Health Survey: https://lovdata.no/dokument/SF/forsk rift/2018-04-27-645
p.000083: 3. Right of Children Between 12- 16 Years to Consent to Participate in Health Research:
p.000083: https://lovdata.no/dokument/SF/forsk rift/2017-06-28-1000
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. Guidelines for Research on Persons with Impaired Informed Consent Capacity (2005)
p.000083: 2. Payment for Research Participants in Medical and Health Research (2009)
p.000083: 3. Guidelines for Research Ethical and Scientific Evaluation of Qualitative Research Projects in Medical and Health
p.000083: Research (2009): https://www.etikkom.no/forskningsetiske- retningslinjer/Medisin-og-helse/Kvalitativ- forskning/
p.000083: 4. Guidelines for Ethical Evaluation and Post-marketing Studies (2003)
p.000083: 5. Guidelines for Genetic Research of Humans (2016) (Norwegian): https://www.etikkom.no/forskningsetiske-
p.000083: retningslinjer/Medisin-og- helse/retningslinjer-for-bruk-av-genetiske- undersokelser-av-mennesker-i-medisinsk-
p.000083: og-helsefaglig-forskning/
p.000083: 1. Guidelines for Research Ethics in the Social Sciences, Humanities, Law and Theology (2016):
p.000083: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research-ethics-in-
p.000083: the-social-sciences--humanities-law-and- theology/
p.000083: 2. A Guide to Internet Research Ethics (2019):
p.000083: https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/
p.000083: Research Ethics Guidelines for Science and Technology (2016): https://www.etikkom.no/en/ethical-guidelines-
p.000083: for-research/guidelines-for-research-ethics-in- science-and-technology/
p.000083:
p.000083: Country Key Organizations Legislation
p.000083: Regulations Guidelines
p.000083:
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000009: General 1. Interagency Advisory Panel on Research Ethics (PRE):
p.000009: http://www.pre.ethics.gc.ca/eng/index
p.000009: 2. National Defence and the Canadian Armed Forces: http://www.forces.gc.ca/en/index.page
p.000009: 3. Correctional Service of Canada:
p.000009: http://www.csc-scc.gc.ca/index-eng.shtml
p.000009:
p.000009:
p.000009:
p.000009: PRE:
p.000009: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2018):
p.000009: http://www.pre.ethics.gc.ca/eng/document s/tcps2-2018-en-interactive-final.pdf
p.000009:
p.000009: National Defence and the Canadian Armed Forces:
p.000009: Research Involving Human Subjects (1998): http://www.forces.gc.ca/en/about- policies-standards-defence-admin-orders-
p.000009: directives-5000/5061-0.page
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs, Biologics, and Devices
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs
p.000009: 1. Health Canada, Therapeutic Products Directorate: http://www.hc- sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
p.000009: dgpsa/tpd-dpt/index-eng.php
p.000009: 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 1. Regulations Amending the Food and Drug Regulations (1024
p.000009: – Clinical Trials) (2001): http://www.hc-sc.gc.ca/dhp- mps/alt_formats/hpfb- dgpsa/pdf/compli-conform/1024- eng.pdf
p.000009: Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2017): http://www.csc-
p.000009: scc.gc.ca/acts-and-regulations/009-cd-en.shtml
p.000009:
p.000009: Health Canada:
p.000009: Good Clinical Practice: Integrated Addendum to E6(R1)
p.000009: ICH Topic E6(R2) (2017)
p.000009: https://www.canada.ca/content/dam/hc- sc/migration/hc-sc/dhp- mps/alt_formats/pdf/prodpharma/applic-
p.000009: demande/guide-ld/ich/efficac/e6r2-step4- eng.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Devices
p.000009: Health Canada, Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md- im/index-eng.php
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Medical Devices Regulations (SOR/98-282) (1998): http://laws- lois.justice.gc.ca/eng/regulations/sor-
p.000009: 98-282/FullText.html
p.000010: 10
p.000010: PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 11: Clinical Trials
p.000010: (2018):
p.000010: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000010: Country Key Organizations Legislation
p.000010: Regulations Guidelines
p.000010:
p.000010: Clinical Trials Registry
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Research Injury
p.000010:
p.000010:
p.000010:
p.000010: Social-Behavioral Research
p.000010:
p.000010:
...
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
p.000012: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000012:
p.000012: 1. 34 CFR 97 subparts A (1991) and D (1997)
p.000012: 2. 34 CFR 98 (1984)
p.000012: 3. 34 CFR 99 (2000)
p.000012: 4. 34 CFR 350.4(c) (1991)
p.000012: 5. 34 CFR 356.3(c) (1991)
p.000012: Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015):
p.000012: https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf
p.000012:
p.000012: Country Key Organizations Legislation
p.000012: Regulations Guidelines
p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
p.000012: Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/
p.000012:
p.000012:
p.000012: Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/
p.000012:
p.000012:
p.000012:
p.000012: Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland
p.000012: Security: www.dhs.gov/
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Housing and Urban Development: www.hud.gov/
p.000012: 1. Department of Justice Office of Justice Programs:
p.000012: http://ojp.gov/
p.000012: 2. Bureau of Prisons:
p.000012: www.bop.gov
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Labor:
p.000012: https://www.dol.gov/
p.000012:
p.000012:
p.000012:
p.000012: Public Health Service Act (1993):
p.000012: http://history.nih.gov/research/d ownloads/PL103-43.pdf
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Public Law 108-458, Section 8306
p.000012: 1. 10 CFR 745 (1991), Subpart A
p.000012: 2. DOE Order 443.1B
p.000012: 3. DOE Order 481.1
p.000012: 45 CFR 46, Subparts A, B, C, D, and E (2018):
p.000012: https://www.hhs.gov/ohrp/sites/defau lt/files/revised-common-rule-reg- text-unofficial-2018- requirements.pdf
p.000012: FDA is not a Common Rule agency. For studies conducted or funded by FDA:
p.000012: 45 CFR 46, Subparts A, D, and E:
p.000012: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000012:
p.000012:
p.000012:
p.000012: 1. 45 CFR 46, Subparts A-D
...
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
p.000014: General
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
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p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Drugs, Biologics, and Devices
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/
p.000014: Social Security Administration:
p.000014: http://www.ssa.gov/
p.000014:
p.000014: Drugs and Biologics
p.000014: Food and Drug Administration: https://www.fda.gov/Drugs and https://www.fda.gov/vaccines-blood- biologics
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Devices
p.000014: Food and Drug Administration, Center for Devices and Radiological
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
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p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: 1. Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (2012): https://uscode.house.gov/browse/pre
p.000014: lim@title21&edition=prelim
p.000014: 2. Public Health Service Act, 42 USC Section 262 (1998): https://uscode.house.gov/browse/pre lim@title42&edition=prelim
p.000014: 3. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW-
p.000014: 114publ255.pdf
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: 1. Food, Drug, and Cosmetic Act, 21 USC Section 360
p.000015: 15
p.000015: 7. Subpart M: Requirements for Submission of Information on the Ethical Conduct of Completed Human Research (2013)
p.000015: 8. Subpart O: Administrative Actions for Noncompliance (2013)
p.000015: 9. Subpart P: Review of Proposed and Completed Human Research (2013)
p.000015: 10. Subpart Q: Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions (2013)
p.000015: 14 CFR 1230, Subpart A
p.000015:
p.000015: 45 CFR 690, Subpart A
p.000015:
p.000015: 45 CFR 46, Subpart A: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000015:
p.000015: Title 21, Code of Federal Regulations: https://www.fda.gov/science- research/clinical-trials-and-human-
p.000015: subject-protection/regulations-good- clinical-practice-and-clinical-trials
p.000015: 1. 21 CFR 50 (Informed Consent)
p.000015: 2. 21 CFR 312 (Investigational New Drug Application)
p.000015: 3. 21 CFR 56 (Institutional Review Boards)
p.000015: 4. 21 CFR 314 (Applications for Approval to Market a New Drug)
p.000015: 5. 21 CFR 54 (Financial Disclosure by Clinical Investigators)
p.000015: 6. 21 CFR 320 (Bioavailability and Bioequivalence Requirements)
p.000015:
p.000015: Title 21, Code of Federal Regulations:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
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p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: General:
p.000015: Good Clinical Practice and Human Subject Protection in FDA-Regulated Clinical Trials: https://www.fda.gov/science-
p.000015: research/science-and-research-special- topics/clinical-trials-and-human-subject- protection
p.000015:
p.000015: Drugs:
p.000015: https://www.fda.gov/drugs/guidance- compliance-regulatory-information/guidances- drugs
p.000015:
p.000015: Biologics:
p.000015: https://www.fda.gov/vaccines-blood- biologics/guidance-compliance-regulatory- information-biologics
p.000015:
p.000015:
p.000015:
p.000015: Good Clinical Practice and Human Subject Protections in FDA-Regulated
p.000015:
p.000015: Country Key Organizations Legislation
p.000015: Regulations Guidelines
p.000015:
p.000015: Drugs, Biologics, and Devices
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Clinical Trials Registry
p.000015: Health: https://www.fda.gov/Medical- Devices
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Food and Drug Administration: https://www.fda.gov/science- research/clinical-trials-and-human-
p.000015: subject-protection/fdas-role- clinicaltrialsgov-information
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: National Institutes of Health ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/home
p.000015: (2012):
p.000015: https://uscode.house.gov/browse/pre lim@title21/chapter9/subchapter5& edition=prelim
p.000015: 2. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW-
p.000015: 114publ255.pdf
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 1. Food and Drug Administration Modernization Act, Section 113 (1997): https://www.fda.gov/regulatory-
p.000015: information/selected-amendments- fdc-act/food-and-drug- administration-modernization-act- fdama-1997
p.000015: 2. Food and Drug Administration Amendments Act, Section 801 (2007): https://www.fda.gov/regulatory-
p.000015: information/selected-amendments- fdc-act/food-and-drug- administration-amendments-act- fdaaa-2007
p.000015: https://www.fda.gov/science- research/clinical-trials-and-human- subject-protection/regulations-good-
p.000015: clinical-practice-and-clinical-trials
p.000015: 1. 21 CFR 50 (Informed Consent)
p.000015: 2. 21 CFR 56 (Institutional Review Boards)
p.000015: 3. 21 CFR 807, Subpart E
p.000015: 4. 21 CFR 812 (Investigational Device Exemptions)
p.000015: 5. 21 CFR 814 (Premarket Approval of Medical Devices)
p.000015: 6. 21 CFR 54 (Financial Disclosure by Clinical Investigators)
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 1. Clinical Trials Regulation and Results Information Submission, 42 CFR 11 (2016):
p.000015: https://www.federalregister.gov/docu ments/2016/09/21/2016- 22129/clinical-trials-registration-and-
p.000015: results-information-submission
p.000015: 2. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (2016):
p.000015: https://www.federalregister.gov/docu ments/2016/09/21/2016- 22379/dissemination-of-nih-funded-
p.000015: clinical-trial-information
p.000015: Clinical Trials: https://www.fda.gov/science- research/science-and-research-special-
p.000015: topics/clinical-trials-and-human-subject- protection
p.000015:
p.000015: Other: https://www.fda.gov/medical- devices/device-advice-comprehensive- regulatory-assistance/guidance-documents-
p.000015: medical-devices-and-radiation-emitting- products
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
...
p.000017: NIH:
p.000017: 1. NIH Policy on Certificates of Confidentiality (2017): https://humansubjects.nih.gov/coc/index
p.000017: 2. Various:
p.000017: http://privacyruleandresearch.nih.gov/
p.000017:
p.000017: AHRQ:
p.000017: Confidentiality in AHRQ-Supported Research (2018): https://grants.nih.gov/grants/guide/notice- files/NOT-HS-18-012.html
p.000017:
p.000017: OCR:
p.000017: 1. OCR 21st Century Cures Act Research Guidance on Activities Preparatory to Research (2017):
p.000017: https://www.hhs.gov/sites/default/files/remote-
p.000017:
p.000017: Country Key Organizations Legislation
p.000017: Regulations Guidelines
p.000017:
p.000017: Privacy/Data Protection
p.000017: AW-111publ5/pdf/PLAW- 111publ5.pdf
p.000017: access-research-12-15-17.pdf
p.000017: 2. OCR 21st Century Cures Act Research Guidance om Streamlining Authorization (2018):
p.000017: https://www.hhs.gov/sites/default/files/hipaa- future-research-authorization-guidance- 06122018%20v2.pdf
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Human Biological Materials
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Homeland Security:
p.000017: www.dhs.gov/
p.000017:
p.000017:
p.000017: Social Security Administration:
p.000017: http://www.ssa.gov/
p.000017:
p.000017: All Common Rule agencies
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000017: Food and Drug Administration:
p.000017: a. Office of In Vitro Diagnostic Device Evaluation and Safety: https://www.fda.gov/medical-
p.000017: devices/products-and-medical- procedures/vitro-diagnostics
p.000017: b. Center for Biologics Research and Evaluation (CBER):
p.000017: - Office of Cellular, Tissue and Gene Therapies
p.000017: - Office of Blood Research and Review: https://www.fda.gov/vaccines-blood- biologics
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Public Law 107-347: https://www.gpo.gov/fdsys/pkg/PL AW-107publ347/pdf/PLAW- 107publ347.pdf
p.000017: Privacy Act (1974): http://www.hhs.gov/foia/privacy/ind ex.html
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Predominantly Exempt categories 4, 7, and 8, and Expedited
p.000018: categories 2, 3, and 5 in the
p.000018: Common Rule (2018): https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text-
p.000018: unofficial-2018-requirements.pdf
p.000018: Various: https://www.hhs.gov/hipaa/for- professionals/special- topics/research/index.html and
p.000018: https://www.hhs.gov/hipaa/for-
p.000018: professionals/faq/research-uses-and-disclosures
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/biological-materials-and- data/index.html
p.000018: 1. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not
p.000018: Individually Identifiable (2006): https://www.fda.gov/regulatory- information/search-fda-guidance-
p.000018: documents/guidance-informed-consent-vitro- diagnostic-device-studies-using-leftover- human-specimens-are-not
p.000018: 2. In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (2010) : https://www.fda.gov/regulatory-
p.000018: information/search-fda-guidance-
p.000018: documents/vitro-diagnostic-ivd-device-studies-
p.000018:
p.000018: Country Key Organizations Legislation
p.000018: Regulations Guidelines
p.000018:
p.000018: Human Biological Materials
p.000018:
p.000018:
p.000018: Genetic Research
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Embryos, Stem Cells, and Cloning
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: All Common Rule agencies
p.000018: 1. DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000018: 2. DHHS National Institutes of Health, Office of Science Policy, Biosafety, Biosecurity, and Emerging Biotechnology
p.000018: Policy Division: https://osp.od.nih.gov/biosafety- biosecurity-and-emerging-biotechnology/
p.000018: 3. DHHS Office for Civil Rights (OCR): https://www.hhs.gov/hipaa/for- professionals/special-topics/genetic-
p.000018: information/index.html
p.000018:
p.000018:
p.000018: Food and Drug Administration, Center for Biologics Evaluation and Research: https://www.fda.gov/vaccines-
p.000018: blood-biologics
p.000018:
p.000018: National Academy of Sciences (NAS):
p.000018: http://www.nationalacademies.org/nrc/
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: National Institutes of Health:
p.000018: http://stemcells.nih.gov/
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: 1. Research on Transplantation of Fetal Tissue, Public Law 103- 43 (1993): http://www.hhs.gov/ohrp/regulation
p.000018: s-and-policy/guidance/public-law- 103-43/index.html
p.000018: 2. Genetic Information Nondiscrimination Act (2008): https://www.gpo.gov/fdsys/pkg/PL AW-110publ233/content-detail.html
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Research on Transplantation of Fetal Tissue. Public Law 103-43
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Common Rule 116(c)(9) (2018) HIPAA Privacy Rule Provisions Implementing GINA Requirements at 45 CFR 160.103;
p.000019: 45 CFR 164.502(a)(5)(i); 45 CFR
p.000019: 164.514(g); and 45 CFR
p.000019: 164.520(b)(1)(iii)(C)
p.000019: frequently-asked-questions
p.000019: 3. CBER-Specific: Various: https://www.fda.gov/vaccines-blood- biologics/other-recommendations-biologics-
p.000019: manufacturers/references-regulatory-process- office-tissues-and-advanced-therapies
p.000019:
p.000019: OHRP:
...
p.000026:
p.000026: Embryos, Stem Cells, and Cloning
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Armenia
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Council of Europe, Bioethics Unit:
p.000026: http://www.coe.int/bioethics
p.000026: rv.do?uri=OJ:C:2013:373:0012:001 5:EN:PDF
p.000026:
p.000026:
p.000026: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997):
p.000026: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000026: 2. Additional Protocol on Prohibition of Human Cloning, ETS No. 168 (1998): http://conventions.coe.int/Treaty/Comm
p.000026: un/QueVoulezVous.asp?NT=168&CM= 7&DF=9/15/2008&CL=ENG
p.000026: WMdSR0EAlMEUUsWb0000dz-
p.000026: kvfzb;sid=Iexx3tq0IOFxyokBvtfvebiRJj93DZf XP54=?FileName=KAAJ07022ENC_002.pdf
p.000026: &SKU=KAAJ07022ENC_PDF&CatalogueNu mber=KA-AJ-07-022-EN-C
p.000026: Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a
p.000026: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS
p.000026: Countries,” Chapter 3, Section 1:
p.000026: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000026: Note: All websites and documents are in Armenian.
p.000026:
p.000026: Drugs, Biologics, and Devices
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Human Biological Materials
p.000026:
p.000026:
p.000026: Austria
p.000026: General
p.000026: 1. Drug and Medical Technology Agency: http://www.pharm.am/
p.000026: 2. Ethics Committee of the Ministry of Health
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Ethical Committee of the National Center for AIDS Prevention: http://www.armaids.am/main/index.php?l ng=1
p.000026:
p.000026: 1. Ministry of Health:
p.000026: http://www.bmg.gv.at
p.000026: 2. Forum of Austrian Ethics Committees: http://www.ethikkommissionen.at
p.000026: 3. Bioethics Commission:
p.000026: 1. Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21:
p.000026: http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=71619
p.000026: 2. Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Medications in
p.000026: Armenia: http://www.arlis.am/DocumentView
p.000026: .aspx?docID=9154
p.000026: RA Law on Prevention of Disease Caused by HIV (2012): http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=78616
p.000026:
p.000026: 1. University Act (2011):
p.000026: http://www.ris.bka.gv.at/Dokumente
p.000026: /Erv/ERV_2002_1_120/ERV_2002
p.000026: _1_120.pdf
p.000026: 2. Hospitals Act (2014):
p.000026: http://www.ris.bka.gv.at/GeltendeFa
p.000027: 27
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Regulation on Leading Ethics Committees (2004): http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen&
p.000027: Gesetzesnummer=20003352&ShowP rintPreview=True
p.000027:
p.000027:
p.000027:
p.000027:
...
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Privacy/Data Protection
p.000027:
p.000027: Note: The Austrian states also have privacy/data protection laws
p.000027: http://www.bundeskanzleramt.at/site/3575
p.000027: /default.aspx
p.000027:
p.000027:
p.000027: Drugs
p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian-
p.000027: federal-office-for-safety-in-health-care/ Devices
p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian-
p.000027: federal-office-for-safety-in-health-care/
p.000027: 1. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 2. Austrian Federal Office for Safety in Health Care: http://www.basg.at/en/austrian-federal-
p.000027: office-for-safety-in-health-care/
p.000027:
p.000027:
p.000027:
p.000027: Austrian Data Protection Authority: https://www.dsb.gv.at/DesktopDefault.asp x?alias=dsken
p.000027: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010285&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027: Austrian Drug Law (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Medical Devices Act (2014): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 1. Austrian Drug Law, Article 32 (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027: 2. Austrian Medical Devices Law, Article 47 (2017): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10011003&Sho wPrintPreview=True
p.000027: 1. Data Protection Act No. 165/1999: https://www.ris.bka.gv.at/GeltendeF assung.wxe?Abfrage=Bundesnorme
p.000027: n&Gesetzesnummer=10001597
p.000027: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000027:
p.000028: 28
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028: Various: http://www.basg.at/arzneimittel/vor-der- zulassung/klinische-pruefungen/
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Various:
p.000028: http://www.basg.at/medizinprodukte/formulare
p.000028: /klinische-pruefung/
p.000028:
p.000028: Country Key Organizations Legislation
p.000028: Regulations Guidelines
p.000028:
p.000028: Human Biological Materials
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Genetic Research
p.000028:
p.000028:
p.000028:
p.000028: Embryos, Stem Cells, and Cloning
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Belarus
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028:
p.000028:
p.000028:
p.000028:
...
p.000028: ?CobId=34240
p.000028: For an overview of human subject protections in Belarus, see “Ethical Review of Biomedical Research in the CIS
p.000028: Countries,” Chapter 3, Section 3:
p.000028: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000028:
p.000028: General
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs, Biologics, and Devices
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. National Bioethics Committee
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. State Pharmacological Committee
p.000028: 3. Centre for Expertise and Testing in Health Care:
p.000028: http://rceth.by/
p.000028: 1. Constitution of the Republic of Belarus, Article 25 (2004): http://www.pravo.by/WEBNPA/text
p.000028: .asp?RN=v19402875
p.000028: 2. Law on Health Care System, Articles 40, 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000028: =v19302435
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Law on Drugs, Articles 15,16 (2009): http://pravo.by/webnpa/text.asp?RN
p.000028: =h10600161
p.000028: 2. Law on Health Care System, Article 40 (2010):
p.000029: 29
p.000029: MOH:
p.000029: 1. Ordinance No. 274 on Establishing the National Bioethics Committee (2006)
p.000029: 2. Decree No. No. 55 on Ethics Committees (2008) (Russian): http://www.levonevski.net/pravo/nor m2009/num05/d05639.html
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: MOH:
p.000029: 1. Ordinance No. 254 on Clinical Drug Trials and Good Clinical Practice (1999): http://www.levonevski.net/pravo/nor
p.000029: m2009/num36/d36922/index.html
p.000029: MOH:
p.000029: 1. Code of Medical Ethics (1999): http://www.levonevski.net/pravo/norm2009/nu m37/d37726.html
p.000029: 2. Guidelines for Ethics Committees on Standard Operational Proceedings (No. 55-0004, 2000):
p.000029: http://www.levonevski.net/pravo/norm2009/nu m35/d35896/index.html
p.000029: 3. Methodological Guidelines of Health Ministry (2000)
p.000029:
p.000029: MOH:
p.000029: Instruction on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical
p.000029: Trials of Drugs and Medical
p.000029:
p.000029: Country Key Organizations Legislation
p.000029: Regulations Guidelines
p.000029:
p.000029: Drugs, Biologics, and Devices
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Privacy/Data Protection
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Human Biological Materials
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Devices
p.000029: 1. Ministry of Health (MOH):
p.000029: http://minzdrav.by/en/
p.000029: 2. Centre for Expertise and Testing in Health Care:
p.000029: http://rceth.by/
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 1. Ministry of Health:
p.000029: http://minzdrav.by/en/
p.000029: 2. National Bioethics Committee
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 1. Ministry of Health (MOH):
p.000029: http://minzdrav.by/en/
p.000029: 2. National Bioethics Committee
p.000029: 3. State Service of Forensic Medicine
p.000029: http://pravo.by/webnpa/text.asp?RN
p.000029: =v19302435
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029: Law on Health Care System, Article 40 (2010): http://pravo.by/webnpa/text.asp?RN
p.000029: =v19302435
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p.000029:
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p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 1. Constitution of the Republic of Belarus, Article 28 (2004): http://www.pravo.by/WEBNPA/text
p.000029: .asp?RN=v19402875
p.000029: 2. Law on Health Care System, Article 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000029: =v19302435
p.000029: Law on Health Care System, Articles 40 and 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000029: =v19302435
p.000029:
p.000030: 30
p.000030: 2. Ordinance No. 161 on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting
p.000030: Clinical Trials of Drugs and Medical devices (1999): http://www.levonevski.net/pravo/nor m2009/num37/d37336.html
p.000030: 3. Decree No. 55 on Ethics Committees (2008): http://www.levonevski.net/pravo/nor m2009/num05/d05639.html
p.000030: 4. Decree No. 50 on Certain Aspects of Clinical Drug Trials (2009)
p.000030:
p.000030: MOH:
p.000030: 1. Ordinance No. 161 on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting
p.000030: Clinical Trials of Drugs and Medical devices (1999): http://www.levonevski.net/pravo/nor m2009/num37/d37336.html
p.000030: 2. Decree No. 216 on Certain Aspects of Clinical Trials of Medical Devices (2008) (Russian):
p.000030: http://86.57.250.247/data/pravo/ipb_p rikazmz/N216_2008.htm
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: MOH:
p.000030: Ordinance No. 111 on Further Development of National Pathology Service (1993):
p.000030: Devices (No. 55-0504, 2004) (Russian): http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
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p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: MOH:
p.000030: Instruction on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical
p.000030: Trials of Drugs and Medical Devices (No. 55-0504, 2004):
p.000030: http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html
p.000030:
p.000030: Country Key Organizations Legislation
p.000030: Regulations Guidelines
p.000030:
p.000030: Human Biological Materials
p.000030:
p.000030:
p.000030:
p.000030: Belgium
p.000030: (SSFM)
p.000030: http://86.57.250.247/data/pravo/ipb_p rikaznew/N111_1993(1994).doc
p.000030:
p.000030: SSFM:
p.000030: Ordinance No. 38-c on Rules for Conducting Morphological Examinations (1999)
p.000030: For an overview of human subject standards in Belgium, see The Ethics Committees:
...
p.000035: dia/filer_public/c6/12/c612c85a-
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p.000036:
p.000036:
p.000036:
p.000036: Rulebook about Testing Procedure for Donor of Transplant Organs in Terms of Diseases Which can be Transmitted by
p.000036: Transplantation (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Documents/%d
p.000036: 0%9f%d1%80%d0%b0%d0%b2%d0%b8%d0
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p.000036: b8%d0%bc%d0%b0_%d0%b7%d0%b0_%d1
p.000036: %82%d0%b5%d1%81%d1%82%d0%b8%d1
p.000036: %80%d0%b0%d1%9a%d0%b5_%d0%b4%d0
p.000036: %b0%d0%b2%d0%b0%d0%bb%d0%b0%d1
p.000036: %86%d0%b0_%d1%99%d1%83%d0%b4%d1
p.000036: %81%d0%ba%d0%b8%d1%85_%d0%be%d1
p.000036: %80%d0%b3%d0%b0%d0%bd%d0%b0_64_1 0.pdf
p.000036:
p.000036: Country Key Organizations Legislation
p.000036: Regulations Guidelines
p.000036:
p.000036: General
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Drugs, Biologics, and Devices
p.000036:
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p.000036:
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p.000036:
p.000036:
p.000036: Research Injury
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Drugs
p.000036: 1. Ministry of Healthcare (MOH):
p.000036: http://www.mh.government.bg/
p.000036: 2. Bulgarian Drug Agency (BDA):
p.000036: http://www.bda.bg/en/
p.000036:
p.000036:
p.000036:
p.000036: Devices
p.000036: Bulgarian Drug Agency (BDA):
p.000036: http://www.bda.bg/en/
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Bulgarian Drug Agency (BDA):
p.000036: http://www.bda.bg/en/
p.000036: 519f-4a22-b390-
p.000036: 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf
p.000036: 4. Medicinal Products in Human Medicine Act (2017): http://www.bda.bg/images/stories/d ocuments/regulations/zakoni/ZLPH
p.000036: M_28122017.pdf
p.000036: 5. Healthcare Act, Articles 197- 206 (2018): http://www.mh.government.bg/medi a/filer_public/2018/02/27/zakon-za-
p.000036: zdraveto.pdf
p.000036:
p.000036: Medicinal Products in Human Medicine Act, Chapter 4 (2018): https://www.lex.bg/laws/ldoc/21355 49536
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Medical Devices Act (2016): http://www.bda.bg/images/stories/d ocuments/legal_acts/ZMI_en_20160 308.pdf
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Medicinal Products in Human Medicine Act, Chapter 4, Articles 91 and 92 (2016): http://www.bda.bg/images/stories/d
p.000036: ocuments/legal_acts/ZLPHM_en.pd f
p.000036:
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p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Regulation No. 31 from 12 August 2007 for Determining the Principles of Good Clinical Practice (2012):
p.000037: http://www.bda.bg/images/stories/doc uments/regulations/naredbi/20180320
p.000037: _Naredda_31.pdf
p.000037:
p.000037: Ordinance No. 10 of 2008 on the Documents Required from the Principal/Coordinating Investigator or Sponsor for
p.000037: Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices During Clinical
p.000037: Investigations and Assessment of the Clinical Data Collected During such Investigations (2010):
...
p.000040:
p.000040: Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8):
p.000040: http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C
p.000040: F%84%CE%BF%CF%85%202004.
p.000040: pdf?OpenElement
p.000040: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000040: 2. Protection of Natural Persons Against the Processing of Personal Data and the Free
p.000041: 41
p.000041:
p.000041: Country Key Organizations Legislation
p.000041: Regulations Guidelines
p.000041:
p.000041: Privacy/Data Protection
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Embryos, Stem Cells, and Cloning
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Czech Republic
p.000041: General
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Drugs, Biologics, and Devices
p.000041:
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p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Ministry of Health, Central Ethics Committee: http://www.mzcr.cz
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Drugs
p.000041: 1. Ministry of Health (MOH):
p.000041: http://www.mzcr.cz
p.000041: 2. State Institute for Drug Control (SUKL): http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Devices
p.000041: State Institute for Drug Control (SUKL):
p.000041: http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Circulation of such Data Act of 2018 (Law 125 (I)):
p.000041: http://www.dataprotection.gov.cy/d ataprotection/dataprotection.nsf/all/ DE97F6F59835A03AC22582DD00
p.000041: 3D895E/$file/%CE%9D%CF%8C
p.000041: %CE%BC%CE%BF%CF%82%201
p.000041: 25(%CE%99)_2018.pdf?openeleme nt
p.000041: Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000041: the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2002)
p.000041:
p.000041: 1. Oviedo Convention on Human Rights and Biomedicine (2001)
p.000041: 2. Act No. 130/2002 Collection on Research and Development Support, as Amended (2018)
p.000041: 3. Act No. 372/2011 on Healthcare Services, As Amended (2019)
p.000041: 4. Act. No. 373/2011 on Specific Healthcare Services, As Amended (2018)
p.000041:
p.000041: Act No. 378/2007 Collection on Pharmaceuticals, As Amended (2019)
p.000041:
p.000041:
p.000041:
p.000041: 1. Act No 268/2014 Coll., on Medical Devices and on Amendment to Act. 634/2004 Coll., on Administrative Fees, As
p.000041: Amended (2017)
p.000041: 2. Decree No 62/2015 Coll. Implementing Certain Provisions of the Act on
p.000042: 42
p.000042:
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p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: MOH:
p.000042: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products
p.000042:
p.000042: Various:
...
p.000052:
p.000052:
p.000052:
p.000052: 1. Act of Quality and Security of Human Tissue and Cells (2019): https://www.buzer.de/s1.htm?g=Ge webegesetz&f=1
p.000052: 2. Transfusion Law (2019): http://www.gesetze-im- internet.de/tfg/
p.000052: 3. Transplantation Law (2019): http://www.gesetze-im- internet.de/tpg/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
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p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: 1. Embryo Protection Act (2011):
p.000052: http://www.gesetze-im- internet.de/eschg/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: Opinion on Human Biobanks for Research (2010):
p.000052: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/DER_StnBiob_En gl_Online_mitKennwort.pdf
p.000052: 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf
p.000052: 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-
p.000052: Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf
p.000052: DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production:
p.000052: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_
p.000052: menschlicher_Gewebe.pdf
p.000053: 53
p.000053:
p.000053: Country Key Organizations Legislation
p.000053: Regulations Guidelines
p.000053: 2. Genetic Engineering Act
p.000053:
p.000053: Genetic Research
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: Embryos, Stem Cells, and Cloning
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Ethics Council:
p.000053: https://www.ethikrat.org/en/
p.000053: (2017):
p.000053: http://www.gesetze-im- internet.de/gentg/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/
p.000053: 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/
p.000053:
...
p.000071: 2. Act of 1 August 2018 on the Organisation of the National Data Protection Commission, Articles 63-65:
p.000071: https://cnpd.public.lu/dam- assets/fr/legislation/droit-lux/Act- of-1-August-2018-on-the-
p.000071: organisation-of-the-National-Data- Protection-Commission-and-the- general-data-protection- framework.pdf
p.000071: Trials on Medicinal Products for Human Use: http://www.legilux.public.lu/leg/a/arc hives/2005/0084/2005A15161.html
p.000071: Include in the Participant Information Sheet and Informed Consent Form
p.000071: 2. Secondary Use of Samples Collected in the Framework of a Research Project
p.000071: 3. Incidental Findings
p.000071:
p.000071: Access: https://www.cner.lu/en- gb/Publications
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
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p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Guidelines Regarding Incidental Findings and Informed Consent Management in the Framework of Whole Genome Sequencing
p.000071: Research Projects: https://www.cner.lu/fr- fr/Publications
p.000071: Notes: Effective February 12, 2019, the name of the country was officially changed to the Republic of North Macedonia.
p.000071: All websites and documents are available in Macedonian.
p.000071: Drugs and Devices Drugs
p.000071:
p.000071: 1. Ministry of Health of Republic of Macedonia:
p.000071: http://moh.gov.mk/
p.000071: 2. Drug and Devices Register:
p.000071: https://lekovi.zdravstvo.gov.mk/
p.000071: 1. Law on Medicinal Products and Medical Devices (Official Gazette No.106/2007) and Laws Amending and Supplementing the
p.000071: Law (2010-2018, according
p.000072: 72
p.000072: 1. Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents
p.000072: (2009): https://lekovi.zdravstvo.gov.mk/docu
p.000072: 1. Guideline for the Clinical Trial Applicant (Annex 3) (Sub-folder 23.2) (2012):
p.000072: https://lekovi.zdravstvo.gov.mk/documents/1/1 2.Guideline for Good Clinical Practice,
p.000072:
p.000072: Country Key Organizations Legislation
p.000072: Regulations Guidelines
p.000072:
p.000072: Drugs and Devices
p.000072: 3. Drug Agency
p.000072: http://malmed.gov.mk/
p.000072: to year of amendment):
p.000072: Click on file folder 1., then open sub-folders: https://lekovi.zdravstvo.gov.mk/doc uments/2
p.000072: 2. Health Care Law (Official Gazette No. 43/2012) and Laws Amending and Supplementing the Law, Article 275:
p.000072: http://www.fzo.org.mk/default.asp?I temID=37115BDC6DEF524D877A 8C36F95A85F6
p.000072: ments.documentcomponent:download file/817325622?t:ac=1/1
p.000072: 1.1. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on
p.000072: Medicinal Products and the Documentation Contents (2010): https://lekovi.zdravstvo.gov.mk/docu
p.000072: ments.documentcomponent:download file/879452170?t:ac=1/1
p.000072: 1.2. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on
p.000072: Medicinal Products and the Documentation Contents (2012): https://lekovi.zdravstvo.gov.mk/docu
p.000072: ments.documentcomponent:download file/880033320?t:ac=1/1
p.000072: 1.3. Rulebook on Amending and Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on
p.000072: Medicinal Products and the Documentation Contents and Annex No.3 (Guideline for the Clinical Trial Applicant )
p.000072: (Document No. 23.3) (2012): https://lekovi.zdravstvo.gov.mk/docu ments/1/1
p.000072: 1.4. Rulebook on Supplementing the Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products
p.000072: and the Documentation Contents (2016) (Document No. 23.4): https://lekovi.zdravstvo.gov.mk/docu ments/1/1
p.000072: 2. Regulation on the Manner of Reporting, Contents of the Reporting Form for Adverse Reactions to Medicinal Products
p.000072: and the Manner of Organisation of Pharmacovigilance System
p.000072: Official Gazette No.62/2009, Document No. 19:
p.000072: https://lekovi.zdravstvo.gov.mk/documents/1/1
p.000072:
p.000073: 73
p.000073:
p.000073: Country Key Organizations Legislation
p.000073: Regulations Guidelines
p.000073:
p.000073: Drugs and Devices
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000073: Research Injury
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: Privacy/Data Protection
p.000073:
p.000073:
p.000073:
p.000073: Devices
p.000073: 1. Ministry of Health of Republic of Macedonia:
p.000073: http://moh.gov.mk/
p.000073: 2. Drug and Devices Register:
p.000073: https://lekovi.zdravstvo.gov.mk/
p.000073: 3. Drug Agency
p.000073: http://malmed.gov.mk/
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
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p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 1. Ministry of Health of Republic of Macedonia:
p.000073: http://moh.gov.mk/
p.000073: 2. Drug Agency:
p.000073: http://malmed.gov.mk/
p.000073:
p.000073:
p.000073: Directorate for Personal Data Protection: www.dzlp.mk
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: Law on Medicinal Products and Medical Devices (Official Gazette No.106/2007) and Laws Amending and Supplementing the
p.000073: Law (2010-2018):
p.000073: Click on file folder 1., then open sub-folders: https://lekovi.zdravstvo.gov.mk/doc uments/2
p.000073:
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p.000073:
p.000073: 1. Law on Ratification on Convention for the Protection of Individuals with Regard to Automatic Processing of Personal
p.000073: Data (2005): http://www.dzlp.mk/sites/default/fil es/pdf/Zakon_za_ratifikacija_na_Ko nvencijata_108.pdf
p.000073: 2. Law on Ratification on Additional Protocol to the
p.000073: (2012):
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p.000073:
p.000073: 1. Rulebook for the Required Documentation and the Method of Application for Clinical Trials on Medical Devices and
p.000073: the Amendments, and Reporting of Drug Adverse Reactions and Events (Official Gazette No. 62/2010):
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/844338380?t:ac=1/2
p.000073: 2. Rulebook on the Manner of Reporting Adverse Effects During the Use of Medical Devices, Types of Reactions they
p.000073: Cause, the Actions of Health Workers and Suppliers, As Well as the Manner of Organizing the System of Monitoring
p.000073: Adverse Effects and Reactions to Medical Devices (Official Gazette No.100/2016) (Document No.8):
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments/1/2
p.000073: Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and Documentation Contents (2009):
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/817325622?t:ac=1/1 Regulations on Protection
p.000073: of Personal Data: http://www.dzlp.mk/mk/podzakonski
p.000073: _akti
p.000074: 74
p.000074:
p.000074: Country Key Organizations Legislation
p.000074: Regulations Guidelines
p.000074:
p.000074: Privacy/Data Protection
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
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p.000074:
p.000074: Human Biological Materials
p.000074:
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p.000074:
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p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
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p.000074: http://moh.gov.mk/
p.000074: 2. Health Insurance Fund of Republic of Macedonia: http://www.fzo.org.mk
p.000074: Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2008):
...
p.000083: for-research/guidelines-for-research-ethics-in- science-and-technology/
p.000083:
p.000083: Country Key Organizations Legislation
p.000083: Regulations Guidelines
p.000083:
p.000083: General
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: Drugs, Biologics, and Devices
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p.000083: Research Injury
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p.000083: Social-Behavioral Research
p.000083: work/about-us/the-national-committee- for-research-ethics-in-science-and- technology-nent/
p.000083: National Committee for Research Ethics on Human Remains: https://www.etikkom.no/en/our-
p.000083: work/about-us/the-national-committee- for-research-ethics-on-human-remains/ Drugs
p.000083: Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: Devices
p.000083: Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: Norwegian System of Patient Injury Compensation: https://www.npe.no/en/information- compensation-claimants/drug-
p.000083: injury/clinical-trials/
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p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. National Committee for Research Ethics in the Social Sciences and the Humanities (NESH)
p.000083: 2. National Committee for Research Ethics on Human Remains (NCEHR):
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1.Medicines Act:
p.000083: https://lovdata.no/dokument/NL/lov
p.000083: /1992-12-04-
p.000083: 132?q=lov%20om%20legemidler 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov
p.000083: /2008-06-20-
p.000083: 44?q=helseforskningsloven
p.000083:
p.000083: Act of 12 January 1995 No. 6 Relating to Medical Devices (1995):
p.000083: http://lovdata.no/dokument/NL/lov/ 1995-01-12-
p.000083: 6?q=lov+om+medisinsk+utstyr 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov
p.000083: /2008-06-20-
p.000083: 44?q=helseforskningsloven
p.000083: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2007)
p.000083: 2. Act on Patient Injury Compensation (2001): https://lovdata.no/dokument/NL/ lov/2001-06-15-53
p.000083: 3. Act on Product Liability, Chapter 3: https://lovdata.no/dokument/NL/lov
p.000083: /1988-12-23-
p.000083: 104?q=produktansvarsloven Research Ethics Act (2017): https://lovdata.no/dokument/NL/lov
p.000083: /2017-04-28-23?q=forskningsetikk
p.000083: 2. Act of Cultural Heritage (1978):
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p.000090:
p.000090:
p.000090: Federal Law #61FZ “On Circulation of Medicines” (2011), Art. 38-44:
p.000090: GOST:
p.000090: Good Clinical Practice. GOST-R 52379-2005 (September 27,
p.000090: 2005):
p.000090: http://acto- russia.org/index.php?option=com_co ntent&task=view&id=17
p.000090:
p.000091: 91
p.000091:
p.000091: Country Key Organizations Legislation
p.000091: Regulations Guidelines
p.000091:
p.000091: Research Injury
p.000091:
p.000091: Privacy/Data Protection
p.000091:
p.000091:
p.000091:
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p.000091: Genetic
p.000091:
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p.000091: Embryos, Stem Cells, and Cloning
p.000091:
p.000091:
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p.000091: San Marino
p.000091: General
p.000091:
p.000091:
p.000091: Research Injury
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p.000091:
p.000091: Serbia
p.000091: Drugs, Biologics, and Devices
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p.000091: Interdepartmental Commission on Genetic-Engineering Activity
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p.000091:
p.000091: San Marino Bioethics Committee (Italian): http://www.sanita.sm/on- line/home/comitato-bioetica/comitato-
p.000091: sammarinese-di-bioetica.html
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: 1. Ministry of Health (MOH):
p.000091: http://www.zdravlje.gov.rs/
p.000091: 2. Serbian Drug Agency
p.000091: http://www.alims.gov.rs/eng/
p.000091: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000091: .docx
p.000091: 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information
p.000091: (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/
p.000091: 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal
p.000091: Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:”
p.000091: http://base.garant.ru/10135402/
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010):
p.000091: http://base.garant.ru/184467/
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine (1998)
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998)
p.000091:
p.000091: Law on Medicines and Medical Devices, Official Gazette of RS No. 30/2010, 107/2012, 113/2017, and 105/2017:
p.000091: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf
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p.000092:
p.000092: Order of the Ministry of Education and Science of the Russian Federation #154: “Statute of the Inter- Departmental
p.000092: Commission on Genetic-Engineering Activity” (2005):
p.000092: http://www.zakonprost.ru/content/ba se/part/438157
p.000092:
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p.000092:
p.000092:
p.000092: MOH:
p.000092: Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical
p.000092: Trials, Official Gazette of RS, 64/2011, 91/2013,
p.000092:
p.000092: Country Key Organizations Legislation
p.000092: Regulations Guidelines
p.000092:
p.000092: Drugs, Biologics, and Devices
p.000092: Research Injury
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p.000092:
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p.000092: Privacy/Data Protection
p.000092:
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p.000092:
p.000092: Genetics
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Embryos, Stem Cells, and Cloning
p.000092:
p.000092:
p.000092:
p.000092: 1. Ministry of Health (MOH):
p.000092: http://www.zdravlje.gov.rs/index.php?
p.000092: 2. Serbian Drug Agency
p.000092: http://www.alims.gov.rs
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Commissioner for Information of Public Importance and Personal Data Protection: https://www.poverenik.rs/en/
p.000092:
p.000092:
p.000092: Ministry of Health (MOH):
p.000092: http://www.zdravlje.gov.rs/index.php?
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: National Health Insurance Fund:
p.000092: http://www.rfzo.rs/
p.000092:
p.000092:
p.000092:
p.000092: Law on Medicines and Medical Devices, Article 72: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic
p.000092: inskim_sredstvima.pdf
p.000092:
p.000092:
p.000092:
p.000092:
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p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Law on the Protection of Personal Data, Official Gazette 87/2018:
p.000092: https://www.paragraf.rs/propisi/zak on-o-zastiti-podataka-o- licnosti.html
p.000092: Law on the Prevention and Diagnosis of Genetically Conditioned Diseases, Genetically Caused Anomalies and Rare
p.000092: Diseases, Official Gazette 8/2015: https://www.paragraf.rs/propisi/zak on_o_prevenciji_i_dijagnostici_gen
p.000092: etickih_bolesti_geneticki_uslovljeni h_anomalija_i_retkih_bolesti.html
p.000092: 1. Law on Organ Transplantation, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do
p.000092: wnload/zakon-o-presadjivanju- ljudskih-organa.pdf
p.000092: 2. Law on Human Cells and Tissues, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do
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p.000093: https://www.alims.gov.rs/ciril/files/2 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf MOH:
p.000093: 1. Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting
p.000093: Clinical Trials, Official Gazette of RS, 64/2011, 91/2013, 60/2016, and 9/2018: https://www.alims.gov.rs/ciril/files/2
p.000093: 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf
p.000093: 2. Law on Patients' Rights, Article 25 Official Gazette of RS, 45/2013 and 25/2019:
p.000093: https://www.paragraf.rs/propisi/zako n_o_pravima_pacijenata.html
p.000093:
p.000093: Country Key Organizations Legislation
p.000093: Regulations Guidelines
p.000093:
p.000093: Embryos, Stem Cells, and Cloning Slovakia General
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Drugs, Biologics, and Devices
p.000093:
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p.000093: Research Injury
p.000093:
p.000093: Privacy/Data Protection
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Human Biological Materials
p.000093:
p.000093:
p.000093: Embryos, Stem Cells, and Cloning
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Slovenia
p.000093:
p.000093:
p.000093:
p.000093: 1. Ministry of Health (Slovak):
p.000093: http://www.health.gov.sk/
p.000093: 2. Institute of Medical Ethics and Bioethics:
p.000093: http://www.bioethics.sk/
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: State Institute for Drug Control:
p.000093: http://www.sukl.sk/en
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Office for Personal Data Protection:
p.000093: https://dataprotection.gov.sk/uoou/en
p.000093: wnload/zakon-o-ljudskim-celijama- i-tkivima.pdf
p.000093:
p.000093: 1. Oviedo Convention on Human Rights and Biomedicine (1998)
p.000093: 2. Additional Protocol on Biomedical Research (2005)
p.000093: 3. Act No. 576/2004 Coll on Health Care, As Amended by Acts No. 350/2005, 282/2006, 662/2007, 345/2009 Coll.
p.000093: 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
p.000093: Coll.
p.000093:
p.000093: Law 277/1994 on Health Care, Section 44
p.000093: 1. Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll.
p.000093: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000093: 1. Act No. 576/2004 Coll. on Health Care, Sections 35-39.
p.000093: 2. Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b).
p.000093: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000093: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000093: 2. Act No. 576/2004 Coll. on Health Care, Section 26.10.a.
p.000093:
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p.000097: ceic/home.htm
p.000097: 3. Institute of Health Carlos III, Ministry of Science and Innovation http://www.isciii.es/htdocs/en/index.jsp
p.000097:
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p.000097: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion Clinica/medicamentos/home.htm
p.000097: 1. Oviedo Convention on Human Rights and Biomedicine (1999): http://www.coe.int/t/dg3/healthbioet
p.000097: hic/texts_and_documents/ETS164S panish.pdf
p.000097: 2. Law 14/2007 on Biomedical Research: http://www.catedraderechoygenoma humano.es/images/novedades/Spani
p.000097: shLawonBiomedicalResearchEnglis h.pdf
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p.000098:
p.000098: 1. Order SCO/362/2008 that Modifies Order SCO/256/2007: http://www.aemps.gob.es/legislacion
p.000098: /espana/investigacionClinica/docs/rc l_2008_410.pdf
p.000098: 2. Order SAS/3470/2009 on Drugs Post Authorization Research: http://www.aemps.gob.es/legislacion
p.000098: /espana/medicamentosUsoHumano/d ocs/farmacovigilancia/rcl_2009_257 7.pdf
p.000098: 3. Royal Decree 1015/2009: Drug Availability for Special Purposes: http://www.boe.es/boe/dias/2009/07/
p.000098: 20/pdfs/BOE-A-2009-12002.pdf
p.000098: 4. Royal Decree 577/2013 Regulating Pharmacovigilance in Human Use Medicines: http://www.boe.es/diario_boe/txt.ph
p.000098: p?id=BOE-A-2013-8191
p.000098: 5. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: http://noticias.juridicas.com/base_da
p.000098: tos/Admin/565124-rd-1090-2015-
p.000098:
p.000098: Country Key Organizations Legislation
p.000098: Regulations Guidelines
p.000098:
p.000098: Drugs, Biologics, and Devices
p.000098:
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p.000098: Research Injury
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p.000098: Privacy/Data Protection
p.000098:
p.000098:
p.000098: Devices
p.000098: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion
p.000098: Clinica/productosSanitarios/home.htm Spanish Agency of Medicines and Medical Devices:
p.000098: http://www.aemps.gob.es/en/home.htm
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p.000102:
p.000102: Privacy/Data Protection
p.000102: Human Biological Materials
p.000102:
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p.000102: Genetic Research
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p.000102: Embryos, Stem Cells, and Cloning
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p.000102:
p.000102: Switzerland
p.000102:
p.000102: 1. Health and Social Care Inspectorate (IVO):
p.000102: https://www.ivo.se/om-ivo/other- languages/english/
p.000102: 2. Biobank Sweden:
p.000102: http://biobanksverige.se/
p.000102:
p.000102:
p.000102:
p.000102: 1. Medical Products Agency:
p.000102: https://lakemedelsverket.se/english/
p.000102: 2. The Swedish Gene Technology Advisory Board (SGTAB): https://www.genteknik.se/
p.000102:
p.000102:
p.000102:
p.000102: National Board of Health and Welfare (SOS):
p.000102: http://www.socialstyrelsen.se/english
p.000102: med-kompletterande- bestammelser_sfs-2018-218
p.000102: 1. Biobanks in Medical Care Act No. 297 (2002): https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk-
p.000102: forfattningssamling/lag-2002297- om-biobanker-i-halso--och_sfs- 2002-297
p.000102: 2. Regulation No. 746 (2002): http://www.notisum.se/rnp/sls/lag/2 0020746.htm
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
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p.000102:
p.000102:
p.000102: Drug Administration Regulations and Guidelines (LVFS 2004:10) on the Intentional Release of Clinical Trials of
p.000102: Medicinal Products Containing or Consisting of Genetically Modified Organisms: http://www.lakemedelsverket.se/upl
p.000102: oad/lvfs/LVFS_2004-10.pdf
p.000102: 1. Legal Regulation of Stem Cell Research 2002:119: http://www.regeringen.se/sb/d/108/a/ 2717
p.000102: 2. Regulations and Guidelines for the Use of Tissues and Cells in Healthcare and Clinical Research - SOSFS 2009:32:
p.000102: http://www.socialstyrelsen.se/sosfs/2 009-32
p.000102:
p.000102:
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p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: SGTAB:
p.000102: Advice for Ethical Assessments: https://www.genteknik.se/wp- content/uploads/2017/09/072_2010-Etisk-
p.000102: v%C3%A4gledning.pdf
p.000102: For an overview of human subject protections in Switzerland, see: http://kofam.ch/en/home/
p.000102:
p.000102: General
p.000102: 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000102: =en
p.000102: 2. Federal Office of Public Health, Portal for Human Research (FOPH): http://kofam.ch/en/home/
p.000102: 3. National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/
p.000102: 3. Swiss Ethics Committees on Research Involving Humans: http://www.swissethics.ch/index_e.html
p.000102: 1. Council of Europe Convention on Human Rights and Biomedicine of 4 April 1997, ETS No. 164, Articles 15- 18:
p.000102: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000102: 2. Federal Constitution of the Swiss Confederation of 18 April, 1999, RS 101, Article 118b:
...
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research (2018): Chapter 3.2: https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018
p.000118:
p.000118: TGA:
p.000118: Australian Regulatory Guidelines for Biologicals (2018): http://www.tga.gov.au/industry/biologicals- argb.htm
p.000118: NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research, Chapter 3.3 (2018): https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research, Chapter 3.2 (2018): https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018
p.000118:
p.000118: Country Key Organizations Legislation
p.000118: Regulations Guidelines
p.000118:
p.000118: Embryos, Stem Cells, and Cloning
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh
p.000118: General
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Drugs, Biologics, and Devices
p.000118:
p.000118:
p.000118: Human Biological Materials
p.000118: licensing-committee
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh Directorate of Drug Administration: http://www.dgda.gov.bd/
p.000118:
p.000118:
p.000118: Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org
p.000118: https://www.legislation.gov.au/Deta ils/C2016C00968
p.000118:
p.000118:
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p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 1. The Drugs Act (1964)
p.000118: 2. Drugs (Control) Ordinance 1982, Ordinance No. VIII: http://bdlaws.minlaw.gov.bd/pdf_pa rt.php?id=623
p.000118: NHMRC:
p.000118: Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2017):
p.000118: https://nhmrc.gov.au/about- us/publications/ethical-guidelines-use-assisted- reproductive-technology
p.000118:
p.000118: 1. Ethical Guidelines for Conducting Research Studies Involving Human Subjects:
p.000118: https://www.bmrcbd.org/application_form/Ethi calGideline
p.000118: 2. Standard Operating Procedures (SOPs):
p.000118: https://www.bmrcbd.org/application_form/SOP s
p.000118: Good Clinical Practice (GCP) Guidelines: http://www.dgda.gov.bd/index.php/2013-03-
p.000118: 31-05-16-29/registered-medical-device-list- 4/129-good-clinical-practice-gcp- guidelines/file
p.000118: Guidelines for Transfer of Human Biological Materials Abroad for Research Purposes (2004)
p.000118: China, People’s Republic of
p.000118: For an overview of clinical research regulations in China, see the ClinRegs report:
p.000118: https://clinregs.niaid.nih.gov/country/china
p.000118:
p.000118: General
p.000118: 1. National Health Commission of the People’s Republic of China (NHC): http://en.nhc.gov.cn/
p.000118: 2. State Administration for Market Regulation: http://www.samr.gov.cn/
p.000118: 3. National Medical Products Administration: http://www.nmpa.gov.cn
p.000118: Law on Practicing Doctors (June 26, 1998), Articles 26 and 37: http://www.gov.cn/banshi/2005- 08/01/content_18970.htm
p.000118: People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2
p.000118: 019-06/10/content_5398829.htm
p.000118: NHFPC:
p.000118: Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016):
p.000118: http://www.gov.cn/gongbao/content/2017/ content_5227817.htm
p.000118:
p.000118: NHFPC, CFDA, and State Administration of TCM:
p.000118: Management Guidelines for Conducting Clinical Research at Medical/Health Institutions (Mandarin) (2014):
p.000118: http://www.nhc.gov.cn/yzygj/s3593g/2014 10/9bd03858c3aa41ed8aed17467645fb68. shtml
p.000118:
p.000118:
p.000118:
p.000119: 119
p.000119:
p.000119: Country Key Organizations Legislation
p.000119: Regulations Guidelines
p.000119:
p.000119: Drugs, Biologics, and Devices
p.000119: Drugs
p.000119: National Medical Products Administration: http://www.nmpa.gov.cn
p.000119:
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p.000119:
p.000119:
p.000119: Devices
p.000119: National Medical Products Administration: http://www.nmpa.gov.cn
p.000119:
p.000119: Drug Administration Law of the People's Republic of China (2019):
p.000119: http://www.npc.gov.cn/npc/c30834/ 201908/26a6b28dd83546d79d17f90
p.000119: c62e59461.shtml
p.000119: 2. Vaccine Management Law of the People’s Republic of China (2019): http://www.npc.gov.cn/npc/c30834/
p.000119: 201907/11447c85e05840b9b12c62b 5b645fe9d.shtml
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p.000120:
p.000120: 1. Regulations for Implementation of the Drug Administration Law of the People's Republic of China (2016):
p.000120: http://www.nmpa.gov.cn/WS04/CL2 076/300567.html
p.000120: 2. Chinese Good Clinical Practice (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html
p.000120: 3. Measures for the Administration of Drug Registration (2007): http://www.nmpa.gov.cn/WS04/CL2 174/300629.html
p.000120: 4. Interim Measures for the Confirmation of Clinical Trial Sites/Institutions (2004): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 079/337621.html
p.000120: 5. Rules on the Administration of Report and Supervision of Adverse Drug Reactions (2011):
p.000120: http://samr.cfda.gov.cn/WS01/CL103 1/62621.html
p.000120: 6. Administrative Measures for the Signing and Issuing of Biological Product (2017): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 077/300708.html
p.000120:
p.000120: 1. Good Clinical Practice on Medical Device Clinical Trials (2016): http://www.nmpa.gov.cn/WS04/CL2 077/300685.html
p.000120: 2. Regulations on the Supervision and Administration of Medical Devices (revised 2017): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 076/331389.html
p.000120: 3. Measures for the Registration and Administration of In Vitro Diagnostic Reagents (2014):
p.000120:
p.000120: 1. Guideline for HIV Vaccine Research Technology (2003): http://samr.cfda.gov.cn/WS01/CL0237/15705.h tml
p.000120: 2. Guideline for Vaccine Research Technology (2004): http://samr.cfda.gov.cn/WS01/CL0055/10307.h tml
p.000120: 3. Guidelines on Ethical Review of Drug Clinical Trials (2010): http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml
p.000120: 4. Interim Guidelines on International Multi-Regional Drug Clinical Trials (2015):
p.000120: http://samr.cfda.gov.cn/WS01/CL0087/114002. html
p.000120: 5. Interim Guidelines for Reporting and Supervision of Adverse Drug Reactions (2015):
p.000120: http://www.nmpa.gov.cn/WS04/CL2196/32411 8.html
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Guiding Principles of the Clinical Trail Technology on In Vitro Diagnostic (IVD) Reagents (2014):
p.000120: http://www.nmpa.gov.cn/WS04/CL2138/29998 8.html
p.000120: 2. Management Measures for the Monitoring and Re-evaluation of Adverse Events on Medical Devices (2019):
p.000120: http://www.nmpa.gov.cn/WS04/CL2077/33007 1.html
p.000120: 3. Templates for Medical Device Clinical Trials – Ethical Application and Approval (2016):
p.000120:
p.000120: Country Key Organizations Legislation
p.000120: Regulations Guidelines
p.000120:
p.000120: Drugs, Biologics, and Devices
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Clinical Trials Registry Privacy/Data Protection
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
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p.000120:
p.000120:
p.000120: Research Injury
p.000120:
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Chinese Clinical Trial Registry: http://www.chictr.org.cn/enIndex.aspx Mainland:
p.000120: 1. Ministry of Industry and Information Technology of People’s Republic of China: http://www.miit.gov.cn/
p.000120: 2. Office of the Central Cyberspace Affairs Commission: http://www.cac.gov.cn/
p.000120: 3. National Information Security Standardization Technical Committee: https://www.tc260.org.cn/ Hong Kong:
...
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Chinese Good Clinical Practice, Article 43 (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html
p.000120: 2. Administrative Measures for Recall of Medical Devices,
p.000120: 1. Ethical Review Application And Review Form
p.000120: 2. Informed Consent Form
p.000120: 3. CRF Template
p.000120: 4. Protocol Template
p.000120: 5. Clinical Trial Report Template
p.000120: 6. Required Documents List for Archiving
p.000120:
p.000120: Access: http://samr.cfda.gov.cn/WS01/CL0087/148126. html
p.000120:
p.000120:
p.000120:
p.000120: FAQs:
p.000120: http://www.chictr.org.cn/questionen.aspx
p.000120:
p.000120: Information Security Technology-Personal Information Security Specification (2017, GB/T 35273-2017):
p.000120: https://www.tc260.org.cn/front/postDetail.html
p.000120: ?id=20180124211617
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Code of Practice on the Identity Card Number and Other Personal Identifiers (2016):
p.000120: https://www.pcpd.org.hk/english/data_privacy_ law/code_of_practices/files/picode_en.pdf
p.000120: 2. Code of Practice on Human Resource Management (2016): https://www.pcpd.org.hk/english/data_privacy_
p.000120: law/code_of_practices/files/PCPD_HR_Bookle t_Eng_AW07_Web.pdf
p.000120: 1. Guideline on Vaccine Clinical Trials, Part 6 (2004): http://samr.cfda.gov.cn/WS01/CL0844/10307.h tml
p.000120: 2. Guideline on Ethical Review of Drug Clinical Trials, Appendix 1, Section 6.10
p.000120:
p.000121: 121
p.000121:
p.000121: Country Key Organizations Legislation
p.000121: Regulations Guidelines
p.000121:
p.000121: Research Injury
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Genetic Research
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Embryos, Stem Cells, and Cloning
p.000121:
p.000121:
p.000121:
p.000121:
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p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/
p.000121: 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Mainland:
p.000121: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/
p.000121: 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/
p.000121: Article 36 (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html
p.000121: 3. Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016), Articles 18.5, 20.8, 36.6, and
p.000121: 37: http://www.gov.cn/gongbao/content/2 017/content_5227817.htm
p.000121: 4. Good Clinical Practice on Medical Device Clinical Trials (2016), Articles 10, 22, 33, and 48:
p.000121: http://www.nmpa.gov.cn/WS04/CL2 077/300685.html
p.000121: People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2
...
p.000122: http://clinregs.niaid.nih.gov/single_country.php?c_id=100
p.000122:
p.000122: General
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs, Biologics, and Devices
p.000122: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs
p.000122: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000122: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Schedule Y of the Drugs and Cosmetics Act (2016): http://www.cdsco.nic.in/writereadda ta/2016Drugs%20and%20Cosmetic
p.000122: s%20Act%201940%20&%20Rules
p.000122: %201945.pdf
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p.000123: 123
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p.000123:
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p.000123:
p.000123:
p.000123:
p.000123:
p.000123: DCGI:
p.000123: 1. Good Clinical Practices for Clinical Research in India (2001): http://rgcb.res.in/wp- content/uploads/2014/07/Good-
p.000123: Clinical-Practice-Guideline.pdf
p.000123: 2. Permission for Clinical Trials: General Statutory Rules 63(E) (2013)
p.000123: 3. Ethics Committee Registration: General Statutory Rules 72(E) (2013)
p.000123: 4. A/V Consent – General Statutory Rules 611 (E) (2015)
p.000123: 5. Phytopharmaceutical Drug: General Statutory Rules 918(E) (2015)
p.000123: 6. Exemption for Academic Research and Animal Toxicity: General Statutory Rules 313(E) (2016)
p.000123: 7. New Drugs and Clinical Trials Rules (2019): https://cdsco.gov.in/opencms/opencm s/system/modules/CDSCO.WEB/ele
p.000123: 1. National Ethical Guidelines For Biomedical and Health Research Involving Human Participants (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123: 2. National Ethical Guidelines for Biomedical Research Involving Children (2017):
p.000123: http://icmr.nic.in/guidelines/National_Ethical_ Guidelines_for_BioMedical_Research_Involvi ng_Children.pdf
p.000123:
p.000123: ICMR:
p.000123: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Section 7 (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123:
p.000123: Country Key Organizations Legislation
p.000123: Regulations Guidelines
p.000123:
p.000123: Drugs, Biologics, and Devices
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Clinical Trials Registry
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Research Injury
p.000123:
p.000123: Devices
p.000123: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000123: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000123: 1. Clinical Trials Registry – India:
p.000123: http://ctri.nic.in/
p.000123: 2. Office of Drugs Controller General
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: 1. Central Drugs Standard Control Organization (CDSCO): https://cdsco.gov.in/opencms/opencm s/en/Home/
...
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 11 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124:
p.000124: DBT:
p.000124: 1. Recombinant DNA Safety Guidelines (1990)
p.000124: 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002)
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 10 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Guidelines for Stem Cell Research (2017): http://icmr.nic.in/guidelines/Guidelines_fo
p.000124: r_stem_cell_research_2017.pdf
p.000124:
p.000125: 125
p.000125:
p.000125: Country Key Organizations Legislation
p.000125: Regulations Guidelines
p.000125:
p.000125: Embryos, Stem Cells, and Cloning Indonesia
p.000125: Controller General of India (DCGI): https://cdsco.gov.in
p.000125: For an overview of health research ethics, see:
p.000125: http://www.fercap-sidcer.org/newsletter/2013/12/PPT/04%20Suriadi%20Guwanan-PPT.pdf
p.000125:
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125:
p.000125:
p.000125: Human Biological Materials
p.000125:
p.000125: Japan
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125: Ministry of Health, National Institute of Health Research and Development: http://indonesia.go.id/en
p.000125:
p.000125:
p.000125: National Agency of Drug and Food Control: http://www.pom.go.id/index.php/home/en
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000125: 2. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: Drugs
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125:
p.000125:
p.000125: Devices
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125: Indonesian Health Act No. 23/1992 Section on Health Research, Article 69
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017):
p.000125: https://www.mhlw.go.jp/file/06-
p.000126: 126
...
p.000128: 2. Guidelines for Research Using Gene- altering Technologies on Human Fertilized Embryos (2019):
p.000128: https://www.lifescience.mext.go.jp/files/pdf/Ov erview_Human_embryo_geneome- editing_guideline2019En.pdf
p.000128: Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomedical Research in the CIS
p.000128: Countries,” Chapter 3, Section 5:
p.000128: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000128:
p.000128: General
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Drugs, Biologics, and Devices
p.000128: Ministry of Healthcare and Social Development, Central Commission on Research Ethics: http://www.mzsr.gov.kz/en
p.000128:
p.000128:
p.000128: Ministry of Healthcare and Social Development, Control Committee of Medical and Pharmacy Activity:
p.000128: https://www.mzsr.gov.kz/en/taxonomy/ter m/674
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Code of the Republic of Kazakhstan "On People's Health and the Health Care System" (18.09.2009 No.193-IV),
p.000128: Articles 74 and 180 (2015): http://online.zakon.kz/Document/?d oc_id=30479065#pos=1;-8
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000129: 129
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: 1. Order of the MHSD of the RK Dated 12.11.2009 No. 697 on the Approval of Regulations on the Medical-Biological
p.000129: Experiments, Preclinical (Non-Clinical) and Clinical Trials
p.000129: 2. Order of the MHSD of the RK dated 19.11.2009 No. 744 on the Approval of Regulations on the Conduct of Clinical
p.000129: Trials and/or Trials on Pharmaceutical and Drug Products, Medical Devices, and Medical Equipment
p.000129: 3. Order of the MHSD Dated 20.05.2014 No.272 on the
p.000129: 1. Guidelines on Ethics in Health Research. (2007)
p.000129: 2. Local Ethics Committees: Policy, Rules and Procedures ( 2014)
p.000129: 3. Guidelines on Ethics in Biomedical Research (2015)
p.000129: Guidelines on Clinical Trials in Kazakhstan (2003)
p.000129:
p.000129: Country Key Organizations Legislation
p.000129: Regulations Guidelines
p.000129:
p.000129: Drugs, Biologics, and Devices
p.000129:
p.000129:
p.000129: Privacy/Data protection
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Korea
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Ministry of Healthcare and Social Development: http://www.mzsr.gov.kz/en
p.000129:
p.000129:
p.000129:
p.000129: Code of the Republic of Kazakhstan “On People's Health and the Health Care System” (18.09.2009 No.193-IV), Article
p.000129: 28 (2015):
p.000129: http://online.zakon.kz/Document/?d oc_id=30479065#pos=1;-8
p.000129: Approval of Regulations on the Implementation of the New Methods of Diagnostic, Treatment, and Rehabilitation
p.000129:
p.000129: Note: All documents are in Korean.
p.000129: General Ministry of Health and Welfare:
p.000129: http://www.mohw.go.kr/eng/index.jsp
p.000129:
p.000129: Bioethics and Safety Act No. No. 15188 (2017.12):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000129:
p.000129: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 28821 (2017.7): http://www.law.go.kr/LSW/
p.000129: lsInfoP.do?lsiSeq=195703&url Mode=engLsInfoR&viewCls=engLsI nfoR#0000
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs, Biologics, and Devices
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs
p.000129: Ministry of Food and Drug Safety (MFDS) (2013):
p.000129: http://www.mfds.go.kr/eng/index.do
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Medical Device Act No. 15486 (2018.3):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=48691&lang=ENG
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000130: 130
p.000130: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/lsInfoP.d
p.000130: o?lsiSeq=98198&urlMode=engLsI nfoR&viewCls=engLsInfoR#0000
p.000130:
p.000130: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 27673 (2016.12): http://elaw.klri.re.kr/kor_service/law
p.000130: View.do?hseq=40268&lang=ENG
p.000130: 2. Regulation on Safety of Medicinal Products, etc. No. 1089(2014.8): http://www.mfds.go.kr/eng/brd/m_18
p.000130: /view.do?seq=69740&srchFr=&srchT o=&srchWord=&srchTp=&itm_seq_ 1=0&itm_seq_2=0&multi_itm_seq=0
p.000130: &company_cd=&company_nm=&pa ge=3
p.000130: 3. Regulations for Clinical Trial Personnel Education and Certification for the Educational
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: MFDS:
p.000130: 1. Guidelines on Human Research Protection Program 0053-01 (2014.3) 2017-.5.30 고시:
p.000130: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000130: =12203
p.000130:
p.000130: Country Key Organizations Legislation
p.000130: Regulations Guidelines
p.000130:
p.000130:
p.000130: Drugs, Biologics, and Devices
p.000130: Institution Notice No.2019-3 (2019.01. 17.) http://www.law.go.kr/admRulLsIn foP.do?admRulSeq=2100000175429
p.000130: 4. Regulation on Approval for Investigational New Drug Application of Drugs, Notice No.2018-42 (2018. 06.04)
p.000130: https://www.mfds.go.kr/eng/brd/m_18/ view.do?seq=71451
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Clinical Trials Registry
p.000130:
p.000130:
p.000130: Research Injury
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Privacy/Data Protection
p.000130: Devices
p.000130: Ministry of Food and Drug Safety:
p.000130: http://www.mfds.go.kr/eng/index.do
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Korea Centers for Disease Control and Prevention (KCDC), Clinical Research Information Service:
p.000130: https://cris.nih.go.kr/cris/en/index.jsp?mo bile=
p.000130: Ministry of Food and Drug Safety (MFDS):
p.000130: http://www.mfds.go.kr/eng/index.do
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: 1. Ministry of the Interior and Safety (MOIS): http://www.mois.go.kr/eng/a01/engMain.
p.000130:
p.000130:
p.000130: Medical Device Act No. 15486 (2018.03.13): http:// www.law.go.kr/LSW/eng/ engLsSc.do? menuId=2§ion=lawNm&quer
p.000130: y=medical+device
p.000130: +act&x=27&y=26#liBgcolor6
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: MFDS:
p.000130: Pharmaceutical Affairs Act No.14328 (2016.12.02)
p.000130: https://elaw.klri.re.kr/kor_service/ lawView.do?hseq=40196&lang=ENG
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: MOIS:
p.000130: Personal Information Protection Act No. 14839 (2017):
p.000131: 131
p.000131:
p.000131:
p.000131: 1. Enforcement Decree of the Medical Device Act No. 27209 (2016.05.31): http://www.law.go.kr/LSW/eng/
p.000131: engLsSc.domenuId=2&s ection=lawNm&query=medical+ device+act&x=23&y=20#liBgcolor2
p.000131: 2. 2. Enforcement Regulations of the Medical Device Act No. 18 (2010.9): http://www.law.go.kr/LSW/lsInfoP.do
p.000131: lsiSeq=107498&urlMode=engLsInfo R&viewCls=engLsInfoR#0000
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Regulation on Safety of Pharmaceuticals, etc. No. 1455 (2018.04.25)
p.000131: https://www.mfds.go.kr/eng/brd/ m_18/view.do? seq=71447&srchFr=&srchTo=&srch Word=&srchTp=&itm_seq_1=0&it
p.000131: m_seq_2=0&multi_itm_seq=0&com pany_cd=&company_nm=&page=2
p.000131:
p.000131: Enforcement Regulations of the Medical Device Act No.1354 (2017.01. 04)
...
p.000131: =13069&srchFr=&srchTo=&srchWord=%EB
p.000131: %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
p.000131: 2. Guidance for Sponsors; Safety Reporting Requirements 0785-01 (2017.8) 2017.8.31 고시:
p.000131: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000131: =13317&srchFr=&srchTo=&srchWord=%EC
p.000131: %95%88%EC%A0%84%EC%84%B1&srchT
p.000131: p=0&itm_seq_1=0&itm_seq_2=0&multi_itm_ seq=0&company_cd=&company_nm=&page= 1
p.000131: MOIS:
p.000131: Guidelines for De-identification of Personal Data (2016.06.30):
p.000131:
p.000131: Country Key Organizations Legislation
p.000131: Regulations Guidelines
p.000131:
p.000131: Privacy/Data Protection
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Human Biological Materials
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Genetic Research
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Embryos, Stem Cells, and Cloning
p.000131: do
p.000131: 2. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46731&lang=ENG
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: MOHW: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la
p.000132: 132
p.000132: Act No. 28355 (2017.10):
p.000132: http://elaw.klri.re.kr/kor_service/law View.do?hseq=45683&lang=ENG
p.000132:
p.000132: 2. Enforcement Rules to Personal Information Protection Act No. 1 (2013.3): http://www.law.go.kr/LSW/eng/eng
p.000132: LsSc.do?menuId=1&query=pers onal&x=0&y=0#liBgcolor21
p.000132: MOHW:
p.000132: Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12):
p.000132: http://www.law.go.kr/LSW/eng/engL sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y=
p.000132: 0#liBgcolor11
p.000132: 1. Enforcement Decree of Bioethics and Safety Act No. 28211 (2017): http://elaw.klri.re.kr/kor_service/law
p.000132: View.do?hseq=45482&lang=ENG
...
p.000132: MOHW:
p.000132: 1. Enforcement Decree of Bioethics and Safety Act No. 28211 (2017): http://elaw.klri.re.kr/kor_service/law
p.000132: View.do?hseq=45482&lang=ENG
p.000132: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL
p.000132: sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11
p.000132: MOHW:
p.000132: 1. Enforcement Decree of Bioethics and Safety Act No.
p.000132: https://www.privacy.go.kr/eng/ news_event_view.do?nttId=7585
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: MFDS:
p.000132: Guidelines on the Evaluation of Quality, Safety, and Efficacy of Recombinant Protein Products 0324-01 (2014.12)
p.000132: 2017.6.1 고시:
p.000132: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000132: =12542&srchFr=&srchTo=&srchWord=%EC
p.000132: %9E%AC%EC%A1%B0%ED%95%A9&srch
p.000132: Tp=0&itm_seq_1=0&itm_seq_2=0&multi_itm
p.000132: _seq=0&company_cd=&company_nm=&page
p.000132: =1
p.000132:
p.000132: MFDS:
p.000132: 1. Guideline on Sponsor-Investigator Trials of Cell Therapy Products for Academic Purpose 0307-01 (2014.12) 2014.12.30
p.000132: 고시:
p.000132:
p.000132: Country Key Organizations Legislation
p.000132: Regulations Guidelines
p.000132:
p.000132: Embryos, Stem Cells, and Cloning
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: Kyrgyzstan
p.000132: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000132: wView.do?hseq=46341&lang=ENG
p.000132: 28211 (2017):
p.000132: http://elaw.klri.re.kr/kor_service/law View.do?hseq=45482&lang=ENG
p.000132:
p.000132: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL
p.000132: sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11
p.000132: 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%
p.000132: 8C&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_ itm_seq=0&company_cd=&company_nm=&page=1
p.000132: 2.Guideline on the Design of Early-Phase Clinical Trials of Cell Therapy and Gene Therapy Products 안내서0309-01
p.000132: (2015.11): https://www.mfds.go.kr/brd/m_210/view.do?seq=12501
p.000132: 3.Guideline on Tumorigenicity Assessment of Stem Cell Therapy Products (2016.05.) https://
p.000132: www.mfds.go.kr/eng/brd/m_27/view.do?seq=70469
p.000132:
p.000132: Note: All websites and documents are in Russian.
p.000132: General 1. Government of the Kyrgyz Republic: http://www.gov.kg
p.000132: 2. Ministry of Health:
p.000132: http://www.med.kg
p.000132: 3. Ministry of Justice of the Kyrgyz Republic: http://cbd.minjust.gov.kg
p.000132:
p.000132: 1. Constitution of Kyrgyz Republic, Chapter II, Article 22 (2010): http://www.gov.kg/?page_id=263&l ang=ru
p.000132: 2. Law on Health Protection of the Kyrgyz Republic (Sept. 1, 2005, No. 6):
p.000132: Articles 34 and 72:
p.000132: http://www.pharm.kg/ru/legislation
p.000132:
p.000132: 1. Code of Professional Ethics of Medical Worker of the Kyrgyz Republic (2004): http://old.med.kg/index.php/ru/doku
p.000132: menty-2/kodex-prof-etiki-2.html
p.000132: 2. Сode of Administrative Responsibility of the Kyrgyz Republic №114 from 04.08.1998г. (Updated June 11, 2008 N 115 and
p.000132: June 23, 2008 N
p.000132: 136) Chapters 7 and 10:
p.000132: http://www.pharm.kg/ru/legislation/
p.000132:
p.000132: Drugs, Biologics, and Devices
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: Research Injury
p.000132: 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg
p.000132: 2. Ministry of Health, National Bioethics Committee
p.000132: 3. Pharmaceutical Union of Kyrgyzstan, Ethics Committee: http://farmunion.kg/o-nas/eticheskij- komitet/
p.000132:
p.000132:
p.000132: 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg
p.000132: 2. Ministry of Health, National Bioethics Committee
p.000132: Law on the Circulation of Medicinal Products
p.000132: of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles
p.000132: 24-25:
p.000132: http://cbd.minjust.gov.kg/act/view/r u-ru/111672
p.000132:
p.000132:
p.000132: Law on the Circulation of Medicinal Products
p.000132: of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles
p.000132: 24-25:
p.000132: http://cbd.minjust.gov.kg/act/view/r u-ru/111672
p.000132: DDMDP:
p.000132: 1. National Standard KMC 1195:2010: Medical Devices: Rules for Clinical Trials (2010):
p.000132: http://www.pharm.kg/ru/legislation/
p.000132: 2. Technical Regulations on the Safety of Medical Products for Medical Application, Approved by the Governmental Order
p.000132: # 74 from February 1, 2012: http://www.pharm.kg/ru/legislation/ DDMDP:
p.000132: National Standard KMC 1195:2010: Medical Devices, Rules for Clinical Trials, Paragraphs 3, 4, and 6 (2010):
p.000132: http://www.pharm.kg/ru/legislation/
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p.000133: Regulations Guidelines
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p.000133: 1. Ministry of Health, Department of Drug and Medical Devices Provision: http://www.pharm.kg
p.000133: 2. Ministry of Health, National Bioethics Committee
p.000133:
p.000133: Ministry of Justice of the Kyrgyz Republic: http://minjust.gov.kg/ru/
p.000133:
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p.000133: 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg
p.000133: 2. Ministry of Health, National Bioethics Committee
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p.000133: 1. Ministry of Health Malaysia, Medical Review and Ethics Committee (MREC)
p.000133: 2. Malaysian Industry-Government Group For High Technology (MIGHT), National Science Council:
p.000133: https://www.might.org.my/download/the- malaysian-code-of-responsible-conduct- in-research/
p.000133:
p.000133:
p.000133:
p.000133: 1. Society of Clinical Research Professionals Malaysia (SCRPM): https://scrpm.ucoz.com/
p.000133: 2. Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA): https://npra.gov.my/index.php/en/
p.000133: Law on Health Protection of the Kyrgyz Republic (09.01.2005
p.000133: No. 6): Article 39:
p.000133: http://www.pharm.kg/ru/legislation
p.000133:
p.000133:
p.000133: Law On the Protection of Traditional Knowledge, as amended by the Law of the Kyrgyz Republic of July 18, 2014 No. 144):
p.000133: http://cbd.minjust.gov.kg/act/view/r u-ru/202149/20?cl=ru-ru
p.000133: Law on Health Protection of the Kyrgyz Republic (09.01.2005
p.000133: No. 6): Article 91:
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p.000136: entral/Guidelines_on_Regulatory/CGTP_guide lines.doc
p.000136:
p.000136: NBB:
p.000136: Guidelines for Institutional Biosafety Committees: https://um.edu.my/docs/default-
p.000136: source/institutional-biosafety-committee- (ibc)/ibc-guidelines.pdf?sfvrsn=2
p.000136: 1. Checklist for Research on Stem Cell and Cell-Based Therapies (2014): http://www.nih.gov.my/mrec/documents/Research_O
p.000136: n_Stem_cell_and_Cell_based_Therapies.pdf
p.000136: 2. Guidance Document and Guidelines for
p.000136:
p.000136: Country Key Organizations Legislation
p.000136: Regulations Guidelines
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p.000136: Embryos, Stem Cells, and Cloning
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p.000136: Human Biological Materials
p.000136:
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p.000136: General
p.000136: Development Division: http://www.moh.gov.my/index.php?mid= 5
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p.000136: 1. Department of Medical Research (DMR): http://www.dmrlm.gov.mm/
p.000136: 2. Ministry of Health National Ethics Committee on Clinical Research: www.moh.gov.mm
p.000136: Ministry of Health, Food and Drug Administration: http://www.fdamyanmar.gov.mm/index.p hp/en/
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p.000136: National Drug Law (1992)
p.000136:
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p.000136: 1. Blood and Blood Products Law (2003) (Burmese): http://www.moh.gov.mm/file/Law/ Blood%20and%20Blood%20Produc
p.000136: t%20Law%20(2003).pdf
p.000136: 2. Body Organ Donation Law (2004)
p.000136:
p.000136: Nepal Health Research Council Act, 1991, Section 3(1): http://www.lawcommission.gov.np/
p.000136: en/documents/2015/08/nepal-health- research-council-act-2047-1991.pdf
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p.000137: Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia (2016): https://www.npra.gov.my/images/00NPRA/bio
p.000137: logic/guidelines/CGTP_guidelinesbio.pdf
p.000137: 3. Medical Development Division: Guidelines for Stem Cell Research and Gene Therapy (2009):
p.000137: http://www.moh.gov.my/moh/resources/auto% 20download%20images/586f38d1c77ed.pdf
p.000137: 4. National Organ, Tissue and Cell Transplantation Policy: http://www.mst.org.my/articles/MALAYSIA%
p.000137: 20TRANSPLANT%20POLICY.pdf
p.000137: 5. National Standards for Cord Blood Banking and Transplantation: http://www.moh.gov.my/moh/resources/auto%
p.000137: 20download%20images/589d78e8689af.pdf
p.000137: 6. National Standards for Stem Cell Transplantation: http://www.moh.gov.my/moh/resources/Arkib/
p.000137: National_Standards_For_Stem_cell_Transplata tion.pdf
p.000137:
p.000137: DMR:
p.000137: Guideline for Submission to Ethics Review Committee (2016)
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p.000137: 1. National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure (2011):
p.000137: http://nhrc.org.np/guidelines
p.000137: 2. Guidelines for Institutional Review
p.000137:
p.000137: Country Key Organizations Legislation
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p.000140: (2007): http://ethics.healthresearch.ph/index.p hp/component/content/article/2- uncategorised/112-ao-001-2007
p.000140: 2. Administrative Order 001 Series 2008: Registration of All Ethics Review Committee at the PHREB (2008):
p.000140: http://ethics.healthresearch.ph/index.p hp/component/content/article/2- uncategorised/111-ao-001
p.000140: 3. PCHRD Special Order No. 146 Series of 2013: Reactivation and Amendment of Functions of the National Ethics Committee
p.000140: http://nec.pchrd.dost.gov.ph/compone nts/com_ethics/pdf_files/nec_so.pdf
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p.000142: Department Circular No. 2015- 0059: Research Ethics Review Committees Registration and Accreditation:
p.000142: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/217-doh-circular
p.000142:
p.000142: CHED:
p.000142: 1. Memo 34 Series 2007: Policy Requirement in the Conduct of Health Research involving Human Subjects:
p.000142: http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/2
p.000142: -uncategorised/130-ched- memorandum
p.000142: 2. Memorandum from the CHED Chairperson: Philippine Health Research Ethics Board – Registration and Accreditation of
p.000142: All Ethics Review Committees: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and-
p.000142: memos/225-ched-memo
p.000142:
p.000142: NCIP:
p.000142: NCIP AO No. 3 Series 2012:
p.000142: Revised Guidelines on Free and Prior Informed Consent
p.000142: (FPIC) and Related Processes of 2012:
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p.000142: National Ethical Guidelines for Health and Health-Related Research, Page 70 (2017):
p.000142: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
p.000142: guidelines-for-health-and-health-related- research
p.000142:
p.000142: Country Key Organizations Legislation
p.000142: Regulations Guidelines
p.000142:
p.000142: Drugs, Biologics, and Devices
p.000142: 2. FDA Circular 2015-026: Adoption of the ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products:
p.000142: Stability Testing of Biotechnological/Biological Products Q5C: http://www.fda.gov.ph/attachments/ar
p.000142: ticle/118205/FC2013-026.pdf
p.000142:
p.000142: DOST, DOH, CHED, and UPM:
p.000142: Joint Memorandum Order 001 Series of 2012: http://www.ethics.healthresearch.ph/i ndex.php/component/content/article/1
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p.000142: Food and Drug Administration:
p.000142: http://www.fda.gov.ph/
p.000142:
p.000142:
p.000142: Philippine Health Research Registry:
p.000142: http://registry.healthresearch.ph/
p.000142:
p.000142:
p.000142: 1. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000142: 2. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
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p.000143: DOST, DOH, CHED, and UPM:
p.000143: Joint Administrative Order No. 001: The Implementing Rules and Regulations of Republic Act 10532 Otherwise Known as
p.000143: “The Philippine National Health Research System Act of 2013:” http://www.ethics.healthresearch.ph/i
p.000143: ndex.php/component/content/article/2
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p.000143: FDA Guidelines: Regulation of Clinical Trials in the Philippines http://www.pcrp.org.ph/pdf/Guidelinesversion LR.PDF
p.000143: FAQs:
p.000143: http://registry.healthresearch.ph/index.php?opti on=com_content&view=article&id=7&Itemid= 185
p.000143: PHREB:
p.000143: National Ethical Guidelines for Health and Health-Related Research (2017):
p.000143: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
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p.000145: 2. Donation of Human Eggs for Research (2008): http://www.bioethics- singapore.org/index/publications/reports/86-
p.000145: reports/168-donation-of-human-eggs-for- research.html
p.000145: 3. Human-Animal Combinations in Stem- Cell Research (2010): http://www.bioethics-
p.000145: singapore.org/index/publications/reports/86- reports/167-human-animal-combinations-in- stem-cell-research.html
p.000145:
p.000145: Guidelines for the Conduct of Clinical Trials in Sri Lanka (2014): http://www.cdda.gov.lk/images/pdf/clinical%2
p.000145: 0trials%20guidelines_oct2014.pdf
p.000145:
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p.000145: FAQs: http://slctr.lk/faq
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p.000146: Regulations Guidelines Taiwan
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p.000146: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.gov.tw/EN/Ministry/In dex.aspx
p.000146: 2. Taiwan Food and Drug Administration (FDA): http://www.fda.gov.tw/EN/index.aspx
p.000146: 1. Human Subjects Research Act (2019) (Chinese): https://law.moj.gov.tw/LawClass/La wAll.aspx?pcode=L0020176
p.000146: 2. Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021
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p.000146: Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021 ‘
p.000146: FDA:
p.000146: Pharmaceutical Affairs Act (2018):
p.000146: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0030001
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p.000147: 1. Regulations on Human Trials (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020162
p.000147: 2. Enforcement Rules of the Medical Care Act (2017) (Chinese): http://law.moj.gov.tw/LawClass/Law
p.000147: Content.aspx?PCODE=L0020023
p.000147: 3. Regulations for the Organization and Operation of Human Research Ethics Review Boards (2018):
p.000147: https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020179
p.000147: 4. Exempt Review Categories for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54295
p.000147: 5. Informed Consent Exemptions for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54273
p.000147: 6. Expedited Review Categories for Human Research (2012): https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54277
p.000147: MOHW:
p.000147: 1. Regulations on Human Trials (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0020162
p.000147: 2. Pharmaceutical Affairs Act Enforcement Rules (2016): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030002
p.000147: 3. Regulations for Drug Safety Monitoring (2013) https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030050
p.000147: 4. Regulations for Good Clinical Practice (2014): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030056
p.000147: 5. Regulations for Governing the
p.000147: Regulations Governing the Organization and Operation of the Human Research Ethics Review Board (2018):
p.000147: http://law.moj.gov.tw/Eng/LawClass/LawCont ent.aspx?PCODE=L0020179
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p.000147: Country Key Organizations Legislation
p.000147: Regulations Guidelines
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p.000147: 1. Ministry of Health and Welfare (MOHW): https://www.mohw.gov.tw/mp-2.html
p.000147: 2. Food and Drug Administration (FDA), MOHW: http://www.fda.gov.tw/EN/index.aspx Ministry of Health and Welfare:
p.000147: https://www.mohw.gov.tw/mp-2.html
p.000147:
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p.000147: Ministry of Justice:
p.000147: http://www.moj.gov.tw/mp095.html
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p.000147:
p.000147:
p.000147: Ministry of Health and Welfare:
p.000147: https://www.mohw.gov.tw/mp-2.html
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: 1. Ministry of Health and Welfare (MOHW): https://www.mohw.gov.tw/mp-2.html
p.000147: 2. Food and Drug Administration (FDA): http://www.fda.gov.tw/EN/index.aspx
p.000147: 3. Ministry of Science and Technology: https://www.most.gov.tw/en/public
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: Personal Information Protection Act (2015):
p.000147: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=I0050021
p.000147:
p.000147: Human Biobank Management Act (2012):
p.000147: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020164
p.000147: 3. Medical Care Act (2018): https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0020021
p.000147:
p.000147:
p.000147:
p.000147: MOHW:
p.000147: Human Biobank Management Act (2012):
p.000147: http://law.moj.gov.tw/Eng//LawClas s/LawContent.aspx?pcode=L00201 64
p.000147:
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p.000148: Management of Medical Devices (2014):
p.000148: http://mohwlaw.mohw.gov.tw/Chi/En gContent.asp?msgid=528&KeyWord
p.000148: =
p.000148: 6. Regulation on Bioavailability and Bioequivalence Studies (2015): https://law.moj.gov.tw/ENG/LawClas
p.000148: s/LawAll.aspx?pcode=L0030065 FDA:
p.000148: Regulation for Good Clinical Practice (2014): https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=L0030056
p.000148:
p.000148: Exempt Review Categories for Human Research (2012) https://gazette.nat.gov.tw/egFront/e_d etail.do?metaid=54295
p.000148: Enforcement Rules of the Personal Data Protection Act (2016):
p.000148: https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=I0050022
...
p.000148:
p.000148: Tajikistan
p.000148: Ministry of Health and Welfare (MOHW):
p.000148: https://www.mohw.gov.tw/mp-2.html
p.000148: Artificial Reproduction Act (2018):
p.000148: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0070024
p.000148: Note: For an overview of human subject protections in Tajikistan, see “Ethical Review of Biomedical Research in the CIS
p.000148: Countries,” Chapter 3, Section 9:
p.000148: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000148: Note: All websites and documents are in Russian.
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Thailand
p.000148: Ministry of Public Health: http://www.health.tj/
p.000148: Order of the Ministry of Public Health of the Republic Tajikistan of 10 March, 2005 No. 118: About the Assertion of the
p.000148: Normative Documents of Republic Committee on Medical Ethics
p.000148: For an overview of the clinical research regulations in Thailand, see:
p.000148: https://clinregs.niaid.nih.gov/single_country.php?c_id=213
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Drugs, Biologics, and Devices
p.000148: 1. National Research Council of Thailand (NCRT): http://en.nrct.go.th/en/home.aspx
p.000148: 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php
p.000148: 3. Forum for Ethical Review Committees in Thailand (FERCIT): http://www.fercit.org/
p.000148:
p.000148:
p.000148:
p.000148: Drugs
p.000148: 1. Food and Drug Administration, Drug Control Division: http://www.fda.moph.go.th/eng/index.stm
p.000148: 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php
p.000148:
p.000148:
p.000148: Devices
p.000148: Food and Drug Administration, Medical Device Control Division: http://www.fda.moph.go.th/eng/medical/p re.stm
p.000148: Medical Professions Act (2009), Articles 47-50: http://www.fercit.org/SIDCER- FERCAP/Handout_10/4.%20Accre ditation-
p.000148: update_surveyor_aj.Sopit.pdf
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Consumer Protection Act (2007)
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: 1988 Medical Device Act: http://www2.fda.moph.go.th/Export ers/law/Document/Mdc/36- MEDICAL%20DEVICE%20ACT.h
p.000148: tm
p.000148: NCRT:
p.000148: Regulation on the Permission of Foreign Researchers (1982): http://www.dnp.go.th/otec/eng_laws_ regs/NRCT_Reg2525E.pdf
p.000148:
p.000148: MCT:
p.000148: Rule of the Medical Council on the Observance of Medical Ethics (1983):
p.000148: http://thailaws.com/law/t_laws/tlaw0 510.pdf
p.000148: MCT:
p.000148: National Guideline for Ethical Research on Human Subjects (2002)
p.000148:
p.000148: FERCIT:
p.000148: Ethical Guidelines for Research on Human Subject in Thailand (2007): http://www.fercit.org/file/Guideline_English_v
p.000148: ersion.pdf
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: FDA:
p.000148: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (2018)
p.000148:
p.000148: MCT:
p.000148: Thailand Good Clinical Practice Guidelines (2002)
p.000148:
p.000149: 149
p.000149:
p.000149: Country Key Organizations Legislation
p.000149: Regulations Guidelines
p.000149:
p.000149: Clinical Trials Registry
p.000149:
...
p.000150: 2. Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in Biomedical Research of the Ministry of
p.000150: Health, Period 2018-2023: http://crc.pasteurhcm.gov.vn/upload/files/1122
p.000150: _2018.pdf
p.000150: Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17
p.000150: (2012):
p.000150: https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf
p.000150: 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van-
p.000150: ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx
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p.000151: 151
p.000151:
p.000151: Country Key Organizations Legislation
p.000151: Regulations Guidelines
p.000151:
p.000151: MIDDLE EAST/NORTH AFRICA
p.000151: Egypt
p.000151:
p.000151: General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151: Iran
p.000151: General
p.000151:
p.000151:
p.000151:
p.000151: Clinical Trials Registry Israel General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151:
p.000151:
p.000151: Privacy/Data Protection
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Genetic Research
p.000151: Medical Professionals Union
p.000151:
p.000151:
p.000151: Egyptian Drug Authority:
p.000151: http://www.eda.mohp.gov.eg/
p.000151:
p.000151:
p.000151: Ministry of Health and Medical Education, Office for the Study of Humanistic and Islamic Science in Medicine and
p.000151: Medical Ethics: http://www.mohme.gov.ir/
p.000151: Iranian Registry of Clinical Trials:
p.000151: http://www.irct.ir/
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151:
p.000151: Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/English/Ministry
p.000151: Units/HealthDivision/MedicalTechnologi es/Drugs/Pages/default.aspx
p.000151:
p.000151: Israeli Law, Information, and Technology Authority: http://www.justice.gov.il/MOJEng/ILITA/
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151: Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dusto r-en001.pdf
p.000151:
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p.000151:
p.000151:
p.000151: Public Health Order (1940)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007-
p.000151: 5FD6A6B8E0A5/18334/Protectiono fPrivacyLaw57411981unofficialtran slatio.pdf
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p.000151:
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p.000151:
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p.000151:
p.000151:
p.000151:
p.000151:
p.000151: FAQs: http://www.irct.ir/faq.php
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Guidelines for Clinical Trials in Human Subjects (2006): https://firstclinical.com/regdocs/doc/?db=INT_
p.000151: Israel_Clinical_Trials
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Instruction of the Supreme Committee for Clinical Studies on Humans Regarding Establishment and Usage of Genetic
p.000151: Samples Reservoir (2005)
p.000151: 2. Amendment (2007)
p.000151:
p.000152: 152
p.000152:
p.000152: Country Key Organizations Legislation
p.000152: Regulations Guidelines
p.000152:
p.000152: Embryos, Stem Cells, and Cloning
p.000152:
p.000152:
p.000152: Jordan
p.000152: Note: All documents are in Arabic.
p.000152: Genetic Intervention Prohibition Law (Human Cloning and Genetic Changes in Reproduction Cells) (1999)
p.000152:
p.000152: Drugs, Biologics, and Devices
p.000152:
p.000152:
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p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Research Injury
p.000152: 1. Ministry of Health: http://www.moh.gov.jo/en/Pages/default.a spx
p.000152: 2. Jordan Food and Drug Administration: http://www.jfda.jo/Default.aspx
p.000152: 1. Law of Clinical Studies, Law No. 2 (2011) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/Pharmaceu ticalStudies/50_211.pdf
p.000152: 2. Drug and Pharmacy Law No. 12 (2013) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/DrugDirec torate/%D9%82%D8%A7%D9
p.000152: %86%D9%88%D9%86%20%D 8%A7%D9%84%D8%AF%D9
p.000152: %88%D8%A7%D8%A1%20% D9%88%D8%A7%D9%84%D8
p.000152: %B5%D9%8A%D8%AF%D9% 84%D8%A9.pdf
p.000152: 3. Narcotic and Psychotropic Law No. 23 (2016) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/DrugsAnd PsychotropicSubstances/%D9% 82%D8%A7%D9%86%D9%88
p.000152: %D9%86%20%D8%A7%D9% 84%D9%85%D8%AE%D8%A F%D8%B1%D8%A7%D8%AA
p.000152: %20%D9%88%D8%A7%D9% 84%D9%85%D8%A4%D8%A B%D8%B1%D8%A7%D8%AA
p.000152: %20%D8%A7%D9%84%D8% B9%D9%82%D9%84%D9%8A
p.000152: %D8%A9.pdf
p.000152:
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p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Regulations for Insurance on Research-Related Injury (2013): http://www.jfda.jo/EchoBusV3.0/Syst
p.000153: emAssets/PDF/AR/LawsAndRegulati
p.000153:
p.000153: Country Key Organizations Legislation
p.000153: Regulations Guidelines
p.000153:
p.000153: Research Injury
p.000153: Embryos, Stem Cells, and Cloning Kuwait
p.000153: General
p.000153:
p.000153: Qatar
p.000153: General
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Social/Behavioral Research
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Human Biological Materials
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Genetic Research
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Ministry of Health, Kuwait Institute for Medical Specialization: http://www.kims.org.kw/
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153: Stem Cell By-law No. 10 (2014)
p.000153:
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p.000154:
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p.000154:
p.000154:
p.000154: Protection of Human Subjects Involved in Research: https://researchwebadmin.moph.gov.
p.000154: qa//DepartmentalDocuments/Policies,
p.000154: %20Regulations%20and%20Guidelin es%20for%20Research%20Involving
p.000154: %20Human.pdf
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Ethical Guidelines for Biomedical Research: http://www.kims.org.kw/Ethical%202.doc
p.000154:
p.000154: 1. IRB - IEC Registration Application: https://researchwebadmin.moph.gov.qa/en/Pag es/IRB.aspx
p.000154: 2. Guidelines on Reviewing and Reporting Adverse Events: https://researchportal.moph.gov.qa/_layouts/15
p.000154: /ResearchPortal/RDLogin.aspx?ReturnUrl=%2 f_layouts%2f15%2fAuthenticate.aspx%3fSour ce%3d%252F&Source=%2F
p.000154: 3. GCP Conduct of Clinical Trials: https://researchwebadmin.moph.gov.qa//D epartmentalDocuments/Standards%20of%
p.000154: 20Good%20Clinical%20Practice.pdf
p.000154: 1. Protection of Human Subjects, Exempt Research: https://researchwebadmin.moph.gov.qa//Depart
p.000154: mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf
p.000154: 2. Protection of Human Subjects, Expedited Research: https://researchwebadmin.moph.gov.qa//Depart
p.000154: mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf
p.000154: Guidance for the Use of Stored Data and Biological Specimens in Human Research:
p.000154: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20the%2
p.000154: 0Use%20of%20Stored%20Data%20and%20Bi ological%20Specimens%20in%20Human%20 Research.pdf
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p.000163: omissoes/conep/documentos/NORM AS-
p.000163: RESOLUCOES/Resoluo_n_446_-
p.000163: _2011_-
p.000163: Sobre_composio_da_CONEP.pdf
p.000163: 8. Resolution CNS No. 466/2012 on Guidelines and Rules for Research Involving humans Subjects:
p.000163: http://conselho.saude.gov.br/resoluco es/2012/466_english.pdf
p.000163: 9. Resolution CNS Nº 506/2016 Accreditation of CEP: http://conselho.saude.gov.br/resoluco es/2016/Reso_506.pdf
p.000163: 10. Resolution CNS No 563/2017 on Research Participant's Right in Ultra-rare Diseases:
p.000163: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_563_-
p.000163: _2017_-
p.000163: _Regulamenta_direito_participante_d e_pesquisa_com_doenas_ultrarraras.p df
p.000163: 11. Resolution CNS No 580/2018 on Research of Strategic Interest for the Unified Health System (SUS):
p.000163: http://conselho.saude.gov.br/resoluco es/2018/Reso580.pdf
p.000163:
p.000163: CNS:
p.000163: 1. Resolution CNS No. 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines,
p.000163: Vaccines, and Diagnostic Tests: http://conselho.saude.gov.br/resoluco es/1997/Res251_en.pdf
p.000163: 2. Resolution CNS No. 301, 16th March 2002: Regarding Placebos: http://conselho.saude.gov.br/resoluco
p.000163: es/2000/Res301_en.pdf
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p.000163:
p.000163: ANVISA:
p.000163: 1. Manual for Submission of “Drug Clinical Development Dossier” (DDCM) (2017):
p.000163: http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+para+Submiss%C3%A3o+de+ Dossi%C3%AA+de+Desenvolvimento+Cl%C
p.000163: 3%ADnico+de+Medicamento+%28DDCM%2 9+e+Dossi%C3%AA+Espec%C3%ADfico+de
p.000163: +Ensaio+Cl%C3%ADnico+-
p.000163: +3%C2%AA+edi%C3%A7%C3%A3o/29e9c5
p.000163: b1-2942-4bb9-a4dd-4fccc6fccda3
p.000163: 2. Manual for Submission of Modifications, Amendments, Suspensions
p.000163:
p.000163: Country Key Organizations Legislation
p.000163: Regulations Guidelines
p.000163:
p.000163: Drugs, Biologics, and Devices
p.000163:
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p.000163: Clinical Trials Registry
p.000163: Research Injury
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p.000163:
p.000163:
p.000163:
p.000163:
p.000163: Devices
p.000163: Brazilian Health Surveillance Agency (ANVISA):
p.000163: http://portal.anvisa.gov.br/english
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163: Brazilian Clinical Trials Registry:
p.000163: http://www.ensaiosclinicos.gov.br/
p.000163:
p.000163: 1. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english
p.000163:
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p.000168:
p.000168:
p.000168: 1. Law for the Protection of Private Life No. 19.628 (1999): http://www.bcn.cl/leyes/141599
p.000168: 2. Law No. 20584. Regulating the Rights and Duties Incumbent upon Persons in Connection with Actions Linked to their
p.000168: Health Care (2012): http://www.leychile.cl/Navegar?idN orma=1039348
p.000168: Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006):
p.000168: http://www.leychile.cl./Navegar?id Norma=253478
p.000168:
p.000168:
p.000168: Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006):
p.000168: http://www.leychile.cl./Navegar?id Norma=253478
p.000168: http://www.ispch.cl/sites/default/files/ res_441.pdf
p.000168: Supreme Decree No. 41 of 2012: Regulation Regarding Clinical Records of December 15, 2012:
p.000168: http://www.leychile.cl/Navegar?idNo rma=1046753
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome,
p.000168: and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo
p.000168: rma=1032919
p.000168: Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome,
p.000168: and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo
p.000168: rma=1032919
p.000168:
p.000168: Note: All websites and documents are in Spanish.
p.000168: General 1. Ministry of Health and Social Protection: http://www.minsalud.gov.co
p.000168: 2. National Institute of Drug and Food Surveillance (INVIMA): https://www.invima.gov.co/
p.000168: 3. Administrative Department of Science, Technology, and Innovation (COLCIENCIAS): http://www.colciencias.gov.co/
p.000168:
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p.000169: 169
p.000169:
p.000169: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 8430 (1993):
p.000169: https://www.minsalud.gov.co/sites/rid
p.000169: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000169:
p.000169: INVIMA:
p.000169: 1. Guide for Research Ethics Committees. Code: ASS-RSA-GU040 Version: 00 (2015):
p.000169: https://www.invima.gov.co/documents/20143/4 53029/ASS-RSA-GU040.pdf/96ea752d-2639- 3024-4287-
p.000169: 4527589fb26b?version=1.0&t=155050830781 4
p.000169: 2. Guide for Assessing and Monitoring of Research Protocols. Code: ASS-RSA- GU039 Version: 03 (2018):
p.000169: https://www.invima.gov.co/documents/20143/1
p.000169:
p.000169: Country Key Organizations Legislation
p.000169: Regulations Guidelines
p.000169:
p.000169: General
p.000169: 208783/Gui%CC%81a+para+la+evaluacio%C C%81n+y+seguimiento+de+protocolos+de+in vestigacio%CC%81n+ASS-RSA-
p.000169: GU039v1.pdf/004a03e7-ee7d-9fe0-89af- 55a43de7a37d?version=1.0&t=156079110732 6
p.000169: 3. Guide for the Presentation of Amendments, New Centers, New Researchers, and Informed Consent of Research Protocols.
p.000169: Version: 01 2018: https://www.invima.gov.co/documents/20143/4 53029/ASS-RSA-GU031.pdf/2130f364-0b2a- 8af3-7672-
p.000169: e9f5e89b6217?version=1.0&t=1540842235665
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: Drugs, Biologics, and Devices
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: Drugs
p.000169: National Institute of Drug and Food Surveillance (INVIMA): http://www.invima.gov.co/
p.000169:
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p.000170: 170
p.000170:
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p.000170:
p.000170:
p.000170:
p.000170:
p.000170: 1. Resolution No. 2378 of 2008, Adapting Good Clinical Practices for Institutions that Conduct Research with Medicines
p.000170: in Human Beings: https://www.invima.gov.co/document s/20143/1024715/RESOLUCION+N o+2378+DE+2008.pdf/e71f5227-
p.000170: 68fe-a85b-bb5c- fae31a5254ff?version=1.0&t=155495 5058893
p.000170: 2. Resolution No. 2011020764 of June 10th, 2011: Regulation Related to the Content and Frequency of Adverse Event
p.000170: Reports in Clinical Investigation in Humans: https://www.invima.gov.co/document s/20143/453029/Resoluci%C3%B3n+
p.000170: 2011020764+de+2011.pdf/e4d84d9e- 3df4-8155-0eef- f50d81e621f4?version=1.0&t=15408 30094266
p.000170: COLCIENCIAS:
p.000170: Policy on Ethical Research, Bioethics, and Scientific Integrity (2018):
p.000170: http://www.colciencias.gov.co/sites/default/file s/ckeditor_files/PDF%20Pol%C3%ADtica.pdf
p.000170:
p.000170: 1. ABC Good Clinical Practice (2009) https://www.invima.gov.co/images/pdf/tecnovi
p.000170: gilancia/buenas_practicas/ABCBPCultima_ver sion.pdf
p.000170: 2. Circular No 600-5776-14: Processes of Good Clinical Practice (2014): https://www.invima.gov.co/images/pdf/tecnovi
p.000170: gilancia/buenas_practicas/normatividad/CIRC ULAR_600-5776-14-2.pdf
p.000170: 3. Guide of Medications and Supplies for Clinical Research, Version 1 (2018):
p.000170: https://www.invima.gov.co/images/stories/for matotramite/ASS-RSA-GU045.pdf
p.000170: 4. Guide for the Evaluation and Follow-up of Research Protocols, Version 3 (2018):
p.000170: https://www.invima.gov.co/images/stories/for matotramite/ASS-RSA-GU039.pdf
p.000170: 5. External Circular No. 600-2006-16: National Reporting Serious Adverse Events (2016):
p.000170: https://www.invima.gov.co/images/pdf/tecnovi gilancia/buenas_practicas/normatividad/Circula
p.000170: r-600-1081-16-Reporte-de-Eventos-adversos- serios-Nacionales-Febrero2016.pdf
p.000170: 6. External Circular No. 600-1414-16: Notification of Deviations (2016):
p.000170:
p.000170: Country Key Organizations Legislation
p.000170: Regulations Guidelines
p.000170:
p.000170: Drugs, Biologics, and Devices
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Research Injury
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Privacy/Data Protection
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Human Biological Materials
p.000170:
p.000170:
p.000170:
p.000170: Devices
p.000170: National Institute of Drug and Food Surveillance: http://www.invima.gov.co/
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Ministry of Health and Social Protection: http://www.minsalud.gov.co
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Ministry of Health and Social Protection: http://www.minsalud.gov.co
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: Ministry of Health and Social Protection: http://www.minsalud.gov.co
p.000170:
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p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: 1. Constitution of Colombia, Article 15 (2003): http://www.corteconstitucional.gov. co/inicio/Constitucion%20politica%
p.000170: 20de%20Colombia%20-
p.000170: %202015.pdf
p.000170: 2. Law 1581 of 2012: General Regimen of Protection of Personal Data: https://www.mintic.gov.co/portal/60
p.000170: 4/articles-4274_documento.pdf
p.000170:
p.000170:
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p.000171:
p.000171:
p.000171: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title III, Chapters I
p.000171: and III (1993):
p.000171: https://www.minsalud.gov.co/sites/rid
p.000171: /Lists/BibliotecaDigital/RIDE/DE/DI J/RESOLUCION-8430-DE- 1993.PDF
p.000171: Scientific, Technical, and Administrative Regulations for Health Research, Resolution No. 008430, Title II, Chapter I,
...
p.000175: o_legislativo.pdf
p.000175:
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p.000175:
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p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Medical Research Involving Human Subjects Regulations (2007)
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: User’s Guide for the Application of Clinical Investigation Protocols: http://www.medicamentos.gob.sv/index.php/es/
p.000175: servicios-m/descargables/ensayos-clinicos
p.000175:
p.000175:
p.000175:
p.000175: 45 CFR 46:
p.000175: http://www.hhs.gov/ohrp/humansubjects/guida nce/45cfr46.html
p.000175:
p.000175: Note: All websites and documents are in Spanish.
p.000175: General Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
p.000175: 1. Regulation on Clinical Research on Humans (2015)
p.000175: 2. Internal Regulations of the National Committee on Health Ethics (2018): http://www.mspas.gob.gt/images/files
p.000175: /acuerdosministeriales/2018/Acuerdo Ministerial1392018NormativaCNES. pdf
p.000175:
p.000175: Drugs, Biologics, and Devices
p.000175: Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
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p.000176: 176
p.000176: 1. Governmental Agreement 712- 99, Articles 91-94 (1999): http://asisehace.gt/media/ag_712_99. pdf
p.000176: 2. Rules for the Regulation of Human Clinical Trials. Ministerial Accord 82-2019: https://medicamentos.mspas.gob.gt/p
p.000176: hocadownload/Acuerdo%20Ministeri
p.000176: Drug Surveillance -- Clinical Trials: http://www.mspas.gob.gt/index.php/servicios/f armacovigilancia
p.000176:
p.000176: Country Key Organizations Legislation
p.000176: Regulations Guidelines
p.000176: al%2082-2019.pdf
p.000176:
p.000176: Haiti
p.000176: General Ministry of Public Health and Population: http://mspp.gouv.ht/newsite/
p.000176:
p.000176: Internal Regulations (2010)
p.000176:
p.000176: Honduras
p.000176: Note: All websites and documents are in Spanish.
p.000176: General Secretariat of Health:
p.000176: http://www.salud.gob.hn/
p.000176:
p.000176:
p.000176: Code, Decree No. 65-91, Articles 175 and 176 (1996): https://www.acnur.org/fileadmin/Do cumentos/BDL/2016/10636.pdf
p.000176:
p.000176:
p.000176: Health Code, Decree No. 65-91, Articles 175 and 176
p.000176:
p.000176: Drugs, Biologics, and Devices
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Human Biological Materials
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Embryos, Stem Cells, and Cloning
p.000176:
p.000176:
p.000176: Jamaica
p.000176: General
p.000176:
p.000176:
p.000176:
p.000176: Drugs, Biologics, and Devices
p.000176:
p.000176:
p.000176: México
p.000176: Secretariat of Health:
p.000176: http://www.salud.gob.hn/
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
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p.000176:
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p.000176:
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p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Ministry of Health, Ethics and Medico-Legal Affairs Panel: http://moh.gov.jm/
p.000176:
p.000176: Ministry of Health, Standards and Regulation Division: http://moh.gov.jm/divisions- agencies/divisions/standards-and-
...
p.000184: Practice: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2
p.000184: %B0200%20_25_Juil_2009.pdf
p.000184:
p.000184: 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
p.000184: %B0387-388_31_juil_2006.pdf
p.000184: 2. Order No. 00200 of 25 July 2009 Amending Order No. 112 of 22 October 1995 Setting the Rules of Good Clinical
p.000184: Practice: http://www.ands.dz/pharmacie- med/arr%C3%AAt%C3%A9_n%C2
p.000184: %B0200%20_25_Juil_2009.pdf
p.000184: FAQs:
p.000184: http://www.pactr.org/ATMWeb/appmanager/at m/atmregistry?_nfpb=true&_pageLabel=atmpo rtal_page_FAQ
p.000184:
p.000184:
p.000184:
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p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: 1. Guidelines for Application for Research Permit (2004): http://www.gov.bw/Global/OP%20Ministry/R
p.000184: ESEARCH%20PERMIT%20GUIDELINES.pd f
p.000184: 2. Guide for a Consent Form (2005)
p.000184: 3. Guidelines for the Review of Research Proposals (2005)
p.000184:
p.000184: Country Key Organizations Legislation
p.000184: Regulations Guidelines
p.000184:
p.000184: Drugs, Biologics, and Devices
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Social-Behavioral Research
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Burkina Faso
p.000184: Ministry of Health, Drug Regulatory Unit: http://www.moh.gov.bw/
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Ministry of Health and Wellness, Research and Development Committee
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Anthropological Research Act 45 (1967):
p.000184: http://webcache.googleusercontent.c om/search?q=cache:A7aea2ZEMhk J:static1.1.sqspcdn.com/static/f/723
p.000184: 732/25889598/1422112465653/ch5
p.000184: 9-
p.000184: 02%2BANTHROPOLOGICAL%2
p.000184: BRESEARCH.pdf%3Ftoken%3DT SMJNydkWHdUJ7iPvvm7Qkzk4u U%253D+&cd=1&hl=en&ct=clnk &gl=us
p.000184: Drugs and Related Substances Regulations (1993)
p.000184: 1. SADC Guidelines for Regulating Clinical Trials in Human Subjects (2006)
p.000184: 2. Guideline for Regulating the Conduct of Clinical Trials Using Medicines in Human Participants (2012):
p.000184: http://www.moh.gov.bw/Publications/drug_reg ulation/CLINICAL%20TRIAL%20GUIDELIN ES%20botswana%20v4-060312.pdf
p.000184:
p.000184: Note: All websites and documents are in French.
p.000184: General Ethics Committee for Health Research
p.000184:
p.000184:
p.000184: Drugs, Biologics, and Devices
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Cameroon
p.000184:
p.000184: Joint Order 2004-147 / MS / MESSE of 11 May 2004 on the Organization and Functioning of the Ethics Committee for Health
p.000184: Research in Burkina Faso
p.000184: Order No. 2010-292/MS /CAB of 1 October 2010 on the Conditions for Granting Authorizations for Clinical Trials:
p.000184: http://elearning.trree.org/pluginfile.ph p/34806/mod_folder/content/0/19_Ar rete_autorisations_essais_cliniques.p
p.000184: df?forcedownload=1
p.000184: For an overview of human subject protections in Cameroon, see:
...
p.000185: (2011) (Fench): https://clinregs.niaid.nih.gov/sites/default/files/ documents/DRC/G-EthicalEval.pdf
p.000185: For an overview of human subject protections in Côte-d'Ivoire, see: http://elearning.trree.org/course/view.php?id=19
p.000185: Note: All websites and documents are in French.
p.000185:
p.000185: Drugs, Biologics, and Devices
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Ethiopia
p.000185: General
p.000185:
p.000185:
p.000185:
p.000185: Drugs and Devices
p.000185:
p.000185:
p.000185: Human Biological Materials
p.000185:
p.000185:
p.000185: Gambia
p.000185: Genetic Research
p.000185: National Committee on Ethics and Research
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Ethiopian Science and Technology Commission, Health Department: http://www.most.gov.et/
p.000185:
p.000185:
p.000185: Food, Medicine, and Health Administration and Control Authority: www.fmhaca.gov.et Ethiopian Science and Technology
p.000185: Commission, Health Department: http://www.most.gov.et/
p.000185:
p.000185:
p.000185:
p.000185: MRC: Gambia Unit:
p.000185: http://www.mrc.gm/
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Proclamation 60/1999, Section 21
p.000185: Decree No 317 / SP / DSPH of 14 July 1987 on the Regulation of Drugs Before and After Marketing in Ivory Coast:
p.000185: http://elearning.trree.org/pluginfile.ph p/34816/mod_folder/content/0/20_Ar rete_Regl_exp_clinique_des_substan
p.000185: ces_med.pdf?forcedownload=1
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Drug Administration and Control Proclamation No. 176/1999, Article 21
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: National Health Research Ethics Review Guideline, Fourth Edition (2014): http://www.ccghr.ca/wp-
p.000185: content/uploads/2013/11/national-research- ethics-review-guidline.pdf
p.000185:
p.000185:
p.000185:
p.000185: National Health Research Ethics Review Guideline, Fourth Edition, Chapter 9 (2005): http://www.ccghr.ca/wp-
p.000185: content/uploads/2013/11/national-research- ethics-review-guidline.pdf
p.000185:
p.000185: Guidelines of the National DNA Bank (2001)
p.000185:
p.000185:
p.000186: 186
p.000186:
p.000186: Country Key Organizations Legislation
p.000186: Regulations Guidelines Ghana
p.000186: For an overview of the clinical trial information in Ghana, see:
p.000186: http://www.fdaghana.gov.gh/index.php?option=com_content&view=article&id=71&Itemid=55
p.000186:
p.000186: Drugs, Biologics, and Devices
p.000186:
p.000186:
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p.000186:
p.000186:
p.000186: Guinea
p.000186: Food and Drugs Authority:
p.000186: http://www.fdaghana.gov.gh
p.000186: Public Health Act, 2012
p.000186: Act 851, Sections 150-166: http://www.fdaghana.gov.gh/images/s tories/pdfs/Clinical%20Trials/REGU
p.000186: LATION%20OF%20CLINICAL%20 TRIALS%20IN%20GHANA.pdf
...
p.000189: For an overview of human subject protections in Mozambique, see:
p.000189: http://elearning.trree.org/course/view.php?id=14&lang=en
p.000189: General
p.000189: Science and Technology
p.000189: Ethics Code
p.000189: (2007):
p.000189: http://elearning.trree.org/pluginfile.php/34764/ mod_folder/content/0/02- CodigoDeEtica.pdf?forcedownload=1
p.000189: Nigeria
p.000189: For an overview of human subject protections in Nigeria, see: http://elearning.trree.org/mod/page/view.php?id=142
p.000189:
p.000189: General
p.000189: National Health Research Ethics Committee: http://nhrec.net/
p.000189: National Health Act 2014
p.000189: 1. Nigerian Code of Health Research Ethics (2007): http://nhrec.net/nhrec/wp- content/uploads/2018/10/NCHRE_Aug_07.zip
p.000189: 2. Policy Statement Regarding Enrollment of Children in Research in Nigeria (2016):
p.000189: http://nhrec.net/nhrec/Final%20NHREC%20Po licy%20Statement%20on%20Enrollment%20o f%20Children%20in%20Research.pdf
p.000189:
p.000190: 190
p.000190:
p.000190: Country Key Organizations Legislation
p.000190: Regulations Guidelines
p.000190:
p.000190: General
p.000190:
p.000190:
p.000190: Drugs, Biologics, and Devices
p.000190:
p.000190:
p.000190: Clinical Trial Registries
p.000190: Social-Behavioral Research
p.000190:
p.000190: Human Biological Materials
p.000190:
p.000190:
p.000190: Rwanda
p.000190: General
p.000190:
p.000190:
p.000190: Senegal
p.000190: General
p.000190:
p.000190:
p.000190: Sierra Leone
p.000190:
p.000190:
p.000190:
p.000190: National Agency for Food, Drug Administration and Control (NAFDAC): http://www.nafdac.gov.ng/
p.000190:
p.000190: National Health Research Ethics Committee: http://nhrec.net/ National Health Research Ethics Committee
p.000190:
p.000190: National Health Research Ethics Committee: http://nhrec.net/
p.000190:
p.000190:
p.000190:
p.000190: Ministry of Health, National Ethics Committee: http://www.moh.gov.rw/index.php?id=2
p.000190:
p.000190:
p.000190: National Committee on Health Research Ethics
p.000190:
p.000190:
p.000190:
p.000190: Decree No. 15 of 1993
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190: Law Supporting the Code of Ethics for Health Research (2009)
p.000190: Various:
p.000190: http://nhrec.net/download-guides-and- forms/
p.000190: Good Clinical Practice Guidelines (2016): http://www.nafdac.gov.ng/images/GUIDELIN ES/DRUG%20GUIDELINES/NAFDAC%20G
p.000190: OOD%20CLINICAL%20PRACTICE%20GUI DELINES%202016%20V%2013.pdf
p.000190: Frequently Asked Questions:
p.000190: http://nctr.nhrec.net
p.000190: Nigerian Code of Health Research Ethics (2007): http://nhrec.net/nhrec/wp- content/uploads/2018/10/NCHRE_Aug_07.zip
p.000190: Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria (2013):
p.000190: http://nhrec.net/nhrec/NHREC_Policy_Stateme nt_on_Biobanks_FINAL.pdf
p.000190:
p.000190: Standard Operating Procedures (2009): http://www.moh.gov.rw/index.php?option=co m_docman&task=doc_download&gid=126&It
p.000190: emid=81
p.000190: For an overview of the clinical research regulations in Sierra Leone, see the ClinRegs report:
p.000190: https://clinregs.niaid.nih.gov/single_country.php?c_id=193
p.000190:
p.000190: General
p.000190:
p.000190:
p.000190: Drugs, Biologics, and Devices
p.000190: Sierra Leone Ethics and Scientific Review Committee
p.000190:
p.000190: 1. Ministry of Health:
p.000190: http://www.sante.gov.bf/
p.000190: 2. Pharmacy Board of Sierra Leone:
p.000190: http://pharmacyboard.gov.sl/
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000191: 191
p.000191: Application Guidelines (2017): https://mohs2017.files.wordpress.com/2017/03/
p.000191: guidelines-and-checklist-for-ethical-clearance- 2017.pdf
p.000191: 1. Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra
p.000191: Leone, Sections: 3.1.7 and 3.2 (2014): http://pharmacyboard.gov.sl/site/LinkClick.asp
p.000191: x?fileticket=9jeTGC2WIZ8%3d&tabid=316& portalid=1&mid=934
...
p.000192:
p.000192: COSTECH:
p.000192: COSTECH Guidelines on Research Permits and Clearance (2006)
p.000192: https://protect2.fireeye.com/url?k=df97c3b9 Cosmetics Act, Sections 61, 66,
p.000192:
p.000192: -83c3dac5-df97f286-0cc47adc5fa2-9df96a 6e749380d6&u=https://www.tmda.go.tz/
p.000192: 67, and 69 (2003):
p.000192: http://www.tfda.or.tz/index.php?opti
p.000193: 193
p.000193:
p.000193: Country Key Organizations Legislation
p.000193: Regulations Guidelines
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193:
p.000193:
p.000193:
p.000193: Devices
p.000193: Tanzania Food and Drugs Authority:
p.000193: http://www.tfda.or.tz/
p.000193: on=com_phocadownload&view=cat egory&download=44:tfdc-acts- 2003&id=52:tfdc-acts- 2003&Itemid=417
p.000193:
p.000193: Medical Device Act (1988)
p.000193:
p.000193:
p.000193:
p.000193: Clinical Trials Registry Uganda
p.000193: Tanzania Clinical Trial Registry:
p.000193: http://www.tzctr.or.tz/
p.000193: FAQs: http://www.tzctr.or.tz/faq.php
p.000193: For an overview of the clinical research regulations in Uganda, see the ClinRegs report:
p.000193: http://clinregs.niaid.nih.gov/single_country.php?c_id=223
p.000193:
p.000193: General
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Zambia
p.000193: General
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193: Uganda National Council for Science and Technology (UNCST): http://www.uncst.go.ug/
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: National Drug Authority:
p.000193: http://www.nda.or.ug/
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Ministry of Health:
p.000193: http://www.moh.gov.zm/
p.000193:
p.000193:
p.000193:
p.000193: Zambia Medicines Regulatory Authority: http://www.zamra.co.zm/
p.000193: Uganda National Council for Science and Technology Act of 1990 (CAP 209):
p.000193: https://ulii.org/ug/legislation/consoli dated-act/209
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drug Conduct of Clinical Trials Regulation (2014): https://www.nda.or.ug/files/downlo ads/Drug%20Conduct%20of%20Cli
p.000193: nical%20trials%20Regulation.pdf
p.000193:
p.000193:
p.000193:
p.000193: National Health Research Act (2013):
p.000193: http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health
p.000193: %20%20Research%20%20Act%20 2013.pdf
p.000193: Medicines and Allied Substances Act, Part VI: Regulation of Clinical Trials, 2013: http://www.zamra.co.zm/wp-
p.000193: content/uploads/2016/10/MASA- No-3-2013.pdf
p.000194: 194
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: National Drug Policy and Authority Act Regulations: https://www.nda.or.ug/ndpa-act- regulations/
p.000194: 1. National Guidelines for Research Involving Humans as Research Participants (2014):
p.000194: https://uncst.go.ug/guidelines-and-forms/
p.000194: 2. Research Registration and Clearance Policy and Guidelines (2016)
p.000194: 3. Research Guidelines and Forms:
p.000194: https://www.uncst.go.ug/guidelines-and-forms/
p.000194: 4. Accredited Research Ethics Committees: https://www.uncst.go.ug/research-ethics- committee-accreditation/
p.000194: 1. Human Medicine Guidelines: https://www.nda.or.ug/human-medicine- guidelines/
p.000194: 2. Clinical Trial Application Forms:
p.000194: https://www.nda.or.ug/application-forms/
p.000194: 3. Guidelines for the Conduct of Drug Related Clinical Trials (2019)
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Guidelines on Regulating the Conduct of Clinical Trials in Human Participants: http://www.zamra.co.zm/wp-
p.000194: content/uploads/2016/10/Guidelines-on- Application-for-Clincal-Trial- Authorisation.pdf
p.000194:
p.000194: Country Key Organizations Legislation
p.000194: Regulations Guidelines
p.000194:
p.000194: Human Biological Materials
p.000194:
p.000194:
p.000194:
p.000194: Zimbabwe
p.000194: General
p.000194:
p.000194:
p.000194: Drugs, Biologics, and Devices
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Privacy/Data Protection
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Human Biological Materials
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medical Research Council of Zimbabwe: http://www.mrcz.org.zw
p.000194:
p.000194: Drugs
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Devices
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/devices.html
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Registrar General: http://www.rg.gov.zw/ Zimbabwe National Statistics Agency: http://www.zimstat.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Research Council of Zimbabwe: www.rcz.ac.zw
p.000194: National Health Research Act, Part VI (2013):
...
p.000195: http://www.nba.ac.zw/index.php/our
p.000195: -resources/finish/1-national- biotechnology-association/2- national-biotechnolgy-authority-act
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000196: ACKNOWLEDGEMENTS
p.000196:
p.000196: The DHHS Office for Human Research Protections thanks the following individuals for providing updates or confirmations
p.000196: of accuracy for the 2020 edition of the International Compilation of Human Research Standards. We are particularly
p.000196: grateful for the assistance provided by Carla Saenz of the Pan American Health Organization, Washington DC.
p.000196:
p.000196:
p.000196: International:
p.000196: CIOMS: Sue le Roux
p.000196: International Society for Biological and Environmental Repositories: Daniel Simeon-Dubach
p.000196: TRUST Project: Doris Schroeder UNAIDS: Peter Godfrey-Faussett
p.000196: World Health Organization: Andreas Reis
p.000196:
p.000196: North America:
p.000196: United States:
p.000196: • Consumer Product Safety Commission: Alice Thaler
p.000196: • Department of Commerce: Anne Andrews
p.000196: • Department of Veterans Affairs: Kristina Borror
p.000196: • DHHS Agency for Healthcare Quality and Research: Hope Hongzhu He
p.000196: • DHHS Food and Drug Administration: Carolyn Hommel
p.000196: • DHHS Office for Civil Rights: Devi Mehta
p.000196: • Department of Justice, Bureau of Prisons: Jody Klein-Saffran
p.000196: • United States Department of Agriculture: David Klurfeld
p.000196: • Social Security Administration: Leola Brooks
p.000196: Europe:
p.000196: European Medicines Agency: Maria Antonietta Antonelli
p.000196: Belgium: Sophie Bertrand Czech Republic: Alice Nemcova
p.000196: Denmark: Ann-Sofie Lydiksen Nygaard Finland: Outi Konttinen
p.000196: France: Emmanuelle Rial-Sebbag Germany: Claudia Leuker
p.000196: Iceland: Rögnvaldur G. Gunnarsson Latvia: Signe Mezinska
p.000196: Lithuania: Vilma Lukaseviciene Luxembourg: Malika Pailhes Macedonia: Marija Todorovska Norway: Camilla Bø Standal
p.000196: Poland: Marek Czarkowski and Agnieszka Seweryniak
p.000196: Serbia: Jelena Rakobradović Slovenia: Marija Lap Sweden: Stefan Eriksson
p.000196: Switzerland: Brigitte Meier and Rosine Muchlow
p.000196: Spain: Iñigo de Miguel Beriain
p.000196: Asia/Pacific:
p.000196: Australia: Jeremy Kenner
p.000196: China, People’s Republic of: Yali Cong and Haihong Zhang
p.000196: Japan: Shimon Tashiro
p.000196: Korea: B.I. Choe, Hye Ryung Lee, Jin Myeong Hwang, Hoseob Ji. Areum Choi, Sang-Min Park, Yoon Joung Chang and Kyoungtae
p.000196: Park
p.000197: 197
p.000197: Malaysia: Chirk Jenn Ng Pakistan: Saima Iqbal Taiwan: Benjamin Kuo
p.000197:
p.000197: Middle East/North Africa:
p.000197: Jordan: Amal Al Omari
p.000197: Sudan: Lamis Beshir and Faiza Osman Turkey: Hamdi Akan
p.000197: Qatar: Eman Sadoun
p.000197:
p.000197: Latin America and the Caribbean: Argentina: Susana Carreño, Ana Palmero, and Diana Salmún
p.000197: Brazil: Sergio Rego, Marisa Palacios, and Marcelo Nóbile Franco
p.000197: Chile: Juan Pablo Beca
p.000197: Colombia: Claudia Ayala Leal and Maria Consuelo Miranda
...
Searching for indicator usage:
(return to top)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Human Assisted Reproductive Technology (HART) Order (2005):
p.000140: http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: ACART:
p.000140: 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000)
p.000140: 2. Guidelines for Research on Gametes and Non-viable Embryos (2005)
p.000140: 3. Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005)
p.000140: 4. Guidelines on Embryo Donation for Reproductive Purposes (2008)
p.000140: 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012)
p.000140: 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013)
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
p.000140: 4. Commission of Higher Education (CHED): www.ched.gov.ph/
p.000140: 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Republic Act No. 10532: An Act Institutionalizing the Philippine National Health Research System (2013):
p.000140: http://www.gov.ph/2013/05/07/repu blic-act-no-10532/
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: PHREB:
p.000140: 1. PNHRS Act Implementing Rules and Regulations: http://www.ethics.healthresearch.ph/i
p.000140: ndex.php/component/content/article/2
p.000140: -uncategorised/214-implementing- rules-of-pnhrs
p.000140: 2. Memorandum: Registration and Accreditation of all Ethics Review Committees in the Philippines (2015):
...
p.000151:
p.000151: 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007-
p.000151: 5FD6A6B8E0A5/18334/Protectiono fPrivacyLaw57411981unofficialtran slatio.pdf
p.000151: 2. Protection of Privacy Law No. 5741, as Amended by Law No. 5745 (1985)
p.000151: Genetic Information Law (2000):
p.000151: http://www.moital.gov.il/NR/exeres
p.000151: /66F4DD4E-FA4A-4B76-94BC- DC29543471DE.htm
p.000151: Professional Ethics Regulations: Conducting Medical Research on Human Beings, Articles 52-61 (2003)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Protection Code for Human Subjects in Medical Research (1999)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Public Health Regulations (Medical Experiments Involving Human Subjects) (1999)
p.000151: 1. Public Health Regulations (Clinical Studies in Human Subjects) – 1980
p.000151: 2. 1990 Amendment
p.000151: 3. 1992 Amendment
p.000151: 4. 2005 Amendment
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: FAQs: http://www.irct.ir/faq.php
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Guidelines for Clinical Trials in Human Subjects (2006): https://firstclinical.com/regdocs/doc/?db=INT_
p.000151: Israel_Clinical_Trials
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Instruction of the Supreme Committee for Clinical Studies on Humans Regarding Establishment and Usage of Genetic
p.000151: Samples Reservoir (2005)
p.000151: 2. Amendment (2007)
p.000151:
p.000152: 152
p.000152:
p.000152: Country Key Organizations Legislation
p.000152: Regulations Guidelines
p.000152:
p.000152: Embryos, Stem Cells, and Cloning
p.000152:
p.000152:
p.000152: Jordan
p.000152: Note: All documents are in Arabic.
p.000152: Genetic Intervention Prohibition Law (Human Cloning and Genetic Changes in Reproduction Cells) (1999)
p.000152:
p.000152: Drugs, Biologics, and Devices
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152:
p.000152: Research Injury
p.000152: 1. Ministry of Health: http://www.moh.gov.jo/en/Pages/default.a spx
p.000152: 2. Jordan Food and Drug Administration: http://www.jfda.jo/Default.aspx
p.000152: 1. Law of Clinical Studies, Law No. 2 (2011) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/Pharmaceu ticalStudies/50_211.pdf
p.000152: 2. Drug and Pharmacy Law No. 12 (2013) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/DrugDirec torate/%D9%82%D8%A7%D9
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.000004:
p.000004: 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950):
p.000004: https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68
p.000004: 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977):
p.000004: http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9
p.000004: International Covenant on Civil and Political Rights, Article 7 (1976):
p.000004: http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx
p.000004:
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p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
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p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
p.000005: 2. Ethical Considerations
p.000005: in Biomedical HIV Prevention Trials (2012):
p.000005: http://www.unaids.org/en/media/unaids/conten
p.000005:
p.000005: Country Key Organizations Legislation
p.000005: Regulations Guidelines
p.000005: tassets/documents/unaidspublication/2012/jc1
p.000005:
p.000005: General
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p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
p.000005:
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p.000005: World Medical Association:
p.000005: http://www.wma.net/e/
p.000005:
p.000005:
p.000005: Drugs
p.000005: International Conference on Harmonization (ICH): http://www.ich.org/
p.000005:
p.000005:
p.000005:
p.000005: World Health Organization (WHO):
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Devices
p.000005: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
p.000005:
p.000005:
p.000006: 6
p.000006: 399_ethical_considerations_en.pdf Universal Declaration on Bioethics and Human Rights (2005):
p.000006: http://portal.unesco.org/en/ev.php- URL_ID=31058&URL_DO=DO_TOPIC&U RL_SECTION=201.html
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p.000026: Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a
p.000026: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS
p.000026: Countries,” Chapter 3, Section 1:
p.000026: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000026: Note: All websites and documents are in Armenian.
p.000026:
p.000026: Drugs, Biologics, and Devices
p.000026:
p.000026:
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p.000026:
p.000026: Human Biological Materials
p.000026:
p.000026:
p.000026: Austria
p.000026: General
p.000026: 1. Drug and Medical Technology Agency: http://www.pharm.am/
p.000026: 2. Ethics Committee of the Ministry of Health
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Ethical Committee of the National Center for AIDS Prevention: http://www.armaids.am/main/index.php?l ng=1
p.000026:
p.000026: 1. Ministry of Health:
p.000026: http://www.bmg.gv.at
p.000026: 2. Forum of Austrian Ethics Committees: http://www.ethikkommissionen.at
p.000026: 3. Bioethics Commission:
p.000026: 1. Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21:
p.000026: http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=71619
p.000026: 2. Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Medications in
p.000026: Armenia: http://www.arlis.am/DocumentView
p.000026: .aspx?docID=9154
p.000026: RA Law on Prevention of Disease Caused by HIV (2012): http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=78616
p.000026:
p.000026: 1. University Act (2011):
p.000026: http://www.ris.bka.gv.at/Dokumente
p.000026: /Erv/ERV_2002_1_120/ERV_2002
p.000026: _1_120.pdf
p.000026: 2. Hospitals Act (2014):
p.000026: http://www.ris.bka.gv.at/GeltendeFa
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p.000027: Regulation on Leading Ethics Committees (2004): http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen&
p.000027: Gesetzesnummer=20003352&ShowP rintPreview=True
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p.000027:
p.000027: Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2013)
p.000027:
p.000027:
p.000027: Bioethics Commission:
p.000027: 1. Codification of Legislation on Medical Research (2011)
p.000027: 2. Research on Persons without the Capacity to Consent (2013)
p.000027:
p.000027: Country Key Organizations Legislation
p.000027: Regulations Guidelines
p.000027:
p.000027: General
p.000027:
p.000027:
p.000027: Drugs, Biologics, and Devices
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p.000120: 1. Regulations for Implementation of the Drug Administration Law of the People's Republic of China (2016):
p.000120: http://www.nmpa.gov.cn/WS04/CL2 076/300567.html
p.000120: 2. Chinese Good Clinical Practice (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html
p.000120: 3. Measures for the Administration of Drug Registration (2007): http://www.nmpa.gov.cn/WS04/CL2 174/300629.html
p.000120: 4. Interim Measures for the Confirmation of Clinical Trial Sites/Institutions (2004): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 079/337621.html
p.000120: 5. Rules on the Administration of Report and Supervision of Adverse Drug Reactions (2011):
p.000120: http://samr.cfda.gov.cn/WS01/CL103 1/62621.html
p.000120: 6. Administrative Measures for the Signing and Issuing of Biological Product (2017): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 077/300708.html
p.000120:
p.000120: 1. Good Clinical Practice on Medical Device Clinical Trials (2016): http://www.nmpa.gov.cn/WS04/CL2 077/300685.html
p.000120: 2. Regulations on the Supervision and Administration of Medical Devices (revised 2017): http://www.nmpa.gov.cn/WS04/CL2
p.000120: 076/331389.html
p.000120: 3. Measures for the Registration and Administration of In Vitro Diagnostic Reagents (2014):
p.000120:
p.000120: 1. Guideline for HIV Vaccine Research Technology (2003): http://samr.cfda.gov.cn/WS01/CL0237/15705.h tml
p.000120: 2. Guideline for Vaccine Research Technology (2004): http://samr.cfda.gov.cn/WS01/CL0055/10307.h tml
p.000120: 3. Guidelines on Ethical Review of Drug Clinical Trials (2010): http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml
p.000120: 4. Interim Guidelines on International Multi-Regional Drug Clinical Trials (2015):
p.000120: http://samr.cfda.gov.cn/WS01/CL0087/114002. html
p.000120: 5. Interim Guidelines for Reporting and Supervision of Adverse Drug Reactions (2015):
p.000120: http://www.nmpa.gov.cn/WS04/CL2196/32411 8.html
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p.000120: 1. Guiding Principles of the Clinical Trail Technology on In Vitro Diagnostic (IVD) Reagents (2014):
p.000120: http://www.nmpa.gov.cn/WS04/CL2138/29998 8.html
p.000120: 2. Management Measures for the Monitoring and Re-evaluation of Adverse Events on Medical Devices (2019):
p.000120: http://www.nmpa.gov.cn/WS04/CL2077/33007 1.html
p.000120: 3. Templates for Medical Device Clinical Trials – Ethical Application and Approval (2016):
p.000120:
p.000120: Country Key Organizations Legislation
p.000120: Regulations Guidelines
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p.000120: Drugs, Biologics, and Devices
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p.000186: _Sante_Publique.pdf
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p.000186: Public Health Code, Articles 301-302 (1997):
p.000186: http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code
p.000187: 187
p.000187: Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for
p.000187: Research in Health (CNERS), Chapters I and II (1998):
p.000187: http://cners-guinee.org/wp- content/uploads/2014/02/Decret-.pdf
p.000187: CNERS:
p.000187: Frequently Asked Questions: http://cners- guinee.org/faq/
p.000187:
p.000187: Country Key Organizations Legislation
p.000187: Regulations Guidelines
p.000187:
p.000187: Research Injury
p.000187: Kenya
p.000187: _Sante_Publique.pdf
p.000187: For an overview of the clinical research regulations in Kenya, see the ClinRegs report:
p.000187: http://clinregs.niaid.nih.gov/single_country.php?c_id=111
p.000187:
p.000187: General
p.000187:
p.000187:
p.000187:
p.000187:
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p.000187: Drugs, Biologics, and Devices
p.000187:
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p.000187: Human Biological Materials
p.000187:
p.000187:
p.000187: Liberia
p.000187: 1. National Council for Science and Technology (NCST): http://www.nacosti.go.ke/
p.000187: 2. Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187:
p.000187:
p.000187: Pharmacy and Poisons Board:
p.000187: http://www.pharmacyboardkenya.org/
p.000187:
p.000187:
p.000187:
p.000187: Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187: 1. Science and Technology Act (2001)
p.000187: 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
p.000187:
p.000187: Pharmacy and Poisons Act, Chapter 244 (2009): http://apps.who.int/medicinedocs/do cuments/s18245en/s18245en.pdf
p.000187:
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p.000187: MOH:
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005)
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, page 44 (2005)
p.000187: MOH:
p.000187: National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008):
p.000187: https://healthresearchweb.org/?action=downloa d&file=Final%20national%20ethical%20guidel ines-last%20draft.pdf
p.000187: Guidelines for Applications to Conduct Clinical Trials in Kenya (2014): http://pharmacyboardkenya.org/downloads/?fil
p.000187: e=Clinical%20Trial%20Guidelines%202014.p df
p.000187: For an overview of the clinical research regulations in Liberia, see the ClinRegs report:
p.000187: https://clinregs.niaid.nih.gov/single_country.php?c_id=122
p.000187:
p.000187: General
p.000187:
p.000187:
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p.000187: Drugs, Biologics, and Devices
p.000187:
p.000187: Madagascar
p.000187: Drugs and Devices
p.000187: Ministry of Health and Social Welfare: http://www.mohsw.gov.lr/
p.000187:
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p.000187: Liberia Medicines and Health Products Regulatory Authority
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p.000187: Law No. 2011-002, Article 122 Regarding Clinical Trials: https://www.ilo.org/dyn/natlex/docs
p.000187: /ELECTRONIC/97799/116199/F10 71917999/MDG-97799.pdf
p.000187: 1. Institutional Review Board (IRB) Policies and Procedures Handbook (2008): http://www.ul-acre.org/wp-
p.000187: content/uploads/2013/03/UL-IRB- Policy-Handbook.pdf
p.000187: 2. Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011): http://clinregs.niaid.nih.gov/documen
p.000187: ts/liberia/G-LIBR-NHSREC.pdf
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p.000191: http://www.hpcsa.co.za/Uploads/edi tor/UserFiles/downloads/legislations
p.000191: /acts/medicines_and_related_sub_ac t_101_of_1965.pdf
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p.000192: Regulations Relating to Research with Human Participants No.
p.000192: R719 (2014):
p.000192: http://www.google.co.za/url?url=http:
p.000192: //www.lawsofsouthafrica.up.ac.za/ind ex.php/browse/medical-and- health/national-health-act-61-of-
p.000192: 2003/regulations-and-notices/61-of- 2003-national-health-act-regs-gnr- 719-19-sept-2014-to-date-
p.000192: pdf/download&rct=j&frm=1&q=&es rc=s&sa=U&ei=W6UtVOOvLa6S7A a34YDwAg&ved=0CBUQFjAA&us g=AFQjCNFpKA9W0jNyeWhk0n0l
p.000192: 0Q-WxazBtg
p.000192: General Regulations Made in Terms of the Medicines and Related Substances Act, 1965 (2003):
p.000192: http://www.hpcsa.co.za/Uploads/edit or/UserFiles/downloads/legislations/a cts/medicines_and_related_sub_act_1
p.000192: 01_of_1965.pdf
p.000192:
p.000192:
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p.000192: 1. Regulations Relating to the Use
p.000192: DH:
p.000192: Ethics in Health Research: Principles, Structures, and Processes (2015): http://www.nhrec.org.za/docs/Documents/Ethic
p.000192: sHealthResearchFinalAused.pdf
p.000192:
p.000192: MRC:
p.000192: 1. Guidelines on Ethics in Medical Research: General Principles (2002)
p.000192: 2. Guidelines on Ethics in the Use of Biohazards and Radiation (2003)
p.000192: 3. Guidelines on Ethics in HIV Vaccine Trials (2003)
p.000192:
p.000192: DH:
p.000192: Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2016):
p.000192: http://www.nhrec.org.za/docs/trainingrequ irements/gcp.pdf
p.000192:
p.000192: FAQs:
p.000192: http://www.sanctr.gov.za/InvestigatorbrnbspInf ormation/FAQ/tabid/200/Default.aspx
p.000192: Ethics in Health Research: Principles, Processes, and Structures, Section 3.3.7(i) (2015):
p.000192: http://www.commerce.uct.ac.za/Downloads/Et hics%20in%20Health%20Research%20Final% 20A%20used.pdf
p.000192:
p.000192: Country Key Organizations Legislation
p.000192: Regulations Guidelines
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p.000192: Materials
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p.000192: Embryos, Stem Cells, and Cloning
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p.000192: Tanzania
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p.000192: Medical Research Council of South Africa (MRC): http://www.mrc.ac.za
p.000192:
p.000192: Medical Research Council of South Africa (MRC): http://www.mrc.ac.za
p.000192: Chapter 8, Sections 53-68
p.000192: (2003):
p.000192: http://www0.sun.ac.za/ruralhealth/u kwandahome/rudasaresources2009/ DOH/ethics/app5.pdf
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p.000157: Regulation: http://www.klinikarastirmalar.org/Det ail/1992/ilac-ve-biyolojik-urunlerin- klinik-arastirmalari-hakkinda-
p.000157: yonetmelikte-degisiklik-yapilmasina- dair-yonetmelik-2015
p.000157: 3. Regulation on Efficacy, Safety, and Clinical Trials of Cosmetic Products (2015):
p.000157: http://www.klinikarastirmalar.org.tr/d oc/file_346.pdf
p.000157: 4. Update on the Regulation of the Management and Inspection of the Support of Research and Development Activities
p.000157: (2016). Official Gazette: http://www.resmigazete.gov.tr/eskiler
p.000157: /2016/08/20160810-7.htm
p.000157: 5. Bylaw on Clinical Research of Traditional and Complementary Medicine (2019): http://www.klinikarastirmalar.org/Det
p.000157: ail/2631/geleneksel-ve-tamamlayici- tip-uygulamalarinin-klinik- arastirmalari-hakkinda-yonetmelik- 2019
p.000157: 7. Guideline on Phase 1 Clinical Research Centers (2019) https://titck.gov.tr/storage/Archive/20
p.000157: 19/legislation/ad316d19-8b9e-420c- 86db-3946c56add1d.pdf
p.000157:
p.000157: Regulation on Research on Medical Devices (2014): http://www.klinikarastirmalar.org.tr/d oc/file_318.pdf
p.000157:
p.000157: CRA:
p.000157: 1. GCP Guideline (2015): http://www.klinikarastirmalar.org.tr/doku man.php?id=374
p.000157: 2. Guideline on the Audit of Pharmacovigilance: https://titck.gov.tr/storage/Archive/2019/l
p.000157: egislation/05ef1188-6756-4165-b0d5- bb0a28bbebb3.pdf
p.000157: 3. Various: http://www.klinikarastirmalar.org.tr/en/do cuments.php?dok_cat=0
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p.000157: Guidance on Insuring Volunteers in a Clinical Trial (2011)
p.000157:
p.000157: Country Key Organizations Legislation
p.000157: Regulations Guidelines
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p.000157: Research Injury Human Biological Materials
p.000157:
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p.000157:
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p.000157: United Arab Emirates
p.000157: 164 (2004)
p.000157: 1. Law on Procurement, Preservation, Grafting, and Transplantation of Organs and Tissues, No. 2238 (1979)
p.000157: 2. Law on Blood and Blood Products, No. 2857 (1983)
p.000157:
p.000157: Regulation on Blood and Blood Products, No. 7314 (1983)
p.000157:
p.000157:
p.000157:
p.000157: Regulation on Centers for Diagnosis and Genetic Diseases, No. 23368 (1998)
p.000157: 1. Regulation on Centers for Medically Assisted Procreation, No. 19551 (1987)
p.000157: 2. Regulation on Organ and Tissue Transplantation Services (2005)
p.000157: 3. Regulation on Cordon Blood Banks (2005)
p.000157:
p.000157: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000157: 2. Good Clinical Practice Guidelines for Advanced Therapy Medicinal Products (2011)
p.000157: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999)
p.000157: 1. Circular on Research of Embryonic Stem Cells (2005)
p.000157: 2. Guideline on Clinical Research of Non- Embryonic Stem Cells (2006)
p.000157:
p.000157: General
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000137: http://www.moh.gov.my/moh/resources/auto% 20download%20images/586f38d1c77ed.pdf
p.000137: 4. National Organ, Tissue and Cell Transplantation Policy: http://www.mst.org.my/articles/MALAYSIA%
p.000137: 20TRANSPLANT%20POLICY.pdf
p.000137: 5. National Standards for Cord Blood Banking and Transplantation: http://www.moh.gov.my/moh/resources/auto%
p.000137: 20download%20images/589d78e8689af.pdf
p.000137: 6. National Standards for Stem Cell Transplantation: http://www.moh.gov.my/moh/resources/Arkib/
p.000137: National_Standards_For_Stem_cell_Transplata tion.pdf
p.000137:
p.000137: DMR:
p.000137: Guideline for Submission to Ethics Review Committee (2016)
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: 1. National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedure (2011):
p.000137: http://nhrc.org.np/guidelines
p.000137: 2. Guidelines for Institutional Review
p.000137:
p.000137: Country Key Organizations Legislation
p.000137: Regulations Guidelines
p.000137:
p.000137: General
p.000137:
p.000137: Drugs, Biologics, and Devices
p.000137:
p.000137: New Zealand
p.000137: General
p.000137:
p.000137:
p.000137: Nepal Health Research Council:
p.000137: http://www.nhrc.org.np/
p.000137:
p.000137:
p.000137: 1. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/
p.000137: 2. National Ethics Advisory Committee (NEAC): http://www.neac.health.govt.nz/
p.000137: 3. Ministry of Health (MOH):
p.000137: http://www.moh.govt.nz/
p.000137: 4. Health and Disability Commissioner (HDC): http://www.hdc.org.nz/
p.000137: 5. Health and Disability Ethics Committees: http://www.ethics.health.govt.nz/
p.000137: 6. Ministry of Business, Innovation and Employment: http://www.mbie.govt.nz/
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: 1. Health Research Council Act 1990, Sections 24 and 25
p.000137: 2. New Zealand Bill of Rights Act, Article 10 (1990)
p.000137: 3. Health and Disability Commissioner Act 1994
p.000137: 4. New Zealand Public Health and Disability Act 2000, Section 16
p.000137: 5. Accident Compensation Act 2001
p.000137:
p.000137: Access:
p.000137: All New Zealand acts, bills, and regulations can be found here: http://www.legislation.govt.nz/
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: HDC:
p.000137: The Code of Health and Disability Services Consumers’ Rights (the Code of Rights) (2004):
p.000137: http://www.hdc.org.nz/the-act-- code/the-code-of-rights
p.000137: Committees (IRCs) for Health Research in Nepal (2016):
p.000137: http://nhrc.org.np/guidelines
p.000137: National Guidelines on Clinical Trials with the Use of Pharmaceutical Products (2005): http://nhrc.org.np/guidelines
p.000137:
p.000137: HRC:
p.000137: 1. Guidelines for Researchers on Health Research Involving Māori (2010)
p.000137: 2. Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members (2010)
p.000137: 3. HRC Research Ethics Guidelines (2017)
p.000137: 4. Pacific Health Research Guidelines (2014)
p.000137:
p.000137: Access: http://www.hrc.govt.nz/ethics-and- regulatory/applying-ethical-approval
p.000137:
p.000137: NEAC:
p.000137: 1. Goals, Objectives, and Desired Outcomes of an Ethical Review System (2003)
p.000137: 2. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012)
p.000137: 3. Ethical Guidelines for Intervention Studies (2012)
p.000137: Access: http://www.neac.health.govt.nz/moh.nsf/indexc m/neac-resources-publications
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: Drugs, Biologics, and Devices
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: Drugs
p.000137: 1. New Zealand Medicines and Medical Devices Safety Authority
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: 1. Accident Compensation Act 2001, Section 32 (2010)
p.000137:
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p.000138:
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p.000138:
p.000138:
p.000138: Medsafe:
p.000138: Medicines Regulations 1984
p.000138: http://www.legislation.govt.nz/regulat
p.000138: MOH:
p.000138: Standard Operating Procedures for Health and Disability Ethics Committees (2012):
p.000138: http://www.ethics.health.govt.nz/operating- procedures
p.000138:
p.000138: Medsafe:
p.000138: Good Clinical Research Practice and
p.000138:
p.000138: Country Key Organizations Legislation
p.000138: Regulations Guidelines
p.000138:
p.000138: Drugs, Biologics, and Devices
p.000138:
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p.000138:
p.000138:
p.000138: Clinical Trials Registry
p.000138:
p.000138: Privacy/Data Protection
p.000138:
p.000138:
p.000138:
p.000138: Human Biological Materials
p.000138: (Medsafe): http://www.medsafe.govt.nz
p.000138: 2. Medicines New Zealand:
p.000138: http://www.medicinesnz.co.nz/
p.000138: 3. Health Research Council (HRC), Standing Committee on Therapeutic Trials: http://www.hrc.govt.nz/about-
p.000138: us/committees/standing-committee- therapeutic-trials-scott
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Devices
p.000138: New Zealand Medicines and Medical Devices Safety Authority (Medsafe): http://www.medsafe.govt.nz
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Australian New Zealand Clinical Trials Registry: http://www.anzctr.org.au/
p.000138: Privacy Commissioner:
p.000138: http://www.privacy.org.nz/
p.000138:
p.000138:
p.000138:
p.000138: 1. Ministry of Health (MOH):
p.000138: http://www.moh.govt.nz/
p.000138: 2. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/ethics-and-
p.000138: regulatory/applying-ethical-approval
p.000138: 3. Te Puni Kokiri (TPK):
p.000138: http://www.tpk.govt.nz/
p.000138: 4. Office of the Health and Disability Commissioner (HDC): http://www.hdc.org.nz
p.000138: 5. Ministry of Business, Innovation and Employment: http://www.mbie.govt.nz/
p.000138: 2. Medicines Act 1981(2012)
p.000138:
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p.000138:
p.000138:
p.000138:
p.000138: 1. Official Information Act 1982 (2012)
p.000138: 2. Public Records Act (2005)
p.000138: 3. Privacy Act 1993 (2012)
p.000138:
p.000138: 1. Health Act 1956 (2012)
p.000138: 2. Human Tissue Act 2008
p.000138: ion/public/1984/0143/latest/DLM956 68.html
p.000138:
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p.000138:
p.000138: Medicines (Database of Medical Devices) Regulations (2003): http://www.legislation.govt.nz/regulat
p.000138: ion/public/2003/0325/latest/DLM224 223.html
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Health Information Privacy Code 1994:
p.000138: http://www.privacy.org.nz/assets/File s/Codes-of-Practice-materials/Health- Information-Privacy-Code-1994-
p.000138: including-Amendment.pdf
p.000138: Obtaining Approval for Clinical Trials (2013):
p.000138: http://www.medsafe.govt.nz/medicines/clinical
p.000138: -trials.asp
p.000138:
p.000138: Medicines New Zealand: Guidelines on Clinical Trials
p.000138: Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial (2015):
p.000138: https://ethics.health.govt.nz/system/files/docum ents/pages/2015-medicines-new-zealand- compensation-guidelines.pdf
p.000138:
p.000138: 1. Standard Operating Procedures for Health and Disability Ethics Committees (2012):
p.000138: http://www.ethics.health.govt.nz/operating- procedures
p.000138: 2. Various: http://medsafe.govt.nz/regulatory/DevicesNew/ 13ConductingClinicalTrials.asp
p.000138: FAQs: http://www.anzctr.org.au/Faq.aspx
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: MOH:
p.000138: Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007):
p.000138: http://www.health.govt.nz/publication/guidelin es-use-human-tissue-future-unspecified- research-purposes
p.000138:
p.000139: 139
p.000139:
p.000139: Country Key Organizations Legislation
p.000139: Regulations Guidelines
p.000139:
p.000139: Genetic Research
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Embryos, Stem Cells, and Cloning
p.000139:
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p.000139: Pakistan
p.000139: General
p.000139:
p.000139: Drugs, Biologics, and Devices
p.000139:
p.000139: Human Biological Materials
p.000139: 1. Environmental Protection Authority: http://www.epa.govt.nz/
p.000139: 2. Health Research Council (HRC), Gene Technology Advisory Committee: http://www.hrc.govt.nz/about-
p.000139: us/committees/gene-technology-advisory- committee-gtac
p.000139: 1. Advisory Committee on Assisted Reproductive Technology (ACART): http://acart.health.govt.nz/
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
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p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
p.000012: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000012:
p.000012: 1. 34 CFR 97 subparts A (1991) and D (1997)
p.000012: 2. 34 CFR 98 (1984)
p.000012: 3. 34 CFR 99 (2000)
p.000012: 4. 34 CFR 350.4(c) (1991)
p.000012: 5. 34 CFR 356.3(c) (1991)
p.000012: Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015):
p.000012: https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf
p.000012:
p.000012: Country Key Organizations Legislation
p.000012: Regulations Guidelines
p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
p.000012: Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/
p.000012:
p.000012:
p.000012: Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/
p.000012:
p.000012:
p.000012:
p.000012: Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland
p.000012: Security: www.dhs.gov/
p.000012:
p.000012:
p.000012:
p.000012:
...
p.000059: =#xcelparam
p.000059: 1. Act CLIV of 1997 on Health Care, Chapter IX
p.000059: 2. Act VI of 2002 on the Promulgation of the Convention on Human Rights and Medicine and the Additional Protocol on
p.000059: Cloning: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000059: .cgi?docid=A0200006.TV&celpara
p.000059: =#xcelparam
p.000059:
p.000059: 1. Act on Scientific Research in the Health Sector No. 44/2014: https://www.government.is/media/v elferdarraduneyti-
p.000060: 60
p.000060:
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p.000060:
p.000060:
p.000060: Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as Regards Transplantation and Storage of
p.000060: Organs and Tissues and Certain Histopathology Examinations: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000060: gi?docid=99800018.EUM&celpara=# xcelparam
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 30/1998. (VI. 24.) of the Minister of Welfare on Regulations on Specific Procedures for Human Reproduction:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=99800030.NM&celpara=#x celparam
p.000060:
p.000060: Regulation on the Structure of Research Projects in the Health Sector, Including Research Protocol, Internal
p.000060: Monitoring, and
p.000060: and Data Processors (2018): http://www.naih.hu/felkeszueles-az- adatvedelmi-rendelet-alkalmazasara.html
p.000060:
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p.000060: Decree 60/2003. (X. 20.) of the Minister of Health, Social and Family Affairs on the Minimum Professional Requirements
p.000060: Necessary for Providing Health Services: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =A0300060.ESC&celpara=#xcelparam
p.000060:
p.000060:
p.000060: Decree 18/1998. (XII. 27.) of the Minister of Health on Implementing Act CLIV of 1997 on Health Care Regarding
p.000060: Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =99800018.EUM&celpara=#xcelparam
p.000060:
p.000060: NBC:
p.000060: 1. Vulnerable Groups Including Children: http://www.vsn.is/en/content/vulnerable- groups-including-children
p.000060:
p.000060: Country Key Organizations Legislation
p.000060: Regulations Guidelines
p.000060:
p.000060: General
p.000060:
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p.000060: Drugs, Biologics, and Devices
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p.000060: Research Injury
p.000060: (NBC):
p.000060: http://www.vsn.is/en
p.000060:
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p.000060:
p.000060:
p.000060: Drugs
p.000060: 1. Icelandic Medicines Agency (MCA):
p.000060: http://www.ima.is/
p.000060: 2. National Bioethics Committee (NBC):
p.000060: www.visindasidanefnd.is
p.000060:
p.000060:
p.000060: Devices
...
p.000124:
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 7.7 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: Clinical Trials Registry – India:
p.000124: FAQs: http://ctri.nic.in/Clinicaltrials/faq.php
p.000124:
p.000124: Office of Drugs Controller General: Registration of Clinical Trial in ICMR Clinical Trial Registry:
p.000124: http://www.cdsco.nic.in/writereaddata/CTRegi stration.doc
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 2.6 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124:
p.000124: Country Key Organizations Legislation
p.000124: Regulations Guidelines
p.000124:
p.000124: Research Injury
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Social-Behavioral Research
p.000124:
p.000124:
p.000124:
p.000124: Privacy/Data Protection
p.000124:
p.000124:
p.000124:
p.000124: Human Biological Materials
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Genetic Research
p.000124:
p.000124:
p.000124:
p.000124:
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p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Embryos, Stem Cells, and Cloning
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124: Ministry of Health and Family Welfare: https://mohfw.gov.in
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: 1. Department of Biotechnology (DBT): http://dbtindia.nic.in/
p.000124: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: 1. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124: 2. Central Drugs Standard Control Organization, Office of Drugs
p.000124:
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p.000124:
p.000124:
p.000124: Environmental Protection Act (1986)
p.000124: http://www.cdsco.nic.in/writereaddat a/ORDER%20and%20Formula%20to
p.000124: %20Determine%20the%20quantum% 20of%20compensation%20in%20the
p.000124: %20cases%20of%20Clinical%20Tria l%20related%20serious%20Adverse
p.000124: %20Events(SAEs)%20of%20Injury% 20other%20than%20Death.pdf
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p.000124:
p.000124:
p.000124:
p.000124: Govt. of India Office Memorandum (O.M. No.19015/53/1997 - IH Pt.) 19th
p.000124: November, 1997 on
p.000124: Exchange of Human Biological Material for Biomedical Research Purposes
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 9 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Sections 2 and 11 (2017):
...
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: Hazardous Substances and New Organisms Act 1996 (2012)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Human Assisted Reproductive Technology Act 2004 (2009)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Human Assisted Reproductive Technology (HART) Order (2005):
p.000140: http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: ACART:
p.000140: 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000)
p.000140: 2. Guidelines for Research on Gametes and Non-viable Embryos (2005)
p.000140: 3. Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005)
p.000140: 4. Guidelines on Embryo Donation for Reproductive Purposes (2008)
p.000140: 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012)
p.000140: 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013)
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
p.000140: 4. Commission of Higher Education (CHED): www.ched.gov.ph/
p.000140: 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
...
p.000012: 29 CFR 21
p.000012:
p.000012:
p.000012:
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
p.000014: General
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Drugs, Biologics, and Devices
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/
p.000014: Social Security Administration:
p.000014: http://www.ssa.gov/
p.000014:
p.000014: Drugs and Biologics
p.000014: Food and Drug Administration: https://www.fda.gov/Drugs and https://www.fda.gov/vaccines-blood- biologics
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
...
p.000030: https://www.famhp.be/en/human_use/medicines/medicines/research_development/ethic_committee
p.000030:
p.000030: General
p.000030: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000030: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000030: -advisory-committee-bioethics
p.000030: Law Relating to Experimentation on Humans (2004):
p.000030: http://www.ejustice.just.fgov.be/cgi
p.000030: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000030: 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
p.000031: Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials
p.000031: Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000031: -advisory-committee-bioethics
p.000031: 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative-
p.000031: bodies/ct-college-clinical-trial-college
p.000031:
p.000031: Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031:
p.000031:
p.000031:
p.000031:
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.000030: https://www.famhp.be/en/human_use/medicines/medicines/research_development/ethic_committee
p.000030:
p.000030: General
p.000030: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000030: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000030: -advisory-committee-bioethics
p.000030: Law Relating to Experimentation on Humans (2004):
p.000030: http://www.ejustice.just.fgov.be/cgi
p.000030: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000030: 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.000186: Regulations Guidelines Ghana
p.000186: For an overview of the clinical trial information in Ghana, see:
p.000186: http://www.fdaghana.gov.gh/index.php?option=com_content&view=article&id=71&Itemid=55
p.000186:
p.000186: Drugs, Biologics, and Devices
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
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p.000186:
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p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: Guinea
p.000186: Food and Drugs Authority:
p.000186: http://www.fdaghana.gov.gh
p.000186: Public Health Act, 2012
p.000186: Act 851, Sections 150-166: http://www.fdaghana.gov.gh/images/s tories/pdfs/Clinical%20Trials/REGU
p.000186: LATION%20OF%20CLINICAL%20 TRIALS%20IN%20GHANA.pdf
p.000186: 1. Guidelines for Good Clinical Practice in Ghana (2015): http://www.fdaghana.gov.gh/images/stories/pdf
p.000186: s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20ON%20GOOD%20C LINICAL%20PRACTICE%20IN%20GHANA
p.000186: .pdf
p.000186: 2. Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices
p.000186: (2015): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20AUTHORI ZATION%20OF%20CLINICAL%20TRIALS
p.000186: %20OF%20MEDICINES,%20GHANA.pdf
p.000186: 3. Guidelines for Conduct of Clinical Trials in Paediatric Population (2016):
p.000186: http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20CONDUCT
p.000186: %20OF%20CLINICAL%20TRIALS%20WIT H%20PAEDIATRIC%20POPULATION%20I N%20GHANA.pdf
p.000186: 4. Guidelines for Conduct of Clinical Trials During Emergencies (2016): http://www.fdaghana.gov.gh/images/stories/pdf
p.000186: s/downloads/drugs%20guidelines/GUIDELINE S%20FOR%20TRIALS%20IN%20EMERGE NCIES1.pdf
p.000186: For an overview of the clinical research regulations in Guinea, see the ClinRegs report:
p.000186: https://clinregs.niaid.nih.gov/single_country.php?c_id=90 Note: All websites and documents are in French.
p.000186:
p.000186: General
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: Research Injury
p.000186: National Ethics Committee on Health Research (CNERS): http://cners- guinee.org/
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: National Ethics Committee on Health Research: http://cners-guinee.org/
p.000186: Public Health Code, Articles 237-316 (1997):
p.000186: http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code
p.000186: _Sante_Publique.pdf
p.000186:
p.000186:
p.000186:
p.000186: Public Health Code, Articles 301-302 (1997):
p.000186: http://www.vertic.org/media/Nation al%20Legislation/Guinea/GN_Code
p.000187: 187
p.000187: Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for
p.000187: Research in Health (CNERS), Chapters I and II (1998):
p.000187: http://cners-guinee.org/wp- content/uploads/2014/02/Decret-.pdf
p.000187: CNERS:
p.000187: Frequently Asked Questions: http://cners- guinee.org/faq/
p.000187:
p.000187: Country Key Organizations Legislation
p.000187: Regulations Guidelines
p.000187:
p.000187: Research Injury
p.000187: Kenya
...
Health / stem cells
Searching for indicator stemXcells:
(return to top)
p.000001:
p.000001: The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines
p.000001: (collectively referred to as “standards”) that govern human subject protections in 133 countries, as well as standards
p.000001: from a number of international and regional organizations. First published in 2005, the Compilation is intended for use
p.000001: by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research
p.000001: protections around the world.
p.000001:
p.000001: Content experts from around the world, listed at the end of the Compilation, provided updates (or confirmations of
p.000001: prior listings), which are reflected in the hundreds of changes entered into this Edition. Two new countries are
p.000001: featured in the 2020 Edition: Nicaragua and Paraguay.
p.000001:
p.000001: ORGANIZATION
p.000001:
p.000001: The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as:
p.000001: 1. General, i.e., applicable to most or all types of human subjects research
p.000001: 2. Drugs, Biologics, and Devices
p.000001: 3. Clinical Trial Registries
p.000001: 4. Research Injury
p.000001: 5. Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards:
p.000001: https://www.hhs.gov/ohrp/international/social- behavioral-research-standards/index.html)
p.000001: 6. Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports)
p.000001: 7. Human Biological Materials
p.000001: 8. Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/)
p.000001: 9. Embryos, Stem Cells, and Cloning
p.000001: These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate
p.000001: understanding of the country’s requirements. The information is then organized into four columns:
p.000001: 1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight
p.000001: role for human subjects research.
p.000001: 2. Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent
p.000001: constitutional provisions.
p.000001: 3. Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies.
p.000001: 4. Guidelines – pertain to non-binding instruments.
p.000001: 1
p.000001:
p.000001: The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in
p.000001: parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018.
p.000001:
p.000001: HOW TO ACCESS A DOCUMENT
p.000001:
p.000001: Documents can be accessed in four possible ways:
p.000001:
p.000001: 1. Link to the web address (URL).
p.000001: 2. Search for a document at the website of the agency listed in the Key Organizations column.
p.000001: 3. Perform an Internet search on the document title.
p.000001: 4. Request a local research ethics committee to provide the document.
p.000001:
p.000001: In many cases the documents are available in English. When the URL links to a non-English website or document, an
p.000001: online language translator usually can render an English version.
p.000001:
p.000001: TOPICS NOT COVERED
p.000001:
...
p.000008: Code of Conduct and Ethical Guidelines for Social Science Research: http://www.unesco.org/new/fileadmin/MULTI
p.000008: MEDIA/HQ/SHS/pdf/Soc_Sci_Code.pdf
p.000008: 1. Declaration of Helsinki, Paragraph 24 (2013): http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000008: 2. Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: 1. Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997):
p.000008: www.who.int/csr/emc97_3.pdf
p.000008: 2. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research
p.000008: (2003): http://www.who.int/reproductivehealth/topics/ ethics/human_tissue_use.pdf
p.000008: Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005)
p.000008: 1. ISBER Best Practices: Recommendations for Repositories (2018)
p.000008:
p.000008: Country Key Organizations Legislation
p.000008: Regulations Guidelines
p.000008:
p.000008: Human Biological Materials
p.000008:
p.000008:
p.000008: Genetic Research
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Embryos, Stem Cells, and Cloning
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Human Genome Organization:
p.000008: http://www.hugo-international.org/
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: UNESCO Bioethics Program: http://portal.unesco.org/shs/en/ev.php- URL_ID=1372&URL_DO=DO_TOPIC&URL
p.000008: _SECTION=201.html
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: International Society for Stem Cell Research: http://www.isscr.org/
p.000008: 2. ISBER Best Practices: Recommendations for Repositories. Fourth Edition. ADDENDUM 1: Liquid Nitrogen-Based Cryogenic
p.000008: Storage of Specimens (2019): https://www.isber.org/page/BPR
p.000008: 1. Statement on the Principled Conduct of Genetic Research (1996): http://www.eubios.info/HUGO.htm
p.000008: 2. Statement on DNA Sampling: Control and Access (1998): http://www.hugo- international.org/img/dna_1998.pdf
p.000008: 3. Statement on Gene Therapy Research (2001): http://www.hugo- international.org/img/gene_2001.pdf
p.000008: 4. Statement on Human Genomic Databases (2002): http://www.hugo- international.org/img/genomic_2002.pdf
p.000008: 1. Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998-1999 (1997):
p.000008: http://unesdoc.unesco.org/images/0011/00110 2/110220e.pdf#page=47
p.000008: 2. International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences
p.000008: (2003): http://unesdoc.unesco.org/images/0013/00133 1/133171e.pdf#page=45
p.000008: Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/docs/default-source/hesc-
p.000008: guidelines/isscrhescguidelines2006.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
...
p.000010: http://www.pre.ethics.gc.ca/eng/policy- politique/initiatives/tcps2-eptc2/Default/ PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 5: Privacy and
p.000010: Confidentiality (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000010: CIHR:
p.000010: CIHR Best Practices for Protecting Privacy in Health Research (2005): http://www.cihr-
p.000010: irsc.gc.ca/e/documents/et_pbp_nov05_sept200 5_e.pdf
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12: Human Biological
p.000010: Materials Including Materials Related to Human Reproduction (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp
p.000010: s2-2018-en-interactive-final.pdf
p.000010: PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 13: Human Genetic
p.000010: Research (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000011: 11
p.000011:
p.000011: Country Key Organizations Legislation
p.000011: Regulations Guidelines
p.000011:
p.000011: Genetic Research
p.000011:
p.000011:
p.000011: Embryos, Stem Cells, and Cloning
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
...
p.000018: categories 2, 3, and 5 in the
p.000018: Common Rule (2018): https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text-
p.000018: unofficial-2018-requirements.pdf
p.000018: Various: https://www.hhs.gov/hipaa/for- professionals/special- topics/research/index.html and
p.000018: https://www.hhs.gov/hipaa/for-
p.000018: professionals/faq/research-uses-and-disclosures
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/biological-materials-and- data/index.html
p.000018: 1. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not
p.000018: Individually Identifiable (2006): https://www.fda.gov/regulatory- information/search-fda-guidance-
p.000018: documents/guidance-informed-consent-vitro- diagnostic-device-studies-using-leftover- human-specimens-are-not
p.000018: 2. In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (2010) : https://www.fda.gov/regulatory-
p.000018: information/search-fda-guidance-
p.000018: documents/vitro-diagnostic-ivd-device-studies-
p.000018:
p.000018: Country Key Organizations Legislation
p.000018: Regulations Guidelines
p.000018:
p.000018: Human Biological Materials
p.000018:
p.000018:
p.000018: Genetic Research
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Embryos, Stem Cells, and Cloning
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: All Common Rule agencies
p.000018: 1. DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000018: 2. DHHS National Institutes of Health, Office of Science Policy, Biosafety, Biosecurity, and Emerging Biotechnology
p.000018: Policy Division: https://osp.od.nih.gov/biosafety- biosecurity-and-emerging-biotechnology/
p.000018: 3. DHHS Office for Civil Rights (OCR): https://www.hhs.gov/hipaa/for- professionals/special-topics/genetic-
p.000018: information/index.html
p.000018:
p.000018:
p.000018: Food and Drug Administration, Center for Biologics Evaluation and Research: https://www.fda.gov/vaccines-
p.000018: blood-biologics
p.000018:
p.000018: National Academy of Sciences (NAS):
p.000018: http://www.nationalacademies.org/nrc/
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: National Institutes of Health:
p.000018: http://stemcells.nih.gov/
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: 1. Research on Transplantation of Fetal Tissue, Public Law 103- 43 (1993): http://www.hhs.gov/ohrp/regulation
p.000018: s-and-policy/guidance/public-law- 103-43/index.html
p.000018: 2. Genetic Information Nondiscrimination Act (2008): https://www.gpo.gov/fdsys/pkg/PL AW-110publ233/content-detail.html
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
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p.000018:
p.000018:
p.000018:
p.000018:
...
p.000019: 164.520(b)(1)(iii)(C)
p.000019: frequently-asked-questions
p.000019: 3. CBER-Specific: Various: https://www.fda.gov/vaccines-blood- biologics/other-recommendations-biologics-
p.000019: manufacturers/references-regulatory-process- office-tissues-and-advanced-therapies
p.000019:
p.000019: OHRP:
p.000019: Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review
p.000019: Boards (2009): http://www.hhs.gov/ohrp/regulations-and- policy/guidance/guidance-on-genetic-
p.000019: information-nondiscrimination-act/index.html
p.000019:
p.000019: NIH:
p.000019: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016):
p.000019: https://osp.od.nih.gov/wp- content/uploads/2013/06/NIH_Guidelines.pdf Application of Current Statutory Authorities to
p.000019: Human Somatic Cell Therapy Products and Gene Therapy
p.000019: Products. October 14, 1993. 58 FR 53248:
p.000019: https://www.fda.gov/media/76647/download
p.000019: 1. Guidelines for Human Embryonic Stem Cell Research (2005): http://www.nap.edu/catalog.php?record_id=11 278
p.000019: 2. 2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://books.nap.edu/catalog.php?record_id=12 260
p.000019: 3. 2010 Final Report of the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010
p.000019: Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://www.nap.edu/catalog.php?record_id=12 923
p.000019: 1. Removing Barriers to Responsible Scientific Research Involving Human
p.000019:
p.000019: Country Key Organizations Legislation
p.000019: Regulations Guidelines
p.000019:
p.000019:
p.000019: Embryos, Stem Cells, and Cloning
p.000019: (1993):
p.000019: https://history.nih.gov/research/dow nloads/PL103-43.pdf
p.000019: Stem Cells, Executive Order 13505 (2009):
p.000019: https://www.gpo.gov/fdsys/pkg/DCPD- 200900136/pdf/DCPD-200900136.pdf
p.000019: 2. NIH Guidelines on Human Stem Cell Research (2009): http://stemcells.nih.gov/policy/2009- guidelines.htm
p.000019: 3. NIH Human Embryonic Stem Cell Registry (2016): https://grants.nih.gov/stem_cells/registry/curre nt.htm
p.000019:
p.000019: Access: http://stemcells.nih.gov/
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
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p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Country Key Organizations Legislation
p.000020: Regulations Guidelines
p.000020:
p.000020: EUROPE
p.000020: Regionwide
p.000020:
p.000020: General
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Drugs, Biologics, and Devices
p.000020: European Commission:
p.000020: 1. European Group on Ethics in Science and New Technologies (EGE): https://ec.europa.eu/research/ege/index.cf m
p.000020: 2. Directorate-General for Research and Innovation: http://ec.europa.eu/research/participants/d
p.000020: ocs/h2020-funding-guide/cross-cutting- issues/ethics_en.htm
p.000020: Council of Europe, Bioethics Unit:
p.000020: http://www.coe.int/bioethics
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
...
p.000025: for Medicinal Products for Human Use (2016): https://www.ema.europa.eu/documents/regulat
p.000025: ory-procedural-guideline/external-guidance- implementation-european-medicines-agency-
p.000025: policy-publication-clinical-data_en-1.pdf
p.000025: 1. Recommendation No. R (97) 5 on the Protection of Medical Data (1997): https://wcd.coe.int/ViewDoc.jsp?id=571075&S
p.000025: ite=CM&BackColorInternet=C3C3C3&BackC olorIntranet=EDB021&BackColorLogged=F5 D383
p.000025: 2. Article 29 Working Party Documentation: http://ec.europa.eu/justice/data- protection/article-29/index_en.htm
p.000025: Guidelines on Good Clinical Practice Specific to Advanced Therapy Medicinal Products:
p.000025: https://ec.europa.eu/health/sites/health/files/file s/eudralex/vol-10/atmp_guidelines_en.pdf
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Recommendation Rec (2016) 6 of the Committee of Ministers to Member States on Research on Biological Materials of Human
p.000025: Origin:
p.000025:
p.000025: Country Key Organizations Legislation
p.000025: Regulations Guidelines
p.000025:
p.000025: Human Biological Materials
p.000025:
p.000025: Genetic Research
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
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p.000025:
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p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Embryos, Stem Cells, and Cloning
p.000025:
p.000025:
p.000025:
p.000025: European Medicines Agency:
p.000025: http://www.ema.europa.eu/
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Council of Europe, Bioethics Unit:
p.000025: http://www.coe.int/bioethics
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
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p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: European Commission:
p.000025: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m
p.000025: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000025: Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation
p.000025: (EC) No. 726/2004: http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2007_1394/reg_2007_1394_e n.pdf
p.000025: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14, ETS No. 164 (1997):
p.000025: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000025: 2. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, CETS No. 195
p.000025: (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 1. Statements by the Commission Re: Article 6 (2006): http://www.uv.es/operuv/docs_7pm/ FP7ECStatementsComm_Ethical.pd
p.000025: f
p.000025: 2. Statement of the Commission Related to Research Activities Involving Human Embryonic Stem Cells (2013):
p.000025: http://eur- lex.europa.eu/LexUriServ/LexUriSe
p.000026: 26
p.000026: https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 1. Recommendation No. R (92) on Genetic Testing and Screening for Health Care Purposes (1992):
p.000026: http://wcd.coe.int/ViewDoc.jsp?id=612007&Si te=CM&BackColorInternet=9999CC&BackCo
p.000026: lorIntranet=FFBB55&BackColorLogged=FFA C75
p.000026: 2. Recommendation Rec (2006)4 of the Committee of Ministers to Members States on Research on Biological Materials of
p.000026: Human Origin (2016): https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff
p.000026: 3. Recommendation Rec(2016)8 of the Committee of Ministers to Member States on the Processing of Personal Health-
p.000026: Related Data for Insurance Purposes, Including Data Resulting from Genetic Tests (2016):
p.000026: https://search.coe.int/cm/Pages/result_details.as px?ObjectId=09000016806b2c5f
p.000026: 1. Commission Staff Working Paper Report on Human Embryonic Stem Cell Research (2003):
p.000026: https://ec.europa.eu/research/press/2003/pdf/se c2003-441report_en.pdf
p.000026: 2. Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007):
p.000026: http://bookshop.europa.eu/ga/recommendations
p.000026: -on-the-ethical-review-of-hesc-fp7-research- projects-pbKAAJ07022/downloads/KA-AJ-07- 022-EN-
p.000026: C/KAAJ07022ENC_002.pdf;pgid=y8dIS7GU
p.000026:
p.000026: Country Key Organizations Legislation
p.000026: Regulations Guidelines
p.000026:
p.000026: Embryos, Stem Cells, and Cloning
p.000026:
p.000026:
p.000026:
p.000026:
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p.000026:
p.000026:
p.000026:
p.000026: Armenia
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Council of Europe, Bioethics Unit:
p.000026: http://www.coe.int/bioethics
p.000026: rv.do?uri=OJ:C:2013:373:0012:001 5:EN:PDF
p.000026:
p.000026:
p.000026: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997):
p.000026: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000026: 2. Additional Protocol on Prohibition of Human Cloning, ETS No. 168 (1998): http://conventions.coe.int/Treaty/Comm
p.000026: un/QueVoulezVous.asp?NT=168&CM= 7&DF=9/15/2008&CL=ENG
p.000026: WMdSR0EAlMEUUsWb0000dz-
p.000026: kvfzb;sid=Iexx3tq0IOFxyokBvtfvebiRJj93DZf XP54=?FileName=KAAJ07022ENC_002.pdf
p.000026: &SKU=KAAJ07022ENC_PDF&CatalogueNu mber=KA-AJ-07-022-EN-C
p.000026: Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a
p.000026: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS
p.000026: Countries,” Chapter 3, Section 1:
p.000026: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000026: Note: All websites and documents are in Armenian.
p.000026:
p.000026: Drugs, Biologics, and Devices
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Human Biological Materials
p.000026:
p.000026:
p.000026: Austria
p.000026: General
p.000026: 1. Drug and Medical Technology Agency: http://www.pharm.am/
...
p.000027:
p.000027:
p.000027:
p.000027: Medical Devices Act (2014): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 1. Austrian Drug Law, Article 32 (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027: 2. Austrian Medical Devices Law, Article 47 (2017): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10011003&Sho wPrintPreview=True
p.000027: 1. Data Protection Act No. 165/1999: https://www.ris.bka.gv.at/GeltendeF assung.wxe?Abfrage=Bundesnorme
p.000027: n&Gesetzesnummer=10001597
p.000027: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000027:
p.000028: 28
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028: Various: http://www.basg.at/arzneimittel/vor-der- zulassung/klinische-pruefungen/
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Various:
p.000028: http://www.basg.at/medizinprodukte/formulare
p.000028: /klinische-pruefung/
p.000028:
p.000028: Country Key Organizations Legislation
p.000028: Regulations Guidelines
p.000028:
p.000028: Human Biological Materials
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Genetic Research
p.000028:
p.000028:
p.000028:
p.000028: Embryos, Stem Cells, and Cloning
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Belarus
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Law on Safety of Blood (2009): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10011145&Sho wPrintPreview=True
p.000028: 2. Law on Quality and Safety of Human Tissue and Cells (2013): http://www.ris.bka.gv.at/GeltendeFa
p.000028: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=20005698&Sho wPrintPreview=True
p.000028: Gene Technology Act (2012): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10010826&Sho wPrintPreview=True
p.000028: Reproductive Medicine Act (2010):
p.000028: http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10003046&Sho wPrintPreview=True
p.000028: Regulation on Tissue Banks (2014):
p.000028: http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen& Gesetzesnummer=20005848&ShowP rintPreview=True
p.000028: Bioethics Commission:
p.000028: 1. Opinion of the Bioethics Commission at the Federal Chancellery: Biobanks for Medical Research (2007)
p.000028: 2. Biobanks for Medical Research - Amendments to the Bioethics Commission Report of May 2007 (2011)
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Bioethics Commission:
p.000028: 1. Stem Cell Research in the Context of the EU’s Sixth Framework Programme Research (2002)
p.000028: 2. Research on Human Embryonic Stem Cells (2009): http://www.bundeskanzleramt.at/DocView.axd
p.000028: ?CobId=34240
p.000028: For an overview of human subject protections in Belarus, see “Ethical Review of Biomedical Research in the CIS
p.000028: Countries,” Chapter 3, Section 3:
p.000028: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000028:
p.000028: General
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs, Biologics, and Devices
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. National Bioethics Committee
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. State Pharmacological Committee
p.000028: 3. Centre for Expertise and Testing in Health Care:
p.000028: http://rceth.by/
p.000028: 1. Constitution of the Republic of Belarus, Article 25 (2004): http://www.pravo.by/WEBNPA/text
p.000028: .asp?RN=v19402875
p.000028: 2. Law on Health Care System, Articles 40, 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000028: =v19302435
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Law on Drugs, Articles 15,16 (2009): http://pravo.by/webnpa/text.asp?RN
p.000028: =h10600161
p.000028: 2. Law on Health Care System, Article 40 (2010):
p.000029: 29
p.000029: MOH:
p.000029: 1. Ordinance No. 274 on Establishing the National Bioethics Committee (2006)
p.000029: 2. Decree No. No. 55 on Ethics Committees (2008) (Russian): http://www.levonevski.net/pravo/nor m2009/num05/d05639.html
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: MOH:
...
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Legal Basis (2018): https://www.autoriteprotectiondonnees.be/fond ement-legal-pour-le-traitement-de-donnees-a-
p.000032: caractere-personnel
p.000032: 2. Consent (2018): https://www.autoriteprotectiondonnees.be/cons entement
p.000032: 3. International Data Transfer (2018): https://www.autoriteprotectiondonnees.be/inter national-0
p.000032: BACB:
p.000032: 1. Opinion No. 42: Umbilical Cord Blood Banks (2007)
p.000032: 2. Opinion No. 43: Commercialization of Human Body Parts (2007)
p.000032: 3. Opinion No. 45: Human Biological Material Banks Intended for Research (2009)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine
p.000032:
p.000032: Country Key Organizations Legislation
p.000032: Regulations Guidelines
p.000032:
p.000032: Human Biological Materials
p.000032: (2012)
p.000032: 5. Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applications or for Scientific Research
p.000032: Purposes (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Embryos, Stem Cells, and Cloning
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Federal Commission for Medical and Scientific Research on Embryos in Vitro:
p.000032: http://health.belgium.be/eportal/Healthcar e/Consultativebodies/Commissions/Embr yoinvitro/19076630?ie2Term=research&i
p.000032: e2section=83
p.000032: 2. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000032: 3. Belgian Advisory Committee on Bioethics: https://www.health.belgium.be/en/belgian
p.000032: -advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Act on Research on Embryos in Vitro (2003): https://organesdeconcertation.sante. belgique.be/fr/organe-d'avis-et-de-
p.000032: concertation/commission-federale- embryons
p.000032: 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007):
p.000032: https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor
p.000032: el_humain/legislation/apres_le_01_ 12_2009
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15 February
p.000032: 1999): https://organesdeconcertation.sante.be lgique.be/fr/organe-d'avis-et-de- concertation/commission-federale-
p.000032: embryons
p.000032: CSS:
p.000032: Various: https://www.health.belgium.be/en/superior- health- council?f%5B0%5D=field_shc_doc%3A1145 BACB:
p.000032: 1. Opinion No. 10: Reproductive Human Cloning (1999)
p.000032: 2. Opinion No. 18: Research on Human Embryos in Vitro (2002)
p.000032: 3. Opinion No. 33: Somatic and Germinal Line Gene Modification (2005)
...
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul
p.000034: ative/pravilnik_klinicka_bos.pdf
p.000034: 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf
p.000034: 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak
p.000034: se-bo.pdf
p.000034: 4. Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016):
p.000034: http://www.almbih.gov.ba/_doc/upust va- vodici/uputstvo_o_nacinu_izvjestava nja_o_sigurnosti.pdf
p.000034:
p.000034: 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul
p.000034: ative/pravilnik_klinicka_bos.pdf
p.000034: 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf
p.000034: 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak
p.000034: se-bo.pdf
p.000034:
p.000034: Country Key Organizations Legislation
p.000034: Regulations Guidelines
p.000034:
p.000034: Drugs, Biologics, and Devices
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Research Injury
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Privacy/Data Protection
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Embryos, Stem Cells
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Federation of Bosnia and Herzegovina Medicines and Medical Devices Agency of Bosnia and Herzegovina:
p.000034: http://www.almbih.gov.ba/
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Republic of Srpska
p.000034: Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000034: ges/Splash.aspx
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Personal Data Protection Agency of Bosnia and Herzegovina: http://www.azlp.gov.ba/Default.aspx?lang Tag=en-
p.000034: US&template_id=147&pageIndex=1
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Federation of Bosnia and Herzegovina
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 1. Medicinal Products and Medicinal Devices Act, Articles 52 and 116 (2008): http://www.almbih.gov.ba/_doc/reg
p.000034: ulative/medicinal_products_and_me dical_devices_act.pdf
p.000034: 2. Law on Health Insurance of the Federation of Bosnia and Herzegovina, Official Gazette No. 46/10
p.000034:
p.000034: 1. Medicinal Products and Medicinal Devices Act, Article 52 and 116
p.000034: 2. Law on Health Insurance of the Republic of Srpska, Official Gazette Republic of Srpska No. 106/09:
p.000034: http://www.farmaceutska- komora.org/images/stories/5Zakon_ o_zdravstvenoj_zastiti.pdf
p.000034: 1. Law on the Protection of Personal Data in Bosnia and Herzegovina (2005): http://www.azlp.gov.ba/propisi/Def
p.000034: ault.aspx?id=5&langTag=en- US&pageIndex=1
...
p.000037: http://www.bda.bg/images/stories/doc uments/regulations/naredbi/20180320
p.000037: _Naredda_31.pdf
p.000037:
p.000037: Ordinance No. 10 of 2008 on the Documents Required from the Principal/Coordinating Investigator or Sponsor for
p.000037: Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices During Clinical
p.000037: Investigations and Assessment of the Clinical Data Collected During such Investigations (2010):
p.000037: http://www.bda.bg/images/stories/doc uments/legal_acts/Ordinance_Clinical
p.000037: _investigations_MD_EN.pdf Regulation 31 from 12 August 2007 for Determining the Principles of Good Clinical Practice,
p.000037: Section 5.8 (2012) (Bulgarian): http://www.bda.bg/images/stories/doc uments/regulations/naredbi/20180320
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Various:
p.000037: http://www.bda.bg/en/114-information-for- companies-section/medical-devices-category
p.000037:
p.000037: Country Key Organizations Legislation
p.000037: Regulations Guidelines
p.000037: _Naredda_31.pdf
p.000037:
p.000037: Privacy/Data Protection
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Human Biological Materials:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Embryos, Stem Cells, and Cloning
p.000037: 1. Bulgarian Commission for Personal Data Protection: https://www.cpdp.bg/en/index.php?p=rubr ic&aid=2
p.000037: 2. Ombudsman: www.ombudsman.bg
p.000037:
p.000037:
p.000037:
p.000037: 1. Executive Agency for Transplantation: http://www2.bgtransplant.bg/bg
p.000037: 2. Council of Ministers, Ethics Committee for Transplantation
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Ministry of Healthcare:
p.000037: http://www.mh.government.bg/
p.000037: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000037: 2. Law for Protection of Personal Data (2018): https://www.cpdp.bg/en/index.php? p=element&aid=373
p.000037:
p.000037: 1. Law Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation
p.000037: of Organs and Tissues of Human Origin (2006): https://www.mh.government.bg/me dia/filer_public/c6/12/c612c85a-
p.000037: 519f-4a22-b390- 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf
p.000037: 2. Law on Transplantation of Organs, Tissues, and Cells (2013): http://bgtransplant.bg/iat/docs/Zako ni_ZTOTK.doc
p.000037: 1. Law Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation
p.000037: of Organs and Tissues of Human Origin (2006): https://www.mh.government.bg/me dia/filer_public/c6/12/c612c85a-
p.000037: 519f-4a22-b390- 5fad298ce80b/zakon-ratifitsirane- protokol-konventsiya-zashtita- pravata-na_choveka_29-08- 2006.pdf
...
p.000038:
p.000038: 1. Law on Mandatory Health Insurance (2013): http://www.hzzo.hr/wp- content/uploads/2013/10/ZOZO_PR
p.000038: OCISCENI_TEKSTv2.pdf?6d8ad4
p.000038: 2. Medicinal Product Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1522.html
p.000038: 3. Rule Book on Amendments to Medicinal Product Act (2014): http://narodne- novine.nn.hr/clanci/sluzbeni/2014_0
p.000039: 39
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: 1. Ordinance on Clinical Trials and Good Clinical Practice (2015): http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03
p.000039: _25_534.html
p.000039: 2. Ordinance on Amendments to the Ordinance on Clinical Trials and Good Clinical Practice (2015):
p.000039: https://narodne- novine.nn.hr/clanci/sluzbeni/2014_07
p.000039: _90_1809.html
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Ordnance on Clinical Trials and Good Clinical Practice, Articles 11 and 16, Act 5.8., 6.8. and
p.000039: 8.2.5 (2015):
p.000039: http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03
p.000039: _25_534.html
p.000039:
p.000039: Country Key Organizations Legislation
p.000039: Regulations Guidelines
p.000039: 7_90_1809.html
p.000039:
p.000039: Privacy/Data Protection
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Human Biological Materials
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Embryos, Stem Cells, and Cloning
p.000039: Croatian Personal Data Protection Agency: http://www.azop.hr/
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Ministry of Health:
p.000039: https://zdravlje.gov.hr/
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Ministry of Health:
p.000039: https://zdravlje.gov.hr/
p.000039: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000039: 2. Implementation Act of the General Data Protection Act (NN 42/18) (2018): https://narodne-
p.000039: novine.nn.hr/clanci/sluzbeni/2018_0 5_42_805.html
p.000039: 1. Law about Blood and Blood Products (2006):
p.000039: http://narodne- novine.nn.hr/clanci/sluzbeni/2006_0 7_79_1916.html
p.000039: 2. Rule Book on Amendments to Law about Blood and Blood Products (2011): http://narodne-
p.000039: novine.nn.hr/clanci/sluzbeni/2011_1 1_124_2476.html
p.000039: 3. Law on the Implementation of Human Tissues and Cells (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1
p.000039: 2_144_3070.html
p.000039: 4. Law on Transplantation of Human Organs for the Purpose of Treatment (2012): http://narodne-
p.000039: novine.nn.hr/clanci/sluzbeni/2012_1 2_144_3071.html
p.000039: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000039: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2003):
p.000039: http://zakon.poslovna.hr/public/Kon vencija-o-zastiti-ljudskih-prava-i- dostojanstva-ljudskog-bica-u-
p.000039: pogledu-primjene-biologije-i- medicine-u-vezi-presadivanja- organa-i-tkiva-ljudskog- porijekla/243337/zakoni.aspx
p.000039:
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p.000039:
p.000039:
p.000039: Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for
p.000039: Collection, Retrieval, Testing, Processing, Preservation, Storage, and Allocation of Human Tissues and Cells (2013):
p.000039: http://www.propisi.hr/print.php?id=9 354
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Ordinance on the Conditions of Space, Professional Workers, Medical-Technical Equipment and Quality Assurance for
p.000039: Collection, Retrieval, Testing, Processing, Preservation, Storage and Allocation of Human Tissues and Cells (2013):
p.000039: http://www.propisi.hr/print.php?id=9 354
p.000039: General (2018): http://azop.hr/info- servis/detaljnije/smjernice
p.000039:
p.000040: 40
p.000040:
p.000040: Country Key Organizations Legislation
p.000040: Regulations Guidelines
p.000040:
p.000040: Embryos, Stem Cells, and Cloning
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Cyprus
p.000040: General
p.000040:
p.000040:
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p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Drugs, Biologics, and Devices
p.000040:
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p.000040:
p.000040: Research Injury
p.000040:
p.000040:
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p.000040:
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p.000040:
p.000040: Privacy/Data Protection
p.000040:
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p.000040:
p.000040:
p.000040:
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p.000040:
p.000040:
p.000040:
p.000040: 1. Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/Moh/phs/phs.nsf/
p.000040: dmlindex_en/dmlindex_en?opendocument
p.000040: 2. Ministry of Health, National Bioethics Committee: http://www.bioethics.gov.cy/moh/cnbc/cn
p.000040: bc.nsf/index_en/index_en?OpenDocumen t
p.000040: Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/moh/moh.nsf/ind ex_en/index_en?OpenDocument
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Commissioner's Office for the Protection of Personal Data: http://www.dataprotection.gov.cy/dataprot
p.000040: ection/dataprotection.nsf/index_en/index_ en?opendocument
p.000040: 2. Medical Fertilization Act, Article 32: (2012): http://www.hzzo- net.hr/dload/zakoni/20_01.pdf
p.000040: 3. Law on the Implementation of Human Tissues and Cells (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1
p.000040: 2_144_3070.html
p.000040:
p.000040: 1. Law No. 31 (III)/2001:
p.000040: Oviedo Convention on Human Rights and Biomedicine
p.000040: 2. The Safeguarding and Protection of Patients’ Rights Law (2004): http://www.bioethics.gov.cy/Moh/c
p.000040: nbc/cnbc.nsf/All/745717D26F0685 82C2257CCA003B350F/$file/Patie nts%20Rights%20Law- English%20translation.pdf
p.000040: Law for Good Clinical Practice (2004):
p.000040: http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C
p.000040: F%84%CE%BF%CF%85%202004.
p.000040: pdf?OpenElement
p.000040:
p.000040: Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8):
p.000040: http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C
p.000040: F%84%CE%BF%CF%85%202004.
p.000040: pdf?OpenElement
p.000040: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000040: 2. Protection of Natural Persons Against the Processing of Personal Data and the Free
p.000041: 41
p.000041:
p.000041: Country Key Organizations Legislation
p.000041: Regulations Guidelines
p.000041:
p.000041: Privacy/Data Protection
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Embryos, Stem Cells, and Cloning
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Czech Republic
p.000041: General
p.000041:
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p.000041: Drugs, Biologics, and Devices
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p.000041:
p.000041:
p.000041: Ministry of Health, Central Ethics Committee: http://www.mzcr.cz
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Drugs
p.000041: 1. Ministry of Health (MOH):
p.000041: http://www.mzcr.cz
p.000041: 2. State Institute for Drug Control (SUKL): http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Devices
p.000041: State Institute for Drug Control (SUKL):
p.000041: http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Circulation of such Data Act of 2018 (Law 125 (I)):
p.000041: http://www.dataprotection.gov.cy/d ataprotection/dataprotection.nsf/all/ DE97F6F59835A03AC22582DD00
p.000041: 3D895E/$file/%CE%9D%CF%8C
p.000041: %CE%BC%CE%BF%CF%82%201
p.000041: 25(%CE%99)_2018.pdf?openeleme nt
p.000041: Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000041: the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2002)
p.000041:
p.000041: 1. Oviedo Convention on Human Rights and Biomedicine (2001)
p.000041: 2. Act No. 130/2002 Collection on Research and Development Support, as Amended (2018)
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p.000042:
p.000042:
p.000042: MOH:
p.000042: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical- devices?highlightWords=501%2F200 0
p.000042:
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p.000042:
p.000042:
p.000042: SUKL:
p.000042: Various:
p.000042: http://www.sukl.cz/medicinal-products- clinical-trials-guidelines-1
p.000042:
p.000042:
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical-devices-guidelines
p.000042:
p.000042: Country Key Organizations Legislation
p.000042: Regulations Guidelines
p.000042: Medical Devices
p.000042: Research Injury 1. Convention on Human
p.000042: Rights
p.000042: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000042: 164 (2001)
p.000042: 2. Law No. 89/2012 Coll. Civil Code: http://www.czechlegislation.com/en
p.000042: /89-2012-sb
p.000042:
p.000042: Privacy/Data Protection
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Embryos, Stem Cells, and Cloning
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Denmark
p.000042: General
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Drugs, Biologics, and Devices
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Research Injury
p.000042: Office for Personal Data Protection:
p.000042: https://www.uoou.cz/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: 1. Ministry of Education, Youth, and Sport: http://www.msmt.cz/index.php?lchan=1& lred=1
p.000042: 2. Research and Development Council, Bioethical Commission: http://www.vyzkum.cz/FrontClanek.aspx? idsekce=15908
p.000042:
p.000042: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Danish Medicines Agency:
p.000042: https://laegemiddelstyrelsen.dk/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Patient Compensation Association:
p.000042: http://pebl.dk/en.aspx
p.000042: 1. Act No. 110/2019 Coll., On Personal Data Processing: https://www.uoou.cz/en/assets/File.
p.000042: ashx?id_org=200156&id_dokument y=1837
p.000042: 2. General Data Protection Regulation (2018): https://gdpr-info.eu/
p.000042: Act of 26 April 2006 on Research on Human Embryonic Stem Cells No. 227/2006 Sb. (Coll.), as amended (2017)
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For
p.000042: ms/R0710.aspx?id=192671
p.000042: 2013 version (English): http://www.nvk.dk/english/act-on- research
p.000042: Act No. 620 on Clinical trials on Medical Products No. 620 (2016):
p.000042: https://www.retsinformation.dk/For ms/r0710.aspx?id=180117
p.000042:
p.000042:
p.000042: 1. Liability for Damages Act (2007): https://protect2.fireeye.com/url?k=8 312f002-df47f9d2-8312c13d-
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p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Executive Order No. 1464 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects
p.000043: (2018) (Danish): https://www.retsinformation.dk/Form s/R0710.aspx?id=201254
p.000043:
p.000043: Executive Order No. 295 on Clinical Trials of Medicinal Products on Humans (2006): https://www.retsinformation.dk/Form
p.000043: s/R0710.aspx?id=9891
p.000043: 1. General (2018): https://www.uoou.cz/gdpr-strucne/ds- 4843/p1=4843
p.000043: 2. International Data Transfer (2018):
p.000043: https://www.uoou.cz/en/vismo/zobraz_dok.asp
p.000043: ?id_org=200156&id_ktg=1165&p1=1165
p.000043:
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p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Guidelines about Notification (Checklist) (2017):
p.000043: http://www.nvk.dk/forsker/forskervejledning
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Guidelines for Applications for Authorisation of Clinical Trials of Medical Products in Humans (2017):
p.000043: https://laegemiddelstyrelsen.dk/en/licensing/cli nical-trials/trials-in-humans/guideline-for-
p.000043: applications-for-authorisation-of-clinical-trials- of-medicinal-products-in-humans/
p.000043:
p.000043: Country Key Organizations Legislation
p.000043: Regulations Guidelines
p.000043:
p.000043: Research Injury
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Privacy/Data Protection
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Human Biological Materials
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Genetic Research
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Embryos, Stem Cells, and Cloning
p.000043:
p.000043:
p.000043: Estonia
p.000043: General
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Danish Data Protection Agency (DPA):
p.000043: https://www.datatilsynet.dk/english/
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Danish Council of Ethics:
p.000043: http://www.etiskraad.dk/english
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Estonian Council on Bioethics:
p.000043: http://www.eetikakeskus.ut.ee/en
p.000043: 0cc47a6a52de- 8126763cf8cbd825&u=https://www
p.000043: .retsinformation.dk/forms/R0710.as px?id=202098
p.000043: 2. Act No. 1022 on the Right to Complain and Receive Compensation within the Health Service (2017):
p.000043: https://www.retsinformation.dk/For ms/R0710.aspx?id=192623
p.000043: 1. Act No. 429 on Processing of Personal Data (2007): https://www.datatilsynet.dk/med ia/6894/danish-data-protection-
p.000043: act.pdf
p.000043: 2. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000043: 1. Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For
p.000043: ms/R0710.aspx?id=192671
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p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Executive Order No. 902 on Medically Assisted Procreation (2019):
p.000044: https://www.retsinformation.dk/Form s/R0710.aspx?id=210080
p.000044:
p.000044:
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p.000044:
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p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Guidelines on the Use of Biological Material in Health Research Projects (2017):
p.000044: http://www.nvk.dk/emner/biobanker/vejledning
p.000044: -om-bio-mat
p.000044:
p.000044:
p.000044:
p.000044: Guidelines on Health Research Projects Involving Genome Research (2018): http://www.nvk.dk/emner/genomer/vejledning-
p.000044: om-genomer
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Code of Ethics of Estonian Scientists: http://www.akadeemia.ee/_repository/File/AL USDOKUD/Code-ethics.pdf
p.000044:
p.000044: Country Key Organizations Legislation
p.000044: Regulations Guidelines
p.000044:
p.000044: General
p.000044:
p.000044: Drugs, Biologics, and Devices
p.000044:
p.000044:
p.000044:
p.000044:
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p.000044:
p.000044: Research Injury
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Privacy/Data Protection
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Genetic Research
p.000044:
p.000044:
p.000044: Embryos, Stem Cells, and Cloning
p.000044:
p.000044:
p.000044: Drugs:
p.000044: 1. State Agency of Medicines: http://www.sam.ee/en/clinical-trials- medicinal-products-estonia
p.000044: 2. Minister of Social Affairs (MSA):
p.000044: https://www.sm.ee/en
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Devices:
p.000044: Estonian Health Board: http://www.terviseamet.ee/en/medical- devices.html
p.000044:
p.000044: 1. Minister of Social Affairs (MSA):
p.000044: https://www.sm.ee/en
p.000044: 2. Estonian Health Insurance Fund:
p.000044: https://www.haigekassa.ee/en
p.000044:
p.000044:
p.000044:
p.000044: Estonian Data Protection Inspectorate: http://www.aki.ee/en/inspectorate
p.000044: of Estonia, Paragraph 18 (2016): https://www.riigiteataja.ee/en/eli/52 1052015001/consolide
p.000044: Medicinal Products Act, Chapter 5 (2015):
p.000044: https://www.riigiteataja.ee/en/eli/ee/ 525112013005/consolide/current
p.000044:
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p.000044:
p.000044:
p.000044: Medical Devices Act (2004): https://www.riigiteataja.ee/en/eli/ee/ 509012015001/consolide/current
p.000044:
p.000044:
p.000044: Medicinal Products Act, Section 90:
p.000044: https://www.riigiteataja.ee/en/eli/ee/ 525112013005/consolide/current
p.000044:
p.000044:
p.000044:
p.000044: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000044: 2. Personal Data Protection Act (2016): https://www.riigiteataja.ee/en/eli/ee/ 512112013011/consolide/current Human
p.000044: Genes Research Act (RT I 2000, 104, 685) (2014): https://www.riigiteataja.ee/en/eli/ee/ 518062014005/consolide
p.000044: 1. Additional Protocol to the Convention for the Protection of
p.000045: 45
p.000045:
p.000045:
p.000045: MSA:
p.000045: 1. 1 RTL 2005, 22, 298: Rules of
p.000045: Procedure of Medical Ethics Committee for Clinical Trials, a List of Data to be Submitted for Obtaining Approval,
p.000045: Procedure for Adoption of Resolutions and Format of Application for Obtaining Approval (2005):
p.000045: https://www.riigiteataja.ee/en/eli/502 052017001/consolide
p.000045: 2. Conditions and Procedure for Conducting Clinical Trials of Medicinal Products. Regulation No. 23 (2005):
p.000045: https://www.riigiteataja.ee/en/eli/502 052017002/consolide
p.000045: Regulation No 86: 2010 of the Minister of Social Affairs on the Conditions and Procedures for the Clinical
p.000045: Investigation of Medical Devices
p.000045: Conditions and Procedure for Conducting Clinical Trials of Medicinal Products. Regulation No. 23 of the Minister of
p.000045: Social Affairs of (2005): https://www.riigiteataja.ee/en/eli/502 052017002/consolide
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p.000045:
p.000045:
p.000045:
p.000045: 1. Research (2018)
p.000045: 2. International Data Transfer (2018): http://www.aki.ee/en/guidelines/transfer- personal-data-foreign-country
p.000045:
p.000045: Country Key Organizations Legislation
p.000045: Regulations Guidelines
p.000045:
p.000045: Embryos, Stem Cells, and Cloning
p.000045:
p.000045:
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p.000045:
p.000045:
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p.000045:
p.000045:
p.000045:
p.000045: Finland
p.000045: General
p.000045:
p.000045:
p.000045:
p.000045:
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p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Drugs, Biologics, and Devices
p.000045:
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p.000045:
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p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi/en/frontpage
p.000045: 2. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en
p.000045:
p.000045:
p.000045: Drugs
p.000045: 1. Finnish Medicines Agency (FIMEA): https://www.fimea.fi/web/en/frontpage
p.000045: 2. Ministry of Social Affairs and Health (MSAH): http://stm.fi/en/frontpage
p.000045: 3. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Devices
p.000045: National Supervisory Authority for Welfare and Health (VALVIRA): http://www.valvira.fi/en/licensing/medical
p.000045: _devices
p.000045: Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition
p.000045: of Cloning Human Beings (2002) (Estonian): https://www.riigiteataja.ee/akt/7856 9
p.000045: 2. Artificial Insemination and Embryo Protection Act, RT I 1997, 51, 824 (2011): https://www.riigiteataja.ee/en/eli/ee/
...
p.000046: 2. Law on Biobanks, No 688/2012 (Finnish and Swedish): http://www.finlex.fi/fi/laki/ajantasa/ 2012/20120688
p.000046:
p.000046:
p.000046:
p.000046: 1. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015):
p.000047: 47
p.000047: maarays_3_2010_kliininen_laitetutki mus.pdf
p.000047: 2. Various: http://www.valvira.fi/en/licensing/me dical_devices/legislation
p.000047:
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p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Decree on Consent for Biobank No. 643/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130643
p.000047: 2. Decree on information on Biobank No. 649/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130649
p.000047: 3. Government Decree on Medical Use of Human Organs, Tissues, and Cells No. 594/2007
p.000047: 4. Ministry Decree on Medical Use of Human Organs, Tissues, and Cells No. 1302/2007
p.000047:
p.000047:
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p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Pharmaceutical Injuries Insurance: General Terms and Conditions (2017):
p.000047: https://www.laakevahinko.fi/en/potilaille/vaku utusehdot/
p.000047: The Ethical Principles of Research with Human Participants and Ethical Review in the Human Sciences in Finland (2019):
p.000047: https://www.tenk.fi/en/ethical-review-in- finland
p.000047:
p.000047: Country Key Organizations Legislation
p.000047: Regulations Guidelines
p.000047:
p.000047: Genetic Research
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Embryos, Stem Cells, and Cloning
p.000047:
p.000047:
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p.000047: France
p.000047: General
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Drugs, Biologics, and Devices
p.000047: 2. Board for Gene Technology:
p.000047: http://www.geenitekniikanlautakunta.fi/en
p.000047:
p.000047:
p.000047:
p.000047: 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
...
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
p.000047: 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden:
p.000047: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf
p.000047:
p.000047:
p.000047: 1. Law No. 2012-300 of 5
p.000047: March 2012 on Research Involving Human Persons: https://www.legifrance.gouv.fr/affic hTexte.do?cidTexte=JORFTEXT00 p.25441587: 0025441587 p.25441587: 2. Law No. 2011-814 of 7 July 2011 on Bioethics p.25441587: p.25441587: Medications for Human Use, Articles 5111-1 and Subsequent Sections for Drugs and Medical Devices: p.25441587: https://www.legifrance.gouv.fr/affic hCode.do?cidTexte=LEGITEXT00 0006072665 p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: Public Health Code Articles R1121-1 and subsequent sections: http://legifrance.gouv.fr/ p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: Decision on Good Clinical Practices: http://www.legifrance.gouv.fr/affichT exte.do?cidTexte=JORFTEXT00000 0819256 p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: TUKIJA: p.25441587: Report on Stem Cells, Cloning, and Research (2005): http://tukija.fi/documents/1481661/1546647/20 p.25441587: 05cells.pdf/c14b7dd0-11b4-428d-bdae- 539566ade614 p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: CCNE: p.25441587: Various: http://www.ccne- ethique.fr/en/type_publication/avis p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: p.25441587: CCNE: p.25441587: Phase I Trials in Cancer (2002) p.25441587: p.25441587: Access: p.25441587: http://www.ccne- ethique.fr/en/type_publication/avis p.25441587:
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p.000048:
p.000048: Country Key Organizations Legislation
p.000048: Regulations Guidelines
p.000048:
p.000048: Social-Behavioral Research
p.000048:
p.000048:
p.000048:
p.000048: Privacy/Data Protection
p.000048:
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p.000048:
p.000048:
p.000048:
p.000048: Human Biological Materials
p.000048: National Consultative Ethics Committee
p.000048:
p.000048:
p.000048:
p.000048: 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home
p.000048: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
...
p.000049: domaine-de-la-sante-la-cnil-adopte-de- nouvelles-mesures-de-simplification
p.000049: 2. Health Research with Consent (2018): https://www.cnil.fr/fr/declaration/mr-001-
p.000049: recherches-dans-le-domaine-de-la-sante-avec- recueil-du-consentement
p.000049: 3. Health Research without Consent (2018): https://www.cnil.fr/fr/declaration/mr-
p.000049: 003-recherches-dans-le-domaine-de-la-sante- sans-recueil-du-consentement
p.000049: 4. Practical Guide on the Protection of Personal Data: What Framework Applies to Research? (2018):
p.000049: https://www.cnil.fr/sites/default/files/atoms/file s/guide-cnom-cnil.pdf
p.000049:
p.000049: CCNE:
p.000049: 1. Ethical Questions Arising from the Transmission of Scientific Information Concerning Research in Biology and
p.000049: Medicine (1995)
p.000049: 2. Biometrics, Identifying Data and Human Rights (2007)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis CCNE:
p.000049: 1. Umbilical Cord Blood Banks for Autologous Use for Research (2002)
p.000049: 2. Ethical Issues Raised by Collections of Biological Material and Associated Information Data: “Biobanks,”
p.000049: “Biolibraries” (2003)
p.000049:
p.000049: Country Key Organizations Legislation
p.000049: Regulations Guidelines
p.000049:
p.000049: Human Biological Materials
p.000049: Genetic Research
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
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p.000049: Embryos, Stem Cells, and Cloning
p.000049:
p.000049:
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p.000049:
p.000049:
p.000049:
p.000049: Georgia
p.000049: ethique.fr
p.000049:
p.000049:
p.000049: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000049: 2. Biomedicine Agency: https://www.agence- biomedecine.fr/About-us
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000049: 2. Biomedicine Agency: http://www.enseignementsup- recherche.gouv.fr/
p.000049: echCodeArticle.do
p.000049:
p.000049:
p.000049: Civil Code Articles 16-10 to 16-
p.000049: 13:
p.000049: http://www.legifrance.gouv.fr/affich Code.do;jsessionid=D2DE0231944 83D3384DE19DE8959BDDA.tpdjo
p.000049: 17v_3?idSectionTA=LEGISCTA00 0006136513&cidTexte=LEGITEX
p.000049: T000006070721&dateTexte=20131 006
p.000049:
p.000049:
p.000049: Law No. 2013-715 of 6th August 2013: http://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT000
p.000049: 027811435&dateTexte=&categorie Lien=id
p.000049:
p.000049:
p.000049:
p.000049: Article R1131-1 and Subsequent Sections of the Public Health Code: https://www.legifrance.gouv.fr/affich
p.000049: Code.do?idArticle=LEGIARTI00001 8615563&idSectionTA=LEGISCTA0
p.000049: 00006196158&cidTexte=LEGITEXT
p.000049: 000006072665&dateTexte=20191011
p.000049:
p.000049:
p.000049:
p.000049: Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following
p.000049: Sections: http://legifrance.gouv.fr/affichCode.d o?idArticle=LEGIARTI00003023346
p.000049: 9&idSectionTA=LEGISCTA0000061
p.000049: 90409&cidTexte=LEGITEXT000006
p.000049: 072665&dateTexte=20151015
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood (2013)
p.000049: 2. Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing
p.000049: (2016)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Commercialization of Human Stem Cells and Other Cell Lines (2006)
p.000049: 2. Opinion on the Ethical Reflection Concerning Research on Human Embryonic Cells and on Human Embryos in Vitro (2010)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS
p.000049: Countries,” Chapter 3, Section 4:
p.000049: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000049:
p.000049: General
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Drugs, Biologics, and Devices
p.000049: Bioethics and Health Law Studies Society: http://www.patientsrights.ge/index.php?pa ge=385&lang=geo
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs:
p.000049: http://rama.moh.gov.ge/
p.000049: 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001)
p.000049: 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195
p.000049: (2010)
p.000049: 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
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p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
p.000050: http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf
p.000050:
p.000050:
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p.000050:
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p.000050:
p.000050:
p.000050:
p.000050: Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996)
p.000050: including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf
p.000050:
p.000050: Country Key Organizations Legislation
p.000050: Regulations Guidelines
p.000050: Research Injury Convention on Human Rights
p.000050: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000050: 164 (2001)
p.000050:
p.000050: Privacy/Data Protection
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Embryos, Stem Cells, and Cloning
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Germany
p.000050: General
p.000050: Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/weite re-sprachen/english/german-medical-
p.000050: association/
p.000050: 2. Central Ethics Committee of the German Medical Association (ZEKO):
p.000050: http://www.zentrale-ethikkommission.de/
p.000050: 3. Permanent Working Party of Research Ethics Committees in Germany:
p.000050: http://www.ak-med-ethik-komm.de/
p.000050: 4. German Ethics Council:
p.000050: https://www.ethikrat.org/en/
p.000050: 5. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000050: 6. German Research Foundation (DFG), Permanent Senate Commission on Key Questions in Clinical Research (SCCR):
p.000050: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/clinical_research/index.ht
p.000050: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000050: 2. Law on Data Protection (2018): https://matsne.gov.ge/en/document/ view/1561437?publication=15
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p.000052: http://www.gesetze-im- internet.de/eschg/
p.000052:
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p.000052:
p.000052:
p.000052: Opinion on Human Biobanks for Research (2010):
p.000052: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/DER_StnBiob_En gl_Online_mitKennwort.pdf
p.000052: 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf
p.000052: 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-
p.000052: Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf
p.000052: DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production:
p.000052: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_
p.000052: menschlicher_Gewebe.pdf
p.000053: 53
p.000053:
p.000053: Country Key Organizations Legislation
p.000053: Regulations Guidelines
p.000053: 2. Genetic Engineering Act
p.000053:
p.000053: Genetic Research
p.000053:
p.000053:
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p.000053:
p.000053: Embryos, Stem Cells, and Cloning
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Ethics Council:
p.000053: https://www.ethikrat.org/en/
p.000053: (2017):
p.000053: http://www.gesetze-im- internet.de/gentg/
p.000053:
p.000053:
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p.000053:
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p.000053:
p.000053:
p.000053:
p.000053: 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/
p.000053: 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/
p.000053:
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p.000054:
p.000054:
p.000054: Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell
p.000054: Act (2017): http://www.gesetze-im- internet.de/zesv/
p.000054:
p.000054:
p.000054:
p.000054: 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004):
p.000054: http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf
p.000054: 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_
p.000054: gfh_positionspapier.pdf
p.000054: Statements: http://www.dfg.de/en/dfg_profile/statutory_bod ies/senate/genetic_research/publications/index. html
p.000054:
p.000054:
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p.000054:
p.000054:
p.000054:
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p.000054:
p.000054:
p.000054: 1. The Import of Human Embryonic Stem Cells (2001): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stellungnahme_Sta mmzellimport.pdf
p.000054: 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004):
p.000054: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stellungnahme_Klo nen.pdf
p.000054: 3. Should the Stem Cell Law be Amended? (2007): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stn_Stammzellgese tz.pdf
p.000054: 4. Human-Animal Mixtures in Research (2011): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/englisch/opinion-human-
p.000054:
p.000054: Country Key Organizations Legislation
p.000054: Regulations Guidelines
p.000054:
p.000054: Embryos, Stem Cells, and Cloning
p.000054:
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p.000054: Greece
p.000054: General
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p.000054:
p.000054: Central Ethics Committee of the German Medical Association (ZEKO):
p.000054: http://www.zentrale-ethikkommission.de/ German Research Foundation (DFG): http://www.dfg.de/en/
p.000054:
p.000054:
p.000054: Central Ethics Committee for Stem Cell Research (ZES): http://www.rki.de/EN/Content/Institute/C
p.000054: ommittees/StemCell/StemCell_content.ht ml
p.000054:
p.000054: National Bioethics Commission (NBC): http://www.bioethics.gr/
p.000054:
p.000054:
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p.000055: 55
p.000055: animal-mixtures-in-research.pdf
p.000055: 5. Stem Cell Research - New Challenges for the Ban on Cloning and Treatment of Artificially Created Germ Cells? (2014):
p.000055: https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc- Empfehlungen/englisch/recommendation-stem- cell-research.pdf
p.000055: 6. Germline Intervention in the Human Embryo (2017): https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc-
p.000055: Empfehlungen/englisch/recommendation- germline-intervention-in-the-human- embryo.pdf
...
p.000056: Directive 2001/20/EC
p.000056: 2. Ministerial Decision ΔΥΓ 3 α/79602/2007: Harmonization of the Greek Legislation with EU Legislation, according to
p.000056: the Directive 2005/28/EC
p.000056: 1. Ministerial Decision ΔΥΓ3 89292/2003: Harmonization of the Greek Legislation with EU Legislation, According to the
p.000056: Directive 2001/20/EC
p.000056: 2. Ministerial Decision ΔΥΓ 3 α/79602/2007 Harmonization of the Greek Legislation with EU Legislation, According to the
p.000056: Directive 2005/28/EC:
p.000056: http://www.bioethics.gr/images/pdf/EKDOSEI S/OPINIONS_AND_REPORTS_2008-
p.000056: 2013_EN.pdf
p.000056: 4. Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 983-incidental-findings-in-research-and- clinical-practice
p.000056: NBC:
p.000056: 1. Recommendation on Clinical Trials: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_clinical_trials_ en.pdf
p.000056: 2. Control of Non-Invasive Clinical Trials for Drugs (2013): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 532-control-of-non-invasive-clinical-trials-for- drugs
p.000056:
p.000056: Country Key Organizations Legislation
p.000056: Regulations Guidelines
p.000056:
p.000056: Privacy/Data Protection
p.000056:
p.000056:
p.000056: Genetic Research
p.000056:
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p.000056: Embryos, Stem Cells, and Cloning
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: National Bioethics Commission (NBC):
p.000056: http://www.bioethics.gr/index.php?catego ry_id=3
p.000056:
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p.000056:
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p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000056: 2. National Authority for Medically Assisted Reproduction
p.000056: Regulation (2016): https://www.lawspot.gr/nomikes- plirofories/nomothesia/genikos- kanonismos-gia-tin-prostasia-
p.000056: dedomenon?lspt_context=gdpr
p.000056: 1. Greek Constitution 1975/1986/2001, Article 5.5
p.000056: 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000056: 2819/2000 and 2915/2000):
p.000056: http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF
p.000056: 4. Act 3418/2005 Code on Medical Ethics
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction)
p.000056: 3. Act 3305/2005 Application of Medically Assisted
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf
p.000056: 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_genetic_data_e ng.pdf
p.000056: 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf
p.000056: 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 91-direct-to-consumer-dtc-genetic-testing
p.000056: 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/
p.000056: OPINION_Incidental_Findings_FINAL_.pdf
p.000056: 6. Opinion on Advances in Human Genome Editing (2016): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION
p.000056: gene%20editing_Final_EN.pdf NBC:
p.000056: 1. Recommendation on the Use of Stem Cells in Biomedicine and Clinical Medicine
p.000056: 2. Recommendation on Human Reproductive Cloning
p.000056: 3. Opinion on Prenatal and Pre- implantation Diagnosis and Embryo Treatment
p.000057: 57
p.000057:
p.000057: Country Key Organizations Legislation
p.000057: Regulations Guidelines
p.000057:
p.000057: Embryos, Stem Cells, and Cloning
p.000057: Hungary
p.000057: Note: All webpages and documents are in Hungarian.
p.000057: Reproduction
p.000057: Access: http://www.bioethics.gr/index.php/gnomes
p.000057:
p.000057: General
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953
p.000057: 2. Act CLIV of 1997 on Health Care, Chapters VIII and IX: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=30903.339193
p.000057: 3. Act VI. of 2002 on the Promulgation of the Oviedo Convention on Human Rights and Biomedicine:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=64201.264663
...
p.000059: 1. Decree 23/2002. (V. 9.) of the Minister of Health on Biomedical Research on Human Beings
p.000059: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam
p.000059: 2. Government Decree 235/2009. (X.20.) on the Regulations of Giving Permission for Human Medical Experiments, for
p.000059: Clinical Studies of Experimental Medicinal Products and for the Clinical Studies of the Medical Devices:
p.000059: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam
p.000059: 3. Government Decree 27/2015 (II.25.) About the National Health Care Service System:
p.000059: http://njt.hu/cgi_bin/njt_doc.cgi?doci d=174246.343548
p.000059:
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p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Preparing to Apply the Privacy Policy in 12 Steps: Guidance for Data Controllers
p.000059:
p.000059: Country Key Organizations Legislation
p.000059: Regulations Guidelines
p.000059:
p.000059: Privacy/Data Protection
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Human Biological Materials
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Genetic Research
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Embryos, Stem Cells, and Cloning
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Iceland
p.000059: General
p.000059: Information: http://www.naih.hu/general- information.html
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Ministry of Human Capacities (EMMI):
p.000059: http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059: 2. Medical Research Council, Committee for Human Reproduction (HRB): https://ett.aeek.hu/hrb/
p.000059:
p.000059: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/hrb/
p.000059:
p.000059:
p.000059: 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000059: 2. National Bioethics Committee
p.000059: Related Data: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=99700047.TV&celp ara=#xcelparam
p.000059: 2. Act CXII of 2011 on Right of Informational Self- Determination and Freedom of Information:
p.000059: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=A1100112.TV&cel para=#xcelparam
p.000059: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Act LXXX of 2006 on the
p.000059: Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Transplantation
p.000059: of Organs and Tissues of Human Origin: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000059: .cgi?docid=A0600080.TV&celpara
...
p.000061: /acrobat-enskar_sidur/16012012_Act- on-Medical-Devices-No-16-2001-as- amended.pdf
p.000061: 2. Regulation on Active Implantable Medical Devices No. 320/2011: http://www.stjornartidindi.is/Advert.a
p.000061: spx?ID=c50d676c-4651-46c2-83b5- ad946f3deeaa
p.000061: 3. Regulation on In Vitro Diagnostic Medical Devices No. 936/2011: http://stjornartidindi.is/Advert.asp
p.000061: x?ID=f20b3e4e-ab25-44d3-8e32- e5f42a7b02f0
p.000061: Regulation on Clinical Trials of Medicinal Products in Humans No 443/2004 (2010):
p.000061: https://www.government.is/media/vel ferdarraduneyti- media/media/Reglugerdir- enska/Regulation-on-clinical-trials-
p.000061: 2. Informed Consent:
p.000061: http://www.vsn.is/en/content/informed-consent
p.000061: 3. Withdrawal of Consent: http://www.vsn.is/en/content/withdrawal- consent
p.000061: 4. Duty to Report Unexpected Events: http://www.vsn.is/en/content/duty-report- unexpected-events
p.000061: 5. Advertising to Recruit Participants: http://www.vsn.is/en/content/advertising- recruit-participants
p.000061:
p.000061: NBC:
p.000061: Various:
p.000061: http://www.vsn.is/en/content/clinical-trials
p.000061:
p.000061: Country Key Organizations Legislation
p.000061: Regulations Guidelines
p.000061:
p.000061: Research Injury
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Privacy/Data Protection
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Human Biological Materials
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Embryos, Stem Cells, and Cloning
p.000061:
p.000061:
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p.000061:
p.000061:
p.000061: Ireland
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Data Protection Authority: http://www.personuvernd.is/information- in-english/
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000061: 2. National Bioethics Committee (NBC): www.visindasidanefnd.is/en
p.000061: 2. Act on Health Insurance No. 112/2008 (2012): https://www.government.is/media/v elferdarraduneyti-
p.000061: media/media/acrobat- enskar_sidur/Act-on-Health- Insurance-No-112-2008-16.pdf
p.000061: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000061: 2. Act No. 90/2018 on Data Protection and the Processing of Personal Data: https://www.althingi.is/altext/148/s/
p.000061: 1296.html
p.000061: Biobanks Act No. 110/2000 (2015):
p.000061: https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Biobanks-Act-as-
p.000061: amended-2015.pdf
p.000061: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000061: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2004)
p.000061: 2. Act on Artificial Fertilisation and Use of Human Gametes and Embryos for Stem-Cell Research, No. 55/1996 (2010):
...
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: General Principles of Processing Personal Data (2018):
p.000064: https://www.garanteprivacy.it/home/doveri#2
p.000064:
p.000064: Country Key Organizations Legislation
p.000064: Regulations Guidelines
p.000064:
p.000064: Privacy/Data Protection
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Genetic Research
p.000064: g/jsp/index.jsp?solotesto=N
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: 1. Instituto Superiore di Sanita (ISS):
p.000064: http://www.iss.it/chis/?lang=2
p.000064: 2. Italian Society of Human Genetics (SIGU): http://www.sigu.net/
p.000064: 2. Italian Personal Data Protection Code, Legislative Decree No. 196 of June 30, 2003:
p.000064: http://www.garanteprivacy.it/garant e/navig/jsp/index.jsp?folderpath=No rmativa%2FItaliana%2FIl+Codice+
p.000064: in+materia+di+protezione+dei+dati
p.000064: +personali
p.000064: Experimentation (May 25, 2000)
p.000064: 2. Regulation for the Implementation of Articles No. 20 and 21 of the Legislative Decree No. 196 of June 30, 2003
p.000064: 3. Ministerial Decree No. 277 (2007)
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: ISS:
p.000064: Guidelines for Phase I Clinical Trials with Investigational Medicinal Products Employed in Gene Somatic Therapy (2004):
p.000064: http://www.iss.it/binary/publ/publi/0478.11066 53420.pdf
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Embryos, Stem Cells, and Cloning
p.000064:
p.000064:
p.000064: Latvia
p.000064: General
p.000064:
p.000064: Drugs, Biologics, and Devices
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Central Medical Ethics Committee
p.000064:
p.000064: Drugs
p.000064: 1. State Agency of Medicines:
p.000064: http://www.zva.gov.lv/?setlang=en&large
p.000064: 2. Central Medical Ethics Committee
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Regulation of Medically Assisted Reproduction, Law No. 40, Article 13 (2004)
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Law on Pharmacy, Section 26 (2013):
p.000064: https://likumi.lv/ta/en/en/id/43127- pharmaceutical-law
p.000064:
p.000064:
p.000064:
p.000064:
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p.000065: 65
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065: Statutes of Central Medical Ethics Committees (1998): http://likumi.lv/doc.php?id=46597
p.000065:
p.000065: Cabinet Regulation No. 289: Regulations Regarding the Procedures for Conduct of Clinical Trials and Non- interventional
p.000065: Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of
p.000065: Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice:
p.000065: https://likumi.lv/ta/en/en/id/207398- regulations-regarding-the-procedures- for-conduct-of-clinical-trials-and-
p.000065: SIGU:
p.000065: Various:
p.000065: http://www.sigu.net/show/documenti/5/1/linee
p.000065: %20guida
p.000065:
...
p.000065: https://likumi.lv/ta/en/en/id/218764- procedures-for-the-clinical-trial-of- medical-devices-intended-for-human- use
p.000065: Drugs:
p.000065: Cabinet Regulation No. 289: Regulations Regarding the Procedures for Conduct of Clinical Trials and Non- interventional
p.000065: Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of
p.000065: Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice, Sections 22, 31.6,
p.000065: 54.10, 55.9,
p.000065: and 61.14 (2010):
p.000065: https://likumi.lv/ta/en/en/id/207398- regulations-regarding-the-procedures- for-conduct-of-clinical-trials-and-
p.000065: non-interventional-trials-of- medicinal-products-labelling-of- investigational-medicinal-products-
p.000065: and-the-procedures-for-assessment- of-conformity-of-clinical-trial-of- medicinal-products-with-the-
p.000065: requirements-of-good-clinical- practice
p.000065:
p.000065: Devices:
p.000065: Cabinet Regulation No. 891:
p.000065:
p.000066: 66
p.000066:
p.000066: Country Key Organizations Legislation
p.000066: Regulations Guidelines
p.000066:
p.000066: Research Injury
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Privacy/Data Protection
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Human Biological Materials
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Genetic Research
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Embryos, Stem Cells, and Cloning
p.000066:
p.000066:
p.000066: Lithuania
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Data State Inspectorate:
p.000066: http://www.dvi.gov.lv/en/
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Central Medical Ethics Committee
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: 1. Ministry of Health:
p.000066: http://www.vm.gov.lv/en/
p.000066: 2. Data State Inspectorate:
p.000066: http://www.dvi.gov.lv/en/
p.000066: 3. Central Medical Ethics Committee
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: 1. Ministry of Health:
p.000066: http://www.vm.gov.lv/en/
p.000066: 2. Central Medical Ethics Committee
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: 1. Personal Data Processing Law (2014): https://likumi.lv/ta/en/en/id/300099- personal-data-processing-law
p.000066: 2. Law on the Rights of Patients, Section 10 (2013): https://likumi.lv/ta/en/en/id/203008-
p.000066: law-on-the-rights-of-patients
p.000066: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law on the Protection
p.000066: of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine (2008):
p.000066: https://likumi.lv/ta/en/en/id/62843- on-the-protection-of-the-body-of- deceased-human-beings-and-the-
p.000066: use-of-human-tissues-and-organs- in-medicine
...
p.000070: Approval for Clinical Trials on Medicinal Product, and Conducting and Controlling Clinical Trials (2017): https://e-
p.000070: seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.277308/QPLLKpOUKw Decree No. V-6 on the Sample Form of the Request to Issue
p.000070: Favorable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form (2016):
p.000070: https://www.e- tar.lt/portal/lt/legalAct/b65b5ca0c440
p.000070: 11e583a295d9366c7ab3/qcrDrSCSCJ
p.000070:
p.000070: Decree No. V-2 on the Procedure to Issue Approvals to Conduct Biomedical Research (2017): https://www.e-
p.000070: tar.lt/portal/lt/legalAct/TAR.47B2353 93D3A/zpczrvbOOR
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: MOH:
p.000070: Decree No. 745 on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Guidelines to Advertise Clinical Trials, Adopted by the Group of Experts on Biomedical Research of the LBEC (2018):
p.000070: http://bioetika.sam.lt/index.php?3396441505
p.000070:
p.000070: Country Key Organizations Legislation
p.000070: Regulations Guidelines
p.000070:
p.000070: Research Injury
p.000070:
p.000070: Privacy/Data Protection
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Human Biological Materials
p.000070:
p.000070: Embryos, Stem Cells, and Cloning
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Luxembourg
p.000070:
p.000070:
p.000070: State Data Protection Inspectorate:
p.000070: https://www.ada.lt/go.php/eng
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Ministry of Health (MOH):
p.000070: http://www.sam.lt/go.php/lit/IMG
p.000070:
p.000070:
p.000070: Ministry of Health (MOH):
p.000070: http://www.sam.lt/go.php/lit/IMG
p.000070:
p.000070:
p.000070:
p.000070: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000070: 2. Law on Legal Protection of Personal Data (2018): https://www.e- tar.lt/portal/lt/legalAct/TAR.5368B5
p.000070: 92234C/VCRurdZydD
p.000070: Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000070: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000070: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2002):
p.000070: http://www.coe.int/en/web/conventi ons/full-list/-/conventions/treaty/168
p.000070: 2. Law on Ethics of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000070: 3. Changes of Law on Ethics of Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0
p.000070: 5f11e7910a89ac20768b0f
p.000070: (2016): https://www.e- tar.lt/portal/lt/legalAct/c86cf490b3be 11e598c4c7724bda031b/IaIhDiebov
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 1. Decree No. V-660 on the Procedure to Issue Authorization for the Transit of Tissues of Human Embryonic Tissue,
p.000070: Embryonic Stem Cells and their Lines, Fetal Tissue, and Fetal Stem Cells throughout the Territory of the Republic of
p.000070: Lithuania (2007): https://www.e- tar.lt/portal/lt/legalAct/TAR.8A75E7 9827FD
p.000070: 2. Decree No. V-659 on the Procedure for Importing of the Stem Cells Taken from the Umbilical Cord or Placenta after
p.000070: the Birth of a Child and the Samples Taken for Genetic Research into the Territory of the Republic of Lithuania and
p.000070: Exporting Therefrom (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.E2473B1 958CA/gEtbNSRzzc
p.000070:
p.000070: Note: All websites and documents are available in French.
p.000070: General National Ethics Commission:
p.000070: http://www.cne.lu
p.000070:
p.000070: Various: http://www.cne.public.lu/fr/publications/a vis.html
p.000070:
p.000070: Drugs, Biologics, and Devices
p.000070: 1. Ministry of Health:
p.000070: http://www.ms.public.lu and
p.000070: Hospitals Act of 1998 (2010):
p.000070: http://legilux.public.lu/eli/etat/leg/lo
p.000071: 71
p.000071: Grand-Ducal Decree of May 30, 2005 on the Conduct of Clinical
p.000071: CNER:
p.000071: 1. Guidance Regarding Elements to
p.000071:
p.000071: Country Key Organizations Legislation
p.000071: Regulations Guidelines
p.000071:
p.000071: Drugs, Biologics, and Devices
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Privacy/Data Protection
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Genetic Research
p.000071:
p.000071:
p.000071:
p.000071: Macedonia
p.000071: http://www.sante.lu
p.000071: 2. National Research Ethics Committee (CNER): http://www.cner.lu
...
p.000074: http://zdravstvo.gov.mk/zakon-za- zdravstvenata-zashtita/
p.000074: 3. Law on Taking and Transplanting of Human Body Organs (Official Gazette No. 47/2011) and Laws Amending and
p.000074: Supplementing the Law (2011-2016): http://zdravstvo.gov.mk/zakon-za- zemanje-i-presaduvanje-na-delovi-
p.000074: na-chovechkoto-telo-zaradi- lekuvanje/
p.000074: 4. Sub-Law Acts : http://www.fzo.org.mk/default.asp?I temID=6541AC10FFC3C5498F088
p.000075: 75
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Regulations for Transplantation of Tissues and Organs (13 regulations): http://www.fzo.org.mk/default.asp?It
p.000075: emID=6541AC10FFC3C5498F0887 C57131D996
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Regulation on Criteria Relating to Space, Personnel and Equipment for Collection, Transplantation and Exchange of
p.000075: Organs and Tissues, the Necessary Space, Equipment and Staff Required to be Provided by the Health Institution for the
p.000075: Collection, Transfer, Exchange and Storage of Organs and Tissues from Human Body for Treatment Purposes (2012):
p.000075: http://zdravstvo.gov.mk/wp- content/uploads/2012/12/za_pobliskite_kriteriu mi_vo_odnos_na_prostorot_kadarot_i_opremat
p.000075: a_za_zemawe_presaduvawe_i_razmenuvawe_ na_organite_i_tkivata_za_potrebniot_pr.pdf
p.000075:
p.000075: Country Key Organizations Legislation
p.000075: Regulations Guidelines
p.000075: 7C57131D996
p.000075:
p.000075: Genetic Research
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Embryos, Stem Cells, and Cloning
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Malta
p.000075: General
p.000075:
p.000075:
p.000075:
p.000075: Drugs, Biologics, and Devices
p.000075: Ministry of Health of the Republic of Macedonia:
p.000075: http://moh.gov.mk/
p.000075:
p.000075:
p.000075:
p.000075: Ministry of Health of the Republic of Macedonia:
p.000075: http://moh.gov.mk/
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Bioethics Committee: http://health.gov.mt/en/regcounc/Bioethic s- Committee/Pages/CommitteeMembers.as px
p.000075: Drugs
p.000075: Medicines Authority:
p.000075: http://medicinesauthority.gov.mt/
p.000075: Law on Patient Rights Protections, Article 21: Action on Human Genome (2012): http://zdravstvo.gov.mk/wp-
p.000075: content/uploads/2012/12/zakon-za- zastita-na-pravata-na-pacientite- precisten.pdf
p.000075: Law on Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to
p.000075: the Application of Biology and Medicine, With Additional Protocol on the Prohibition of Cloning Human Beings and
p.000075: Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2009):
p.000075: http://www.pravo.org.mk/document Detail.php?id=5543
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: 1. Medicines Act, 2003: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8924&l=1
p.000075: 2. Subsidiary Legislation, 458.43, Clinical Trials Regulations, 2004: http://justiceservices.gov.mt/Downl
p.000075: oadDocument.aspx?app=lom&itemi d=11281&l=1
...
p.000077: n=view&view=doc&lang=1&id=31 1759
p.000077: MOH:
p.000077: 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trial:
p.000077: http://lex.justice.md/md/362783/ 2. Order No.648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of
p.000077: Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000077: %20MS%20nr.%20648.pdf
p.000077: 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trials:
p.000077: http://lex.justice.md/md/362783/ 2. Order No. 648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of
p.000077: Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000077: %20MS%20nr.%20648.pdf
p.000077: Decision of Government No. 1123 Dated 14.12.2010 on the Approval of the Requirements for the Assurance of Personal Data
p.000077: Security at their Processing within the Information Systems of Personal Data: http://www.datepersonale.md/file/hot
p.000077: ariri/cerinte_securitate%20eng_10122 8.pdf
p.000078: 78
p.000078:
p.000078: Country Key Organizations Legislation
p.000078: Regulations Guidelines
p.000078:
p.000078: Privacy/Data Protection
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Human Biological Materials
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Embryos, Stem Cells, and Cloning
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Montenegro Drugs, Biologics, and Devices
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health (MOH):
p.000078: http://www.ms.gov.md/
p.000078: 2. Transplant Agency
p.000078: http://lex.justice.md/md/334622
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health (MOH):
p.000078: http://www.ms.gov.md/
p.000078: 2. National Commission on Biological Security: http://lex.justice.md/index.php?action=vie w&view=doc&lang=1&id=303353
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000078: 2. Agency for Medicines and Medical Devices: https://www.calims.me/Portal/faces/glavn a?_adf.ctrl-state=rsbe35pln_83
p.000078: 4. Law No.133 Dated 08.07.2011 on the Protection of Personal Data: http://lex.justice.md/index.php?actio
p.000078: n=view&view=doc&lang=1&id=34 0495
p.000078: 5. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000078: 6. LP143 Din 19.07.18, MO309-
p.000078: 320/17.08.18 Article 482
p.000078: 1. Law No. 42 Dated 06.03.2008
p.000078: on Transplantation of Organs, Tissues and Human Cells: http://lex.justice.md/index.php?actio
p.000078: n=view&view=doc&lang=1&id=32 7709
p.000078: 2. LP79 Din 24.05.18, MO195-
...
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000079: Montenegro” No. 79/2004, 53/09, and 40/11): https://www.calims.me/Portal/faces/ servlet1?putanja=CG-
p.000079: Zakon%2520o%2520medicinskim
p.000079: %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181
p.000079: 1. Law on Medicines (“Official Gazette of Montenegro”, No. 56/2011 and 06/13): https://www.calims.me/Portal/faces/
p.000079: servlet1?putanja=CG_Zakon_o_ljek ovima.pdf&_afrWindowMode=0&_ afrLoop=3654755254077715&_adf. ctrl-state=13nzchbscd_171
p.000079: 2. Law on Medical Devices (“Official Gazette of Montenegro” No. 79/2004, 53/09, and 40/11):
p.000079: https://www.calims.me/Portal/faces/ servlet1?putanja=CG- Zakon%2520o%2520medicinskim
p.000079: %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181
p.000079: Law on the Protection of Personal Data (Official Gazette of Montenegro No. 79/08, 70/09, 44/12):
p.000079: http://www.azlp.me/docs/zajednicka
p.000079: /zakoni/zakon-o-zastiti-podataka-o- licnosti.pdf
p.000079: Law on the Collection and Use of Biological Samples (Official Gazette of Montenegro No.
p.000079: 14/2010):
p.000079: http://www.mzdravlja.gov.me/Reso urceManager/FileDownload.aspx?ri d=57491&rType=2&file=ZAKON
p.000079: %20O%20UZIMANJU%20I%20K ORI%C5%A0%C4%86ENJU%20B IOLO%C5%A0KIH%20UZORAK
p.000079: A.pdf
p.000079:
p.000080: 80
p.000080:
p.000080: Country Key Organizations Legislation
p.000080: Regulations Guidelines
p.000080:
p.000080: Genetics
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Embryos, Stem Cells, and Cloning
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Netherlands
p.000080: General
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Drugs, Biologics, and Devices
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Clinical Trials Registry
p.000080: Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: 1. Ministry of Health, Welfare, and Sport (VWS): http://www.government.nl/ministries/vws #ref-minvws
p.000080: 2. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000080: 3. Medicines Evaluation Board (MEB): http://english.cbg-meb.nl/
p.000080: 1. Netherlands Trial Register: http://www.trialregister.nl/trialreg/index.a sp
p.000080: 2. Central Committee Register
p.000080: Law on the Protection of Genetic Data (Official Gazette of Montenegro No. 25/2010): http://www.mzdravlja.gov.me/Reso
p.000080: urceManager/FileDownload.aspx?ri d=57566&rType=2&file=ZAKON
p.000080: %20O%20ZA%C5%A0TITI%20G ENETI%C4%8CKIH%20PODATA
p.000080: KA%20.pdf
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: 1. Population Screening Act (1996): http://wetten.overheid.nl/BWBR000 5699/geldigheidsdatum_24-09-2015
p.000080: 2. Medical Research Involving Human Subjects Act (2012)
p.000080:
p.000080: 2006 English version: http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7- 2013-afkomstig-van-vws.pdf
p.000080:
p.000080:
p.000080: Medicines Act (2007): http://wetten.overheid.nl/BWBR002 1505
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
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p.000081:
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p.000081: 2. Concerning Requirements of Expertise of Accredited Review Board Members (2002)
p.000081: 3. Concerning the Organization and Working Method of Accredited Review Board Members (2003)
p.000081: 4. External Review Guideline (2004)
p.000081: 5. Research Contract Review Guideline (2009)
p.000081: VWS:
p.000081: 1. Medicines Act Decree (2007):
p.000081: http://www.ccmo.nl/attachments/files
p.000081: /eng-decree-on-scientific-research- with-medicinal-products.pdf
p.000081: 2. Medicines Act Regulation (2007): http://wetten.overheid.nl/BWBR0022 160
p.000081:
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p.000081:
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p.000081:
p.000081: Various: http://www.ccmo.nl/en/publications-of-the- ccmo
p.000081:
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p.000081:
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p.000081:
p.000081:
p.000081:
p.000081:
p.000081: CCMO:
p.000081: Clinical Research with Medicinal Products in the Netherlands: Instructional Manual (2005):
p.000081: http://www.vumc.nl/afdelingen- themas/1646433/7876770/7876776/7955410/C
p.000081: linical_research_with_medi1.pdf
p.000081:
p.000081: Country Key Organizations Legislation
p.000081: Regulations Guidelines
p.000081:
p.000081: Clinical Trials Registry
p.000081: Research Injury
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Social-Behavioral Research
p.000081:
...
p.000081: 2013-afkomstig-van-vws.pdf
p.000081:
p.000081:
p.000081:
p.000081: Regulation on Mandatory Insurance Regarding Medical Research Involving Human Subjects (2003):
p.000081: https://zoek.officielebekendmakingen
p.000081: .nl/stb-2014-477.html
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
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p.000081: CCMO:
p.000081: 1. General Data Protection Regulation (2018): http://www.ccmo.nl/en/algemene- verordening-gegevensbescherming?5ad0a79c-
p.000081: a970-44d7-8c78-6de7c35ff8ba
p.000081: 2. Adaptations to the Trial Information Form Due to New European Privacy Legislation (2018)
p.000081:
p.000081: FMWV:
p.000081: 1. Code for Adequate Secondary Use of Data (2004): http://www.federa.org/sites/default/files/bijlage
p.000081: n/coreon/code_of_conduct_for_medical_resear ch_1.pdf
p.000081: 2. Explanatory Report Accompanying the Code (2004): http://www.federa.org/sites/default/files/bijlage
p.000081: n/coreon/explanatory_report1.pdf
p.000081: Code for Proper Secondary Use of Human Tissue in the Netherlands (2002):
p.000081: http://www.federa.org/sites/default/files/bijlage n/coreon/codepropersecondaryuseofhumantissu e1_0.pdf
p.000081: IenM, VWS, and CCMO: Guidelines for Researchers and Sponsors with Regard to the Assessment by Official Bodies of
p.000081: Clinical Research Involving Gene Therapeutics in the Netherlands (2012): http://www.ggo-
p.000081: vergunningverlening.nl/dsresource?type=pdf& objectid=rivmp:193539&versionid=&subobjec tname=
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p.000082:
p.000082: Country Key Organizations Legislation
p.000082: Regulations Guidelines
p.000082:
p.000082: Embryos, Stem Cells, and Cloning
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: Norway
p.000082: General
p.000082: Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000082:
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p.000082:
p.000082:
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p.000082: work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/
p.000082:
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p.000082:
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p.000082: work/about-us/the-national-committee- for-research-ethics-in-the-social-sciences- and-the-humanities-nesh/
p.000082:
p.000082:
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p.000082: https://www.etikkom.no/en/our-
p.000082: 1. Foetal Tissue Act (2001) (Dutch): http://wetten.overheid.nl/BWBR001 2983/
p.000082: 2. Embryos Act (2002): http://www.ccmo.nl/attachments/file s/embryos-act.pdf
p.000082:
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p.000082: 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovdata/ lov-20060630-056-eng.pdf
p.000082: 3. Act on Health Care Research (2008): http://www.lovdata.no/cgi-
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p.000084: 1. Act Relating to the Application of Biotechnology in Human Medicine, Etc. (December 5, 2003, No. 100):
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /2008-06-20-
p.000084: 44?q=helseforskningsloven
p.000084: 2. Gene Technology Act:
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /1993-04-02-38?q=genteknologi
p.000084: 3. Act on Health Care Research:
p.000085: 85
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p.000085: Guidelines for Research Ethics on Human Remains:
p.000085: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research--ethics-on- human-remains/
p.000085:
p.000085:
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p.000085:
p.000085:
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p.000085:
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p.000085: 1. Guidelines for Genetic Research in Humans (Norwegian): https://www.etikkom.no/forskningsetiske-
p.000085: retningslinjer/Medisin-og-helse/retningslinjer- for-bruk-av-genetiske-undersokelser-av-
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p.000085: 2. Guidelines for Research Ethics in Science and Technology (2016): https://www.etikkom.no/en/ethical-guidelines-
p.000085: for-research/guidelines-for-research-ethics-in-
p.000085:
p.000085: Country Key Organizations Legislation
p.000085: Regulations Guidelines
p.000085:
p.000085: Genetic Research
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Embryos, Stem Cells, and Cloning
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Poland
p.000085: General
p.000085:
p.000085:
p.000085:
p.000085:
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p.000085:
p.000085:
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p.000085: English/Committee-for-Medical-and- Health-Research/
p.000085: 5. National Committee for Research Ethics in Science and Technology (NENT): https://www.etikkom.no/en/our-
p.000085: work/about-us/the-national-committee- for-research-ethics-in-science-and- technology-nent/
p.000085: 1. Norwegian Directorate of Health: https://www.helsedirektoratet.no/tema/gen teknologi
p.000085: 2. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000085: work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/
p.000085: 3. Regional Committees for Medical Research Ethics (REK): https://www.etikkom.no/en/In-
p.000085: English/Committee-for-Medical-and- Health-Research/
p.000085:
p.000085: 1. Ministry of Health, Bioethics Appeals Commission (MOH) Bioethics Appeals Commission (MOH):
p.000085: https://www.gov.pl/zdrowie/odwolawcza- komisja-bioetyczna
p.000085: 2. Center of Bioethics, Polish Chamber of Physicians and Dentists (NIL): http://www.nil.org.pl/dzialalnosc/orodek-
p.000085: bioetyki
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...
p.000087: LO_III_CAPITULO_I/portaria_57- 2005.pdf
p.000087:
p.000087: Various: http://www.infarmed.pt/portal/page/ portal/INFARMED/LEGISLACAO/ LEGISLACAO_FARMACEUTICA
p.000087: _COMPILADA/TITULO_V/TITU LO_V_CAPITULO_II
p.000087: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000087: 164 (2001)
p.000087: 1. Constitution, Article 35 (1997)
p.000087: 2. Act on the Protection of Personal Data, No. 67/98 (1998): http://www.cnpd.pt/english/bin/legis lation/Law6798EN.HTM
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087: Decree-Law No. 102/2007 of April 2
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Various:
p.000087: http://www.cnecv.gov.pt/cnecv/en/opinions/
p.000087:
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p.000087: Various: http://www.infarmed.pt/portal/page/portal/INF ARMED/DISPOSITIVOS_MEDICOS/NOTAS
p.000087: _INFORMATIVAS
p.000087:
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p.000088: Regulations Guidelines
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088: Genetic Research
p.000088:
p.000088: Embryos, Stem Cells, and Cloning
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Romania
p.000088: General
p.000088:
p.000088:
p.000088: Drugs, Biologics, and Devices
p.000088:
p.000088:
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p.000088:
p.000088:
p.000088:
p.000088: Research Injury
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health: http://www.portugal.gov.pt/en/the- ministries/ministry-of-health.aspx National Council of Ethics
p.000088: for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088:
p.000088:
p.000088: 1. Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088: 2. National Agency for Medicines and Medical Devices: https://www.anm.ro/en/
p.000088: 3. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/
p.000088:
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p.000088:
p.000088:
p.000088:
p.000088:
p.000088: 1. National Agency for Medicines and Medical Devices: http://www.anm.ro/anmdm/en/index.html
p.000088: 2. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/ National
p.000088: Supervisory Authority for Personal Data Processing:
p.000088: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law 12/2005
p.000088:
...
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
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p.000089: 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC-
p.000089: 419999D9B693/0/47CNECV2005.pdf
p.000089: 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D-
p.000089: D70A7E9AD961/0/p048_en.pdf
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: MOH:
p.000089: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
p.000089:
p.000089:
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p.000089:
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p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: The New General Data Protection Regulation (2018):
p.000089:
p.000089: Country Key Organizations Legislation
p.000089: Regulations Guidelines
p.000089:
p.000089: Privacy/Data Protection
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Human Biological Materials
p.000089:
p.000089:
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p.000089: Embryos, Stem Cells, and Cloning
p.000089:
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p.000089:
p.000089:
p.000089: Russia
p.000089: http://www.dataprotection.ro/index.jsp?pa ge=documents&lang=en
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ministry of Health (MOH):
p.000089: http://www.ms.ro/
p.000089: Regard to the Processing of Personal Data and on the Free Movement of Such Data: http://www.dataprotection.ro/servlet
p.000089: /ViewDocument?id=174
p.000089: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law No. 95/2006
p.000089: Regarding the Reform in Health Field. Title
p.000089: VI. Performing of Sampling and Transplant of Organs, Tissues and Human Origin Cells with Therapeutic Purpose:
p.000089: http://www.transplant.ro/Lege/Lege
p.000089: -2006-95.pdf
p.000089:
p.000089: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard
p.000089: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2001)
p.000089: 2. Law No. 301 from 2004 Penal Code – Chapter IV – Crimes and Felonies Regarding Genetic Manipulation:
p.000089: http://www.codpenal.ro/legislatie/do cument/lege-301-din-2004-codul- penal-capitol-4-crime-si-delicte-
p.000089: privind-manipularea-genetica-1260- 63259.html
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Quality and Safety of
...
p.000090: http://www.rg.ru/2013/02/22/etika- dok.html
p.000090: 3. Ministry of Health Order of April 1, 2016 No. 200н "On Approval of the Rules of Good Clinical Practice:”
p.000090: http://acto- russia.org/files/prikaz_200n.docx
p.000090: Standard Form of Protocol for Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment, and
p.000090: Rehabilitation”: http://base.consultant.ru/cons/cgi/online.cgi?req
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p.000090: 2. Ministry of Health Order 435h “On Ethics Committee of the Ministry of Health of the Russian Federation” (July 10,
p.000090: 2015): http://base.consultant.ru/cons/cgi/online.cgi?req
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p.000090: Research Injury
p.000090:
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p.000090:
p.000090:
p.000090:
p.000090: Federal Law #61FZ “On Circulation of Medicines” (2011), Art. 38-44:
p.000090: GOST:
p.000090: Good Clinical Practice. GOST-R 52379-2005 (September 27,
p.000090: 2005):
p.000090: http://acto- russia.org/index.php?option=com_co ntent&task=view&id=17
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p.000091: Regulations Guidelines
p.000091:
p.000091: Research Injury
p.000091:
p.000091: Privacy/Data Protection
p.000091:
p.000091:
p.000091:
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p.000091: Genetic
p.000091:
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p.000091:
p.000091: Embryos, Stem Cells, and Cloning
p.000091:
p.000091:
p.000091:
p.000091: San Marino
p.000091: General
p.000091:
p.000091:
p.000091: Research Injury
p.000091:
p.000091:
p.000091: Serbia
p.000091: Drugs, Biologics, and Devices
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p.000091: Interdepartmental Commission on Genetic-Engineering Activity
p.000091:
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p.000091:
p.000091:
p.000091: San Marino Bioethics Committee (Italian): http://www.sanita.sm/on- line/home/comitato-bioetica/comitato-
p.000091: sammarinese-di-bioetica.html
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p.000091:
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p.000091: 1. Ministry of Health (MOH):
p.000091: http://www.zdravlje.gov.rs/
p.000091: 2. Serbian Drug Agency
p.000091: http://www.alims.gov.rs/eng/
p.000091: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000091: .docx
p.000091: 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information
p.000091: (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/
p.000091: 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal
p.000091: Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:”
p.000091: http://base.garant.ru/10135402/
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p.000091: http://base.garant.ru/184467/
p.000091:
...
p.000091: Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998)
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p.000092:
p.000092:
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p.000092: http://www.zakonprost.ru/content/ba se/part/438157
p.000092:
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p.000092:
p.000092:
p.000092: MOH:
p.000092: Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical
p.000092: Trials, Official Gazette of RS, 64/2011, 91/2013,
p.000092:
p.000092: Country Key Organizations Legislation
p.000092: Regulations Guidelines
p.000092:
p.000092: Drugs, Biologics, and Devices
p.000092: Research Injury
p.000092:
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p.000092: Privacy/Data Protection
p.000092:
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p.000092:
p.000092: Genetics
p.000092:
p.000092:
p.000092:
p.000092:
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p.000092:
p.000092:
p.000092: Embryos, Stem Cells, and Cloning
p.000092:
p.000092:
p.000092:
p.000092: 1. Ministry of Health (MOH):
p.000092: http://www.zdravlje.gov.rs/index.php?
p.000092: 2. Serbian Drug Agency
p.000092: http://www.alims.gov.rs
p.000092:
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p.000092: Commissioner for Information of Public Importance and Personal Data Protection: https://www.poverenik.rs/en/
p.000092:
p.000092:
p.000092: Ministry of Health (MOH):
p.000092: http://www.zdravlje.gov.rs/index.php?
p.000092:
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p.000092: National Health Insurance Fund:
p.000092: http://www.rfzo.rs/
p.000092:
p.000092:
p.000092:
p.000092: Law on Medicines and Medical Devices, Article 72: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic
p.000092: inskim_sredstvima.pdf
p.000092:
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p.000092: Law on the Protection of Personal Data, Official Gazette 87/2018:
p.000092: https://www.paragraf.rs/propisi/zak on-o-zastiti-podataka-o- licnosti.html
p.000092: Law on the Prevention and Diagnosis of Genetically Conditioned Diseases, Genetically Caused Anomalies and Rare
p.000092: Diseases, Official Gazette 8/2015: https://www.paragraf.rs/propisi/zak on_o_prevenciji_i_dijagnostici_gen
p.000092: etickih_bolesti_geneticki_uslovljeni h_anomalija_i_retkih_bolesti.html
p.000092: 1. Law on Organ Transplantation, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do
p.000092: wnload/zakon-o-presadjivanju- ljudskih-organa.pdf
p.000092: 2. Law on Human Cells and Tissues, Official Gazette No. 57/2018: https://www.paragraf.rs/propisi_do
p.000093: 93
p.000093: 60/2016, and 9/2018:
p.000093: https://www.alims.gov.rs/ciril/files/2 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf MOH:
p.000093: 1. Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting
p.000093: Clinical Trials, Official Gazette of RS, 64/2011, 91/2013, 60/2016, and 9/2018: https://www.alims.gov.rs/ciril/files/2
p.000093: 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf
p.000093: 2. Law on Patients' Rights, Article 25 Official Gazette of RS, 45/2013 and 25/2019:
p.000093: https://www.paragraf.rs/propisi/zako n_o_pravima_pacijenata.html
p.000093:
p.000093: Country Key Organizations Legislation
p.000093: Regulations Guidelines
p.000093:
p.000093: Embryos, Stem Cells, and Cloning Slovakia General
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Drugs, Biologics, and Devices
p.000093:
p.000093:
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p.000093: Research Injury
p.000093:
p.000093: Privacy/Data Protection
p.000093:
p.000093:
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p.000093: Human Biological Materials
p.000093:
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p.000093: Embryos, Stem Cells, and Cloning
p.000093:
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p.000093:
p.000093:
p.000093: Slovenia
p.000093:
p.000093:
p.000093:
p.000093: 1. Ministry of Health (Slovak):
p.000093: http://www.health.gov.sk/
p.000093: 2. Institute of Medical Ethics and Bioethics:
p.000093: http://www.bioethics.sk/
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: State Institute for Drug Control:
p.000093: http://www.sukl.sk/en
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Office for Personal Data Protection:
p.000093: https://dataprotection.gov.sk/uoou/en
p.000093: wnload/zakon-o-ljudskim-celijama- i-tkivima.pdf
p.000093:
p.000093: 1. Oviedo Convention on Human Rights and Biomedicine (1998)
p.000093: 2. Additional Protocol on Biomedical Research (2005)
p.000093: 3. Act No. 576/2004 Coll on Health Care, As Amended by Acts No. 350/2005, 282/2006, 662/2007, 345/2009 Coll.
p.000093: 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
p.000093: Coll.
p.000093:
p.000093: Law 277/1994 on Health Care, Section 44
p.000093: 1. Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll.
p.000093: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000093: 1. Act No. 576/2004 Coll. on Health Care, Sections 35-39.
p.000093: 2. Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b).
...
p.000095: 1. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Transplantation of Organs and
p.000095: Tissues of Human Origin (2006)
p.000095: 2. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No.
p.000095: 61/2007: http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297
p.000095: 3. Rules on Donation and Procurement of Human Tissues
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p.000096: 1. Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014:
p.000096: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV6611
p.000096: 2. Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012: http://www.pisrs.si/Pis.web/pregledP
p.000096: redpisa?id=PRAV9508
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p.000096: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000096: 2. On Interventions into the Human Corpse Which are Not Part of the Routine Autopsy and on Handling with Biologic
p.000096: Material of Human Origin (2004):
p.000096: http://bswww.mf.uni- lj.si/pls/bs/BS_full_rec?lang=SLO&c_docid=1 05859
p.000096:
p.000096: Country Key Organizations Legislation
p.000096: Regulations Guidelines
p.000096:
p.000096: Human Biological Materials
p.000096:
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p.000096: Genetic
p.000096:
p.000096:
p.000096:
p.000096: Embryos, Stem Cells, and Cloning
p.000096: 5. Institute Service of Slovenia for Transfusion Medicine: http://www.ztm.si/en/
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000096:
p.000096:
p.000096: 1. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000096: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000096: and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014
p.000096: 4. Act Regulating the Collection and Transplantation of Human Body Parts for the Purposes of Medical Treatment,
p.000096: Official Gazette No. 56/2015: http://www.uradni- list.si/1/objava.jsp?sop=2015-01- 2357
p.000096: Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes
p.000096: (2009)
p.000096: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000096: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000096: 2. Infertility Treatment and Procedures of Biomedically- Assisted Procreation Act, Official Gazette No. 70/2000,
p.000096: Section 9 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2000-01- 3307
p.000096: 3. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No.
p.000096: 61/2007 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297
p.000096: 4. Rules on Donation and Procurement of Human Tissues and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014
p.000096:
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p.000099: Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V: http://www.catedraderechoygenoma
p.000099: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: 1. Royal Decree 65/2006 of Requirements for the Import and Export of Biological Samples:
p.000099: http://www.boe.es/boe/dias/2006/02/ 07/pdfs/A04626-04636.pdf
p.000099: 2. Royal Decree 1723/2012 Regarding Activities of Collection, Clinical Use and Territorial Coordination of Human Organs
p.000099: for Transplants and Establishing Their Quality and Safety Requirements: http://noticias.juridicas.com/base_da
p.000099: tos/Admin/rd1716-2011.html
p.000099: 3. Royal Decree 1716/2011 on Biobanks: http://www.comitedebioetica.es/nor mativa/docs/RD%201716_2011_de
p.000099: %20autorizacion%20y%20funciona miento%20de%20los%20biobancos. pdf
p.000099: 4. Royal Decree 9/2014 on Quality and Security Rules Regarding Donating, Gathering, Evaluation, Processing, Storage,
p.000099: Preservation, and Distribution of Human Cells and Tissues and Rules Regarding Coordination and Functioning of their Use
p.000099: in Human Beings: http://www.boe.es/buscar/doc.php?id
p.000099: =BOE-A-2014-7065
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p.000100: Regulations Guidelines
p.000100:
p.000100: Embryos, Stem Cells, and Cloning
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p.000100: Sweden
p.000100: 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000100: 2. National Commission for the Donation and Use of Embryos, Cells, and Human Tissues for Biomedical Research:
p.000100: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml
p.000100: 3. National Biobank Register: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml
p.000100: 4. National Stem Cell Bank: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/fd-organizacion/fd-
p.000100: estructura-directiva/fd-subdireccion- general-investigacion-terapia-celular- medicina-regenerativa/fd-centros-
p.000100: unidades/banco-nacional-lineas- celulares.shtml
p.000100: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000100: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2000)
p.000100: 2. Law 14/2006 on Methods of Assisted Human Reproduction, Chapters IV and V
p.000100: 3. Law 14/2007 of July 3 on Biomedical Research, Title III: http://www.catedraderechoygenoma
p.000100: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000100: Royal Decree 1527/2010 By Which the Guarantees Commission for the Donation and Use of Human Cells and Tissues and
p.000100: Registration Research Projects is Regulated: http://www.boe.es/diario_boe/txt.ph p?id=BOE-A-2010-18654
p.000100: For an overview of human subject protections in Sweden, see CODEX: Rules and Guidelines for Research:
p.000100: http://www.codex.uu.se/en/index.shtml
p.000100:
p.000100: General
...
p.000101: x?url=/rnp/sls/lag/20130794.htm
p.000101: 4. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000101: 5. Act (2018:218) Complement to the GDPR: https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk-
p.000101: forfattningssamling/lag-2018218-
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p.000102:
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p.000102:
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p.000102:
p.000102: SFS 2009:641 - Public Access to Information and Secrecy Ordinance: http://www.notisum.se/rnp/sls/lag/20 090641.htm
p.000102: Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2017):
p.000102: https://www.vr.se/english/analysis-and- assignments/we-analyse-and-evaluate/all-
p.000102: publications/publications/2017-08-31-good- research-practice.html
p.000102: 1. General Data Protection Regulation (2018): https://www.datainspektionen.se/lagar-
p.000102: -regler/dataskyddsforordningen/
p.000102: 2. Transmission to Third Countries (2018): https://www.datainspektionen.se/lagar--
p.000102: regler/dataskyddsforordningen/tredjelandsoverf oring/
p.000102:
p.000102: Country Key Organizations Legislation
p.000102: Regulations Guidelines
p.000102:
p.000102: Privacy/Data Protection
p.000102: Human Biological Materials
p.000102:
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p.000102:
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p.000102: Genetic Research
p.000102:
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p.000102: Embryos, Stem Cells, and Cloning
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p.000102:
p.000102: Switzerland
p.000102:
p.000102: 1. Health and Social Care Inspectorate (IVO):
p.000102: https://www.ivo.se/om-ivo/other- languages/english/
p.000102: 2. Biobank Sweden:
p.000102: http://biobanksverige.se/
p.000102:
p.000102:
p.000102:
p.000102: 1. Medical Products Agency:
p.000102: https://lakemedelsverket.se/english/
p.000102: 2. The Swedish Gene Technology Advisory Board (SGTAB): https://www.genteknik.se/
p.000102:
p.000102:
p.000102:
p.000102: National Board of Health and Welfare (SOS):
p.000102: http://www.socialstyrelsen.se/english
p.000102: med-kompletterande- bestammelser_sfs-2018-218
p.000102: 1. Biobanks in Medical Care Act No. 297 (2002): https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk-
p.000102: forfattningssamling/lag-2002297- om-biobanker-i-halso--och_sfs- 2002-297
p.000102: 2. Regulation No. 746 (2002): http://www.notisum.se/rnp/sls/lag/2 0020746.htm
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
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p.000102:
p.000102: Drug Administration Regulations and Guidelines (LVFS 2004:10) on the Intentional Release of Clinical Trials of
p.000102: Medicinal Products Containing or Consisting of Genetically Modified Organisms: http://www.lakemedelsverket.se/upl
p.000102: oad/lvfs/LVFS_2004-10.pdf
p.000102: 1. Legal Regulation of Stem Cell Research 2002:119: http://www.regeringen.se/sb/d/108/a/ 2717
...
p.000106: compilation/20121176/index.html
p.000106: 1. Ordinance of 14 February 2007 on Human Genetic Testing, RS 810.122.1: http://www.admin.ch/opc/fr/classifie
p.000106: d-compilation/20051790/index.html
p.000106: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000106: HRO), RS 810.301 Articles 5 - 8, 10, 15, 21, 24-30, 33-34, 37 - 39, 41, 44-45 and Annex 2):
p.000106: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000106: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000106: Articles 7, 9, 12, 16 - 18 and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html
p.000106: 1. Ordinance of 14 February 2007 on Human Genetic Testing, RS 810.122.1 (French): http://www.admin.ch/opc/fr/classifie
p.000106: d-compilation/20051790/index.html
p.000106: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000106: HRO), RS 810.301, Articles 28 - 32: http://www.admin.ch/opc/en/classifi
p.000106:
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p.000106:
p.000106:
p.000106: SAMS:
p.000106: Biobanks: Obtainment, Preservation and Utilization of Human Biological Material (2006):
p.000106: http://www.samw.ch/en/Ethics/Guidelines/Arch ive.html
p.000106:
p.000106: Country Key Organizations Legislation
p.000106: Regulations Guidelines
p.000106:
p.000106: Genetic Research
p.000106:
p.000106:
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p.000106: Embryos, Stem Cells, and Cloning
p.000106:
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p.000106:
p.000106: Ukraine
p.000106: General
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Drugs, Biologics, and Devices
p.000106:
p.000106:
p.000106:
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p.000106:
p.000106:
p.000106:
p.000106:
p.000106: Swiss National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/
p.000106:
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p.000106: Ukrainian Ministry of Health:
p.000106: http://www.moz.gov.ua/en/
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: 1. Ministry of Health of Ukraine State Expert Center: http://www.dec.gov.ua
p.000106: 2. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index-
p.000106: 3. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles
p.000106: 3, 32 - 35, 42, and 49: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html Embryos in Vivo:
p.000106: Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30 Articles 2, 25
p.000106: - 27, 39, 40, 44,
p.000106: and 62: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000106:
p.000106: Others:
p.000106: Federal Act of 19 December 2003 on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA), RS 810.31:
p.000106: http://www.admin.ch/opc/en/classifi ed- compilation/20022165/index.html
p.000106:
p.000106:
p.000106:
p.000106:
p.000106: 1. Constitution of Ukraine Art. 28 (1996)
p.000106: 2. Health Care Law, Article 45 (1992)
p.000106: 3. Criminal Code of Ukraine 2001, Article 141 and 142
p.000106: 1. Ministry of Health Act On Procedure of Clinical Trials and Basic Statute of Ethics Commission 23.09/2009 No. 690
p.000106: (2014): http://zakon5.rada.gov.ua/laws/sho
p.000107: 107
p.000107: ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305
p.000107: Articles 22 and 35, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html
p.000107: 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS
p.000107: 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html
p.000107: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000107: HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000107: Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi
p.000107: ed-compilation/20121176/index.html
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines
p.000107: (2009): http://zakon5.rada.gov.ua/rada/show/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: NEK-CNE:
p.000107: 1. Pre-Implantation Genetic Diagnosis, 2007/9:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf
p.000107: 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006: http://www.nek-cne.ch/fileadmin/nek-cne-
p.000107: dateien/Themen/Stellungnahmen/en/embryonen
p.000107: _en.pdf
p.000107: 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/PID_II_d.pdf
p.000107:
p.000107: Access:
p.000107: http://www.nek-cne.ch/en/topics/opinions/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
...
p.000107: Human Tissues and Cells: http://zakon3.rada.gov.ua/laws/sho w/z1124-12
p.000107: v0095282-09
p.000107: 2. Ministry of Health Act 14.12.2009 N 944 on Approval of the Clinical Trial and Expertise of Clinical Trials:
p.000107: http://zakon4.rada.gov.ua/laws/show
p.000107: /z0053-10
p.000107:
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p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of
p.000107: Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007) with Changes from 23.09.2009
p.000107: No. 690:
p.000107: http://zakon1.rada.gov.ua/laws/show
p.000107: /z1206-07
p.000107: 3. Methodological Aspects of Central EC Activity of Ukrainian Ministry of Health (2007)
p.000107: 4. Ethical Aspects of Placebo Controlled Clinical Trials in Patients with MS (2008)
p.000107: 5. Optimization of Local Ethics Committee Activities (2009)
p.000107:
p.000107: Ministry of Health:
p.000107: Guidelines for Pre-Clinical and Clinical Trials: http://www.dec.gov.ua/index.php/ekspertiza-
p.000107: materialiv-doklinichnikh-ta-klinichnikh- viprobuvan/metodichni-rekomendatsiji- shchodo-provedennya-doklinichnikh-ta-
p.000107: klinichnikh-viprobuvan
p.000107:
p.000108: 108
p.000108:
p.000108: Country Key Organizations Legislation
p.000108: Regulations Guidelines
p.000108:
p.000108: Embryos, Stem Cells, and Cloning
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: United Kingdom
p.000108: 1. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index- en/bioethics-committee
p.000108: 2. Ukrainian Ministry of Health:
p.000108: http://www.moz.gov.ua/en/
p.000108: 1. Act on the Banning
p.000108: of Human Reproductive Clonin g (2004):
p.000108: http://zakon0.rada.gov.ua/laws/sho w/2231-15
p.000108: 2. Act on the Transplantation on Human Using Anatomic Materials (2019): http://zakon.rada.gov.ua/laws/show/ 2427-19
p.000108: 1. Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of
p.000108: Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007):
p.000108: http://zakon1.rada.gov.ua/laws/show
p.000108: /z1206-07
p.000108: 2. Ukrainian Ministry of Health Order No. 787 on Approval of the Use of Reproductive Technologies in Ukraine
p.000108: 09.09.2013: http://zakon4.rada.gov.ua/laws/show
p.000108: /z1697-13
p.000108: Unless otherwise noted, all laws, regulations, and guidelines listed for England also apply to the entire United
p.000108: Kingdom.
p.000108: For an overview of clinical research regulations in the United Kingdom, see the ClinRegs report:
p.000108: http://clinregs.niaid.nih.gov/single_country.php?c_id=226
p.000108: General England:
p.000108:
p.000108: Health Research Authority (HRA):
p.000108: http://www.hra.nhs.uk/
p.000108:
p.000108:
p.000108:
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p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Department of Health and Social Care (DHSC):
...
p.000113: Regulations 2006 (Different provisions apply to England, Wales, Northern Ireland, and/or Scotland.):
p.000113: http://www.legislation.gov.uk/uksi/ 2006/1659/contents/made
p.000113:
p.000113:
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114: Using Information About People in Health Research (2017): https://mrc.ukri.org/documents/pdf/using-
p.000114: information-about-people-in-health-research- 2017/
p.000114:
p.000114: 1. Research Data and Tissue Resources: https://www.hra.nhs.uk/planning-and-
p.000114: improving-research/research-planning/research- data-and-tissue-resources/
p.000114: 2. Section 251 and the Confidentiality Advisory Group (CAG): http://www.hra.nhs.uk/about-the-hra/our-
p.000114: committees/section-251/
p.000114:
p.000114: Guidance for Professionals:
p.000114: https://www.hta.gov.uk/guidance-professionals
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Human Tissue and Biological Samples for Use in Research (2014): https://mrc.ukri.org/publications/browse/human
p.000114: -tissue-and-biological-samples-for-use-in- research/
p.000114:
p.000114: Country Key Organizations Legislation
p.000114: Regulations Guidelines
p.000114:
p.000114: Human Biological Materials
p.000114:
p.000114:
p.000114: Genetics Research
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Embryos, Stem Cells, and Cloning
p.000114: Scotland:
p.000114: Healthcare Improvement Scotland: http://www.healthcareimprovementscotlan d.org/our_work/governance_and_assuranc
p.000114: e/human_tissue_banks.aspx
p.000114: 1. Public Health Genetics Foundation:
p.000114: http://www.phgfoundation.org/
p.000114: 2. Gene Therapy Advisory Committee: http://www.hra.nhs.uk/resources/applying- to-recs/gene-therapy-advisory-committee-
p.000114: gtac/
p.000114: 3. Genomics England:
p.000114: https://www.genomicsengland.co.uk/
p.000114: 1. Human Fertilisation and Embryology Authority: http://www.hfea.gov.uk/
p.000114: 2. Human Tissue Authority (HTA):
p.000114: https://www.hta.gov.uk/regulated-sectors
p.000114:
p.000114: Human Tissue (Scotland) Act 2006:
p.000114: http://www.legislation.gov.uk/asp/2 006/4/contents
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 1. Human Fertilisation and Embryology Act (1990): http://www.legislation.gov.uk/ukpg a/1990/37/contents
p.000114: 2. HFE Act (2008):
p.000114: http://www.legislation.gov.uk/ukpg a/2008/22/contents
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Human Fertilisation and Embryology Regulation and Chronology: https://www.hfea.gov.uk/about- us/how-we-regulate/
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: HFEA Code of Practice 9th Edition (2018):
p.000114: https://www.hfea.gov.uk/media/2609/june- 2018-code-of-practice-9th-edition-draft.pdf
p.000114:
p.000114:
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p.000117: 5.11.1, 8.2.5 , 8.2.7 (2018):
p.000117: https://www.tga.gov.au/publication/note- guidance-good-clinical-practice
p.000117:
p.000117: Medicines Australia:
p.000117: Industry Standard Compensation Guidelines (2012): https://medicinesaustralia.com.au/policy/clinica
p.000117: l-trials/indemity-and-compensation-guidelines/
p.000117:
p.000117: NHMRC, ARC, and UA:
p.000117: National Statement on Ethical Conduct in Human Research. Paragraphs 5.1.38 and 5.1.39 (2018):
p.000117: https://www.nhmrc.gov.au/about- us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018
p.000117: National Statement on Ethical Conduct in Human Research, Chapter 3.1 (2019): https://www.nhmrc.gov.au/about-
p.000117: us/publications/national-statement-ethical- conduct-human-research-2007-updated- 2018
p.000117: 1. Australian Privacy Principles Guidelines (2019): https://www.oaic.gov.au/privacy/australian-
p.000117: privacy-principles-guidelines/
p.000117: 2. Guidelines under Section 95 of the
p.000117:
p.000117: Country Key Organizations Legislation
p.000117: Regulations Guidelines
p.000117:
p.000117: have privacy/data protection laws: https://www.oaic.gov.a u/privacy/privacy-in- your-state/
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: Human Biological Materials
p.000117:
p.000117: Note: All Australian states and territories also have laws on human biological materials.
p.000117:
p.000117:
p.000117:
p.000117: Genetic Research
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: Embryos, Stem Cells, and Cloning
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. Therapeutic Goods Administration (TGA):
p.000117: http://www.tga.gov.au/
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. Office of the Gene Technology Regulator: http://www.ogtr.gov.au/
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. National Health and Medical Research Council: Embryo Research Licensing Committee:
p.000117: https://nhmrc.gov.au/embryo-research-
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
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p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: Gene Technology Act 2000 (2016):
p.000117: https://www.legislation.gov.au/Deta ils/C2016C00792
p.000117:
p.000117:
p.000117: 1. Prohibition of Human Cloning for Reproduction Act 2002 (2017): https://www.legislation.gov.au/Deta ils/C2017C00306
p.000117: 2. Research Involving Human Embryos Act 2002 (2016):
p.000118: 118
p.000118: the Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under- section-95-privacy-act-1988
p.000118: 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2015): https://nhmrc.gov.au/about-
...
p.000118: https://www.legislation.gov.au/Detail s/F2016C00615
p.000118:
p.000118:
p.000118: Research Involving Human Embryos Regulations (2017): https://www.legislation.gov.au/Detail s/F2017L01213
p.000118: Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under-section-95- privacy-act-1988
p.000118: 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2019): https://nhmrc.gov.au/about-
p.000118: us/publications/guidelines-approved-under- section-95a-privacy-act-1988
p.000118: 4. Guidelines Approved under Section 95AA of the Privacy Act 1988 (2014): https://www.nhmrc.gov.au/about-
p.000118: us/publications/guidelines-approved-under- section-95aa-privacy-act-1988-cth
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research (2018): Chapter 3.2: https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018
p.000118:
p.000118: TGA:
p.000118: Australian Regulatory Guidelines for Biologicals (2018): http://www.tga.gov.au/industry/biologicals- argb.htm
p.000118: NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research, Chapter 3.3 (2018): https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018 NHMRC, ARC, and UA:
p.000118: National Statement on Ethical Conduct in Human Research, Chapter 3.2 (2018): https://www.nhmrc.gov.au/about-
p.000118: us/publications/national-statement-ethical- conduct-human-research-2007-updated-2018
p.000118:
p.000118: Country Key Organizations Legislation
p.000118: Regulations Guidelines
p.000118:
p.000118: Embryos, Stem Cells, and Cloning
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh
p.000118: General
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Drugs, Biologics, and Devices
p.000118:
p.000118:
p.000118: Human Biological Materials
p.000118: licensing-committee
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: Bangladesh Directorate of Drug Administration: http://www.dgda.gov.bd/
p.000118:
p.000118:
p.000118: Bangladesh Medical Research Council, National Research Ethics Committee: http://www.bmrcbd.org
p.000118: https://www.legislation.gov.au/Deta ils/C2016C00968
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 1. The Drugs Act (1964)
p.000118: 2. Drugs (Control) Ordinance 1982, Ordinance No. VIII: http://bdlaws.minlaw.gov.bd/pdf_pa rt.php?id=623
p.000118: NHMRC:
p.000118: Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2017):
p.000118: https://nhmrc.gov.au/about- us/publications/ethical-guidelines-use-assisted- reproductive-technology
p.000118:
p.000118: 1. Ethical Guidelines for Conducting Research Studies Involving Human Subjects:
p.000118: https://www.bmrcbd.org/application_form/Ethi calGideline
p.000118: 2. Standard Operating Procedures (SOPs):
p.000118: https://www.bmrcbd.org/application_form/SOP s
p.000118: Good Clinical Practice (GCP) Guidelines: http://www.dgda.gov.bd/index.php/2013-03-
...
p.000120: 3. CRF Template
p.000120: 4. Protocol Template
p.000120: 5. Clinical Trial Report Template
p.000120: 6. Required Documents List for Archiving
p.000120:
p.000120: Access: http://samr.cfda.gov.cn/WS01/CL0087/148126. html
p.000120:
p.000120:
p.000120:
p.000120: FAQs:
p.000120: http://www.chictr.org.cn/questionen.aspx
p.000120:
p.000120: Information Security Technology-Personal Information Security Specification (2017, GB/T 35273-2017):
p.000120: https://www.tc260.org.cn/front/postDetail.html
p.000120: ?id=20180124211617
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Code of Practice on the Identity Card Number and Other Personal Identifiers (2016):
p.000120: https://www.pcpd.org.hk/english/data_privacy_ law/code_of_practices/files/picode_en.pdf
p.000120: 2. Code of Practice on Human Resource Management (2016): https://www.pcpd.org.hk/english/data_privacy_
p.000120: law/code_of_practices/files/PCPD_HR_Bookle t_Eng_AW07_Web.pdf
p.000120: 1. Guideline on Vaccine Clinical Trials, Part 6 (2004): http://samr.cfda.gov.cn/WS01/CL0844/10307.h tml
p.000120: 2. Guideline on Ethical Review of Drug Clinical Trials, Appendix 1, Section 6.10
p.000120:
p.000121: 121
p.000121:
p.000121: Country Key Organizations Legislation
p.000121: Regulations Guidelines
p.000121:
p.000121: Research Injury
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Genetic Research
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Embryos, Stem Cells, and Cloning
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/
p.000121: 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Mainland:
p.000121: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/
p.000121: 2. Ministry of Science and Technology of the People’s Republic of China (MOST): http://www.most.cn/eng/
p.000121: Article 36 (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html
p.000121: 3. Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016), Articles 18.5, 20.8, 36.6, and
p.000121: 37: http://www.gov.cn/gongbao/content/2 017/content_5227817.htm
p.000121: 4. Good Clinical Practice on Medical Device Clinical Trials (2016), Articles 10, 22, 33, and 48:
p.000121: http://www.nmpa.gov.cn/WS04/CL2 077/300685.html
p.000121: People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2
p.000121: 019-06/10/content_5398829.htm
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: 1. Ethical Principles and Conduct Norms for Human Assisted Reproductive Technologies. (2003):
p.000121: http://www.moh.gov.cn/qjjys/s3581/2 00805/f69a925d55b44be2a9b4ada7fc dec835.shtml
p.000121: 2. Administrative Measures for Clinical Application of Medical Technology (2018): http://www.jzswjw.gov.cn/upfile/201
p.000121: 809/2018092558392053.pdf
p.000121: 3. Interim Measures for the Administrative Measures of Stem Cell Clinical Research (2015):
p.000121: http://www.nmpa.gov.cn/WS04/CL2 077/300673.html
p.000121: (2010):
p.000121: http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: 1. Service Guidelines for the Collection, Selling, Export. and Admission Application of Human Genetic Resources (2015):
p.000121: http://www.most.gov.cn/tztg/201507/t2015070 3_120547.htm
p.000121: 2. Service Guideline for the Approval of Administrative Licensing Items for Exporting Human Genetic Resources Outside
p.000121: of China: https://fuwu.most.gov.cn/r/cms/zwpt/web/asset s/pdf/4.rlyczycjspfwzn.pdf
p.000121:
p.000121: NHC and MOST:
p.000121: 1. Ethical Guidelines for Research on Human Embryo Stem Cells (2003): http://www.most.gov.cn/fggw/zfwj/zfwj2003/2
p.000121: 00512/t20051214_54948.htm
p.000121: 2. Interim Guidelines for the Quality Control of Stem Cell Preparations and Preclinical Research (2015):
p.000121: http://www.nmpa.gov.cn/WS04/CL2196/32412 4.html
p.000121:
p.000122: 122
p.000122:
p.000122: Country Key Organizations Legislation
p.000122: Regulations Guidelines
p.000122:
p.000122: Embryos, Stem Cells, and Cloning
p.000122:
p.000122:
p.000122:
p.000122: India
p.000122: Hong Kong:
p.000122: Legislative Council of the Hong Kong Special Administrative Region of the People’s Republic of China:
p.000122: http://www.legco.gov.hk/index.html
p.000122:
p.000122: Human Reproductive Technology (Amendment) Ordinance 2016: https://www.legco.gov.hk/yr15-
p.000122: 16/english/ord/ord020-2016-e.pdf
p.000122: For an overview of the clinical research regulations in India, see the ClinRegs report:
p.000122: http://clinregs.niaid.nih.gov/single_country.php?c_id=100
p.000122:
p.000122: General
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs, Biologics, and Devices
p.000122: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs
p.000122: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000122: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Schedule Y of the Drugs and Cosmetics Act (2016): http://www.cdsco.nic.in/writereadda ta/2016Drugs%20and%20Cosmetic
p.000122: s%20Act%201940%20&%20Rules
p.000122: %201945.pdf
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000123: 123
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: DCGI:
p.000123: 1. Good Clinical Practices for Clinical Research in India (2001): http://rgcb.res.in/wp- content/uploads/2014/07/Good-
...
p.000124: ).pdf
p.000124: 3. Compensation in Case of Injury or Death During Clinical Trial, Schedule Y, Appendix XII (2013) (Scroll down to see
p.000124: English version): http://www.pharmamedtechbi.com/~/ media/Supporting%20Documents/Ph armasia%20News/2013/February/Cli
p.000124: nical%20Trials%20Compensation%2 0Guidelines.pdf
p.000124: 4. Compensation Formula for Clinical Trial Injury Other than Death (2014) :
p.000124:
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 7.7 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: Clinical Trials Registry – India:
p.000124: FAQs: http://ctri.nic.in/Clinicaltrials/faq.php
p.000124:
p.000124: Office of Drugs Controller General: Registration of Clinical Trial in ICMR Clinical Trial Registry:
p.000124: http://www.cdsco.nic.in/writereaddata/CTRegi stration.doc
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 2.6 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124:
p.000124: Country Key Organizations Legislation
p.000124: Regulations Guidelines
p.000124:
p.000124: Research Injury
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Social-Behavioral Research
p.000124:
p.000124:
p.000124:
p.000124: Privacy/Data Protection
p.000124:
p.000124:
p.000124:
p.000124: Human Biological Materials
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Genetic Research
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Embryos, Stem Cells, and Cloning
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124: Ministry of Health and Family Welfare: https://mohfw.gov.in
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: 1. Department of Biotechnology (DBT): http://dbtindia.nic.in/
p.000124: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: 1. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000124: 2. Central Drugs Standard Control Organization, Office of Drugs
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Environmental Protection Act (1986)
p.000124: http://www.cdsco.nic.in/writereaddat a/ORDER%20and%20Formula%20to
p.000124: %20Determine%20the%20quantum% 20of%20compensation%20in%20the
p.000124: %20cases%20of%20Clinical%20Tria l%20related%20serious%20Adverse
p.000124: %20Events(SAEs)%20of%20Injury% 20other%20than%20Death.pdf
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: Govt. of India Office Memorandum (O.M. No.19015/53/1997 - IH Pt.) 19th
p.000124: November, 1997 on
p.000124: Exchange of Human Biological Material for Biomedical Research Purposes
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 9 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Sections 2 and 11 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 11 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124:
p.000124: DBT:
p.000124: 1. Recombinant DNA Safety Guidelines (1990)
p.000124: 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002)
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 10 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Guidelines for Stem Cell Research (2017): http://icmr.nic.in/guidelines/Guidelines_fo
p.000124: r_stem_cell_research_2017.pdf
p.000124:
p.000125: 125
p.000125:
p.000125: Country Key Organizations Legislation
p.000125: Regulations Guidelines
p.000125:
p.000125: Embryos, Stem Cells, and Cloning Indonesia
p.000125: Controller General of India (DCGI): https://cdsco.gov.in
p.000125: For an overview of health research ethics, see:
p.000125: http://www.fercap-sidcer.org/newsletter/2013/12/PPT/04%20Suriadi%20Guwanan-PPT.pdf
p.000125:
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125:
p.000125:
p.000125: Human Biological Materials
p.000125:
p.000125: Japan
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125: Ministry of Health, National Institute of Health Research and Development: http://indonesia.go.id/en
p.000125:
p.000125:
p.000125: National Agency of Drug and Food Control: http://www.pom.go.id/index.php/home/en
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000125: 2. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: Drugs
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125:
p.000125:
p.000125: Devices
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
...
p.000127: http://law.e- gov.go.jp/htmldata/H09/H09F036010 00028.html
p.000127: 2. Ministerial Ordinance on Good Clinical Practice for Medical Devices, Article 14 and 23 (2016): http://law.e-
p.000127: gov.go.jp/htmldata/H17/H17F190010 00036.html
p.000127:
p.000127:
p.000127: NIPH Clinical Trials Search: http://rctportal.niph.go.jp/en/
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Guidelines for Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/guidelines01.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines02.p df https://www.ppc.go.jp/files/pdf/guidelines03.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines04.p df
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Ethics Guidelines for Medical and Health Research Involving Human Subjects, Chapter 2, No. 5, 1-(3) and No. 6, 2-(2)
p.000127: (2017):
p.000127: http://www.lifescience.mext.go.jp/files/pdf/n1859_01
p.000127: .pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: On Research and Development Utilizing Human Tissues Removed by Surgery and Other Procedures (1998) (Japanese):
p.000127: https://www.mhlw.go.jp/www1/shingi/s9812/s 1216-2_10.html
p.000127:
p.000127: Country Key Organizations Legislation
p.000127: Regulations Guidelines
p.000127:
p.000127: Genetic Research
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Embryos, Stem Cells, and Cloning
p.000127: 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. html
p.000127: 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000127: 3. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000127: 4. Ministry of Economy, Trade, and Industry (METI): http://www.meti.go.jp/english/
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. html
p.000127: 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000127: 3. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: 1. Act on Regulation of Human Cloning Techniques (2014): http://law.e- gov.go.jp/htmldata/H12/H12HO146
p.000127: .html
p.000127: 2000 version (English): http://www.cas.go.jp/jp/seisaku/hou rei/data/htc.pdf
p.000127: 2. Act on Safety of Regenerative Medicine (2013): http://www.mhlw.go.jp/file/06- Seisakujouhou-10800000-
p.000127: Iseikyoku/0000030847.pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: 1. Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2009):
p.000128: http://www.lifescience.mext.go.jp/file s/pdf/n1564_01.pdf
p.000128: 2. Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019): https://www.lifescience.mext.go.jp/fil
p.000128: es/pdf/n2163_01.pdf
p.000128: 3. Rules for Enforcement of Act on Safety of Regenerative Medicine (2018): https://www.mhlw.go.jp/content/0004
p.000128: 52630.pdf
p.000128: CSTI:
p.000128: Fundamental Principles of Research on the Human Genome (2000)
p.000128:
p.000128: MEXT, MHLW, and METI:
p.000128: Ethics Guidelines for Human Genome/Gene Analysis Research (2017): http://www.lifescience.mext.go.jp/files/pdf/n18
p.000128: 59_03r2.pdf
p.000128: 2008 version (English): http://www.lifescience.mext.go.jp/files/pdf/n79 6_00.pdf
p.000128:
p.000128: MHLW:
p.000128: Guidelines for Clinical Research in Gene Therapy and Others (2019): https://www.neurology-
p.000128: jp.org/news/pdf/news_20190307_02_02.pdf CSTP:
p.000128: Fundamental Philosophy on Handling of Human Embryo (2004): http://www.lifescience.mext.go.jp/files/pdf/6_2 8.pdf
p.000128:
p.000128: MEXT:
p.000128: 1. Guidelines on the Derivation of Human Embryonic Stem Cells (2014): http://www.lifescience.mext.go.jp/files/pdf/n15
p.000128: 53_01.pdf
p.000128: 2. Guidelines on Research on Producing Germ Cells from Human Induced Pluripotent Stem Cells or Human Tissue Stem Cells
p.000128: (2015): http://www.lifescience.mext.go.jp/files/pdf/n14 92_01r2.pdf
p.000128: 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_02r2.pdf
p.000128: 3. Guidelines on the Handling of a Specified Embryo (2019): https://www.lifescience.mext.go.jp/files/pdf/n2 163_07.pdf
p.000128: 4. Guidelines on the Distribution of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCdistributionguideline2019.pdf
p.000128:
p.000128: Country Key Organizations Legislation
p.000128: Regulations Guidelines
p.000128:
p.000128: Embryos, Stem Cells, and Cloning
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Kazakhstan
p.000128: 5. Guidelines on the Utilization of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCutilizationguideline2019.pdf
p.000128:
p.000128: MEXT and MHLW:
p.000128: 1. Ethical Guidelines for Research on Assisted Reproductive Technology to Develop Human Fertilized Embryos (2017):
p.000128: http://www.lifescience.mext.go.jp/files/pdf/n18 59_05.pdf
p.000128: 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_01r2.pdf
p.000128: 2. Guidelines for Research Using Gene- altering Technologies on Human Fertilized Embryos (2019):
p.000128: https://www.lifescience.mext.go.jp/files/pdf/Ov erview_Human_embryo_geneome- editing_guideline2019En.pdf
p.000128: Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomedical Research in the CIS
p.000128: Countries,” Chapter 3, Section 5:
p.000128: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000128:
p.000128: General
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Drugs, Biologics, and Devices
p.000128: Ministry of Healthcare and Social Development, Central Commission on Research Ethics: http://www.mzsr.gov.kz/en
p.000128:
p.000128:
p.000128: Ministry of Healthcare and Social Development, Control Committee of Medical and Pharmacy Activity:
p.000128: https://www.mzsr.gov.kz/en/taxonomy/ter m/674
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Code of the Republic of Kazakhstan "On People's Health and the Health Care System" (18.09.2009 No.193-IV),
p.000128: Articles 74 and 180 (2015): http://online.zakon.kz/Document/?d oc_id=30479065#pos=1;-8
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000129: 129
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
...
p.000131: https://mfds.go.kr/eng/brd/m_40/ view.do?seq=69732
p.000131:
p.000131:
p.000131: MOIS:
p.000131: 1. Enforcement Decrees to Personal Information Protection
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Guidelines for Clinical Trial Indemnity and Its Process 0053-01 (2013.10)
p.000131: 2017.6.1 고시:
p.000131: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000131: =13069&srchFr=&srchTo=&srchWord=%EB
p.000131: %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
p.000131: 2. Guidance for Sponsors; Safety Reporting Requirements 0785-01 (2017.8) 2017.8.31 고시:
p.000131: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000131: =13317&srchFr=&srchTo=&srchWord=%EC
p.000131: %95%88%EC%A0%84%EC%84%B1&srchT
p.000131: p=0&itm_seq_1=0&itm_seq_2=0&multi_itm_ seq=0&company_cd=&company_nm=&page= 1
p.000131: MOIS:
p.000131: Guidelines for De-identification of Personal Data (2016.06.30):
p.000131:
p.000131: Country Key Organizations Legislation
p.000131: Regulations Guidelines
p.000131:
p.000131: Privacy/Data Protection
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Human Biological Materials
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Genetic Research
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: Embryos, Stem Cells, and Cloning
p.000131: do
p.000131: 2. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 1. Ministry of Health and Welfare (MOHW): http://www.mohw.go.kr/eng/index.jsp
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46731&lang=ENG
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: MOHW:
p.000131: Bioethics and Safety Act No. 15188 (2017.12):
p.000131: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000131:
p.000131:
...
p.000132: View.do?hseq=45482&lang=ENG
p.000132: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL
p.000132: sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11
p.000132: MOHW:
p.000132: 1. Enforcement Decree of Bioethics and Safety Act No. 28211 (2017): http://elaw.klri.re.kr/kor_service/law
p.000132: View.do?hseq=45482&lang=ENG
p.000132: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL
p.000132: sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11
p.000132: MOHW:
p.000132: 1. Enforcement Decree of Bioethics and Safety Act No.
p.000132: https://www.privacy.go.kr/eng/ news_event_view.do?nttId=7585
p.000132:
p.000132:
p.000132:
p.000132:
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p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: MFDS:
p.000132: Guidelines on the Evaluation of Quality, Safety, and Efficacy of Recombinant Protein Products 0324-01 (2014.12)
p.000132: 2017.6.1 고시:
p.000132: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000132: =12542&srchFr=&srchTo=&srchWord=%EC
p.000132: %9E%AC%EC%A1%B0%ED%95%A9&srch
p.000132: Tp=0&itm_seq_1=0&itm_seq_2=0&multi_itm
p.000132: _seq=0&company_cd=&company_nm=&page
p.000132: =1
p.000132:
p.000132: MFDS:
p.000132: 1. Guideline on Sponsor-Investigator Trials of Cell Therapy Products for Academic Purpose 0307-01 (2014.12) 2014.12.30
p.000132: 고시:
p.000132:
p.000132: Country Key Organizations Legislation
p.000132: Regulations Guidelines
p.000132:
p.000132: Embryos, Stem Cells, and Cloning
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: Kyrgyzstan
p.000132: 2. Ministry of Food and Drug Safety (MFDS): http://www.mfds.go.kr/eng/index.do
p.000132: wView.do?hseq=46341&lang=ENG
p.000132: 28211 (2017):
p.000132: http://elaw.klri.re.kr/kor_service/law View.do?hseq=45482&lang=ENG
p.000132:
p.000132: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/eng/engL
p.000132: sSc.do?menuId=1&query=BIOETHI CS+AND+SAFETY+ACT&x=0&y= 0#liBgcolor11
p.000132: 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%
p.000132: 8C&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_ itm_seq=0&company_cd=&company_nm=&page=1
p.000132: 2.Guideline on the Design of Early-Phase Clinical Trials of Cell Therapy and Gene Therapy Products 안내서0309-01
p.000132: (2015.11): https://www.mfds.go.kr/brd/m_210/view.do?seq=12501
p.000132: 3.Guideline on Tumorigenicity Assessment of Stem Cell Therapy Products (2016.05.) https://
p.000132: www.mfds.go.kr/eng/brd/m_27/view.do?seq=70469
p.000132:
p.000132: Note: All websites and documents are in Russian.
p.000132: General 1. Government of the Kyrgyz Republic: http://www.gov.kg
p.000132: 2. Ministry of Health:
p.000132: http://www.med.kg
p.000132: 3. Ministry of Justice of the Kyrgyz Republic: http://cbd.minjust.gov.kg
p.000132:
p.000132: 1. Constitution of Kyrgyz Republic, Chapter II, Article 22 (2010): http://www.gov.kg/?page_id=263&l ang=ru
p.000132: 2. Law on Health Protection of the Kyrgyz Republic (Sept. 1, 2005, No. 6):
p.000132: Articles 34 and 72:
p.000132: http://www.pharm.kg/ru/legislation
p.000132:
...
p.000135: https://www.npra.gov.my/images/Guidelines_ Central/Guidelines_on_Clinical_Trial/MALAY SIANGUIDELINEFORPHASEIUNITINSPEC
p.000135: TION.pdf
p.000135:
p.000135: CRC:
p.000135: Malaysian Phase I Clinical Trial Guidelines: https://clinicalresearch.my/mp1g/
p.000135:
p.000135: NIH:
p.000135: Guidelines for Conducting Research in Ministry of Health Institutions and Facilities (2015):
p.000135: https://www.pharmacy.gov.my/v2/sites/default/ files/document-upload/nih-guidelines-
p.000135: conducting-research-moh-institutions-facilities- revision-01-2015.pdf
p.000135: Frequently Asked Questions:
p.000135: https://www.nmrr.gov.my/doc/FREQUENTLY
p.000135: _ASKED_QUESTIONS_FAQ.pdf
p.000135: NPRA:
p.000135: Malaysian Guideline for Good Clinical Practice, Section 5.8: Compensation to Subjects and Investigators
p.000135: https://www.crc.gov.my/wp- content/uploads/2018/03/Malaysian_gcp_4th_ Edition28Final_29.pdf
p.000135:
p.000135:
p.000135: MIGHT:
p.000135: Malaysian Code of Responsible Conduct, Section 8: https://uitmethics.uitm.edu.my/v1/images/stori
p.000135: es/guidelines/my_code.pdf
p.000135:
p.000135: Country Key Organizations Legislation
p.000135: Regulations Guidelines
p.000135:
p.000135: Social-Behavioral Research Privacy/Data Protection
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: Human Biological Materials
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: Genetic Research
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: Embryos, Stem Cells and Cloning
p.000135: http://iptk.moh.gov.my/iptk/index.php/ho me
p.000135: 1. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p
p.000135: hp?r=portal2
p.000135: 2. Ministry of Communications and Multimedia (KKMM), Personal Data Protection Commissioner Malaysia.
p.000135: http://www.pdp.gov.my/index.php/en/
p.000135: 3. Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA): https://npra.gov.my/index.php/en
p.000135: 1. National Committee for Clinical Research: http://www.nccr.gov.my/
p.000135: 2. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p
p.000135: hp?r=portal2
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 1. Malaysian Medical Council:
p.000135: http://mmc.gov.my/
p.000135: 2. Laws of Malaysia. Attorney General’s Chambers of Malaysia (AGC): http://www.agc.gov.my/agcportal/index.p
p.000135: hp?r=portal2
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 1. Ministry of Health, National Pharmaceutical Control Bureau (NPCB): https://npra.gov.my/index.php/en/
p.000135: 2. Ministry of Health, Medical
p.000135:
p.000135: Act 709: Personal Data Protection Act 2010, Sections 39
p.000135: and 40: http://www.pdp.gov.my/images/LA WS_OF_MALAYSIA_PDPA.pdf
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: 1. Act 130: Human Tissues Act (1974): Section 2 Removal of parts of bodies for therapeutc purpose
p.000135: http://www.agc.gov.my/agcportal/u ploads/files/Publications/LOM/EN/ Act%20130.pdf
p.000135: 2. Act 699: DNA Identification Act 2009. Malaysian Government Gazette of 3 September 2009:
...
p.000136: Gazette of 30 Aug 2012.
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Biosafety (Approval and Notification) Regulations 2010: http://bch.cbd.int/database/attachment
p.000136: /?id=17640
p.000136:
p.000136: KKMM:
p.000136: Compliance to Personal Data Protection Act (PDPA): A Quick Guide: http://www.pdp.gov.my/images/slaid-
p.000136: seminar/PDPA-Compliance---Jan-2019.pdf
p.000136:
p.000136: NPRA:
p.000136: Malaysian Guideline for Good Clinical Practice, Confidential Information: https://www.crc.gov.my/wp-
p.000136: content/uploads/2018/03/Malaysian_gcp_4th_ Edition28Final_29.pdf
p.000136:
p.000136: NCCR:
p.000136: Guideline on the Use of Human Biological Tissues for Research (2016): https://www.nmrr.gov.my/doc/Guideline-on-
p.000136: Human-Tissue-in-Clinical-Research.pdf
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: MMC:
p.000136: Medical Genetics and Genetic Services. MMC Guidelines 010/2006: http://www.npra.gov.my/images/Guidelines_C
p.000136: entral/Guidelines_on_Regulatory/CGTP_guide lines.doc
p.000136:
p.000136: NBB:
p.000136: Guidelines for Institutional Biosafety Committees: https://um.edu.my/docs/default-
p.000136: source/institutional-biosafety-committee- (ibc)/ibc-guidelines.pdf?sfvrsn=2
p.000136: 1. Checklist for Research on Stem Cell and Cell-Based Therapies (2014): http://www.nih.gov.my/mrec/documents/Research_O
p.000136: n_Stem_cell_and_Cell_based_Therapies.pdf
p.000136: 2. Guidance Document and Guidelines for
p.000136:
p.000136: Country Key Organizations Legislation
p.000136: Regulations Guidelines
p.000136:
p.000136: Embryos, Stem Cells, and Cloning
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Myanmar
p.000136: General
p.000136:
p.000136:
p.000136:
p.000136: Drugs, Biologics, and Devices
p.000136:
p.000136: Human Biological Materials
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Nepal
p.000136: General
p.000136: Development Division: http://www.moh.gov.my/index.php?mid= 5
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
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p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: 1. Department of Medical Research (DMR): http://www.dmrlm.gov.mm/
p.000136: 2. Ministry of Health National Ethics Committee on Clinical Research: www.moh.gov.mm
p.000136: Ministry of Health, Food and Drug Administration: http://www.fdamyanmar.gov.mm/index.p hp/en/
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: Nepal Health Research Council, Ethical Review Board: http://www.nhrc.org.np/
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
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p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136:
p.000136: National Drug Law (1992)
p.000136:
p.000136:
p.000136: 1. Blood and Blood Products Law (2003) (Burmese): http://www.moh.gov.mm/file/Law/ Blood%20and%20Blood%20Produc
p.000136: t%20Law%20(2003).pdf
p.000136: 2. Body Organ Donation Law (2004)
p.000136:
...
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Health Information Privacy Code 1994:
p.000138: http://www.privacy.org.nz/assets/File s/Codes-of-Practice-materials/Health- Information-Privacy-Code-1994-
p.000138: including-Amendment.pdf
p.000138: Obtaining Approval for Clinical Trials (2013):
p.000138: http://www.medsafe.govt.nz/medicines/clinical
p.000138: -trials.asp
p.000138:
p.000138: Medicines New Zealand: Guidelines on Clinical Trials
p.000138: Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial (2015):
p.000138: https://ethics.health.govt.nz/system/files/docum ents/pages/2015-medicines-new-zealand- compensation-guidelines.pdf
p.000138:
p.000138: 1. Standard Operating Procedures for Health and Disability Ethics Committees (2012):
p.000138: http://www.ethics.health.govt.nz/operating- procedures
p.000138: 2. Various: http://medsafe.govt.nz/regulatory/DevicesNew/ 13ConductingClinicalTrials.asp
p.000138: FAQs: http://www.anzctr.org.au/Faq.aspx
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: MOH:
p.000138: Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007):
p.000138: http://www.health.govt.nz/publication/guidelin es-use-human-tissue-future-unspecified- research-purposes
p.000138:
p.000139: 139
p.000139:
p.000139: Country Key Organizations Legislation
p.000139: Regulations Guidelines
p.000139:
p.000139: Genetic Research
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Embryos, Stem Cells, and Cloning
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Pakistan
p.000139: General
p.000139:
p.000139: Drugs, Biologics, and Devices
p.000139:
p.000139: Human Biological Materials
p.000139: 1. Environmental Protection Authority: http://www.epa.govt.nz/
p.000139: 2. Health Research Council (HRC), Gene Technology Advisory Committee: http://www.hrc.govt.nz/about-
p.000139: us/committees/gene-technology-advisory- committee-gtac
p.000139: 1. Advisory Committee on Assisted Reproductive Technology (ACART): http://acart.health.govt.nz/
p.000139: 2. Ethics Committee on Assisted Reproductive Technology (ECART): http://ecart.health.govt.nz/
p.000139: 3. Ministry of Health:
p.000139: http://www.moh.govt.nz/
p.000139:
p.000139:
p.000139:
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p.000139:
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p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: Hazardous Substances and New Organisms Act 1996 (2012)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Human Assisted Reproductive Technology Act 2004 (2009)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000143: 143
p.000143: DOST, DOH, CHED, and UPM:
p.000143: Joint Administrative Order No. 001: The Implementing Rules and Regulations of Republic Act 10532 Otherwise Known as
p.000143: “The Philippine National Health Research System Act of 2013:” http://www.ethics.healthresearch.ph/i
p.000143: ndex.php/component/content/article/2
p.000143: -uncategorised/214-implementing- rules-of-pnhrs
p.000143:
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p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: FDA Guidelines: Regulation of Clinical Trials in the Philippines http://www.pcrp.org.ph/pdf/Guidelinesversion LR.PDF
p.000143: FAQs:
p.000143: http://registry.healthresearch.ph/index.php?opti on=com_content&view=article&id=7&Itemid= 185
p.000143: PHREB:
p.000143: National Ethical Guidelines for Health and Health-Related Research (2017):
p.000143: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
p.000143: guidelines-for-health-and-health-related- research
p.000143:
p.000143: Country Key Organizations Legislation
p.000143: Regulations Guidelines
p.000143:
p.000143: Social-Behavioral Research
p.000143:
p.000143:
p.000143: Privacy/Data Protection
p.000143:
p.000143:
p.000143:
p.000143: Embryos, Stem Cells, and Cloning
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Singapore
p.000143: General
p.000143: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000143: 2. Philippine Social Science Council (PSSC): http://pssc.org.ph/
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: 1. Ministry of Health (MOH):
p.000143: http://www.moh.gov.sg/
p.000143: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Republic Act No. 10173: Data Privacy Act of 2012: http://www.officialgazette.gov.ph/2 012/08/15/republic-act-no-10173/
p.000143:
p.000143:
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p.000143:
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p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Human Biomedical Research Act 2015:
p.000143: https://sso.agc.gov.sg/Act/HBRA20 15
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Data Privacy Act Implementing Rules and Regulations (2016): https://privacy.gov.ph/implementing-
p.000143: rules-and-regulations-of-republic-act- no-10173-known-as-the-data-privacy- act-of-2012/
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: MOH:
p.000143: Human Biomedical Research Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015
p.000143: -S621-2017
p.000143: National Ethical Guidelines for Health and Health-Related Research, Pages 108-118. (2017):
...
p.000145: -S621-2017
p.000145: 2. Health Products (Clinical Trials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S331-2016
p.000145: Medicines (Clinical Trials) Regulations (2016): https://sso.agc.gov.sg/SL/MA1975- S335-2016
p.000145:
p.000145:
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p.000145:
p.000145:
p.000145: Medicines (Clinical Trials) Regulations (2000): http://statutes.agc.gov.sg/aol/search/d isplay/view.w3p;orderBy=date-
p.000145: rev,loadTime;page=0;query=Id%3A7 e3c748b-8089-4699-a4b2-
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p.000145:
p.000145: HSA:
p.000145: Singapore Guideline for Good Clinical Practice (2016): http://www.ich.org/fileadmin/Public_Web_Site
p.000145: /ICH_Products/Guidelines/Efficacy/E6/E6_R2 Step_4_2016_1109.pdf
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: PDPC:
p.000145: Sector Specific Guidelines Promulgated by PDPC:
p.000145: https://www.pdpc.gov.sg/Legislation-and- Guidelines/Guidelines
p.000145:
p.000145: BAC:
p.000145: Personal Information in Biomedical Research (2007): http://www.bioethics- singapore.org/index/publications/reports/170-
p.000145: personal-information-in-biomedical- research.html
p.000145: MOH:
p.000145: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and-
p.000145: legislation/human-biomedical-research-act
p.000145:
p.000145: Country Key Organizations Legislation
p.000145: Regulations Guidelines
p.000145:
p.000145: Human Biological Materials
p.000145:
p.000145:
p.000145:
p.000145: Genetic Research
p.000145:
p.000145:
p.000145:
p.000145: Embryos, Stem Cells, and Cloning
p.000145:
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p.000145: Sri Lanka
p.000145: Drugs and Devices
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Clinical Trials Registry
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000145:
p.000145:
p.000145: 1. Ministry of Health (MOH):
p.000145: http://www.moh.gov.sg/
p.000145: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org/
p.000145:
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p.000145:
p.000145: Cosmetics, Devices, and Drugs Regulatory Authority, Subcommittee on Clinical Trials:
p.000145: http://www.cdda.gov.lk/index.php?option
p.000145: =com_content&view=article&id=78&Ite mid=115&lang=en
p.000145: Sri Lanka Clinical Trials Registry:
p.000145: http://www.slctr.lk/
p.000145: Bill No. 25/2015, Part 6: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145: 2. Human Cloning and Other Prohibited Practices Act (Cap 131B): https://sso.agc.gov.sg/Act/HCOPPA 2004
p.000145:
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p.000145:
p.000145:
p.000145:
p.000145: National Medicines Regulatory Authority Act of 2015: http://www.cdda.gov.lk/images/stori
...
p.000148: https://law.moj.gov.tw/ENG/LawClas s/LawAll.aspx?pcode=I0050022
p.000148: 1. Regulations on Human Trials (2009): http://law.moj.gov.tw/Eng/LawClass/ LawContent.aspx?pcode=L0020162
p.000148: 2. Administrative Regulations on the Establishment of Human Biobanks (2011) https://law.moj.gov.tw/ENG/LawClas
p.000148: s/LawAll.aspx?pcode=L0020173
p.000148:
p.000148: MOHW:
p.000148: 1. Regulations on Commercial Benefit Feedback of Human Biobanks (2010) (Chinese): https://law.moj.gov.tw/LawClass/La
p.000148: wAll.aspx?pcode=L0020170
p.000148: 2. Administrative Regulations on the Establishment of Human Biobanks (2011): https://law.moj.gov.tw/ENG/LawClas
p.000148: s/LawAll.aspx?pcode=L0020173
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p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: 1. Good Tissue Practice (2002) (Chinese): http://www.fda.gov.tw/TC/includes/GetFile.ash
p.000148: x?id=1153&chk=342a5c73-c206-4756-ade9- 9c63265c859d&mid=46&name=fdContent
p.000148: 2. Guidelines for the Collection and Use of Human Specimens for Research (2006) (Chinese):
p.000148: http://www.fda.gov.tw/TC/includes/GetFile.ash x?id=1598&chk=6056f7dd-eb0a-48bf-ae7e- 8a2a5875e6e0&mid=46&name=fdContent
p.000148: MOHW:
p.000148: Guidance for Information Safety of Human Biobank (2010) (Chinese): http://regulation.cde.org.tw/doc_data_display?s
p.000148: id=1929&doctype2=
p.000148:
p.000148: Country Key Organizations Legislation
p.000148: Regulations Guidelines
p.000148:
p.000148: Embryos, Stem Cells, and Cloning
p.000148:
p.000148: Tajikistan
p.000148: Ministry of Health and Welfare (MOHW):
p.000148: https://www.mohw.gov.tw/mp-2.html
p.000148: Artificial Reproduction Act (2018):
p.000148: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0070024
p.000148: Note: For an overview of human subject protections in Tajikistan, see “Ethical Review of Biomedical Research in the CIS
p.000148: Countries,” Chapter 3, Section 9:
p.000148: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000148: Note: All websites and documents are in Russian.
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Thailand
p.000148: Ministry of Public Health: http://www.health.tj/
p.000148: Order of the Ministry of Public Health of the Republic Tajikistan of 10 March, 2005 No. 118: About the Assertion of the
p.000148: Normative Documents of Republic Committee on Medical Ethics
p.000148: For an overview of the clinical research regulations in Thailand, see:
p.000148: https://clinregs.niaid.nih.gov/single_country.php?c_id=213
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Drugs, Biologics, and Devices
p.000148: 1. National Research Council of Thailand (NCRT): http://en.nrct.go.th/en/home.aspx
p.000148: 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php
p.000148: 3. Forum for Ethical Review Committees in Thailand (FERCIT): http://www.fercit.org/
p.000148:
p.000148:
p.000148:
p.000148: Drugs
...
p.000151: Genetic Information Law (2000):
p.000151: http://www.moital.gov.il/NR/exeres
p.000151: /66F4DD4E-FA4A-4B76-94BC- DC29543471DE.htm
p.000151: Professional Ethics Regulations: Conducting Medical Research on Human Beings, Articles 52-61 (2003)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Protection Code for Human Subjects in Medical Research (1999)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Public Health Regulations (Medical Experiments Involving Human Subjects) (1999)
p.000151: 1. Public Health Regulations (Clinical Studies in Human Subjects) – 1980
p.000151: 2. 1990 Amendment
p.000151: 3. 1992 Amendment
p.000151: 4. 2005 Amendment
p.000151:
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p.000151:
p.000151: FAQs: http://www.irct.ir/faq.php
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Guidelines for Clinical Trials in Human Subjects (2006): https://firstclinical.com/regdocs/doc/?db=INT_
p.000151: Israel_Clinical_Trials
p.000151:
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p.000151:
p.000151: 1. Instruction of the Supreme Committee for Clinical Studies on Humans Regarding Establishment and Usage of Genetic
p.000151: Samples Reservoir (2005)
p.000151: 2. Amendment (2007)
p.000151:
p.000152: 152
p.000152:
p.000152: Country Key Organizations Legislation
p.000152: Regulations Guidelines
p.000152:
p.000152: Embryos, Stem Cells, and Cloning
p.000152:
p.000152:
p.000152: Jordan
p.000152: Note: All documents are in Arabic.
p.000152: Genetic Intervention Prohibition Law (Human Cloning and Genetic Changes in Reproduction Cells) (1999)
p.000152:
p.000152: Drugs, Biologics, and Devices
p.000152:
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p.000152: Research Injury
p.000152: 1. Ministry of Health: http://www.moh.gov.jo/en/Pages/default.a spx
p.000152: 2. Jordan Food and Drug Administration: http://www.jfda.jo/Default.aspx
p.000152: 1. Law of Clinical Studies, Law No. 2 (2011) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/Pharmaceu ticalStudies/50_211.pdf
p.000152: 2. Drug and Pharmacy Law No. 12 (2013) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/DrugDirec torate/%D9%82%D8%A7%D9
p.000152: %86%D9%88%D9%86%20%D 8%A7%D9%84%D8%AF%D9
p.000152: %88%D8%A7%D8%A1%20% D9%88%D8%A7%D9%84%D8
p.000152: %B5%D9%8A%D8%AF%D9% 84%D8%A9.pdf
p.000152: 3. Narcotic and Psychotropic Law No. 23 (2016) http://www.jfda.jo/EchoBusV3. 0/SystemAssets/PDF/AR/Laws
p.000152: AndRegulation/Drug/DrugsAnd PsychotropicSubstances/%D9% 82%D8%A7%D9%86%D9%88
p.000152: %D9%86%20%D8%A7%D9% 84%D9%85%D8%AE%D8%A F%D8%B1%D8%A7%D8%AA
p.000152: %20%D9%88%D8%A7%D9% 84%D9%85%D8%A4%D8%A B%D8%B1%D8%A7%D8%AA
p.000152: %20%D8%A7%D9%84%D8% B9%D9%82%D9%84%D9%8A
p.000152: %D8%A9.pdf
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p.000153: Regulations for Insurance on Research-Related Injury (2013): http://www.jfda.jo/EchoBusV3.0/Syst
p.000153: emAssets/PDF/AR/LawsAndRegulati
p.000153:
p.000153: Country Key Organizations Legislation
p.000153: Regulations Guidelines
p.000153:
p.000153: Research Injury
p.000153: Embryos, Stem Cells, and Cloning Kuwait
p.000153: General
p.000153:
p.000153: Qatar
p.000153: General
p.000153:
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p.000153: Social/Behavioral Research
p.000153:
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p.000153:
p.000153:
p.000153: Human Biological Materials
p.000153:
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p.000153: Genetic Research
p.000153:
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p.000153:
p.000153:
p.000153:
p.000153: Ministry of Health, Kuwait Institute for Medical Specialization: http://www.kims.org.kw/
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
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p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
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p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153: Ministry of Public Health, Health Research Governance Department:
p.000153: https://researchwebadmin.moph.gov.qa/en
p.000153: /Pages/Regulations.aspx
p.000153:
p.000153: Stem Cell By-law No. 10 (2014)
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p.000154:
p.000154: 1. IRB - IEC Registration Application: https://researchwebadmin.moph.gov.qa/en/Pag es/IRB.aspx
p.000154: 2. Guidelines on Reviewing and Reporting Adverse Events: https://researchportal.moph.gov.qa/_layouts/15
p.000154: /ResearchPortal/RDLogin.aspx?ReturnUrl=%2 f_layouts%2f15%2fAuthenticate.aspx%3fSour ce%3d%252F&Source=%2F
p.000154: 3. GCP Conduct of Clinical Trials: https://researchwebadmin.moph.gov.qa//D epartmentalDocuments/Standards%20of%
p.000154: 20Good%20Clinical%20Practice.pdf
p.000154: 1. Protection of Human Subjects, Exempt Research: https://researchwebadmin.moph.gov.qa//Depart
p.000154: mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf
p.000154: 2. Protection of Human Subjects, Expedited Research: https://researchwebadmin.moph.gov.qa//Depart
p.000154: mentalDocuments/Policies,%20Regulations%2 0and%20Guidelines%20for%20Research%20I nvolving%20Human.pdf
p.000154: Guidance for the Use of Stored Data and Biological Specimens in Human Research:
p.000154: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20the%2
p.000154: 0Use%20of%20Stored%20Data%20and%20Bi ological%20Specimens%20in%20Human%20 Research.pdf
p.000154: 1. Guidance for the Design, Ethical Review, and Conduct of Genomic Research in Qatar:
p.000154: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20the%2
p.000154:
p.000154: Country Key Organizations Legislation
p.000154: Regulations Guidelines
p.000154:
p.000154: Genetic Research
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Embryos, Stem Cells, and Cloning
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Saudi Arabia
p.000154: General
p.000154:
p.000154:
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p.000154: Social-Behavioral Research
p.000154:
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p.000154: Sudan
p.000154: General
p.000154:
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p.000154:
p.000154:
p.000154:
p.000154:
p.000154: Ministry of Public Health, Health Research Governance Department:
p.000154: https://researchwebadmin.moph.gov.qa/en
p.000154: /Pages/Regulations.aspx
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: National Committee of BioEthics:
p.000154: http://bioethics.kacst.edu.sa/?lang=en-US
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154: National Committee of BioEthics
p.000154:
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p.000154: Federal Ministry of Health:
p.000154: http://www.fmoh.gov.sd/
p.000154:
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p.000154:
p.000154: Law of Ethics of Research on Living Creatures: http://bioethics.kacst.edu.sa/getattac hment/4bd0d4e2-1b93-4c32-b483-
p.000154: 57902227fae2/Bioethic-Rgl-fin- bks.aspx
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p.000155: Implementing Regulations of the Law of Ethics of Research on Living Creatures (2016):
p.000155: http://prod.kau.edu.sa/Med/ali/files/P ublications/Guide/National_Committ e_of_BioEthics-
p.000155: Regulations_of_the_Law_of_Ethics_ of_Research_on_Living_Creatures.pd f
p.000155: Implementing Regulations of the Law of Ethics of Research on Living Creatures, Expedited Research (Article 10.18g) and
p.000155: Categories of Social-Behavioral Research That do not Require Continuing Review (Article 10.32) (2016):
p.000155: http://prod.kau.edu.sa/Med/ali/files/P ublications/Guide/National_Committ e_of_BioEthics-
p.000155: Regulations_of_the_Law_of_Ethics_ of_Research_on_Living_Creatures.pd f
p.000155: 0Design,%20Ethical%20Review,%20and%20 Conduct%20of%20Genomic%20Research%20 in%20Qatar.pdf
p.000155: 2. Guidelines for Gene Transfer Research in Humans: https://researchwebadmin.moph.gov.qa//Depart
p.000155: mentalDocuments/Guidelines%20for%20Gene
p.000155: %20Transfer%20Research%20in%20Humans. pdf
p.000155: Guidance for Research Involving Humans: Guidance for Research Involving
p.000155: Human Stem Cells, Germ Cells, and Cells Obtained from Cord Blood:
p.000155: https://researchwebadmin.moph.gov.qa//Depart mentalDocuments/Guidance%20for%20Resear
p.000155: ch%20Involving%20Human%20%20Stem%20 Cells.pdf
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p.000155:
p.000155: 1. National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008):
p.000155: http://sites.google.com/site/healthresearchlibrar y/national-guidelines
p.000155:
p.000155: Country Key Organizations Legislation
p.000155: Regulations Guidelines
p.000155:
p.000155: General
p.000155:
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p.000155: Drugs, Biologics, and Devices
p.000155:
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p.000155: Human Biological Materials
p.000155:
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p.000155: Genetic Research
p.000155:
p.000155: Tunisia
p.000155: Drugs, Biologics, and Devices
p.000155:
p.000155:
p.000155: Turkey
p.000155: General
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p.000155: National Medicines and Poisons Board: http://www.nmpb.gov.sd/en/
p.000155:
p.000155:
p.000155: 1. Federal Ministry of Health:
p.000155: http://www.fmoh.gov.sd/
p.000155: 2. National Council on Biosafety
p.000155:
p.000155: University of Khartoum, Institute of Endemic Diseases: http://iend.uofk.edu/index.php?lang=en
p.000155:
p.000155: Ministry of Public Health, Institut Pasteur: www.pasteur.tn
p.000155:
p.000155:
p.000155:
p.000155: Ministry of Health (Turkish):
p.000155: http://www.saglik.gov.tr/
p.000155:
p.000155:
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p.000157: (2016). Official Gazette: http://www.resmigazete.gov.tr/eskiler
p.000157: /2016/08/20160810-7.htm
p.000157: 5. Bylaw on Clinical Research of Traditional and Complementary Medicine (2019): http://www.klinikarastirmalar.org/Det
p.000157: ail/2631/geleneksel-ve-tamamlayici- tip-uygulamalarinin-klinik- arastirmalari-hakkinda-yonetmelik- 2019
p.000157: 7. Guideline on Phase 1 Clinical Research Centers (2019) https://titck.gov.tr/storage/Archive/20
p.000157: 19/legislation/ad316d19-8b9e-420c- 86db-3946c56add1d.pdf
p.000157:
p.000157: Regulation on Research on Medical Devices (2014): http://www.klinikarastirmalar.org.tr/d oc/file_318.pdf
p.000157:
p.000157: CRA:
p.000157: 1. GCP Guideline (2015): http://www.klinikarastirmalar.org.tr/doku man.php?id=374
p.000157: 2. Guideline on the Audit of Pharmacovigilance: https://titck.gov.tr/storage/Archive/2019/l
p.000157: egislation/05ef1188-6756-4165-b0d5- bb0a28bbebb3.pdf
p.000157: 3. Various: http://www.klinikarastirmalar.org.tr/en/do cuments.php?dok_cat=0
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
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p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: Guidance on Insuring Volunteers in a Clinical Trial (2011)
p.000157:
p.000157: Country Key Organizations Legislation
p.000157: Regulations Guidelines
p.000157:
p.000157: Research Injury Human Biological Materials
p.000157:
p.000157:
p.000157:
p.000157: Genetic Research
p.000157:
p.000157:
p.000157: Embryos, Stem Cells, and Cloning
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: United Arab Emirates
p.000157: 164 (2004)
p.000157: 1. Law on Procurement, Preservation, Grafting, and Transplantation of Organs and Tissues, No. 2238 (1979)
p.000157: 2. Law on Blood and Blood Products, No. 2857 (1983)
p.000157:
p.000157: Regulation on Blood and Blood Products, No. 7314 (1983)
p.000157:
p.000157:
p.000157:
p.000157: Regulation on Centers for Diagnosis and Genetic Diseases, No. 23368 (1998)
p.000157: 1. Regulation on Centers for Medically Assisted Procreation, No. 19551 (1987)
p.000157: 2. Regulation on Organ and Tissue Transplantation Services (2005)
p.000157: 3. Regulation on Cordon Blood Banks (2005)
p.000157:
p.000157: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000157: 2. Good Clinical Practice Guidelines for Advanced Therapy Medicinal Products (2011)
p.000157: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999)
p.000157: 1. Circular on Research of Embryonic Stem Cells (2005)
p.000157: 2. Guideline on Clinical Research of Non- Embryonic Stem Cells (2006)
p.000157:
p.000157: General
p.000157: Health Authority - Abu Dhabi:
p.000157: http://www.haad.ae/haad/
p.000157: Standard Operating Procedures for Research Ethics Committees (2012): http://www.haad.ae/HAAD/LinkClick.aspx?fil
p.000157: eticket=UL7o8f5mukc%3D&tabid=820
p.000157:
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p.000157:
p.000158: 158
p.000158:
p.000158: Country Key Organizations Legislation
p.000158: Regulations Guidelines
p.000158:
p.000158: LATIN AMERICA and the CARIBBEAN
p.000158: Regionwide
p.000158: General Caribbean Public Health Agency: http://carpha.org/What-We-Do/Research-
p.000158: Training-and-Policy-Development
p.000158:
p.000158: Drugs, Biologics, and Devices
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Argentina
p.000158: Drugs
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158:
p.000158: Devices
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158: Good Clinical Practices: Document for the Americas (2005): http://www.paho.org/english/ad/ths/ev/GCP- Eng-doct.pdf
p.000158:
p.000158: A Model Regulatory Program for Medical Devices: An International Guide (2001):
p.000158: http://www.paho.org/English/HSP/HSE/medica l_devices.pdf
p.000158: Note: Several provinces have their own regulations pertaining to human subjects research.
p.000158:
p.000158: General
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
...
p.000165: 2018/2015/Lei/L13123.htm
p.000165: 4. Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015: http://www.planalto.gov.br/ccivil_0
p.000166: 166
p.000166: ANVISA:
p.000166: Resolution – RDC No. 20 of 10 April 2014: http://www.saude.pr.gov.br/arquivos/ File/RDC_20_de_10_de_abril_2014_
p.000166: Transporte_de_material_Biologico.pd f
p.000166: CTNBio:
p.000166: 1. Instruction CTNBio No. 8 of 9 July 1997: http://ctnbio.mcti.gov.br/instrucoes- normativas/-
p.000166: /asset_publisher/3dOuwS2h7LU6/con tent/instrucao-normativa-ctnbio- n%C2%BA-8-de-09-07-97
p.000166: 2. Instruction CTNBio No. 9 of 10 October 1997: http://www.agrobiobrasil.org.br/wp- content/uploads/2014/06/CTNBio-
p.000166: Normative-Instruction-n%C2%BA-9- of-October-10-1997.pdf
p.000166:
p.000166: CNS/CONEP:
p.000166: Resolution CNS No. 340/2004: On Research on Human Genetics (2004):
p.000166: http://conselho.saude.gov.br/resoluco es/2004/Res340_en.pdf
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166: CNS/CONEP:
p.000166: 1. Guidance to Researchers and Ethics Committees about the Item
p.000166: V.1.a of CNS Resolution 340 2004: http://conselho.saude.gov.br/images/comissoes/
p.000166: conep/documentos/CARTAS/CartaCircular041
p.000166: -15.pdf
p.000166: 2. Statement on Pharmacogenetic Studies in Brazil N/° 011/2012/CONEP, 12 January 2012:
p.000166: http://www.fcm.unicamp.br/fcm/sites/default/fi les/11_-
p.000166: _Comunicado_sobre_estudos_farmacogenetico s_no_Brasil.pdf
p.000166:
p.000166: Country Key Organizations Legislation
p.000166: Regulations Guidelines
p.000166:
p.000166: Genetic Research
p.000166: Embryos, Stem Cells, and Cloning
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
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p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166: Chile
p.000166:
p.000166:
p.000166: 1. National Biosafety Technical Commission: http://ctnbio.mcti.gov.br/inicio
p.000166: 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000166: 3. National Health Council (CNS):
p.000166: http://www.conselho.saude.gov.br/
p.000166: 3/_ato2015- 2018/2016/decreto/D8772.htm
p.000166: 1. Biosafety Law 11.105/05 (2005): http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/lei/l11105.htm
p.000166: 2. Decree No. 5,591, of November 22, 2005: http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/Decreto/D5591.htm
p.000166:
p.000166: ANVISA:
p.000166: 1. Resolution RDC No. 9, 14 March 2011: http://bvsms.saude.gov.br/bvs/saudele gis/anvisa/2011/prt0009_14_03_2011
p.000166: .html
p.000166: 2. Resolution RDC No. 29, 12 May 2008: http://bvsms.saude.gov.br/bvs/saudele gis/anvisa/2008/rdc0029_12_05_200 8.html
p.000166: 3. Resolution RDC No.260, 21 December 2018: Regulation for Conducting Clinical Trials with Investigational Advanced
p.000166: Therapy Product in Brazil, and Makes Other Arrangements: http://portal.anvisa.gov.br/documents/
p.000166: 10181/2718376/RDC_260_2018_.pdf
p.000166: /dd889184-bd4a-40ea-ae1c- b93155b20ea1
p.000166:
p.000166: Note: All websites and documents are in Spanish.
p.000166: General 1. Ministry of Health:
p.000166: http://www.minsal.cl
p.000166: 2. Institute of Public Health:
p.000166: http://www.ispch.cl
p.000166:
p.000166: 1. Law No. 20.120 Regarding Scientific Research in Human Beings, their Genome, and the Prohibition of Human Cloning
p.000166: (2006): http://www.leychile.cl/Navegar?idN orma=253478
...
p.000168: 20.120 Regarding Scientific Research in Human Beings, the Genome, and the Prohibition of Human Cloning. Official Diary
p.000168: of November 19, 2011: http://www.leychile.cl/Navegar?idNo rma=1032919
p.000168: 2. Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use.
p.000168: Official Diary of June 25, 2011: http://www.ispch.cl/ley20285/t_activ a/marco_normativo/7c/ds_minsal_3_ 2010.pdf
p.000168: 3. Exempt Resolution 2263, July 30th 2015 Modifying Resolution Nº 403 Ex. February 5, 2015 that Approves the Guidelines
p.000168: for Use Control of Pharmaceuticals Products in Scientific Research: http://www.leychile.cl/Navegar?i dNorma=1080011
p.000168: 1. Supreme Decree No. 3 of 2010. Regulation of the National Control System of Pharmaceutical Products for Human Use.
p.000168: Official Diary of Jun 25, 2011: http://www.ispch.cl/ley20285/t_activ a/marco_normativo/7c/ds_minsal_3_ 2010.pdf
p.000168: 2. General Technical Rule No. 140 Regarding the National System of Pharmacovigilance of Pharmaceutical Products for
p.000168: Human Use. June 20, 2012: http://web.minsal.cl/portal/url/item/c4 a31ad6db50e085e040010165017a39. pdf
p.000168: 3. Resolution No. 441, Notification of Adverse events in Clinical Research in Chile, February13, 2012:
p.000168:
p.000168: Country Key Organizations Legislation
p.000168: Regulations Guidelines
p.000168:
p.000168: Research Injury
p.000168: Privacy/Data Protection
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Genetic Research
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Embryos, Stem Cells, and Cloning
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Colombia
p.000168:
p.000168: 1. Ministry of Health:
p.000168: http://www.minsal.cl
p.000168: 2. Ministry of the Secretary General of the Government: http://www.msgg.gob.cl
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Ministry of Health:
p.000168: http://www.minsal.cl
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Ministry of Health:
p.000168: http://www.minsal.cl
p.000168:
p.000168:
p.000168: 1. Law for the Protection of Private Life No. 19.628 (1999): http://www.bcn.cl/leyes/141599
p.000168: 2. Law No. 20584. Regulating the Rights and Duties Incumbent upon Persons in Connection with Actions Linked to their
p.000168: Health Care (2012): http://www.leychile.cl/Navegar?idN orma=1039348
p.000168: Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006):
p.000168: http://www.leychile.cl./Navegar?id Norma=253478
p.000168:
p.000168:
p.000168: Law No. 20.120: Scientific Research Involving Human Beings, Their Genome, and Prohibition of Human Cloning (2006):
p.000168: http://www.leychile.cl./Navegar?id Norma=253478
p.000168: http://www.ispch.cl/sites/default/files/ res_441.pdf
p.000168: Supreme Decree No. 41 of 2012: Regulation Regarding Clinical Records of December 15, 2012:
p.000168: http://www.leychile.cl/Navegar?idNo rma=1046753
p.000168:
p.000168:
p.000168:
p.000168:
p.000168:
p.000168: Supreme Decree No. 114 of 2010: Regulation on Law No. 20.120 Regarding Scientific Research in Human Beings, the Genome,
p.000168: and the Prohibition of Human Cloning. Official Diary of November 19, 2011: http://www.leychile.cl/Navegar?idNo
p.000168: rma=1032919
...
p.000174: http://www.controlsanitario.gob.e c/wp- content/uploads/downloads/2017/ 08/Normativa-Ensayos- Cli%CC%81nicos-Registro-
p.000174: Oficial.pdf
p.000174: 2. Regulation for the Approval of Ethics Committees (2014): http://instituciones.msp.gob.ec/i
p.000174: mages/Documentos/CNBS/1%20 normativa/Registro%20Oficial% 20Comites%20de%20Etica%20j ulio%202014.pdf
p.000174: 3. Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292 (March 11, 2008):
p.000174: https://www.controlsanitario.gob. ec/wp- content/uploads/downloads/2017/ 01/A.M.-66-REGLAMENTO- DE-PROYECTOS-EN-
p.000174: INVESTIGACION-DE- SALUD.pdf
p.000174: Ministerial Agreement No. 005216, Public Registry No. 427, Confidential Information in National Health System (January,
p.000174: 29, 2015):
p.000174: http://instituciones.msp.gob.ec/cz6/im ages/lotaip/Enero2015/Acuerdo%20 Ministerial%205216.pdf
p.000174: 1. Executive Order 1205, July 13, 2012: Regulation for the Organic Law on the Donation and Transplantation of Organs,
p.000174: Tissues, and Cells: http://181.211.7.45/legal_sis_v2/f iles/externa/Reglamento_General
p.000174: _a_la_Ley_Organica_Donacion_ y_Trasplantes.pdf
p.000174: 2. Import and Export of Human Biological Samples for research.
p.000174: Approval of Clinical Trials: https://www.controlsanitario.gob.ec/ensayos- clinicos/
p.000174:
p.000174: Country Key Organizations Legislation
p.000174: Regulations Guidelines
p.000174:
p.000174: Biological Materials
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174: Genetic Research
p.000174:
p.000174:
p.000174: Embryos, Stem Cells, and Cloning
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174: El Salvador
p.000174: General
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
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p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174: Ministry of Public Health:
p.000174: http://www.salud.gob.ec/
p.000174:
p.000174: 1. Ministry of Public Health:
p.000174: http://www.salud.gob.ec/
p.000174: 2. National Institute of Donation and Transplantation of Organs, Tissues, and Cells:
p.000174: http://www.donaciontrasplante.gob.ec/ind ot/
p.000174:
p.000174:
p.000174:
p.000174: National Health Research Ethics Committee: http://www.cneis.org.sv/
p.000174:
p.000174:
p.000174:
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p.000174:
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p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174: Organic Health Law, December 22, 2006, Articles 209-210
p.000174: (2011)
p.000174: Organic Health Law of 22 December 2006, Article 214
p.000174: (2018)
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174:
p.000174: 1. Law on Duties and Rights of Patients and Healthcare Providers, Articles 9 and 16 (2016):
p.000174: https://www.asamblea.gob.sv/sites/d efault/files/documents/decretos/171 117_073651293_archivo_document
p.000174: o_legislativo.pdf
p.000174: 2. Law on the Comprehensive Protection of Childhood and Adolescence, Article 19 (2009):
p.000174: https://www.asamblea.gob.sv/sites/d
p.000175: 175
p.000175: Ministerial Agreement No. 0088, Public Registry No. 34, (July 12,
p.000175: 2017):
p.000175: http://www.controlsanitario.gob.ec/w p- content/uploads/downloads/2017/08/ Acuerdo-Ministerial-0088-
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p.000175: /acuerdosministeriales/2018/Acuerdo Ministerial1392018NormativaCNES. pdf
p.000175:
p.000175: Drugs, Biologics, and Devices
p.000175: Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000176: 176
p.000176: 1. Governmental Agreement 712- 99, Articles 91-94 (1999): http://asisehace.gt/media/ag_712_99. pdf
p.000176: 2. Rules for the Regulation of Human Clinical Trials. Ministerial Accord 82-2019: https://medicamentos.mspas.gob.gt/p
p.000176: hocadownload/Acuerdo%20Ministeri
p.000176: Drug Surveillance -- Clinical Trials: http://www.mspas.gob.gt/index.php/servicios/f armacovigilancia
p.000176:
p.000176: Country Key Organizations Legislation
p.000176: Regulations Guidelines
p.000176: al%2082-2019.pdf
p.000176:
p.000176: Haiti
p.000176: General Ministry of Public Health and Population: http://mspp.gouv.ht/newsite/
p.000176:
p.000176: Internal Regulations (2010)
p.000176:
p.000176: Honduras
p.000176: Note: All websites and documents are in Spanish.
p.000176: General Secretariat of Health:
p.000176: http://www.salud.gob.hn/
p.000176:
p.000176:
p.000176: Code, Decree No. 65-91, Articles 175 and 176 (1996): https://www.acnur.org/fileadmin/Do cumentos/BDL/2016/10636.pdf
p.000176:
p.000176:
p.000176: Health Code, Decree No. 65-91, Articles 175 and 176
p.000176:
p.000176: Drugs, Biologics, and Devices
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Human Biological Materials
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Embryos, Stem Cells, and Cloning
p.000176:
p.000176:
p.000176: Jamaica
p.000176: General
p.000176:
p.000176:
p.000176:
p.000176: Drugs, Biologics, and Devices
p.000176:
p.000176:
p.000176: México
p.000176: Secretariat of Health:
p.000176: http://www.salud.gob.hn/
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
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p.000176:
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p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Ministry of Health, Ethics and Medico-Legal Affairs Panel: http://moh.gov.jm/
p.000176:
p.000176: Ministry of Health, Standards and Regulation Division: http://moh.gov.jm/divisions- agencies/divisions/standards-and-
p.000176: regulation-division/
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Law of Donation and Transplantation of Anatomical Organs in Human Beings (2014):
p.000176: http://www.tsc.gob.hn/leyes/Ley_do nacion_transp_organos_2014.pdf n. 329-2013
p.000176: Penal Code Decree No. 130- 2017 (2019):
p.000176: https://criterio.hn/wp- content/uploads/2019/05/C%C3
p.000176: %B3digo-Penal-1.pdf
p.000176:
p.000176:
p.000176:
p.000176:
p.000176:
p.000176: Food and Drugs Act (1975):
p.000176: http://www.moj.gov.jm/sites/default
p.000176: /files/laws/Food%20and%20Drugs
p.000176: %20Act%20LN%2065%20of%207
p.000176: 5.pdf
p.000176: Regulation for the Health Control of Products, Services, and Health Establishments (2015):
p.000176: https://honduras.eregulations.org/med ia/Acuerdo-06-2005- REGLAMENTO-PARA-EL- CONTROL-SANITARIO.pdf
p.000176:
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p.000176:
p.000176:
p.000176: Food and Drugs Regulations (1975):
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p.000178: http://www.minsa.gob.pa/
p.000178: 2. National Committee of Research Bioethics: https://cnbi.senacyt.gob.pa
p.000178: Law Nº 84 on Research with Human Beings (2019): https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Ley-N°84-
p.000178: del-14-de-mayo-de-2019-Ley-de- investigación.pdf
p.000178:
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p.000178:
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p.000178:
p.000178:
p.000178:
p.000178:
p.000178: Law 1 of 2001, Official Gazette
p.000178: 24,218:
p.000178: http://www.perezcarrera.com/leyes/l ey-registro-sanitario-panama.pdf
p.000178: 1. Law Nº 68, November 20, 2003: https://cnbi.senacyt.gob.pa/wp-
p.000179: 179
p.000179: MINSA:
p.000179: 1. Executive Decree Nº1, January 21, 2013: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto-
p.000179: Ejecutivo-N°1-del-21-de-Enero- de-2013.pdf
p.000179: 2. Executive Decree N°1843 on the National Research Ethics Committee of Panama (2014):
p.000179: https://www.gacetaoficial.gob.pa/.../G acetaNo_27716_20150206.pdf
p.000179: 3. Executive Decree N° 6 on the National Research Ethics Committee of Panama (2015):
p.000179: https://www.gacetaoficial.gob.pa/pdf Temp/27716/GacetaNo_27716_2015 0206.pdf
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Executive Directive No. 1458 of 6 November 2012: https://www.gacetaoficial.gob.pa/pdf
p.000179:
p.000179: Country Key Organizations Legislation
p.000179: Regulations Guidelines
p.000179:
p.000179: Privacy/Data Protection
p.000179:
p.000179:
p.000179:
p.000179: Human Biological Materials
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p.000179: Embryos, Stem Cells, and Cloning
p.000179:
p.000179: Paraguay
p.000179: Note: All websites and documents are in Spanish.
p.000179: content/uploads/2019/07/Ley-68- del-20-de-noviembre-de-2003.pdf 2. Law Nº81, March 26, 2019:
p.000179: https://www.gacetaoficial.gob.pa/pd fTemp/28743_A/GacetaNo_28743a
p.000179: _20190329.pdf
p.000179: Law 3 of 2010, Official Gazette 26,468-B on Transplant of Organs and Tissues: https://www.gacetaoficial.gob.pa/pd
p.000179: fTemp/26468_B/GacetaNo_26468b
p.000179: _20100210.pdf
p.000179: Law No. 3, 15 January 2004: https://docs.panama.justia.com/fede rales/leyes/3-de-2004-jan-19- 2004.pdf
p.000179: Temp/27160_A/39630.pdf
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Executive Directive No. 179 of 8
p.000179: June 2018: https://www.gacetaoficial.gob.pa/pdf Temp/28546_A/68013.pdf
p.000179:
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p.000179:
p.000179: Executive Decree Nº179, June 8, 2018: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto-Ejecutivo-
p.000179: N°-179-del-8-de-junio-de-2018.pdf
p.000179:
p.000179: General
p.000179:
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p.000179: Drugs, Biologics, and Devices
p.000179:
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p.000179: Perú
p.000179: National Institute of Health, Research Ethics Committee: http://www.ins.gov.py/
p.000179:
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p.000179: Ministry of Public Health and Social Welfare: https://www.mspbs.gov.py/index.php
p.000179:
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p.000179: Law 1119/97 Regarding Health Products and Other Products, Article 30: https://www.mspbs.gov.py/depende
p.000179: ncias/dnvs/adjunto/1d0e83- LEYN11191997DEPRODUCTOSP ARALASALUDYOTROS.pdf
p.000179: Statute and Operating Procedures (2017) (Spanish): https://www.mspbs.gov.py/dependen cias/cnbioetica/adjunto/a03ba4-
p.000179: CEIINS.VersionFinal.pdf
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p.000192: 1. Regulations Relating to the Use
p.000192: DH:
p.000192: Ethics in Health Research: Principles, Structures, and Processes (2015): http://www.nhrec.org.za/docs/Documents/Ethic
p.000192: sHealthResearchFinalAused.pdf
p.000192:
p.000192: MRC:
p.000192: 1. Guidelines on Ethics in Medical Research: General Principles (2002)
p.000192: 2. Guidelines on Ethics in the Use of Biohazards and Radiation (2003)
p.000192: 3. Guidelines on Ethics in HIV Vaccine Trials (2003)
p.000192:
p.000192: DH:
p.000192: Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2016):
p.000192: http://www.nhrec.org.za/docs/trainingrequ irements/gcp.pdf
p.000192:
p.000192: FAQs:
p.000192: http://www.sanctr.gov.za/InvestigatorbrnbspInf ormation/FAQ/tabid/200/Default.aspx
p.000192: Ethics in Health Research: Principles, Processes, and Structures, Section 3.3.7(i) (2015):
p.000192: http://www.commerce.uct.ac.za/Downloads/Et hics%20in%20Health%20Research%20Final% 20A%20used.pdf
p.000192:
p.000192: Country Key Organizations Legislation
p.000192: Regulations Guidelines
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p.000192: Materials
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p.000192: Genetic Research
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p.000192: Embryos, Stem Cells, and Cloning
p.000192:
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p.000192: Tanzania
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p.000192: Medical Research Council of South Africa (MRC): http://www.mrc.ac.za
p.000192:
p.000192: Medical Research Council of South Africa (MRC): http://www.mrc.ac.za
p.000192: Chapter 8, Sections 53-68
p.000192: (2003):
p.000192: http://www0.sun.ac.za/ruralhealth/u kwandahome/rudasaresources2009/ DOH/ethics/app5.pdf
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p.000192: National Health Act No. 61, Chapter 8, Section 57 (2003): http://www0.sun.ac.za/ruralhealth/u
p.000192: kwandahome/rudasaresources2009/ DOH/ethics/app5.pdf
p.000192: of Human Biological Material, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf
p.000192: 2. Regulations Regarding General Control of Human Bodies, Tissues, Blood Products and Gametes, 2 March 2012
p.000192: 3. Regulations Relating to Blood and Blood Products, 2 March 2012: http://www.sashg.org/documents/Gov
p.000192: Gazette2Mar2012.pdf
p.000192: 4. Regulations Relating to Artificial Insemination of Persons, 2 March 2012: http://www.sashg.org/documents/Gov
p.000192: Gazette2Mar2012.pdf
p.000192:
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p.000192: Regulations relating to Stem Cell Banks, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf
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Social / Access to Social Goods
Searching for indicator socialXwelfare:
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p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032: Bosnia and Herzegovina
p.000032: Note: All websites and documents are in Bosnian.
p.000032: General 1. Convention on
p.000032: Human Rights
p.000032: and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (2007):
p.000032: 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2007)
p.000032: 3. Law on Health Protection, MoH Republic of Srpska (2015): http://www.vladars.net/sr-SP-
p.000032: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20zdravstven
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p.000033:
p.000033: Country Key Organizations Legislation
p.000033: Regulations Guidelines
p.000033:
p.000033: General
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p.000033: Drugs, Biologics, and Devices
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p.000033: Federation of Bosnia and Herzegovina
p.000033: 1. Ministry of Health:
p.000033: http://www.fmoh.gov.ba/
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
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p.000033: Republic of Srpska
p.000033: 1. Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000033: ges/Splash.aspx
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
p.000033: oj%20zastiti%20sa%20izmjenama
p.000033: %20106-99%20%2044-15.pdf
p.000033: 4. Law on Health Protection, MoH Federation of Bosnia and Herzegovina, No 46/10:
p.000033: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- zdravstvenoj-zastiti
p.000033:
p.000033: 1. Law on Drugs No. 58/08: http://www.almbih.gov.ba/_doc/reg ulative/medicinal_products_and_me dical_devices_act.pdf
p.000033: 2. Law on Changes and Amendments of the Law on Drugs No. 29/05: http://www.almbih.gov.ba/_doc/reg
p.000033: ulative/fbih/Zakon_o_lijekovima- sluzbene_novine_FBiH_broj_29- 05.pdf
p.000033: 3. Law on Drugs Federation of Bosnia and Herzegovina, No 109/2012: http://www.fmoh.gov.ba/index.php/
p.000033: zakoni-i-strategije/zakoni/zakon-o- lijekovima-fbih
p.000033:
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p.000033: 1. Law on Drugs No. 58/08: http://www.almbih.gov.ba/_doc/reg ulative/medicinal_products_and_me dical_devices_act.pdf
p.000033: 2. Law on Changes and Amendments of Law on Drugs No. 34/08: http://www.almbih.gov.ba/_doc/reg
p.000033: ulative/rs/ID_Zakona_o_lijekovima
p.000033: _34_08.pdf
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p.000034: 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul
p.000034: ative/pravilnik_klinicka_bos.pdf
p.000034: 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf
p.000034: 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak
p.000034: se-bo.pdf
p.000034: 4. Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016):
p.000034: http://www.almbih.gov.ba/_doc/upust va- vodici/uputstvo_o_nacinu_izvjestava nja_o_sigurnosti.pdf
p.000034:
p.000034: 1. Regulation about Clinical testing of IMP and Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul
p.000034: ative/pravilnik_klinicka_bos.pdf
p.000034: 2. Regulation about Medical Devices (2010): http://www.almbih.gov.ba/_doc/regul ative/pravilnik_ms_bos.pdf
p.000034: 3. Standards of GCP in Conducting CTs (2012): http://www.almbih.gov.ba/_doc/regul ative/Smjernice_dobre_klinicke_prak
p.000034: se-bo.pdf
p.000034:
p.000034: Country Key Organizations Legislation
p.000034: Regulations Guidelines
p.000034:
p.000034: Drugs, Biologics, and Devices
p.000034:
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p.000034: Research Injury
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p.000034: Privacy/Data Protection
p.000034:
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p.000034:
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p.000034: Embryos, Stem Cells
p.000034:
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p.000034: Federation of Bosnia and Herzegovina Medicines and Medical Devices Agency of Bosnia and Herzegovina:
p.000034: http://www.almbih.gov.ba/
p.000034:
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p.000034: Republic of Srpska
p.000034: Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000034: ges/Splash.aspx
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Personal Data Protection Agency of Bosnia and Herzegovina: http://www.azlp.gov.ba/Default.aspx?lang Tag=en-
p.000034: US&template_id=147&pageIndex=1
p.000034:
p.000034:
p.000034:
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p.000034: Federation of Bosnia and Herzegovina
p.000034:
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p.000034:
p.000034:
p.000034:
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p.000034:
p.000034:
p.000034: 1. Medicinal Products and Medicinal Devices Act, Articles 52 and 116 (2008): http://www.almbih.gov.ba/_doc/reg
p.000034: ulative/medicinal_products_and_me dical_devices_act.pdf
p.000034: 2. Law on Health Insurance of the Federation of Bosnia and Herzegovina, Official Gazette No. 46/10
p.000034:
p.000034: 1. Medicinal Products and Medicinal Devices Act, Article 52 and 116
p.000034: 2. Law on Health Insurance of the Republic of Srpska, Official Gazette Republic of Srpska No. 106/09:
p.000034: http://www.farmaceutska- komora.org/images/stories/5Zakon_ o_zdravstvenoj_zastiti.pdf
p.000034: 1. Law on the Protection of Personal Data in Bosnia and Herzegovina (2005): http://www.azlp.gov.ba/propisi/Def
p.000034: ault.aspx?id=5&langTag=en- US&pageIndex=1
p.000034: 2. Law on Amendments to the Law on the Protection of Personal Data in Bosnia and Herzegovina, Official Gazette of
p.000034: Bosnia and Herzegovina No. 76/11 (2011): http://www.azlp.gov.ba/Default.asp x?langTag=en- US&template_id=147&pageIndex=
p.000001: 1
p.000001: 4. Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016):
p.000001: http://www.almbih.gov.ba/_doc/upust va- vodici/uputstvo_o_nacinu_izvjestava nja_o_sigurnosti.pdf
p.000001:
p.000001: Regulation about Clinical Testing of IMP and Medical Devices, 4/10:
p.000001: http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf
p.000001:
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p.000001: Regulation about Clinical Testing of IMP and Medical Devices, 4/10:
p.000001: http://www.almbih.gov.ba/_doc/regul ative/pravilnik_klinicka_bos.pdf
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Regulation on the Manner of Keeping the Records of Personal Data Filing Systems and the Pertinent Records Form (2009):
p.000001: http://www.azlp.gov.ba/propisi/defaul t.aspx?id=1321&langTag=bs-BA
p.000035: 35
p.000035:
p.000035: Country Key Organizations Legislation
p.000035: Regulations Guidelines
p.000035:
p.000035: and Cloning
p.000035:
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p.000035: Bulgaria
p.000035: General
p.000035: Ministry of Health: http://www.fmoh.gov.ba/
p.000035:
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p.000035: Republic of Srpska
p.000035: Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000035: ges/Splash.aspx
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p.000035: Ministry of Healthcare:
p.000035: http://www.mh.government.bg/
p.000035: 1. Law on Transplantation of Organs and Tissues, Official Gazette of Bosnia and Herzegovina No. 75/09:
p.000035: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- transplantaciji-organa-i-tkiva-u- svrhu-lijecenja
p.000035: 2. Law on Blood and Blood Products, Official Gazette of Bosnia and Herzegovina No. 09/10:
p.000035: http://www.fbihvlada.gov.ba/bosans ki/zakoni/2010/zakoni/8bos.htm
p.000035:
p.000035: 1. Law on Transplantation of Organs (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Doc
p.000035: uments/Zakon%20o%20transplanta ciji%20ljudskih%20organa.pdf
p.000035: 2. Law on Transplantation of Human Tissues and Cells (2010): http://www.vladars.net/sr-SP-
p.000035: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20transplanta ciji%20ljudskih%20tkiva%20i%20c elija.pdf
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 1. Constitution of the Republic of Bulgaria, Amendment SG. 18/25, Article 29 (2015): http://www.parliament.bg/bg/const
p.000035: 2. Oviedo Convention on Human Rights and Biomedicine (2003)
p.000035: 3. Law Ratifying the Additional Protocol on Biomedical Research (2006): https://www.mh.government.bg/me
p.000035: dia/filer_public/c6/12/c612c85a-
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p.000036: Rulebook about Testing Procedure for Donor of Transplant Organs in Terms of Diseases Which can be Transmitted by
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p.000047: 4. Ministry Decree on Medical Use of Human Organs, Tissues, and Cells No. 1302/2007
p.000047:
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p.000047: Pharmaceutical Injuries Insurance: General Terms and Conditions (2017):
p.000047: https://www.laakevahinko.fi/en/potilaille/vaku utusehdot/
p.000047: The Ethical Principles of Research with Human Participants and Ethical Review in the Human Sciences in Finland (2019):
p.000047: https://www.tenk.fi/en/ethical-review-in- finland
p.000047:
p.000047: Country Key Organizations Legislation
p.000047: Regulations Guidelines
p.000047:
p.000047: Genetic Research
p.000047:
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p.000047: Embryos, Stem Cells, and Cloning
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p.000047: France
p.000047: General
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p.000047: Drugs, Biologics, and Devices
p.000047: 2. Board for Gene Technology:
p.000047: http://www.geenitekniikanlautakunta.fi/en
p.000047:
p.000047:
p.000047:
p.000047: 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
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p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000047: 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa
p.000047: /1995/19950377
p.000047: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
p.000047: 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden:
p.000047: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf
p.000047:
p.000047:
p.000047: 1. Law No. 2012-300 of 5
...
p.000085:
p.000085: 1. Ministry of Health, Bioethics Appeals Commission (MOH) Bioethics Appeals Commission (MOH):
p.000085: https://www.gov.pl/zdrowie/odwolawcza- komisja-bioetyczna
p.000085: 2. Center of Bioethics, Polish Chamber of Physicians and Dentists (NIL): http://www.nil.org.pl/dzialalnosc/orodek-
p.000085: bioetyki
p.000085: Drugs
p.000085: Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products: http://www.urpl.gov.pl/en
p.000085: https://lovdata.no/dokument/NL/lov
p.000085: /2008-06-20-
p.000085: 44?q=helseforskningsloven
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 1. Act Relating to the Application of Biotechnology in Human Medicine, etc. (Biotechnology Act) (December 5, 2003, No.
p.000085: 100): https://lovdata.no/dokument/NL/lov
p.000085: /2003-12-05-
p.000085: 100?q=humanmedisinsk%20bruk
p.000085: 2. Act on Health Care Research:
p.000085: https://lovdata.no/dokument/NL/lov
p.000085: /2008-06-20-
p.000085: 44?q=helseforskningsloven
p.000085:
p.000085:
p.000085:
p.000085: 1. Constitution of the Republic of Poland, Article 39 (1997): http://www.sejm.gov.pl/prawo/kons t/polski/kon1.htm
p.000085: 2. Medical Profession Act, Articles 21-29 (1996): http://isap.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20190000537
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Pharmaceutical Law (2017): http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000499
p.000085:
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p.000085:
p.000085:
p.000085:
p.000085: MOH:
p.000085: Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics
p.000085: Committees (1999): http://isap.sejm.gov.pl/DetailsServlet
p.000085: ?id=WDU19990470480
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Decree of the Minister of Health on Clinical Trials on Minors (2004):
p.000085: http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20041041108
p.000085: science-and-technology/
p.000085:
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p.000085:
p.000085:
p.000085:
p.000085:
p.000085: NIL:
p.000085: Code of Medical Ethics, Chapter II (2003):
p.000085: http://www.nil.org.pl/dokumenty/kodeks-etyki- lekarskiej
p.000085:
p.000086: 86
p.000086:
p.000086: Country Key Organizations Legislation
p.000086: Regulations Guidelines
p.000086:
p.000086: Drugs, Biologics, and Devices
p.000086: Devices
p.000086: Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products:
p.000086: http://www.urpl.gov.pl/en/medical- devices
p.000086:
p.000086: Act on Medical Devices: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000175
p.000086:
p.000086: 1. Regulation of the Minister of Health on Detailed Conditions to be Met for Clinical Evaluation of Medical Devices or
p.000086: Active Implantable Medical Devices (2011): http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20110630331
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: Research Injury
p.000086:
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p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: 1. Royal Decree 1720/2007: http://www.davara.com/documentos/ relacionados/proteccion/RD_1720- 2007_english.pdf
p.000099: 2. Royal Decree of 19 January 2008
p.000099:
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p.000099:
p.000099:
p.000099: AEMPS:
p.000099: Revised Instructions for Updating the Section “Protection of Personal Data in the Subject Information Sheet (HIP /CI)
p.000099: Regarding the Regulation (EU) No.
p.000099: 2016/679 General Data Protection (2018):
p.000099: https://www.aemps.gob.es/investigacionClinica
p.000099: /medicamentos/docs/anexo8c-Ins-AEMPS- EC.pdf
p.000099:
p.000099: Country Key Organizations Legislation
p.000099: Regulations Guidelines
p.000099:
p.000099: Privacy/Data Protection
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Human Biological Materials
p.000099:
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p.000099:
p.000099: Genetic
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Ministry of Health, Consumer Affairs, and Social Welfare: http://www.msssi.gob.es/en/home.htm
p.000099:
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p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000099: December 5 on the Protection of Personal Data and Guaranteeing Digital Rights: https://www.boe.es/biblioteca_juridi
p.000099: ca/codigos/codigo.php?id=055_Prot eccion_de_Datos_de_Caracter_Pers onal&modo=1
p.000099: Law 14/2007 of July 3 on Biomedical Research, Title I, Article 11; Title III, Article 37; Title V:
p.000099: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000099:
p.000099:
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p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V: http://www.catedraderechoygenoma
p.000099: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: 1. Royal Decree 65/2006 of Requirements for the Import and Export of Biological Samples:
p.000099: http://www.boe.es/boe/dias/2006/02/ 07/pdfs/A04626-04636.pdf
p.000099: 2. Royal Decree 1723/2012 Regarding Activities of Collection, Clinical Use and Territorial Coordination of Human Organs
...
p.000179: Country Key Organizations Legislation
p.000179: Regulations Guidelines
p.000179:
p.000179: Privacy/Data Protection
p.000179:
p.000179:
p.000179:
p.000179: Human Biological Materials
p.000179:
p.000179:
p.000179:
p.000179: Embryos, Stem Cells, and Cloning
p.000179:
p.000179: Paraguay
p.000179: Note: All websites and documents are in Spanish.
p.000179: content/uploads/2019/07/Ley-68- del-20-de-noviembre-de-2003.pdf 2. Law Nº81, March 26, 2019:
p.000179: https://www.gacetaoficial.gob.pa/pd fTemp/28743_A/GacetaNo_28743a
p.000179: _20190329.pdf
p.000179: Law 3 of 2010, Official Gazette 26,468-B on Transplant of Organs and Tissues: https://www.gacetaoficial.gob.pa/pd
p.000179: fTemp/26468_B/GacetaNo_26468b
p.000179: _20100210.pdf
p.000179: Law No. 3, 15 January 2004: https://docs.panama.justia.com/fede rales/leyes/3-de-2004-jan-19- 2004.pdf
p.000179: Temp/27160_A/39630.pdf
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Executive Directive No. 179 of 8
p.000179: June 2018: https://www.gacetaoficial.gob.pa/pdf Temp/28546_A/68013.pdf
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Executive Decree Nº179, June 8, 2018: https://cnbi.senacyt.gob.pa/wp- content/uploads/2019/07/Decreto-Ejecutivo-
p.000179: N°-179-del-8-de-junio-de-2018.pdf
p.000179:
p.000179: General
p.000179:
p.000179:
p.000179:
p.000179: Drugs, Biologics, and Devices
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Perú
p.000179: National Institute of Health, Research Ethics Committee: http://www.ins.gov.py/
p.000179:
p.000179:
p.000179: Ministry of Public Health and Social Welfare: https://www.mspbs.gov.py/index.php
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Law 1119/97 Regarding Health Products and Other Products, Article 30: https://www.mspbs.gov.py/depende
p.000179: ncias/dnvs/adjunto/1d0e83- LEYN11191997DEPRODUCTOSP ARALASALUDYOTROS.pdf
p.000179: Statute and Operating Procedures (2017) (Spanish): https://www.mspbs.gov.py/dependen cias/cnbioetica/adjunto/a03ba4-
p.000179: CEIINS.VersionFinal.pdf
p.000179: For an overview of clinical research regulations in Peru, see the ClinRegs report:
p.000179: http://clinregs.niaid.nih.gov/single_country.php?c_id=170
p.000179:
p.000179: General
p.000179:
p.000179:
p.000179: Drugs, Biologics, and Devices
p.000179: National Institute of Health:
p.000179: http://www.ins.gob.pe/
p.000179:
p.000179:
p.000179: 1. National Institute of Health (INS) General Office on Research and Technology Transfer (OGITT):
p.000179: http://www.ins.gob.pe/
p.000179: 2. National Directorate of Drugs and Medical Devices (MINSA): www.digemid.minsa.gob.pe
p.000179: General Health Law No. 26842, Article 28 (1997): https://www.gob.pe/institucion/mins a/normas-legales/256661-26842
p.000179:
p.000179:
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p.000179:
p.000179:
p.000180: 180
p.000180:
p.000180:
p.000180:
p.000180: INS:
p.000180: Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials (2017):
p.000180: https://www.gob.pe/institucion/minsa
p.000180: /normas-legales/189280-021-2017-sa
p.000180: 2. Errata - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (2017): https://busquedas.elperuano.pe/norma
p.000180:
p.000180:
p.000180:
p.000180: OGITT:
p.000180: Procedures Manual for Clinical Trials (2017)
p.000180:
p.000180: Country Key Organizations Legislation
p.000180: Regulations Guidelines
...
p.000187: 2. Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187:
p.000187:
p.000187: Pharmacy and Poisons Board:
p.000187: http://www.pharmacyboardkenya.org/
p.000187:
p.000187:
p.000187:
p.000187: Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187: 1. Science and Technology Act (2001)
p.000187: 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
p.000187:
p.000187: Pharmacy and Poisons Act, Chapter 244 (2009): http://apps.who.int/medicinedocs/do cuments/s18245en/s18245en.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: MOH:
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005)
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, page 44 (2005)
p.000187: MOH:
p.000187: National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008):
p.000187: https://healthresearchweb.org/?action=downloa d&file=Final%20national%20ethical%20guidel ines-last%20draft.pdf
p.000187: Guidelines for Applications to Conduct Clinical Trials in Kenya (2014): http://pharmacyboardkenya.org/downloads/?fil
p.000187: e=Clinical%20Trial%20Guidelines%202014.p df
p.000187: For an overview of the clinical research regulations in Liberia, see the ClinRegs report:
p.000187: https://clinregs.niaid.nih.gov/single_country.php?c_id=122
p.000187:
p.000187: General
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Drugs, Biologics, and Devices
p.000187:
p.000187: Madagascar
p.000187: Drugs and Devices
p.000187: Ministry of Health and Social Welfare: http://www.mohsw.gov.lr/
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Liberia Medicines and Health Products Regulatory Authority
p.000187:
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p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Law No. 2011-002, Article 122 Regarding Clinical Trials: https://www.ilo.org/dyn/natlex/docs
p.000187: /ELECTRONIC/97799/116199/F10 71917999/MDG-97799.pdf
p.000187: 1. Institutional Review Board (IRB) Policies and Procedures Handbook (2008): http://www.ul-acre.org/wp-
p.000187: content/uploads/2013/03/UL-IRB- Policy-Handbook.pdf
p.000187: 2. Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011): http://clinregs.niaid.nih.gov/documen
p.000187: ts/liberia/G-LIBR-NHSREC.pdf
p.000187: Operational Guidelines of the National Research Ethics Board (2019):
p.000187: https://clinregs.niaid.nih.gov/sites/default/files/ documents/liberia/G-NREB-revised.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Guideline for Application to
p.000187: Conduct Clinical Trials in Liberia (2014):
p.000187: https://clinregs.niaid.nih.gov/documents/liberia
p.000187: /G-LibClinTrial.pdf
p.000187:
p.000187:
p.000187:
p.000188: 188
p.000188:
p.000188: Country Key Organizations Legislation
p.000188: Regulations Guidelines Malawi
p.000188: For an overview of the clinical research regulations in Malawi, see the ClinRegs report:
p.000188: http://clinregs.niaid.nih.gov/single_country.php?c_id=129
p.000188:
p.000188: General
p.000188:
p.000188:
p.000188:
p.000188:
...
Searching for indicator access:
(return to top)
p.000001: 2. Drugs, Biologics, and Devices
p.000001: 3. Clinical Trial Registries
p.000001: 4. Research Injury
p.000001: 5. Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards:
p.000001: https://www.hhs.gov/ohrp/international/social- behavioral-research-standards/index.html)
p.000001: 6. Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports)
p.000001: 7. Human Biological Materials
p.000001: 8. Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/)
p.000001: 9. Embryos, Stem Cells, and Cloning
p.000001: These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate
p.000001: understanding of the country’s requirements. The information is then organized into four columns:
p.000001: 1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight
p.000001: role for human subjects research.
p.000001: 2. Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent
p.000001: constitutional provisions.
p.000001: 3. Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies.
p.000001: 4. Guidelines – pertain to non-binding instruments.
p.000001: 1
p.000001:
p.000001: The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in
p.000001: parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018.
p.000001:
p.000001: HOW TO ACCESS A DOCUMENT
p.000001:
p.000001: Documents can be accessed in four possible ways:
p.000001:
p.000001: 1. Link to the web address (URL).
p.000001: 2. Search for a document at the website of the agency listed in the Key Organizations column.
p.000001: 3. Perform an Internet search on the document title.
p.000001: 4. Request a local research ethics committee to provide the document.
p.000001:
p.000001: In many cases the documents are available in English. When the URL links to a non-English website or document, an
p.000001: online language translator usually can render an English version.
p.000001:
p.000001: TOPICS NOT COVERED
p.000001:
p.000001: In order to focus its scope, the International Compilation of Human Research Standards does not include standards from
p.000001: the state, provincial, or local levels. Nor does the Compilation cover:
p.000001:
p.000001: 1. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects standards, but do not
p.000001: direct the content of those regulations.
p.000001: 2. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical bioethics,
p.000001: product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice,
p.000001: bioequivalence testing, or informed consent in clinical practice.
p.000001: 3. Ethics codes of academic, medical, or other professional organizations – see the Ethics Codes Collection:
p.000001: http://ethics.iit.edu/ecodes/about
...
p.000005:
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p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
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p.000005:
p.000005:
p.000005: World Medical Association:
p.000005: http://www.wma.net/e/
p.000005:
p.000005:
p.000005: Drugs
p.000005: International Conference on Harmonization (ICH): http://www.ich.org/
p.000005:
p.000005:
p.000005:
p.000005: World Health Organization (WHO):
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Devices
p.000005: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
p.000005:
p.000005:
p.000006: 6
p.000006: 399_ethical_considerations_en.pdf Universal Declaration on Bioethics and Human Rights (2005):
p.000006: http://portal.unesco.org/en/ev.php- URL_ID=31058&URL_DO=DO_TOPIC&U RL_SECTION=201.html
p.000006: 1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011)
p.000006: 2. Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
p.000006: 3. Managing Ethical Issues in Infectious Disease Outbreaks: Guidance Document (2016)
p.000006: 4. WHO Guidelines on Ethical Issues in Public Health Surveillance (2017)
p.000006:
p.000006: Access: http://www.who.int/ethics/publications/en/ Declaration of Helsinki (2013):
p.000006: https://www.wma.net/policies-post/wma- declaration-of-helsinki-ethical-principles-for-
p.000006: medical-research-involving-human-subjects/
p.000006:
p.000006: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (2016):
p.000006: https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4_2016_1109.pdf
p.000006: 1. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2005):
p.000006: http://whqlibdoc.who.int/publications/2005/92 4159392X_eng.pdf
p.000006: 2. Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
p.000006:
p.000006: IMDRF:
p.000006: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects-
p.000006:
p.000006: Country Key Organizations Legislation
p.000006: Regulations Guidelines
p.000006:
p.000006: Drugs, Biologics, and Devices
p.000006: Good Clinical Practice” (2015): http://www.imdrf.org/docs/imdrf/final/proced ural/imdrf-proc-150326-statement-
p.000006: iso141552011.pdf
p.000006:
p.000006: Archived Documents from the Global Harmonization Task Force (GHTF), replaced by the IMDRF in 2012:
p.000006: 1. Clinical Evaluation (2007)
p.000006: 2. Clinical Evidence – Key Definitions and Concepts (2007)
p.000006: 3. Post-Market Clinical Follow-Up Studies (2010)
p.000006: 4. Clinical Investigations (2010)
p.000006: 5. Reportable Events During Pre-Market Clinical Investigations (2012)
p.000006: 6. Clinical Evidence for IVD Medical Devices (2012)
p.000006: 7. Scientific Validity Determination and Performance Evaluation (2012)
p.000006: 8. Clinical Performance Studies for IVD Medical Devices (2012)
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Clinical Trials Registry
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Research Injury
p.000006:
p.000006:
p.000006: International Standards Organization:
p.000006: http://www.iso.org/iso/home.html
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: World Health Organization – International Clinical Trials Registry Platform: http://www.who.int/ictrp/en/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000006:
p.000006: International Committee of Medical Journal Editors: http://www.icmje.org/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000007: 7
p.000007: Access: http://www.imdrf.org/ghtf/ghtf- archived-docs.asp
p.000007: Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice. Standard Number 14155:2011:
p.000007: http://www.iso.org/iso/iso_catalogue/catalogu e_ics/catalogue_detail_ics.htm?csnumber=455 57
p.000007: Resolution WHA 58.34 (2005): http://www.wpro.who.int/health_research/poli cy_documents/ministerial_summit_on_health_
p.000007: research_may2005.pdf?ua=1
p.000007: Declaration of Helsinki, Article 35 (2013):
p.000007: http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000007: Clinical Trial Registration: http://icmje.org/recommendations/browse/pub lishing-and-editorial-issues/clinical-trial-
p.000007: registration.html
p.000007: Declaration of Helsinki, Paragraph 15 (2013):
p.000007: http://www.wma.net/en/30publications/10poli
p.000007:
p.000007: Country Key Organizations Legislation
p.000007: Regulations Guidelines
p.000007: cies/b3/index.html
p.000007:
p.000007: Research Injury
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Social- Behavioral Research
p.000007: Privacy/Data Protection
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Human Biological Materials
p.000007: International Conference on Harmonization (ICH): http://www.ich.org/
p.000007:
p.000007:
p.000007:
p.000007: Council for International Organizations of Medical Sciences: http://www.cioms.ch/
p.000007:
p.000007:
p.000007:
p.000007: UNESCO: http://www.unesco.org/
p.000007:
p.000007:
...
p.000008: Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005)
p.000008: 1. ISBER Best Practices: Recommendations for Repositories (2018)
p.000008:
p.000008: Country Key Organizations Legislation
p.000008: Regulations Guidelines
p.000008:
p.000008: Human Biological Materials
p.000008:
p.000008:
p.000008: Genetic Research
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Embryos, Stem Cells, and Cloning
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Human Genome Organization:
p.000008: http://www.hugo-international.org/
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: UNESCO Bioethics Program: http://portal.unesco.org/shs/en/ev.php- URL_ID=1372&URL_DO=DO_TOPIC&URL
p.000008: _SECTION=201.html
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: International Society for Stem Cell Research: http://www.isscr.org/
p.000008: 2. ISBER Best Practices: Recommendations for Repositories. Fourth Edition. ADDENDUM 1: Liquid Nitrogen-Based Cryogenic
p.000008: Storage of Specimens (2019): https://www.isber.org/page/BPR
p.000008: 1. Statement on the Principled Conduct of Genetic Research (1996): http://www.eubios.info/HUGO.htm
p.000008: 2. Statement on DNA Sampling: Control and Access (1998): http://www.hugo- international.org/img/dna_1998.pdf
p.000008: 3. Statement on Gene Therapy Research (2001): http://www.hugo- international.org/img/gene_2001.pdf
p.000008: 4. Statement on Human Genomic Databases (2002): http://www.hugo- international.org/img/genomic_2002.pdf
p.000008: 1. Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998-1999 (1997):
p.000008: http://unesdoc.unesco.org/images/0011/00110 2/110220e.pdf#page=47
p.000008: 2. International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences
p.000008: (2003): http://unesdoc.unesco.org/images/0013/00133 1/133171e.pdf#page=45
p.000008: Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/docs/default-source/hesc-
p.000008: guidelines/isscrhescguidelines2006.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Country Key Organizations Legislation
p.000009: Regulations Guidelines
p.000009:
p.000009:
p.000009: NORTH AMERICA
p.000009: Canada
p.000009: Note: Several Canadian provinces and territories also have human subject research standards.
p.000009: General 1. Interagency Advisory Panel on Research Ethics (PRE):
p.000009: http://www.pre.ethics.gc.ca/eng/index
p.000009: 2. National Defence and the Canadian Armed Forces: http://www.forces.gc.ca/en/index.page
p.000009: 3. Correctional Service of Canada:
p.000009: http://www.csc-scc.gc.ca/index-eng.shtml
p.000009:
p.000009:
p.000009:
p.000009: PRE:
...
p.000017: 1. HIPAA Privacy Rule, 45 CFR parts 160 and 164, Subparts A and C (2002): http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/privacyrule/index.htm l
p.000017: 2. HIPAA Security Rule, 45 CFR parts 160, 162, and 164 (2009): http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/securityrule/index.ht ml
p.000017: 3. HIPAA Breach Notification Rule, 45 CFR §164.400-414: http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/breachnotificationrule
p.000017: /index.html
p.000017: FAQ:
p.000017: http://www.research.va.gov/resources/ORD_A dmin/clinical_trials/registration-faq.pdf
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Frequently Asked Questions and Vignettes: https://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp
p.000017:
p.000017: NIH:
p.000017: 1. NIH Policy on Certificates of Confidentiality (2017): https://humansubjects.nih.gov/coc/index
p.000017: 2. Various:
p.000017: http://privacyruleandresearch.nih.gov/
p.000017:
p.000017: AHRQ:
p.000017: Confidentiality in AHRQ-Supported Research (2018): https://grants.nih.gov/grants/guide/notice- files/NOT-HS-18-012.html
p.000017:
p.000017: OCR:
p.000017: 1. OCR 21st Century Cures Act Research Guidance on Activities Preparatory to Research (2017):
p.000017: https://www.hhs.gov/sites/default/files/remote-
p.000017:
p.000017: Country Key Organizations Legislation
p.000017: Regulations Guidelines
p.000017:
p.000017: Privacy/Data Protection
p.000017: AW-111publ5/pdf/PLAW- 111publ5.pdf
p.000017: access-research-12-15-17.pdf
p.000017: 2. OCR 21st Century Cures Act Research Guidance om Streamlining Authorization (2018):
p.000017: https://www.hhs.gov/sites/default/files/hipaa- future-research-authorization-guidance- 06122018%20v2.pdf
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Human Biological Materials
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Homeland Security:
p.000017: www.dhs.gov/
p.000017:
p.000017:
p.000017: Social Security Administration:
p.000017: http://www.ssa.gov/
p.000017:
p.000017: All Common Rule agencies
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000017: Food and Drug Administration:
p.000017: a. Office of In Vitro Diagnostic Device Evaluation and Safety: https://www.fda.gov/medical-
p.000017: devices/products-and-medical- procedures/vitro-diagnostics
p.000017: b. Center for Biologics Research and Evaluation (CBER):
p.000017: - Office of Cellular, Tissue and Gene Therapies
p.000017: - Office of Blood Research and Review: https://www.fda.gov/vaccines-blood- biologics
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Public Law 107-347: https://www.gpo.gov/fdsys/pkg/PL AW-107publ347/pdf/PLAW- 107publ347.pdf
p.000017: Privacy Act (1974): http://www.hhs.gov/foia/privacy/ind ex.html
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
...
p.000019: NIH:
p.000019: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016):
p.000019: https://osp.od.nih.gov/wp- content/uploads/2013/06/NIH_Guidelines.pdf Application of Current Statutory Authorities to
p.000019: Human Somatic Cell Therapy Products and Gene Therapy
p.000019: Products. October 14, 1993. 58 FR 53248:
p.000019: https://www.fda.gov/media/76647/download
p.000019: 1. Guidelines for Human Embryonic Stem Cell Research (2005): http://www.nap.edu/catalog.php?record_id=11 278
p.000019: 2. 2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://books.nap.edu/catalog.php?record_id=12 260
p.000019: 3. 2010 Final Report of the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010
p.000019: Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://www.nap.edu/catalog.php?record_id=12 923
p.000019: 1. Removing Barriers to Responsible Scientific Research Involving Human
p.000019:
p.000019: Country Key Organizations Legislation
p.000019: Regulations Guidelines
p.000019:
p.000019:
p.000019: Embryos, Stem Cells, and Cloning
p.000019: (1993):
p.000019: https://history.nih.gov/research/dow nloads/PL103-43.pdf
p.000019: Stem Cells, Executive Order 13505 (2009):
p.000019: https://www.gpo.gov/fdsys/pkg/DCPD- 200900136/pdf/DCPD-200900136.pdf
p.000019: 2. NIH Guidelines on Human Stem Cell Research (2009): http://stemcells.nih.gov/policy/2009- guidelines.htm
p.000019: 3. NIH Human Embryonic Stem Cell Registry (2016): https://grants.nih.gov/stem_cells/registry/curre nt.htm
p.000019:
p.000019: Access: http://stemcells.nih.gov/
p.000019:
p.000019:
p.000019:
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p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Country Key Organizations Legislation
p.000020: Regulations Guidelines
p.000020:
p.000020: EUROPE
p.000020: Regionwide
p.000020:
p.000020: General
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Drugs, Biologics, and Devices
p.000020: European Commission:
p.000020: 1. European Group on Ethics in Science and New Technologies (EGE): https://ec.europa.eu/research/ege/index.cf m
p.000020: 2. Directorate-General for Research and Innovation: http://ec.europa.eu/research/participants/d
p.000020: ocs/h2020-funding-guide/cross-cutting- issues/ethics_en.htm
p.000020: Council of Europe, Bioethics Unit:
p.000020: http://www.coe.int/bioethics
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: Drugs
p.000020: European Commission:
p.000020: DG SANTE: Directorate-General for Health and Food Safety: http://ec.europa.eu/health/index_en.htm
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
...
p.000027: agency-for-health-and-food-safety/
p.000027: 2. Austrian Federal Office for Safety in Health Care: http://www.basg.at/en/austrian-federal-
p.000027: office-for-safety-in-health-care/
p.000027:
p.000027:
p.000027:
p.000027: Austrian Data Protection Authority: https://www.dsb.gv.at/DesktopDefault.asp x?alias=dsken
p.000027: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010285&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027: Austrian Drug Law (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Medical Devices Act (2014): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 1. Austrian Drug Law, Article 32 (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027: 2. Austrian Medical Devices Law, Article 47 (2017): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10011003&Sho wPrintPreview=True
p.000027: 1. Data Protection Act No. 165/1999: https://www.ris.bka.gv.at/GeltendeF assung.wxe?Abfrage=Bundesnorme
p.000027: n&Gesetzesnummer=10001597
p.000027: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000027:
p.000028: 28
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028: Various: http://www.basg.at/arzneimittel/vor-der- zulassung/klinische-pruefungen/
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Various:
p.000028: http://www.basg.at/medizinprodukte/formulare
p.000028: /klinische-pruefung/
p.000028:
p.000028: Country Key Organizations Legislation
p.000028: Regulations Guidelines
p.000028:
p.000028: Human Biological Materials
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Genetic Research
p.000028:
p.000028:
p.000028:
p.000028: Embryos, Stem Cells, and Cloning
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Belarus
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Law on Safety of Blood (2009): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10011145&Sho wPrintPreview=True
p.000028: 2. Law on Quality and Safety of Human Tissue and Cells (2013): http://www.ris.bka.gv.at/GeltendeFa
p.000028: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=20005698&Sho wPrintPreview=True
p.000028: Gene Technology Act (2012): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10010826&Sho wPrintPreview=True
p.000028: Reproductive Medicine Act (2010):
p.000028: http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10003046&Sho wPrintPreview=True
p.000028: Regulation on Tissue Banks (2014):
p.000028: http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen& Gesetzesnummer=20005848&ShowP rintPreview=True
p.000028: Bioethics Commission:
p.000028: 1. Opinion of the Bioethics Commission at the Federal Chancellery: Biobanks for Medical Research (2007)
p.000028: 2. Biobanks for Medical Research - Amendments to the Bioethics Commission Report of May 2007 (2011)
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Bioethics Commission:
p.000028: 1. Stem Cell Research in the Context of the EU’s Sixth Framework Programme Research (2002)
p.000028: 2. Research on Human Embryonic Stem Cells (2009): http://www.bundeskanzleramt.at/DocView.axd
p.000028: ?CobId=34240
p.000028: For an overview of human subject protections in Belarus, see “Ethical Review of Biomedical Research in the CIS
p.000028: Countries,” Chapter 3, Section 3:
p.000028: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000028:
p.000028: General
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs, Biologics, and Devices
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. National Bioethics Committee
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. State Pharmacological Committee
p.000028: 3. Centre for Expertise and Testing in Health Care:
p.000028: http://rceth.by/
p.000028: 1. Constitution of the Republic of Belarus, Article 25 (2004): http://www.pravo.by/WEBNPA/text
p.000028: .asp?RN=v19402875
p.000028: 2. Law on Health Care System, Articles 40, 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000028: =v19302435
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Law on Drugs, Articles 15,16 (2009): http://pravo.by/webnpa/text.asp?RN
p.000028: =h10600161
p.000028: 2. Law on Health Care System, Article 40 (2010):
p.000029: 29
p.000029: MOH:
p.000029: 1. Ordinance No. 274 on Establishing the National Bioethics Committee (2006)
...
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
p.000031: Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials
p.000031: Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000031: -advisory-committee-bioethics
p.000031: 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative-
p.000031: bodies/ct-college-clinical-trial-college
p.000031:
p.000031: Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Belgian Data Protection Authority:
p.000031: https://www.dataprotectionauthority.be/
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
...
p.000032: 1. Opinion No. 58: Financing Expensive Medication: https://www.health.belgium.be/sites/default/file
p.000032: s/uploads/fields/fpshealth_theme_file/opinion_ 58_web.pdf
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Legal Basis (2018): https://www.autoriteprotectiondonnees.be/fond ement-legal-pour-le-traitement-de-donnees-a-
p.000032: caractere-personnel
p.000032: 2. Consent (2018): https://www.autoriteprotectiondonnees.be/cons entement
p.000032: 3. International Data Transfer (2018): https://www.autoriteprotectiondonnees.be/inter national-0
p.000032: BACB:
p.000032: 1. Opinion No. 42: Umbilical Cord Blood Banks (2007)
p.000032: 2. Opinion No. 43: Commercialization of Human Body Parts (2007)
p.000032: 3. Opinion No. 45: Human Biological Material Banks Intended for Research (2009)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine
p.000032:
p.000032: Country Key Organizations Legislation
p.000032: Regulations Guidelines
p.000032:
p.000032: Human Biological Materials
p.000032: (2012)
p.000032: 5. Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applications or for Scientific Research
p.000032: Purposes (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Embryos, Stem Cells, and Cloning
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Federal Commission for Medical and Scientific Research on Embryos in Vitro:
p.000032: http://health.belgium.be/eportal/Healthcar e/Consultativebodies/Commissions/Embr yoinvitro/19076630?ie2Term=research&i
p.000032: e2section=83
p.000032: 2. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000032: 3. Belgian Advisory Committee on Bioethics: https://www.health.belgium.be/en/belgian
p.000032: -advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Act on Research on Embryos in Vitro (2003): https://organesdeconcertation.sante. belgique.be/fr/organe-d'avis-et-de-
p.000032: concertation/commission-federale- embryons
p.000032: 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007):
p.000032: https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor
p.000032: el_humain/legislation/apres_le_01_ 12_2009
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15 February
p.000032: 1999): https://organesdeconcertation.sante.be lgique.be/fr/organe-d'avis-et-de- concertation/commission-federale-
p.000032: embryons
p.000032: CSS:
p.000032: Various: https://www.health.belgium.be/en/superior- health- council?f%5B0%5D=field_shc_doc%3A1145 BACB:
p.000032: 1. Opinion No. 10: Reproductive Human Cloning (1999)
p.000032: 2. Opinion No. 18: Research on Human Embryos in Vitro (2002)
p.000032: 3. Opinion No. 33: Somatic and Germinal Line Gene Modification (2005)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032: Bosnia and Herzegovina
p.000032: Note: All websites and documents are in Bosnian.
p.000032: General 1. Convention on
p.000032: Human Rights
p.000032: and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (2007):
p.000032: 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2007)
p.000032: 3. Law on Health Protection, MoH Republic of Srpska (2015): http://www.vladars.net/sr-SP-
p.000032: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20zdravstven
p.000032:
p.000033: 33
p.000033:
p.000033: Country Key Organizations Legislation
p.000033: Regulations Guidelines
p.000033:
p.000033: General
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Drugs, Biologics, and Devices
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Federation of Bosnia and Herzegovina
p.000033: 1. Ministry of Health:
p.000033: http://www.fmoh.gov.ba/
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Republic of Srpska
p.000033: 1. Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000033: ges/Splash.aspx
...
p.000045: set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Medical Devices Act No. 629/2010 (Finnish): http://www.finlex.fi/fi/laki/kokoelm a/2010/20100085.pdf
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Decree of the National Research Ethics Council of Finland No. 1347/1991
p.000046: 2. Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016
p.000046: 3. Decrees on the National Committee on Medical Research Ethics No. 820/2010 and 788/2018
p.000046: 4. Decree on Fees, No. 1287/2018
p.000046:
p.000046: 1. Decree on Clinical Trials on Medicinal Products No. 841/2010
p.000046: 2. Other Decrees:
p.000046: http://www.finlex.fi/fi/laki/smur/1987
p.000046: /19870395#nojalla
p.000046:
p.000046: FIMEA:
p.000046: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2012:
p.000046: http://www.fimea.fi/download/22302
p.000046: _Maarays_2- 2012_kliiniset_laaketutkimukset.pdf
p.000046:
p.000046: 1. Decree (Decision) on Clinical Investigations (2010): http://www.finlex.fi/data/normit/3964 4-
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: 1. Report on Children in Medical Research (2003)
p.000046: 2. Operating Procedures of the National Committee on Medical Research Ethics (2019)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: Templates for Clinical Trial Information Leaflet and Consent Form (2018)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046: Country Key Organizations Legislation
p.000046: Regulations Guidelines
p.000046:
p.000046: Drugs, Biologics, and Devices
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Research Injury
p.000046:
p.000046:
p.000046:
p.000046: Social-Behavioral Research
p.000046:
p.000046:
p.000046: Privacy/Data Protection
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Human Biological Materials
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Genetic Research
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Finnish Patient Insurance Centre:
p.000046: https://www.pvk.fi/fi/
p.000046: 2. Pharmaceutical Injuries Insurance
p.000046: http://www.laakevahinko.fi/in-english/
p.000046:
p.000046: Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000046:
p.000046:
p.000046: Office of the Data Protection Ombudsman: https://tietosuoja.fi/en/home
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: National Supervisory Authority for Welfare and Health (Valvira): http://www.valvira.fi/web/en
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
...
p.000048: 48
p.000048:
p.000048: Country Key Organizations Legislation
p.000048: Regulations Guidelines
p.000048:
p.000048: Social-Behavioral Research
p.000048:
p.000048:
p.000048:
p.000048: Privacy/Data Protection
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
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p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: Human Biological Materials
p.000048: National Consultative Ethics Committee
p.000048:
p.000048:
p.000048:
p.000048: 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home
p.000048: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
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p.000048:
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p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Protection of Persons Committee (CPP)
p.000048: 2. Ministry of Higher Education, Research, and Innovation: http://www.enseignementsup- recherche.gouv.fr/
p.000048: 3. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne-
p.000048:
p.000048:
p.000048:
...
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Decree No. 2017-1549 of 8 November 2017 on the Conservation and Preparation for Scientific Purposes of Elements of the
p.000049: Human Body and Amending the Public Health Code
p.000049: Opinion on the Ethics of Research in the Sciences of Human Behavior No. 38 (1993): http://www.ccne-
p.000049: ethique.fr/en/publications/opinion-ethics- research-sciences-human- behaviour#.WNkybNfytEY
p.000049: CNIL:
p.000049: 1. Health Research: CNIL Adopts New Simplification Measures (2018): https://www.cnil.fr/fr/recherches-dans-le-
p.000049: domaine-de-la-sante-la-cnil-adopte-de- nouvelles-mesures-de-simplification
p.000049: 2. Health Research with Consent (2018): https://www.cnil.fr/fr/declaration/mr-001-
p.000049: recherches-dans-le-domaine-de-la-sante-avec- recueil-du-consentement
p.000049: 3. Health Research without Consent (2018): https://www.cnil.fr/fr/declaration/mr-
p.000049: 003-recherches-dans-le-domaine-de-la-sante- sans-recueil-du-consentement
p.000049: 4. Practical Guide on the Protection of Personal Data: What Framework Applies to Research? (2018):
p.000049: https://www.cnil.fr/sites/default/files/atoms/file s/guide-cnom-cnil.pdf
p.000049:
p.000049: CCNE:
p.000049: 1. Ethical Questions Arising from the Transmission of Scientific Information Concerning Research in Biology and
p.000049: Medicine (1995)
p.000049: 2. Biometrics, Identifying Data and Human Rights (2007)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis CCNE:
p.000049: 1. Umbilical Cord Blood Banks for Autologous Use for Research (2002)
p.000049: 2. Ethical Issues Raised by Collections of Biological Material and Associated Information Data: “Biobanks,”
p.000049: “Biolibraries” (2003)
p.000049:
p.000049: Country Key Organizations Legislation
p.000049: Regulations Guidelines
p.000049:
p.000049: Human Biological Materials
p.000049: Genetic Research
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Embryos, Stem Cells, and Cloning
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Georgia
p.000049: ethique.fr
p.000049:
p.000049:
p.000049: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000049: 2. Biomedicine Agency: https://www.agence- biomedecine.fr/About-us
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000049: 2. Biomedicine Agency: http://www.enseignementsup- recherche.gouv.fr/
p.000049: echCodeArticle.do
p.000049:
p.000049:
p.000049: Civil Code Articles 16-10 to 16-
p.000049: 13:
p.000049: http://www.legifrance.gouv.fr/affich Code.do;jsessionid=D2DE0231944 83D3384DE19DE8959BDDA.tpdjo
p.000049: 17v_3?idSectionTA=LEGISCTA00 0006136513&cidTexte=LEGITEX
p.000049: T000006070721&dateTexte=20131 006
p.000049:
p.000049:
p.000049: Law No. 2013-715 of 6th August 2013: http://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT000
p.000049: 027811435&dateTexte=&categorie Lien=id
p.000049:
p.000049:
p.000049:
p.000049: Article R1131-1 and Subsequent Sections of the Public Health Code: https://www.legifrance.gouv.fr/affich
p.000049: Code.do?idArticle=LEGIARTI00001 8615563&idSectionTA=LEGISCTA0
p.000049: 00006196158&cidTexte=LEGITEXT
p.000049: 000006072665&dateTexte=20191011
p.000049:
p.000049:
p.000049:
p.000049: Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following
p.000049: Sections: http://legifrance.gouv.fr/affichCode.d o?idArticle=LEGIARTI00003023346
p.000049: 9&idSectionTA=LEGISCTA0000061
p.000049: 90409&cidTexte=LEGITEXT000006
p.000049: 072665&dateTexte=20151015
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood (2013)
p.000049: 2. Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing
p.000049: (2016)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Commercialization of Human Stem Cells and Other Cell Lines (2006)
p.000049: 2. Opinion on the Ethical Reflection Concerning Research on Human Embryonic Cells and on Human Embryos in Vitro (2010)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS
p.000049: Countries,” Chapter 3, Section 4:
p.000049: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000049:
p.000049: General
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Drugs, Biologics, and Devices
p.000049: Bioethics and Health Law Studies Society: http://www.patientsrights.ge/index.php?pa ge=385&lang=geo
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs:
p.000049: http://rama.moh.gov.ge/
p.000049: 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001)
p.000049: 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195
p.000049: (2010)
p.000049: 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
p.000049:
p.000050: 50
p.000050:
p.000050:
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p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
p.000050: http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000056: 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf
p.000056: 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 91-direct-to-consumer-dtc-genetic-testing
p.000056: 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/
p.000056: OPINION_Incidental_Findings_FINAL_.pdf
p.000056: 6. Opinion on Advances in Human Genome Editing (2016): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION
p.000056: gene%20editing_Final_EN.pdf NBC:
p.000056: 1. Recommendation on the Use of Stem Cells in Biomedicine and Clinical Medicine
p.000056: 2. Recommendation on Human Reproductive Cloning
p.000056: 3. Opinion on Prenatal and Pre- implantation Diagnosis and Embryo Treatment
p.000057: 57
p.000057:
p.000057: Country Key Organizations Legislation
p.000057: Regulations Guidelines
p.000057:
p.000057: Embryos, Stem Cells, and Cloning
p.000057: Hungary
p.000057: Note: All webpages and documents are in Hungarian.
p.000057: Reproduction
p.000057: Access: http://www.bioethics.gr/index.php/gnomes
p.000057:
p.000057: General
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953
p.000057: 2. Act CLIV of 1997 on Health Care, Chapters VIII and IX: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=30903.339193
p.000057: 3. Act VI. of 2002 on the Promulgation of the Oviedo Convention on Human Rights and Biomedicine:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=64201.264663
p.000057: 4. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine,
p.000057: Concerning Biomedical Research
...
p.000061: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000061: 2. Act No. 90/2018 on Data Protection and the Processing of Personal Data: https://www.althingi.is/altext/148/s/
p.000061: 1296.html
p.000061: Biobanks Act No. 110/2000 (2015):
p.000061: https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Biobanks-Act-as-
p.000061: amended-2015.pdf
p.000061: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000061: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2004)
p.000061: 2. Act on Artificial Fertilisation and Use of Human Gametes and Embryos for Stem-Cell Research, No. 55/1996 (2010):
p.000061: http://eng.velferdarraduneyti.is/medi a/acrobat- enskar_sidur/Act_No_55_1996_on_ Artificial_Fertilisation_etc_as_amen
p.000061: ded.pdf
p.000061: of-medicinal-products-in-humans-no- 443-2004-as-amended.pdf
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Regulations on the Keeping and Utilization of Biological Samples in Biobanks No. 1146/2010:
p.000061: https://www.reglugerd.is/reglugerdir/ eftir- raduneytum/heilbrigdisraduneyti/nr/1 6910
p.000061: Regulation on Artificial Fertilization No. 144/2009: https://www.reglugerd.is/reglugerdir/
p.000061: eftir-raduneytum/heilbrigdis/nr/10797
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: NBC:
p.000061: 1. Access to and Utilisation of Health Data and Bio-Samples: http://www.vsn.is/en/content/access-and-
p.000061: utilisation-health-data-and-bio-samples
p.000061: 2. Biobanks:
p.000061: http://www.vsn.is/en/content/biobanks
p.000061: See this summary on Clinical Trials Involving Medical Products:
p.000061: http://health.gov.ie/blog/policy/clinical-trials-involving-medicinal-products/
p.000061:
p.000061: General
p.000061: Department of Health:
p.000061: http://health.gov.ie/
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062: 1. Operational Procedures for Research Ethics Committees: Guidance 2004: http://health.gov.ie/wp-
p.000062: content/uploads/2014/07/Operational_Procedur es1.pdf
p.000062: 2. Health Service Executive National
p.000062:
p.000062: Country Key Organizations Legislation
p.000062: Regulations Guidelines
p.000062:
p.000062: General
p.000062:
p.000062: Drugs, Biologics, and Devices
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Research Injury
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Privacy/Data Protection
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Human Biological Materials
p.000062:
p.000062:
p.000062:
p.000062: Genetic Research
p.000062:
p.000062:
p.000062: Italy
p.000062: General
p.000062:
p.000062:
p.000062: 1. Department of Health:
p.000062: http://health.gov.ie/
p.000062: 2. Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
...
p.000071:
p.000071:
p.000071:
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p.000071:
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p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: National Research Ethics Committee (CNER):
p.000071: http://www.cner.lu
p.000071: i/2018/03/08/a222/jo
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: 1. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural
p.000071: Persons with Regard to the
p.000071: Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data
p.000071: Protection Regulation): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000071: 2. Act of 1 August 2018 on the Organisation of the National Data Protection Commission, Articles 63-65:
p.000071: https://cnpd.public.lu/dam- assets/fr/legislation/droit-lux/Act- of-1-August-2018-on-the-
p.000071: organisation-of-the-National-Data- Protection-Commission-and-the- general-data-protection- framework.pdf
p.000071: Trials on Medicinal Products for Human Use: http://www.legilux.public.lu/leg/a/arc hives/2005/0084/2005A15161.html
p.000071: Include in the Participant Information Sheet and Informed Consent Form
p.000071: 2. Secondary Use of Samples Collected in the Framework of a Research Project
p.000071: 3. Incidental Findings
p.000071:
p.000071: Access: https://www.cner.lu/en- gb/Publications
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
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p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Guidelines Regarding Incidental Findings and Informed Consent Management in the Framework of Whole Genome Sequencing
p.000071: Research Projects: https://www.cner.lu/fr- fr/Publications
p.000071: Notes: Effective February 12, 2019, the name of the country was officially changed to the Republic of North Macedonia.
p.000071: All websites and documents are available in Macedonian.
p.000071: Drugs and Devices Drugs
p.000071:
p.000071: 1. Ministry of Health of Republic of Macedonia:
p.000071: http://moh.gov.mk/
p.000071: 2. Drug and Devices Register:
p.000071: https://lekovi.zdravstvo.gov.mk/
p.000071: 1. Law on Medicinal Products and Medical Devices (Official Gazette No.106/2007) and Laws Amending and Supplementing the
p.000071: Law (2010-2018, according
p.000072: 72
p.000072: 1. Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and the Documentation Contents
p.000072: (2009): https://lekovi.zdravstvo.gov.mk/docu
p.000072: 1. Guideline for the Clinical Trial Applicant (Annex 3) (Sub-folder 23.2) (2012):
p.000072: https://lekovi.zdravstvo.gov.mk/documents/1/1 2.Guideline for Good Clinical Practice,
p.000072:
p.000072: Country Key Organizations Legislation
p.000072: Regulations Guidelines
p.000072:
p.000072: Drugs and Devices
p.000072: 3. Drug Agency
p.000072: http://malmed.gov.mk/
p.000072: to year of amendment):
...
p.000088: Supervisory Authority for Personal Data Processing:
p.000088: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law 12/2005
p.000088:
p.000088: 1. Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001)
p.000088: 2. Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000088: 164 (2001)
p.000088:
p.000088: 1. Law No. 667/2001 On the Protection of Individuals with
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ordinance No. 57/16.08.2002 (2002):
p.000089: http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie
p.000089: MOH:
p.000089: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of
p.000089: Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: 1. Opinion 15/CNECV/95 on Embryo Research (1995)
p.000089: 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC-
p.000089: 419999D9B693/0/47CNECV2005.pdf
p.000089: 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D-
p.000089: D70A7E9AD961/0/p048_en.pdf
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: MOH:
p.000089: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: The New General Data Protection Regulation (2018):
p.000089:
p.000089: Country Key Organizations Legislation
p.000089: Regulations Guidelines
p.000089:
p.000089: Privacy/Data Protection
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Human Biological Materials
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Embryos, Stem Cells, and Cloning
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
...
p.000102: SGTAB:
p.000102: Advice for Ethical Assessments: https://www.genteknik.se/wp- content/uploads/2017/09/072_2010-Etisk-
p.000102: v%C3%A4gledning.pdf
p.000102: For an overview of human subject protections in Switzerland, see: http://kofam.ch/en/home/
p.000102:
p.000102: General
p.000102: 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000102: =en
p.000102: 2. Federal Office of Public Health, Portal for Human Research (FOPH): http://kofam.ch/en/home/
p.000102: 3. National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/
p.000102: 3. Swiss Ethics Committees on Research Involving Humans: http://www.swissethics.ch/index_e.html
p.000102: 1. Council of Europe Convention on Human Rights and Biomedicine of 4 April 1997, ETS No. 164, Articles 15- 18:
p.000102: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000102: 2. Federal Constitution of the Swiss Confederation of 18 April, 1999, RS 101, Article 118b:
p.000103: 103
p.000103: 1. Ordinance of 20 September 2013 on Clinical Trials in Human Research with the Exception of Clinical Trials (Human
p.000103: Research Ordinance, HRO), RS 810.301: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000103: 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305:
p.000103: https://www.admin.ch/opc/en/classif
p.000103: Swiss Clinical Trial Organisation, Guidelines for Good Operational Practice (GGOP) (2017):
p.000103: https://www.scto.ch/en/publications/guidel ines.html
p.000103:
p.000103: Access:
p.000103: http://www.scto.ch/en/News.html
p.000103:
p.000103: Country Key Organizations Legislation
p.000103: Regulations Guidelines
p.000103:
p.000103: General
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Drugs, Biologics, and Devices
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Drugs
p.000103: 1. Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en
p.000103: 2. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000103: =en
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Devices
p.000103: Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en
p.000103: http://www.admin.ch/opc/en/classifi ed- compilation/19995395/index.html
p.000103: 3. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30:
p.000103: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000103:
p.000103: 1. Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA), RS
p.000103: 812.21, Articles 53- 54: http://www.admin.ch/opc/en/classifi ed- compilation/20002716/index.html
p.000103: 2. Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30:
p.000103: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
...
p.000107: 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS
p.000107: 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html
p.000107: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000107: HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000107: Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi
p.000107: ed-compilation/20121176/index.html
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines
p.000107: (2009): http://zakon5.rada.gov.ua/rada/show/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: NEK-CNE:
p.000107: 1. Pre-Implantation Genetic Diagnosis, 2007/9:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf
p.000107: 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006: http://www.nek-cne.ch/fileadmin/nek-cne-
p.000107: dateien/Themen/Stellungnahmen/en/embryonen
p.000107: _en.pdf
p.000107: 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/PID_II_d.pdf
p.000107:
p.000107: Access:
p.000107: http://www.nek-cne.ch/en/topics/opinions/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Bioethics Committee:
p.000107: 1. Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006)
p.000107: 2. Ethics Expertise of Clinical Trials Medicines (2007)
p.000107:
p.000107: Country Key Organizations Legislation
p.000107: Regulations Guidelines
p.000107:
p.000107: Drugs, Biologics, and Devices
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Research Injury
p.000107:
p.000107:
p.000107: Privacy/Data Protection
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Human Biological Materials
p.000107: en/bioethics-committee
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health:
p.000107: http://www.moz.gov.ua/en/
p.000107:
p.000107:
p.000107: 1. State Service of Ukraine on Personal Data Protection
p.000107: 2. Ukrainian Parliament Commissioner for Human Rights: www.ombudsman.gov.ua
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health:
p.000107: http://www.moz.gov.ua/en/
p.000107: w/z1010-09
p.000107: 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
p.000107:
p.000107:
p.000107:
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. People's Republic of China Cyber Security Law (2016): http://www.cac.gov.cn/2016- 11/07/c_1119867116.htm
p.000120: 2. People's Republic of China Electronic Commerce Law, Articles 23-25 and 32 (2018): http://www.cac.gov.cn/2018-
p.000120: 09/01/c_1123362506.htm
p.000120:
p.000120:
p.000120: Personal Data (Privacy) Ordinance (2018): https://www.elegislation.gov.hk/hk/ cap486!en-zh-Hant- HK.pdf?FROMCAPINDEX=Y
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Tort Liability law of the People's Republic of China, Chapter 7 (2009): http://www.gov.cn/flfg/2009-
p.000120: 12/26/content_1497435.htm
p.000120: http://www.nmpa.gov.cn/WS04/CL2 077/300661.html
p.000120:
p.000120: 4. Amendment of Measures for the Registration and Administration of In Vitro Diagnostic Reagents (updated Art.20 in
p.000120: 2017): http://www.nmpa.gov.cn/WS04/CL2 077/300690.html
p.000120: 5. Administrative Measures for Recall of Medical Devices (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html
p.000120:
p.000120:
p.000120:
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Chinese Good Clinical Practice, Article 43 (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html
p.000120: 2. Administrative Measures for Recall of Medical Devices,
p.000120: 1. Ethical Review Application And Review Form
p.000120: 2. Informed Consent Form
p.000120: 3. CRF Template
p.000120: 4. Protocol Template
p.000120: 5. Clinical Trial Report Template
p.000120: 6. Required Documents List for Archiving
p.000120:
p.000120: Access: http://samr.cfda.gov.cn/WS01/CL0087/148126. html
p.000120:
p.000120:
p.000120:
p.000120: FAQs:
p.000120: http://www.chictr.org.cn/questionen.aspx
p.000120:
p.000120: Information Security Technology-Personal Information Security Specification (2017, GB/T 35273-2017):
p.000120: https://www.tc260.org.cn/front/postDetail.html
p.000120: ?id=20180124211617
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Code of Practice on the Identity Card Number and Other Personal Identifiers (2016):
p.000120: https://www.pcpd.org.hk/english/data_privacy_ law/code_of_practices/files/picode_en.pdf
p.000120: 2. Code of Practice on Human Resource Management (2016): https://www.pcpd.org.hk/english/data_privacy_
p.000120: law/code_of_practices/files/PCPD_HR_Bookle t_Eng_AW07_Web.pdf
p.000120: 1. Guideline on Vaccine Clinical Trials, Part 6 (2004): http://samr.cfda.gov.cn/WS01/CL0844/10307.h tml
p.000120: 2. Guideline on Ethical Review of Drug Clinical Trials, Appendix 1, Section 6.10
p.000120:
p.000121: 121
p.000121:
p.000121: Country Key Organizations Legislation
p.000121: Regulations Guidelines
p.000121:
p.000121: Research Injury
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Genetic Research
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: Embryos, Stem Cells, and Cloning
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
...
p.000137: http://nhrc.org.np/guidelines
p.000137: 2. Guidelines for Institutional Review
p.000137:
p.000137: Country Key Organizations Legislation
p.000137: Regulations Guidelines
p.000137:
p.000137: General
p.000137:
p.000137: Drugs, Biologics, and Devices
p.000137:
p.000137: New Zealand
p.000137: General
p.000137:
p.000137:
p.000137: Nepal Health Research Council:
p.000137: http://www.nhrc.org.np/
p.000137:
p.000137:
p.000137: 1. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/
p.000137: 2. National Ethics Advisory Committee (NEAC): http://www.neac.health.govt.nz/
p.000137: 3. Ministry of Health (MOH):
p.000137: http://www.moh.govt.nz/
p.000137: 4. Health and Disability Commissioner (HDC): http://www.hdc.org.nz/
p.000137: 5. Health and Disability Ethics Committees: http://www.ethics.health.govt.nz/
p.000137: 6. Ministry of Business, Innovation and Employment: http://www.mbie.govt.nz/
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: 1. Health Research Council Act 1990, Sections 24 and 25
p.000137: 2. New Zealand Bill of Rights Act, Article 10 (1990)
p.000137: 3. Health and Disability Commissioner Act 1994
p.000137: 4. New Zealand Public Health and Disability Act 2000, Section 16
p.000137: 5. Accident Compensation Act 2001
p.000137:
p.000137: Access:
p.000137: All New Zealand acts, bills, and regulations can be found here: http://www.legislation.govt.nz/
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: HDC:
p.000137: The Code of Health and Disability Services Consumers’ Rights (the Code of Rights) (2004):
p.000137: http://www.hdc.org.nz/the-act-- code/the-code-of-rights
p.000137: Committees (IRCs) for Health Research in Nepal (2016):
p.000137: http://nhrc.org.np/guidelines
p.000137: National Guidelines on Clinical Trials with the Use of Pharmaceutical Products (2005): http://nhrc.org.np/guidelines
p.000137:
p.000137: HRC:
p.000137: 1. Guidelines for Researchers on Health Research Involving Māori (2010)
p.000137: 2. Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members (2010)
p.000137: 3. HRC Research Ethics Guidelines (2017)
p.000137: 4. Pacific Health Research Guidelines (2014)
p.000137:
p.000137: Access: http://www.hrc.govt.nz/ethics-and- regulatory/applying-ethical-approval
p.000137:
p.000137: NEAC:
p.000137: 1. Goals, Objectives, and Desired Outcomes of an Ethical Review System (2003)
p.000137: 2. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012)
p.000137: 3. Ethical Guidelines for Intervention Studies (2012)
p.000137: Access: http://www.neac.health.govt.nz/moh.nsf/indexc m/neac-resources-publications
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: Drugs, Biologics, and Devices
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: Drugs
p.000137: 1. New Zealand Medicines and Medical Devices Safety Authority
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: 1. Accident Compensation Act 2001, Section 32 (2010)
p.000137:
p.000138: 138
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Medsafe:
p.000138: Medicines Regulations 1984
p.000138: http://www.legislation.govt.nz/regulat
p.000138: MOH:
p.000138: Standard Operating Procedures for Health and Disability Ethics Committees (2012):
p.000138: http://www.ethics.health.govt.nz/operating- procedures
p.000138:
p.000138: Medsafe:
p.000138: Good Clinical Research Practice and
p.000138:
p.000138: Country Key Organizations Legislation
p.000138: Regulations Guidelines
p.000138:
p.000138: Drugs, Biologics, and Devices
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Clinical Trials Registry
p.000138:
p.000138: Privacy/Data Protection
p.000138:
p.000138:
p.000138:
p.000138: Human Biological Materials
p.000138: (Medsafe): http://www.medsafe.govt.nz
p.000138: 2. Medicines New Zealand:
p.000138: http://www.medicinesnz.co.nz/
...
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: Hazardous Substances and New Organisms Act 1996 (2012)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Human Assisted Reproductive Technology Act 2004 (2009)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Human Assisted Reproductive Technology (HART) Order (2005):
p.000140: http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: ACART:
p.000140: 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000)
p.000140: 2. Guidelines for Research on Gametes and Non-viable Embryos (2005)
p.000140: 3. Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005)
p.000140: 4. Guidelines on Embryo Donation for Reproductive Purposes (2008)
p.000140: 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012)
p.000140: 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013)
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
p.000140: 4. Commission of Higher Education (CHED): www.ched.gov.ph/
p.000140: 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Republic Act No. 10532: An Act Institutionalizing the Philippine National Health Research System (2013):
p.000140: http://www.gov.ph/2013/05/07/repu blic-act-no-10532/
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: PHREB:
...
p.000158:
p.000158: A Model Regulatory Program for Medical Devices: An International Guide (2001):
p.000158: http://www.paho.org/English/HSP/HSE/medica l_devices.pdf
p.000158: Note: Several provinces have their own regulations pertaining to human subjects research.
p.000158:
p.000158: General
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Drugs, Biologics, and Devices
p.000158: Ministry of Health:
p.000158: https://www.argentina.gob.ar/salud
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Drugs
p.000158: National Administration of Drugs, Foods, and Medical Devices (ANMAT):
p.000158: https://www.argentina.gob.ar/anmat
p.000158: Civil and Commercial Code, Articles 26, 58, and 59 (2015): http://servicios.infoleg.gob.ar/infole
p.000158: gInternet/anexos/235000- 239999/235975/norma.htm
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000159: 159
p.000159: Ministerial Resolution 1480/2011 Approving the Guidelines for Human Health Research and Creating the National Registry
p.000159: of Health Research: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm
p.000159:
p.000159: 1. Provision ANMAT 6677/10: Regulatory Guideline for Good Clinical Practices in Clinical Pharmacological Studies
p.000159: (2010): http://www.anmat.gov.ar/Comunicad os/Dispo_6677-10_en.pdf
p.000159: 2. Provision ANMAT 12.792/2016: Request for Import of Medication /Treatment and Materials – Procedure (2016):
p.000159: http://www.anmat.gov.ar/boletin_an mat/Noviembre_2016/Dispo_12792- 16.pdf
p.000159: 3. Provision ANMAT 828/2017: Authorization of Expanded Access Programs: http://www.anmat.gov.ar/boletin_an
p.000159: mat/enero_2017/Dispo_0828-17.pdf
p.000159: Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of Health
p.000159: Research: http://servicios.infoleg.gob.ar/infolegInternet/a nexos/185000-189999/187206/norma.htm
p.000159:
p.000159: Country Key Organizations Legislation
p.000159: Regulations Guidelines
p.000159:
p.000159: Drugs, Biologics, and Devices
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: Clinical Trial Registries
p.000159:
p.000159:
p.000159:
p.000159: Privacy/Data Protection
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: Devices
p.000159: National Administration of Drugs, Foods, and Medical Devices (ANMAT):
p.000159: https://www.argentina.gob.ar/anmat
p.000159:
p.000159:
p.000159:
p.000159: National Registry of Health Research: https://www.argentina.gob.ar/salud/registr oinvestigaciones
p.000159:
p.000159:
p.000159:
p.000159: National Directorate for the Protection of Personal Data: https://www.argentina.gob.ar/aaip/datospe rsonales
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
...
p.000165: 3. Ministry of Health (MS) – National Institute of Cancer (INCA): https://www.inca.gov.br/en
p.000165: 4. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english
p.000165: Research Purposes (2011):
p.000165: https://www.inca.gov.br/sites/ufu.sti
p.000165: .inca.local/files//media/document//p ortaria-ms-gm-2201-11.pdf
p.000165: Material Stored in Previous Research: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS-
p.000165: RESOLUCOES/Resoluo_n_441_-
p.000165: _2011_-
p.000165: _Armazenamento_de_Material_Biolg ico.pdf
p.000165: 2. Decree CNS No. 2201 of 14 Sep 2001 - The National Bio- Repository and Biobank Guideline:
p.000165: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Portaria_MS_n%C2
p.000165: %BA_2.201_de_2011.pdf
p.000165: conep/documentos/CARTAS/CartaCircular014
p.000165: .pdf
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: Genetic Research
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 1. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000165: 2. National Biosafety Technical Commission (CTNBio): http://ctnbio.mcti.gov.br/inicio
p.000165: 3. National Health Council (CNS):
p.000165: http://www.conselho.saude.gov.br/
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 1. Biosafety Law 11.105/05 (2005): http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/lei/l11105.htm
p.000165: 2. Decree No. 5,591, of November 22, 2005: http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/Decreto/D5591.htm
p.000165: 3. Law 13.123/2015 (2015):
p.000165: Brazilian Legislation on Biodiversity Access (Genetic Heritage): http://www.planalto.gov.br/ccivil_0 3/_Ato2015-
p.000165: 2018/2015/Lei/L13123.htm
p.000165: 4. Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015: http://www.planalto.gov.br/ccivil_0
p.000166: 166
p.000166: ANVISA:
p.000166: Resolution – RDC No. 20 of 10 April 2014: http://www.saude.pr.gov.br/arquivos/ File/RDC_20_de_10_de_abril_2014_
p.000166: Transporte_de_material_Biologico.pd f
p.000166: CTNBio:
p.000166: 1. Instruction CTNBio No. 8 of 9 July 1997: http://ctnbio.mcti.gov.br/instrucoes- normativas/-
p.000166: /asset_publisher/3dOuwS2h7LU6/con tent/instrucao-normativa-ctnbio- n%C2%BA-8-de-09-07-97
p.000166: 2. Instruction CTNBio No. 9 of 10 October 1997: http://www.agrobiobrasil.org.br/wp- content/uploads/2014/06/CTNBio-
p.000166: Normative-Instruction-n%C2%BA-9- of-October-10-1997.pdf
p.000166:
p.000166: CNS/CONEP:
p.000166: Resolution CNS No. 340/2004: On Research on Human Genetics (2004):
p.000166: http://conselho.saude.gov.br/resoluco es/2004/Res340_en.pdf
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166: CNS/CONEP:
p.000166: 1. Guidance to Researchers and Ethics Committees about the Item
p.000166: V.1.a of CNS Resolution 340 2004: http://conselho.saude.gov.br/images/comissoes/
p.000166: conep/documentos/CARTAS/CartaCircular041
p.000166: -15.pdf
p.000166: 2. Statement on Pharmacogenetic Studies in Brazil N/° 011/2012/CONEP, 12 January 2012:
p.000166: http://www.fcm.unicamp.br/fcm/sites/default/fi les/11_-
p.000166: _Comunicado_sobre_estudos_farmacogenetico s_no_Brasil.pdf
p.000166:
p.000166: Country Key Organizations Legislation
p.000166: Regulations Guidelines
p.000166:
p.000166: Genetic Research
...
p.000176:
p.000176: Note: All websites and documents are in Spanish.
p.000176: General 1. Secretariat of Health:
p.000176: https://www.gob.mx/salud
p.000176: 2. General Health Council:
p.000176:
p.000176: General Health Law, Title V, Chapter 1, Articles 96-103:
p.000176:
p.000177: 177
p.000177:
p.000177: 1. Rule NOM-012-SSA3-2012
p.000177: Establishing Criteria for the
p.000177:
p.000177: CONBIOETICA:
p.000177: National Guidelines on the Composition
p.000177:
p.000177: Country Key Organizations Legislation
p.000177: Regulations Guidelines
p.000177:
p.000177: General
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: Drugs, Biologics, and Devices
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: Privacy/Data Protection
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: Human Biological Materials
p.000177:
p.000177:
p.000177: Genetic Research
p.000177: http://www.csg.gob.mx/
p.000177: 3. National Bioethics Commission (CONBIOETICA): https://www.gob.mx/salud/conbioetica
p.000177: 4. Federal Commission for Protection Against Health Risks (COFEPRIS): https://www.gob.mx/cofepris
p.000177:
p.000177:
p.000177: Federal Commission for Protection Against Health Risks (COFEPRIS): https://www.gob.mx/cofepris
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: Federal Institute on Access to Public Information:
p.000177: www.inai.org.mx/
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: Secretariat of Health:
p.000177: https://www.gob.mx/salud
p.000177:
p.000177:
p.000177:
p.000177: National Institute of Genomic Medicine: http://www.inmegen.gob.mx/
p.000177: Health Research (2018): http://www.diputados.gob.mx/Leyes Biblio/pdf/142_241218.pdf
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: General Health Law, Title V, Chapter I, Articles 96-103: Health Research (2014)
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: 1. Federal Law for the Protection of Personal Data in the Possession of Private Individuals (2017):
p.000177: http://www.dof.gob.mx/nota_detalle
p.000177: .php?codigo=5469949&fecha=26/0 1/2017
p.000177: 2. Federal Law on Transparency and Access to Public Information (2017): http://www.diputados.gob.mx/Leyes
p.000177: Biblio/pdf/LFTAIP_270117.pdf General Health Law, Title XIV, Articles 313-342 (2018): http://www.salud.gob.mx/unidades/
p.000177: cdi/legis/lgs/index-t14.htm
p.000177:
p.000177: 1. Biosafety Law on Genetically Modified Organisms (2017): http://www.dof.gob.mx/nota_detalle
p.000177: .php?codigo=5468449&fecha=03/0 1/2017
p.000178: 178
p.000178: Conduct of Health Research Projects (2013): http://www.salud.gob.mx/unidades/cd i/nom/compi/rlgsmpsam.html
p.000178: 2. Regulation on the General Health Law in the Matter of Health Research (2014): http://www.diputados.gob.mx/Leyes
p.000178: Biblio/regley/Reg_LGS_MIS.pdf Regulation on the General Health Law in the Matter of Health Research (2014):
p.000178: http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LGS_MIS.pdf
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: Regulation of the General Law of Health in Matter of Transplants (2014):
p.000178: http://www.diputados.gob.mx/Leyes Biblio/regley/Reg_LGS_MT.pdf Regulation on the General Health Law in the Matter of
p.000178: Health Research, Title Four, Chapter Two (2014):
p.000178: http://www.diputados.gob.mx/Leyes
p.000178: and Functioning of Research Ethics Committees (2018): https://www.gob.mx/cms/uploads/attachment/fi
p.000178: le/460756/7_Guia_CEI_2018_6a.pdf
p.000178:
p.000178:
p.000178:
p.000178:
p.000178:
p.000178: 1. Guidelines to Fulfill Good Clinical Practice in Health Research (2012):
p.000178: http://www.imss.gob.mx/sites/all/statics/profesi onalesSalud/investigacionSalud/normativaNac/ 6_Lineamientos_BPC.pdf
...
p.000180: /normas-legales/286523-655-2019- minsa
p.000180: Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials, Articles 102-103 (2017):
p.000180: https://www.gob.pe/institucion/minsa
p.000180: /normas-legales/189280-021-2017-sa Regulation on Clinical Trials in Peru: Articles 27-29:
p.000180: http://www.ins.gob.pe/portal/jerarqui a/2/990/reglamento-de-ensayos- clinicos/jer.990
p.000180: 1. Supreme Decree No. 003- 2013-JUS, Regulation of Law No. 29733 for the protection of personal information (2013):
p.000180: https://www.minjus.gob.pe/wp- content/uploads/2013/04/DS-3-2013- JUS.REGLAMENTO.LPDP_.pdf
p.000180: 2. Supreme Decree No. 009-2017- SA, Regulation of Law No. 30024 for Electronic Medical Charts (2017):
p.000180: https://busquedas.elperuano.pe/norma slegales/aprueban-el-reglamento-de- la-ley-n-30024-ley-que-crea-el-r-
p.000180: decreto-supremo-n-009-2017-sa- 1500555-3/
p.000180:
p.000180: Trinidad and Tobago
p.000180: 1. Ministry of Health
p.000180: http://www.health.gov.tt/
p.000180: 2. University of the West Indies (UWI), St. Augustine: https://sta.uwi.edu/research/ethics.asp
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000181: 181
p.000181:
p.000181: UWI:
p.000181: 1. UWI Policy on Research Ethics
p.000181: 2. Application Guidelines
p.000181: 3. Ethics Committee Protocols
p.000181:
p.000181: Country Key Organizations Legislation
p.000181: Regulations Guidelines
p.000181:
p.000181: Trinidad and Tobago
p.000181: Uruguay
p.000181: Note: All websites and documents are in Spanish.
p.000181: Access:
p.000181: https://sta.uwi.edu/research/ethics.asp
p.000181:
p.000181: General
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: Drugs, Biologics, and Devices
p.000181:
p.000181:
p.000181:
p.000181: Research Injury
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: Privacy/Data Protection
p.000181:
p.000181:
p.000181:
p.000181: Human Biological Materials
p.000181:
p.000181: Venezuela
p.000181: Ministry of Public Health:
p.000181: http://www.msp.gub.uy/
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: Ministry of Public Health:
p.000181: http://www.msp.gub.uy/
p.000181:
p.000181:
p.000181:
p.000181: Ministry of Public Health:
p.000181: http://www.msp.gub.uy/
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: Ministry of Public Health:
p.000181: http://www.msp.gub.uy/
p.000181:
p.000181:
p.000181:
p.000181: 1. Ministry of Public Health:
p.000181: http://www.msp.gub.uy/
p.000181: 2. National Institute on Donation and Transplantation: www.indt.edu.uy
p.000181: 1. Decree 189/998 http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/ GMC_RES_1996-
p.000181: 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF
p.000181: 2. Decree 379/008:
p.000181: http://www.elderechodigital.com.uy
p.000181: /smu/legisla/D0800379.html Decree 189/998: http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/
p.000181: GMC_RES_1996-
p.000181: 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF
p.000181: 1. Decree 189/998 http://www.mercosur.int/msweb/No rmas/normas_web/Resoluciones/PT/ GMC_RES_1996-
p.000181: 129_PT_RT%20Verifica%20BPPes quisaClinica.PDF
p.000181: 2. Decree 379/008:
p.000181: http://www.elderechodigital.com.uy
...
p.000189: 3. National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (2012)
p.000189: 4. National Policy Requirements and Guidance for the Provision of Insurance Cover for Research Participants in Clinical
p.000189: Trials in Malawi (2012)
p.000189:
p.000189: NHSRC:
p.000189: 1. Operational Guidelines (2001)
p.000189: 2. Summary Guidelines for Writing Research Proposals (2001)
p.000189:
p.000189: COMREC:
p.000189: General Guidelines on Health Research (2014): http://www.medcol.mw/comrec/wp-
p.000189: content/uploads/2014/07/comrec_guidelines.pd f
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: Framework of Guidelines for Research in the Social Sciences and Humanities in
p.000189:
p.000189: Country Key Organizations Legislation
p.000189: Regulations Guidelines
p.000189:
p.000189: Social-Behavioral Research
p.000189:
p.000189: Human Biological Materials
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: Genetic Research
p.000189:
p.000189:
p.000189: Mali
p.000189:
p.000189:
p.000189:
p.000189: National Commission for Science and Technology: www.ncst.mw
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: National Research Council of Malawi (NRCM): www.sdnp.org.mw/nrcm/
p.000189:
p.000189:
p.000189:
p.000189: National Regulatory Requirement and Position on Accessing, Collection, Storage, and Use of Human Biological Specimens
p.000189: for Research (2014): https://www.ncst.mw/wp- content/uploads/2014/03/National- regulatory-requirement-on-human-
p.000189: samples.pdf
p.000189: Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi (2002)
p.000189: Malawi (2011): http://www.ncst.mw/wp- content/uploads/2014/03/NATIONAL- FRAMEWORK-OF-GUIDELINES-IN-
p.000189: SSH.pdf
p.000189: Circular on Human Biological Samples and Participants Recompense in Research Involving Human Subjects (2019):
p.000189: https://clinregs.niaid.nih.gov/sites/default/files/ documents/malawi/CIRCULAR.ON_.SAMPL ES.AND_.RECOMPENSE-RECs.pdf
p.000189: For an overview of human subject protections in Mali, see:
p.000189: https://clinregs.niaid.nih.gov/single_country.php?c_id=132&utm_medium=GovDelivery&utm_source=ClinRegs&utm_campaign=MaliP
p.000189: ublication#_top
p.000189:
p.000189: Drugs, Biologics, and Devices
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: Mozambique
p.000189: Directorate of Pharmacy and Medicine
p.000189: Law No. 09-059 of 28
p.000189: December 2009 Governing Biomedical Research on Humans: https://clinregs.niaid.nih.gov/docum ents/LawNo09-059.pdf
p.000189: Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (2017)
p.000189: (French): https://clinregs.niaid.nih.gov/sites/def ault/files/documents/mali/DecreeNo2 017-0245.pdf
p.000189: For an overview of human subject protections in Mozambique, see:
p.000189: http://elearning.trree.org/course/view.php?id=14&lang=en
p.000189: General
p.000189: Science and Technology
p.000189: Ethics Code
p.000189: (2007):
p.000189: http://elearning.trree.org/pluginfile.php/34764/ mod_folder/content/0/02- CodigoDeEtica.pdf?forcedownload=1
p.000189: Nigeria
p.000189: For an overview of human subject protections in Nigeria, see: http://elearning.trree.org/mod/page/view.php?id=142
p.000189:
p.000189: General
p.000189: National Health Research Ethics Committee: http://nhrec.net/
...
Searching for indicator accessXtoXinformation:
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p.000077: http://ms.gov.md/?q=comitetul-national- etica
p.000077: 2. Medicines and Medical Devices Agency:
p.000077: http://www.amed.md/
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Ministry of Health
p.000077: (MOH): http://www.ms.gov.md/
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: National Center for Personal Data Protection of the Republic of Moldova: http://www.datepersonale.md/en/start/
p.000077: 1. Law No. 1409 Dated 17.12.1997 on Medicines, Articles 11 and 12: http://lex.justice.md/index.php?actio
p.000077: n=view&view=doc&lang=1&id=31 1586
p.000077: 2. Law No. 263 Dated 27.10.2005 on Patients’ Rights and Responsibilities. Articles 9, 10, 11, 12, 13, and 14:
p.000077: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=31 3060
p.000077:
p.000077: 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
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: 1. Convention No. 108 for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1981):
p.000077: http://datepersonale.md/en/internati onal003/
p.000077: 2. Decision of Parliament No. 483-XIV Dated 02.07.1999 on Ratification of Convention No. 108:
p.000077: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=30 9121
p.000077: 3. Law No. 982 Dated 11.05.2000 on Access to Information: http://lex.justice.md/index.php?actio
p.000077: n=view&view=doc&lang=1&id=31 1759
p.000077: MOH:
p.000077: 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trial:
p.000077: http://lex.justice.md/md/362783/ 2. Order No.648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of
p.000077: Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000077: %20MS%20nr.%20648.pdf
p.000077: 1. Government Decision No. 5/18.01.2016 Regarding the National Committee for Ethical Expertise of Clinical Trials:
p.000077: http://lex.justice.md/md/362783/ 2. Order No. 648/12.08.2016 Concerning the Regulation of Authorizing the Conduct of
p.000077: Clinical Trials in the Republic of Moldova: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000077: %20MS%20nr.%20648.pdf
p.000077: Decision of Government No. 1123 Dated 14.12.2010 on the Approval of the Requirements for the Assurance of Personal Data
p.000077: Security at their Processing within the Information Systems of Personal Data: http://www.datepersonale.md/file/hot
p.000077: ariri/cerinte_securitate%20eng_10122 8.pdf
p.000078: 78
p.000078:
p.000078: Country Key Organizations Legislation
p.000078: Regulations Guidelines
p.000078:
p.000078: Privacy/Data Protection
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: Human Biological Materials
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
...
p.000101: Regulations Guidelines
p.000101:
p.000101: Drugs, Biologics, and Devices
p.000101: Drugs
p.000101: Medical Products Agency:
p.000101: https://lakemedelsverket.se/english/
p.000101:
p.000101:
p.000101:
p.000101: Devices
p.000101: Medical Products Agency: http://www.lakemedelsverket.se/english/pr oduct/Medical-devices/Clinical- Investigations/
p.000101:
p.000101: 1. Pharmaceuticals Act No. No 2015:315: https://open.karnovgroup.se/halso- och-sjukvard/lakemedelslagen
p.000101:
p.000101:
p.000101: 1. Swedish Medical Devices Act (SFS 1993:584): http://www.notisum.se/rnp/sls/lag/1 9930584.htm
p.000101: 2. Medical Devices Ordinance (SFS1993:876): http://www.riksdagen.se/sv/dokume nt-lagar/dokument/svensk-
p.000101: forfattningssamling/forordning- 1993876-om-medicintekniska_sfs- 1993-876
p.000101:
p.000101: MPA Regulations on Clinical Trials in Humans -- LVFS 2011:19:
p.000101: http://www.lakemedelsverket.se/upl oad/lvfs/LVFS_2011_19.pdf
p.000101:
p.000101: Swedish Implementation of Directive 93/42/EEC -- LVFS 2003:11:
p.000101: https://lakemedelsverket.se/uploa d/lvfs/LVFS_2003-11.pdf
p.000101:
p.000101: Social-Behavioral Research
p.000101:
p.000101:
p.000101:
p.000101:
p.000101: Privacy/Data Protection
p.000101: Swedish Research Council
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101: Swedish Data Protection Agency (SDPA):
p.000101: http://www.datainspektionen.se/in-english/
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101: 1. Patient Data Act: SFS 2008:355: http://www.notisum.se/rnp/sls/lag/2 0080355.htm
p.000101: 2. SFS 2009:400 - Public Access to Information and Secrecy Act: http://www.notisum.se/rnp/sls/lag/2 0090400.htm
p.000101: 3. Act on Certain Health Research Registers, SFS 2013:794: http://www.notisum.se/Pub/Doc.asp
p.000101: x?url=/rnp/sls/lag/20130794.htm
p.000101: 4. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000101: 5. Act (2018:218) Complement to the GDPR: https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk-
p.000101: forfattningssamling/lag-2018218-
p.000101:
p.000102: 102
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: SFS 2009:641 - Public Access to Information and Secrecy Ordinance: http://www.notisum.se/rnp/sls/lag/20 090641.htm
p.000102: Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2017):
p.000102: https://www.vr.se/english/analysis-and- assignments/we-analyse-and-evaluate/all-
p.000102: publications/publications/2017-08-31-good- research-practice.html
p.000102: 1. General Data Protection Regulation (2018): https://www.datainspektionen.se/lagar-
p.000102: -regler/dataskyddsforordningen/
p.000102: 2. Transmission to Third Countries (2018): https://www.datainspektionen.se/lagar--
p.000102: regler/dataskyddsforordningen/tredjelandsoverf oring/
p.000102:
p.000102: Country Key Organizations Legislation
p.000102: Regulations Guidelines
p.000102:
p.000102: Privacy/Data Protection
p.000102: Human Biological Materials
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Genetic Research
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Embryos, Stem Cells, and Cloning
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Switzerland
p.000102:
p.000102: 1. Health and Social Care Inspectorate (IVO):
p.000102: https://www.ivo.se/om-ivo/other- languages/english/
p.000102: 2. Biobank Sweden:
p.000102: http://biobanksverige.se/
p.000102:
p.000102:
p.000102:
p.000102: 1. Medical Products Agency:
p.000102: https://lakemedelsverket.se/english/
p.000102: 2. The Swedish Gene Technology Advisory Board (SGTAB): https://www.genteknik.se/
p.000102:
p.000102:
p.000102:
...
p.000194:
p.000194:
p.000194: Privacy/Data Protection
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Human Biological Materials
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medical Research Council of Zimbabwe: http://www.mrcz.org.zw
p.000194:
p.000194: Drugs
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Devices
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/devices.html
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Registrar General: http://www.rg.gov.zw/ Zimbabwe National Statistics Agency: http://www.zimstat.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Research Council of Zimbabwe: www.rcz.ac.zw
p.000194: National Health Research Act, Part VI (2013):
p.000194: http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health
p.000194: %20%20Research%20%20Act%20 2013.pdf
p.000194:
p.000194: 1. Medical Research Government Notice Act (1974)
p.000194: 2. Research Act (1986)
p.000194:
p.000194: Medicines and Allied Substances Control Act, Chapter 15:03 (1997)
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medicines and Allied Substances Control Act, Chapter 15:03 (1997):
p.000194: https://www.unodc.org/res/cld/docu ment/zwe/medicines-and-allied- substances-control- act_html/Zimbabwe_Medicines_and
p.000194: _Allied_Substances_Control_Act.p df
p.000194: 1. Constitution of Zimbabwe of 2013, Section 57: https://www.constituteproject.org/co nstitution/Zimbabwe_2013.pdf
p.000194: 2. Access to Information and Protection of Privacy Act, Chapter 10:27: www.fesmedia-
p.000194: africa.org/uploads/media/Acess_to_ Information_Zimbabwe
p.000194: Research Act (2001): http://faolex.fao.org/docs/pdf/zim93 551.pdf
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: 1. Medicines and Allied Substances Control Act, General Regulations (1991)
p.000194: 2. Statutory Instrument 150 of 1991
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medicines and Allied Substances Control (Condom) Regulations (2005):
p.000194: http://www.mcaz.co.zw/index.php/do wnloads/category/15-regulations-and- guidelines?download=29:condom- regulations
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Various: http://www.mrcz.org.zw/faqs/
p.000194:
p.000194:
p.000194:
p.000194: 1. Guidelines for Good Clinical Practice (2012): http://www.medbox.org/guidelines-
p.000194: for-good-clinical-trial-practice-in-zimbabwe- 2012/download.pdf
p.000194: 2. Pharmacy Guidelines for Investigational Drugs (2016): http://www.mcaz.co.zw/index.php/downloads/f
p.000194: ile/114-pharmacy-guidelines-for- investigational-drugs-draft-1
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
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p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Various: http://www.rcz.ac.zw/research- registration/
p.000194:
p.000194:
p.000194:
p.000195: 195
p.000195:
p.000195: Country Key Organizations Legislation
p.000195: Regulations Guidelines
p.000195:
p.000195: Genetic Research
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Searching for indicator foia:
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p.000017:
p.000017: Privacy/Data Protection
p.000017: AW-111publ5/pdf/PLAW- 111publ5.pdf
p.000017: access-research-12-15-17.pdf
p.000017: 2. OCR 21st Century Cures Act Research Guidance om Streamlining Authorization (2018):
p.000017: https://www.hhs.gov/sites/default/files/hipaa- future-research-authorization-guidance- 06122018%20v2.pdf
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Human Biological Materials
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Homeland Security:
p.000017: www.dhs.gov/
p.000017:
p.000017:
p.000017: Social Security Administration:
p.000017: http://www.ssa.gov/
p.000017:
p.000017: All Common Rule agencies
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000017: Food and Drug Administration:
p.000017: a. Office of In Vitro Diagnostic Device Evaluation and Safety: https://www.fda.gov/medical-
p.000017: devices/products-and-medical- procedures/vitro-diagnostics
p.000017: b. Center for Biologics Research and Evaluation (CBER):
p.000017: - Office of Cellular, Tissue and Gene Therapies
p.000017: - Office of Blood Research and Review: https://www.fda.gov/vaccines-blood- biologics
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Public Law 107-347: https://www.gpo.gov/fdsys/pkg/PL AW-107publ347/pdf/PLAW- 107publ347.pdf
p.000017: Privacy Act (1974): http://www.hhs.gov/foia/privacy/ind ex.html
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Predominantly Exempt categories 4, 7, and 8, and Expedited
p.000018: categories 2, 3, and 5 in the
p.000018: Common Rule (2018): https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text-
p.000018: unofficial-2018-requirements.pdf
p.000018: Various: https://www.hhs.gov/hipaa/for- professionals/special- topics/research/index.html and
p.000018: https://www.hhs.gov/hipaa/for-
p.000018: professionals/faq/research-uses-and-disclosures
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/biological-materials-and- data/index.html
p.000018: 1. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not
p.000018: Individually Identifiable (2006): https://www.fda.gov/regulatory- information/search-fda-guidance-
p.000018: documents/guidance-informed-consent-vitro- diagnostic-device-studies-using-leftover- human-specimens-are-not
p.000018: 2. In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (2010) : https://www.fda.gov/regulatory-
p.000018: information/search-fda-guidance-
p.000018: documents/vitro-diagnostic-ivd-device-studies-
...
Searching for indicator freedomXofXinformation:
(return to top)
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Clinical Trials Registry
p.000051:
p.000051: Research Injury
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Privacy/Data Protection
p.000051:
p.000051: Note: The 16 German states also have data protection
p.000051: Drugs
p.000051: 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html
p.000051: 2. Paul-Ehrlich-Institut (PEI):
p.000051: http://www.pei.de/EN/home/node.html4
p.000051: 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Devices
p.000051: 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html
p.000051: 2. Paul-Ehrlich-Institut (PEI):
p.000051: http://www.pei.de/EN/home/node.html4
p.000051: 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000051: German Clinical Trials Register (DRKS):
p.000051: https://www.drks.de/drks_web/setLocale_ EN.do
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: 1. Federal Commissioner for Data Protection and Freedom of Information: https://www.bfdi.bund.de/EN/
p.000051: 2. Datenschutzkonferenz (DSK): https://www.datenschutzkonferenz- online.de/
p.000051:
p.000051: Medicinal Products Act, Sixth Chapter (2019): http://www.gesetze-im- internet.de/amg_1976/
p.000051:
p.000051: 2016 English version, without amendments:
p.000051: Medicinal Products Act, Sixth Chapter (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a mg.html#p0925
p.000051:
p.000051:
p.000051:
p.000051: Act on Medical Devices, Fourth Chapter (2019): http://www.gesetze-im- internet.de/mpg/
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: 1. Medicinal Products Act, Section 40(3) (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a
p.000051: mg.html#p0926
p.000051: 2. Act on Medical Devices, Section 20(3) (2019): http://www.gesetze-im- internet.de/mpg/ 20.html
p.000051: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000051: 2. Federal Data Protection Act (BDSG) (2017): https://www.gesetze-im- internet.de/englisch_bdsg/index.htm
p.000052: 52
p.000052:
p.000052: 1. Promulgation on the Principles of the Conduct of Clinical Trials of Drugs According to the Rules (1987)
p.000052: 2. Second Promulgation on the Clinical Trial of Drugs in Human (1997)
p.000052: 3. Regulation on the Application of Good Clinical Practice in the Conduct of Clinical Trials of Medicinal Products for
p.000052: Human Use (2012):
p.000052: http://www.gesetze-im- internet.de/gcp-v/
p.000052:
p.000052: Regulation on Clinical Trials of Medical Devices (2014): http://www.gesetze-im- internet.de/mpkpv/
p.000052:
p.000052: BfArM and PEI:
p.000052: Third Notification on the Clinical Trials of Medicinal Products for Humans (2006):
...
p.000059:
p.000059: Privacy/Data Protection
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Human Biological Materials
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Genetic Research
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Embryos, Stem Cells, and Cloning
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Iceland
p.000059: General
p.000059: Information: http://www.naih.hu/general- information.html
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: Ministry of Human Capacities (EMMI):
p.000059: http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059:
p.000059: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059: 2. Medical Research Council, Committee for Human Reproduction (HRB): https://ett.aeek.hu/hrb/
p.000059:
p.000059: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000059: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/hrb/
p.000059:
p.000059:
p.000059: 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000059: 2. National Bioethics Committee
p.000059: Related Data: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=99700047.TV&celp ara=#xcelparam
p.000059: 2. Act CXII of 2011 on Right of Informational Self- Determination and Freedom of Information:
p.000059: http://net.jogtar.hu/jr/gen/hjegy_d oc.cgi?docid=A1100112.TV&cel para=#xcelparam
p.000059: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Act LXXX of 2006 on the
p.000059: Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Transplantation
p.000059: of Organs and Tissues of Human Origin: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000059: .cgi?docid=A0600080.TV&celpara
p.000059: =#xcelparam
p.000059: Act XXI of 2008 on the Rules of Protection of Human Genetic Data, of Human Genetic Examinations and Research and of the
p.000059: Operation of Biobanks: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000059: .cgi?docid=A0800021.TV&celpara
p.000059: =#xcelparam
p.000059: 1. Act CLIV of 1997 on Health Care, Chapter IX
p.000059: 2. Act VI of 2002 on the Promulgation of the Convention on Human Rights and Medicine and the Additional Protocol on
p.000059: Cloning: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000059: .cgi?docid=A0200006.TV&celpara
p.000059: =#xcelparam
p.000059:
p.000059: 1. Act on Scientific Research in the Health Sector No. 44/2014: https://www.government.is/media/v elferdarraduneyti-
p.000060: 60
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 18/1998 (XII 27) EüM on Implementing Act CLIV of 1997 on Health Care as Regards Transplantation and Storage of
p.000060: Organs and Tissues and Certain Histopathology Examinations: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000060: gi?docid=99800018.EUM&celpara=# xcelparam
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
...
Social / Age
Searching for indicator age:
(return to top)
p.000056:
p.000056:
p.000056: Genetic Research
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: Embryos, Stem Cells, and Cloning
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: National Bioethics Commission (NBC):
p.000056: http://www.bioethics.gr/index.php?catego ry_id=3
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000056: 2. National Authority for Medically Assisted Reproduction
p.000056: Regulation (2016): https://www.lawspot.gr/nomikes- plirofories/nomothesia/genikos- kanonismos-gia-tin-prostasia-
p.000056: dedomenon?lspt_context=gdpr
p.000056: 1. Greek Constitution 1975/1986/2001, Article 5.5
p.000056: 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000056: 2819/2000 and 2915/2000):
p.000056: http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF
p.000056: 4. Act 3418/2005 Code on Medical Ethics
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction)
p.000056: 3. Act 3305/2005 Application of Medically Assisted
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf
p.000056: 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_genetic_data_e ng.pdf
p.000056: 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf
p.000056: 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 91-direct-to-consumer-dtc-genetic-testing
p.000056: 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/
p.000056: OPINION_Incidental_Findings_FINAL_.pdf
...
Social / Child
Searching for indicator child:
(return to top)
p.000070: 92234C/VCRurdZydD
p.000070: Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000070: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000070: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2002):
p.000070: http://www.coe.int/en/web/conventi ons/full-list/-/conventions/treaty/168
p.000070: 2. Law on Ethics of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000070: 3. Changes of Law on Ethics of Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0
p.000070: 5f11e7910a89ac20768b0f
p.000070: (2016): https://www.e- tar.lt/portal/lt/legalAct/c86cf490b3be 11e598c4c7724bda031b/IaIhDiebov
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 1. Decree No. V-660 on the Procedure to Issue Authorization for the Transit of Tissues of Human Embryonic Tissue,
p.000070: Embryonic Stem Cells and their Lines, Fetal Tissue, and Fetal Stem Cells throughout the Territory of the Republic of
p.000070: Lithuania (2007): https://www.e- tar.lt/portal/lt/legalAct/TAR.8A75E7 9827FD
p.000070: 2. Decree No. V-659 on the Procedure for Importing of the Stem Cells Taken from the Umbilical Cord or Placenta after
p.000070: the Birth of a Child and the Samples Taken for Genetic Research into the Territory of the Republic of Lithuania and
p.000070: Exporting Therefrom (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.E2473B1 958CA/gEtbNSRzzc
p.000070:
p.000070: Note: All websites and documents are available in French.
p.000070: General National Ethics Commission:
p.000070: http://www.cne.lu
p.000070:
p.000070: Various: http://www.cne.public.lu/fr/publications/a vis.html
p.000070:
p.000070: Drugs, Biologics, and Devices
p.000070: 1. Ministry of Health:
p.000070: http://www.ms.public.lu and
p.000070: Hospitals Act of 1998 (2010):
p.000070: http://legilux.public.lu/eli/etat/leg/lo
p.000071: 71
p.000071: Grand-Ducal Decree of May 30, 2005 on the Conduct of Clinical
p.000071: CNER:
p.000071: 1. Guidance Regarding Elements to
p.000071:
p.000071: Country Key Organizations Legislation
p.000071: Regulations Guidelines
p.000071:
p.000071: Drugs, Biologics, and Devices
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Privacy/Data Protection
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Genetic Research
p.000071:
p.000071:
p.000071:
p.000071: Macedonia
p.000071: http://www.sante.lu
p.000071: 2. National Research Ethics Committee (CNER): http://www.cner.lu
p.000071: 3. Division of Pharmacy and Medicines of the Ministry of Health: http://www.sante.public.lu/fr/politique-
...
Searching for indicator children:
(return to top)
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
...
p.000012: 29 CFR 21
p.000012:
p.000012:
p.000012:
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
p.000014: General
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Drugs, Biologics, and Devices
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/
p.000014: Social Security Administration:
p.000014: http://www.ssa.gov/
p.000014:
p.000014: Drugs and Biologics
p.000014: Food and Drug Administration: https://www.fda.gov/Drugs and https://www.fda.gov/vaccines-blood- biologics
p.000014:
p.000014:
p.000014:
p.000014:
...
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Medicines Act No. 395/1987: http://www.finlex.fi/fi/laki/smur/19 87/19870395
p.000045: 2. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000045: set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Medical Devices Act No. 629/2010 (Finnish): http://www.finlex.fi/fi/laki/kokoelm a/2010/20100085.pdf
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Decree of the National Research Ethics Council of Finland No. 1347/1991
p.000046: 2. Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016
p.000046: 3. Decrees on the National Committee on Medical Research Ethics No. 820/2010 and 788/2018
p.000046: 4. Decree on Fees, No. 1287/2018
p.000046:
p.000046: 1. Decree on Clinical Trials on Medicinal Products No. 841/2010
p.000046: 2. Other Decrees:
p.000046: http://www.finlex.fi/fi/laki/smur/1987
p.000046: /19870395#nojalla
p.000046:
p.000046: FIMEA:
p.000046: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2012:
p.000046: http://www.fimea.fi/download/22302
p.000046: _Maarays_2- 2012_kliiniset_laaketutkimukset.pdf
p.000046:
p.000046: 1. Decree (Decision) on Clinical Investigations (2010): http://www.finlex.fi/data/normit/3964 4-
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: 1. Report on Children in Medical Research (2003)
p.000046: 2. Operating Procedures of the National Committee on Medical Research Ethics (2019)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: Templates for Clinical Trial Information Leaflet and Consent Form (2018)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046: Country Key Organizations Legislation
p.000046: Regulations Guidelines
p.000046:
p.000046: Drugs, Biologics, and Devices
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Research Injury
p.000046:
p.000046:
p.000046:
p.000046: Social-Behavioral Research
p.000046:
p.000046:
p.000046: Privacy/Data Protection
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Human Biological Materials
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Genetic Research
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Finnish Patient Insurance Centre:
p.000046: https://www.pvk.fi/fi/
p.000046: 2. Pharmaceutical Injuries Insurance
p.000046: http://www.laakevahinko.fi/in-english/
p.000046:
p.000046: Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000046:
p.000046:
...
p.000060: Organs and Tissues and Certain Histopathology Examinations: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000060: gi?docid=99800018.EUM&celpara=# xcelparam
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 30/1998. (VI. 24.) of the Minister of Welfare on Regulations on Specific Procedures for Human Reproduction:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=99800030.NM&celpara=#x celparam
p.000060:
p.000060: Regulation on the Structure of Research Projects in the Health Sector, Including Research Protocol, Internal
p.000060: Monitoring, and
p.000060: and Data Processors (2018): http://www.naih.hu/felkeszueles-az- adatvedelmi-rendelet-alkalmazasara.html
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
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p.000060:
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p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Decree 60/2003. (X. 20.) of the Minister of Health, Social and Family Affairs on the Minimum Professional Requirements
p.000060: Necessary for Providing Health Services: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =A0300060.ESC&celpara=#xcelparam
p.000060:
p.000060:
p.000060: Decree 18/1998. (XII. 27.) of the Minister of Health on Implementing Act CLIV of 1997 on Health Care Regarding
p.000060: Transplantation and Storage of Organs and Tissues and Certain Histopathology Examinations:
p.000060: http://net.jogtar.hu/jr/gen/hjegy_doc.cgi?docid
p.000060: =99800018.EUM&celpara=#xcelparam
p.000060:
p.000060: NBC:
p.000060: 1. Vulnerable Groups Including Children: http://www.vsn.is/en/content/vulnerable- groups-including-children
p.000060:
p.000060: Country Key Organizations Legislation
p.000060: Regulations Guidelines
p.000060:
p.000060: General
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs, Biologics, and Devices
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Research Injury
p.000060: (NBC):
p.000060: http://www.vsn.is/en
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs
p.000060: 1. Icelandic Medicines Agency (MCA):
p.000060: http://www.ima.is/
p.000060: 2. National Bioethics Committee (NBC):
p.000060: www.visindasidanefnd.is
p.000060:
p.000060:
p.000060: Devices
p.000060: Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Icelandic Health Insurance Agency (MCA):
p.000060: http://www.sjukra.is/english
p.000060: media/media/acrobat- enskar_sidur/Health-Sector- Research-Act-No-44-2014.pdf
p.000060: 3. Oviedo Convention on Human Rights and Biomedicine (2004)
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Medicinal Products Act No. 93/1994 (2013):
p.000060: http://eng.velferdarraduneyti.is/acts- of-Parliament/nr/20128
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Act on Medical Devices No 16/2001 (2011):
...
p.000082:
p.000082: National Committee for Research Ethics in the Social Sciences and the Humanities (NESH): https://www.etikkom.no/en/our-
p.000082: work/about-us/the-national-committee- for-research-ethics-in-the-social-sciences- and-the-humanities-nesh/
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: National Committee for Research Ethics in Science and Technology (NENT):
p.000082: https://www.etikkom.no/en/our-
p.000082: 1. Foetal Tissue Act (2001) (Dutch): http://wetten.overheid.nl/BWBR001 2983/
p.000082: 2. Embryos Act (2002): http://www.ccmo.nl/attachments/file s/embryos-act.pdf
p.000082:
p.000082: 1. Oviedo Convention on Human Rights and Biomedicine (2006)
p.000082: 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovdata/ lov-20060630-056-eng.pdf
p.000082: 3. Act on Health Care Research (2008): http://www.lovdata.no/cgi-
p.000082: wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov
p.000082: *&&
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
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p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
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p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. Organization of Health Research: https://lovdata.no/dokument/SF/forsk rift/2009-07-01-955
p.000083: 2. Population-Based Health Survey: https://lovdata.no/dokument/SF/forsk rift/2018-04-27-645
p.000083: 3. Right of Children Between 12- 16 Years to Consent to Participate in Health Research:
p.000083: https://lovdata.no/dokument/SF/forsk rift/2017-06-28-1000
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. Guidelines for Research on Persons with Impaired Informed Consent Capacity (2005)
p.000083: 2. Payment for Research Participants in Medical and Health Research (2009)
p.000083: 3. Guidelines for Research Ethical and Scientific Evaluation of Qualitative Research Projects in Medical and Health
p.000083: Research (2009): https://www.etikkom.no/forskningsetiske- retningslinjer/Medisin-og-helse/Kvalitativ- forskning/
p.000083: 4. Guidelines for Ethical Evaluation and Post-marketing Studies (2003)
p.000083: 5. Guidelines for Genetic Research of Humans (2016) (Norwegian): https://www.etikkom.no/forskningsetiske-
p.000083: retningslinjer/Medisin-og- helse/retningslinjer-for-bruk-av-genetiske- undersokelser-av-mennesker-i-medisinsk-
p.000083: og-helsefaglig-forskning/
p.000083: 1. Guidelines for Research Ethics in the Social Sciences, Humanities, Law and Theology (2016):
p.000083: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research-ethics-in-
p.000083: the-social-sciences--humanities-law-and- theology/
p.000083: 2. A Guide to Internet Research Ethics (2019):
p.000083: https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/
...
p.000109: 2017/1322/contents/made
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Adults with Incapacity (Scotland) Act 2000, Section 51: http://www.scotland.gov.uk/Topics/ Justice/law/awi/legislation
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Ionising Radiation (Medical Exposure) (Northern Ireland) Regulations (2018): http://www.legislation.gov.uk/nisr/2
p.000109: 018/17/contents/made
p.000109:
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p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002): http://www.scotland-
p.000110: legislation.hmso.gov.uk/legislation/s cotland/ssi2002/20020190.htm
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: 1. Research Involving Human Participants in Developing Societies (2004):
p.000110: https://mrc.ukri.org/publications/browse/researc h-involving-human-participants-in-developing- societies/
p.000110: 2. Medical Research Involving Children (2004): https://mrc.ukri.org/documents/pdf/medical- research-involving-children/
p.000110: 3. Medical Research Involving Adults Who Cannot Consent (2007): https://mrc.ukri.org/documents/pdf/medical-
p.000110: research-involving-adults-who-cannot-consent/
p.000110: 4. Good Research Practice: Principles and Guidelines (2012): https://mrc.ukri.org/publications/browse/good-
p.000110: research-practice-principles-and-guidelines/
p.000110:
p.000110: CSO:
p.000110: Research Governance Framework for Health and Community Care (2006): http://www.cso.scot.nhs.uk/wp-
p.000110: content/uploads/2013/02/RGF-Second-Edition- February-06.pdf
p.000110:
p.000110: Research Governance Framework for Health and Social Care in Wales Second Edition (2009):
p.000110: http://www.wales.nhs.uk/sites3/Documents/952/Rese arch%20Governance%20Framework%202009%20% 28English%291.pdf
p.000110:
p.000110: Country Key Organizations Legislation
p.000110: Regulations Guidelines
p.000110:
p.000110: Drugs, Biologics, and Devices
p.000110: Drugs
p.000110: 1. Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/organisati
p.000110: ons/medicines-and-healthcare-products- regulatory-agency
p.000110: 2. Administration of Radioactive Substances Advisory Committee (ARSAC) (UK): https://www.gov.uk/government/organisati
p.000110: ons/administration-of-radioactive- substances-advisory-committee
p.000110: 3. Department of Environment, Food & Rural affairs (DEFRA) https://www.gov.uk/government/organisati
p.000110: ons/department-for-environment-food- rural-affairs
p.000110: 4. Health and Safety Executive (HSE)
p.000110: http://www.hse.gov.uk/
p.000110:
p.000110: Medicines Act (1968): http://www.legislation.gov.uk/ukpg a/1968/67/contents
p.000110:
...
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Schedule Y of the Drugs and Cosmetics Act (2016): http://www.cdsco.nic.in/writereadda ta/2016Drugs%20and%20Cosmetic
p.000122: s%20Act%201940%20&%20Rules
p.000122: %201945.pdf
p.000122:
p.000122:
p.000122:
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p.000123: 123
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p.000123:
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p.000123:
p.000123:
p.000123:
p.000123:
p.000123: DCGI:
p.000123: 1. Good Clinical Practices for Clinical Research in India (2001): http://rgcb.res.in/wp- content/uploads/2014/07/Good-
p.000123: Clinical-Practice-Guideline.pdf
p.000123: 2. Permission for Clinical Trials: General Statutory Rules 63(E) (2013)
p.000123: 3. Ethics Committee Registration: General Statutory Rules 72(E) (2013)
p.000123: 4. A/V Consent – General Statutory Rules 611 (E) (2015)
p.000123: 5. Phytopharmaceutical Drug: General Statutory Rules 918(E) (2015)
p.000123: 6. Exemption for Academic Research and Animal Toxicity: General Statutory Rules 313(E) (2016)
p.000123: 7. New Drugs and Clinical Trials Rules (2019): https://cdsco.gov.in/opencms/opencm s/system/modules/CDSCO.WEB/ele
p.000123: 1. National Ethical Guidelines For Biomedical and Health Research Involving Human Participants (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123: 2. National Ethical Guidelines for Biomedical Research Involving Children (2017):
p.000123: http://icmr.nic.in/guidelines/National_Ethical_ Guidelines_for_BioMedical_Research_Involvi ng_Children.pdf
p.000123:
p.000123: ICMR:
p.000123: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Section 7 (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123:
p.000123: Country Key Organizations Legislation
p.000123: Regulations Guidelines
p.000123:
p.000123: Drugs, Biologics, and Devices
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Clinical Trials Registry
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Research Injury
p.000123:
p.000123: Devices
p.000123: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000123: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000123: 1. Clinical Trials Registry – India:
p.000123: http://ctri.nic.in/
p.000123: 2. Office of Drugs Controller General
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: 1. Central Drugs Standard Control Organization (CDSCO): https://cdsco.gov.in/opencms/opencm s/en/Home/
p.000123: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000123:
p.000123:
p.000123: Drugs & Cosmetics Act, 1940 (2005):
p.000123: https://cdsco.gov.in/opencms/op encms/en/Notifications/Gazette- Notifications/
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Drugs & Cosmetics Act, 1940 (2005):
p.000123: http://www.cdsco.nic.in/writereadda ta/Drugs&CosmeticAct.pdf
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
...
p.000189: For an overview of human subject protections in Mali, see:
p.000189: https://clinregs.niaid.nih.gov/single_country.php?c_id=132&utm_medium=GovDelivery&utm_source=ClinRegs&utm_campaign=MaliP
p.000189: ublication#_top
p.000189:
p.000189: Drugs, Biologics, and Devices
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: Mozambique
p.000189: Directorate of Pharmacy and Medicine
p.000189: Law No. 09-059 of 28
p.000189: December 2009 Governing Biomedical Research on Humans: https://clinregs.niaid.nih.gov/docum ents/LawNo09-059.pdf
p.000189: Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (2017)
p.000189: (French): https://clinregs.niaid.nih.gov/sites/def ault/files/documents/mali/DecreeNo2 017-0245.pdf
p.000189: For an overview of human subject protections in Mozambique, see:
p.000189: http://elearning.trree.org/course/view.php?id=14&lang=en
p.000189: General
p.000189: Science and Technology
p.000189: Ethics Code
p.000189: (2007):
p.000189: http://elearning.trree.org/pluginfile.php/34764/ mod_folder/content/0/02- CodigoDeEtica.pdf?forcedownload=1
p.000189: Nigeria
p.000189: For an overview of human subject protections in Nigeria, see: http://elearning.trree.org/mod/page/view.php?id=142
p.000189:
p.000189: General
p.000189: National Health Research Ethics Committee: http://nhrec.net/
p.000189: National Health Act 2014
p.000189: 1. Nigerian Code of Health Research Ethics (2007): http://nhrec.net/nhrec/wp- content/uploads/2018/10/NCHRE_Aug_07.zip
p.000189: 2. Policy Statement Regarding Enrollment of Children in Research in Nigeria (2016):
p.000189: http://nhrec.net/nhrec/Final%20NHREC%20Po licy%20Statement%20on%20Enrollment%20o f%20Children%20in%20Research.pdf
p.000189:
p.000190: 190
p.000190:
p.000190: Country Key Organizations Legislation
p.000190: Regulations Guidelines
p.000190:
p.000190: General
p.000190:
p.000190:
p.000190: Drugs, Biologics, and Devices
p.000190:
p.000190:
p.000190: Clinical Trial Registries
p.000190: Social-Behavioral Research
p.000190:
p.000190: Human Biological Materials
p.000190:
p.000190:
p.000190: Rwanda
p.000190: General
p.000190:
p.000190:
p.000190: Senegal
p.000190: General
p.000190:
p.000190:
p.000190: Sierra Leone
p.000190:
p.000190:
p.000190:
p.000190: National Agency for Food, Drug Administration and Control (NAFDAC): http://www.nafdac.gov.ng/
p.000190:
p.000190: National Health Research Ethics Committee: http://nhrec.net/ National Health Research Ethics Committee
p.000190:
p.000190: National Health Research Ethics Committee: http://nhrec.net/
p.000190:
p.000190:
p.000190:
p.000190: Ministry of Health, National Ethics Committee: http://www.moh.gov.rw/index.php?id=2
p.000190:
p.000190:
p.000190: National Committee on Health Research Ethics
p.000190:
p.000190:
p.000190:
p.000190: Decree No. 15 of 1993
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
p.000190:
...
Social / Fetus/Neonate
Searching for indicator fetuses:
(return to top)
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
...
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
...
p.000106: (2014): http://zakon5.rada.gov.ua/laws/sho
p.000107: 107
p.000107: ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305
p.000107: Articles 22 and 35, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html
p.000107: 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS
p.000107: 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html
p.000107: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000107: HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000107: Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi
p.000107: ed-compilation/20121176/index.html
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines
p.000107: (2009): http://zakon5.rada.gov.ua/rada/show/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: NEK-CNE:
p.000107: 1. Pre-Implantation Genetic Diagnosis, 2007/9:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf
p.000107: 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006: http://www.nek-cne.ch/fileadmin/nek-cne-
p.000107: dateien/Themen/Stellungnahmen/en/embryonen
p.000107: _en.pdf
p.000107: 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/PID_II_d.pdf
p.000107:
p.000107: Access:
p.000107: http://www.nek-cne.ch/en/topics/opinions/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Bioethics Committee:
p.000107: 1. Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006)
p.000107: 2. Ethics Expertise of Clinical Trials Medicines (2007)
p.000107:
p.000107: Country Key Organizations Legislation
p.000107: Regulations Guidelines
p.000107:
p.000107: Drugs, Biologics, and Devices
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Research Injury
p.000107:
p.000107:
p.000107: Privacy/Data Protection
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Human Biological Materials
p.000107: en/bioethics-committee
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health:
p.000107: http://www.moz.gov.ua/en/
p.000107:
p.000107:
...
Searching for indicator neonates:
(return to top)
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000048: 48
p.000048:
p.000048: Country Key Organizations Legislation
p.000048: Regulations Guidelines
p.000048:
p.000048: Social-Behavioral Research
p.000048:
p.000048:
p.000048:
p.000048: Privacy/Data Protection
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: Human Biological Materials
p.000048: National Consultative Ethics Committee
p.000048:
p.000048:
p.000048:
p.000048: 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home
p.000048: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Protection of Persons Committee (CPP)
p.000048: 2. Ministry of Higher Education, Research, and Innovation: http://www.enseignementsup- recherche.gouv.fr/
p.000048: 3. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne-
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Act N° 78-17 of 6 January 1978 on Information Technology, Data Files, and Civil Liberties (2018):
p.000048: https://www.cnil.fr/fr/la-loi- informatique-et-libertes
p.000048: 2. Law No. 2016-1321 of 7
p.000048: October 2016 for a Numeric Republic: https://www.legifrance.gouv.fr/affic hLoiPubliee.do?idDocument=JORF
p.000048: DOLE000031589829&type=genera l&legislature=14
p.000048: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000048: 4. Data Protection Act (2018): https://www.legifrance.gouv.fr/affic hLoiPreparation.do;jsessionid=AD5
p.000048: 660270AD9F70B94275AC8233216 80.tplgfr22s_3?idDocument=JORF DOLE000036195293&type=conten u&id=2&typeLoi=proj&legislature
p.000048: =15
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
...
Searching for indicator restricted:
(return to top)
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Clinical Trials Registry
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000145:
p.000145:
p.000145: 1. Ministry of Health (MOH):
p.000145: http://www.moh.gov.sg/
p.000145: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org/
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Cosmetics, Devices, and Drugs Regulatory Authority, Subcommittee on Clinical Trials:
p.000145: http://www.cdda.gov.lk/index.php?option
p.000145: =com_content&view=article&id=78&Ite mid=115&lang=en
p.000145: Sri Lanka Clinical Trials Registry:
p.000145: http://www.slctr.lk/
p.000145: Bill No. 25/2015, Part 6: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145: 2. Human Cloning and Other Prohibited Practices Act (Cap 131B): https://sso.agc.gov.sg/Act/HCOPPA 2004
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: National Medicines Regulatory Authority Act of 2015: http://www.cdda.gov.lk/images/stori
p.000145: es/new/pdf/legislations/5e_nmdra.p df
p.000145: 9f66af6f7820;rec=0
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Human Biomedical Research (Restricted Research) Regulations 2017:
p.000145: https://sso.agc.gov.sg/SL/HBRA2015
p.000145: -S622-2017
p.000145:
p.000145: BAC:
p.000145: Human Tissue Research (2002): http://www.bioethics- singapore.org/index/publications/reports/173-
p.000145: human-tissue-research.html
p.000145: BAC:
p.000145: Genetic Testing and Genetic Research (2005): http://www.bioethics- singapore.org/index/publications/reports/171-
p.000145: genetic-testing-and-genetic-research.html
p.000145: MOH:
p.000145: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and-
p.000145: legislation/human-biomedical-research-act
p.000145:
p.000145: BAC:
p.000145: 1. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (2002):
p.000145: http://www.bioethics- singapore.org/index/publications/reports/86- reports/174-stem-cell-research.html
p.000145: 2. Donation of Human Eggs for Research (2008): http://www.bioethics- singapore.org/index/publications/reports/86-
p.000145: reports/168-donation-of-human-eggs-for- research.html
p.000145: 3. Human-Animal Combinations in Stem- Cell Research (2010): http://www.bioethics-
p.000145: singapore.org/index/publications/reports/86- reports/167-human-animal-combinations-in- stem-cell-research.html
p.000145:
p.000145: Guidelines for the Conduct of Clinical Trials in Sri Lanka (2014): http://www.cdda.gov.lk/images/pdf/clinical%2
p.000145: 0trials%20guidelines_oct2014.pdf
p.000145:
p.000145:
p.000145: FAQs: http://slctr.lk/faq
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000146: Country Key Organizations Legislation
p.000146: Regulations Guidelines Taiwan
p.000146:
p.000146: General
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
p.000146:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000001: 9. Embryos, Stem Cells, and Cloning
p.000001: These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate
p.000001: understanding of the country’s requirements. The information is then organized into four columns:
p.000001: 1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight
p.000001: role for human subjects research.
p.000001: 2. Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent
p.000001: constitutional provisions.
p.000001: 3. Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies.
p.000001: 4. Guidelines – pertain to non-binding instruments.
p.000001: 1
p.000001:
p.000001: The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in
p.000001: parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018.
p.000001:
p.000001: HOW TO ACCESS A DOCUMENT
p.000001:
p.000001: Documents can be accessed in four possible ways:
p.000001:
p.000001: 1. Link to the web address (URL).
p.000001: 2. Search for a document at the website of the agency listed in the Key Organizations column.
p.000001: 3. Perform an Internet search on the document title.
p.000001: 4. Request a local research ethics committee to provide the document.
p.000001:
p.000001: In many cases the documents are available in English. When the URL links to a non-English website or document, an
p.000001: online language translator usually can render an English version.
p.000001:
p.000001: TOPICS NOT COVERED
p.000001:
p.000001: In order to focus its scope, the International Compilation of Human Research Standards does not include standards from
p.000001: the state, provincial, or local levels. Nor does the Compilation cover:
p.000001:
p.000001: 1. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects standards, but do not
p.000001: direct the content of those regulations.
p.000001: 2. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical bioethics,
p.000001: product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice,
p.000001: bioequivalence testing, or informed consent in clinical practice.
p.000001: 3. Ethics codes of academic, medical, or other professional organizations – see the Ethics Codes Collection:
p.000001: http://ethics.iit.edu/ecodes/about
p.000001: 4. Working papers, drafts, commentaries, or discussion papers.
p.000001:
p.000001: NEW STANDARDS, UPDATES, AND BROKEN LINKS
p.000001:
p.000001: To request inclusion of a new standard in the Compilation or to report updates or broken links, contact OHRP@HHS.gov .
p.000001:
p.000001: DISCLAIMER
p.000001:
p.000001: Although this Compilation contains information of a legal nature, it has been developed for informational purposes only
p.000001: and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any
...
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: MOH:
p.000030: Ordinance No. 111 on Further Development of National Pathology Service (1993):
p.000030: Devices (No. 55-0504, 2004) (Russian): http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: MOH:
p.000030: Instruction on Accreditation of Health Care Institutions and Attestation of Specialists Involved in Conducting Clinical
p.000030: Trials of Drugs and Medical Devices (No. 55-0504, 2004):
p.000030: http://www.levonevski.net/pravo/norm2009/nu m24/d24926.html
p.000030:
p.000030: Country Key Organizations Legislation
p.000030: Regulations Guidelines
p.000030:
p.000030: Human Biological Materials
p.000030:
p.000030:
p.000030:
p.000030: Belgium
p.000030: (SSFM)
p.000030: http://86.57.250.247/data/pravo/ipb_p rikaznew/N111_1993(1994).doc
p.000030:
p.000030: SSFM:
p.000030: Ordinance No. 38-c on Rules for Conducting Morphological Examinations (1999)
p.000030: For an overview of human subject standards in Belgium, see The Ethics Committees:
p.000030: https://www.famhp.be/en/human_use/medicines/medicines/research_development/ethic_committee
p.000030:
p.000030: General
p.000030: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000030: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000030: -advisory-committee-bioethics
p.000030: Law Relating to Experimentation on Humans (2004):
p.000030: http://www.ejustice.just.fgov.be/cgi
p.000030: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000030: 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
...
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
p.000031: Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials
p.000031: Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000031: -advisory-committee-bioethics
p.000031: 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative-
p.000031: bodies/ct-college-clinical-trial-college
p.000031:
p.000031: Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Belgian Data Protection Authority:
p.000031: https://www.dataprotectionauthority.be/
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): http://www.health.belgium.be/en
p.000031: 3. Superior Health Council (CSS): http://www.health.belgium.be/eportal/Abo utus/relatedinstitutions/SuperiorHealthCo
p.000031: uncil/index.htm
p.000031: Law Relating to Experimentation on Humans (2004):
p.000031: http://www.ejustice.just.fgov.be/cgi
p.000031: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Law Relating to Experimentation on Humans, Chapter XVII (Responsibility and Insurance) Article 29 (2004):
p.000031: https://www.famhp.be/en/human_us e/medicines/medicines/research_dev elopment/ethic_committee
p.000031: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000031: 3. Act on the Protection of Natural Persons with Regard to the Processing of Personal Data (30 July 2018):
p.000031: https://www.dataprotectionauthority
p.000031: .be/legislation-and-standards
p.000031: Law Relating to the Use of Human Biological Materials (19 December 2008): https://www.afmps.be/fr/humain/pro
p.000031: duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor el_humain/legislation/apres_le_01_ 12_2009
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032: 1. Royal Decrees to Experimentation on Humans: https://www.famhp.be/en/human_use/ medicines/medicines/research_develo
p.000032: pment/ethic_committee
p.000032: 2. Royal Decrees on Clinical Trials: https://consultativebodies.health.belgi um.be/en/advisory-and-consultative-
p.000032: bodies/ct-college-clinical-trial-college
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Decree of February 13, 2001 Implementing the Law of December 8, 1999: http://www.privacycommission.be/sit
p.000032: es/privacycommission/files/document s/Royal_Decree_2001.pdf
p.000032:
p.000032:
p.000032:
p.000032: Royal Decrees to the Use of Human Biological Materials: https://www.afmps.be/fr/humain/prod
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000012:
p.000012: Public Law 108-458, Section 8306
p.000012: 1. 10 CFR 745 (1991), Subpart A
p.000012: 2. DOE Order 443.1B
p.000012: 3. DOE Order 481.1
p.000012: 45 CFR 46, Subparts A, B, C, D, and E (2018):
p.000012: https://www.hhs.gov/ohrp/sites/defau lt/files/revised-common-rule-reg- text-unofficial-2018- requirements.pdf
p.000012: FDA is not a Common Rule agency. For studies conducted or funded by FDA:
p.000012: 45 CFR 46, Subparts A, D, and E:
p.000012: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000012:
p.000012:
p.000012:
p.000012: 1. 45 CFR 46, Subparts A-D
p.000012: 2. DHS Directive 026-04, Human Subjects Research (2007): https://www.dhs.gov/xlibrary/assets/f
p.000012: oia/mgmt-directive-026-04- protection-of-human-subjects.pdf
p.000012: 24 CFR 60.101, which cites 45 CFR part 46, subpart A.
p.000012: 1. 28 CFR 22 Privacy Regulation (1976): http://www.ecfr.gov/cgi- bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/
p.000012: 28cfr22_main_02.tpl
p.000012: 2. 42 U.S.C. § 3789g
p.000012: Confidentiality of Information (1984)
p.000012: http://www.gpo.gov/fdsys/pkg/USC ODE-2010-title42/html/USCODE- 2010-title42-chap46-subchapVIII- sec3789g.htm
p.000012: 3. 28 CFR 46 (1991), Subpart A:
p.000012: http://www.ecfr.gov/cgi-bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/ 28cfr46_main_02.tpl
p.000012: 29 CFR 21
p.000012:
p.000012:
p.000012:
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
...
p.000022: of the EU/EEA and Submitted in Marketing Authorization Applications to the EU Regulatory Authorities (2012):
p.000022: http://www.ema.europa.eu/docs/en_GB/docum
p.000022:
p.000022: Country Key Organizations Legislation
p.000022: Regulations Guidelines
p.000022: ent_library/Regulatory_and_procedural_guideli
p.000022:
p.000022: Drugs, Biologics, and Devices
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Clinical Trials Registry
p.000022: Research Injury
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Devices
p.000022: DG GROWTH: Internal Market, Industry, Entrepreneurship, SMEs: https://ec.europa.eu/growth/sectors/medic al-devices_en
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: EU Clinical Trials Register:
p.000022: https://www.clinicaltrialsregister.eu/
p.000022:
p.000022: European Commission:
p.000022: DG SANTE: Directorate-General for Health and Food Safety: http://ec.europa.eu/health/index_en.htm
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 1. Directive 93/42/EEC Concerning Medical Devices: http://eur- lex.europa.eu/LexUriServ/LexUriSe
p.000022: rv.do?uri=CONSLEG:1993L0042:2 0071011:en:PDF
p.000022: 2. Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVD): https://ec.europa.eu/growth/single-
p.000022: market/european- standards/harmonised-standards/iv- diagnostic-medical-devices_en
p.000022: 3. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive
p.000022: 90/385/EEC on Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices:
p.000022: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000022: :32007L0047&from=EN
p.000022:
p.000022:
p.000022:
p.000022: 1. Clinical Trials Directive 2001/20/EC: http://ec.europa.eu/health/human- use/clinical- trials/directive/index_en.htm
p.000022: 2. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for
p.000022: Human Use, Repealing Directive 2001/20/EC:
p.000022: ne/2012/04/WC500125437.pdf
p.000022: 3. Guideline for Good Clinical Practice E6(R2) (2016): http://www.ema.europa.eu/docs/en_GB/docum
p.000022: ent_library/Scientific_guideline/2009/09/WC5 00002874.pdf
p.000022:
p.000022: Various: http://ec.europa.eu/consumers/sectors/medical- devices/documents/guidelines/index_en.htm
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: FAQs:
p.000022: https://www.clinicaltrialsregister.eu/doc/EU_C TR_FAQ.pdf
p.000023: 23
p.000023:
p.000023: Country Key Organizations Legislation
p.000023: Regulations Guidelines
p.000023:
p.000023: Research Injury
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: Privacy/Data Protection
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000006: 1. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2005):
p.000006: http://whqlibdoc.who.int/publications/2005/92 4159392X_eng.pdf
p.000006: 2. Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
p.000006:
p.000006: IMDRF:
p.000006: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects-
p.000006:
p.000006: Country Key Organizations Legislation
p.000006: Regulations Guidelines
p.000006:
p.000006: Drugs, Biologics, and Devices
p.000006: Good Clinical Practice” (2015): http://www.imdrf.org/docs/imdrf/final/proced ural/imdrf-proc-150326-statement-
p.000006: iso141552011.pdf
p.000006:
p.000006: Archived Documents from the Global Harmonization Task Force (GHTF), replaced by the IMDRF in 2012:
p.000006: 1. Clinical Evaluation (2007)
p.000006: 2. Clinical Evidence – Key Definitions and Concepts (2007)
p.000006: 3. Post-Market Clinical Follow-Up Studies (2010)
p.000006: 4. Clinical Investigations (2010)
p.000006: 5. Reportable Events During Pre-Market Clinical Investigations (2012)
p.000006: 6. Clinical Evidence for IVD Medical Devices (2012)
p.000006: 7. Scientific Validity Determination and Performance Evaluation (2012)
p.000006: 8. Clinical Performance Studies for IVD Medical Devices (2012)
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Clinical Trials Registry
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Research Injury
p.000006:
p.000006:
p.000006: International Standards Organization:
p.000006: http://www.iso.org/iso/home.html
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: World Health Organization – International Clinical Trials Registry Platform: http://www.who.int/ictrp/en/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000006:
p.000006: International Committee of Medical Journal Editors: http://www.icmje.org/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000007: 7
p.000007: Access: http://www.imdrf.org/ghtf/ghtf- archived-docs.asp
p.000007: Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice. Standard Number 14155:2011:
p.000007: http://www.iso.org/iso/iso_catalogue/catalogu e_ics/catalogue_detail_ics.htm?csnumber=455 57
p.000007: Resolution WHA 58.34 (2005): http://www.wpro.who.int/health_research/poli cy_documents/ministerial_summit_on_health_
p.000007: research_may2005.pdf?ua=1
p.000007: Declaration of Helsinki, Article 35 (2013):
p.000007: http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000007: Clinical Trial Registration: http://icmje.org/recommendations/browse/pub lishing-and-editorial-issues/clinical-trial-
p.000007: registration.html
p.000007: Declaration of Helsinki, Paragraph 15 (2013):
p.000007: http://www.wma.net/en/30publications/10poli
p.000007:
p.000007: Country Key Organizations Legislation
p.000007: Regulations Guidelines
p.000007: cies/b3/index.html
p.000007:
p.000007: Research Injury
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Social- Behavioral Research
...
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: General:
p.000015: Good Clinical Practice and Human Subject Protection in FDA-Regulated Clinical Trials: https://www.fda.gov/science-
p.000015: research/science-and-research-special- topics/clinical-trials-and-human-subject- protection
p.000015:
p.000015: Drugs:
p.000015: https://www.fda.gov/drugs/guidance- compliance-regulatory-information/guidances- drugs
p.000015:
p.000015: Biologics:
p.000015: https://www.fda.gov/vaccines-blood- biologics/guidance-compliance-regulatory- information-biologics
p.000015:
p.000015:
p.000015:
p.000015: Good Clinical Practice and Human Subject Protections in FDA-Regulated
p.000015:
p.000015: Country Key Organizations Legislation
p.000015: Regulations Guidelines
p.000015:
p.000015: Drugs, Biologics, and Devices
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Clinical Trials Registry
p.000015: Health: https://www.fda.gov/Medical- Devices
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: Food and Drug Administration: https://www.fda.gov/science- research/clinical-trials-and-human-
p.000015: subject-protection/fdas-role- clinicaltrialsgov-information
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: National Institutes of Health ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/home
p.000015: (2012):
p.000015: https://uscode.house.gov/browse/pre lim@title21/chapter9/subchapter5& edition=prelim
p.000015: 2. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW-
p.000015: 114publ255.pdf
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 1. Food and Drug Administration Modernization Act, Section 113 (1997): https://www.fda.gov/regulatory-
p.000015: information/selected-amendments- fdc-act/food-and-drug- administration-modernization-act- fdama-1997
p.000015: 2. Food and Drug Administration Amendments Act, Section 801 (2007): https://www.fda.gov/regulatory-
p.000015: information/selected-amendments- fdc-act/food-and-drug- administration-amendments-act- fdaaa-2007
p.000015: https://www.fda.gov/science- research/clinical-trials-and-human- subject-protection/regulations-good-
p.000015: clinical-practice-and-clinical-trials
p.000015: 1. 21 CFR 50 (Informed Consent)
p.000015: 2. 21 CFR 56 (Institutional Review Boards)
p.000015: 3. 21 CFR 807, Subpart E
p.000015: 4. 21 CFR 812 (Investigational Device Exemptions)
p.000015: 5. 21 CFR 814 (Premarket Approval of Medical Devices)
p.000015: 6. 21 CFR 54 (Financial Disclosure by Clinical Investigators)
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015: 1. Clinical Trials Regulation and Results Information Submission, 42 CFR 11 (2016):
...
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: Templates for Clinical Trial Information Leaflet and Consent Form (2018)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046: Country Key Organizations Legislation
p.000046: Regulations Guidelines
p.000046:
p.000046: Drugs, Biologics, and Devices
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Research Injury
p.000046:
p.000046:
p.000046:
p.000046: Social-Behavioral Research
p.000046:
p.000046:
p.000046: Privacy/Data Protection
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Human Biological Materials
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Genetic Research
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Finnish Patient Insurance Centre:
p.000046: https://www.pvk.fi/fi/
p.000046: 2. Pharmaceutical Injuries Insurance
p.000046: http://www.laakevahinko.fi/in-english/
p.000046:
p.000046: Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000046:
p.000046:
p.000046: Office of the Data Protection Ombudsman: https://tietosuoja.fi/en/home
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: National Supervisory Authority for Welfare and Health (Valvira): http://www.valvira.fi/web/en
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000046:
p.000046: EU Regulations:
p.000046: Medical Device Regulation 2017/745: http://eur- lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000046: :32017R0745&from=EN
p.000046: In Vitro Diagnostic Medical Devices Regulation 2017/746: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000046: :32017R0746&from=EN
p.000046: Patient Injuries Act No. 585/1986:
p.000046: http://www.finlex.fi/fi/laki/ajantasa/ 1986/19860585
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000046: 2. Data Protection Act (1050/2018): https://www.finlex.fi/en/laki/kaanno kset/2018/20181050
p.000046: 1. Act on the Medical Use of Human Organs, Tissues, and Cells No. 101/2001 (Finnish and Swedish):
p.000046: http://www.finlex.fi/fi/laki/ajantasa/ 2001/20010101
p.000046: 2. Law on Biobanks, No 688/2012 (Finnish and Swedish): http://www.finlex.fi/fi/laki/ajantasa/ 2012/20120688
p.000046:
p.000046:
p.000046:
p.000046: 1. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015):
p.000047: 47
p.000047: maarays_3_2010_kliininen_laitetutki mus.pdf
p.000047: 2. Various: http://www.valvira.fi/en/licensing/me dical_devices/legislation
...
p.000047: Regulations Guidelines
p.000047:
p.000047: Genetic Research
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Embryos, Stem Cells, and Cloning
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: France
p.000047: General
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Drugs, Biologics, and Devices
p.000047: 2. Board for Gene Technology:
p.000047: http://www.geenitekniikanlautakunta.fi/en
p.000047:
p.000047:
p.000047:
p.000047: 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000047: 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa
p.000047: /1995/19950377
p.000047: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
p.000047: 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden:
p.000047: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf
p.000047:
p.000047:
p.000047: 1. Law No. 2012-300 of 5
...
p.000048: 48
p.000048:
p.000048: Country Key Organizations Legislation
p.000048: Regulations Guidelines
p.000048:
p.000048: Social-Behavioral Research
p.000048:
p.000048:
p.000048:
p.000048: Privacy/Data Protection
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
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p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: Human Biological Materials
p.000048: National Consultative Ethics Committee
p.000048:
p.000048:
p.000048:
p.000048: 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home
p.000048: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
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p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Protection of Persons Committee (CPP)
p.000048: 2. Ministry of Higher Education, Research, and Innovation: http://www.enseignementsup- recherche.gouv.fr/
p.000048: 3. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne-
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Act N° 78-17 of 6 January 1978 on Information Technology, Data Files, and Civil Liberties (2018):
p.000048: https://www.cnil.fr/fr/la-loi- informatique-et-libertes
p.000048: 2. Law No. 2016-1321 of 7
p.000048: October 2016 for a Numeric Republic: https://www.legifrance.gouv.fr/affic hLoiPubliee.do?idDocument=JORF
p.000048: DOLE000031589829&type=genera l&legislature=14
p.000048: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000048: 4. Data Protection Act (2018): https://www.legifrance.gouv.fr/affic hLoiPreparation.do;jsessionid=AD5
p.000048: 660270AD9F70B94275AC8233216 80.tplgfr22s_3?idDocument=JORF DOLE000036195293&type=conten u&id=2&typeLoi=proj&legislature
p.000048: =15
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Donation and Use of the Components and Products of the Human Body, Articles L1211-1 to L1274-3 (2004):
p.000048: http://www.legifrance.gouv.fr/
...
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
p.000050: http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996)
p.000050: including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf
p.000050:
p.000050: Country Key Organizations Legislation
p.000050: Regulations Guidelines
p.000050: Research Injury Convention on Human Rights
p.000050: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000050: 164 (2001)
p.000050:
p.000050: Privacy/Data Protection
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Embryos, Stem Cells, and Cloning
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Germany
p.000050: General
p.000050: Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/weite re-sprachen/english/german-medical-
p.000050: association/
p.000050: 2. Central Ethics Committee of the German Medical Association (ZEKO):
p.000050: http://www.zentrale-ethikkommission.de/
p.000050: 3. Permanent Working Party of Research Ethics Committees in Germany:
p.000050: http://www.ak-med-ethik-komm.de/
p.000050: 4. German Ethics Council:
p.000050: https://www.ethikrat.org/en/
p.000050: 5. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000050: 6. German Research Foundation (DFG), Permanent Senate Commission on Key Questions in Clinical Research (SCCR):
p.000050: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/clinical_research/index.ht
p.000050: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000050: 2. Law on Data Protection (2018): https://matsne.gov.ge/en/document/ view/1561437?publication=15
p.000050: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000050: Cloning ETS No. 168 (2001)
p.000050: 2. Law on Health Care, Article 142 (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000050:
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p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: BÄK:
p.000051: (Model) Professional Code for Physicians in Germany, Article 15 (2018): http://www.bundesaerztekammer.de/fileadmin/
p.000051: user_upload/downloads/pdf- Ordner/MBO/MBO-AE_EN_2018.pdf
p.000051:
p.000051: Country Key Organizations Legislation
p.000051: Regulations Guidelines
p.000051: ml
p.000051:
p.000051: Drugs, Biologics, and Devices
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Clinical Trials Registry
p.000051:
p.000051: Research Injury
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Privacy/Data Protection
p.000051:
p.000051: Note: The 16 German states also have data protection
p.000051: Drugs
p.000051: 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html
p.000051: 2. Paul-Ehrlich-Institut (PEI):
p.000051: http://www.pei.de/EN/home/node.html4
p.000051: 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Devices
p.000051: 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html
p.000051: 2. Paul-Ehrlich-Institut (PEI):
p.000051: http://www.pei.de/EN/home/node.html4
p.000051: 3. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000051: German Clinical Trials Register (DRKS):
p.000051: https://www.drks.de/drks_web/setLocale_ EN.do
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: 1. Federal Commissioner for Data Protection and Freedom of Information: https://www.bfdi.bund.de/EN/
p.000051: 2. Datenschutzkonferenz (DSK): https://www.datenschutzkonferenz- online.de/
p.000051:
p.000051: Medicinal Products Act, Sixth Chapter (2019): http://www.gesetze-im- internet.de/amg_1976/
p.000051:
p.000051: 2016 English version, without amendments:
p.000051: Medicinal Products Act, Sixth Chapter (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a mg.html#p0925
p.000051:
p.000051:
p.000051:
p.000051: Act on Medical Devices, Fourth Chapter (2019): http://www.gesetze-im- internet.de/mpg/
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: 1. Medicinal Products Act, Section 40(3) (2016): http://www.gesetze-im- internet.de/englisch_amg/englisch_a
p.000051: mg.html#p0926
p.000051: 2. Act on Medical Devices, Section 20(3) (2019): http://www.gesetze-im- internet.de/mpg/ 20.html
p.000051: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000051: 2. Federal Data Protection Act (BDSG) (2017): https://www.gesetze-im- internet.de/englisch_bdsg/index.htm
p.000052: 52
p.000052:
p.000052: 1. Promulgation on the Principles of the Conduct of Clinical Trials of Drugs According to the Rules (1987)
...
p.000055: Opinion on Stem Cell Research (2002): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do
p.000055: wnloads/pdf-Ordner/Zeko/Stammzell.pdf
p.000055: Opinion on Stem Cell Research (2006): http://www.dfg.de/download/pdf/dfg_magazin/
p.000055: forschungspolitik/stammzellforschung/stammz ellforschung_deutschland_lang_0610.pdf
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Research Ethics for Biological Sciences (2008): http://www.bioethics.gr/index.php/en/gnomes/
p.000055: 86-research-ethics-in-biological-sciences
p.000055: 2. A Guide for Research Ethics Committees for Biological Research (2008): http://www.bioethics.gr/images/pdf/ENGLISH/
p.000055: OPINIONS_REPORTS/guide.pdf
p.000055: 3. Conflict of Interest in Biomedical Research (2014):
p.000055:
p.000055: Country Key Organizations Legislation
p.000055: Regulations Guidelines
p.000055:
p.000055: General
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Drugs, Biologics, and Devices
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Research Injury
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Privacy/Data Protection
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. National Organization for Medicines (NOM): http://www.eof.gr/web/guest/home, then click on “EN” in upper left hand
p.000055: section for English
p.000055: 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055: National Bioethics Commission (NBC):
p.000055: http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Hellenic Data Protection Authority:
p.000055: http://www.dpa.gr/
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000055: Regard to
p.000055: the Application of Biology and Medicine (1998)
p.000055: 2. Act 3418/2005 Code on Medical Ethics
p.000055:
p.000055: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000055: Regard to
p.000055: the Application of Biology and Medicine (1998)
p.000055: 2. Act 3418/2005 Code on Medical Ethics
p.000055:
p.000055: 1. Greek Constitution 1975/1986/2001 Article 9.1
p.000055: 2. Act 2619/98 (Biomedicine Convention of the Council of Europe) (1998)
p.000055: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000055: 2819/2000 and 2915/2000):
p.000055: http://www.dpa.gr/portal/page?_pag eid=33,19052&_dad=portal&_sche ma=PORTAL
p.000055: 4. Act 3418/2005 Code on Medical Ethics
...
p.000061: http://health.gov.ie/blog/policy/clinical-trials-involving-medicinal-products/
p.000061:
p.000061: General
p.000061: Department of Health:
p.000061: http://health.gov.ie/
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062: 1. Operational Procedures for Research Ethics Committees: Guidance 2004: http://health.gov.ie/wp-
p.000062: content/uploads/2014/07/Operational_Procedur es1.pdf
p.000062: 2. Health Service Executive National
p.000062:
p.000062: Country Key Organizations Legislation
p.000062: Regulations Guidelines
p.000062:
p.000062: General
p.000062:
p.000062: Drugs, Biologics, and Devices
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Research Injury
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Privacy/Data Protection
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Human Biological Materials
p.000062:
p.000062:
p.000062:
p.000062: Genetic Research
p.000062:
p.000062:
p.000062: Italy
p.000062: General
p.000062:
p.000062:
p.000062: 1. Department of Health:
p.000062: http://health.gov.ie/
p.000062: 2. Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Data Protection Commissioner (DPC):
p.000062: http://www.dataprotection.ie/docs/Home/ 4.htm
p.000062: Health Research Board (HRB):
p.000062: http://www.hrb.ie/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062: 1. National Bioethics Committee (CNB): http://www.governo.it/bioetica/eng/index. html
p.000062: 2. National Monitoring Center for Clinical Trials (OSS):
p.000062:
p.000062:
p.000062: European Communities (Clinical Trials on Medicinal Products for Human Use) Amendment 2004 (S.I. No. 190
p.000062: of 2004):
p.000062: http://www.irishstatutebook.ie/eli/2 004/si/878/made/en/print
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: 1. Data Protection Act (1988), as Amended (2003): http://www.irishstatutebook.ie/2003
p.000062: /en/act/pub/0006/index.html
p.000062: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000062: 3. Data Protection Act 2018: https://www.oireachtas.ie/en/bills/bi ll/2018/10/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
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p.000063: 63
p.000063:
p.000063:
p.000063: European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004):
p.000063: http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html
p.000063:
...
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: Research Injury
p.000063:
p.000063:
p.000063:
p.000063: Privacy/Data Protection
p.000063: Devices
p.000063: Ministry of Health, Directorate General for Medicines and Medical Devices: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: Ministry of Labour and Social Policy:
p.000063: www.lavoro.gov.it
p.000063:
p.000063:
p.000063:
p.000063: Italian Data Protection Independent Authority: http://www.garanteprivacy.it/garante/navi
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000063:
p.000064: 64
p.000064:
p.000064: Ministerial Decree 2 of August 2005: Procedures for the Presentation of Documentation to Notify about Clinical
p.000064: Investigations with Medical Devices
p.000064: Ministerial Decree 14 of July 2009: Minimum Requirements for Insurance Policies Which Safeguard Participants to
p.000064: Clinical Trials of Medicinal Products
p.000064: 1. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical
p.000064:
p.000064: Administrative Procedures Concerning the Conduction of Clinical Investigations with CE-Marked Medical Devices (2007)
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: General Principles of Processing Personal Data (2018):
p.000064: https://www.garanteprivacy.it/home/doveri#2
p.000064:
p.000064: Country Key Organizations Legislation
p.000064: Regulations Guidelines
p.000064:
p.000064: Privacy/Data Protection
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Genetic Research
p.000064: g/jsp/index.jsp?solotesto=N
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: 1. Instituto Superiore di Sanita (ISS):
p.000064: http://www.iss.it/chis/?lang=2
p.000064: 2. Italian Society of Human Genetics (SIGU): http://www.sigu.net/
p.000064: 2. Italian Personal Data Protection Code, Legislative Decree No. 196 of June 30, 2003:
p.000064: http://www.garanteprivacy.it/garant e/navig/jsp/index.jsp?folderpath=No rmativa%2FItaliana%2FIl+Codice+
p.000064: in+materia+di+protezione+dei+dati
p.000064: +personali
p.000064: Experimentation (May 25, 2000)
p.000064: 2. Regulation for the Implementation of Articles No. 20 and 21 of the Legislative Decree No. 196 of June 30, 2003
p.000064: 3. Ministerial Decree No. 277 (2007)
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: ISS:
p.000064: Guidelines for Phase I Clinical Trials with Investigational Medicinal Products Employed in Gene Somatic Therapy (2004):
p.000064: http://www.iss.it/binary/publ/publi/0478.11066 53420.pdf
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Embryos, Stem Cells, and Cloning
p.000064:
p.000064:
p.000064: Latvia
p.000064: General
p.000064:
p.000064: Drugs, Biologics, and Devices
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
...
p.000079: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000079: %20MS%20nr.%20648.pdf
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Rulebook on More Detailed Conditions and Documentation Required for Approval and Conduct of Clinical Trials of
p.000079: Medicines for Human Use (2013):
p.000079: https://www.calims.me/Portal/faces/ser vlet1?_afrLoop=26656243505641585&
p.000079: _afrWindowMode=0&putanja=Ruleboo k%2520on%2520Clinial%2520trials.pd f&_adf.ctrl-state=wdqo8wvwo_214
p.000079:
p.000079: Country Key Organizations Legislation
p.000079: Regulations Guidelines
p.000079:
p.000079: Drugs, Biologics, and Devices
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Research Injury
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Privacy/Data Protection
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Human Biological Materials
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: 1. Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000079: 2. Agency for Medicines and Medical Devices: https://www.calims.me/Portal/faces/glavn a?_adf.ctrl-state=rsbe35pln_83
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: National Security Agency: http://www.anb.gov.me/en/Home?alphabe t=lat
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000079: Montenegro” No. 79/2004, 53/09, and 40/11): https://www.calims.me/Portal/faces/ servlet1?putanja=CG-
p.000079: Zakon%2520o%2520medicinskim
p.000079: %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181
p.000079: 1. Law on Medicines (“Official Gazette of Montenegro”, No. 56/2011 and 06/13): https://www.calims.me/Portal/faces/
p.000079: servlet1?putanja=CG_Zakon_o_ljek ovima.pdf&_afrWindowMode=0&_ afrLoop=3654755254077715&_adf. ctrl-state=13nzchbscd_171
p.000079: 2. Law on Medical Devices (“Official Gazette of Montenegro” No. 79/2004, 53/09, and 40/11):
p.000079: https://www.calims.me/Portal/faces/ servlet1?putanja=CG- Zakon%2520o%2520medicinskim
p.000079: %2520sredstvima.pdf&_afrWindow Mode=0&_afrLoop=365499429817 7994&_adf.ctrl- state=13nzchbscd_181
p.000079: Law on the Protection of Personal Data (Official Gazette of Montenegro No. 79/08, 70/09, 44/12):
p.000079: http://www.azlp.me/docs/zajednicka
p.000079: /zakoni/zakon-o-zastiti-podataka-o- licnosti.pdf
p.000079: Law on the Collection and Use of Biological Samples (Official Gazette of Montenegro No.
p.000079: 14/2010):
p.000079: http://www.mzdravlja.gov.me/Reso urceManager/FileDownload.aspx?ri d=57491&rType=2&file=ZAKON
p.000079: %20O%20UZIMANJU%20I%20K ORI%C5%A0%C4%86ENJU%20B IOLO%C5%A0KIH%20UZORAK
p.000079: A.pdf
p.000079:
p.000080: 80
p.000080:
p.000080: Country Key Organizations Legislation
p.000080: Regulations Guidelines
p.000080:
p.000080: Genetics
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
...
p.000084: Regulations Guidelines
p.000084:
p.000084: Social- Behavioral Research
p.000084: https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-on-human-remains/
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /1978-06-09-50
p.000084: research-ethics-in-the-social-sciences-- humanities-law-and-theology/
p.000084: 2. Guide to Internet Research Ethics (2018):
p.000084: https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Privacy/Data Protection
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Human Biological Materials
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Genetic Research
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Norwegian Data Protection Authority: https://www.datatilsynet.no/en/
p.000084:
p.000084:
p.000084:
p.000084: 1. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000084: work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/
p.000084: 2. Regional Committees for Medical Research Ethics (REK): https://rekportalen.no/#home/REK
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: 1. Norwegian Directorate of Health: https://www.helsedirektoratet.no/tema/gen teknologi
p.000084: 2. Norwegian Biotechnology Advisory Board: http://www.bion.no/english/
p.000084: 3. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000084: work/about-us/the-national-committee- for-medical-and-health-research-ethics-
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000084: 2. Personal Data Act (2018):
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /2018-06-15-
p.000084: 38?q=personopplysningsloven
p.000084: 1. Act Relating to the Application of Biotechnology in Human Medicine, etc. (Biotechnology Act) (December 5, 2003, No.
p.000084: 100): https://lovdata.no/dokument/NL/lov
p.000084: /2003-12-05-
p.000084: 100?q=humanmedisinsk%20bruk
p.000084: 2. Act on Health Care Research (2008):
p.000084: http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov
p.000084: *&&
p.000084: 1. Act Relating to the Application of Biotechnology in Human Medicine, Etc. (December 5, 2003, No. 100):
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /2008-06-20-
p.000084: 44?q=helseforskningsloven
p.000084: 2. Gene Technology Act:
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /1993-04-02-38?q=genteknologi
p.000084: 3. Act on Health Care Research:
p.000085: 85
p.000085: NCEHR:
p.000085: Guidelines for Research Ethics on Human Remains:
...
p.000090: 2015): http://base.consultant.ru/cons/cgi/online.cgi?req
p.000090: =doc;base=LAW;n=183677
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: Research Injury
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: Federal Law #61FZ “On Circulation of Medicines” (2011), Art. 38-44:
p.000090: GOST:
p.000090: Good Clinical Practice. GOST-R 52379-2005 (September 27,
p.000090: 2005):
p.000090: http://acto- russia.org/index.php?option=com_co ntent&task=view&id=17
p.000090:
p.000091: 91
p.000091:
p.000091: Country Key Organizations Legislation
p.000091: Regulations Guidelines
p.000091:
p.000091: Research Injury
p.000091:
p.000091: Privacy/Data Protection
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Genetic
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Embryos, Stem Cells, and Cloning
p.000091:
p.000091:
p.000091:
p.000091: San Marino
p.000091: General
p.000091:
p.000091:
p.000091: Research Injury
p.000091:
p.000091:
p.000091: Serbia
p.000091: Drugs, Biologics, and Devices
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Interdepartmental Commission on Genetic-Engineering Activity
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: San Marino Bioethics Committee (Italian): http://www.sanita.sm/on- line/home/comitato-bioetica/comitato-
p.000091: sammarinese-di-bioetica.html
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: 1. Ministry of Health (MOH):
p.000091: http://www.zdravlje.gov.rs/
p.000091: 2. Serbian Drug Agency
p.000091: http://www.alims.gov.rs/eng/
p.000091: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000091: .docx
p.000091: 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information
p.000091: (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/
p.000091: 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal
p.000091: Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:”
p.000091: http://base.garant.ru/10135402/
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010):
p.000091: http://base.garant.ru/184467/
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine (1998)
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998)
p.000091:
p.000091: Law on Medicines and Medical Devices, Official Gazette of RS No. 30/2010, 107/2012, 113/2017, and 105/2017:
p.000091: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf
p.000092: 92
p.000092:
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p.000092:
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p.000092:
p.000092:
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p.000096: Official Gazette No. 56/2015: http://www.uradni- list.si/1/objava.jsp?sop=2015-01- 2357
p.000096: Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes
p.000096: (2009)
p.000096: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000096: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000096: 2. Infertility Treatment and Procedures of Biomedically- Assisted Procreation Act, Official Gazette No. 70/2000,
p.000096: Section 9 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2000-01- 3307
p.000096: 3. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No.
p.000096: 61/2007 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297
p.000096: 4. Rules on Donation and Procurement of Human Tissues and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014
p.000096:
p.000096:
p.000096:
p.000097: 97
p.000097:
p.000097: Country Key Organizations Legislation
p.000097: Regulations Guidelines Spain
p.000097: Note: Many of the 17 Spanish autonomous regions have their own laws and regulations on human subject protections.
p.000097:
p.000097: General
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097: Drugs, Biologics, and Devices
p.000097: 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000097: 2. Coordinating Center for Ethical Committees on Clinical Research (Spanish): http://www.msc.es/profesionales/farmacia/
p.000097: ceic/home.htm
p.000097: 3. Institute of Health Carlos III, Ministry of Science and Innovation http://www.isciii.es/htdocs/en/index.jsp
p.000097:
p.000097: Drugs
p.000097: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion Clinica/medicamentos/home.htm
p.000097: 1. Oviedo Convention on Human Rights and Biomedicine (1999): http://www.coe.int/t/dg3/healthbioet
p.000097: hic/texts_and_documents/ETS164S panish.pdf
p.000097: 2. Law 14/2007 on Biomedical Research: http://www.catedraderechoygenoma humano.es/images/novedades/Spani
p.000097: shLawonBiomedicalResearchEnglis h.pdf
p.000097:
p.000097:
p.000097:
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p.000098:
p.000098:
p.000098:
p.000098: 1. Order SCO/362/2008 that Modifies Order SCO/256/2007: http://www.aemps.gob.es/legislacion
p.000098: /espana/investigacionClinica/docs/rc l_2008_410.pdf
p.000098: 2. Order SAS/3470/2009 on Drugs Post Authorization Research: http://www.aemps.gob.es/legislacion
p.000098: /espana/medicamentosUsoHumano/d ocs/farmacovigilancia/rcl_2009_257 7.pdf
p.000098: 3. Royal Decree 1015/2009: Drug Availability for Special Purposes: http://www.boe.es/boe/dias/2009/07/
p.000098: 20/pdfs/BOE-A-2009-12002.pdf
p.000098: 4. Royal Decree 577/2013 Regulating Pharmacovigilance in Human Use Medicines: http://www.boe.es/diario_boe/txt.ph
p.000098: p?id=BOE-A-2013-8191
p.000098: 5. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: http://noticias.juridicas.com/base_da
p.000098: tos/Admin/565124-rd-1090-2015-
p.000098:
p.000098: Country Key Organizations Legislation
p.000098: Regulations Guidelines
p.000098:
p.000098: Drugs, Biologics, and Devices
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Research Injury
p.000098:
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p.000098:
p.000098:
p.000098: Privacy/Data Protection
p.000098:
p.000098:
p.000098: Devices
p.000098: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion
p.000098: Clinica/productosSanitarios/home.htm Spanish Agency of Medicines and Medical Devices:
p.000098: http://www.aemps.gob.es/en/home.htm
p.000098:
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p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: 1. Spanish Data Protection Authority: https://www.agpd.es/portalweb/index-ides- idphp.php
p.000098: 2. Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/en/investigacion
p.000098: Clinica/medicamentos/home.htm
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Royal Decree 1591/2009, Regulating Sanitary Devices: http://www.ont.es/infesp/Legislacin/ RD_1591_2009.pdf
p.000098: 1. Law 14/2007 on Biomedical Research, Article 18: http://www.catedraderechoygenoma humano.es/images/novedades/Spani
p.000098: shLawonBiomedicalResearchEnglis h.pdf
p.000098: 2. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for
p.000098: Human Use, Repealing Directive 2001/20/EC: http://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL
p.000098: EX:32014R0536&from=EN
p.000098: 3. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: https://www.aemps.gob.es/legislaci
p.000098: on/espana/investigacionClinica/docs
p.000098: /Royal-Decree-1090-2015_4- December.pdf
p.000098: 1. Law 14/2007 on Biomedical Research, Title I, Article 5: http://www.catedraderechoygenoma
p.000098: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000098: 2. EU General Data Protection Regulation (2018): https://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL
p.000098: EX:32016R0679&from=EN
p.000098: 3. Organic Law 3/2018 of
p.000098:
p.000099: 99
p.000099: de-4-dic-regula-los-ensayos- clinicos-con-medicamentos-los- comites.html
p.000099:
p.000099: Various: http://www.aemps.es/actividad/psch b/implantables1.htm#circulares
p.000099:
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p.000099:
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p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: 1. Royal Decree 1720/2007: http://www.davara.com/documentos/ relacionados/proteccion/RD_1720- 2007_english.pdf
p.000099: 2. Royal Decree of 19 January 2008
p.000099:
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p.000099:
p.000099:
p.000099: AEMPS:
p.000099: Revised Instructions for Updating the Section “Protection of Personal Data in the Subject Information Sheet (HIP /CI)
p.000099: Regarding the Regulation (EU) No.
p.000099: 2016/679 General Data Protection (2018):
p.000099: https://www.aemps.gob.es/investigacionClinica
p.000099: /medicamentos/docs/anexo8c-Ins-AEMPS- EC.pdf
p.000099:
p.000099: Country Key Organizations Legislation
p.000099: Regulations Guidelines
p.000099:
p.000099: Privacy/Data Protection
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Human Biological Materials
p.000099:
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p.000099:
p.000099: Genetic
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: Ministry of Health, Consumer Affairs, and Social Welfare: http://www.msssi.gob.es/en/home.htm
p.000099:
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p.000099:
p.000099:
p.000099:
p.000099: Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000099: December 5 on the Protection of Personal Data and Guaranteeing Digital Rights: https://www.boe.es/biblioteca_juridi
p.000099: ca/codigos/codigo.php?id=055_Prot eccion_de_Datos_de_Caracter_Pers onal&modo=1
p.000099: Law 14/2007 of July 3 on Biomedical Research, Title I, Article 11; Title III, Article 37; Title V:
p.000099: http://www.catedraderechoygenoma humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000099:
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p.000099:
p.000099:
p.000099:
p.000099: Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V: http://www.catedraderechoygenoma
p.000099: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099:
p.000099: 1. Royal Decree 65/2006 of Requirements for the Import and Export of Biological Samples:
p.000099: http://www.boe.es/boe/dias/2006/02/ 07/pdfs/A04626-04636.pdf
p.000099: 2. Royal Decree 1723/2012 Regarding Activities of Collection, Clinical Use and Territorial Coordination of Human Organs
p.000099: for Transplants and Establishing Their Quality and Safety Requirements: http://noticias.juridicas.com/base_da
p.000099: tos/Admin/rd1716-2011.html
...
p.000102: http://www.socialstyrelsen.se/english
p.000102: med-kompletterande- bestammelser_sfs-2018-218
p.000102: 1. Biobanks in Medical Care Act No. 297 (2002): https://www.riksdagen.se/sv/dokum ent-lagar/dokument/svensk-
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p.000102: 2. Regulation No. 746 (2002): http://www.notisum.se/rnp/sls/lag/2 0020746.htm
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Act on Genetic Integrity (2006:351):
p.000102: http://www.notisum.se/rnp/sls/lag/2 0060351.htm
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: Drug Administration Regulations and Guidelines (LVFS 2004:10) on the Intentional Release of Clinical Trials of
p.000102: Medicinal Products Containing or Consisting of Genetically Modified Organisms: http://www.lakemedelsverket.se/upl
p.000102: oad/lvfs/LVFS_2004-10.pdf
p.000102: 1. Legal Regulation of Stem Cell Research 2002:119: http://www.regeringen.se/sb/d/108/a/ 2717
p.000102: 2. Regulations and Guidelines for the Use of Tissues and Cells in Healthcare and Clinical Research - SOSFS 2009:32:
p.000102: http://www.socialstyrelsen.se/sosfs/2 009-32
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102:
p.000102: SGTAB:
p.000102: Advice for Ethical Assessments: https://www.genteknik.se/wp- content/uploads/2017/09/072_2010-Etisk-
p.000102: v%C3%A4gledning.pdf
p.000102: For an overview of human subject protections in Switzerland, see: http://kofam.ch/en/home/
p.000102:
p.000102: General
p.000102: 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000102: =en
p.000102: 2. Federal Office of Public Health, Portal for Human Research (FOPH): http://kofam.ch/en/home/
p.000102: 3. National Advisory Commission on Biomedical Ethics (NEK-CNE): http://www.nek-cne.ch/en/homepage/
p.000102: 3. Swiss Ethics Committees on Research Involving Humans: http://www.swissethics.ch/index_e.html
p.000102: 1. Council of Europe Convention on Human Rights and Biomedicine of 4 April 1997, ETS No. 164, Articles 15- 18:
p.000102: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000102: 2. Federal Constitution of the Swiss Confederation of 18 April, 1999, RS 101, Article 118b:
p.000103: 103
p.000103: 1. Ordinance of 20 September 2013 on Clinical Trials in Human Research with the Exception of Clinical Trials (Human
p.000103: Research Ordinance, HRO), RS 810.301: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000103: 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305:
p.000103: https://www.admin.ch/opc/en/classif
p.000103: Swiss Clinical Trial Organisation, Guidelines for Good Operational Practice (GGOP) (2017):
p.000103: https://www.scto.ch/en/publications/guidel ines.html
p.000103:
p.000103: Access:
p.000103: http://www.scto.ch/en/News.html
p.000103:
p.000103: Country Key Organizations Legislation
p.000103: Regulations Guidelines
p.000103:
p.000103: General
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Drugs, Biologics, and Devices
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: Drugs
...
p.000120:
p.000120: 1. Guiding Principles of the Clinical Trail Technology on In Vitro Diagnostic (IVD) Reagents (2014):
p.000120: http://www.nmpa.gov.cn/WS04/CL2138/29998 8.html
p.000120: 2. Management Measures for the Monitoring and Re-evaluation of Adverse Events on Medical Devices (2019):
p.000120: http://www.nmpa.gov.cn/WS04/CL2077/33007 1.html
p.000120: 3. Templates for Medical Device Clinical Trials – Ethical Application and Approval (2016):
p.000120:
p.000120: Country Key Organizations Legislation
p.000120: Regulations Guidelines
p.000120:
p.000120: Drugs, Biologics, and Devices
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Clinical Trials Registry Privacy/Data Protection
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Research Injury
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Chinese Clinical Trial Registry: http://www.chictr.org.cn/enIndex.aspx Mainland:
p.000120: 1. Ministry of Industry and Information Technology of People’s Republic of China: http://www.miit.gov.cn/
p.000120: 2. Office of the Central Cyberspace Affairs Commission: http://www.cac.gov.cn/
p.000120: 3. National Information Security Standardization Technical Committee: https://www.tc260.org.cn/ Hong Kong:
p.000120: 1. Privacy Commissioner for Personal Data, Hong Kong: http://www.pcpd.org.hk
p.000120: 2. eHealth Electronic Health Record Sharing System: https://www.ehealth.gov.hk/en/home/inde x.html
p.000120:
p.000120:
p.000120:
p.000120: 1. National Health Commission of the People’s Republic of China (NHC): http://www.nhfpc.gov.cn/
p.000120: 2. National Medical Products Administration: http://www.nmpa.gov.cn
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. People's Republic of China Cyber Security Law (2016): http://www.cac.gov.cn/2016- 11/07/c_1119867116.htm
p.000120: 2. People's Republic of China Electronic Commerce Law, Articles 23-25 and 32 (2018): http://www.cac.gov.cn/2018-
p.000120: 09/01/c_1123362506.htm
p.000120:
p.000120:
p.000120: Personal Data (Privacy) Ordinance (2018): https://www.elegislation.gov.hk/hk/ cap486!en-zh-Hant- HK.pdf?FROMCAPINDEX=Y
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: Tort Liability law of the People's Republic of China, Chapter 7 (2009): http://www.gov.cn/flfg/2009-
p.000120: 12/26/content_1497435.htm
p.000120: http://www.nmpa.gov.cn/WS04/CL2 077/300661.html
p.000120:
p.000120: 4. Amendment of Measures for the Registration and Administration of In Vitro Diagnostic Reagents (updated Art.20 in
p.000120: 2017): http://www.nmpa.gov.cn/WS04/CL2 077/300690.html
p.000120: 5. Administrative Measures for Recall of Medical Devices (2017): http://www.nmpa.gov.cn/WS04/CL2 186/300689.html
p.000120:
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p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120:
p.000120: 1. Chinese Good Clinical Practice, Article 43 (2003): http://www.nmpa.gov.cn/WS04/CL2 077/300595.html
p.000120: 2. Administrative Measures for Recall of Medical Devices,
...
p.000123: 6. Exemption for Academic Research and Animal Toxicity: General Statutory Rules 313(E) (2016)
p.000123: 7. New Drugs and Clinical Trials Rules (2019): https://cdsco.gov.in/opencms/opencm s/system/modules/CDSCO.WEB/ele
p.000123: 1. National Ethical Guidelines For Biomedical and Health Research Involving Human Participants (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123: 2. National Ethical Guidelines for Biomedical Research Involving Children (2017):
p.000123: http://icmr.nic.in/guidelines/National_Ethical_ Guidelines_for_BioMedical_Research_Involvi ng_Children.pdf
p.000123:
p.000123: ICMR:
p.000123: National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Section 7 (2017):
p.000123: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000123:
p.000123: Country Key Organizations Legislation
p.000123: Regulations Guidelines
p.000123:
p.000123: Drugs, Biologics, and Devices
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Clinical Trials Registry
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Research Injury
p.000123:
p.000123: Devices
p.000123: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000123: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000123: 1. Clinical Trials Registry – India:
p.000123: http://ctri.nic.in/
p.000123: 2. Office of Drugs Controller General
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: 1. Central Drugs Standard Control Organization (CDSCO): https://cdsco.gov.in/opencms/opencm s/en/Home/
p.000123: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000123:
p.000123:
p.000123: Drugs & Cosmetics Act, 1940 (2005):
p.000123: https://cdsco.gov.in/opencms/op encms/en/Notifications/Gazette- Notifications/
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: Drugs & Cosmetics Act, 1940 (2005):
p.000123: http://www.cdsco.nic.in/writereadda ta/Drugs&CosmeticAct.pdf
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
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p.000123:
p.000123:
p.000124: 124
p.000124: ments/download_file_division.jsp?nu m_id=NDI2MQ==
p.000124:
p.000124: CDSCO:
p.000124: 1. Medical Devices Rules, 2017.
p.000124: 2. General Statutory Rules 78(E) http://134t7045rwgf19lpbh29libk9d3. wpengine.netdna-cdn.com/wp-
p.000124: content/uploads/sites/11/2017/07/Indi a-Medical-Device-Rules.pdf
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124:
p.000124: DCGI:
p.000124: CDSCO:
p.000124: 1. Compensation: General Statutory Rules 53 (E): http://www.manupatra.com/manufeed
p.000124: /contents/PDF/634969625902580076. pdf
p.000124: 2. Compensation and Reporting of SAE timelines GSR 889 (E) 2014 (scroll down to see English version):
p.000124: http://www.cdsco.nic.in/writereaddat a/Notificatiohn%20on%20Compensat ion%20on%20clincial%20trial%20(1
p.000124: ).pdf
p.000124: 3. Compensation in Case of Injury or Death During Clinical Trial, Schedule Y, Appendix XII (2013) (Scroll down to see
p.000124: English version): http://www.pharmamedtechbi.com/~/ media/Supporting%20Documents/Ph armasia%20News/2013/February/Cli
p.000124: nical%20Trials%20Compensation%2 0Guidelines.pdf
...
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124:
p.000124: DBT:
p.000124: 1. Recombinant DNA Safety Guidelines (1990)
p.000124: 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002)
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 10 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Guidelines for Stem Cell Research (2017): http://icmr.nic.in/guidelines/Guidelines_fo
p.000124: r_stem_cell_research_2017.pdf
p.000124:
p.000125: 125
p.000125:
p.000125: Country Key Organizations Legislation
p.000125: Regulations Guidelines
p.000125:
p.000125: Embryos, Stem Cells, and Cloning Indonesia
p.000125: Controller General of India (DCGI): https://cdsco.gov.in
p.000125: For an overview of health research ethics, see:
p.000125: http://www.fercap-sidcer.org/newsletter/2013/12/PPT/04%20Suriadi%20Guwanan-PPT.pdf
p.000125:
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125:
p.000125:
p.000125: Human Biological Materials
p.000125:
p.000125: Japan
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125: Ministry of Health, National Institute of Health Research and Development: http://indonesia.go.id/en
p.000125:
p.000125:
p.000125: National Agency of Drug and Food Control: http://www.pom.go.id/index.php/home/en
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000125: 2. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: Drugs
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125:
p.000125:
p.000125: Devices
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125: Indonesian Health Act No. 23/1992 Section on Health Research, Article 69
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017):
p.000125: https://www.mhlw.go.jp/file/06-
p.000126: 126
p.000126: 1. Regulation No. 39/1995 on Health Research and Development
p.000126: 2. Presidential Decree No. 100/1993: Research by Foreigners
...
p.000148: id=1929&doctype2=
p.000148:
p.000148: Country Key Organizations Legislation
p.000148: Regulations Guidelines
p.000148:
p.000148: Embryos, Stem Cells, and Cloning
p.000148:
p.000148: Tajikistan
p.000148: Ministry of Health and Welfare (MOHW):
p.000148: https://www.mohw.gov.tw/mp-2.html
p.000148: Artificial Reproduction Act (2018):
p.000148: https://law.moj.gov.tw/ENG/LawCl ass/LawAll.aspx?pcode=L0070024
p.000148: Note: For an overview of human subject protections in Tajikistan, see “Ethical Review of Biomedical Research in the CIS
p.000148: Countries,” Chapter 3, Section 9:
p.000148: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000148: Note: All websites and documents are in Russian.
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Thailand
p.000148: Ministry of Public Health: http://www.health.tj/
p.000148: Order of the Ministry of Public Health of the Republic Tajikistan of 10 March, 2005 No. 118: About the Assertion of the
p.000148: Normative Documents of Republic Committee on Medical Ethics
p.000148: For an overview of the clinical research regulations in Thailand, see:
p.000148: https://clinregs.niaid.nih.gov/single_country.php?c_id=213
p.000148:
p.000148: General
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Drugs, Biologics, and Devices
p.000148: 1. National Research Council of Thailand (NCRT): http://en.nrct.go.th/en/home.aspx
p.000148: 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php
p.000148: 3. Forum for Ethical Review Committees in Thailand (FERCIT): http://www.fercit.org/
p.000148:
p.000148:
p.000148:
p.000148: Drugs
p.000148: 1. Food and Drug Administration, Drug Control Division: http://www.fda.moph.go.th/eng/index.stm
p.000148: 2. Medical Council of Thailand (MCT): http://www.tmc.or.th/en_home.php
p.000148:
p.000148:
p.000148: Devices
p.000148: Food and Drug Administration, Medical Device Control Division: http://www.fda.moph.go.th/eng/medical/p re.stm
p.000148: Medical Professions Act (2009), Articles 47-50: http://www.fercit.org/SIDCER- FERCAP/Handout_10/4.%20Accre ditation-
p.000148: update_surveyor_aj.Sopit.pdf
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: Consumer Protection Act (2007)
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: 1988 Medical Device Act: http://www2.fda.moph.go.th/Export ers/law/Document/Mdc/36- MEDICAL%20DEVICE%20ACT.h
p.000148: tm
p.000148: NCRT:
p.000148: Regulation on the Permission of Foreign Researchers (1982): http://www.dnp.go.th/otec/eng_laws_ regs/NRCT_Reg2525E.pdf
p.000148:
p.000148: MCT:
p.000148: Rule of the Medical Council on the Observance of Medical Ethics (1983):
p.000148: http://thailaws.com/law/t_laws/tlaw0 510.pdf
p.000148: MCT:
p.000148: National Guideline for Ethical Research on Human Subjects (2002)
p.000148:
p.000148: FERCIT:
p.000148: Ethical Guidelines for Research on Human Subject in Thailand (2007): http://www.fercit.org/file/Guideline_English_v
p.000148: ersion.pdf
p.000148:
p.000148:
p.000148:
p.000148:
p.000148: FDA:
p.000148: Rules, Procedures and Conditions for Accepting Ethics Committee for Research Involving Human Subjects (2018)
p.000148:
p.000148: MCT:
p.000148: Thailand Good Clinical Practice Guidelines (2002)
p.000148:
p.000149: 149
p.000149:
p.000149: Country Key Organizations Legislation
p.000149: Regulations Guidelines
p.000149:
p.000149: Clinical Trials Registry
p.000149:
p.000149: Privacy/Data Protection
p.000149:
p.000149: Uzbekistan
p.000149: Thai Clinical Trials Registry:
p.000149: http://www.clinicaltrials.in.th/
p.000149:
p.000149:
p.000149: Office of the Information Commission: http://www.oic.go.th/content_eng/default_ eng.asp
p.000149:
p.000149:
p.000149:
p.000149: Official Information Act, B.E. 2540 (1997):
p.000149: http://www.oic.go.th/content_eng/ac t.htm
p.000149: FAQs:
p.000149: http://www.clinicaltrials.in.th/index.php?meun
p.000149: =home&smenu=4&task=home&task1=openpa ge&task2=view&topid=4
p.000149:
p.000149: Note: All websites and documents are in Uzbek and Russian.
p.000149: General 1. Government of the Republic of Uzbekistan: http://www.gov.uz
p.000149: 2. Ministry of Health:
p.000149: http://www.minzdrav.uz
p.000149:
p.000149: 1. Constitution of Republic of Uzbekistan, Articles 24, 26, 40, 44 (1992): http://www.gov.uz
p.000149: 2. Law on Protection of Citizens’ Health (1997): http://www.minzdrav.uz
p.000149:
p.000149: Drugs, Biologics, and Devices
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149: Human Biological Materials
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149:
p.000149: Vietnam
p.000149: 1. Ministry of Health, Pharmacological Committee of the Central Department for Quality Control of Pharmaceuticals and
p.000149: Medical Equipment: http://www.minzdrav.uz
p.000149: 2. Ministry of Health, National Ethics Committee
p.000149: 3. Scientific Boards of Medical Institutes
p.000149: 1. Ministry of Health, Pharmacological Committee of the Central Department for Quality Control of Pharmaceuticals and
p.000149: Medical Equipment: http://www.minzdrav.uz
p.000149: 2. Ministry of Health, National Ethics Committee
p.000149: 3. Scientific Boards of Medical Institutes
p.000149: 1. Law on Protection of Citizens’ Health (1997): http://www.minzdrav.uz
p.000149: 2. Law on Drugs and Pharmaceutical Activity (1997)
p.000149: 3. Law on Narcotic and Psychoactive Drugs (2000)
p.000149: 1. Guidelines on Conducting Clinical Trials and Determining Clinical Sites (2001)
p.000149: 2. National Standard of Uzbekistan: Good Clinical Practice (2013)
...
p.000159: http://servicios.infoleg.gob.ar/infolegI nternet/verNorma.do?id=279820
p.000159:
p.000159: Provision ANMAT No. 969/97 on the Regulation of Good Clinical Practice with Medical Devices (1997):
p.000159: http://www.anmat.gov.ar/webanmat/ Legislacion/Medicamentos/Disp_969
p.000159: -97_actualizada.pdf
p.000159: Resolution 1480/2011 Approving a Guide for Human Subjects Research: http://servicios.infoleg.gob.ar/infolegI
p.000159: nternet/anexos/185000- 189999/187206/norma.htm
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159:
p.000159: FAQs: https://sisa.msal.gov.ar/sisa/#Renis
p.000160: 160
p.000160:
p.000160: Country Key Organizations Legislation
p.000160: Regulations Guidelines
p.000160:
p.000160: Human Biological Materials
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Barbados
p.000160:
p.000160:
p.000160:
p.000160: Bermuda
p.000160: General
p.000160:
p.000160: Bolivia
p.000160: General
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: Drugs, Biologics, and Devices
p.000160: Ministry of Health:
p.000160: https://www.argentina.gob.ar/salud
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: University of the West Indies – Cave Hill / Ministry of Health: http://www.cavehill.uwi.edu/researchethic s/home.aspx
p.000160:
p.000160: Department of Health:
p.000160: https://www.gov.bm/department/health
p.000160:
p.000160:
p.000160: 1. Ministry of Health and Sport (MHS): http://www.sns.gob.bo
p.000160: 2. National Bioethics Committee (NBC)
p.000160:
p.000160:
p.000160:
p.000160: 1. Ministry of Health and Sport, National Pharmacological Commission (MHS): http://www.sns.gob.bo
p.000160: 2. National Bioethics Committee (NBC)
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: 1. Legal Decree No. 15.629 of July 18, 1978, Articles 147 and 148.
p.000160: 2. New Political Constitution of the State, Article 44 (2009): https://www.constituteproject.org/co
p.000160: nstitution/Bolivia_2009.pdf
p.000160: 1. Resolution 1789/2006: Authorization for Import and Export of Biological Material for Diagnosis, Research and
p.000160: Surveillance Purposes: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/120000- 124999/122199/norma.htm
p.000160: 2. Resolution 1480/2011: Approving the Guidelines for Human Health Research and Creating the National Registry of
p.000160: Health Research, Section A3: http://servicios.infoleg.gob.ar/infolegI nternet/anexos/185000- 189999/187206/norma.htm
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160: 1. Regulations on Public Health Research, Chapter V (1978)
p.000160: 2. Rules and Regulations of the National Bioethics Committee
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
p.000160:
...
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171: National Health Research Council (Spanish): http://www.ministeriodesalud.go.cr/index. php/consejos/conis (scroll to
p.000171: bottom of page to Investigaciones Registradas)
p.000171: Regulatory Law of Biomedical Research No. 9234 (2014): http://www.pgrweb.go.cr/scij/Busqu
p.000171: eda/Normativa/Normas/nrm_texto_ completo.aspx?param1=NRTC&nV alor1=1&nValor2=77070&nValor3
p.000171: =96424&strTipM=TC
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000171:
p.000172: 172
p.000172: 1. Regulatory Decree N° 39061-S (2016) on the Regulatory Law of Biomedical Research N° 39533- S:
p.000172: http://www.pgrweb.go.cr/scij/Busque da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor
p.000172: 1=1&nValor2=81213&nValor3=103 450&strTipM=TC
p.000172: 2. Reforms to the Regulatory Decree No. 39533-S (2016) Regulatory Law of Biomedical Research No. 9234:
p.000172: http://www.pgrweb.go.cr/scij/Busque da/Normativa/Normas/nrm_texto_co mpleto.aspx?param1=NRTC&nValor
p.000172: 1=1&nValor2=81213&nValor3=103 450&strTipM=TC
p.000172: Various: http://www.ministeriodesalud.go.cr/index.php/ consejos/conis
p.000172:
p.000172: Country Key Organizations Legislation
p.000172: Regulations Guidelines Cuba
p.000172: Note: All websites and documents are in Spanish.
p.000172:
p.000172: Drugs, Biologics, and Devices Clinical Trials Registry
p.000172:
p.000172: Dominica
p.000172: General
p.000172: Center for State Control of Medications: http://www.cecmed.cu/ Public Cuban Registry of Clinical Trials:
p.000172: http://registroclinico.sld.cu/en/home
p.000172:
p.000172: Ministry of Health: http://www.dominica.gov.dm/cms/index.p hp?q=node/21
p.000172: Various: http://www.cecmed.cu/ensayos- clinicos/autorizos
p.000172:
p.000172:
p.000172:
p.000172:
p.000172: Guidelines for the Conduct of Research on Human Subjects (2005)
p.000172:
p.000172:
p.000172: Dominican Republic
p.000172: General National Council on Health Bioethics:
p.000172: http://conabios.gob.do/
p.000172:
p.000172: National Health Law 42-01, Chapter VI: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf
p.000172:
p.000172: Regulation for Evaluation Request for a Clinical Investigation Project: http://conabios.gob.do/index.php/regl amentos
p.000172:
p.000172: Biological Materials
p.000172:
p.000172:
p.000172: Ecuador
p.000172: Note: All websites and documents are in Spanish.
p.000172: National Health Law 42-01, Book Five: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf
p.000172:
p.000172: General
p.000172: Ministry of Public Health :
p.000172: http://www.salud.gob.ec/
p.000172: 1. Constitution of the Republic: http://www.asambleanacional.gob.e c/sites/default/files/documents/old/c
p.000172: onstitucion_de_bolsillo.pdf
p.000172: 2. Organic Health Law of 22 December 2006, Articles 207- 208 (2018)
p.000172: 3. Code on Childhood and Adolescence. Law 100 Official Register 737 of January 3, 2003 (2019)
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000173: 173
p.000173: 1. Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292 (March 11, 2008):
p.000173: https://www.controlsanitario.gob.ec/ wp- content/uploads/downloads/2017/01/ A.M.-66-REGLAMENTO-DE- PROYECTOS-EN-
p.000173: INVESTIGACION-DE-SALUD.pdf
...
Searching for indicator property:
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p.000001: 4. Guidelines – pertain to non-binding instruments.
p.000001: 1
p.000001:
p.000001: The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in
p.000001: parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018.
p.000001:
p.000001: HOW TO ACCESS A DOCUMENT
p.000001:
p.000001: Documents can be accessed in four possible ways:
p.000001:
p.000001: 1. Link to the web address (URL).
p.000001: 2. Search for a document at the website of the agency listed in the Key Organizations column.
p.000001: 3. Perform an Internet search on the document title.
p.000001: 4. Request a local research ethics committee to provide the document.
p.000001:
p.000001: In many cases the documents are available in English. When the URL links to a non-English website or document, an
p.000001: online language translator usually can render an English version.
p.000001:
p.000001: TOPICS NOT COVERED
p.000001:
p.000001: In order to focus its scope, the International Compilation of Human Research Standards does not include standards from
p.000001: the state, provincial, or local levels. Nor does the Compilation cover:
p.000001:
p.000001: 1. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects standards, but do not
p.000001: direct the content of those regulations.
p.000001: 2. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical bioethics,
p.000001: product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice,
p.000001: bioequivalence testing, or informed consent in clinical practice.
p.000001: 3. Ethics codes of academic, medical, or other professional organizations – see the Ethics Codes Collection:
p.000001: http://ethics.iit.edu/ecodes/about
p.000001: 4. Working papers, drafts, commentaries, or discussion papers.
p.000001:
p.000001: NEW STANDARDS, UPDATES, AND BROKEN LINKS
p.000001:
p.000001: To request inclusion of a new standard in the Compilation or to report updates or broken links, contact OHRP@HHS.gov .
p.000001:
p.000001: DISCLAIMER
p.000001:
p.000001: Although this Compilation contains information of a legal nature, it has been developed for informational purposes only
p.000001: and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any
p.000001: jurisdiction. In addition, because new standards are issued on a continuing basis, this Compilation is not an
p.000001: exhaustive source of all current applicable laws, regulations, and guidelines relating to human subject protections.
p.000001: While in-country persons have been requested to review listings to assure their accuracy and completeness, researchers
p.000001: and other individuals should check with local authorities and/or research ethics committees before commencing research
p.000001: activities.
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: TABLE OF CONTENTS
p.000002: INTERNATIONAL 5
p.000002: NORTH AMERICA 10
...
Social / Soldier
Searching for indicator armedXforces:
(return to top)
p.000008: 2. Statement on DNA Sampling: Control and Access (1998): http://www.hugo- international.org/img/dna_1998.pdf
p.000008: 3. Statement on Gene Therapy Research (2001): http://www.hugo- international.org/img/gene_2001.pdf
p.000008: 4. Statement on Human Genomic Databases (2002): http://www.hugo- international.org/img/genomic_2002.pdf
p.000008: 1. Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998-1999 (1997):
p.000008: http://unesdoc.unesco.org/images/0011/00110 2/110220e.pdf#page=47
p.000008: 2. International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences
p.000008: (2003): http://unesdoc.unesco.org/images/0013/00133 1/133171e.pdf#page=45
p.000008: Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/docs/default-source/hesc-
p.000008: guidelines/isscrhescguidelines2006.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Country Key Organizations Legislation
p.000009: Regulations Guidelines
p.000009:
p.000009:
p.000009: NORTH AMERICA
p.000009: Canada
p.000009: Note: Several Canadian provinces and territories also have human subject research standards.
p.000009: General 1. Interagency Advisory Panel on Research Ethics (PRE):
p.000009: http://www.pre.ethics.gc.ca/eng/index
p.000009: 2. National Defence and the Canadian Armed Forces: http://www.forces.gc.ca/en/index.page
p.000009: 3. Correctional Service of Canada:
p.000009: http://www.csc-scc.gc.ca/index-eng.shtml
p.000009:
p.000009:
p.000009:
p.000009: PRE:
p.000009: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2018):
p.000009: http://www.pre.ethics.gc.ca/eng/document s/tcps2-2018-en-interactive-final.pdf
p.000009:
p.000009: National Defence and the Canadian Armed Forces:
p.000009: Research Involving Human Subjects (1998): http://www.forces.gc.ca/en/about- policies-standards-defence-admin-orders-
p.000009: directives-5000/5061-0.page
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs, Biologics, and Devices
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs
p.000009: 1. Health Canada, Therapeutic Products Directorate: http://www.hc- sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
p.000009: dgpsa/tpd-dpt/index-eng.php
p.000009: 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 1. Regulations Amending the Food and Drug Regulations (1024
p.000009: – Clinical Trials) (2001): http://www.hc-sc.gc.ca/dhp- mps/alt_formats/hpfb- dgpsa/pdf/compli-conform/1024- eng.pdf
p.000009: Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2017): http://www.csc-
p.000009: scc.gc.ca/acts-and-regulations/009-cd-en.shtml
p.000009:
p.000009: Health Canada:
p.000009: Good Clinical Practice: Integrated Addendum to E6(R1)
p.000009: ICH Topic E6(R2) (2017)
p.000009: https://www.canada.ca/content/dam/hc- sc/migration/hc-sc/dhp- mps/alt_formats/pdf/prodpharma/applic-
p.000009: demande/guide-ld/ich/efficac/e6r2-step4- eng.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Devices
p.000009: Health Canada, Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md- im/index-eng.php
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000132: (2015.11): https://www.mfds.go.kr/brd/m_210/view.do?seq=12501
p.000132: 3.Guideline on Tumorigenicity Assessment of Stem Cell Therapy Products (2016.05.) https://
p.000132: www.mfds.go.kr/eng/brd/m_27/view.do?seq=70469
p.000132:
p.000132: Note: All websites and documents are in Russian.
p.000132: General 1. Government of the Kyrgyz Republic: http://www.gov.kg
p.000132: 2. Ministry of Health:
p.000132: http://www.med.kg
p.000132: 3. Ministry of Justice of the Kyrgyz Republic: http://cbd.minjust.gov.kg
p.000132:
p.000132: 1. Constitution of Kyrgyz Republic, Chapter II, Article 22 (2010): http://www.gov.kg/?page_id=263&l ang=ru
p.000132: 2. Law on Health Protection of the Kyrgyz Republic (Sept. 1, 2005, No. 6):
p.000132: Articles 34 and 72:
p.000132: http://www.pharm.kg/ru/legislation
p.000132:
p.000132: 1. Code of Professional Ethics of Medical Worker of the Kyrgyz Republic (2004): http://old.med.kg/index.php/ru/doku
p.000132: menty-2/kodex-prof-etiki-2.html
p.000132: 2. Сode of Administrative Responsibility of the Kyrgyz Republic №114 from 04.08.1998г. (Updated June 11, 2008 N 115 and
p.000132: June 23, 2008 N
p.000132: 136) Chapters 7 and 10:
p.000132: http://www.pharm.kg/ru/legislation/
p.000132:
p.000132: Drugs, Biologics, and Devices
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132:
p.000132: Research Injury
p.000132: 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg
p.000132: 2. Ministry of Health, National Bioethics Committee
p.000132: 3. Pharmaceutical Union of Kyrgyzstan, Ethics Committee: http://farmunion.kg/o-nas/eticheskij- komitet/
p.000132:
p.000132:
p.000132: 1. Ministry of Health, Department of Drug and Medical Devices Provision (DDMDP): http://www.pharm.kg
p.000132: 2. Ministry of Health, National Bioethics Committee
p.000132: Law on the Circulation of Medicinal Products
p.000132: of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles
p.000132: 24-25:
p.000132: http://cbd.minjust.gov.kg/act/view/r u-ru/111672
p.000132:
p.000132:
p.000132: Law on the Circulation of Medicinal Products
p.000132: of the Kyrgyz Republic, as amended by the Law of the Kyrgyz Republic of May 3, 2018 N 44, Chapter VII, Articles
p.000132: 24-25:
p.000132: http://cbd.minjust.gov.kg/act/view/r u-ru/111672
p.000132: DDMDP:
p.000132: 1. National Standard KMC 1195:2010: Medical Devices: Rules for Clinical Trials (2010):
p.000132: http://www.pharm.kg/ru/legislation/
p.000132: 2. Technical Regulations on the Safety of Medical Products for Medical Application, Approved by the Governmental Order
p.000132: # 74 from February 1, 2012: http://www.pharm.kg/ru/legislation/ DDMDP:
p.000132: National Standard KMC 1195:2010: Medical Devices, Rules for Clinical Trials, Paragraphs 3, 4, and 6 (2010):
p.000132: http://www.pharm.kg/ru/legislation/
p.000132:
p.000133: 133
p.000133:
p.000133: Country Key Organizations Legislation
p.000133: Regulations Guidelines
p.000133:
p.000133: Human Biological Materials
p.000133:
p.000133:
p.000133:
p.000133: Social-Behavioral Research
p.000133:
p.000133:
p.000133:
p.000133:
p.000133: Privacy/Data Protection
p.000133:
p.000133:
...
p.000150: quyen-han-Hoi-dong-dao-duc-nghien-cuu-y- sinh-hoc-354849.aspx
p.000150: 2. Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in Biomedical Research of the Ministry of
p.000150: Health, Period 2018-2023: http://crc.pasteurhcm.gov.vn/upload/files/1122
p.000150: _2018.pdf
p.000150: Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17
p.000150: (2012):
p.000150: https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf
p.000150: 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van-
p.000150: ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx
p.000150:
p.000150:
p.000150:
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p.000150:
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: Country Key Organizations Legislation
p.000151: Regulations Guidelines
p.000151:
p.000151: MIDDLE EAST/NORTH AFRICA
p.000151: Egypt
p.000151:
p.000151: General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151: Iran
p.000151: General
p.000151:
p.000151:
p.000151:
p.000151: Clinical Trials Registry Israel General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151:
p.000151:
p.000151: Privacy/Data Protection
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Genetic Research
p.000151: Medical Professionals Union
p.000151:
p.000151:
p.000151: Egyptian Drug Authority:
p.000151: http://www.eda.mohp.gov.eg/
p.000151:
p.000151:
p.000151: Ministry of Health and Medical Education, Office for the Study of Humanistic and Islamic Science in Medicine and
p.000151: Medical Ethics: http://www.mohme.gov.ir/
p.000151: Iranian Registry of Clinical Trials:
p.000151: http://www.irct.ir/
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151:
p.000151: Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/English/Ministry
p.000151: Units/HealthDivision/MedicalTechnologi es/Drugs/Pages/default.aspx
p.000151:
p.000151: Israeli Law, Information, and Technology Authority: http://www.justice.gov.il/MOJEng/ILITA/
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151: Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dusto r-en001.pdf
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Public Health Order (1940)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007-
...
Social / Women
Searching for indicator women:
(return to top)
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
...
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
p.000014: 14
p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
p.000014: 2. EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000014: (2016) https://www.epa.gov/osa/epa-order-100017- policy-and-procedures-protection-human-
p.000014: research-subjects-epa-conducted-or
p.000014:
p.000014: Country Key Organizations Legislation
p.000014: Regulations Guidelines
p.000014: Nursing Women (2013)
p.000014:
p.000014: General
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Drugs, Biologics, and Devices
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: National Aeronautics and Space Administration: www.nasa.gov/ National Science Foundation: www.nsf.gov/
p.000014: Social Security Administration:
p.000014: http://www.ssa.gov/
p.000014:
p.000014: Drugs and Biologics
p.000014: Food and Drug Administration: https://www.fda.gov/Drugs and https://www.fda.gov/vaccines-blood- biologics
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: Devices
p.000014: Food and Drug Administration, Center for Devices and Radiological
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: 1. Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (2012): https://uscode.house.gov/browse/pre
p.000014: lim@title21&edition=prelim
p.000014: 2. Public Health Service Act, 42 USC Section 262 (1998): https://uscode.house.gov/browse/pre lim@title42&edition=prelim
p.000014: 3. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW-
p.000014: 114publ255.pdf
p.000014:
...
p.000030:
p.000030: General
p.000030: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000030: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000030: -advisory-committee-bioethics
p.000030: Law Relating to Experimentation on Humans (2004):
p.000030: http://www.ejustice.just.fgov.be/cgi
p.000030: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000030: 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000068: 1. V-405, Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage, and Providing
p.000068: Information on Biomedical Research (2010): https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.372121
p.000068: 2. Government of the Republic of Lithuania: Decree No. 1458 on State Fees (2017):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/TAR.E3A145 C8DD49/adJtSaHbRM
p.000068: 3. V-15, Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation
p.000068: in Biomedical Research and the Time Spent (2018):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/2a0242a0b5fe 11e5a6588fb85a3cc84b/ILdhwknYP P
p.000068: 4.V-28, Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research
p.000068: and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent
p.000068: (2018):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/0f2f1b70b9db 11e5a6588fb85a3cc84b/asr
p.000068: 5. V-1483, Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and
p.000068: Temporary Impact on the Subject’s Health (2018):
p.000068: https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/828d5 3e095ef11e4b92e9028929aad91/asr
p.000068: 6. V-235/A1-83, Decree on the
p.000068:
p.000068: Country Key Organizations Legislation
p.000068: Regulations Guidelines
p.000068:
p.000068: General
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: Lithuanian Bioethics Committee (LBEC):
p.000068: http://bioetika.sam.lt/index.php?23518515 30
p.000068: Procedure for a Minor’s Participation in Biomedical Research (2018): https://www.e-
p.000068: tar.lt/portal/lt/legalAct/104c2540d3e7 11e583a295d9366c7ab3
p.000068: 1. V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28 (2011):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/TAR.480CDD 584ADB
p.000068: 2. V-7, Decree on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol and the CV of
p.000068: Investigator (2017):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/352d55b0c441 11e583a295d9366c7ab3/Maiuzzfyns
p.000068: 3. V-24, Decree on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue
p.000068: Favorable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the
p.000068: Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research (2016): https://www.e-
p.000068: tar.lt/portal/lt/legalAct/3790a050be7e 11e5a6588fb85a3cc84b
p.000068: 4. V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical
p.000068: Research Ethical Assessment Form (2016): https://www.e- tar.lt/portal/lt/legalAct/27a3460090f0
p.000068: 11e4bb408baba2bdddf3/UqgJXDRU qi
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical
p.000068: Research of the LBEC (2018): http://bioetika.sam.lt/get_file.php?file=bmNlV 3pKeWhhWjJlcW1xZ2xxQnNrWlprbXM2VW
p.000068: tKblJ5Wlp1ekptZG1hV2V5c3JXbUdGa3IzR2 NrNkNab1pxVng2aVprR2ZIWk0yWG81ekxr MnlYY21tV3lwSEtvbWFjbkp4bWNwcCUyQ
p.000068: mNZT2FlMjdUWThacno4ZW1iTlBHbWNlb mJzbVZ4SjJWYWFHZW9HYW1tNmhvajVo bmFwR1ZrbW1jbFdSd2xwdGxsR1pzbHB5W
...
Searching for indicator youth:
(return to top)
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: SUKL:
p.000042: Various:
p.000042: http://www.sukl.cz/medicinal-products- clinical-trials-guidelines-1
p.000042:
p.000042:
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical-devices-guidelines
p.000042:
p.000042: Country Key Organizations Legislation
p.000042: Regulations Guidelines
p.000042: Medical Devices
p.000042: Research Injury 1. Convention on Human
p.000042: Rights
p.000042: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000042: 164 (2001)
p.000042: 2. Law No. 89/2012 Coll. Civil Code: http://www.czechlegislation.com/en
p.000042: /89-2012-sb
p.000042:
p.000042: Privacy/Data Protection
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Embryos, Stem Cells, and Cloning
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Denmark
p.000042: General
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Drugs, Biologics, and Devices
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Research Injury
p.000042: Office for Personal Data Protection:
p.000042: https://www.uoou.cz/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: 1. Ministry of Education, Youth, and Sport: http://www.msmt.cz/index.php?lchan=1& lred=1
p.000042: 2. Research and Development Council, Bioethical Commission: http://www.vyzkum.cz/FrontClanek.aspx? idsekce=15908
p.000042:
p.000042: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Danish Medicines Agency:
p.000042: https://laegemiddelstyrelsen.dk/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Patient Compensation Association:
p.000042: http://pebl.dk/en.aspx
p.000042: 1. Act No. 110/2019 Coll., On Personal Data Processing: https://www.uoou.cz/en/assets/File.
p.000042: ashx?id_org=200156&id_dokument y=1837
p.000042: 2. General Data Protection Regulation (2018): https://gdpr-info.eu/
p.000042: Act of 26 April 2006 on Research on Human Embryonic Stem Cells No. 227/2006 Sb. (Coll.), as amended (2017)
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For
p.000042: ms/R0710.aspx?id=192671
p.000042: 2013 version (English): http://www.nvk.dk/english/act-on- research
p.000042: Act No. 620 on Clinical trials on Medical Products No. 620 (2016):
p.000042: https://www.retsinformation.dk/For ms/r0710.aspx?id=180117
p.000042:
p.000042:
p.000042: 1. Liability for Damages Act (2007): https://protect2.fireeye.com/url?k=8 312f002-df47f9d2-8312c13d-
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
...
Social / education
Searching for indicator education:
(return to top)
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
p.000012: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000012:
p.000012: 1. 34 CFR 97 subparts A (1991) and D (1997)
p.000012: 2. 34 CFR 98 (1984)
p.000012: 3. 34 CFR 99 (2000)
p.000012: 4. 34 CFR 350.4(c) (1991)
p.000012: 5. 34 CFR 356.3(c) (1991)
p.000012: Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015):
p.000012: https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf
p.000012:
p.000012: Country Key Organizations Legislation
p.000012: Regulations Guidelines
p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
...
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: SUKL:
p.000042: Various:
p.000042: http://www.sukl.cz/medicinal-products- clinical-trials-guidelines-1
p.000042:
p.000042:
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical-devices-guidelines
p.000042:
p.000042: Country Key Organizations Legislation
p.000042: Regulations Guidelines
p.000042: Medical Devices
p.000042: Research Injury 1. Convention on Human
p.000042: Rights
p.000042: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000042: 164 (2001)
p.000042: 2. Law No. 89/2012 Coll. Civil Code: http://www.czechlegislation.com/en
p.000042: /89-2012-sb
p.000042:
p.000042: Privacy/Data Protection
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Embryos, Stem Cells, and Cloning
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Denmark
p.000042: General
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Drugs, Biologics, and Devices
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Research Injury
p.000042: Office for Personal Data Protection:
p.000042: https://www.uoou.cz/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: 1. Ministry of Education, Youth, and Sport: http://www.msmt.cz/index.php?lchan=1& lred=1
p.000042: 2. Research and Development Council, Bioethical Commission: http://www.vyzkum.cz/FrontClanek.aspx? idsekce=15908
p.000042:
p.000042: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Danish Medicines Agency:
p.000042: https://laegemiddelstyrelsen.dk/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Patient Compensation Association:
p.000042: http://pebl.dk/en.aspx
p.000042: 1. Act No. 110/2019 Coll., On Personal Data Processing: https://www.uoou.cz/en/assets/File.
p.000042: ashx?id_org=200156&id_dokument y=1837
p.000042: 2. General Data Protection Regulation (2018): https://gdpr-info.eu/
p.000042: Act of 26 April 2006 on Research on Human Embryonic Stem Cells No. 227/2006 Sb. (Coll.), as amended (2017)
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For
p.000042: ms/R0710.aspx?id=192671
p.000042: 2013 version (English): http://www.nvk.dk/english/act-on- research
p.000042: Act No. 620 on Clinical trials on Medical Products No. 620 (2016):
p.000042: https://www.retsinformation.dk/For ms/r0710.aspx?id=180117
p.000042:
p.000042:
p.000042: 1. Liability for Damages Act (2007): https://protect2.fireeye.com/url?k=8 312f002-df47f9d2-8312c13d-
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
p.000043:
...
p.000048: 48
p.000048:
p.000048: Country Key Organizations Legislation
p.000048: Regulations Guidelines
p.000048:
p.000048: Social-Behavioral Research
p.000048:
p.000048:
p.000048:
p.000048: Privacy/Data Protection
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: Human Biological Materials
p.000048: National Consultative Ethics Committee
p.000048:
p.000048:
p.000048:
p.000048: 1. National Commission of Information and Liberty (CNIL): https://www.cnil.fr/en/home
p.000048: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Protection of Persons Committee (CPP)
p.000048: 2. Ministry of Higher Education, Research, and Innovation: http://www.enseignementsup- recherche.gouv.fr/
p.000048: 3. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne-
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Act N° 78-17 of 6 January 1978 on Information Technology, Data Files, and Civil Liberties (2018):
p.000048: https://www.cnil.fr/fr/la-loi- informatique-et-libertes
p.000048: 2. Law No. 2016-1321 of 7
p.000048: October 2016 for a Numeric Republic: https://www.legifrance.gouv.fr/affic hLoiPubliee.do?idDocument=JORF
p.000048: DOLE000031589829&type=genera l&legislature=14
p.000048: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000048: 4. Data Protection Act (2018): https://www.legifrance.gouv.fr/affic hLoiPreparation.do;jsessionid=AD5
p.000048: 660270AD9F70B94275AC8233216 80.tplgfr22s_3?idDocument=JORF DOLE000036195293&type=conten u&id=2&typeLoi=proj&legislature
p.000048: =15
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Donation and Use of the Components and Products of the Human Body, Articles L1211-1 to L1274-3 (2004):
p.000048: http://www.legifrance.gouv.fr/
p.000048: 2. Public Health Code Articles L1243-3 and following sections: (2012): http://www.legifrance.gouv.fr/initR
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: CNIL:
p.000049: Decree N° 2019-536 of 29 May 2019 Enacted for the Application of Act No. 78-17 of 6 January 1978 on Data Processing,
p.000049: Data Files, and Civil Liberties: https://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT0000
p.000049: 38528420&categorieLien=id
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
...
p.000052: 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf
p.000052: 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-
p.000052: Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf
p.000052: DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production:
p.000052: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_
p.000052: menschlicher_Gewebe.pdf
p.000053: 53
p.000053:
p.000053: Country Key Organizations Legislation
p.000053: Regulations Guidelines
p.000053: 2. Genetic Engineering Act
p.000053:
p.000053: Genetic Research
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: Embryos, Stem Cells, and Cloning
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Ethics Council:
p.000053: https://www.ethikrat.org/en/
p.000053: (2017):
p.000053: http://www.gesetze-im- internet.de/gentg/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/
p.000053: 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054: Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell
p.000054: Act (2017): http://www.gesetze-im- internet.de/zesv/
p.000054:
p.000054:
p.000054:
p.000054: 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004):
p.000054: http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf
p.000054: 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_
p.000054: gfh_positionspapier.pdf
...
p.000091: sammarinese-di-bioetica.html
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: 1. Ministry of Health (MOH):
p.000091: http://www.zdravlje.gov.rs/
p.000091: 2. Serbian Drug Agency
p.000091: http://www.alims.gov.rs/eng/
p.000091: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000091: .docx
p.000091: 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information
p.000091: (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/
p.000091: 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal
p.000091: Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:”
p.000091: http://base.garant.ru/10135402/
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010):
p.000091: http://base.garant.ru/184467/
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine (1998)
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998)
p.000091:
p.000091: Law on Medicines and Medical Devices, Official Gazette of RS No. 30/2010, 107/2012, 113/2017, and 105/2017:
p.000091: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf
p.000092: 92
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Order of the Ministry of Education and Science of the Russian Federation #154: “Statute of the Inter- Departmental
p.000092: Commission on Genetic-Engineering Activity” (2005):
p.000092: http://www.zakonprost.ru/content/ba se/part/438157
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: MOH:
p.000092: Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical
p.000092: Trials, Official Gazette of RS, 64/2011, 91/2013,
p.000092:
p.000092: Country Key Organizations Legislation
p.000092: Regulations Guidelines
p.000092:
p.000092: Drugs, Biologics, and Devices
p.000092: Research Injury
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Privacy/Data Protection
p.000092:
p.000092:
p.000092:
p.000092: Genetics
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Embryos, Stem Cells, and Cloning
p.000092:
p.000092:
p.000092:
p.000092: 1. Ministry of Health (MOH):
p.000092: http://www.zdravlje.gov.rs/index.php?
p.000092: 2. Serbian Drug Agency
p.000092: http://www.alims.gov.rs
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Commissioner for Information of Public Importance and Personal Data Protection: https://www.poverenik.rs/en/
p.000092:
p.000092:
p.000092: Ministry of Health (MOH):
...
p.000124:
p.000124: DBT:
p.000124: 1. Recombinant DNA Safety Guidelines (1990)
p.000124: 2. Ethical Policies on the Human Genome, Genetic Research, and Services (2002)
p.000124:
p.000124: ICMR:
p.000124: National Ethical Guidelines For Biomedical and Health Research Involving Human Participants, Section 10 (2017):
p.000124: http://icmr.nic.in/guidelines/ICMR_Ethical_Gu idelines_2017.pdf
p.000124: National Guidelines for Stem Cell Research (2017): http://icmr.nic.in/guidelines/Guidelines_fo
p.000124: r_stem_cell_research_2017.pdf
p.000124:
p.000125: 125
p.000125:
p.000125: Country Key Organizations Legislation
p.000125: Regulations Guidelines
p.000125:
p.000125: Embryos, Stem Cells, and Cloning Indonesia
p.000125: Controller General of India (DCGI): https://cdsco.gov.in
p.000125: For an overview of health research ethics, see:
p.000125: http://www.fercap-sidcer.org/newsletter/2013/12/PPT/04%20Suriadi%20Guwanan-PPT.pdf
p.000125:
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125:
p.000125:
p.000125: Human Biological Materials
p.000125:
p.000125: Japan
p.000125: General
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: Drugs, Biologics, and Devices
p.000125: Ministry of Health, National Institute of Health Research and Development: http://indonesia.go.id/en
p.000125:
p.000125:
p.000125: National Agency of Drug and Food Control: http://www.pom.go.id/index.php/home/en
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000125: 2. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: Drugs
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125:
p.000125:
p.000125: Devices
p.000125: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125: Indonesian Health Act No. 23/1992 Section on Health Research, Article 69
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017):
p.000125: https://www.mhlw.go.jp/file/06-
p.000126: 126
p.000126: 1. Regulation No. 39/1995 on Health Research and Development
p.000126: 2. Presidential Decree No. 100/1993: Research by Foreigners
p.000126: 1. Ministry of Health Decree No. 56/2000: Guidelines on Clinical Trials of Traditional Drugs
p.000126: 2. Guidelines on Good Clinical Practice (2001)
...
p.000127: gov.go.jp/htmldata/H17/H17F190010 00036.html
p.000127:
p.000127:
p.000127: NIPH Clinical Trials Search: http://rctportal.niph.go.jp/en/
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Guidelines for Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/guidelines01.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines02.p df https://www.ppc.go.jp/files/pdf/guidelines03.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines04.p df
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Ethics Guidelines for Medical and Health Research Involving Human Subjects, Chapter 2, No. 5, 1-(3) and No. 6, 2-(2)
p.000127: (2017):
p.000127: http://www.lifescience.mext.go.jp/files/pdf/n1859_01
p.000127: .pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: On Research and Development Utilizing Human Tissues Removed by Surgery and Other Procedures (1998) (Japanese):
p.000127: https://www.mhlw.go.jp/www1/shingi/s9812/s 1216-2_10.html
p.000127:
p.000127: Country Key Organizations Legislation
p.000127: Regulations Guidelines
p.000127:
p.000127: Genetic Research
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Embryos, Stem Cells, and Cloning
p.000127: 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. html
p.000127: 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000127: 3. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000127: 4. Ministry of Economy, Trade, and Industry (METI): http://www.meti.go.jp/english/
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: 1. Council for Science, Technology, and Innovation (CSTI): http://www8.cao.go.jp/cstp/english/index. html
p.000127: 2. Ministry of Education, Culture, Sports, Science, and Technology (MEXT): http://www.mext.go.jp/english/
p.000127: 3. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: 1. Act on Regulation of Human Cloning Techniques (2014): http://law.e- gov.go.jp/htmldata/H12/H12HO146
p.000127: .html
p.000127: 2000 version (English): http://www.cas.go.jp/jp/seisaku/hou rei/data/htc.pdf
p.000127: 2. Act on Safety of Regenerative Medicine (2013): http://www.mhlw.go.jp/file/06- Seisakujouhou-10800000-
p.000127: Iseikyoku/0000030847.pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: 1. Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2009):
p.000128: http://www.lifescience.mext.go.jp/file s/pdf/n1564_01.pdf
p.000128: 2. Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019): https://www.lifescience.mext.go.jp/fil
p.000128: es/pdf/n2163_01.pdf
p.000128: 3. Rules for Enforcement of Act on Safety of Regenerative Medicine (2018): https://www.mhlw.go.jp/content/0004
p.000128: 52630.pdf
p.000128: CSTI:
p.000128: Fundamental Principles of Research on the Human Genome (2000)
p.000128:
p.000128: MEXT, MHLW, and METI:
...
p.000129: http://www.mohw.go.kr/eng/index.jsp
p.000129:
p.000129: Bioethics and Safety Act No. No. 15188 (2017.12):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000129:
p.000129: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 28821 (2017.7): http://www.law.go.kr/LSW/
p.000129: lsInfoP.do?lsiSeq=195703&url Mode=engLsInfoR&viewCls=engLsI nfoR#0000
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs, Biologics, and Devices
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs
p.000129: Ministry of Food and Drug Safety (MFDS) (2013):
p.000129: http://www.mfds.go.kr/eng/index.do
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Medical Device Act No. 15486 (2018.3):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=48691&lang=ENG
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000130: 130
p.000130: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/lsInfoP.d
p.000130: o?lsiSeq=98198&urlMode=engLsI nfoR&viewCls=engLsInfoR#0000
p.000130:
p.000130: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 27673 (2016.12): http://elaw.klri.re.kr/kor_service/law
p.000130: View.do?hseq=40268&lang=ENG
p.000130: 2. Regulation on Safety of Medicinal Products, etc. No. 1089(2014.8): http://www.mfds.go.kr/eng/brd/m_18
p.000130: /view.do?seq=69740&srchFr=&srchT o=&srchWord=&srchTp=&itm_seq_ 1=0&itm_seq_2=0&multi_itm_seq=0
p.000130: &company_cd=&company_nm=&pa ge=3
p.000130: 3. Regulations for Clinical Trial Personnel Education and Certification for the Educational
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: MFDS:
p.000130: 1. Guidelines on Human Research Protection Program 0053-01 (2014.3) 2017-.5.30 고시:
p.000130: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000130: =12203
p.000130:
p.000130: Country Key Organizations Legislation
p.000130: Regulations Guidelines
p.000130:
p.000130:
p.000130: Drugs, Biologics, and Devices
p.000130: Institution Notice No.2019-3 (2019.01. 17.) http://www.law.go.kr/admRulLsIn foP.do?admRulSeq=2100000175429
p.000130: 4. Regulation on Approval for Investigational New Drug Application of Drugs, Notice No.2018-42 (2018. 06.04)
p.000130: https://www.mfds.go.kr/eng/brd/m_18/ view.do?seq=71451
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Clinical Trials Registry
p.000130:
p.000130:
p.000130: Research Injury
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Privacy/Data Protection
p.000130: Devices
p.000130: Ministry of Food and Drug Safety:
p.000130: http://www.mfds.go.kr/eng/index.do
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Korea Centers for Disease Control and Prevention (KCDC), Clinical Research Information Service:
...
p.000140: 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012)
p.000140: 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013)
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
p.000140: 4. Commission of Higher Education (CHED): www.ched.gov.ph/
p.000140: 5. National Commission for Indigenous Peoples (NCIP): www.ncip.gov.ph
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Republic Act No. 10532: An Act Institutionalizing the Philippine National Health Research System (2013):
p.000140: http://www.gov.ph/2013/05/07/repu blic-act-no-10532/
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: PHREB:
p.000140: 1. PNHRS Act Implementing Rules and Regulations: http://www.ethics.healthresearch.ph/i
p.000140: ndex.php/component/content/article/2
p.000140: -uncategorised/214-implementing- rules-of-pnhrs
p.000140: 2. Memorandum: Registration and Accreditation of all Ethics Review Committees in the Philippines (2015):
p.000140: http://www.ethics.healthresearch.ph/i ndex.php/orders-and- memorandums/10-orders-and- memos/226-phreb-memo
p.000140: http://nbcpakistan.org.pk/assets/hbm-nbc- guidelines-final-18june-2016.pdf Protocol/Guidelines for Stem Cell
p.000140: Research/Regulation in Pakistan: http://nbcpakistan.org.pk/?page_id=61
p.000140:
p.000140: PHREB:
p.000140: National Ethical Guidelines for Health and Health-Related Research (2017):
p.000140: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
p.000140: guidelines-for-health-and-health-related- research
p.000140:
p.000140: DOST:
p.000140: 1. Administrative Order 001 Series 2007: Requirement for Review of All Research Involving Human Subjects/Participants
...
p.000144: http://www.nea.gov.sg/anti-pollution- radiation-protection/radiation-protection
p.000144:
p.000144: 1. Ministry of Health (MOH):
p.000144: http://www.moh.gov.sg/
p.000144: 2. Health Sciences Authority:
p.000144: http://www.hsa.gov.sg
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Personal Data Protection Commission (PDPC): https://www.pdpc.gov.sg
p.000144: 2. Bioethics Advisory Committee
p.000144: (BAC): https://www.bioethics- singapore.org
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Ministry of Health (MOH):
p.000144: http://www.moh.gov.sg/
p.000144: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007
p.000144: 2. Radiation Protection Act (2007): https://sso.agc.gov.sg/Act/RPA2007
p.000144:
p.000144:
p.000144: 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15
p.000144: 2. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Personal Data Protection Act (2012):
p.000144: https://sso.agc.gov.sg/Act/PDPA20 12
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Medical (Therapy, Education, and Research) Act (1973): https://sso.agc.gov.sg/Act/MTERA1
p.000972: 972
p.000972: 2. Human Biomedical Research
p.000145: 145
p.000145: https://sso.agc.gov.sg/SL/MA1975- S335-2016
p.000145: 4. Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016: https://sso.agc.gov.sg/SL/MA1975-
p.000145: S336-2016
p.000145:
p.000145: 1. Health Products (Medical Device) Regulations (2010): http://sso.gov.sg/SL/HPA2007-S436- 2010
p.000145: 2. Radiation Protection (Non- Ionising Radiation) Regulations (Cap 262 Rg 1): http://sso.gov.sg/SL/RPA1991-RG1
p.000145: 1. Human Biomedical Research Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015
p.000145: -S621-2017
p.000145: 2. Health Products (Clinical Trials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S331-2016
p.000145: Medicines (Clinical Trials) Regulations (2016): https://sso.agc.gov.sg/SL/MA1975- S335-2016
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Medicines (Clinical Trials) Regulations (2000): http://statutes.agc.gov.sg/aol/search/d isplay/view.w3p;orderBy=date-
p.000145: rev,loadTime;page=0;query=Id%3A7 e3c748b-8089-4699-a4b2-
p.000145:
p.000145:
p.000145:
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p.000145:
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p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: HSA:
p.000145: Singapore Guideline for Good Clinical Practice (2016): http://www.ich.org/fileadmin/Public_Web_Site
p.000145: /ICH_Products/Guidelines/Efficacy/E6/E6_R2 Step_4_2016_1109.pdf
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: PDPC:
p.000145: Sector Specific Guidelines Promulgated by PDPC:
p.000145: https://www.pdpc.gov.sg/Legislation-and- Guidelines/Guidelines
p.000145:
p.000145: BAC:
...
p.000150: _2018.pdf
p.000150: Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17
p.000150: (2012):
p.000150: https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf
p.000150: 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van-
p.000150: ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx
p.000150:
p.000150:
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p.000150:
p.000150:
p.000150:
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: Country Key Organizations Legislation
p.000151: Regulations Guidelines
p.000151:
p.000151: MIDDLE EAST/NORTH AFRICA
p.000151: Egypt
p.000151:
p.000151: General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151: Iran
p.000151: General
p.000151:
p.000151:
p.000151:
p.000151: Clinical Trials Registry Israel General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151:
p.000151:
p.000151: Privacy/Data Protection
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Genetic Research
p.000151: Medical Professionals Union
p.000151:
p.000151:
p.000151: Egyptian Drug Authority:
p.000151: http://www.eda.mohp.gov.eg/
p.000151:
p.000151:
p.000151: Ministry of Health and Medical Education, Office for the Study of Humanistic and Islamic Science in Medicine and
p.000151: Medical Ethics: http://www.mohme.gov.ir/
p.000151: Iranian Registry of Clinical Trials:
p.000151: http://www.irct.ir/
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151:
p.000151: Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/English/Ministry
p.000151: Units/HealthDivision/MedicalTechnologi es/Drugs/Pages/default.aspx
p.000151:
p.000151: Israeli Law, Information, and Technology Authority: http://www.justice.gov.il/MOJEng/ILITA/
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151: Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dusto r-en001.pdf
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Public Health Order (1940)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007-
p.000151: 5FD6A6B8E0A5/18334/Protectiono fPrivacyLaw57411981unofficialtran slatio.pdf
p.000151: 2. Protection of Privacy Law No. 5741, as Amended by Law No. 5745 (1985)
p.000151: Genetic Information Law (2000):
p.000151: http://www.moital.gov.il/NR/exeres
p.000151: /66F4DD4E-FA4A-4B76-94BC- DC29543471DE.htm
...
p.000175: http://cssp.gob.sv/wp- content/uploads/2016/05/Reglamento
p.000175: -de-la-ley-de-Deberes-y-Derechos- de-los-Pacientes-y-prestadores-de- Servicios-de-Salud.pdf
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 1. Standard Operating Procedures for the Ethical Evaluation of Health Research (2015): http://cssp.gob.sv/wp-
p.000175: content/uploads/2016/06/MANUAL-CNEIS- 2017-03-15.pdf
p.000175: 2. Manual on the Functioning of the National Health Research Ethics Committee (2017): http://cssp.gob.sv/wp-
p.000175: content/uploads/2016/06/manual_funcionamien to_comite_nacional_etica_investigacion_en_sa lud.pdf
p.000175:
p.000175: Country Key Organizations Legislation
p.000175: Regulations Guidelines
p.000175:
p.000175: General
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Drugs and Devices
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Grenada
p.000175: General
p.000175:
p.000175:
p.000175:
p.000175: Guyana
p.000175: General
p.000175:
p.000175:
p.000175: Guatemala
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: National Directorate of Medications: http://www.medicamentos.gob.sv/index.p hp/es/
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: St. George’s University/Windward Islands Research and Education Foundation: http://www.sgu.edu/school-of-
p.000175: medicine/institutional-review-board.html
p.000175: efault/files/documents/decretos/F31 2B814-45C5-48EB-A71D-
p.000175: 0DFC612FF135.pdf
p.000175: 3. Law on the Integrated National System of Health, Article 28 (2019): https://www.diariooficial.gob.sv/dia
p.000175: rios/do-2019/05-mayo/17-05- 2019.pdf
p.000175: Medication Law, Articles 29 and 66 (2012):
p.000175: https://www.asamblea.gob.sv/sites/d efault/files/documents/decretos/171 117_073104135_archivo_document
p.000175: o_legislativo.pdf
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Medical Research Involving Human Subjects Regulations (2007)
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: User’s Guide for the Application of Clinical Investigation Protocols: http://www.medicamentos.gob.sv/index.php/es/
p.000175: servicios-m/descargables/ensayos-clinicos
p.000175:
p.000175:
p.000175:
p.000175: 45 CFR 46:
p.000175: http://www.hhs.gov/ohrp/humansubjects/guida nce/45cfr46.html
p.000175:
p.000175: Note: All websites and documents are in Spanish.
p.000175: General Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
p.000175: 1. Regulation on Clinical Research on Humans (2015)
p.000175: 2. Internal Regulations of the National Committee on Health Ethics (2018): http://www.mspas.gob.gt/images/files
p.000175: /acuerdosministeriales/2018/Acuerdo Ministerial1392018NormativaCNES. pdf
p.000175:
p.000175: Drugs, Biologics, and Devices
...
Searching for indicator educational:
(return to top)
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
p.000005: 2. Ethical Considerations
p.000005: in Biomedical HIV Prevention Trials (2012):
p.000005: http://www.unaids.org/en/media/unaids/conten
p.000005:
p.000005: Country Key Organizations Legislation
p.000005: Regulations Guidelines
p.000005: tassets/documents/unaidspublication/2012/jc1
p.000005:
p.000005: General
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: World Medical Association:
p.000005: http://www.wma.net/e/
p.000005:
p.000005:
p.000005: Drugs
p.000005: International Conference on Harmonization (ICH): http://www.ich.org/
p.000005:
p.000005:
p.000005:
p.000005: World Health Organization (WHO):
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Devices
p.000005: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
p.000005:
p.000005:
p.000006: 6
p.000006: 399_ethical_considerations_en.pdf Universal Declaration on Bioethics and Human Rights (2005):
p.000006: http://portal.unesco.org/en/ev.php- URL_ID=31058&URL_DO=DO_TOPIC&U RL_SECTION=201.html
p.000006: 1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011)
p.000006: 2. Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
p.000006: 3. Managing Ethical Issues in Infectious Disease Outbreaks: Guidance Document (2016)
p.000006: 4. WHO Guidelines on Ethical Issues in Public Health Surveillance (2017)
p.000006:
p.000006: Access: http://www.who.int/ethics/publications/en/ Declaration of Helsinki (2013):
...
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
p.000012: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000012:
p.000012: 1. 34 CFR 97 subparts A (1991) and D (1997)
p.000012: 2. 34 CFR 98 (1984)
p.000012: 3. 34 CFR 99 (2000)
p.000012: 4. 34 CFR 350.4(c) (1991)
p.000012: 5. 34 CFR 356.3(c) (1991)
p.000012: Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015):
p.000012: https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf
p.000012:
p.000012: Country Key Organizations Legislation
p.000012: Regulations Guidelines
p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
p.000012: Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/
p.000012:
p.000012:
p.000012: Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/
p.000012:
p.000012:
p.000012:
p.000012: Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland
p.000012: Security: www.dhs.gov/
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Housing and Urban Development: www.hud.gov/
...
p.000129:
p.000129: Bioethics and Safety Act No. No. 15188 (2017.12):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=46341&lang=ENG
p.000129:
p.000129: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 28821 (2017.7): http://www.law.go.kr/LSW/
p.000129: lsInfoP.do?lsiSeq=195703&url Mode=engLsInfoR&viewCls=engLsI nfoR#0000
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs, Biologics, and Devices
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Drugs
p.000129: Ministry of Food and Drug Safety (MFDS) (2013):
p.000129: http://www.mfds.go.kr/eng/index.do
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: Medical Device Act No. 15486 (2018.3):
p.000129: http://elaw.klri.re.kr/kor_service/la wView.do?hseq=48691&lang=ENG
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000130: 130
p.000130: 2. Enforcement Rule of Bioethics and Safety Act No. 143 (2009.12): http://www.law.go.kr/LSW/lsInfoP.d
p.000130: o?lsiSeq=98198&urlMode=engLsI nfoR&viewCls=engLsInfoR#0000
p.000130:
p.000130: 1. Enforcement Decree of Pharmaceutical Affairs Act No. 27673 (2016.12): http://elaw.klri.re.kr/kor_service/law
p.000130: View.do?hseq=40268&lang=ENG
p.000130: 2. Regulation on Safety of Medicinal Products, etc. No. 1089(2014.8): http://www.mfds.go.kr/eng/brd/m_18
p.000130: /view.do?seq=69740&srchFr=&srchT o=&srchWord=&srchTp=&itm_seq_ 1=0&itm_seq_2=0&multi_itm_seq=0
p.000130: &company_cd=&company_nm=&pa ge=3
p.000130: 3. Regulations for Clinical Trial Personnel Education and Certification for the Educational
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: MFDS:
p.000130: 1. Guidelines on Human Research Protection Program 0053-01 (2014.3) 2017-.5.30 고시:
p.000130: http://www.mfds.go.kr/brd/m_210/view.do?seq
p.000130: =12203
p.000130:
p.000130: Country Key Organizations Legislation
p.000130: Regulations Guidelines
p.000130:
p.000130:
p.000130: Drugs, Biologics, and Devices
p.000130: Institution Notice No.2019-3 (2019.01. 17.) http://www.law.go.kr/admRulLsIn foP.do?admRulSeq=2100000175429
p.000130: 4. Regulation on Approval for Investigational New Drug Application of Drugs, Notice No.2018-42 (2018. 06.04)
p.000130: https://www.mfds.go.kr/eng/brd/m_18/ view.do?seq=71451
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Clinical Trials Registry
p.000130:
p.000130:
p.000130: Research Injury
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Privacy/Data Protection
p.000130: Devices
p.000130: Ministry of Food and Drug Safety:
p.000130: http://www.mfds.go.kr/eng/index.do
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130:
p.000130: Korea Centers for Disease Control and Prevention (KCDC), Clinical Research Information Service:
p.000130: https://cris.nih.go.kr/cris/en/index.jsp?mo bile=
p.000130: Ministry of Food and Drug Safety (MFDS):
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000045:
p.000045: Embryos, Stem Cells, and Cloning
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Finland
p.000045: General
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Drugs, Biologics, and Devices
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi/en/frontpage
p.000045: 2. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en
p.000045:
p.000045:
p.000045: Drugs
p.000045: 1. Finnish Medicines Agency (FIMEA): https://www.fimea.fi/web/en/frontpage
p.000045: 2. Ministry of Social Affairs and Health (MSAH): http://stm.fi/en/frontpage
p.000045: 3. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Devices
p.000045: National Supervisory Authority for Welfare and Health (VALVIRA): http://www.valvira.fi/en/licensing/medical
p.000045: _devices
p.000045: Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition
p.000045: of Cloning Human Beings (2002) (Estonian): https://www.riigiteataja.ee/akt/7856 9
p.000045: 2. Artificial Insemination and Embryo Protection Act, RT I 1997, 51, 824 (2011): https://www.riigiteataja.ee/en/eli/ee/
p.000045: 530102013057/consolide/current
p.000045:
p.000045: Medical Research Act No. 488/1999 (Amended 295/2004,
p.000045: 794/2010, and 143/2015):
p.000045: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Medicines Act No. 395/1987: http://www.finlex.fi/fi/laki/smur/19 87/19870395
p.000045: 2. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000045: set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Medical Devices Act No. 629/2010 (Finnish): http://www.finlex.fi/fi/laki/kokoelm a/2010/20100085.pdf
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Decree of the National Research Ethics Council of Finland No. 1347/1991
p.000046: 2. Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016
p.000046: 3. Decrees on the National Committee on Medical Research Ethics No. 820/2010 and 788/2018
p.000046: 4. Decree on Fees, No. 1287/2018
p.000046:
p.000046: 1. Decree on Clinical Trials on Medicinal Products No. 841/2010
p.000046: 2. Other Decrees:
p.000046: http://www.finlex.fi/fi/laki/smur/1987
p.000046: /19870395#nojalla
p.000046:
p.000046: FIMEA:
p.000046: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2012:
p.000046: http://www.fimea.fi/download/22302
p.000046: _Maarays_2- 2012_kliiniset_laaketutkimukset.pdf
p.000046:
...
p.000052:
p.000052: laws: http://www.datenschut z- bayern.de/infoquel/ds- inst/deutschland.html Human Biological Materials
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: Genetic Research
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: German Ethics Council:
p.000052: https://www.ethikrat.org/en/
p.000052:
p.000052:
p.000052:
p.000052: Central Ethics Committee of the German Medical Association (ZEKO) (German): http://www.zentrale-ethikkommission.de/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: German Society of Surgery (DGCH):
p.000052: http://www.dgch.de/index.php?id=118
p.000052: l
p.000052:
p.000052:
p.000052:
p.000052: 1. Act of Quality and Security of Human Tissue and Cells (2019): https://www.buzer.de/s1.htm?g=Ge webegesetz&f=1
p.000052: 2. Transfusion Law (2019): http://www.gesetze-im- internet.de/tfg/
p.000052: 3. Transplantation Law (2019): http://www.gesetze-im- internet.de/tpg/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
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p.000052:
p.000052:
p.000052: 1. Embryo Protection Act (2011):
p.000052: http://www.gesetze-im- internet.de/eschg/
p.000052:
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p.000052:
p.000052: Opinion on Human Biobanks for Research (2010):
p.000052: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/DER_StnBiob_En gl_Online_mitKennwort.pdf
p.000052: 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf
p.000052: 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-
p.000052: Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf
p.000052: DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production:
p.000052: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_
p.000052: menschlicher_Gewebe.pdf
p.000053: 53
p.000053:
p.000053: Country Key Organizations Legislation
p.000053: Regulations Guidelines
p.000053: 2. Genetic Engineering Act
p.000053:
p.000053: Genetic Research
p.000053:
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p.000053:
p.000053:
p.000053: Embryos, Stem Cells, and Cloning
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
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p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Ethics Council:
p.000053: https://www.ethikrat.org/en/
p.000053: (2017):
p.000053: http://www.gesetze-im- internet.de/gentg/
p.000053:
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p.000053:
p.000053:
p.000053: 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/
p.000053: 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/
p.000053:
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p.000054: Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell
p.000054: Act (2017): http://www.gesetze-im- internet.de/zesv/
p.000054:
p.000054:
p.000054:
p.000054: 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004):
p.000054: http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf
p.000054: 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_
p.000054: gfh_positionspapier.pdf
p.000054: Statements: http://www.dfg.de/en/dfg_profile/statutory_bod ies/senate/genetic_research/publications/index. html
p.000054:
p.000054:
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p.000054:
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p.000054:
p.000054:
p.000054: 1. The Import of Human Embryonic Stem Cells (2001): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stellungnahme_Sta mmzellimport.pdf
p.000054: 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004):
...
p.000054:
p.000054: Country Key Organizations Legislation
p.000054: Regulations Guidelines
p.000054:
p.000054: Embryos, Stem Cells, and Cloning
p.000054:
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p.000054:
p.000054: Greece
p.000054: General
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p.000054:
p.000054:
p.000054: Central Ethics Committee of the German Medical Association (ZEKO):
p.000054: http://www.zentrale-ethikkommission.de/ German Research Foundation (DFG): http://www.dfg.de/en/
p.000054:
p.000054:
p.000054: Central Ethics Committee for Stem Cell Research (ZES): http://www.rki.de/EN/Content/Institute/C
p.000054: ommittees/StemCell/StemCell_content.ht ml
p.000054:
p.000054: National Bioethics Commission (NBC): http://www.bioethics.gr/
p.000054:
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p.000055: animal-mixtures-in-research.pdf
p.000055: 5. Stem Cell Research - New Challenges for the Ban on Cloning and Treatment of Artificially Created Germ Cells? (2014):
p.000055: https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc- Empfehlungen/englisch/recommendation-stem- cell-research.pdf
p.000055: 6. Germline Intervention in the Human Embryo (2017): https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc-
p.000055: Empfehlungen/englisch/recommendation- germline-intervention-in-the-human- embryo.pdf
p.000055: 7. Intervening in the Human Germline (2019): https://www.ethikrat.org/fileadmin/Publikation
p.000055: en/Stellungnahmen/englisch/opinion- intervening-in-the-human-germline- summary.pdf
p.000055: Opinion on Stem Cell Research (2002): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do
p.000055: wnloads/pdf-Ordner/Zeko/Stammzell.pdf
p.000055: Opinion on Stem Cell Research (2006): http://www.dfg.de/download/pdf/dfg_magazin/
p.000055: forschungspolitik/stammzellforschung/stammz ellforschung_deutschland_lang_0610.pdf
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Research Ethics for Biological Sciences (2008): http://www.bioethics.gr/index.php/en/gnomes/
p.000055: 86-research-ethics-in-biological-sciences
p.000055: 2. A Guide for Research Ethics Committees for Biological Research (2008): http://www.bioethics.gr/images/pdf/ENGLISH/
p.000055: OPINIONS_REPORTS/guide.pdf
p.000055: 3. Conflict of Interest in Biomedical Research (2014):
p.000055:
p.000055: Country Key Organizations Legislation
p.000055: Regulations Guidelines
p.000055:
p.000055: General
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Drugs, Biologics, and Devices
p.000055:
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p.000055: Research Injury
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p.000055: Privacy/Data Protection
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p.000056: dedomenon?lspt_context=gdpr
p.000056: 1. Greek Constitution 1975/1986/2001, Article 5.5
p.000056: 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000056: 2819/2000 and 2915/2000):
p.000056: http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF
p.000056: 4. Act 3418/2005 Code on Medical Ethics
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction)
p.000056: 3. Act 3305/2005 Application of Medically Assisted
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf
p.000056: 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_genetic_data_e ng.pdf
p.000056: 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf
p.000056: 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 91-direct-to-consumer-dtc-genetic-testing
p.000056: 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/
p.000056: OPINION_Incidental_Findings_FINAL_.pdf
p.000056: 6. Opinion on Advances in Human Genome Editing (2016): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION
p.000056: gene%20editing_Final_EN.pdf NBC:
p.000056: 1. Recommendation on the Use of Stem Cells in Biomedicine and Clinical Medicine
p.000056: 2. Recommendation on Human Reproductive Cloning
p.000056: 3. Opinion on Prenatal and Pre- implantation Diagnosis and Embryo Treatment
p.000057: 57
p.000057:
p.000057: Country Key Organizations Legislation
p.000057: Regulations Guidelines
p.000057:
p.000057: Embryos, Stem Cells, and Cloning
p.000057: Hungary
p.000057: Note: All webpages and documents are in Hungarian.
p.000057: Reproduction
p.000057: Access: http://www.bioethics.gr/index.php/gnomes
p.000057:
p.000057: General
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953
...
p.000088:
p.000088: 1. Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001)
p.000088: 2. Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000088:
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p.000088:
p.000088:
p.000088: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000088: 164 (2001)
p.000088:
p.000088: 1. Law No. 667/2001 On the Protection of Individuals with
p.000089: 89
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p.000089:
p.000089:
p.000089: Ordinance No. 57/16.08.2002 (2002):
p.000089: http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie
p.000089: MOH:
p.000089: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of
p.000089: Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: 1. Opinion 15/CNECV/95 on Embryo Research (1995)
p.000089: 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC-
p.000089: 419999D9B693/0/47CNECV2005.pdf
p.000089: 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D-
p.000089: D70A7E9AD961/0/p048_en.pdf
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: MOH:
p.000089: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
p.000089:
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p.000089:
p.000089:
p.000089:
p.000089: The New General Data Protection Regulation (2018):
p.000089:
p.000089: Country Key Organizations Legislation
p.000089: Regulations Guidelines
p.000089:
p.000089: Privacy/Data Protection
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Human Biological Materials
p.000089:
p.000089:
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p.000089:
p.000089:
p.000089: Embryos, Stem Cells, and Cloning
p.000089:
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p.000089:
p.000089:
p.000089: Russia
p.000089: http://www.dataprotection.ro/index.jsp?pa ge=documents&lang=en
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ministry of Health (MOH):
p.000089: http://www.ms.ro/
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p.000117: 1. Australian Privacy Principles Guidelines (2019): https://www.oaic.gov.au/privacy/australian-
p.000117: privacy-principles-guidelines/
p.000117: 2. Guidelines under Section 95 of the
p.000117:
p.000117: Country Key Organizations Legislation
p.000117: Regulations Guidelines
p.000117:
p.000117: have privacy/data protection laws: https://www.oaic.gov.a u/privacy/privacy-in- your-state/
p.000117:
p.000117:
p.000117:
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p.000117:
p.000117:
p.000117: Human Biological Materials
p.000117:
p.000117: Note: All Australian states and territories also have laws on human biological materials.
p.000117:
p.000117:
p.000117:
p.000117: Genetic Research
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: Embryos, Stem Cells, and Cloning
p.000117:
p.000117:
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p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. Therapeutic Goods Administration (TGA):
p.000117: http://www.tga.gov.au/
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. Office of the Gene Technology Regulator: http://www.ogtr.gov.au/
p.000117: 1. National Health and Medical Research Council (NHMRC): http://www.nhmrc.gov.au/
p.000117: 2. National Health and Medical Research Council: Embryo Research Licensing Committee:
p.000117: https://nhmrc.gov.au/embryo-research-
p.000117:
p.000117:
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p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: Gene Technology Act 2000 (2016):
p.000117: https://www.legislation.gov.au/Deta ils/C2016C00792
p.000117:
p.000117:
p.000117: 1. Prohibition of Human Cloning for Reproduction Act 2002 (2017): https://www.legislation.gov.au/Deta ils/C2017C00306
p.000117: 2. Research Involving Human Embryos Act 2002 (2016):
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p.000118: the Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under- section-95-privacy-act-1988
p.000118: 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2015): https://nhmrc.gov.au/about-
p.000118: us/publications/guidelines-approved- under-section-95a-privacy-act-1988
p.000118: 4. Guidelines Approved under Section 95AA of the Privacy Act 1988 (2014): https://www.nhmrc.gov.au/about-
p.000118: us/publications/guidelines-approved- under-section-95aa-privacy-act-1988- cth
p.000118: 5. Privacy Regulation 2013 (2019): https://www.legislation.gov.au/Detail s/F2019C00361
p.000118:
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p.000118:
p.000118: Gene Technology Regulations 2001 (2016):
p.000118: https://www.legislation.gov.au/Detail s/F2016C00615
p.000118:
p.000118:
p.000118: Research Involving Human Embryos Regulations (2017): https://www.legislation.gov.au/Detail s/F2017L01213
p.000118: Privacy Act 1988 (2014): https://nhmrc.gov.au/about- us/publications/guidelines-under-section-95- privacy-act-1988
p.000118: 3. Guidelines Approved under Section 95A of the Privacy Act 1988 (2019): https://nhmrc.gov.au/about-
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p.000121: 3. Guidelines on Ethical Review of Biomedical Research Involving Human Subjects (2016), Articles 18.5, 20.8, 36.6, and
p.000121: 37: http://www.gov.cn/gongbao/content/2 017/content_5227817.htm
p.000121: 4. Good Clinical Practice on Medical Device Clinical Trials (2016), Articles 10, 22, 33, and 48:
p.000121: http://www.nmpa.gov.cn/WS04/CL2 077/300685.html
p.000121: People’s Republic of China Human Genetic Resources Management Regulations (2019): http://www.gov.cn/zhengce/content/2
p.000121: 019-06/10/content_5398829.htm
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
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p.000121:
p.000121:
p.000121: 1. Ethical Principles and Conduct Norms for Human Assisted Reproductive Technologies. (2003):
p.000121: http://www.moh.gov.cn/qjjys/s3581/2 00805/f69a925d55b44be2a9b4ada7fc dec835.shtml
p.000121: 2. Administrative Measures for Clinical Application of Medical Technology (2018): http://www.jzswjw.gov.cn/upfile/201
p.000121: 809/2018092558392053.pdf
p.000121: 3. Interim Measures for the Administrative Measures of Stem Cell Clinical Research (2015):
p.000121: http://www.nmpa.gov.cn/WS04/CL2 077/300673.html
p.000121: (2010):
p.000121: http://samr.cfda.gov.cn/WS01/CL0058/55613.h tml
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121:
p.000121: 1. Service Guidelines for the Collection, Selling, Export. and Admission Application of Human Genetic Resources (2015):
p.000121: http://www.most.gov.cn/tztg/201507/t2015070 3_120547.htm
p.000121: 2. Service Guideline for the Approval of Administrative Licensing Items for Exporting Human Genetic Resources Outside
p.000121: of China: https://fuwu.most.gov.cn/r/cms/zwpt/web/asset s/pdf/4.rlyczycjspfwzn.pdf
p.000121:
p.000121: NHC and MOST:
p.000121: 1. Ethical Guidelines for Research on Human Embryo Stem Cells (2003): http://www.most.gov.cn/fggw/zfwj/zfwj2003/2
p.000121: 00512/t20051214_54948.htm
p.000121: 2. Interim Guidelines for the Quality Control of Stem Cell Preparations and Preclinical Research (2015):
p.000121: http://www.nmpa.gov.cn/WS04/CL2196/32412 4.html
p.000121:
p.000122: 122
p.000122:
p.000122: Country Key Organizations Legislation
p.000122: Regulations Guidelines
p.000122:
p.000122: Embryos, Stem Cells, and Cloning
p.000122:
p.000122:
p.000122:
p.000122: India
p.000122: Hong Kong:
p.000122: Legislative Council of the Hong Kong Special Administrative Region of the People’s Republic of China:
p.000122: http://www.legco.gov.hk/index.html
p.000122:
p.000122: Human Reproductive Technology (Amendment) Ordinance 2016: https://www.legco.gov.hk/yr15-
p.000122: 16/english/ord/ord020-2016-e.pdf
p.000122: For an overview of the clinical research regulations in India, see the ClinRegs report:
p.000122: http://clinregs.niaid.nih.gov/single_country.php?c_id=100
p.000122:
p.000122: General
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs, Biologics, and Devices
p.000122: Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122: Drugs
p.000122: 1. Central Drugs Standard Control Organization, Office of Drugs Controller General of India (DCGI): http://cdsco.nic.in
p.000122: 2. Indian Council of Medical Research (ICMR): http://www.icmr.nic.in/
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
p.000122:
...
p.000127: .html
p.000127: 2000 version (English): http://www.cas.go.jp/jp/seisaku/hou rei/data/htc.pdf
p.000127: 2. Act on Safety of Regenerative Medicine (2013): http://www.mhlw.go.jp/file/06- Seisakujouhou-10800000-
p.000127: Iseikyoku/0000030847.pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
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p.000127:
p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: 1. Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2009):
p.000128: http://www.lifescience.mext.go.jp/file s/pdf/n1564_01.pdf
p.000128: 2. Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019): https://www.lifescience.mext.go.jp/fil
p.000128: es/pdf/n2163_01.pdf
p.000128: 3. Rules for Enforcement of Act on Safety of Regenerative Medicine (2018): https://www.mhlw.go.jp/content/0004
p.000128: 52630.pdf
p.000128: CSTI:
p.000128: Fundamental Principles of Research on the Human Genome (2000)
p.000128:
p.000128: MEXT, MHLW, and METI:
p.000128: Ethics Guidelines for Human Genome/Gene Analysis Research (2017): http://www.lifescience.mext.go.jp/files/pdf/n18
p.000128: 59_03r2.pdf
p.000128: 2008 version (English): http://www.lifescience.mext.go.jp/files/pdf/n79 6_00.pdf
p.000128:
p.000128: MHLW:
p.000128: Guidelines for Clinical Research in Gene Therapy and Others (2019): https://www.neurology-
p.000128: jp.org/news/pdf/news_20190307_02_02.pdf CSTP:
p.000128: Fundamental Philosophy on Handling of Human Embryo (2004): http://www.lifescience.mext.go.jp/files/pdf/6_2 8.pdf
p.000128:
p.000128: MEXT:
p.000128: 1. Guidelines on the Derivation of Human Embryonic Stem Cells (2014): http://www.lifescience.mext.go.jp/files/pdf/n15
p.000128: 53_01.pdf
p.000128: 2. Guidelines on Research on Producing Germ Cells from Human Induced Pluripotent Stem Cells or Human Tissue Stem Cells
p.000128: (2015): http://www.lifescience.mext.go.jp/files/pdf/n14 92_01r2.pdf
p.000128: 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_02r2.pdf
p.000128: 3. Guidelines on the Handling of a Specified Embryo (2019): https://www.lifescience.mext.go.jp/files/pdf/n2 163_07.pdf
p.000128: 4. Guidelines on the Distribution of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCdistributionguideline2019.pdf
p.000128:
p.000128: Country Key Organizations Legislation
p.000128: Regulations Guidelines
p.000128:
p.000128: Embryos, Stem Cells, and Cloning
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Kazakhstan
p.000128: 5. Guidelines on the Utilization of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCutilizationguideline2019.pdf
p.000128:
p.000128: MEXT and MHLW:
p.000128: 1. Ethical Guidelines for Research on Assisted Reproductive Technology to Develop Human Fertilized Embryos (2017):
p.000128: http://www.lifescience.mext.go.jp/files/pdf/n18 59_05.pdf
p.000128: 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_01r2.pdf
p.000128: 2. Guidelines for Research Using Gene- altering Technologies on Human Fertilized Embryos (2019):
p.000128: https://www.lifescience.mext.go.jp/files/pdf/Ov erview_Human_embryo_geneome- editing_guideline2019En.pdf
p.000128: Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomedical Research in the CIS
p.000128: Countries,” Chapter 3, Section 5:
p.000128: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000128:
p.000128: General
p.000128:
p.000128:
p.000128:
p.000128:
...
p.000139: 3. Ministry of Health:
p.000139: http://www.moh.govt.nz/
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: Hazardous Substances and New Organisms Act 1996 (2012)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Human Assisted Reproductive Technology Act 2004 (2009)
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
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p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: Human Assisted Reproductive Technology (HART) Order (2005):
p.000140: http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140:
p.000140: ACART:
p.000140: 1. Guidelines on the Use, Storage, and Disposal of Sperm from a Deceased Man (2000)
p.000140: 2. Guidelines for Research on Gametes and Non-viable Embryos (2005)
p.000140: 3. Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research (2005)
p.000140: 4. Guidelines on Embryo Donation for Reproductive Purposes (2008)
p.000140: 5. Guidelines on Extending the Storage Period of Gametes and Embryos (2012)
p.000140: 6. Guidelines on Donation of Eggs or Sperm between Certain Family Members (2013)
p.000140: 7. Guidelines on Surrogacy Arrangements Involving Assisted Reproductive Procedures (2013)
p.000140: 8. Guidelines on Preimplantation Genetic Diagnosis with Human Leucocyte Antigen Tissue Typing (2014)
p.000140:
p.000140: Access: https://acart.health.govt.nz/publications-and- resources/guidelines-and-advice-issued-ecart
p.000140:
p.000140: Various:
p.000140: http://nbcpakistan.org.pk/guidelines.html
p.000140: Guidelines For Healthcare Professionals Interaction with Pharmaceutical Trade and Industry (PPI Guidelines):
p.000140: http://nbcpakistan.org.pk/?page_id=61
p.000140: Ethical Guidelines for Collection, Usage, Storage, and Export of Human Biological Materials (HBM):
p.000140:
p.000140: Country Key Organizations Legislation
p.000140: Regulations Guidelines
p.000140:
p.000140: Human Biological Materials Embryos, Stem
p.000140: Cells, and Cloning
p.000140:
p.000140: Philippines
p.000140: General
p.000140:
p.000140: National Bioethics Committee:
p.000140: http://nbcpakistan.org.pk/
p.000140:
p.000140:
p.000140: 1. Philippine Health Research Ethics Board (PHREB): www.ethics.healthresearch.ph
p.000140: 2. Department of Science and Technology (DOST): http://www.dost.gov.ph/
p.000140: 3. Department of Health (DOH):
p.000140: http://www.doh.gov.ph/
...
Social / genetic heritage
Searching for indicator geneticXheritage:
(return to top)
p.000165: 4. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english
p.000165: Research Purposes (2011):
p.000165: https://www.inca.gov.br/sites/ufu.sti
p.000165: .inca.local/files//media/document//p ortaria-ms-gm-2201-11.pdf
p.000165: Material Stored in Previous Research: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS-
p.000165: RESOLUCOES/Resoluo_n_441_-
p.000165: _2011_-
p.000165: _Armazenamento_de_Material_Biolg ico.pdf
p.000165: 2. Decree CNS No. 2201 of 14 Sep 2001 - The National Bio- Repository and Biobank Guideline:
p.000165: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Portaria_MS_n%C2
p.000165: %BA_2.201_de_2011.pdf
p.000165: conep/documentos/CARTAS/CartaCircular014
p.000165: .pdf
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: Genetic Research
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 1. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000165: 2. National Biosafety Technical Commission (CTNBio): http://ctnbio.mcti.gov.br/inicio
p.000165: 3. National Health Council (CNS):
p.000165: http://www.conselho.saude.gov.br/
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 1. Biosafety Law 11.105/05 (2005): http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/lei/l11105.htm
p.000165: 2. Decree No. 5,591, of November 22, 2005: http://www.planalto.gov.br/ccivil_0 3/_ato2004- 2006/2005/Decreto/D5591.htm
p.000165: 3. Law 13.123/2015 (2015):
p.000165: Brazilian Legislation on Biodiversity Access (Genetic Heritage): http://www.planalto.gov.br/ccivil_0 3/_Ato2015-
p.000165: 2018/2015/Lei/L13123.htm
p.000165: 4. Law Decree No 8.772/2016 (2016), Regulating Law No. 13.123/2015: http://www.planalto.gov.br/ccivil_0
p.000166: 166
p.000166: ANVISA:
p.000166: Resolution – RDC No. 20 of 10 April 2014: http://www.saude.pr.gov.br/arquivos/ File/RDC_20_de_10_de_abril_2014_
p.000166: Transporte_de_material_Biologico.pd f
p.000166: CTNBio:
p.000166: 1. Instruction CTNBio No. 8 of 9 July 1997: http://ctnbio.mcti.gov.br/instrucoes- normativas/-
p.000166: /asset_publisher/3dOuwS2h7LU6/con tent/instrucao-normativa-ctnbio- n%C2%BA-8-de-09-07-97
p.000166: 2. Instruction CTNBio No. 9 of 10 October 1997: http://www.agrobiobrasil.org.br/wp- content/uploads/2014/06/CTNBio-
p.000166: Normative-Instruction-n%C2%BA-9- of-October-10-1997.pdf
p.000166:
p.000166: CNS/CONEP:
p.000166: Resolution CNS No. 340/2004: On Research on Human Genetics (2004):
p.000166: http://conselho.saude.gov.br/resoluco es/2004/Res340_en.pdf
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166:
p.000166: CNS/CONEP:
p.000166: 1. Guidance to Researchers and Ethics Committees about the Item
p.000166: V.1.a of CNS Resolution 340 2004: http://conselho.saude.gov.br/images/comissoes/
p.000166: conep/documentos/CARTAS/CartaCircular041
p.000166: -15.pdf
p.000166: 2. Statement on Pharmacogenetic Studies in Brazil N/° 011/2012/CONEP, 12 January 2012:
p.000166: http://www.fcm.unicamp.br/fcm/sites/default/fi les/11_-
p.000166: _Comunicado_sobre_estudos_farmacogenetico s_no_Brasil.pdf
p.000166:
p.000166: Country Key Organizations Legislation
p.000166: Regulations Guidelines
p.000166:
p.000166: Genetic Research
p.000166: Embryos, Stem Cells, and Cloning
p.000166:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000023: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (1997):
p.000023: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000023: 2. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Article 13,
p.000023: 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
p.000023: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural
p.000023: Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive
p.000023: 95/46/EC (General Data Protection Regulation):
p.000023: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000023: :32016R0679&from=EN
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: EDPB:
p.000023: 1. Guidelines on consent under Regulation 2016/679, WP259 rev.01: http://ec.europa.eu/newsroom/article29/item-
p.000023: detail.cfm?item_id=623051
p.000023: 2. Transfers of Personal Data to Third Countries: Applying Articles 25 and 26 of the EU Data Protection Directive
p.000023: (1998): Consent (2018): http://ec.europa.eu/justice/article- 29/documentation/opinion-
p.000023: recommendation/files/1998/wp12_en.pdf
p.000023: 3. Adequacy Referential (2018): http://ec.europa.eu/newsroom/article29/docume nt.cfm?action=display&doc_id=49724
p.000023: 4. Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR)
p.000023: and the General Data Protection regulation (GDPR) (2019): https://edpb.europa.eu/our-work-tools/our-
p.000023: documents/opinion-art-70/opinion-32019- concerning-questions-and-answers- interplay_en
p.000023:
p.000024: 24
p.000024:
p.000024: Country Key Organizations Legislation
p.000024: Regulations Guidelines
p.000024:
p.000024: Privacy/Data Protection
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: Human Biological Samples
p.000024: European Medicines Agency (EMA):
p.000024: http://www.ema.europa.eu/
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: Council of Europe:
p.000024: Data Protection and Cybercrime Division: http://www.coe.int/t/dghl/standardsetting/ dataprotection/default_EN.asp
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: European Commission:
p.000024: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024: Council of Europe, Bioethics Unit:
p.000024: http://www.coe.int/bioethics
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
...
p.000025: 2. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, CETS No. 195
p.000025: (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 1. Statements by the Commission Re: Article 6 (2006): http://www.uv.es/operuv/docs_7pm/ FP7ECStatementsComm_Ethical.pd
p.000025: f
p.000025: 2. Statement of the Commission Related to Research Activities Involving Human Embryonic Stem Cells (2013):
p.000025: http://eur- lex.europa.eu/LexUriServ/LexUriSe
p.000026: 26
p.000026: https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: 1. Recommendation No. R (92) on Genetic Testing and Screening for Health Care Purposes (1992):
p.000026: http://wcd.coe.int/ViewDoc.jsp?id=612007&Si te=CM&BackColorInternet=9999CC&BackCo
p.000026: lorIntranet=FFBB55&BackColorLogged=FFA C75
p.000026: 2. Recommendation Rec (2006)4 of the Committee of Ministers to Members States on Research on Biological Materials of
p.000026: Human Origin (2016): https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff
p.000026: 3. Recommendation Rec(2016)8 of the Committee of Ministers to Member States on the Processing of Personal Health-
p.000026: Related Data for Insurance Purposes, Including Data Resulting from Genetic Tests (2016):
p.000026: https://search.coe.int/cm/Pages/result_details.as px?ObjectId=09000016806b2c5f
p.000026: 1. Commission Staff Working Paper Report on Human Embryonic Stem Cell Research (2003):
p.000026: https://ec.europa.eu/research/press/2003/pdf/se c2003-441report_en.pdf
p.000026: 2. Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007):
p.000026: http://bookshop.europa.eu/ga/recommendations
p.000026: -on-the-ethical-review-of-hesc-fp7-research- projects-pbKAAJ07022/downloads/KA-AJ-07- 022-EN-
p.000026: C/KAAJ07022ENC_002.pdf;pgid=y8dIS7GU
p.000026:
p.000026: Country Key Organizations Legislation
p.000026: Regulations Guidelines
p.000026:
p.000026: Embryos, Stem Cells, and Cloning
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Armenia
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Council of Europe, Bioethics Unit:
p.000026: http://www.coe.int/bioethics
p.000026: rv.do?uri=OJ:C:2013:373:0012:001 5:EN:PDF
p.000026:
p.000026:
p.000026: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997):
p.000026: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000026: 2. Additional Protocol on Prohibition of Human Cloning, ETS No. 168 (1998): http://conventions.coe.int/Treaty/Comm
p.000026: un/QueVoulezVous.asp?NT=168&CM= 7&DF=9/15/2008&CL=ENG
p.000026: WMdSR0EAlMEUUsWb0000dz-
p.000026: kvfzb;sid=Iexx3tq0IOFxyokBvtfvebiRJj93DZf XP54=?FileName=KAAJ07022ENC_002.pdf
p.000026: &SKU=KAAJ07022ENC_PDF&CatalogueNu mber=KA-AJ-07-022-EN-C
p.000026: Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a
p.000026: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS
p.000026: Countries,” Chapter 3, Section 1:
...
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Genetic Research
p.000028:
p.000028:
p.000028:
p.000028: Embryos, Stem Cells, and Cloning
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Belarus
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Ministry of Health:
p.000028: http://www.bmg.gv.at
p.000028: 2. Bioethics Commission:
p.000028: http://www.bundeskanzleramt.at/site/3575
p.000028: /default.aspx
p.000028: 1. Law on Safety of Blood (2009): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10011145&Sho wPrintPreview=True
p.000028: 2. Law on Quality and Safety of Human Tissue and Cells (2013): http://www.ris.bka.gv.at/GeltendeFa
p.000028: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=20005698&Sho wPrintPreview=True
p.000028: Gene Technology Act (2012): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000028: &Gesetzesnummer=10010826&Sho wPrintPreview=True
p.000028: Reproductive Medicine Act (2010):
p.000028: http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10003046&Sho wPrintPreview=True
p.000028: Regulation on Tissue Banks (2014):
p.000028: http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen& Gesetzesnummer=20005848&ShowP rintPreview=True
p.000028: Bioethics Commission:
p.000028: 1. Opinion of the Bioethics Commission at the Federal Chancellery: Biobanks for Medical Research (2007)
p.000028: 2. Biobanks for Medical Research - Amendments to the Bioethics Commission Report of May 2007 (2011)
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Bioethics Commission:
p.000028: 1. Stem Cell Research in the Context of the EU’s Sixth Framework Programme Research (2002)
p.000028: 2. Research on Human Embryonic Stem Cells (2009): http://www.bundeskanzleramt.at/DocView.axd
p.000028: ?CobId=34240
p.000028: For an overview of human subject protections in Belarus, see “Ethical Review of Biomedical Research in the CIS
p.000028: Countries,” Chapter 3, Section 3:
p.000028: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000028:
p.000028: General
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs, Biologics, and Devices
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. National Bioethics Committee
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Drugs
p.000028: 1. Ministry of Health (MOH):
p.000028: http://minzdrav.by/en/
p.000028: 2. State Pharmacological Committee
p.000028: 3. Centre for Expertise and Testing in Health Care:
p.000028: http://rceth.by/
p.000028: 1. Constitution of the Republic of Belarus, Article 25 (2004): http://www.pravo.by/WEBNPA/text
p.000028: .asp?RN=v19402875
p.000028: 2. Law on Health Care System, Articles 40, 46 (2010): http://pravo.by/webnpa/text.asp?RN
p.000028: =v19302435
p.000028:
p.000028:
p.000028:
p.000028:
...
p.000030:
p.000030: SSFM:
p.000030: Ordinance No. 38-c on Rules for Conducting Morphological Examinations (1999)
p.000030: For an overview of human subject standards in Belgium, see The Ethics Committees:
p.000030: https://www.famhp.be/en/human_use/medicines/medicines/research_development/ethic_committee
p.000030:
p.000030: General
p.000030: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000030: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000030: -advisory-committee-bioethics
p.000030: Law Relating to Experimentation on Humans (2004):
p.000030: http://www.ejustice.just.fgov.be/cgi
p.000030: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000030: 1. Royal Decree Dated 4 April 2014 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans Regarding the Ethics Committee: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2014040446&table_name=loi
p.000030: 2. Royal Decree Dated 30 June 2004 Determining the Measures for Carrying Out the Law Dated 7 May 2004 Relating to
p.000030: Experiments on Humans, Modified by the Royal Decree Dated 18 May 2006: http://www.ejustice.just.fgov.be/cgi_l
p.000030: oi/change_lg.pl?language=fr&la=F& cn=2004063030&table_name=loi
p.000030: FAMHP:
p.000030: Various Circulars: https://www.famhp.be/en/human_use/medicine s/medicines/research_development/ethic_com mittee
p.000030:
p.000030: BACB:
p.000030: 1. Opinion No. 13: Experimentation on Humans (2001)
p.000030: 2. Opinion No. 31: Experiments on Pregnant and Breastfeeding Women (2004)
p.000030: 3. Opinion No. 36: Ethical Testing of Research in Certain Branches of the Life Sciences (2006)
p.000030: 4. Opinion No. 40: Scope of the (Belgian) Law Relating to Human Experimentation (French and Dutch) (2007)
p.000030: 5. Opinion No. 51: Publication of the Results of Human Experimentation (2012)
p.000030: 6. Opinion No. 62: Ethical Implications of the “Statute” of the Pregnant Partner of a Male Participant in a Clinical
p.000030: Trial (2015)
p.000030: 7. Opinion No. 69: Experiments and Other Scientific Research Involving Inmates (2017)
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
p.000031: Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials
p.000031: Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000031: -advisory-committee-bioethics
p.000031: 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative-
p.000031: bodies/ct-college-clinical-trial-college
p.000031:
p.000031: Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Belgian Data Protection Authority:
p.000031: https://www.dataprotectionauthority.be/
...
p.000031: https://www.famhp.be/en/human_us e/medicines/medicines/research_dev elopment/ethic_committee
p.000031: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000031: 3. Act on the Protection of Natural Persons with Regard to the Processing of Personal Data (30 July 2018):
p.000031: https://www.dataprotectionauthority
p.000031: .be/legislation-and-standards
p.000031: Law Relating to the Use of Human Biological Materials (19 December 2008): https://www.afmps.be/fr/humain/pro
p.000031: duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor el_humain/legislation/apres_le_01_ 12_2009
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032: 1. Royal Decrees to Experimentation on Humans: https://www.famhp.be/en/human_use/ medicines/medicines/research_develo
p.000032: pment/ethic_committee
p.000032: 2. Royal Decrees on Clinical Trials: https://consultativebodies.health.belgi um.be/en/advisory-and-consultative-
p.000032: bodies/ct-college-clinical-trial-college
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Decree of February 13, 2001 Implementing the Law of December 8, 1999: http://www.privacycommission.be/sit
p.000032: es/privacycommission/files/document s/Royal_Decree_2001.pdf
p.000032:
p.000032:
p.000032:
p.000032: Royal Decrees to the Use of Human Biological Materials: https://www.afmps.be/fr/humain/prod
p.000032: uits_de_sante/materiel_corporel_hum ain/banques_de_materiel_corporel_h umain/legislation/apres_le_01_12_20 09
p.000032: BACB:
p.000032: 1. Opinion No. 58: Financing Expensive Medication: https://www.health.belgium.be/sites/default/file
p.000032: s/uploads/fields/fpshealth_theme_file/opinion_ 58_web.pdf
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Legal Basis (2018): https://www.autoriteprotectiondonnees.be/fond ement-legal-pour-le-traitement-de-donnees-a-
p.000032: caractere-personnel
p.000032: 2. Consent (2018): https://www.autoriteprotectiondonnees.be/cons entement
p.000032: 3. International Data Transfer (2018): https://www.autoriteprotectiondonnees.be/inter national-0
p.000032: BACB:
p.000032: 1. Opinion No. 42: Umbilical Cord Blood Banks (2007)
p.000032: 2. Opinion No. 43: Commercialization of Human Body Parts (2007)
p.000032: 3. Opinion No. 45: Human Biological Material Banks Intended for Research (2009)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine
p.000032:
p.000032: Country Key Organizations Legislation
p.000032: Regulations Guidelines
p.000032:
p.000032: Human Biological Materials
p.000032: (2012)
p.000032: 5. Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applications or for Scientific Research
p.000032: Purposes (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Embryos, Stem Cells, and Cloning
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Federal Commission for Medical and Scientific Research on Embryos in Vitro:
p.000032: http://health.belgium.be/eportal/Healthcar e/Consultativebodies/Commissions/Embr yoinvitro/19076630?ie2Term=research&i
p.000032: e2section=83
p.000032: 2. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000032: 3. Belgian Advisory Committee on Bioethics: https://www.health.belgium.be/en/belgian
p.000032: -advisory-committee-bioethics
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: 1. Act on Research on Embryos in Vitro (2003): https://organesdeconcertation.sante. belgique.be/fr/organe-d'avis-et-de-
p.000032: concertation/commission-federale- embryons
p.000032: 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007):
p.000032: https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor
p.000032: el_humain/legislation/apres_le_01_ 12_2009
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15 February
p.000032: 1999): https://organesdeconcertation.sante.be lgique.be/fr/organe-d'avis-et-de- concertation/commission-federale-
p.000032: embryons
p.000032: CSS:
p.000032: Various: https://www.health.belgium.be/en/superior- health- council?f%5B0%5D=field_shc_doc%3A1145 BACB:
p.000032: 1. Opinion No. 10: Reproductive Human Cloning (1999)
p.000032: 2. Opinion No. 18: Research on Human Embryos in Vitro (2002)
p.000032: 3. Opinion No. 33: Somatic and Germinal Line Gene Modification (2005)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032: Bosnia and Herzegovina
p.000032: Note: All websites and documents are in Bosnian.
p.000032: General 1. Convention on
p.000032: Human Rights
p.000032: and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (2007):
p.000032: 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2007)
p.000032: 3. Law on Health Protection, MoH Republic of Srpska (2015): http://www.vladars.net/sr-SP-
p.000032: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20zdravstven
p.000032:
p.000033: 33
p.000033:
p.000033: Country Key Organizations Legislation
p.000033: Regulations Guidelines
p.000033:
p.000033: General
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Drugs, Biologics, and Devices
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Federation of Bosnia and Herzegovina
p.000033: 1. Ministry of Health:
p.000033: http://www.fmoh.gov.ba/
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Republic of Srpska
...
p.000048: 2. Law No. 2016-1321 of 7
p.000048: October 2016 for a Numeric Republic: https://www.legifrance.gouv.fr/affic hLoiPubliee.do?idDocument=JORF
p.000048: DOLE000031589829&type=genera l&legislature=14
p.000048: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000048: 4. Data Protection Act (2018): https://www.legifrance.gouv.fr/affic hLoiPreparation.do;jsessionid=AD5
p.000048: 660270AD9F70B94275AC8233216 80.tplgfr22s_3?idDocument=JORF DOLE000036195293&type=conten u&id=2&typeLoi=proj&legislature
p.000048: =15
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048:
p.000048: 1. Donation and Use of the Components and Products of the Human Body, Articles L1211-1 to L1274-3 (2004):
p.000048: http://www.legifrance.gouv.fr/
p.000048: 2. Public Health Code Articles L1243-3 and following sections: (2012): http://www.legifrance.gouv.fr/initR
p.000049: 49
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: CNIL:
p.000049: Decree N° 2019-536 of 29 May 2019 Enacted for the Application of Act No. 78-17 of 6 January 1978 on Data Processing,
p.000049: Data Files, and Civil Liberties: https://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT0000
p.000049: 38528420&categorieLien=id
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Decree No. 2017-1549 of 8 November 2017 on the Conservation and Preparation for Scientific Purposes of Elements of the
p.000049: Human Body and Amending the Public Health Code
p.000049: Opinion on the Ethics of Research in the Sciences of Human Behavior No. 38 (1993): http://www.ccne-
p.000049: ethique.fr/en/publications/opinion-ethics- research-sciences-human- behaviour#.WNkybNfytEY
p.000049: CNIL:
p.000049: 1. Health Research: CNIL Adopts New Simplification Measures (2018): https://www.cnil.fr/fr/recherches-dans-le-
p.000049: domaine-de-la-sante-la-cnil-adopte-de- nouvelles-mesures-de-simplification
p.000049: 2. Health Research with Consent (2018): https://www.cnil.fr/fr/declaration/mr-001-
p.000049: recherches-dans-le-domaine-de-la-sante-avec- recueil-du-consentement
p.000049: 3. Health Research without Consent (2018): https://www.cnil.fr/fr/declaration/mr-
p.000049: 003-recherches-dans-le-domaine-de-la-sante- sans-recueil-du-consentement
p.000049: 4. Practical Guide on the Protection of Personal Data: What Framework Applies to Research? (2018):
p.000049: https://www.cnil.fr/sites/default/files/atoms/file s/guide-cnom-cnil.pdf
p.000049:
p.000049: CCNE:
p.000049: 1. Ethical Questions Arising from the Transmission of Scientific Information Concerning Research in Biology and
p.000049: Medicine (1995)
p.000049: 2. Biometrics, Identifying Data and Human Rights (2007)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis CCNE:
p.000049: 1. Umbilical Cord Blood Banks for Autologous Use for Research (2002)
p.000049: 2. Ethical Issues Raised by Collections of Biological Material and Associated Information Data: “Biobanks,”
p.000049: “Biolibraries” (2003)
p.000049:
p.000049: Country Key Organizations Legislation
p.000049: Regulations Guidelines
p.000049:
p.000049: Human Biological Materials
p.000049: Genetic Research
p.000049:
p.000049:
...
p.000049: echCodeArticle.do
p.000049:
p.000049:
p.000049: Civil Code Articles 16-10 to 16-
p.000049: 13:
p.000049: http://www.legifrance.gouv.fr/affich Code.do;jsessionid=D2DE0231944 83D3384DE19DE8959BDDA.tpdjo
p.000049: 17v_3?idSectionTA=LEGISCTA00 0006136513&cidTexte=LEGITEX
p.000049: T000006070721&dateTexte=20131 006
p.000049:
p.000049:
p.000049: Law No. 2013-715 of 6th August 2013: http://www.legifrance.gouv.fr/affich Texte.do?cidTexte=JORFTEXT000
p.000049: 027811435&dateTexte=&categorie Lien=id
p.000049:
p.000049:
p.000049:
p.000049: Article R1131-1 and Subsequent Sections of the Public Health Code: https://www.legifrance.gouv.fr/affich
p.000049: Code.do?idArticle=LEGIARTI00001 8615563&idSectionTA=LEGISCTA0
p.000049: 00006196158&cidTexte=LEGITEXT
p.000049: 000006072665&dateTexte=20191011
p.000049:
p.000049:
p.000049:
p.000049: Decree No. 2015-155 of 11 February, 2015: Public Health Code on Research on Embryos Article R2151-1 and Following
p.000049: Sections: http://legifrance.gouv.fr/affichCode.d o?idArticle=LEGIARTI00003023346
p.000049: 9&idSectionTA=LEGISCTA0000061
p.000049: 90409&cidTexte=LEGITEXT000006
p.000049: 072665&dateTexte=20151015
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood (2013)
p.000049: 2. Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing
p.000049: (2016)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Commercialization of Human Stem Cells and Other Cell Lines (2006)
p.000049: 2. Opinion on the Ethical Reflection Concerning Research on Human Embryonic Cells and on Human Embryos in Vitro (2010)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS
p.000049: Countries,” Chapter 3, Section 4:
p.000049: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000049:
p.000049: General
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Drugs, Biologics, and Devices
p.000049: Bioethics and Health Law Studies Society: http://www.patientsrights.ge/index.php?pa ge=385&lang=geo
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs:
p.000049: http://rama.moh.gov.ge/
p.000049: 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001)
p.000049: 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195
p.000049: (2010)
p.000049: 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
p.000049:
p.000050: 50
p.000050:
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p.000050:
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p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
...
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: Genetic Research
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: German Ethics Council:
p.000052: https://www.ethikrat.org/en/
p.000052:
p.000052:
p.000052:
p.000052: Central Ethics Committee of the German Medical Association (ZEKO) (German): http://www.zentrale-ethikkommission.de/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: German Society of Surgery (DGCH):
p.000052: http://www.dgch.de/index.php?id=118
p.000052: l
p.000052:
p.000052:
p.000052:
p.000052: 1. Act of Quality and Security of Human Tissue and Cells (2019): https://www.buzer.de/s1.htm?g=Ge webegesetz&f=1
p.000052: 2. Transfusion Law (2019): http://www.gesetze-im- internet.de/tfg/
p.000052: 3. Transplantation Law (2019): http://www.gesetze-im- internet.de/tpg/
p.000052:
p.000052:
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p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: 1. Embryo Protection Act (2011):
p.000052: http://www.gesetze-im- internet.de/eschg/
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
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p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: Opinion on Human Biobanks for Research (2010):
p.000052: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/englisch/DER_StnBiob_En gl_Online_mitKennwort.pdf
p.000052: 1. Opinion on the (Re)Use of Human Body Material for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-Ordner/Zeko/Koerpermat-1.pdf
p.000052: 2. First Addendum: The (Re)Use of Human Body Material of Deceased Persons for Medical Research Purposes (2003):
p.000052: http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do wnloads/pdf-
p.000052: Ordner/Zeko/Erste_Ergaenzung_Koerpermateri alien.pdf
p.000052: DGCH Guidelines on Good Professional Practice (GPP) for the Procurement of Human Tissue and Cells for Drug Production:
p.000052: http://www.dgch.de/fileadmin/media/pdf/servic emeldungen/069_Gewebegesetz_GFP- Leitfaden_der_DGCH_fuer_die_Gewinnung_
p.000052: menschlicher_Gewebe.pdf
p.000053: 53
p.000053:
p.000053: Country Key Organizations Legislation
p.000053: Regulations Guidelines
p.000053: 2. Genetic Engineering Act
p.000053:
p.000053: Genetic Research
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: Embryos, Stem Cells, and Cloning
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054: Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell
p.000054: Act (2017): http://www.gesetze-im- internet.de/zesv/
p.000054:
p.000054:
p.000054:
p.000054: 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004):
p.000054: http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf
p.000054: 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_
p.000054: gfh_positionspapier.pdf
p.000054: Statements: http://www.dfg.de/en/dfg_profile/statutory_bod ies/senate/genetic_research/publications/index. html
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054: 1. The Import of Human Embryonic Stem Cells (2001): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stellungnahme_Sta mmzellimport.pdf
p.000054: 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004):
p.000054: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stellungnahme_Klo nen.pdf
p.000054: 3. Should the Stem Cell Law be Amended? (2007): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stn_Stammzellgese tz.pdf
p.000054: 4. Human-Animal Mixtures in Research (2011): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/englisch/opinion-human-
p.000054:
p.000054: Country Key Organizations Legislation
p.000054: Regulations Guidelines
p.000054:
p.000054: Embryos, Stem Cells, and Cloning
p.000054:
p.000054:
p.000054:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054: Greece
p.000054: General
p.000054:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054: Central Ethics Committee of the German Medical Association (ZEKO):
p.000054: http://www.zentrale-ethikkommission.de/ German Research Foundation (DFG): http://www.dfg.de/en/
p.000054:
p.000054:
p.000054: Central Ethics Committee for Stem Cell Research (ZES): http://www.rki.de/EN/Content/Institute/C
p.000054: ommittees/StemCell/StemCell_content.ht ml
p.000054:
p.000054: National Bioethics Commission (NBC): http://www.bioethics.gr/
p.000054:
p.000054:
p.000054:
p.000054:
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p.000055: 55
p.000055: animal-mixtures-in-research.pdf
p.000055: 5. Stem Cell Research - New Challenges for the Ban on Cloning and Treatment of Artificially Created Germ Cells? (2014):
p.000055: https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc- Empfehlungen/englisch/recommendation-stem- cell-research.pdf
p.000055: 6. Germline Intervention in the Human Embryo (2017): https://www.ethikrat.org/fileadmin/Publikation en/Ad-hoc-
p.000055: Empfehlungen/englisch/recommendation- germline-intervention-in-the-human- embryo.pdf
p.000055: 7. Intervening in the Human Germline (2019): https://www.ethikrat.org/fileadmin/Publikation
p.000055: en/Stellungnahmen/englisch/opinion- intervening-in-the-human-germline- summary.pdf
p.000055: Opinion on Stem Cell Research (2002): http://www.zentrale- ethikkommission.de/fileadmin/user_upload/do
p.000055: wnloads/pdf-Ordner/Zeko/Stammzell.pdf
p.000055: Opinion on Stem Cell Research (2006): http://www.dfg.de/download/pdf/dfg_magazin/
p.000055: forschungspolitik/stammzellforschung/stammz ellforschung_deutschland_lang_0610.pdf
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Research Ethics for Biological Sciences (2008): http://www.bioethics.gr/index.php/en/gnomes/
p.000055: 86-research-ethics-in-biological-sciences
p.000055: 2. A Guide for Research Ethics Committees for Biological Research (2008): http://www.bioethics.gr/images/pdf/ENGLISH/
p.000055: OPINIONS_REPORTS/guide.pdf
p.000055: 3. Conflict of Interest in Biomedical Research (2014):
p.000055:
p.000055: Country Key Organizations Legislation
p.000055: Regulations Guidelines
p.000055:
p.000055: General
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Drugs, Biologics, and Devices
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Research Injury
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Privacy/Data Protection
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. National Organization for Medicines (NOM): http://www.eof.gr/web/guest/home, then click on “EN” in upper left hand
p.000055: section for English
p.000055: 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055: National Bioethics Commission (NBC):
p.000055: http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055:
p.000055:
...
p.000056: dedomenon?lspt_context=gdpr
p.000056: 1. Greek Constitution 1975/1986/2001, Article 5.5
p.000056: 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000056: 2819/2000 and 2915/2000):
p.000056: http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF
p.000056: 4. Act 3418/2005 Code on Medical Ethics
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction)
p.000056: 3. Act 3305/2005 Application of Medically Assisted
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf
p.000056: 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_genetic_data_e ng.pdf
p.000056: 3. Opinion on Prenatal and Pre- Implantation Diagnosis and Embryo Treatment:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/1_pd_pgd_opin_eng2. pdf
p.000056: 4. Opinion on Direct-To-Consumer Genetic Testing (2012): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 91-direct-to-consumer-dtc-genetic-testing
p.000056: 5. Opinion on Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/images/pdf/GNOMES/
p.000056: OPINION_Incidental_Findings_FINAL_.pdf
p.000056: 6. Opinion on Advances in Human Genome Editing (2016): http://www.bioethics.gr/images/pdf/GNOMES/ OPINION
p.000056: gene%20editing_Final_EN.pdf NBC:
p.000056: 1. Recommendation on the Use of Stem Cells in Biomedicine and Clinical Medicine
p.000056: 2. Recommendation on Human Reproductive Cloning
p.000056: 3. Opinion on Prenatal and Pre- implantation Diagnosis and Embryo Treatment
p.000057: 57
p.000057:
p.000057: Country Key Organizations Legislation
p.000057: Regulations Guidelines
p.000057:
p.000057: Embryos, Stem Cells, and Cloning
p.000057: Hungary
p.000057: Note: All webpages and documents are in Hungarian.
p.000057: Reproduction
p.000057: Access: http://www.bioethics.gr/index.php/gnomes
p.000057:
p.000057: General
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
...
p.000063:
p.000063: Country Key Organizations Legislation
p.000063: Regulations Guidelines
p.000063:
p.000063: General
p.000063: Drugs, Biologics,
p.000063: and Devices
p.000063: http://oss-sper-clin.agenziafarmaco.it/
p.000063: Drugs
p.000063: 1. National Monitoring Center for Clinical Trials: http://www.agenziafarmaco.com/en/conte
p.000063: nt/national-monitoring-centre-clinical- trials
p.000063: 2. Italian Medicines Agency:
p.000063: http://www.agenziafarmaco.it/
p.000063: 3. Ministry of Health (MOH):
p.000063: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: 1. Decree of the President of the Republic: Regulations to Simplify the Procedures and to Verify and Check New Systems
p.000063: and Experimental Therapeutic Protocols (September 21, 2001) (Italian)
p.000063: 2. Legislative Decree No. 211: Transposition of Directive 2001/20/EC Relating to the Implementation of Good Clinical
p.000063: Practice in the Conduct of Clinical Trials on Medicinal Products for Clinical Use (2003)
p.000063: 3. Legislative Decree No. 200: Transposition of Directive 2005/28 EC Laying down Principles and Detailed Guidelines as
p.000063: Regards Investigational Medical Products for Human Use, as Well as the Requirements for Authorizing of Manufacturing or
p.000063: Importing of such Products (2007) (Italian): http://www.aifa.gov.it/allegati/dlgs_ 200-6nov2007.pdf
p.000063:
p.000063:
p.000063: 1. Ministerial Decree of 21 December 2007: Directions for Submitting the Request for Authorisation of a Clinical Trial
p.000063: on a Medicinal Product for Human Use to the Competent Authority, for Communicating Substantial Amendments, for
p.000063: Declaring the End of the Trial and for the Request of an Opinion to the Ethics Committee
p.000063: 2. Ministerial Decree of 31 March 2008: Definition of the Minimum Requirements that Contract Research Organisations
p.000063: (CROs) Shall Satisfy in Order to Work within Clinical Trials on Medicinal Products
p.000063:
p.000063:
p.000063:
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p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: Research Injury
p.000063:
p.000063:
p.000063:
p.000063: Privacy/Data Protection
p.000063: Devices
p.000063: Ministry of Health, Directorate General for Medicines and Medical Devices: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: Ministry of Labour and Social Policy:
p.000063: www.lavoro.gov.it
p.000063:
p.000063:
p.000063:
p.000063: Italian Data Protection Independent Authority: http://www.garanteprivacy.it/garante/navi
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000063:
p.000064: 64
p.000064:
p.000064: Ministerial Decree 2 of August 2005: Procedures for the Presentation of Documentation to Notify about Clinical
p.000064: Investigations with Medical Devices
p.000064: Ministerial Decree 14 of July 2009: Minimum Requirements for Insurance Policies Which Safeguard Participants to
p.000064: Clinical Trials of Medicinal Products
p.000064: 1. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical
p.000064:
...
p.000068: and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent
p.000068: (2018):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/0f2f1b70b9db 11e5a6588fb85a3cc84b/asr
p.000068: 5. V-1483, Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and
p.000068: Temporary Impact on the Subject’s Health (2018):
p.000068: https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/828d5 3e095ef11e4b92e9028929aad91/asr
p.000068: 6. V-235/A1-83, Decree on the
p.000068:
p.000068: Country Key Organizations Legislation
p.000068: Regulations Guidelines
p.000068:
p.000068: General
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: Lithuanian Bioethics Committee (LBEC):
p.000068: http://bioetika.sam.lt/index.php?23518515 30
p.000068: Procedure for a Minor’s Participation in Biomedical Research (2018): https://www.e-
p.000068: tar.lt/portal/lt/legalAct/104c2540d3e7 11e583a295d9366c7ab3
p.000068: 1. V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28 (2011):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/TAR.480CDD 584ADB
p.000068: 2. V-7, Decree on the Sample Form of the Biomedical Research Protocol, Summary of the Protocol and the CV of
p.000068: Investigator (2017):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/352d55b0c441 11e583a295d9366c7ab3/Maiuzzfyns
p.000068: 3. V-24, Decree on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue
p.000068: Favorable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the
p.000068: Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research (2016): https://www.e-
p.000068: tar.lt/portal/lt/legalAct/3790a050be7e 11e5a6588fb85a3cc84b
p.000068: 4. V-4, Decree on the Request to Issue Approval to Conduct Biomedical Research, the Application Form and the Biomedical
p.000068: Research Ethical Assessment Form (2016): https://www.e- tar.lt/portal/lt/legalAct/27a3460090f0
p.000068: 11e4bb408baba2bdddf3/UqgJXDRU qi
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical
p.000068: Research of the LBEC (2018): http://bioetika.sam.lt/get_file.php?file=bmNlV 3pKeWhhWjJlcW1xZ2xxQnNrWlprbXM2VW
p.000068: tKblJ5Wlp1ekptZG1hV2V5c3JXbUdGa3IzR2 NrNkNab1pxVng2aVprR2ZIWk0yWG81ekxr MnlYY21tV3lwSEtvbWFjbkp4bWNwcCUyQ
p.000068: mNZT2FlMjdUWThacno4ZW1iTlBHbWNlb mJzbVZ4SjJWYWFHZW9HYW1tNmhvajVo bmFwR1ZrbW1jbFdSd2xwdGxsR1pzbHB5W
p.000068: nlXQmdxRzZhWVozRmNKMXJuZyUzRCUz RA==&view=1
p.000068:
p.000069: 69
p.000069:
p.000069: Country Key Organizations Legislation
p.000069: Regulations Guidelines
p.000069:
p.000069: Drugs, Biologics, and Devices
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: Research Injury
p.000069: Drugs
p.000069: 1. Ministry of Health (MOH):
...
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: Devices
p.000069: Ministry of Health (MOH):
p.000069: http://www.sam.lt/go.php/lit/IMG
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: State Health Care Accreditation Agency Under the Ministry of Health (SHCA):
p.000069: http://www.vaspvt.gov.lt/en
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: Ministry of Health (MOH): http://www.sam.lt/go.php/lit/IMG
p.000069:
p.000069: 1. Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000069: 2. Law on Pharmacy (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.FF33B 3BF23DD/asr
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: 1. Law on Ethics of Biomedical Research (2016): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/dReKXfNQaQ
p.000069: 2. Changes of Law on Ethics of Biomedical Research (2017): https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0
p.000069: 5f11e7910a89ac20768b0f
p.000069: Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000069:
p.000070: 70
p.000070:
p.000070: 1. Decree No. 320 on the Rules of Good Clinical Practice (2006): https://www.e- tar.lt/portal/lt/legalAct/TAR.EF5F8A
p.000070: 32B830/WkRbILGNxF
p.000070: 2. Decree No. 435 on the Procedure for Issuing a Favorable Opinion to Conduct Clinical Trials on Medicinal Product,
p.000070: Approval for Clinical Trials on Medicinal Product, and Conducting and Controlling Clinical Trials (2017): https://e-
p.000070: seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.277308/QPLLKpOUKw Decree No. V-6 on the Sample Form of the Request to Issue
p.000070: Favorable Opinion to Conduct Clinical Trial on Medicinal Product Form and the Ethical Assessment Form (2016):
p.000070: https://www.e- tar.lt/portal/lt/legalAct/b65b5ca0c440
p.000070: 11e583a295d9366c7ab3/qcrDrSCSCJ
p.000070:
p.000070: Decree No. V-2 on the Procedure to Issue Approvals to Conduct Biomedical Research (2017): https://www.e-
p.000070: tar.lt/portal/lt/legalAct/TAR.47B2353 93D3A/zpczrvbOOR
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: MOH:
p.000070: Decree No. 745 on the Rules of Compulsory Civil Liability Insurance for the Principal Investigator and the Sponsor
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Guidelines to Advertise Clinical Trials, Adopted by the Group of Experts on Biomedical Research of the LBEC (2018):
p.000070: http://bioetika.sam.lt/index.php?3396441505
p.000070:
p.000070: Country Key Organizations Legislation
p.000070: Regulations Guidelines
p.000070:
p.000070: Research Injury
p.000070:
p.000070: Privacy/Data Protection
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Human Biological Materials
p.000070:
p.000070: Embryos, Stem Cells, and Cloning
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Luxembourg
p.000070:
p.000070:
p.000070: State Data Protection Inspectorate:
p.000070: https://www.ada.lt/go.php/eng
p.000070:
p.000070:
p.000070:
...
p.000088:
p.000088: 1. Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001)
p.000088: 2. Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000088: 164 (2001)
p.000088:
p.000088: 1. Law No. 667/2001 On the Protection of Individuals with
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ordinance No. 57/16.08.2002 (2002):
p.000089: http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie
p.000089: MOH:
p.000089: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of
p.000089: Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: 1. Opinion 15/CNECV/95 on Embryo Research (1995)
p.000089: 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC-
p.000089: 419999D9B693/0/47CNECV2005.pdf
p.000089: 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D-
p.000089: D70A7E9AD961/0/p048_en.pdf
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: MOH:
p.000089: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: The New General Data Protection Regulation (2018):
p.000089:
p.000089: Country Key Organizations Legislation
p.000089: Regulations Guidelines
p.000089:
p.000089: Privacy/Data Protection
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Human Biological Materials
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Embryos, Stem Cells, and Cloning
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Russia
p.000089: http://www.dataprotection.ro/index.jsp?pa ge=documents&lang=en
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ministry of Health (MOH):
p.000089: http://www.ms.ro/
p.000089: Regard to the Processing of Personal Data and on the Free Movement of Such Data: http://www.dataprotection.ro/servlet
p.000089: /ViewDocument?id=174
p.000089: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law No. 95/2006
p.000089: Regarding the Reform in Health Field. Title
...
p.000106: (2014): http://zakon5.rada.gov.ua/laws/sho
p.000107: 107
p.000107: ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305
p.000107: Articles 22 and 35, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi ed-compilation/20121176/index.html
p.000107: 1. Ordinance of 2 February 2005 on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS
p.000107: 810.311: http://www.admin.ch/opc/en/classifi ed-compilation/20042542/index.html
p.000107: 2. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000107: HRO), RS 810.301, Articles 44 – 46, and Annex 2: http://www.admin.ch/opc/en/classifi ed-compilation/20121177/index.html
p.000107: 3. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305,
p.000107: Articles 49, 53, 55, and 56, and Annexes 3 and 4: http://www.admin.ch/opc/en/classifi
p.000107: ed-compilation/20121176/index.html
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: 1. Ukrainian Ministry of Health Order No. 95 About Approval of Documents Related to the Quality Assurance of Medicines
p.000107: (2009): http://zakon5.rada.gov.ua/rada/show/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: NEK-CNE:
p.000107: 1. Pre-Implantation Genetic Diagnosis, 2007/9:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/en/pid_en.pdf
p.000107: 2. Research Involving Human Embryos and Fetuses. Opinion No. 11/2006: http://www.nek-cne.ch/fileadmin/nek-cne-
p.000107: dateien/Themen/Stellungnahmen/en/embryonen
p.000107: _en.pdf
p.000107: 3. Pre-Implantation Genetic Diagnosis II, Opinion No. 14/2007:
p.000107: http://www.nek-cne.ch/fileadmin/nek-cne- dateien/Themen/Stellungnahmen/PID_II_d.pdf
p.000107:
p.000107: Access:
p.000107: http://www.nek-cne.ch/en/topics/opinions/
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Bioethics Committee:
p.000107: 1. Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006)
p.000107: 2. Ethics Expertise of Clinical Trials Medicines (2007)
p.000107:
p.000107: Country Key Organizations Legislation
p.000107: Regulations Guidelines
p.000107:
p.000107: Drugs, Biologics, and Devices
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Research Injury
p.000107:
p.000107:
p.000107: Privacy/Data Protection
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Human Biological Materials
p.000107: en/bioethics-committee
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health:
p.000107: http://www.moz.gov.ua/en/
p.000107:
p.000107:
p.000107: 1. State Service of Ukraine on Personal Data Protection
p.000107: 2. Ukrainian Parliament Commissioner for Human Rights: www.ombudsman.gov.ua
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health:
...
Searching for indicator philosophy:
(return to top)
p.000127:
p.000127:
p.000127: 1. Act on Regulation of Human Cloning Techniques (2014): http://law.e- gov.go.jp/htmldata/H12/H12HO146
p.000127: .html
p.000127: 2000 version (English): http://www.cas.go.jp/jp/seisaku/hou rei/data/htc.pdf
p.000127: 2. Act on Safety of Regenerative Medicine (2013): http://www.mhlw.go.jp/file/06- Seisakujouhou-10800000-
p.000127: Iseikyoku/0000030847.pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000128: 128
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: 1. Ordinance for Enforcement of Act on Regulation of Human Cloning Techniques (2009):
p.000128: http://www.lifescience.mext.go.jp/file s/pdf/n1564_01.pdf
p.000128: 2. Ordinance for Enforcement of Act on Safety of Regenerative Medicine (2019): https://www.lifescience.mext.go.jp/fil
p.000128: es/pdf/n2163_01.pdf
p.000128: 3. Rules for Enforcement of Act on Safety of Regenerative Medicine (2018): https://www.mhlw.go.jp/content/0004
p.000128: 52630.pdf
p.000128: CSTI:
p.000128: Fundamental Principles of Research on the Human Genome (2000)
p.000128:
p.000128: MEXT, MHLW, and METI:
p.000128: Ethics Guidelines for Human Genome/Gene Analysis Research (2017): http://www.lifescience.mext.go.jp/files/pdf/n18
p.000128: 59_03r2.pdf
p.000128: 2008 version (English): http://www.lifescience.mext.go.jp/files/pdf/n79 6_00.pdf
p.000128:
p.000128: MHLW:
p.000128: Guidelines for Clinical Research in Gene Therapy and Others (2019): https://www.neurology-
p.000128: jp.org/news/pdf/news_20190307_02_02.pdf CSTP:
p.000128: Fundamental Philosophy on Handling of Human Embryo (2004): http://www.lifescience.mext.go.jp/files/pdf/6_2 8.pdf
p.000128:
p.000128: MEXT:
p.000128: 1. Guidelines on the Derivation of Human Embryonic Stem Cells (2014): http://www.lifescience.mext.go.jp/files/pdf/n15
p.000128: 53_01.pdf
p.000128: 2. Guidelines on Research on Producing Germ Cells from Human Induced Pluripotent Stem Cells or Human Tissue Stem Cells
p.000128: (2015): http://www.lifescience.mext.go.jp/files/pdf/n14 92_01r2.pdf
p.000128: 2010 version (English): http://www.lifescience.mext.go.jp/files/pdf/n15 67_02r2.pdf
p.000128: 3. Guidelines on the Handling of a Specified Embryo (2019): https://www.lifescience.mext.go.jp/files/pdf/n2 163_07.pdf
p.000128: 4. Guidelines on the Distribution of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCdistributionguideline2019.pdf
p.000128:
p.000128: Country Key Organizations Legislation
p.000128: Regulations Guidelines
p.000128:
p.000128: Embryos, Stem Cells, and Cloning
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128:
p.000128: Kazakhstan
p.000128: 5. Guidelines on the Utilization of Human Embryonic Stem Cells (2019): https://www.lifescience.mext.go.jp/files/pdf/hE
p.000128: SCutilizationguideline2019.pdf
p.000128:
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000004: TRUST Project:
p.000004: http://www.globalcodeofconduct.org
p.000004:
p.000004:
p.000004:
p.000004: UNAIDS:
p.000004: http://www.unaids.org/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950):
p.000004: https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68
p.000004: 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977):
p.000004: http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9
p.000004: International Covenant on Civil and Political Rights, Article 7 (1976):
p.000004: http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
p.000005: 2. Ethical Considerations
p.000005: in Biomedical HIV Prevention Trials (2012):
p.000005: http://www.unaids.org/en/media/unaids/conten
p.000005:
p.000005: Country Key Organizations Legislation
p.000005: Regulations Guidelines
p.000005: tassets/documents/unaidspublication/2012/jc1
p.000005:
p.000005: General
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: World Medical Association:
p.000005: http://www.wma.net/e/
p.000005:
p.000005:
p.000005: Drugs
p.000005: International Conference on Harmonization (ICH): http://www.ich.org/
p.000005:
p.000005:
p.000005:
p.000005: World Health Organization (WHO):
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000109: 1. HRA Guidance: https://www.hra.nhs.uk/planning-and- improving-research/
p.000109: 2. Integrated Research Application System: https://www.myresearchproject.org.uk/
p.000109:
p.000109: Country Key Organizations Legislation
p.000109: Regulations Guidelines
p.000109:
p.000109: General
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Medical Research Council (MRC):
p.000109: https://www.mrc.ac.uk/
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Scotland:
p.000109: 1. NHSScotland, Chief Scientist Office (CSO): http://www.cso.scot.nhs.uk/
p.000109: 2. NHS Research Scotland:
p.000109: http://www.nhsresearchscotland.org.uk/
p.000109:
p.000109: Wales:
p.000109: Health and Care Research Wales: http://www.healthandcareresearch.gov.wal es/
p.000109:
p.000109:
p.000109: Northern Ireland:
p.000109: 1. Department of Health, Social Services and Public Safety: http://www.dhsspsni.gov.uk/
p.000109: 2. Office for Research Ethics. Committees Northern Ireland: http://www.hscbusiness.hscni.net/orecni.ht m
p.000109: 3. Care Act (2014): http://www.legislation.gov.uk/ukpg a/2014/23/contents/enacted/data.ht m
p.000109: 4. Ionising Radiation (Medical Exposure) Regulations (2017): http://www.legislation.gov.uk/uksi/
p.000109: 2017/1322/contents/made
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Adults with Incapacity (Scotland) Act 2000, Section 51: http://www.scotland.gov.uk/Topics/ Justice/law/awi/legislation
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: Ionising Radiation (Medical Exposure) (Northern Ireland) Regulations (2018): http://www.legislation.gov.uk/nisr/2
p.000109: 018/17/contents/made
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: Adults with Incapacity (Ethics Committee) (Scotland) Regulations (2002): http://www.scotland-
p.000110: legislation.hmso.gov.uk/legislation/s cotland/ssi2002/20020190.htm
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110: 1. Research Involving Human Participants in Developing Societies (2004):
p.000110: https://mrc.ukri.org/publications/browse/researc h-involving-human-participants-in-developing- societies/
p.000110: 2. Medical Research Involving Children (2004): https://mrc.ukri.org/documents/pdf/medical- research-involving-children/
p.000110: 3. Medical Research Involving Adults Who Cannot Consent (2007): https://mrc.ukri.org/documents/pdf/medical-
p.000110: research-involving-adults-who-cannot-consent/
p.000110: 4. Good Research Practice: Principles and Guidelines (2012): https://mrc.ukri.org/publications/browse/good-
p.000110: research-practice-principles-and-guidelines/
p.000110:
p.000110: CSO:
p.000110: Research Governance Framework for Health and Community Care (2006): http://www.cso.scot.nhs.uk/wp-
p.000110: content/uploads/2013/02/RGF-Second-Edition- February-06.pdf
p.000110:
p.000110: Research Governance Framework for Health and Social Care in Wales Second Edition (2009):
p.000110: http://www.wales.nhs.uk/sites3/Documents/952/Rese arch%20Governance%20Framework%202009%20% 28English%291.pdf
p.000110:
p.000110: Country Key Organizations Legislation
p.000110: Regulations Guidelines
p.000110:
p.000110: Drugs, Biologics, and Devices
p.000110: Drugs
p.000110: 1. Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/organisati
p.000110: ons/medicines-and-healthcare-products- regulatory-agency
p.000110: 2. Administration of Radioactive Substances Advisory Committee (ARSAC) (UK): https://www.gov.uk/government/organisati
p.000110: ons/administration-of-radioactive- substances-advisory-committee
p.000110: 3. Department of Environment, Food & Rural affairs (DEFRA) https://www.gov.uk/government/organisati
p.000110: ons/department-for-environment-food- rural-affairs
p.000110: 4. Health and Safety Executive (HSE)
p.000110: http://www.hse.gov.uk/
p.000110:
p.000110: Medicines Act (1968): http://www.legislation.gov.uk/ukpg a/1968/67/contents
p.000110:
p.000110: 1. Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031 (2004):
p.000110: http://www.legislation.gov.uk/uksi/2 004/1031/contents/made
p.000110: 2. Amendment Regulations (SI 2006/1928) http://www.legislation.gov.uk/uk si/2006/1928/contents/made
p.000110: 3. Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and Adults with Incapacity (Scotland)
p.000110: Act 2000 to Facilitate Clinical Research in Emergency Settings (SI 2006/2984): http://www.legislation.gov.uk/uksi/2
p.000110: 006/2984/pdfs/uksi_20062984_en.pd f
p.000110: 4. SI 2008 No.941 The
p.000110: Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment Regulations 2008:
p.000110: http://www.legislation.gov.uk/uksi/2 008/941/contents/made
p.000110: 5. Genetically Modified Organisms (Deliberate Release) Regulations 2002: http://www.legislation.gov.uk/uksi/2
p.000110: 002/2443/contents/made
p.000110: 6. Genetically Modified Organisms (Contained Use) Regulations 2014 (England, Scotland and Wales):
p.000110: http://www.legislation.gov.uk/uksi/2 014/1663/part/1/made
p.000110: 7. Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015:
p.000110: http://www.legislation.gov.uk/nisr/2 015/339/contents/made
p.000110:
p.000111: 111
p.000111:
p.000111: Country Key Organizations Legislation
p.000111: Regulations Guidelines
p.000111:
p.000111: Drugs, Biologics, and Devices
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: Clinical Trials Registry
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: Research Injury
p.000111: Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk
p.000111:
p.000111:
p.000111: National Institute for Health Research:
p.000111: http://www.nihr.ac.uk/
p.000111: Health Research Authority (HRA):
p.000111: http://www.hra.nhs.uk/
p.000111:
p.000111:
p.000111:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000110: content/uploads/2013/02/RGF-Second-Edition- February-06.pdf
p.000110:
p.000110: Research Governance Framework for Health and Social Care in Wales Second Edition (2009):
p.000110: http://www.wales.nhs.uk/sites3/Documents/952/Rese arch%20Governance%20Framework%202009%20% 28English%291.pdf
p.000110:
p.000110: Country Key Organizations Legislation
p.000110: Regulations Guidelines
p.000110:
p.000110: Drugs, Biologics, and Devices
p.000110: Drugs
p.000110: 1. Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/organisati
p.000110: ons/medicines-and-healthcare-products- regulatory-agency
p.000110: 2. Administration of Radioactive Substances Advisory Committee (ARSAC) (UK): https://www.gov.uk/government/organisati
p.000110: ons/administration-of-radioactive- substances-advisory-committee
p.000110: 3. Department of Environment, Food & Rural affairs (DEFRA) https://www.gov.uk/government/organisati
p.000110: ons/department-for-environment-food- rural-affairs
p.000110: 4. Health and Safety Executive (HSE)
p.000110: http://www.hse.gov.uk/
p.000110:
p.000110: Medicines Act (1968): http://www.legislation.gov.uk/ukpg a/1968/67/contents
p.000110:
p.000110: 1. Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031 (2004):
p.000110: http://www.legislation.gov.uk/uksi/2 004/1031/contents/made
p.000110: 2. Amendment Regulations (SI 2006/1928) http://www.legislation.gov.uk/uk si/2006/1928/contents/made
p.000110: 3. Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and Adults with Incapacity (Scotland)
p.000110: Act 2000 to Facilitate Clinical Research in Emergency Settings (SI 2006/2984): http://www.legislation.gov.uk/uksi/2
p.000110: 006/2984/pdfs/uksi_20062984_en.pd f
p.000110: 4. SI 2008 No.941 The
p.000110: Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment Regulations 2008:
p.000110: http://www.legislation.gov.uk/uksi/2 008/941/contents/made
p.000110: 5. Genetically Modified Organisms (Deliberate Release) Regulations 2002: http://www.legislation.gov.uk/uksi/2
p.000110: 002/2443/contents/made
p.000110: 6. Genetically Modified Organisms (Contained Use) Regulations 2014 (England, Scotland and Wales):
p.000110: http://www.legislation.gov.uk/uksi/2 014/1663/part/1/made
p.000110: 7. Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015:
p.000110: http://www.legislation.gov.uk/nisr/2 015/339/contents/made
p.000110:
p.000111: 111
p.000111:
p.000111: Country Key Organizations Legislation
p.000111: Regulations Guidelines
p.000111:
p.000111: Drugs, Biologics, and Devices
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: Clinical Trials Registry
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111:
p.000111: Research Injury
p.000111: Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk
p.000111:
p.000111:
p.000111: National Institute for Health Research:
p.000111: http://www.nihr.ac.uk/
p.000111: Health Research Authority (HRA):
p.000111: http://www.hra.nhs.uk/
p.000111:
p.000111:
p.000111:
p.000111: Devices
p.000111: Medicines and Healthcare Products Regulatory Agency (MHRA): https://www.gov.uk/government/collection
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000027: Drugs, Biologics, and Devices
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Research Injury
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Privacy/Data Protection
p.000027:
p.000027: Note: The Austrian states also have privacy/data protection laws
p.000027: http://www.bundeskanzleramt.at/site/3575
p.000027: /default.aspx
p.000027:
p.000027:
p.000027: Drugs
p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian-
p.000027: federal-office-for-safety-in-health-care/ Devices
p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian-
p.000027: federal-office-for-safety-in-health-care/
p.000027: 1. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 2. Austrian Federal Office for Safety in Health Care: http://www.basg.at/en/austrian-federal-
p.000027: office-for-safety-in-health-care/
p.000027:
p.000027:
p.000027:
p.000027: Austrian Data Protection Authority: https://www.dsb.gv.at/DesktopDefault.asp x?alias=dsken
p.000027: ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10010285&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027: Austrian Drug Law (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Medical Devices Act (2014): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen &Gesetzesnummer=10011003
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 1. Austrian Drug Law, Article 32 (2013): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10010441&Sho wPrintPreview=True
p.000027: 2. Austrian Medical Devices Law, Article 47 (2017): http://www.ris.bka.gv.at/GeltendeFa ssung.wxe?Abfrage=Bundesnormen
p.000027: &Gesetzesnummer=10011003&Sho wPrintPreview=True
p.000027: 1. Data Protection Act No. 165/1999: https://www.ris.bka.gv.at/GeltendeF assung.wxe?Abfrage=Bundesnorme
p.000027: n&Gesetzesnummer=10001597
p.000027: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000027:
p.000028: 28
p.000028:
p.000028: Access: http://www.bundeskanzleramt.at/site/4070/defa ult.aspx
p.000028:
p.000028: Various: http://www.basg.at/arzneimittel/vor-der- zulassung/klinische-pruefungen/
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: Various:
p.000028: http://www.basg.at/medizinprodukte/formulare
p.000028: /klinische-pruefung/
p.000028:
...
p.000030:
p.000030: Access: https://www.health.belgium.be/en/list- opinions
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: Country Key Organizations Legislation
p.000031: Regulations Guidelines
p.000031:
p.000031: Drugs, Biologics, and Devices
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Research Injury
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Privacy/Data Protection
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Human Biological Materials
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP):
p.000031: Drugs: https://www.famhp.be/en/human_use/med icines/medicines/research_development/cl inical_trials
p.000031: Devices: https://www.famhp.be/en/human_use/heal th_products/medical_devices_accessories
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): https://www.health.belgium.be/en/belgian
p.000031: -advisory-committee-bioethics
p.000031: 3. Clinical Trial College https://consultativebodies.health.belgium. be/en/advisory-and-consultative-
p.000031: bodies/ct-college-clinical-trial-college
p.000031:
p.000031: Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Belgian Data Protection Authority:
p.000031: https://www.dataprotectionauthority.be/
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: 1. Federal Agency for Medicines and Health Products (FAMHP): https://www.famhp.be/en/human_use/med icines/medicines
p.000031: 2. Belgian Advisory Committee on Bioethics (BACB): http://www.health.belgium.be/en
p.000031: 3. Superior Health Council (CSS): http://www.health.belgium.be/eportal/Abo utus/relatedinstitutions/SuperiorHealthCo
p.000031: uncil/index.htm
p.000031: Law Relating to Experimentation on Humans (2004):
p.000031: http://www.ejustice.just.fgov.be/cgi
p.000031: _loi/change_lg.pl?language=fr&la= F&cn=2004050732&table_name=lo i
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Law Relating to Experimentation on Humans, Chapter XVII (Responsibility and Insurance) Article 29 (2004):
p.000031: https://www.famhp.be/en/human_us e/medicines/medicines/research_dev elopment/ethic_committee
p.000031: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000031: 3. Act on the Protection of Natural Persons with Regard to the Processing of Personal Data (30 July 2018):
p.000031: https://www.dataprotectionauthority
p.000031: .be/legislation-and-standards
p.000031: Law Relating to the Use of Human Biological Materials (19 December 2008): https://www.afmps.be/fr/humain/pro
p.000031: duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor el_humain/legislation/apres_le_01_ 12_2009
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032: 1. Royal Decrees to Experimentation on Humans: https://www.famhp.be/en/human_use/ medicines/medicines/research_develo
...
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Research (2018)
p.000045: 2. International Data Transfer (2018): http://www.aki.ee/en/guidelines/transfer- personal-data-foreign-country
p.000045:
p.000045: Country Key Organizations Legislation
p.000045: Regulations Guidelines
p.000045:
p.000045: Embryos, Stem Cells, and Cloning
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Finland
p.000045: General
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Drugs, Biologics, and Devices
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Ministry of Social Affairs and Health (MSAH): http://www.stm.fi/en/frontpage
p.000045: 2. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en
p.000045:
p.000045:
p.000045: Drugs
p.000045: 1. Finnish Medicines Agency (FIMEA): https://www.fimea.fi/web/en/frontpage
p.000045: 2. Ministry of Social Affairs and Health (MSAH): http://stm.fi/en/frontpage
p.000045: 3. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Devices
p.000045: National Supervisory Authority for Welfare and Health (VALVIRA): http://www.valvira.fi/en/licensing/medical
p.000045: _devices
p.000045: Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition
p.000045: of Cloning Human Beings (2002) (Estonian): https://www.riigiteataja.ee/akt/7856 9
p.000045: 2. Artificial Insemination and Embryo Protection Act, RT I 1997, 51, 824 (2011): https://www.riigiteataja.ee/en/eli/ee/
p.000045: 530102013057/consolide/current
p.000045:
p.000045: Medical Research Act No. 488/1999 (Amended 295/2004,
p.000045: 794/2010, and 143/2015):
p.000045: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: 1. Medicines Act No. 395/1987: http://www.finlex.fi/fi/laki/smur/19 87/19870395
p.000045: 2. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000045: set/1999/en19990488
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045: Medical Devices Act No. 629/2010 (Finnish): http://www.finlex.fi/fi/laki/kokoelm a/2010/20100085.pdf
p.000046: 46
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Decree of the National Research Ethics Council of Finland No. 1347/1991
p.000046: 2. Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016
p.000046: 3. Decrees on the National Committee on Medical Research Ethics No. 820/2010 and 788/2018
p.000046: 4. Decree on Fees, No. 1287/2018
p.000046:
...
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046:
p.000046:
p.000046: TUKIJA:
p.000046: Templates for Clinical Trial Information Leaflet and Consent Form (2018)
p.000046:
p.000046: Access:
p.000046: http://tukija.fi/en/publications1
p.000046:
p.000046: Country Key Organizations Legislation
p.000046: Regulations Guidelines
p.000046:
p.000046: Drugs, Biologics, and Devices
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Research Injury
p.000046:
p.000046:
p.000046:
p.000046: Social-Behavioral Research
p.000046:
p.000046:
p.000046: Privacy/Data Protection
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Human Biological Materials
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: Genetic Research
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. Finnish Patient Insurance Centre:
p.000046: https://www.pvk.fi/fi/
p.000046: 2. Pharmaceutical Injuries Insurance
p.000046: http://www.laakevahinko.fi/in-english/
p.000046:
p.000046: Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000046:
p.000046:
p.000046: Office of the Data Protection Ombudsman: https://tietosuoja.fi/en/home
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: National Supervisory Authority for Welfare and Health (Valvira): http://www.valvira.fi/web/en
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. National Committee on Medical Research Ethics (TUKIJA): http://www.tukija.fi/en
p.000046:
p.000046: EU Regulations:
p.000046: Medical Device Regulation 2017/745: http://eur- lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000046: :32017R0745&from=EN
p.000046: In Vitro Diagnostic Medical Devices Regulation 2017/746: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
p.000046: :32017R0746&from=EN
p.000046: Patient Injuries Act No. 585/1986:
p.000046: http://www.finlex.fi/fi/laki/ajantasa/ 1986/19860585
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000046: 2. Data Protection Act (1050/2018): https://www.finlex.fi/en/laki/kaanno kset/2018/20181050
p.000046: 1. Act on the Medical Use of Human Organs, Tissues, and Cells No. 101/2001 (Finnish and Swedish):
p.000046: http://www.finlex.fi/fi/laki/ajantasa/ 2001/20010101
p.000046: 2. Law on Biobanks, No 688/2012 (Finnish and Swedish): http://www.finlex.fi/fi/laki/ajantasa/ 2012/20120688
p.000046:
p.000046:
p.000046:
p.000046: 1. Medical Research Act No. 488/1999 (Amended 295/2004, 794/2010, and 143/2015):
p.000047: 47
p.000047: maarays_3_2010_kliininen_laitetutki mus.pdf
p.000047: 2. Various: http://www.valvira.fi/en/licensing/me dical_devices/legislation
p.000047:
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p.000047:
p.000047:
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p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Decree on Consent for Biobank No. 643/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130643
p.000047: 2. Decree on information on Biobank No. 649/2013: http://www.finlex.fi/fi/laki/alkup/201 3/20130649
p.000047: 3. Government Decree on Medical Use of Human Organs, Tissues, and Cells No. 594/2007
p.000047: 4. Ministry Decree on Medical Use of Human Organs, Tissues, and Cells No. 1302/2007
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Pharmaceutical Injuries Insurance: General Terms and Conditions (2017):
p.000047: https://www.laakevahinko.fi/en/potilaille/vaku utusehdot/
p.000047: The Ethical Principles of Research with Human Participants and Ethical Review in the Human Sciences in Finland (2019):
p.000047: https://www.tenk.fi/en/ethical-review-in- finland
p.000047:
p.000047: Country Key Organizations Legislation
p.000047: Regulations Guidelines
p.000047:
p.000047: Genetic Research
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Embryos, Stem Cells, and Cloning
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
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p.000047:
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p.000047:
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p.000047:
p.000047:
p.000047:
p.000047: France
p.000047: General
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Drugs, Biologics, and Devices
p.000047: 2. Board for Gene Technology:
p.000047: http://www.geenitekniikanlautakunta.fi/en
p.000047:
p.000047:
p.000047:
p.000047: 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000047: 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa
p.000047: /1995/19950377
p.000047: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
...
p.000053:
p.000053:
p.000053:
p.000053: German Society of Human Genetics (GfH): http://www.gfhev.de/en/gfh/
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Research Foundation (DFG), Permanent Senate Commission on Genetic Research:
p.000053: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/genetic_research/index.ht ml
p.000053: Federal Ministry of Education and Research (BMBF): http://www.bmbf.de/en/index.php
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: German Ethics Council:
p.000053: https://www.ethikrat.org/en/
p.000053: (2017):
p.000053: http://www.gesetze-im- internet.de/gentg/
p.000053:
p.000053:
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p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: 1. Embryo Protection Act (2011): http://www.gesetze-im- internet.de/eschg/
p.000053: 2. Stem Cell Act (2017): http://www.gesetze-im- internet.de/stzg/
p.000053:
p.000053:
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p.000054:
p.000054:
p.000054:
p.000054:
p.000054: Regulation on the Central Ethics Committee for Stem Cell Research and the Competent Authority Pursuant to the Stem Cell
p.000054: Act (2017): http://www.gesetze-im- internet.de/zesv/
p.000054:
p.000054:
p.000054:
p.000054: 1. DNA Banking and Personal Data in Biomedical Research: Technical, Social, and Ethical Questions (2004):
p.000054: http://www.medgenetik.de/sonderdruck/en/DN A%20Banking_engl_060605.pdf
p.000054: 2. Position Paper of the German Society of Human Genetics (2007): http://www.medgenetik.de/sonderdruck/2007_
p.000054: gfh_positionspapier.pdf
p.000054: Statements: http://www.dfg.de/en/dfg_profile/statutory_bod ies/senate/genetic_research/publications/index. html
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000054: 1. The Import of Human Embryonic Stem Cells (2001): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stellungnahme_Sta mmzellimport.pdf
p.000054: 2. Cloning for Reproductive Purposes and Cloning for the Purposes of Biomedical Research (2004):
p.000054: https://www.ethikrat.org/fileadmin/Publikation en/Stellungnahmen/Archiv/Stellungnahme_Klo nen.pdf
p.000054: 3. Should the Stem Cell Law be Amended? (2007): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/Archiv/Stn_Stammzellgese tz.pdf
p.000054: 4. Human-Animal Mixtures in Research (2011): https://www.ethikrat.org/fileadmin/Publikation
p.000054: en/Stellungnahmen/englisch/opinion-human-
p.000054:
p.000054: Country Key Organizations Legislation
p.000054: Regulations Guidelines
p.000054:
p.000054: Embryos, Stem Cells, and Cloning
p.000054:
p.000054:
p.000054:
p.000054:
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p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Research Ethics for Biological Sciences (2008): http://www.bioethics.gr/index.php/en/gnomes/
p.000055: 86-research-ethics-in-biological-sciences
p.000055: 2. A Guide for Research Ethics Committees for Biological Research (2008): http://www.bioethics.gr/images/pdf/ENGLISH/
p.000055: OPINIONS_REPORTS/guide.pdf
p.000055: 3. Conflict of Interest in Biomedical Research (2014):
p.000055:
p.000055: Country Key Organizations Legislation
p.000055: Regulations Guidelines
p.000055:
p.000055: General
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Drugs, Biologics, and Devices
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Research Injury
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Privacy/Data Protection
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. National Organization for Medicines (NOM): http://www.eof.gr/web/guest/home, then click on “EN” in upper left hand
p.000055: section for English
p.000055: 2. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055: National Bioethics Commission (NBC):
p.000055: http://www.bioethics.gr/index.php?catego ry_id=3
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Hellenic Data Protection Authority:
p.000055: http://www.dpa.gr/
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000055: Regard to
p.000055: the Application of Biology and Medicine (1998)
p.000055: 2. Act 3418/2005 Code on Medical Ethics
p.000055:
p.000055: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000055: Regard to
p.000055: the Application of Biology and Medicine (1998)
p.000055: 2. Act 3418/2005 Code on Medical Ethics
p.000055:
p.000055: 1. Greek Constitution 1975/1986/2001 Article 9.1
p.000055: 2. Act 2619/98 (Biomedicine Convention of the Council of Europe) (1998)
p.000055: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000055: 2819/2000 and 2915/2000):
p.000055: http://www.dpa.gr/portal/page?_pag eid=33,19052&_dad=portal&_sche ma=PORTAL
p.000055: 4. Act 3418/2005 Code on Medical Ethics
p.000055: 5. General Data Protection
p.000056: 56
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Ministerial Decision ΔΥΓ3 89292/2003: Harmonization of the Greek Legislation with EU Legislation, According to the
p.000056: Directive 2001/20/EC
p.000056: 2. Ministerial Decision ΔΥΓ 3 α/79602/2007: Harmonization of the Greek Legislation with EU Legislation, according to
p.000056: the Directive 2005/28/EC
...
p.000056: 2013_EN.pdf
p.000056: 4. Incidental Findings in Research and Clinical Practice (2015): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 983-incidental-findings-in-research-and- clinical-practice
p.000056: NBC:
p.000056: 1. Recommendation on Clinical Trials: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_clinical_trials_ en.pdf
p.000056: 2. Control of Non-Invasive Clinical Trials for Drugs (2013): http://www.bioethics.gr/index.php/en/gnomes/
p.000056: 532-control-of-non-invasive-clinical-trials-for- drugs
p.000056:
p.000056: Country Key Organizations Legislation
p.000056: Regulations Guidelines
p.000056:
p.000056: Privacy/Data Protection
p.000056:
p.000056:
p.000056: Genetic Research
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
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p.000056:
p.000056: Embryos, Stem Cells, and Cloning
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: National Bioethics Commission (NBC):
p.000056: http://www.bioethics.gr/index.php?catego ry_id=3
p.000056:
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p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. National Bioethics Commission (NBC): http://www.bioethics.gr/index.php?catego ry_id=3
p.000056: 2. National Authority for Medically Assisted Reproduction
p.000056: Regulation (2016): https://www.lawspot.gr/nomikes- plirofories/nomothesia/genikos- kanonismos-gia-tin-prostasia-
p.000056: dedomenon?lspt_context=gdpr
p.000056: 1. Greek Constitution 1975/1986/2001, Article 5.5
p.000056: 2. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 3. Act 2472/1997 on the Protection of Individuals with Regard to the Processing of Personal Data (As Amended by Laws
p.000056: 2819/2000 and 2915/2000):
p.000056: http://www.dpa.gr/pls/portal/docs/P AGE/APDPX/ENGLISH_INDEX/L EGAL%20FRAMEWORK/LAW% 202472-97-NOV2013-EN.PDF
p.000056: 4. Act 3418/2005 Code on Medical Ethics
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Act 2619/98: Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with
p.000056: Regard to
p.000056: the Application of Biology and Medicine (1998)
p.000056: 2. Civil Code (Act 3089/2002, Medically Assisted Reproduction)
p.000056: 3. Act 3305/2005 Application of Medically Assisted
p.000056:
p.000056:
p.000056:
p.000056:
p.000056: 1. Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedical Research:
p.000056: http://www.bioethics.gr/images/pdf/ENGLISH/ OPINIONS_REPORTS/biobanks_recom_eng. pdf
p.000056: 2. Recommendation on the Collection and Use of Genetic Data: http://www.bioethics.gr/images/pdf/ENGLISH/
p.000056: OPINIONS_REPORTS/recom_genetic_data_e ng.pdf
...
p.000058: 2. Decree 35/2005 (VIII.26.) of
p.000058: the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the
p.000058: Application of Good Clinical Practice: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0500035.EUM
p.000058: 3. Decree No. 235/2009 (X.20.)
p.000058: from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical
p.000058: Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices:
p.000058: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Clinical Trials:
p.000058: Decree 35/2005 (VIII. 26) of the Minister of Health on the Clinical Trial and Application of Correct Clinical Practices
p.000058: of Investigational Medicinal Products Intended for Use in Humans: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000058: gi?docid=A0500035.EUM&celpara= #xcelparam
p.000058:
p.000058: Country Key Organizations Legislation
p.000058: Regulations Guidelines
p.000058:
p.000058: Drugs, Biologics, and Devices
p.000058:
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p.000058: Research Injury
p.000058:
p.000058:
p.000058:
p.000058: Privacy/Data Protection
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Devices
p.000058: 1. Authority for Medical Devices, National Healthcare Service System: http://www.enkk.hu/index.php/hun/
p.000058: 2. Medical Research Council, Ethics Committee for Clinical Pharmacology: https://ett.aeek.hu/kfeb/
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p.000058:
p.000058: National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000058:
p.000058:
p.000058: Hungarian National Authority for Data Protection and Freedom of
p.000058: .cgi?docid=99700154.TV
p.000058:
p.000058:
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p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Act CLIV of 1997 on Health Care, Chapter VIII, Section 159: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000058: .cgi?docid=99700154.TV
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p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Act XCV of 2005 on Medicinal Products for Human Use, Section 3, Paragraph 5: http://net.jogtar.hu/jr/gen/getdoc.cgi
p.000058: ?docid=a0500095.tv&dbnum=62
p.000058: 1. Act XLVII of 1997 on the Handling of Medical and Other
p.000059: 59
p.000059: Non-Interventional Trials:
p.000059: Decree 23/2002. (V. 9) of the Minister of Health on Biomedical Research on Human Beings:
p.000059: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam
p.000059:
p.000059: Clinical Trials:
p.000059: Decree 4/2009. (III. 17.) of the Minister of Health on Medical Devices: http://net.jogtar.hu/jr/gen/hjegy_doc.c
p.000059: gi?docid=A0900004.EUM&celpara= #xcelparam
p.000059:
p.000059: Non-Interventional Trials:
p.000059: 1. Decree 23/2002. (V. 9.) of the Minister of Health on Biomedical Research on Human Beings
p.000059: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam
p.000059: 2. Government Decree 235/2009. (X.20.) on the Regulations of Giving Permission for Human Medical Experiments, for
p.000059: Clinical Studies of Experimental Medicinal Products and for the Clinical Studies of the Medical Devices:
p.000059: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam
...
p.000061: Regulation on Clinical Trials of Medicinal Products in Humans No 443/2004 (2010):
p.000061: https://www.government.is/media/vel ferdarraduneyti- media/media/Reglugerdir- enska/Regulation-on-clinical-trials-
p.000061: 2. Informed Consent:
p.000061: http://www.vsn.is/en/content/informed-consent
p.000061: 3. Withdrawal of Consent: http://www.vsn.is/en/content/withdrawal- consent
p.000061: 4. Duty to Report Unexpected Events: http://www.vsn.is/en/content/duty-report- unexpected-events
p.000061: 5. Advertising to Recruit Participants: http://www.vsn.is/en/content/advertising- recruit-participants
p.000061:
p.000061: NBC:
p.000061: Various:
p.000061: http://www.vsn.is/en/content/clinical-trials
p.000061:
p.000061: Country Key Organizations Legislation
p.000061: Regulations Guidelines
p.000061:
p.000061: Research Injury
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Privacy/Data Protection
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Human Biological Materials
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Embryos, Stem Cells, and Cloning
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Ireland
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Data Protection Authority: http://www.personuvernd.is/information- in-english/
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: 1. Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000061: 2. National Bioethics Committee (NBC): www.visindasidanefnd.is/en
p.000061: 2. Act on Health Insurance No. 112/2008 (2012): https://www.government.is/media/v elferdarraduneyti-
p.000061: media/media/acrobat- enskar_sidur/Act-on-Health- Insurance-No-112-2008-16.pdf
p.000061: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000061: 2. Act No. 90/2018 on Data Protection and the Processing of Personal Data: https://www.althingi.is/altext/148/s/
p.000061: 1296.html
p.000061: Biobanks Act No. 110/2000 (2015):
p.000061: https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Biobanks-Act-as-
p.000061: amended-2015.pdf
p.000061: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000061: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2004)
p.000061: 2. Act on Artificial Fertilisation and Use of Human Gametes and Embryos for Stem-Cell Research, No. 55/1996 (2010):
p.000061: http://eng.velferdarraduneyti.is/medi a/acrobat- enskar_sidur/Act_No_55_1996_on_ Artificial_Fertilisation_etc_as_amen
p.000061: ded.pdf
p.000061: of-medicinal-products-in-humans-no- 443-2004-as-amended.pdf
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: Regulations on the Keeping and Utilization of Biological Samples in Biobanks No. 1146/2010:
...
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061: NBC:
p.000061: 1. Access to and Utilisation of Health Data and Bio-Samples: http://www.vsn.is/en/content/access-and-
p.000061: utilisation-health-data-and-bio-samples
p.000061: 2. Biobanks:
p.000061: http://www.vsn.is/en/content/biobanks
p.000061: See this summary on Clinical Trials Involving Medical Products:
p.000061: http://health.gov.ie/blog/policy/clinical-trials-involving-medicinal-products/
p.000061:
p.000061: General
p.000061: Department of Health:
p.000061: http://health.gov.ie/
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062: 1. Operational Procedures for Research Ethics Committees: Guidance 2004: http://health.gov.ie/wp-
p.000062: content/uploads/2014/07/Operational_Procedur es1.pdf
p.000062: 2. Health Service Executive National
p.000062:
p.000062: Country Key Organizations Legislation
p.000062: Regulations Guidelines
p.000062:
p.000062: General
p.000062:
p.000062: Drugs, Biologics, and Devices
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Research Injury
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Privacy/Data Protection
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Human Biological Materials
p.000062:
p.000062:
p.000062:
p.000062: Genetic Research
p.000062:
p.000062:
p.000062: Italy
p.000062: General
p.000062:
p.000062:
p.000062: 1. Department of Health:
p.000062: http://health.gov.ie/
p.000062: 2. Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Data Protection Commissioner (DPC):
p.000062: http://www.dataprotection.ie/docs/Home/ 4.htm
p.000062: Health Research Board (HRB):
p.000062: http://www.hrb.ie/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062: Health Products and Regulatory Authority: https://www.hpra.ie/
p.000062:
p.000062:
p.000062:
p.000062: 1. National Bioethics Committee (CNB): http://www.governo.it/bioetica/eng/index. html
p.000062: 2. National Monitoring Center for Clinical Trials (OSS):
p.000062:
p.000062:
p.000062: European Communities (Clinical Trials on Medicinal Products for Human Use) Amendment 2004 (S.I. No. 190
p.000062: of 2004):
p.000062: http://www.irishstatutebook.ie/eli/2 004/si/878/made/en/print
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062: 1. Data Protection Act (1988), as Amended (2003): http://www.irishstatutebook.ie/2003
p.000062: /en/act/pub/0006/index.html
p.000062: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000062: 3. Data Protection Act 2018: https://www.oireachtas.ie/en/bills/bi ll/2018/10/
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000062:
p.000063: 63
p.000063:
p.000063:
p.000063: European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004):
p.000063: http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html
p.000063:
p.000063: European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, Section 13(6)(k) and
p.000063: Schedule 1, Part 2, Paragraph 4 (S.I. No. 190
p.000063: of 2004):
p.000063: http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html
p.000063: Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018: http://www.hrb.ie/funding/gdpr-
...
p.000063: http://lenus.ie/hse/bitstream/10147/96983/1/Ph armacogenetic06.pdf
p.000063:
p.000063: CNB:
p.000063: Various: http://www.governo.it/bioetica/eng/opinions.ht ml
p.000063:
p.000063: Country Key Organizations Legislation
p.000063: Regulations Guidelines
p.000063:
p.000063: General
p.000063: Drugs, Biologics,
p.000063: and Devices
p.000063: http://oss-sper-clin.agenziafarmaco.it/
p.000063: Drugs
p.000063: 1. National Monitoring Center for Clinical Trials: http://www.agenziafarmaco.com/en/conte
p.000063: nt/national-monitoring-centre-clinical- trials
p.000063: 2. Italian Medicines Agency:
p.000063: http://www.agenziafarmaco.it/
p.000063: 3. Ministry of Health (MOH):
p.000063: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: 1. Decree of the President of the Republic: Regulations to Simplify the Procedures and to Verify and Check New Systems
p.000063: and Experimental Therapeutic Protocols (September 21, 2001) (Italian)
p.000063: 2. Legislative Decree No. 211: Transposition of Directive 2001/20/EC Relating to the Implementation of Good Clinical
p.000063: Practice in the Conduct of Clinical Trials on Medicinal Products for Clinical Use (2003)
p.000063: 3. Legislative Decree No. 200: Transposition of Directive 2005/28 EC Laying down Principles and Detailed Guidelines as
p.000063: Regards Investigational Medical Products for Human Use, as Well as the Requirements for Authorizing of Manufacturing or
p.000063: Importing of such Products (2007) (Italian): http://www.aifa.gov.it/allegati/dlgs_ 200-6nov2007.pdf
p.000063:
p.000063:
p.000063: 1. Ministerial Decree of 21 December 2007: Directions for Submitting the Request for Authorisation of a Clinical Trial
p.000063: on a Medicinal Product for Human Use to the Competent Authority, for Communicating Substantial Amendments, for
p.000063: Declaring the End of the Trial and for the Request of an Opinion to the Ethics Committee
p.000063: 2. Ministerial Decree of 31 March 2008: Definition of the Minimum Requirements that Contract Research Organisations
p.000063: (CROs) Shall Satisfy in Order to Work within Clinical Trials on Medicinal Products
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: Research Injury
p.000063:
p.000063:
p.000063:
p.000063: Privacy/Data Protection
p.000063: Devices
p.000063: Ministry of Health, Directorate General for Medicines and Medical Devices: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: Ministry of Labour and Social Policy:
p.000063: www.lavoro.gov.it
p.000063:
p.000063:
p.000063:
p.000063: Italian Data Protection Independent Authority: http://www.garanteprivacy.it/garante/navi
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000063:
p.000064: 64
p.000064:
p.000064: Ministerial Decree 2 of August 2005: Procedures for the Presentation of Documentation to Notify about Clinical
p.000064: Investigations with Medical Devices
p.000064: Ministerial Decree 14 of July 2009: Minimum Requirements for Insurance Policies Which Safeguard Participants to
p.000064: Clinical Trials of Medicinal Products
p.000064: 1. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical
p.000064:
p.000064: Administrative Procedures Concerning the Conduction of Clinical Investigations with CE-Marked Medical Devices (2007)
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: General Principles of Processing Personal Data (2018):
p.000064: https://www.garanteprivacy.it/home/doveri#2
p.000064:
p.000064: Country Key Organizations Legislation
p.000064: Regulations Guidelines
p.000064:
p.000064: Privacy/Data Protection
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Genetic Research
p.000064: g/jsp/index.jsp?solotesto=N
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: 1. Instituto Superiore di Sanita (ISS):
p.000064: http://www.iss.it/chis/?lang=2
p.000064: 2. Italian Society of Human Genetics (SIGU): http://www.sigu.net/
...
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Regulation on Criteria Relating to Space, Personnel and Equipment for Collection, Transplantation and Exchange of
p.000075: Organs and Tissues, the Necessary Space, Equipment and Staff Required to be Provided by the Health Institution for the
p.000075: Collection, Transfer, Exchange and Storage of Organs and Tissues from Human Body for Treatment Purposes (2012):
p.000075: http://zdravstvo.gov.mk/wp- content/uploads/2012/12/za_pobliskite_kriteriu mi_vo_odnos_na_prostorot_kadarot_i_opremat
p.000075: a_za_zemawe_presaduvawe_i_razmenuvawe_ na_organite_i_tkivata_za_potrebniot_pr.pdf
p.000075:
p.000075: Country Key Organizations Legislation
p.000075: Regulations Guidelines
p.000075: 7C57131D996
p.000075:
p.000075: Genetic Research
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Embryos, Stem Cells, and Cloning
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Malta
p.000075: General
p.000075:
p.000075:
p.000075:
p.000075: Drugs, Biologics, and Devices
p.000075: Ministry of Health of the Republic of Macedonia:
p.000075: http://moh.gov.mk/
p.000075:
p.000075:
p.000075:
p.000075: Ministry of Health of the Republic of Macedonia:
p.000075: http://moh.gov.mk/
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Bioethics Committee: http://health.gov.mt/en/regcounc/Bioethic s- Committee/Pages/CommitteeMembers.as px
p.000075: Drugs
p.000075: Medicines Authority:
p.000075: http://medicinesauthority.gov.mt/
p.000075: Law on Patient Rights Protections, Article 21: Action on Human Genome (2012): http://zdravstvo.gov.mk/wp-
p.000075: content/uploads/2012/12/zakon-za- zastita-na-pravata-na-pacientite- precisten.pdf
p.000075: Law on Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to
p.000075: the Application of Biology and Medicine, With Additional Protocol on the Prohibition of Cloning Human Beings and
p.000075: Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2009):
p.000075: http://www.pravo.org.mk/document Detail.php?id=5543
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: 1. Medicines Act, 2003: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8924&l=1
p.000075: 2. Subsidiary Legislation, 458.43, Clinical Trials Regulations, 2004: http://justiceservices.gov.mt/Downl
p.000075: oadDocument.aspx?app=lom&itemi d=11281&l=1
p.000075: 3. Subsidiary Legislation, 458.47, Good Clinical Practice and Requirements for Manufacturing or Import Authorisation of
p.000075: Investigational Medicinal Products (Human
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Various: http://health.gov.mt/en/regcounc/Bioethics- Committee/Pages/Opinions.aspx
p.000075:
p.000075:
p.000075:
p.000075: Guidance Notes on Good Clinical Practice (2010):
p.000075: http://medicinesauthority.gov.mt/clinicaltrials.h tm
p.000075:
p.000076: 76
p.000076:
p.000076: Country Key Organizations Legislation
p.000076: Regulations Guidelines
p.000076:
p.000076: Drugs, Biologics, and Devices
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Privacy/Data Protection
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Moldova
p.000076:
p.000076:
p.000076:
p.000076: Devices
p.000076: 1. Medicines Authority:
p.000076: http://medicinesauthority.gov.mt/
p.000076: 2. Malta Competition and Consumer Affairs Authority, Technical Regulations Division, Regulatory Affairs Directorate:
p.000076: http://www.mccaa.org.mt/en/regulatory- affairs-directorate
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Office of the Information and Data Protection Commissioner: http://idpc.gov.mt/index.aspx
p.000076: Use) Regulations, 2004: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=11285&l=1
p.000076:
p.000076: 1. Product Safety Act, 2001: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8893&l=1
p.000076: 2. Subsidiary Legislation, 427.16, In Vitro Diagnostic Medical Devices Regulations, 2003
p.000076: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10756&l=1
p.000076: 3. Subsidiary Legislation, 427.44, Medical Devices Regulations, 2010: http://justiceservices.gov.mt/Downl
p.000076: oadDocument.aspx?app=lom&itemi d=10781&l=1
p.000076: 4. Subsidiary Legislation, 427.10, Active Implantable Medical Devices Regulations, 2010:
p.000076: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10753&l=1
p.000076: 1. Data Protection Act, 2002: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8906&l=1
p.000076: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000076: For an overview of human subject protections in Moldova, see “Ethical Review of Biomedical Research in the CIS
p.000076: Countries,” Chapter 3, Section 7:
p.000076: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000076: Note: All websites and documents are in Moldovian.
p.000076:
...
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Various: http://www.ccmo.nl/en/publications-of-the- ccmo
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: CCMO:
p.000081: Clinical Research with Medicinal Products in the Netherlands: Instructional Manual (2005):
p.000081: http://www.vumc.nl/afdelingen- themas/1646433/7876770/7876776/7955410/C
p.000081: linical_research_with_medi1.pdf
p.000081:
p.000081: Country Key Organizations Legislation
p.000081: Regulations Guidelines
p.000081:
p.000081: Clinical Trials Registry
p.000081: Research Injury
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Social-Behavioral Research
p.000081:
p.000081: Privacy/Data Protection
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Human Biological Materials
p.000081:
p.000081:
p.000081: Genetic Research
p.000081: (Dutch): https://www.toetsingonline.nl/to/ccmo_se arch.nsf/Searchform?OpenForm Ministry of Health, Welfare and Sport:
p.000081: http://www.government.nl/ministries/vws #ref-minvws
p.000081:
p.000081:
p.000081: National Ethics Council for Social and Behavioural Sciences: http://www.nethics.nl/
p.000081: 1. Dutch Data Protection Authority:
p.000081: https://cbpweb.nl/en
p.000081: 2. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000081: 3. Federation of Biomedical Scientific Societies (FMWV): http://www.federa.org/
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Federation of Biomedical Scientific Societies (FMWV): http://www.federa.org/
p.000081:
p.000081:
p.000081: 1. Ministry of Infrastructure and the Environment (IenM): http://www.government.nl/ministries/ien m
p.000081: 2. Dutch Health Care Inspectorate (IGZ): http://www.igz.nl/english/
p.000081: 3. Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000081:
p.000081:
p.000081: Medical Research Involving Human Subjects Act, Article 7 (2006):
p.000081: http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7- 2013-afkomstig-van-vws.pdf
p.000081:
p.000081:
p.000081:
p.000081: 1. Personal Data Protection Act (2004): http://wetten.overheid.nl/BWBR001 1468
p.000081: 2. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081: Civil Code, Article 467 (1994): http://www.ccmo.nl/attachments/file s/wgbo-pdf.pdf
p.000081:
p.000081:
p.000081: Medical Research Involving Human Subjects Act (2006): http://www.ccmo.nl/attachments/file s/wmo-engelse-vertaling-29-7-
p.000081: 2013-afkomstig-van-vws.pdf
p.000081:
p.000081:
p.000081:
p.000081: Regulation on Mandatory Insurance Regarding Medical Research Involving Human Subjects (2003):
p.000081: https://zoek.officielebekendmakingen
p.000081: .nl/stb-2014-477.html
p.000081:
p.000081:
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p.000084:
p.000084:
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p.000084:
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p.000084:
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p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: NESH:
p.000084: 1. Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2016):
p.000084: https://www.etikkom.no/en/ethical- guidelines-for-research/guidelines-for-
p.000084:
p.000084: Country Key Organizations Legislation
p.000084: Regulations Guidelines
p.000084:
p.000084: Social- Behavioral Research
p.000084: https://www.etikkom.no/en/our- work/about-us/the-national-committee- for-research-ethics-on-human-remains/
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /1978-06-09-50
p.000084: research-ethics-in-the-social-sciences-- humanities-law-and-theology/
p.000084: 2. Guide to Internet Research Ethics (2018):
p.000084: https://www.etikkom.no/en/ethical-guidelines- for-research/ethical-guidelines-for-internet- research/
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Privacy/Data Protection
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Human Biological Materials
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Genetic Research
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: Norwegian Data Protection Authority: https://www.datatilsynet.no/en/
p.000084:
p.000084:
p.000084:
p.000084: 1. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000084: work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/
p.000084: 2. Regional Committees for Medical Research Ethics (REK): https://rekportalen.no/#home/REK
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: 1. Norwegian Directorate of Health: https://www.helsedirektoratet.no/tema/gen teknologi
p.000084: 2. Norwegian Biotechnology Advisory Board: http://www.bion.no/english/
p.000084: 3. National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000084: work/about-us/the-national-committee- for-medical-and-health-research-ethics-
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000084: 2. Personal Data Act (2018):
p.000084: https://lovdata.no/dokument/NL/lov
p.000084: /2018-06-15-
p.000084: 38?q=personopplysningsloven
p.000084: 1. Act Relating to the Application of Biotechnology in Human Medicine, etc. (Biotechnology Act) (December 5, 2003, No.
p.000084: 100): https://lovdata.no/dokument/NL/lov
p.000084: /2003-12-05-
p.000084: 100?q=humanmedisinsk%20bruk
p.000084: 2. Act on Health Care Research (2008):
p.000084: http://www.lovdata.no/cgi- wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov
...
p.000088: Regulations Guidelines
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088: Genetic Research
p.000088:
p.000088: Embryos, Stem Cells, and Cloning
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Romania
p.000088: General
p.000088:
p.000088:
p.000088: Drugs, Biologics, and Devices
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Research Injury
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health: http://www.portugal.gov.pt/en/the- ministries/ministry-of-health.aspx National Council of Ethics
p.000088: for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088:
p.000088:
p.000088: 1. Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088: 2. National Agency for Medicines and Medical Devices: https://www.anm.ro/en/
p.000088: 3. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: 1. National Agency for Medicines and Medical Devices: http://www.anm.ro/anmdm/en/index.html
p.000088: 2. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/ National
p.000088: Supervisory Authority for Personal Data Processing:
p.000088: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law 12/2005
p.000088:
p.000088: 1. Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001)
p.000088: 2. Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000088: 164 (2001)
p.000088:
p.000088: 1. Law No. 667/2001 On the Protection of Individuals with
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
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p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Ordinance No. 57/16.08.2002 (2002):
p.000089: http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie
p.000089: MOH:
p.000089: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of
p.000089: Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
p.000089:
p.000089:
...
p.000098: 4. Royal Decree 577/2013 Regulating Pharmacovigilance in Human Use Medicines: http://www.boe.es/diario_boe/txt.ph
p.000098: p?id=BOE-A-2013-8191
p.000098: 5. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: http://noticias.juridicas.com/base_da
p.000098: tos/Admin/565124-rd-1090-2015-
p.000098:
p.000098: Country Key Organizations Legislation
p.000098: Regulations Guidelines
p.000098:
p.000098: Drugs, Biologics, and Devices
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Research Injury
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
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p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Privacy/Data Protection
p.000098:
p.000098:
p.000098: Devices
p.000098: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion
p.000098: Clinica/productosSanitarios/home.htm Spanish Agency of Medicines and Medical Devices:
p.000098: http://www.aemps.gob.es/en/home.htm
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
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p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: 1. Spanish Data Protection Authority: https://www.agpd.es/portalweb/index-ides- idphp.php
p.000098: 2. Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/en/investigacion
p.000098: Clinica/medicamentos/home.htm
p.000098:
p.000098:
p.000098:
p.000098:
p.000098: Royal Decree 1591/2009, Regulating Sanitary Devices: http://www.ont.es/infesp/Legislacin/ RD_1591_2009.pdf
p.000098: 1. Law 14/2007 on Biomedical Research, Article 18: http://www.catedraderechoygenoma humano.es/images/novedades/Spani
p.000098: shLawonBiomedicalResearchEnglis h.pdf
p.000098: 2. Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for
p.000098: Human Use, Repealing Directive 2001/20/EC: http://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL
p.000098: EX:32014R0536&from=EN
p.000098: 3. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: https://www.aemps.gob.es/legislaci
p.000098: on/espana/investigacionClinica/docs
p.000098: /Royal-Decree-1090-2015_4- December.pdf
p.000098: 1. Law 14/2007 on Biomedical Research, Title I, Article 5: http://www.catedraderechoygenoma
p.000098: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000098: 2. EU General Data Protection Regulation (2018): https://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL
p.000098: EX:32016R0679&from=EN
p.000098: 3. Organic Law 3/2018 of
p.000098:
p.000099: 99
p.000099: de-4-dic-regula-los-ensayos- clinicos-con-medicamentos-los- comites.html
p.000099:
p.000099: Various: http://www.aemps.es/actividad/psch b/implantables1.htm#circulares
p.000099:
p.000099:
p.000099:
p.000099:
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p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100: Sweden
p.000100: 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000100: 2. National Commission for the Donation and Use of Embryos, Cells, and Human Tissues for Biomedical Research:
p.000100: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml
p.000100: 3. National Biobank Register: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/organizacion.shtml
p.000100: 4. National Stem Cell Bank: http://www.isciii.es/ISCIII/es/contenidos/f d-el-instituto/fd-organizacion/fd-
p.000100: estructura-directiva/fd-subdireccion- general-investigacion-terapia-celular- medicina-regenerativa/fd-centros-
p.000100: unidades/banco-nacional-lineas- celulares.shtml
p.000100: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000100: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2000)
p.000100: 2. Law 14/2006 on Methods of Assisted Human Reproduction, Chapters IV and V
p.000100: 3. Law 14/2007 of July 3 on Biomedical Research, Title III: http://www.catedraderechoygenoma
p.000100: humano.es/images/novedades/Spani shLawonBiomedicalResearchEnglis h.pdf
p.000100: Royal Decree 1527/2010 By Which the Guarantees Commission for the Donation and Use of Human Cells and Tissues and
p.000100: Registration Research Projects is Regulated: http://www.boe.es/diario_boe/txt.ph p?id=BOE-A-2010-18654
p.000100: For an overview of human subject protections in Sweden, see CODEX: Rules and Guidelines for Research:
p.000100: http://www.codex.uu.se/en/index.shtml
p.000100:
p.000100: General
p.000100: 1. Swedish Ethical Review Authority: https://etikprovningsmyndigheten.se/
p.000100: 2. Ethics Review Appeal Board: https://www.onep.se/en/start/
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100: Swedish Research Council:
p.000100: http://www.vr.se/english
p.000100: Act No. 460 on the Ethical Review of Research Involving Humans (2003): https://www.riksdagen.se/sv/dokum
p.000100: ent-lagar/dokument/svensk- forfattningssamling/lag-2003460- om-etikprovning-av-forskning- som_sfs-2003-460
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
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p.000100:
p.000100:
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p.000100:
p.000101: 101
p.000101: 1. Ordinance No. 615 Concerning the Ethical Vetting of Research Involving Humans (2003):
p.000101: https://www.riksdagen.se/sv/dokume nt-lagar/dokument/svensk- forfattningssamling/forordning-
p.000101: 2003615-om-etikprovning-av_sfs- 2003-615
p.000101: 2. Statute with Instructions for the Swedish Ethical Review Authority (2018:1879) https://svenskforfattningssamling.se/
p.000101: sites/default/files/sfs/2018- 11/SFS2018-1879.pdf
p.000101: 3. Statute with Instructions for the Ethics Review Appeals Board (2007:1068) http://rkrattsbaser.gov.se/sfst?bet=20
p.000101: 07:1068
p.000101:
p.000101:
p.000101:
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p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101:
p.000101: Good Research Practice (2017): https://www.vr.se/english/analysis-and- assignments/we-analyse-and-evaluate/all-
p.000101: publications/publications/2017-08-31-good- research-practice.html
p.000101:
p.000101: Country Key Organizations Legislation
p.000101: Regulations Guidelines
p.000101:
p.000101: Drugs, Biologics, and Devices
p.000101: Drugs
p.000101: Medical Products Agency:
p.000101: https://lakemedelsverket.se/english/
p.000101:
p.000101:
p.000101:
p.000101: Devices
p.000101: Medical Products Agency: http://www.lakemedelsverket.se/english/pr oduct/Medical-devices/Clinical- Investigations/
p.000101:
p.000101: 1. Pharmaceuticals Act No. No 2015:315: https://open.karnovgroup.se/halso- och-sjukvard/lakemedelslagen
p.000101:
p.000101:
p.000101: 1. Swedish Medical Devices Act (SFS 1993:584): http://www.notisum.se/rnp/sls/lag/1 9930584.htm
p.000101: 2. Medical Devices Ordinance (SFS1993:876): http://www.riksdagen.se/sv/dokume nt-lagar/dokument/svensk-
p.000101: forfattningssamling/forordning- 1993876-om-medicintekniska_sfs- 1993-876
p.000101:
p.000101: MPA Regulations on Clinical Trials in Humans -- LVFS 2011:19:
p.000101: http://www.lakemedelsverket.se/upl oad/lvfs/LVFS_2011_19.pdf
p.000101:
p.000101: Swedish Implementation of Directive 93/42/EEC -- LVFS 2003:11:
...
p.000107: klinichnikh-viprobuvan
p.000107:
p.000108: 108
p.000108:
p.000108: Country Key Organizations Legislation
p.000108: Regulations Guidelines
p.000108:
p.000108: Embryos, Stem Cells, and Cloning
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: United Kingdom
p.000108: 1. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index- en/bioethics-committee
p.000108: 2. Ukrainian Ministry of Health:
p.000108: http://www.moz.gov.ua/en/
p.000108: 1. Act on the Banning
p.000108: of Human Reproductive Clonin g (2004):
p.000108: http://zakon0.rada.gov.ua/laws/sho w/2231-15
p.000108: 2. Act on the Transplantation on Human Using Anatomic Materials (2019): http://zakon.rada.gov.ua/laws/show/ 2427-19
p.000108: 1. Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of
p.000108: Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007):
p.000108: http://zakon1.rada.gov.ua/laws/show
p.000108: /z1206-07
p.000108: 2. Ukrainian Ministry of Health Order No. 787 on Approval of the Use of Reproductive Technologies in Ukraine
p.000108: 09.09.2013: http://zakon4.rada.gov.ua/laws/show
p.000108: /z1697-13
p.000108: Unless otherwise noted, all laws, regulations, and guidelines listed for England also apply to the entire United
p.000108: Kingdom.
p.000108: For an overview of clinical research regulations in the United Kingdom, see the ClinRegs report:
p.000108: http://clinregs.niaid.nih.gov/single_country.php?c_id=226
p.000108: General England:
p.000108:
p.000108: Health Research Authority (HRA):
p.000108: http://www.hra.nhs.uk/
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: Department of Health and Social Care (DHSC):
p.000108: https://www.gov.uk/government/organisati ons/department-of-health-and-social-care
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
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p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: 1. Mental Capacity Act (2005) (England and Wales only): http://www.legislation.gov.uk/ukpg a/2005/9/contents
p.000108: 2. Health and Social Care Act (2012): http://www.legislation.gov.uk/ukpg a/2012/7/contents/enacted
p.000109: 109
p.000109: 1. Research Governance Framework for Health and Social Care UK Policy Framework for Health and Social Care Research
p.000109: (2018): https://www.hra.nhs.uk/planning- and-improving-research/policies- standards-legislation/uk-policy-
p.000109: framework-health-social-care- research/
p.000109: 2. Governance Arrangements for Research Ethics Committees (2018): https://www.hra.nhs.uk/planning-
p.000109: and-improving-research/policies- standards-legislation/governance- arrangement-research-ethics- committees/
p.000109: 1. HRA Guidance: https://www.hra.nhs.uk/planning-and- improving-research/
p.000109: 2. Integrated Research Application System: https://www.myresearchproject.org.uk/
p.000109:
p.000109: Country Key Organizations Legislation
p.000109: Regulations Guidelines
p.000109:
p.000109: General
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
p.000109:
...
p.000110: Act 2000 to Facilitate Clinical Research in Emergency Settings (SI 2006/2984): http://www.legislation.gov.uk/uksi/2
p.000110: 006/2984/pdfs/uksi_20062984_en.pd f
p.000110: 4. SI 2008 No.941 The
p.000110: Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment Regulations 2008:
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p.000110: 5. Genetically Modified Organisms (Deliberate Release) Regulations 2002: http://www.legislation.gov.uk/uksi/2
p.000110: 002/2443/contents/made
p.000110: 6. Genetically Modified Organisms (Contained Use) Regulations 2014 (England, Scotland and Wales):
p.000110: http://www.legislation.gov.uk/uksi/2 014/1663/part/1/made
p.000110: 7. Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015:
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p.000111:
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p.000111: http://www.nihr.ac.uk/
p.000111: Health Research Authority (HRA):
p.000111: http://www.hra.nhs.uk/
p.000111:
p.000111:
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p.000111:
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p.000111: 2. Health Research Authority (HRA):
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p.000111:
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p.000112: Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument No. 1031, Regulation 15(5)(i)(j)(k) and
p.000112: Schedule 3 Part 1, Paragraphs 1(g) and 3(c) (2004):
p.000112: http://www.legislation.gov.uk/uksi/2 004/1031/contents/made
p.000112: Guidelines for Phase I Clinical Trials (2012):
p.000112: http://www.abpi.org.uk/our- work/library/guidelines/Pages/phase-1-trials- 2012.aspx
p.000112: Clinical Trials Toolkit:
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...
p.000112:
p.000112: Medical Devices Guidance: http://www.hra.nhs.uk/resources/before-you- apply/types-of-study/medical-devices-research- 2/
p.000112: ISRCTN:
p.000112: FAQs: http://www.isrctn.com/page/faqs
p.000112:
p.000112: HRA:
p.000112: Transparency: Researchers’ Responsibilities: https://www.hra.nhs.uk/planning-and-
p.000112: improving-research/research-planning/research- registration-and-research-project-identifiers/
p.000112:
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p.000112:
p.000112: NHS Indemnity Arrangements for Clinical Negligence Claims in the NHS:
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p.000112:
p.000112: Country Key Organizations Legislation
p.000112: Regulations Guidelines
p.000112:
p.000112: Research Injury
p.000112:
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p.000112: Social-Behavioral Research
p.000112:
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p.000112:
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p.000112:
p.000112: Privacy/Data Protection
p.000112:
p.000112: Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112:
p.000112: Association of the British Healthcare Industry (ABHI): http://www.abhi.org.uk/
p.000112:
p.000112:
p.000112: Economic and Social Research Council
p.000112:
p.000112:
p.000112: UK Research Integrity Office
p.000112:
p.000112:
p.000112:
p.000112: United Kingdom:
p.000112: Information Commissioner’s Office:
p.000112: https://ico.org.uk/
p.000112:
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p.000112: Health Research Authority:
p.000112: https://www.hra.nhs.uk
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p.000113: 2. Clinical Trial Compensation Guidelines (2014):
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p.000113: Clinical Investigations Compensation Guidelines (2014): http://www.abhi.org.uk/multimedia/groups/clini cal-
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p.000113: Country Key Organizations Legislation
p.000113: Regulations Guidelines
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p.000113: Privacy/Data Protection
p.000113:
p.000113:
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p.000113:
p.000113:
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p.000113:
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p.000113: Human Biological Materials
p.000113: Medical Research Council (MRC):
p.000113: http://www.mrc.ac.uk/
p.000113:
p.000113:
p.000113:
p.000113: England and Wales:
p.000113: 1. Health Research Authority (HRA) (England): http://www.hra.nhs.uk/
p.000113: 2. Confidentiality Advisory Group (CAG):
p.000113: http://www.hra.nhs.uk/about-the-hra/our- committees/section-251
p.000113:
p.000113: United Kingdom:
p.000113: Human Tissue Authority (HTA):
p.000113: http://www.hta.gov.uk/
p.000113:
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p.000113:
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p.000113: (Applies to England, Wales, and Northern Ireland. Section 45 also applies in Scotland.)
p.000113: 2. Statutory Instrument 2006 No. 1260: The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and
p.000113: Supply of Information about Transplants) Regulations 2006: http://www.legislation.gov.uk/uksi/ 2006/1260/contents/made
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p.000113: 3. Statutory Instrument 2006 No. 1659: The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants)
p.000113: Regulations 2006 (Different provisions apply to England, Wales, Northern Ireland, and/or Scotland.):
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p.000114: Regulations Guidelines
p.000114:
p.000114: Human Biological Materials
p.000114:
p.000114:
p.000114: Genetics Research
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Embryos, Stem Cells, and Cloning
p.000114: Scotland:
p.000114: Healthcare Improvement Scotland: http://www.healthcareimprovementscotlan d.org/our_work/governance_and_assuranc
p.000114: e/human_tissue_banks.aspx
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p.000114: 2. Gene Therapy Advisory Committee: http://www.hra.nhs.uk/resources/applying- to-recs/gene-therapy-advisory-committee-
p.000114: gtac/
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p.000114: 2. Human Tissue Authority (HTA):
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p.000114:
p.000114: Human Tissue (Scotland) Act 2006:
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p.000137: HDC:
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p.000137: http://www.hdc.org.nz/the-act-- code/the-code-of-rights
p.000137: Committees (IRCs) for Health Research in Nepal (2016):
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p.000137: National Guidelines on Clinical Trials with the Use of Pharmaceutical Products (2005): http://nhrc.org.np/guidelines
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p.000137: 1. Guidelines for Researchers on Health Research Involving Māori (2010)
p.000137: 2. Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members (2010)
p.000137: 3. HRC Research Ethics Guidelines (2017)
p.000137: 4. Pacific Health Research Guidelines (2014)
p.000137:
p.000137: Access: http://www.hrc.govt.nz/ethics-and- regulatory/applying-ethical-approval
p.000137:
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p.000137: 1. Goals, Objectives, and Desired Outcomes of an Ethical Review System (2003)
p.000137: 2. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012)
p.000137: 3. Ethical Guidelines for Intervention Studies (2012)
p.000137: Access: http://www.neac.health.govt.nz/moh.nsf/indexc m/neac-resources-publications
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p.000137:
p.000137: Drugs, Biologics, and Devices
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p.000137:
p.000137:
p.000137: Drugs
p.000137: 1. New Zealand Medicines and Medical Devices Safety Authority
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p.000137: 1. Accident Compensation Act 2001, Section 32 (2010)
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p.000138: MOH:
p.000138: Standard Operating Procedures for Health and Disability Ethics Committees (2012):
p.000138: http://www.ethics.health.govt.nz/operating- procedures
p.000138:
p.000138: Medsafe:
p.000138: Good Clinical Research Practice and
p.000138:
p.000138: Country Key Organizations Legislation
p.000138: Regulations Guidelines
p.000138:
p.000138: Drugs, Biologics, and Devices
p.000138:
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p.000138:
p.000138: Clinical Trials Registry
p.000138:
p.000138: Privacy/Data Protection
p.000138:
p.000138:
p.000138:
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p.000138: (Medsafe): http://www.medsafe.govt.nz
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p.000138: 3. Health Research Council (HRC), Standing Committee on Therapeutic Trials: http://www.hrc.govt.nz/about-
p.000138: us/committees/standing-committee- therapeutic-trials-scott
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p.000138: Devices
p.000138: New Zealand Medicines and Medical Devices Safety Authority (Medsafe): http://www.medsafe.govt.nz
p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Australian New Zealand Clinical Trials Registry: http://www.anzctr.org.au/
p.000138: Privacy Commissioner:
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p.000138:
p.000138:
p.000138:
p.000138: 1. Ministry of Health (MOH):
p.000138: http://www.moh.govt.nz/
p.000138: 2. Health Research Council (HRC) Ethics Committee: http://www.hrc.govt.nz/ethics-and-
p.000138: regulatory/applying-ethical-approval
p.000138: 3. Te Puni Kokiri (TPK):
p.000138: http://www.tpk.govt.nz/
p.000138: 4. Office of the Health and Disability Commissioner (HDC): http://www.hdc.org.nz
p.000138: 5. Ministry of Business, Innovation and Employment: http://www.mbie.govt.nz/
p.000138: 2. Medicines Act 1981(2012)
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p.000138: 2. Public Records Act (2005)
p.000138: 3. Privacy Act 1993 (2012)
p.000138:
p.000138: 1. Health Act 1956 (2012)
p.000138: 2. Human Tissue Act 2008
p.000138: ion/public/1984/0143/latest/DLM956 68.html
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p.000138:
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p.000138:
p.000138:
p.000138:
p.000138:
p.000138: Health Information Privacy Code 1994:
...
p.000138: https://ethics.health.govt.nz/system/files/docum ents/pages/2015-medicines-new-zealand- compensation-guidelines.pdf
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p.000138: 2. Various: http://medsafe.govt.nz/regulatory/DevicesNew/ 13ConductingClinicalTrials.asp
p.000138: FAQs: http://www.anzctr.org.au/Faq.aspx
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p.000138:
p.000138:
p.000138: MOH:
p.000138: Guidelines for the Use of Human Tissue for Future Unspecified Research Purposes (2007):
p.000138: http://www.health.govt.nz/publication/guidelin es-use-human-tissue-future-unspecified- research-purposes
p.000138:
p.000139: 139
p.000139:
p.000139: Country Key Organizations Legislation
p.000139: Regulations Guidelines
p.000139:
p.000139: Genetic Research
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: Embryos, Stem Cells, and Cloning
p.000139:
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p.000139: Pakistan
p.000139: General
p.000139:
p.000139: Drugs, Biologics, and Devices
p.000139:
p.000139: Human Biological Materials
p.000139: 1. Environmental Protection Authority: http://www.epa.govt.nz/
p.000139: 2. Health Research Council (HRC), Gene Technology Advisory Committee: http://www.hrc.govt.nz/about-
p.000139: us/committees/gene-technology-advisory- committee-gtac
p.000139: 1. Advisory Committee on Assisted Reproductive Technology (ACART): http://acart.health.govt.nz/
p.000139: 2. Ethics Committee on Assisted Reproductive Technology (ECART): http://ecart.health.govt.nz/
p.000139: 3. Ministry of Health:
p.000139: http://www.moh.govt.nz/
p.000139:
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p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139:
p.000139:
p.000139: National Bioethics Committee:
p.000139: http://nbcpakistan.org.pk/
p.000139: Hazardous Substances and New Organisms Act 1996 (2012)
p.000139:
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p.000139: Human Assisted Reproductive Technology Act 2004 (2009)
p.000139:
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p.000140:
p.000140: Human Assisted Reproductive Technology (HART) Order (2005):
p.000140: http://www.legislation.govt.nz/regulat ion/public/2005/0181/latest/DLM335 192.html
p.000140:
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p.000143:
p.000143: Human Biomedical Research Act 2015:
p.000143: https://sso.agc.gov.sg/Act/HBRA20 15
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: Data Privacy Act Implementing Rules and Regulations (2016): https://privacy.gov.ph/implementing-
p.000143: rules-and-regulations-of-republic-act- no-10173-known-as-the-data-privacy- act-of-2012/
p.000143:
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p.000143:
p.000143: MOH:
p.000143: Human Biomedical Research Regulations 2017: https://sso.agc.gov.sg/SL/HBRA2015
p.000143: -S621-2017
p.000143: National Ethical Guidelines for Health and Health-Related Research, Pages 108-118. (2017):
p.000143: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4-neg
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: National Ethical Guidelines for Health and Health-Related Research, Pages 91, 157
p.000143: and 163 (2017):
p.000143: http://www.ethics.healthresearch.ph/index.php/ phoca-downloads/category/4- neg?download=96:2017-national-ethical-
p.000143: guidelines-for-health-and-health-related- research
p.000143:
p.000143: MOH:
p.000143: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and-
p.000143: legislation/human-biomedical-research-act
p.000143:
p.000143:
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p.000143:
p.000143:
p.000143: Drugs, Biologics, and Devices
p.000143:
p.000143:
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p.000143:
p.000143:
p.000143: Drugs
p.000143: Health Sciences Authority of Singapore (HSA): http://www.hsa.gov.sg
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: 1. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007
p.000143: 2. Medicines Act (Cap 176):
p.000143: https://sso.agc.gov.sg/Act/MA1975
p.000143:
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p.000144:
p.000144:
p.000144: 1. Health Products (Clinical Trials) Regulations 2016: https://sso.agc.gov.sg/SL/HPA2007- S331-2016
p.000144: 2. Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016:
p.000144: https://sso.agc.gov.sg/SL/HPA2007- S332-2016
p.000144: 3. Medicines (Clinical Trials) Regulations 2016:
p.000144: BAC:
p.000144: Ethics Guidelines for Human Biomedical Research (2015): http://www.bioethics-
p.000144: singapore.org/index/publications/reports/86- reports/ethics-guidelines-for-human- biomedical-research.html
p.000144:
p.000144: HSA:
p.000144: Singapore Guideline for Good Clinical Practice (2016): http://www.ich.org/fileadmin/Public_Web_Site
p.000144: /ICH_Products/Guidelines/Efficacy/E6/E6_R2 Step_4_2016_1109.pdf
p.000144:
p.000144: Country Key Organizations Legislation
p.000144: Regulations Guidelines
p.000144:
p.000144: Drugs, Biologics, and Devices
p.000144:
p.000144:
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p.000144: Research Injury
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p.000144:
p.000144: Privacy/Data Protection
p.000144:
p.000144:
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p.000144:
p.000144:
p.000144:
p.000144: Human Biological Materials
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Devices
p.000144: 1. Health Sciences Authority (HSA):
p.000144: http://www.hsa.gov.sg
p.000144: 2. National Environment Agency (NEA), Centre For Radiation Protection And Nuclear Science:
p.000144: http://www.nea.gov.sg/anti-pollution- radiation-protection/radiation-protection
p.000144:
p.000144: 1. Ministry of Health (MOH):
p.000144: http://www.moh.gov.sg/
p.000144: 2. Health Sciences Authority:
p.000144: http://www.hsa.gov.sg
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Personal Data Protection Commission (PDPC): https://www.pdpc.gov.sg
p.000144: 2. Bioethics Advisory Committee
p.000144: (BAC): https://www.bioethics- singapore.org
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Ministry of Health (MOH):
p.000144: http://www.moh.gov.sg/
p.000144: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007
p.000144: 2. Radiation Protection Act (2007): https://sso.agc.gov.sg/Act/RPA2007
p.000144:
p.000144:
p.000144: 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15
p.000144: 2. Health Products Act (Cap 122D): https://sso.agc.gov.sg/Act/HPA2007
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: Personal Data Protection Act (2012):
p.000144: https://sso.agc.gov.sg/Act/PDPA20 12
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144:
p.000144: 1. Medical (Therapy, Education, and Research) Act (1973): https://sso.agc.gov.sg/Act/MTERA1
p.000972: 972
p.000972: 2. Human Biomedical Research
p.000145: 145
p.000145: https://sso.agc.gov.sg/SL/MA1975- S335-2016
p.000145: 4. Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016: https://sso.agc.gov.sg/SL/MA1975-
p.000145: S336-2016
p.000145:
p.000145: 1. Health Products (Medical Device) Regulations (2010): http://sso.gov.sg/SL/HPA2007-S436- 2010
...
p.000145: Sector Specific Guidelines Promulgated by PDPC:
p.000145: https://www.pdpc.gov.sg/Legislation-and- Guidelines/Guidelines
p.000145:
p.000145: BAC:
p.000145: Personal Information in Biomedical Research (2007): http://www.bioethics- singapore.org/index/publications/reports/170-
p.000145: personal-information-in-biomedical- research.html
p.000145: MOH:
p.000145: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and-
p.000145: legislation/human-biomedical-research-act
p.000145:
p.000145: Country Key Organizations Legislation
p.000145: Regulations Guidelines
p.000145:
p.000145: Human Biological Materials
p.000145:
p.000145:
p.000145:
p.000145: Genetic Research
p.000145:
p.000145:
p.000145:
p.000145: Embryos, Stem Cells, and Cloning
p.000145:
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p.000145: Sri Lanka
p.000145: Drugs and Devices
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Clinical Trials Registry
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org
p.000145:
p.000145:
p.000145: 1. Ministry of Health (MOH):
p.000145: http://www.moh.gov.sg/
p.000145: 2. Bioethics Advisory Committee (BAC): http://www.bioethics- singapore.org/
p.000145:
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p.000145:
p.000145:
p.000145: Cosmetics, Devices, and Drugs Regulatory Authority, Subcommittee on Clinical Trials:
p.000145: http://www.cdda.gov.lk/index.php?option
p.000145: =com_content&view=article&id=78&Ite mid=115&lang=en
p.000145: Sri Lanka Clinical Trials Registry:
p.000145: http://www.slctr.lk/
p.000145: Bill No. 25/2015, Part 6: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: 1. Human Biomedical Research Act 2015: https://sso.agc.gov.sg/Act/HBRA20 15
p.000145: 2. Human Cloning and Other Prohibited Practices Act (Cap 131B): https://sso.agc.gov.sg/Act/HCOPPA 2004
p.000145:
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p.000145:
p.000145: National Medicines Regulatory Authority Act of 2015: http://www.cdda.gov.lk/images/stori
p.000145: es/new/pdf/legislations/5e_nmdra.p df
p.000145: 9f66af6f7820;rec=0
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p.000145:
p.000145:
p.000145: Human Biomedical Research (Restricted Research) Regulations 2017:
p.000145: https://sso.agc.gov.sg/SL/HBRA2015
p.000145: -S622-2017
p.000145:
p.000145: BAC:
p.000145: Human Tissue Research (2002): http://www.bioethics- singapore.org/index/publications/reports/173-
p.000145: human-tissue-research.html
p.000145: BAC:
p.000145: Genetic Testing and Genetic Research (2005): http://www.bioethics- singapore.org/index/publications/reports/171-
p.000145: genetic-testing-and-genetic-research.html
p.000145: MOH:
p.000145: Resources on Human Biomedical Research Act: https://www.moh.gov.sg/policies-and-
p.000145: legislation/human-biomedical-research-act
p.000145:
p.000145: BAC:
p.000145: 1. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (2002):
p.000145: http://www.bioethics- singapore.org/index/publications/reports/86- reports/174-stem-cell-research.html
p.000145: 2. Donation of Human Eggs for Research (2008): http://www.bioethics- singapore.org/index/publications/reports/86-
p.000145: reports/168-donation-of-human-eggs-for- research.html
p.000145: 3. Human-Animal Combinations in Stem- Cell Research (2010): http://www.bioethics-
p.000145: singapore.org/index/publications/reports/86- reports/167-human-animal-combinations-in- stem-cell-research.html
p.000145:
p.000145: Guidelines for the Conduct of Clinical Trials in Sri Lanka (2014): http://www.cdda.gov.lk/images/pdf/clinical%2
p.000145: 0trials%20guidelines_oct2014.pdf
p.000145:
p.000145:
p.000145: FAQs: http://slctr.lk/faq
p.000145:
p.000145:
p.000146: 146
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p.000150: Health, Period 2018-2023: http://crc.pasteurhcm.gov.vn/upload/files/1122
p.000150: _2018.pdf
p.000150: Guidelines for Clinical Trials of Drugs, Chapter III, Articles 10, 16, and 17
p.000150: (2012):
p.000150: https://clinregs.niaid.nih.gov/documents/vietna m/C-ClinDrugTrial.pdf
p.000150: 2. Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Vietnamese): https://thuvienphapluat.vn/van-
p.000150: ban/The-thao-Y-te/Circular-29-2018-TT-BYT- clinical-trial-of-drugs-401541.aspx
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p.000151: Country Key Organizations Legislation
p.000151: Regulations Guidelines
p.000151:
p.000151: MIDDLE EAST/NORTH AFRICA
p.000151: Egypt
p.000151:
p.000151: General
p.000151:
p.000151:
p.000151: Drugs, Biologics, and Devices
p.000151:
p.000151: Iran
p.000151: General
p.000151:
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p.000151:
p.000151: Clinical Trials Registry Israel General
p.000151:
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p.000151: Drugs, Biologics, and Devices
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p.000151: Privacy/Data Protection
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p.000151:
p.000151: Genetic Research
p.000151: Medical Professionals Union
p.000151:
p.000151:
p.000151: Egyptian Drug Authority:
p.000151: http://www.eda.mohp.gov.eg/
p.000151:
p.000151:
p.000151: Ministry of Health and Medical Education, Office for the Study of Humanistic and Islamic Science in Medicine and
p.000151: Medical Ethics: http://www.mohme.gov.ir/
p.000151: Iranian Registry of Clinical Trials:
p.000151: http://www.irct.ir/
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151:
p.000151: Ministry of Health, Pharmaceutical Administration: http://www.health.gov.il/English/Ministry
p.000151: Units/HealthDivision/MedicalTechnologi es/Drugs/Pages/default.aspx
p.000151:
p.000151: Israeli Law, Information, and Technology Authority: http://www.justice.gov.il/MOJEng/ILITA/
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Ministry of Health:
p.000151: http://www.health.gov.il/english/
p.000151: Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dusto r-en001.pdf
p.000151:
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p.000151:
p.000151: Public Health Order (1940)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: 1. Privacy Protection Act No. 5741 (1981): http://www.justice.gov.il/NR/rdonly res/6A5EC09A-BDBC-419F-8007-
p.000151: 5FD6A6B8E0A5/18334/Protectiono fPrivacyLaw57411981unofficialtran slatio.pdf
p.000151: 2. Protection of Privacy Law No. 5741, as Amended by Law No. 5745 (1985)
p.000151: Genetic Information Law (2000):
p.000151: http://www.moital.gov.il/NR/exeres
p.000151: /66F4DD4E-FA4A-4B76-94BC- DC29543471DE.htm
p.000151: Professional Ethics Regulations: Conducting Medical Research on Human Beings, Articles 52-61 (2003)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Protection Code for Human Subjects in Medical Research (1999)
p.000151:
p.000151:
p.000151:
p.000151:
p.000151: Public Health Regulations (Medical Experiments Involving Human Subjects) (1999)
p.000151: 1. Public Health Regulations (Clinical Studies in Human Subjects) – 1980
p.000151: 2. 1990 Amendment
p.000151: 3. 1992 Amendment
p.000151: 4. 2005 Amendment
p.000151:
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p.000157:
p.000157: Country Key Organizations Legislation
p.000157: Regulations Guidelines
p.000157:
p.000157: Research Injury Human Biological Materials
p.000157:
p.000157:
p.000157:
p.000157: Genetic Research
p.000157:
p.000157:
p.000157: Embryos, Stem Cells, and Cloning
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: United Arab Emirates
p.000157: 164 (2004)
p.000157: 1. Law on Procurement, Preservation, Grafting, and Transplantation of Organs and Tissues, No. 2238 (1979)
p.000157: 2. Law on Blood and Blood Products, No. 2857 (1983)
p.000157:
p.000157: Regulation on Blood and Blood Products, No. 7314 (1983)
p.000157:
p.000157:
p.000157:
p.000157: Regulation on Centers for Diagnosis and Genetic Diseases, No. 23368 (1998)
p.000157: 1. Regulation on Centers for Medically Assisted Procreation, No. 19551 (1987)
p.000157: 2. Regulation on Organ and Tissue Transplantation Services (2005)
p.000157: 3. Regulation on Cordon Blood Banks (2005)
p.000157:
p.000157: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000157: 2. Good Clinical Practice Guidelines for Advanced Therapy Medicinal Products (2011)
p.000157: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999)
p.000157: 1. Circular on Research of Embryonic Stem Cells (2005)
p.000157: 2. Guideline on Clinical Research of Non- Embryonic Stem Cells (2006)
p.000157:
p.000157: General
p.000157: Health Authority - Abu Dhabi:
p.000157: http://www.haad.ae/haad/
p.000157: Standard Operating Procedures for Research Ethics Committees (2012): http://www.haad.ae/HAAD/LinkClick.aspx?fil
p.000157: eticket=UL7o8f5mukc%3D&tabid=820
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p.000158: Regulations Guidelines
p.000158:
p.000158: LATIN AMERICA and the CARIBBEAN
p.000158: Regionwide
p.000158: General Caribbean Public Health Agency: http://carpha.org/What-We-Do/Research-
p.000158: Training-and-Policy-Development
p.000158:
p.000158: Drugs, Biologics, and Devices
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Argentina
p.000158: Drugs
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158:
p.000158: Devices
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158: Good Clinical Practices: Document for the Americas (2005): http://www.paho.org/english/ad/ths/ev/GCP- Eng-doct.pdf
p.000158:
p.000158: A Model Regulatory Program for Medical Devices: An International Guide (2001):
p.000158: http://www.paho.org/English/HSP/HSE/medica l_devices.pdf
p.000158: Note: Several provinces have their own regulations pertaining to human subjects research.
p.000158:
p.000158: General
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Drugs, Biologics, and Devices
p.000158: Ministry of Health:
p.000158: https://www.argentina.gob.ar/salud
p.000158:
...
p.000185:
p.000185: General
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Drugs, Biologics, and Devices Côte-d'Ivoire
p.000185: Decree-Law Framework on Public Health, Title VII: Regarding the National Medical Ethics Committee, Biomedical Research,
p.000185: Transplantation of Organs and Tissues, Genetic Treatment, and Cloning: https://www.mindbank.info/item/25 43
p.000185: 1. Proposal for Ministerial Order No. 1250 Establishing the National Advisory Committee on Ethics Health (2004):
p.000185: https://healthresearchweb.org/?action=downloa d&file=DRCPOlicy.pdf
p.000185: 2. Guidelines for the Ethical Evaluation of Research Involving Human Subjects in the Democratic Republic of Congo
p.000185: (2011) (Fench): https://clinregs.niaid.nih.gov/sites/default/files/ documents/DRC/G-EthicalEval.pdf
p.000185: For an overview of human subject protections in Côte-d'Ivoire, see: http://elearning.trree.org/course/view.php?id=19
p.000185: Note: All websites and documents are in French.
p.000185:
p.000185: Drugs, Biologics, and Devices
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Ethiopia
p.000185: General
p.000185:
p.000185:
p.000185:
p.000185: Drugs and Devices
p.000185:
p.000185:
p.000185: Human Biological Materials
p.000185:
p.000185:
p.000185: Gambia
p.000185: Genetic Research
p.000185: National Committee on Ethics and Research
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Ethiopian Science and Technology Commission, Health Department: http://www.most.gov.et/
p.000185:
p.000185:
p.000185: Food, Medicine, and Health Administration and Control Authority: www.fmhaca.gov.et Ethiopian Science and Technology
p.000185: Commission, Health Department: http://www.most.gov.et/
p.000185:
p.000185:
p.000185:
p.000185: MRC: Gambia Unit:
p.000185: http://www.mrc.gm/
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Proclamation 60/1999, Section 21
p.000185: Decree No 317 / SP / DSPH of 14 July 1987 on the Regulation of Drugs Before and After Marketing in Ivory Coast:
p.000185: http://elearning.trree.org/pluginfile.ph p/34816/mod_folder/content/0/20_Ar rete_Regl_exp_clinique_des_substan
p.000185: ces_med.pdf?forcedownload=1
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Drug Administration and Control Proclamation No. 176/1999, Article 21
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: National Health Research Ethics Review Guideline, Fourth Edition (2014): http://www.ccghr.ca/wp-
p.000185: content/uploads/2013/11/national-research- ethics-review-guidline.pdf
p.000185:
p.000185:
p.000185:
p.000185: National Health Research Ethics Review Guideline, Fourth Edition, Chapter 9 (2005): http://www.ccghr.ca/wp-
p.000185: content/uploads/2013/11/national-research- ethics-review-guidline.pdf
p.000185:
p.000185: Guidelines of the National DNA Bank (2001)
p.000185:
p.000185:
p.000186: 186
p.000186:
p.000186: Country Key Organizations Legislation
p.000186: Regulations Guidelines Ghana
p.000186: For an overview of the clinical trial information in Ghana, see:
p.000186: http://www.fdaghana.gov.gh/index.php?option=com_content&view=article&id=71&Itemid=55
p.000186:
p.000186: Drugs, Biologics, and Devices
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: Guinea
p.000186: Food and Drugs Authority:
p.000186: http://www.fdaghana.gov.gh
p.000186: Public Health Act, 2012
p.000186: Act 851, Sections 150-166: http://www.fdaghana.gov.gh/images/s tories/pdfs/Clinical%20Trials/REGU
p.000186: LATION%20OF%20CLINICAL%20 TRIALS%20IN%20GHANA.pdf
p.000186: 1. Guidelines for Good Clinical Practice in Ghana (2015): http://www.fdaghana.gov.gh/images/stories/pdf
p.000186: s/downloads/drugs%20guidelines/Clinical%20 Trials/GUIDELINES%20ON%20GOOD%20C LINICAL%20PRACTICE%20IN%20GHANA
p.000186: .pdf
p.000186: 2. Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices
p.000186: (2015): http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20AUTHORI ZATION%20OF%20CLINICAL%20TRIALS
p.000186: %20OF%20MEDICINES,%20GHANA.pdf
p.000186: 3. Guidelines for Conduct of Clinical Trials in Paediatric Population (2016):
p.000186: http://www.fdaghana.gov.gh/images/stories/pdf s/downloads/drugs%20guidelines/Clinical%20
p.000186: Trials/GUIDELINES%20FOR%20CONDUCT
p.000186: %20OF%20CLINICAL%20TRIALS%20WIT H%20PAEDIATRIC%20POPULATION%20I N%20GHANA.pdf
p.000186: 4. Guidelines for Conduct of Clinical Trials During Emergencies (2016): http://www.fdaghana.gov.gh/images/stories/pdf
p.000186: s/downloads/drugs%20guidelines/GUIDELINE S%20FOR%20TRIALS%20IN%20EMERGE NCIES1.pdf
p.000186: For an overview of the clinical research regulations in Guinea, see the ClinRegs report:
p.000186: https://clinregs.niaid.nih.gov/single_country.php?c_id=90 Note: All websites and documents are in French.
p.000186:
p.000186: General
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186:
p.000186: Research Injury
p.000186: National Ethics Committee on Health Research (CNERS): http://cners- guinee.org/
p.000186:
p.000186:
...
p.000187:
p.000187:
p.000187:
p.000187: Ministry of Health (MOH):
p.000187: www.health.go.ke/
p.000187: 1. Science and Technology Act (2001)
p.000187: 2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
p.000187:
p.000187: Pharmacy and Poisons Act, Chapter 244 (2009): http://apps.who.int/medicinedocs/do cuments/s18245en/s18245en.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: MOH:
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005)
p.000187: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, page 44 (2005)
p.000187: MOH:
p.000187: National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008):
p.000187: https://healthresearchweb.org/?action=downloa d&file=Final%20national%20ethical%20guidel ines-last%20draft.pdf
p.000187: Guidelines for Applications to Conduct Clinical Trials in Kenya (2014): http://pharmacyboardkenya.org/downloads/?fil
p.000187: e=Clinical%20Trial%20Guidelines%202014.p df
p.000187: For an overview of the clinical research regulations in Liberia, see the ClinRegs report:
p.000187: https://clinregs.niaid.nih.gov/single_country.php?c_id=122
p.000187:
p.000187: General
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Drugs, Biologics, and Devices
p.000187:
p.000187: Madagascar
p.000187: Drugs and Devices
p.000187: Ministry of Health and Social Welfare: http://www.mohsw.gov.lr/
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Liberia Medicines and Health Products Regulatory Authority
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Law No. 2011-002, Article 122 Regarding Clinical Trials: https://www.ilo.org/dyn/natlex/docs
p.000187: /ELECTRONIC/97799/116199/F10 71917999/MDG-97799.pdf
p.000187: 1. Institutional Review Board (IRB) Policies and Procedures Handbook (2008): http://www.ul-acre.org/wp-
p.000187: content/uploads/2013/03/UL-IRB- Policy-Handbook.pdf
p.000187: 2. Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011): http://clinregs.niaid.nih.gov/documen
p.000187: ts/liberia/G-LIBR-NHSREC.pdf
p.000187: Operational Guidelines of the National Research Ethics Board (2019):
p.000187: https://clinregs.niaid.nih.gov/sites/default/files/ documents/liberia/G-NREB-revised.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Guideline for Application to
p.000187: Conduct Clinical Trials in Liberia (2014):
p.000187: https://clinregs.niaid.nih.gov/documents/liberia
p.000187: /G-LibClinTrial.pdf
p.000187:
p.000187:
p.000187:
p.000188: 188
p.000188:
p.000188: Country Key Organizations Legislation
p.000188: Regulations Guidelines Malawi
p.000188: For an overview of the clinical research regulations in Malawi, see the ClinRegs report:
p.000188: http://clinregs.niaid.nih.gov/single_country.php?c_id=129
p.000188:
p.000188: General
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
...
p.000191:
p.000191: Country Key Organizations Legislation
p.000191: Regulations Guidelines
p.000191:
p.000191: Drugs, Biologics, and Devices
p.000191: V2.pdf
p.000191: 3. Guideline for Conducting Clinical Trials: http://pharmacyboard.gov.sl/site/LinkClick.asp
p.000191: x?fileticket=YrGQkXzfLP8%3d&tabid=316& portalid=1&mid=934&forcedownload=true
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: South Africa
p.000191: For an overview of human subject protections in South Africa, see:
p.000191: http://elearning.trree.org/course/view.php?id=9&lang=en
p.000191: For an overview of the clinical research regulations, see the ClinRegs report:
p.000191: http://clinregs.niaid.nih.gov/single_country.php?c_id=199
p.000191: Forms: http://pharmacyboard.gov.sl/site/Downloads/Fo rms.aspx
p.000191:
p.000191: General
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: Drugs, Biologics, and Devices
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: Clinical Trials Registry
p.000191: Social-Behavioral Research
p.000191:
p.000191:
p.000191:
p.000191: Human Biological
p.000191: 1. Department of Health (DH):
p.000191: http://www.doh.gov.za
p.000191: 2. National Health Research Ethics Council: http://www.nhrec.org.za/
p.000191: 3. Medical Research Council of South Africa (MRC): http://www.mrc.ac.za
p.000191: 4. Human Sciences Research Council (HSRC): http://www.hsrc.ac.za/index.phtml
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: 1. Department of Health (DH):
p.000191: http://www.doh.gov.za
p.000191: 2. Health Products Regulatory Authority: https://www.sahpra.org.za/
p.000191:
p.000191:
p.000191:
p.000191: South African National Clinical Trials Register: http://www.sanctr.gov.za/
p.000191: Department of Health
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: Department of Health (DH):
p.000191: http://www.doh.gov.za
p.000191: 1. Constitution of South Africa, Section 12 (2) (1996)
p.000191: 2. National Health Act No. 61, Chapter 9 (2003): http://www.saflii.org/za/legis/consol
p.000191: _act/nha2003147.pdf
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: Medicines and Related Substances Control Act, 101 of 1965
p.000191: http://www.hpcsa.co.za/Uploads/edi tor/UserFiles/downloads/legislations
p.000191: /acts/medicines_and_related_sub_ac t_101_of_1965.pdf
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: National Health Act No. 61,
p.000191:
p.000192: 192
p.000192: Regulations Relating to Research with Human Participants No.
p.000192: R719 (2014):
p.000192: http://www.google.co.za/url?url=http:
p.000192: //www.lawsofsouthafrica.up.ac.za/ind ex.php/browse/medical-and- health/national-health-act-61-of-
p.000192: 2003/regulations-and-notices/61-of- 2003-national-health-act-regs-gnr- 719-19-sept-2014-to-date-
p.000192: pdf/download&rct=j&frm=1&q=&es rc=s&sa=U&ei=W6UtVOOvLa6S7A a34YDwAg&ved=0CBUQFjAA&us g=AFQjCNFpKA9W0jNyeWhk0n0l
p.000192: 0Q-WxazBtg
p.000192: General Regulations Made in Terms of the Medicines and Related Substances Act, 1965 (2003):
p.000192: http://www.hpcsa.co.za/Uploads/edit or/UserFiles/downloads/legislations/a cts/medicines_and_related_sub_act_1
p.000192: 01_of_1965.pdf
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192: 1. Regulations Relating to the Use
p.000192: DH:
...
p.000192: Gazette2Mar2012.pdf
p.000192: 4. Regulations Relating to Artificial Insemination of Persons, 2 March 2012: http://www.sashg.org/documents/Gov
p.000192: Gazette2Mar2012.pdf
p.000192:
p.000192:
p.000192:
p.000192: Regulations relating to Stem Cell Banks, 2 March 2012: http://www.sashg.org/documents/Gov Gazette2Mar2012.pdf
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192: Guidelines on Ethics in Reproductive Biology and Genetic Research (2002): http://www.sahealthinfo.org/ethics/book2.htm
p.000192: Guidelines on Ethics in Reproductive Biology and Genetic Research (2002):
p.000192: http://www.kznhealth.gov.za/research/ethics2.p df
p.000192: For an overview of human subject protections in Tanzania, see:
p.000192: http://elearning.trree.org/mod/resource/view.php?id=41&lang=en
p.000192: For an overview of the clinical research regulations in Tanzania, see the ClinRegs report:
p.000192: http://clinregs.niaid.nih.gov/single_country.php?c_id=212
p.000192:
p.000192: General
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000192: Drugs, Biologics, and Devices
p.000192: 1. Ministry of Health (MOH)
p.000192: 2. National Institute for Medical Research (NIMR), National Health Research Ethics Committee (NHREC):
p.000192: http://www.nimr.or.tz/
p.000192: 3. Tanzania Commission for Science and Technology (COSTECH): www.costech.or.tz
p.000192:
p.000192:
p.000192:
p.000192: Drugs
p.000192: Tanzania Food and Drugs Authority:
p.000192: 1. National Institute for Medical Research, Act of Parliament No. 23, of 1979: http://www.parliament.go.tz/Polis/P
p.000192: AMS/Docs/23-1979.pdf
p.000192: 2. Tanzania Commission for Science and Technology, Act No. 7 of 1986
p.000192: 3. Amendment of NIMR Act 1997, Tanzania Government Gazette, No. 675
p.000192:
p.000192: Tanzania Food, Drugs, and
p.000192: NIMR:
p.000192: 1. Coordination of Health Research in Tanzania
p.000192: 2. Coordination of Formation of Institutional Health Research Committees to Formally Approve for Local Health Research
p.000192: 3. Coordination of Research in Tanzania
p.000192: NHREC:
p.000192: 1. Brochure for Health Researchers in Tanzania (2006)
p.000192: 2. Guidelines on Ethics for Health Research in Tanzania (2009): https://clinregs.niaid.nih.gov/documents/tanzan
p.000192: ia/G-EthicsHR.pdf
p.000192:
p.000192: COSTECH:
p.000192: COSTECH Guidelines on Research Permits and Clearance (2006)
p.000192: https://protect2.fireeye.com/url?k=df97c3b9 Cosmetics Act, Sections 61, 66,
p.000192:
p.000192: -83c3dac5-df97f286-0cc47adc5fa2-9df96a 6e749380d6&u=https://www.tmda.go.tz/
p.000192: 67, and 69 (2003):
p.000192: http://www.tfda.or.tz/index.php?opti
p.000193: 193
p.000193:
p.000193: Country Key Organizations Legislation
p.000193: Regulations Guidelines
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193:
p.000193:
p.000193:
p.000193: Devices
p.000193: Tanzania Food and Drugs Authority:
p.000193: http://www.tfda.or.tz/
p.000193: on=com_phocadownload&view=cat egory&download=44:tfdc-acts- 2003&id=52:tfdc-acts- 2003&Itemid=417
p.000193:
p.000193: Medical Device Act (1988)
p.000193:
p.000193:
p.000193:
p.000193: Clinical Trials Registry Uganda
p.000193: Tanzania Clinical Trial Registry:
p.000193: http://www.tzctr.or.tz/
p.000193: FAQs: http://www.tzctr.or.tz/faq.php
p.000193: For an overview of the clinical research regulations in Uganda, see the ClinRegs report:
p.000193: http://clinregs.niaid.nih.gov/single_country.php?c_id=223
p.000193:
p.000193: General
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Zambia
p.000193: General
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drugs, Biologics, and Devices
p.000193: Uganda National Council for Science and Technology (UNCST): http://www.uncst.go.ug/
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: National Drug Authority:
p.000193: http://www.nda.or.ug/
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Ministry of Health:
p.000193: http://www.moh.gov.zm/
p.000193:
p.000193:
p.000193:
p.000193: Zambia Medicines Regulatory Authority: http://www.zamra.co.zm/
p.000193: Uganda National Council for Science and Technology Act of 1990 (CAP 209):
p.000193: https://ulii.org/ug/legislation/consoli dated-act/209
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: Drug Conduct of Clinical Trials Regulation (2014): https://www.nda.or.ug/files/downlo ads/Drug%20Conduct%20of%20Cli
p.000193: nical%20trials%20Regulation.pdf
p.000193:
p.000193:
p.000193:
p.000193: National Health Research Act (2013):
p.000193: http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health
p.000193: %20%20Research%20%20Act%20 2013.pdf
p.000193: Medicines and Allied Substances Act, Part VI: Regulation of Clinical Trials, 2013: http://www.zamra.co.zm/wp-
p.000193: content/uploads/2016/10/MASA- No-3-2013.pdf
p.000194: 194
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: National Drug Policy and Authority Act Regulations: https://www.nda.or.ug/ndpa-act- regulations/
p.000194: 1. National Guidelines for Research Involving Humans as Research Participants (2014):
p.000194: https://uncst.go.ug/guidelines-and-forms/
p.000194: 2. Research Registration and Clearance Policy and Guidelines (2016)
p.000194: 3. Research Guidelines and Forms:
p.000194: https://www.uncst.go.ug/guidelines-and-forms/
p.000194: 4. Accredited Research Ethics Committees: https://www.uncst.go.ug/research-ethics- committee-accreditation/
p.000194: 1. Human Medicine Guidelines: https://www.nda.or.ug/human-medicine- guidelines/
p.000194: 2. Clinical Trial Application Forms:
p.000194: https://www.nda.or.ug/application-forms/
p.000194: 3. Guidelines for the Conduct of Drug Related Clinical Trials (2019)
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Guidelines on Regulating the Conduct of Clinical Trials in Human Participants: http://www.zamra.co.zm/wp-
p.000194: content/uploads/2016/10/Guidelines-on- Application-for-Clincal-Trial- Authorisation.pdf
p.000194:
p.000194: Country Key Organizations Legislation
p.000194: Regulations Guidelines
p.000194:
p.000194: Human Biological Materials
p.000194:
p.000194:
p.000194:
p.000194: Zimbabwe
p.000194: General
p.000194:
p.000194:
p.000194: Drugs, Biologics, and Devices
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Privacy/Data Protection
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Human Biological Materials
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medical Research Council of Zimbabwe: http://www.mrcz.org.zw
p.000194:
p.000194: Drugs
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Devices
p.000194: Medicines Control Authority of Zimbabwe: http://www.mcaz.co.zw/devices.html
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Registrar General: http://www.rg.gov.zw/ Zimbabwe National Statistics Agency: http://www.zimstat.co.zw/
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Research Council of Zimbabwe: www.rcz.ac.zw
p.000194: National Health Research Act, Part VI (2013):
p.000194: http://www.parliament.gov.zm/sites/ default/files/documents/acts/Health
p.000194: %20%20Research%20%20Act%20 2013.pdf
p.000194:
p.000194: 1. Medical Research Government Notice Act (1974)
p.000194: 2. Research Act (1986)
p.000194:
p.000194: Medicines and Allied Substances Control Act, Chapter 15:03 (1997)
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medicines and Allied Substances Control Act, Chapter 15:03 (1997):
p.000194: https://www.unodc.org/res/cld/docu ment/zwe/medicines-and-allied- substances-control- act_html/Zimbabwe_Medicines_and
p.000194: _Allied_Substances_Control_Act.p df
p.000194: 1. Constitution of Zimbabwe of 2013, Section 57: https://www.constituteproject.org/co nstitution/Zimbabwe_2013.pdf
p.000194: 2. Access to Information and Protection of Privacy Act, Chapter 10:27: www.fesmedia-
p.000194: africa.org/uploads/media/Acess_to_ Information_Zimbabwe
p.000194: Research Act (2001): http://faolex.fao.org/docs/pdf/zim93 551.pdf
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: 1. Medicines and Allied Substances Control Act, General Regulations (1991)
p.000194: 2. Statutory Instrument 150 of 1991
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Medicines and Allied Substances Control (Condom) Regulations (2005):
p.000194: http://www.mcaz.co.zw/index.php/do wnloads/category/15-regulations-and- guidelines?download=29:condom- regulations
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Various: http://www.mrcz.org.zw/faqs/
p.000194:
p.000194:
p.000194:
p.000194: 1. Guidelines for Good Clinical Practice (2012): http://www.medbox.org/guidelines-
p.000194: for-good-clinical-trial-practice-in-zimbabwe- 2012/download.pdf
p.000194: 2. Pharmacy Guidelines for Investigational Drugs (2016): http://www.mcaz.co.zw/index.php/downloads/f
p.000194: ile/114-pharmacy-guidelines-for- investigational-drugs-draft-1
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Various: http://www.rcz.ac.zw/research- registration/
p.000194:
p.000194:
p.000194:
p.000195: 195
p.000195:
p.000195: Country Key Organizations Legislation
p.000195: Regulations Guidelines
p.000195:
p.000195: Genetic Research
p.000195: National Biotechnology Authority of Zimbabwe: http://www.nba.ac.zw/
p.000195: National Biotechnology Authority Act, Chapter 14:31 (2006):
p.000195: http://www.nba.ac.zw/index.php/our
p.000195: -resources/finish/1-national- biotechnology-association/2- national-biotechnolgy-authority-act
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000196: ACKNOWLEDGEMENTS
p.000196:
p.000196: The DHHS Office for Human Research Protections thanks the following individuals for providing updates or confirmations
p.000196: of accuracy for the 2020 edition of the International Compilation of Human Research Standards. We are particularly
p.000196: grateful for the assistance provided by Carla Saenz of the Pan American Health Organization, Washington DC.
p.000196:
p.000196:
p.000196: International:
p.000196: CIOMS: Sue le Roux
p.000196: International Society for Biological and Environmental Repositories: Daniel Simeon-Dubach
p.000196: TRUST Project: Doris Schroeder UNAIDS: Peter Godfrey-Faussett
p.000196: World Health Organization: Andreas Reis
p.000196:
p.000196: North America:
p.000196: United States:
p.000196: • Consumer Product Safety Commission: Alice Thaler
p.000196: • Department of Commerce: Anne Andrews
p.000196: • Department of Veterans Affairs: Kristina Borror
p.000196: • DHHS Agency for Healthcare Quality and Research: Hope Hongzhu He
p.000196: • DHHS Food and Drug Administration: Carolyn Hommel
p.000196: • DHHS Office for Civil Rights: Devi Mehta
p.000196: • Department of Justice, Bureau of Prisons: Jody Klein-Saffran
p.000196: • United States Department of Agriculture: David Klurfeld
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000003: Madagascar 188
p.000003: Malawi 189
p.000003: Mali 190
p.000003: Mozambique 190
p.000003: Nigeria 190
p.000003: Rwanda 191
p.000003: Senegal 191
p.000003: Sierra Leone 191
p.000003: South Africa 192
p.000003: Tanzania 193
p.000003: Uganda 194
p.000003: Zambia 194
p.000003: Zimbabwe 195
p.000003: ACKNOWLEDGEMENTS 197
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Country Key Organizations Legislation
p.000004: Regulations Guidelines
p.000004:
p.000004:
p.000004: INTERNATIONAL
p.000004: General Council for International Organizations of
p.000004: Medical Sciences (CIOMS):
p.000004: http://www.cioms.ch/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: International Committee of the Red Cross (ICRC): www.icrc.org
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Office of the United Nations High Commissioner for Human Rights (OHCHR): http://www.ohchr.org/english/
p.000004:
p.000004: TRUST Project:
p.000004: http://www.globalcodeofconduct.org
p.000004:
p.000004:
p.000004:
p.000004: UNAIDS:
p.000004: http://www.unaids.org/
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 1. Geneva Convention Relative to the Treatment of Prisoners of War, Articles 13 and 130 (1950):
p.000004: https://www.icrc.org/applic/ihl/ihl. nsf/7c4d08d9b287a421412567390 03e636b/6fef854a3517b75ac12564 1e004a9e68
p.000004: 2. Additional Protocol I Relating to the Protection of Victims of International Armed Conflicts, Article 11 (1977):
p.000004: http://www.icrc.org/ihl.nsf/7c4d08 d9b287a42141256739003e636b/f6 c8b9fee14a77fdc125641e0052b07 9
p.000004: International Covenant on Civil and Political Rights, Article 7 (1976):
p.000004: http://www.ohchr.org/en/professio nalinterest/pages/ccpr.aspx
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: International Ethical Guidelines for http://www.saveservices.org/wp- content/uploads/Analysis-of-113-
p.000005: Lawsuits-9.16.2019.xlsxResearch Involving Humans (2016): https://cioms.ch/shop/product/international-
p.000005: ethical-guidelines-for-health-related-research- involving-humans/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Global Code of Conduct for Research in Resource-Poor Settings (2018): http://www.globalcodeofconduct.org/wp-
p.000005: content/uploads/2018/05/Global-Code-of- Conduct-Brochure.pdf
p.000005: 1. Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (2011):
p.000005: http://www.unaids.org/sites/default/files/medi a_asset/JC1853_GPP_Guidelines_2011_en_0. pdf
p.000005: 2. Ethical Considerations
p.000005: in Biomedical HIV Prevention Trials (2012):
p.000005: http://www.unaids.org/en/media/unaids/conten
p.000005:
p.000005: Country Key Organizations Legislation
p.000005: Regulations Guidelines
p.000005: tassets/documents/unaidspublication/2012/jc1
p.000005:
p.000005: General
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
p.000006: http://www.wma.net/e/
p.000006:
p.000007: 7
p.000007: Access: http://www.imdrf.org/ghtf/ghtf- archived-docs.asp
p.000007: Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice. Standard Number 14155:2011:
p.000007: http://www.iso.org/iso/iso_catalogue/catalogu e_ics/catalogue_detail_ics.htm?csnumber=455 57
p.000007: Resolution WHA 58.34 (2005): http://www.wpro.who.int/health_research/poli cy_documents/ministerial_summit_on_health_
p.000007: research_may2005.pdf?ua=1
p.000007: Declaration of Helsinki, Article 35 (2013):
p.000007: http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000007: Clinical Trial Registration: http://icmje.org/recommendations/browse/pub lishing-and-editorial-issues/clinical-trial-
p.000007: registration.html
p.000007: Declaration of Helsinki, Paragraph 15 (2013):
p.000007: http://www.wma.net/en/30publications/10poli
p.000007:
p.000007: Country Key Organizations Legislation
p.000007: Regulations Guidelines
p.000007: cies/b3/index.html
p.000007:
p.000007: Research Injury
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Social- Behavioral Research
p.000007: Privacy/Data Protection
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Human Biological Materials
p.000007: International Conference on Harmonization (ICH): http://www.ich.org/
p.000007:
p.000007:
p.000007:
p.000007: Council for International Organizations of Medical Sciences: http://www.cioms.ch/
p.000007:
p.000007:
p.000007:
p.000007: UNESCO: http://www.unesco.org/
p.000007:
p.000007:
p.000007: World Medical Association:
p.000007: http://www.wma.net/e/index.htm
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: World Health Organization:
p.000007: http://www.who.int/en/
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: World Medical Association
p.000007:
p.000007:
p.000007:
p.000007: International Air Transport Association:
p.000007: http://www.iata.org/
p.000007: International Society for Biological and Environmental Repositories:
p.000007: http://www.isber.org
p.000008: 8
p.000008: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice , Section 5.8 (2016):
p.000008: https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4.pdf
p.000008: International Ethical Guidelines for Health-related Research Involving Humans (2016), Guideline 14:
p.000008: https://cioms.ch/shop/product/international- ethical-guidelines-for-health-related-research- involving-humans/
p.000008: Code of Conduct and Ethical Guidelines for Social Science Research: http://www.unesco.org/new/fileadmin/MULTI
p.000008: MEDIA/HQ/SHS/pdf/Soc_Sci_Code.pdf
p.000008: 1. Declaration of Helsinki, Paragraph 24 (2013): http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000008: 2. Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: 1. Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997):
p.000008: www.who.int/csr/emc97_3.pdf
p.000008: 2. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research
p.000008: (2003): http://www.who.int/reproductivehealth/topics/ ethics/human_tissue_use.pdf
p.000008: Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005)
p.000008: 1. ISBER Best Practices: Recommendations for Repositories (2018)
p.000008:
p.000008: Country Key Organizations Legislation
p.000008: Regulations Guidelines
p.000008:
p.000008: Human Biological Materials
p.000008:
p.000008:
p.000008: Genetic Research
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
...
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194: Various: http://www.rcz.ac.zw/research- registration/
p.000194:
p.000194:
p.000194:
p.000195: 195
p.000195:
p.000195: Country Key Organizations Legislation
p.000195: Regulations Guidelines
p.000195:
p.000195: Genetic Research
p.000195: National Biotechnology Authority of Zimbabwe: http://www.nba.ac.zw/
p.000195: National Biotechnology Authority Act, Chapter 14:31 (2006):
p.000195: http://www.nba.ac.zw/index.php/our
p.000195: -resources/finish/1-national- biotechnology-association/2- national-biotechnolgy-authority-act
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000196: ACKNOWLEDGEMENTS
p.000196:
p.000196: The DHHS Office for Human Research Protections thanks the following individuals for providing updates or confirmations
p.000196: of accuracy for the 2020 edition of the International Compilation of Human Research Standards. We are particularly
p.000196: grateful for the assistance provided by Carla Saenz of the Pan American Health Organization, Washington DC.
p.000196:
p.000196:
p.000196: International:
p.000196: CIOMS: Sue le Roux
p.000196: International Society for Biological and Environmental Repositories: Daniel Simeon-Dubach
p.000196: TRUST Project: Doris Schroeder UNAIDS: Peter Godfrey-Faussett
p.000196: World Health Organization: Andreas Reis
p.000196:
p.000196: North America:
p.000196: United States:
p.000196: • Consumer Product Safety Commission: Alice Thaler
p.000196: • Department of Commerce: Anne Andrews
p.000196: • Department of Veterans Affairs: Kristina Borror
p.000196: • DHHS Agency for Healthcare Quality and Research: Hope Hongzhu He
p.000196: • DHHS Food and Drug Administration: Carolyn Hommel
p.000196: • DHHS Office for Civil Rights: Devi Mehta
p.000196: • Department of Justice, Bureau of Prisons: Jody Klein-Saffran
p.000196: • United States Department of Agriculture: David Klurfeld
p.000196: • Social Security Administration: Leola Brooks
p.000196: Europe:
p.000196: European Medicines Agency: Maria Antonietta Antonelli
p.000196: Belgium: Sophie Bertrand Czech Republic: Alice Nemcova
p.000196: Denmark: Ann-Sofie Lydiksen Nygaard Finland: Outi Konttinen
p.000196: France: Emmanuelle Rial-Sebbag Germany: Claudia Leuker
p.000196: Iceland: Rögnvaldur G. Gunnarsson Latvia: Signe Mezinska
p.000196: Lithuania: Vilma Lukaseviciene Luxembourg: Malika Pailhes Macedonia: Marija Todorovska Norway: Camilla Bø Standal
p.000196: Poland: Marek Czarkowski and Agnieszka Seweryniak
p.000196: Serbia: Jelena Rakobradović Slovenia: Marija Lap Sweden: Stefan Eriksson
p.000196: Switzerland: Brigitte Meier and Rosine Muchlow
p.000196: Spain: Iñigo de Miguel Beriain
p.000196: Asia/Pacific:
p.000196: Australia: Jeremy Kenner
p.000196: China, People’s Republic of: Yali Cong and Haihong Zhang
p.000196: Japan: Shimon Tashiro
...
General/Other / common rule
Searching for indicator 45XcfrX46:
(return to top)
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
p.000011:
p.000011: 1. Protection of Pupil Rights Amendment (1974)
p.000011: 2. Family Educational Rights and Privacy Act (1974)
p.000011:
p.000011:
p.000012: 12
p.000012: 22 CFR 225, Subpart A
p.000012:
p.000012:
p.000012:
p.000012: Executive Order 12333, Subparts A, B, C, and D 16 CFR 1028, Subpart A
p.000012:
p.000012: 1. 7 CFR 1c, Subpart A
p.000012: 2. 45 CFR 46, Subparts B, C, and D
p.000012: 15 CFR 27, Subpart A
p.000012:
p.000012:
p.000012: 1. 32 CFR 219, Subpart A 2. DoDI 3216.02 (2011):
p.000012: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000012:
p.000012: 1. 34 CFR 97 subparts A (1991) and D (1997)
p.000012: 2. 34 CFR 98 (1984)
p.000012: 3. 34 CFR 99 (2000)
p.000012: 4. 34 CFR 350.4(c) (1991)
p.000012: 5. 34 CFR 356.3(c) (1991)
p.000012: Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2015):
p.000012: https://www.usaid.gov/sites/default/files/docu ments/1870/200.pdf
p.000012:
p.000012: Country Key Organizations Legislation
p.000012: Regulations Guidelines
p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
p.000012: Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/
p.000012:
p.000012:
p.000012: Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/
p.000012:
p.000012:
p.000012:
p.000012: Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland
p.000012: Security: www.dhs.gov/
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Housing and Urban Development: www.hud.gov/
p.000012: 1. Department of Justice Office of Justice Programs:
p.000012: http://ojp.gov/
p.000012: 2. Bureau of Prisons:
p.000012: www.bop.gov
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Labor:
p.000012: https://www.dol.gov/
p.000012:
p.000012:
p.000012:
p.000012: Public Health Service Act (1993):
p.000012: http://history.nih.gov/research/d ownloads/PL103-43.pdf
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Public Law 108-458, Section 8306
p.000012: 1. 10 CFR 745 (1991), Subpart A
p.000012: 2. DOE Order 443.1B
p.000012: 3. DOE Order 481.1
p.000012: 45 CFR 46, Subparts A, B, C, D, and E (2018):
p.000012: https://www.hhs.gov/ohrp/sites/defau lt/files/revised-common-rule-reg- text-unofficial-2018- requirements.pdf
p.000012: FDA is not a Common Rule agency. For studies conducted or funded by FDA:
p.000012: 45 CFR 46, Subparts A, D, and E:
p.000012: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000012:
p.000012:
p.000012:
p.000012: 1. 45 CFR 46, Subparts A-D
p.000012: 2. DHS Directive 026-04, Human Subjects Research (2007): https://www.dhs.gov/xlibrary/assets/f
p.000012: oia/mgmt-directive-026-04- protection-of-human-subjects.pdf
p.000012: 24 CFR 60.101, which cites 45 CFR part 46, subpart A.
p.000012: 1. 28 CFR 22 Privacy Regulation (1976): http://www.ecfr.gov/cgi- bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/
p.000012: 28cfr22_main_02.tpl
p.000012: 2. 42 U.S.C. § 3789g
p.000012: Confidentiality of Information (1984)
p.000012: http://www.gpo.gov/fdsys/pkg/USC ODE-2010-title42/html/USCODE- 2010-title42-chap46-subchapVIII- sec3789g.htm
p.000012: 3. 28 CFR 46 (1991), Subpart A:
p.000012: http://www.ecfr.gov/cgi-bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/ 28cfr46_main_02.tpl
p.000012: 29 CFR 21
p.000012:
p.000012:
p.000012:
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
...
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p.000014:
p.000014: Devices
p.000014: Food and Drug Administration, Center for Devices and Radiological
p.000014:
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p.000014:
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p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: 1. Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (2012): https://uscode.house.gov/browse/pre
p.000014: lim@title21&edition=prelim
p.000014: 2. Public Health Service Act, 42 USC Section 262 (1998): https://uscode.house.gov/browse/pre lim@title42&edition=prelim
p.000014: 3. 21st Century Cures Act, Section 3024 (2016): https://www.govinfo.gov/content/pk g/PLAW-114publ255/pdf/PLAW-
p.000014: 114publ255.pdf
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014: 1. Food, Drug, and Cosmetic Act, 21 USC Section 360
p.000015: 15
p.000015: 7. Subpart M: Requirements for Submission of Information on the Ethical Conduct of Completed Human Research (2013)
p.000015: 8. Subpart O: Administrative Actions for Noncompliance (2013)
p.000015: 9. Subpart P: Review of Proposed and Completed Human Research (2013)
p.000015: 10. Subpart Q: Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions (2013)
p.000015: 14 CFR 1230, Subpart A
p.000015:
p.000015: 45 CFR 690, Subpart A
p.000015:
p.000015: 45 CFR 46, Subpart A: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000015:
p.000015: Title 21, Code of Federal Regulations: https://www.fda.gov/science- research/clinical-trials-and-human-
p.000015: subject-protection/regulations-good- clinical-practice-and-clinical-trials
p.000015: 1. 21 CFR 50 (Informed Consent)
p.000015: 2. 21 CFR 312 (Investigational New Drug Application)
p.000015: 3. 21 CFR 56 (Institutional Review Boards)
p.000015: 4. 21 CFR 314 (Applications for Approval to Market a New Drug)
p.000015: 5. 21 CFR 54 (Financial Disclosure by Clinical Investigators)
p.000015: 6. 21 CFR 320 (Bioavailability and Bioequivalence Requirements)
p.000015:
p.000015: Title 21, Code of Federal Regulations:
p.000015:
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p.000015:
p.000015:
p.000015:
p.000015: General:
p.000015: Good Clinical Practice and Human Subject Protection in FDA-Regulated Clinical Trials: https://www.fda.gov/science-
p.000015: research/science-and-research-special- topics/clinical-trials-and-human-subject- protection
p.000015:
p.000015: Drugs:
p.000015: https://www.fda.gov/drugs/guidance- compliance-regulatory-information/guidances- drugs
p.000015:
p.000015: Biologics:
p.000015: https://www.fda.gov/vaccines-blood- biologics/guidance-compliance-regulatory- information-biologics
p.000015:
p.000015:
p.000015:
p.000015: Good Clinical Practice and Human Subject Protections in FDA-Regulated
p.000015:
...
p.000175:
p.000175: General
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Drugs and Devices
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Grenada
p.000175: General
p.000175:
p.000175:
p.000175:
p.000175: Guyana
p.000175: General
p.000175:
p.000175:
p.000175: Guatemala
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: National Directorate of Medications: http://www.medicamentos.gob.sv/index.p hp/es/
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: St. George’s University/Windward Islands Research and Education Foundation: http://www.sgu.edu/school-of-
p.000175: medicine/institutional-review-board.html
p.000175: efault/files/documents/decretos/F31 2B814-45C5-48EB-A71D-
p.000175: 0DFC612FF135.pdf
p.000175: 3. Law on the Integrated National System of Health, Article 28 (2019): https://www.diariooficial.gob.sv/dia
p.000175: rios/do-2019/05-mayo/17-05- 2019.pdf
p.000175: Medication Law, Articles 29 and 66 (2012):
p.000175: https://www.asamblea.gob.sv/sites/d efault/files/documents/decretos/171 117_073104135_archivo_document
p.000175: o_legislativo.pdf
p.000175:
p.000175:
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p.000175:
p.000175:
p.000175: Medical Research Involving Human Subjects Regulations (2007)
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: User’s Guide for the Application of Clinical Investigation Protocols: http://www.medicamentos.gob.sv/index.php/es/
p.000175: servicios-m/descargables/ensayos-clinicos
p.000175:
p.000175:
p.000175:
p.000175: 45 CFR 46:
p.000175: http://www.hhs.gov/ohrp/humansubjects/guida nce/45cfr46.html
p.000175:
p.000175: Note: All websites and documents are in Spanish.
p.000175: General Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
p.000175: 1. Regulation on Clinical Research on Humans (2015)
p.000175: 2. Internal Regulations of the National Committee on Health Ethics (2018): http://www.mspas.gob.gt/images/files
p.000175: /acuerdosministeriales/2018/Acuerdo Ministerial1392018NormativaCNES. pdf
p.000175:
p.000175: Drugs, Biologics, and Devices
p.000175: Ministry of Public Health and Social Assistance: http://www.mspas.gob.gt/
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
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p.000175:
p.000176: 176
p.000176: 1. Governmental Agreement 712- 99, Articles 91-94 (1999): http://asisehace.gt/media/ag_712_99. pdf
p.000176: 2. Rules for the Regulation of Human Clinical Trials. Ministerial Accord 82-2019: https://medicamentos.mspas.gob.gt/p
p.000176: hocadownload/Acuerdo%20Ministeri
p.000176: Drug Surveillance -- Clinical Trials: http://www.mspas.gob.gt/index.php/servicios/f armacovigilancia
p.000176:
p.000176: Country Key Organizations Legislation
p.000176: Regulations Guidelines
p.000176: al%2082-2019.pdf
p.000176:
p.000176: Haiti
p.000176: General Ministry of Public Health and Population: http://mspp.gouv.ht/newsite/
p.000176:
p.000176: Internal Regulations (2010)
p.000176:
p.000176: Honduras
p.000176: Note: All websites and documents are in Spanish.
p.000176: General Secretariat of Health:
p.000176: http://www.salud.gob.hn/
p.000176:
p.000176:
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p.000010:
p.000011: 11
p.000011:
p.000011: Country Key Organizations Legislation
p.000011: Regulations Guidelines
p.000011:
p.000011: Genetic Research
p.000011:
p.000011:
p.000011: Embryos, Stem Cells, and Cloning
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
p.000011: Department of Commerce, National Institute of Standards and Technology: www.commerce.gov/ Department of Defense, Human
p.000011: and Animal RDT&E Protection Programs: http://www.acq.osd.mil/rd/hptb/programs
p.000011: /regulatory/
p.000011: Department of Education:
p.000011: www.ed.gov/
p.000011:
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p.000012:
p.000012: General
p.000012: Department of Energy: http://science.energy.gov/ber/human- subjects/
p.000012: Department of Health and Human Services, Office for Human Research Protections: www.hhs.gov/ohrp/
p.000012:
p.000012:
p.000012: Department of Health and Human Services, Food and Drug Administration: https://www.fda.gov/
p.000012:
p.000012:
p.000012:
p.000012: Department of Health and Human Services, National Institutes of Health: https://www.nih.gov/ Department of Homeland
p.000012: Security: www.dhs.gov/
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Housing and Urban Development: www.hud.gov/
p.000012: 1. Department of Justice Office of Justice Programs:
p.000012: http://ojp.gov/
p.000012: 2. Bureau of Prisons:
p.000012: www.bop.gov
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Department of Labor:
p.000012: https://www.dol.gov/
p.000012:
p.000012:
p.000012:
p.000012: Public Health Service Act (1993):
p.000012: http://history.nih.gov/research/d ownloads/PL103-43.pdf
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Public Law 108-458, Section 8306
p.000012: 1. 10 CFR 745 (1991), Subpart A
p.000012: 2. DOE Order 443.1B
p.000012: 3. DOE Order 481.1
p.000012: 45 CFR 46, Subparts A, B, C, D, and E (2018):
p.000012: https://www.hhs.gov/ohrp/sites/defau lt/files/revised-common-rule-reg- text-unofficial-2018- requirements.pdf
p.000012: FDA is not a Common Rule agency. For studies conducted or funded by FDA:
p.000012: 45 CFR 46, Subparts A, D, and E:
p.000012: http://www.hhs.gov/ohrp/humansubj ects/guidance/45cfr46.html
p.000012:
p.000012:
p.000012:
p.000012: 1. 45 CFR 46, Subparts A-D
p.000012: 2. DHS Directive 026-04, Human Subjects Research (2007): https://www.dhs.gov/xlibrary/assets/f
p.000012: oia/mgmt-directive-026-04- protection-of-human-subjects.pdf
p.000012: 24 CFR 60.101, which cites 45 CFR part 46, subpart A.
p.000012: 1. 28 CFR 22 Privacy Regulation (1976): http://www.ecfr.gov/cgi- bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/
p.000012: 28cfr22_main_02.tpl
p.000012: 2. 42 U.S.C. § 3789g
p.000012: Confidentiality of Information (1984)
p.000012: http://www.gpo.gov/fdsys/pkg/USC ODE-2010-title42/html/USCODE- 2010-title42-chap46-subchapVIII- sec3789g.htm
p.000012: 3. 28 CFR 46 (1991), Subpart A:
p.000012: http://www.ecfr.gov/cgi-bin/text- idx?c=ecfr&tpl=/ecfrbrowse/Title28/ 28cfr46_main_02.tpl
p.000012: 29 CFR 21
p.000012:
p.000012:
p.000012:
p.000012: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/index.html
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: NIH Single IRB Policy (2016): https://grants.nih.gov/policy/clinical- trials/single-irb-policy-multi-site-research.htm
p.000012:
p.000013: 13
p.000013:
p.000013: Country Key Organizations Legislation
p.000013: Regulations Guidelines
p.000013:
p.000013: General
p.000013: Department of Transportation:
p.000013: www.dot.gov/
p.000013: Department of Veterans Affairs:
p.000013: 1. Office of Research Oversight (ORO): http://www.va.gov/oro/
p.000013: 2. Office of Research and Development: www.research.va.gov Environmental Protection Agency, Program in Human Research
p.000013: Ethics: https://www.epa.gov/osa/basic- information-about-human-subjects- research-0
p.000013: 49 CFR 11, Subpart A
p.000013:
p.000013: 1. 38 FR 16 (1991), Subpart A
p.000013: 2. 38 CFR 17.85 (1998)
p.000013:
p.000013:
p.000013: 40 CFR 26
p.000013: 1. Subpart A: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
p.000013: (Common Rule)
p.000013: 2. Subpart B: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects
p.000013: who are Children or Pregnant or Nursing Women (2006)
p.000013: 3. Subpart C: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in
p.000013: Observational Research Conducted or Supported by EPA (2006)
p.000013: 4. Subpart D: Observational Research: Additional Protections for Children Involved as Subjects in Observational
p.000013: Research Conducted or Supported by EPA (2006)
p.000013: 5. Subpart K: Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure
p.000013: of Non-pregnant, Non-nursing Adults (2013)
p.000013: 6. Subpart L: Prohibition of Third-Party Research Involving Intentional Exposure to a Pesticide of Human Subjects who
p.000013: are Children or Pregnant or
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p.000014:
p.000014:
p.000014: Various:
p.000014: https://www.research.va.gov/resources/policies
p.000014: /human_research.cfm
p.000014:
p.000014:
p.000014: 1. Scientific and Ethical Approaches for Observational Exposure Studies (2008):
p.000014: http://www.epa.gov/nerl/sots/SEAOES_doc200 80707.pdf
...
p.000015: Clinical Trials: https://www.fda.gov/science- research/science-and-research-special-
p.000015: topics/clinical-trials-and-human-subject- protection
p.000015:
p.000015: Other: https://www.fda.gov/medical- devices/device-advice-comprehensive- regulatory-assistance/guidance-documents-
p.000015: medical-devices-and-radiation-emitting- products
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p.000015: FAQs on ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/manage- recs/faq
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p.000016:
p.000016: Country Key Organizations Legislation
p.000016: Regulations Guidelines
p.000016:
p.000016: Clinical Trials Registry
p.000016:
p.000016:
p.000016: Research Injury
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p.000016:
p.000016: Social-Behavioral Research
p.000016:
p.000016:
p.000016:
p.000016: Privacy/Data Protection
p.000016: Department of Veterans Affairs:
p.000016: 1. Office of Research Oversight (ORO): http://www1.va.gov/oro/
p.000016: 2. Office of Research and Development: www.research.va.gov
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: Department of Defense, Regulatory Affairs: http://www.acq.osd.mil/rd/hptb/programs/ regulatory/
p.000016: Department of Veterans Affairs:
p.000016: 1. Office of Research Oversight (ORO): www1.va.gov/oro/
p.000016: 2. Office of Research and Development: www.research.va.gov
p.000016: All Common Rule agencies.
p.000016:
p.000016:
p.000016: National Science Foundation:
p.000016: https://www.nsf.gov/
p.000016:
p.000016: All Common Rule agencies Department of Health and Human Services (DHHS):
p.000016: 1. National Institutes of Health (NIH):
p.000016: http://privacyruleandresearch.nih.gov/
p.000016: 2. Agency for Healthcare Research and Quality (AHRQ): https://www.ahrq.gov/
p.000016: 3. Office for Civil Rights (OCR):
p.000016: http://www.hhs.gov/ocr/hipaa/
p.000016:
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p.000016:
p.000016:
p.000016: 38 CFR 17.85: Treatment of Research-Related Injuries to Human Subjects: https://www.gpo.gov/fdsys/pkg/CF
p.000016: R-2013-title38-vol1/pdf/CFR-2013- title38-vol1-sec17-85.pdf
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 1. Privacy Act, 5 U.S.C. § 552a (1974): http://www.justice.gov/opcl/privacy act1974.htm
p.000016: 2. Health Insurance Portability and Accountability Act (1996): https://www.gpo.gov/fdsys/pkg/PL
p.000016: AW-104publ191/content-detail.html
p.000016: 3. Confidential Information Protection and Statistical Efficiency Act (CIPSEA) (2002):
p.000016: http://www.eia.gov/cipsea/cipsea.pd f
p.000016: 4. Health Information Technology for Economic and Clinical Health (HITECH) Act (2009): https://www.gpo.gov/fdsys/pkg/PL
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Sections 116(a)(6) and (7) of the Common Rule: https://www.hhs.gov/ohrp/sites/defaul
p.000017: t/files/revised-common-rule-reg-text- unofficial-2018-requirements.pdf DoDI 3216.02 (2011):
p.000017: http://www.dtic.mil/whs/directives/co rres/pdf/321602p.pdf
p.000017:
p.000017: Handbook 1200.5, Appendix F, Paragraph 2a(11)
p.000017:
p.000017:
p.000017:
p.000017: Predominantly Exempt categories 1, 2, and 3, and Expedited
p.000017: categories 6 and 7.
p.000017:
p.000017:
p.000017: Common Rule 111(a)(7) (2018)
p.000017: 1. HIPAA Privacy Rule, 45 CFR parts 160 and 164, Subparts A and C (2002): http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/privacyrule/index.htm l
p.000017: 2. HIPAA Security Rule, 45 CFR parts 160, 162, and 164 (2009): http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/securityrule/index.ht ml
p.000017: 3. HIPAA Breach Notification Rule, 45 CFR §164.400-414: http://www.hhs.gov/ocr/privacy/hipaa
p.000017: /administrative/breachnotificationrule
p.000017: /index.html
p.000017: FAQ:
p.000017: http://www.research.va.gov/resources/ORD_A dmin/clinical_trials/registration-faq.pdf
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Frequently Asked Questions and Vignettes: https://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp
p.000017:
p.000017: NIH:
p.000017: 1. NIH Policy on Certificates of Confidentiality (2017): https://humansubjects.nih.gov/coc/index
p.000017: 2. Various:
p.000017: http://privacyruleandresearch.nih.gov/
p.000017:
p.000017: AHRQ:
p.000017: Confidentiality in AHRQ-Supported Research (2018): https://grants.nih.gov/grants/guide/notice- files/NOT-HS-18-012.html
p.000017:
p.000017: OCR:
p.000017: 1. OCR 21st Century Cures Act Research Guidance on Activities Preparatory to Research (2017):
p.000017: https://www.hhs.gov/sites/default/files/remote-
p.000017:
p.000017: Country Key Organizations Legislation
p.000017: Regulations Guidelines
p.000017:
p.000017: Privacy/Data Protection
p.000017: AW-111publ5/pdf/PLAW- 111publ5.pdf
p.000017: access-research-12-15-17.pdf
p.000017: 2. OCR 21st Century Cures Act Research Guidance om Streamlining Authorization (2018):
p.000017: https://www.hhs.gov/sites/default/files/hipaa- future-research-authorization-guidance- 06122018%20v2.pdf
p.000017:
p.000017:
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p.000017:
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p.000017:
p.000017: Human Biological Materials
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Homeland Security:
p.000017: www.dhs.gov/
p.000017:
p.000017:
p.000017: Social Security Administration:
p.000017: http://www.ssa.gov/
p.000017:
p.000017: All Common Rule agencies
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Department of Health and Human Services, Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000017: Food and Drug Administration:
p.000017: a. Office of In Vitro Diagnostic Device Evaluation and Safety: https://www.fda.gov/medical-
p.000017: devices/products-and-medical- procedures/vitro-diagnostics
p.000017: b. Center for Biologics Research and Evaluation (CBER):
p.000017: - Office of Cellular, Tissue and Gene Therapies
p.000017: - Office of Blood Research and Review: https://www.fda.gov/vaccines-blood- biologics
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Public Law 107-347: https://www.gpo.gov/fdsys/pkg/PL AW-107publ347/pdf/PLAW- 107publ347.pdf
p.000017: Privacy Act (1974): http://www.hhs.gov/foia/privacy/ind ex.html
p.000017:
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p.000018:
p.000018:
p.000018: Predominantly Exempt categories 4, 7, and 8, and Expedited
p.000018: categories 2, 3, and 5 in the
p.000018: Common Rule (2018): https://www.hhs.gov/ohrp/sites/defaul t/files/revised-common-rule-reg-text-
p.000018: unofficial-2018-requirements.pdf
p.000018: Various: https://www.hhs.gov/hipaa/for- professionals/special- topics/research/index.html and
p.000018: https://www.hhs.gov/hipaa/for-
p.000018: professionals/faq/research-uses-and-disclosures
p.000018:
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p.000018:
p.000018:
p.000018: Various: https://www.hhs.gov/ohrp/regulations-and- policy/guidance/biological-materials-and- data/index.html
p.000018: 1. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not
p.000018: Individually Identifiable (2006): https://www.fda.gov/regulatory- information/search-fda-guidance-
p.000018: documents/guidance-informed-consent-vitro- diagnostic-device-studies-using-leftover- human-specimens-are-not
p.000018: 2. In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (2010) : https://www.fda.gov/regulatory-
p.000018: information/search-fda-guidance-
p.000018: documents/vitro-diagnostic-ivd-device-studies-
p.000018:
p.000018: Country Key Organizations Legislation
p.000018: Regulations Guidelines
p.000018:
p.000018: Human Biological Materials
p.000018:
p.000018:
p.000018: Genetic Research
p.000018:
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p.000018: Embryos, Stem Cells, and Cloning
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: All Common Rule agencies
p.000018: 1. DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
p.000018: 2. DHHS National Institutes of Health, Office of Science Policy, Biosafety, Biosecurity, and Emerging Biotechnology
p.000018: Policy Division: https://osp.od.nih.gov/biosafety- biosecurity-and-emerging-biotechnology/
p.000018: 3. DHHS Office for Civil Rights (OCR): https://www.hhs.gov/hipaa/for- professionals/special-topics/genetic-
p.000018: information/index.html
p.000018:
p.000018:
p.000018: Food and Drug Administration, Center for Biologics Evaluation and Research: https://www.fda.gov/vaccines-
p.000018: blood-biologics
p.000018:
p.000018: National Academy of Sciences (NAS):
p.000018: http://www.nationalacademies.org/nrc/
p.000018:
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p.000018: National Institutes of Health:
p.000018: http://stemcells.nih.gov/
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: 1. Research on Transplantation of Fetal Tissue, Public Law 103- 43 (1993): http://www.hhs.gov/ohrp/regulation
p.000018: s-and-policy/guidance/public-law- 103-43/index.html
p.000018: 2. Genetic Information Nondiscrimination Act (2008): https://www.gpo.gov/fdsys/pkg/PL AW-110publ233/content-detail.html
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p.000018: Research on Transplantation of Fetal Tissue. Public Law 103-43
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p.000019:
p.000019:
p.000019: Common Rule 116(c)(9) (2018) HIPAA Privacy Rule Provisions Implementing GINA Requirements at 45 CFR 160.103;
p.000019: 45 CFR 164.502(a)(5)(i); 45 CFR
p.000019: 164.514(g); and 45 CFR
p.000019: 164.520(b)(1)(iii)(C)
p.000019: frequently-asked-questions
p.000019: 3. CBER-Specific: Various: https://www.fda.gov/vaccines-blood- biologics/other-recommendations-biologics-
p.000019: manufacturers/references-regulatory-process- office-tissues-and-advanced-therapies
p.000019:
p.000019: OHRP:
p.000019: Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review
p.000019: Boards (2009): http://www.hhs.gov/ohrp/regulations-and- policy/guidance/guidance-on-genetic-
p.000019: information-nondiscrimination-act/index.html
p.000019:
p.000019: NIH:
p.000019: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2016):
p.000019: https://osp.od.nih.gov/wp- content/uploads/2013/06/NIH_Guidelines.pdf Application of Current Statutory Authorities to
p.000019: Human Somatic Cell Therapy Products and Gene Therapy
p.000019: Products. October 14, 1993. 58 FR 53248:
p.000019: https://www.fda.gov/media/76647/download
p.000019: 1. Guidelines for Human Embryonic Stem Cell Research (2005): http://www.nap.edu/catalog.php?record_id=11 278
p.000019: 2. 2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://books.nap.edu/catalog.php?record_id=12 260
p.000019: 3. 2010 Final Report of the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010
p.000019: Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research:
p.000019: http://www.nap.edu/catalog.php?record_id=12 923
p.000019: 1. Removing Barriers to Responsible Scientific Research Involving Human
p.000019:
p.000019: Country Key Organizations Legislation
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000005: Drugs, Biologics, and Devices
p.000005:
p.000005: United Nations Educational, Scientific, and Cultural Organization, Bioethics Program (UNESCO):
p.000005: https://en.unesco.org/
p.000005: World Health Organization:
p.000005: http://www.who.int/en/
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p.000005: World Medical Association:
p.000005: http://www.wma.net/e/
p.000005:
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p.000005: Drugs
p.000005: International Conference on Harmonization (ICH): http://www.ich.org/
p.000005:
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p.000005: World Health Organization (WHO):
p.000005: http://www.who.int/en/
p.000005:
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p.000005: Devices
p.000005: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
p.000005:
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p.000006: 6
p.000006: 399_ethical_considerations_en.pdf Universal Declaration on Bioethics and Human Rights (2005):
p.000006: http://portal.unesco.org/en/ev.php- URL_ID=31058&URL_DO=DO_TOPIC&U RL_SECTION=201.html
p.000006: 1. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011)
p.000006: 2. Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
p.000006: 3. Managing Ethical Issues in Infectious Disease Outbreaks: Guidance Document (2016)
p.000006: 4. WHO Guidelines on Ethical Issues in Public Health Surveillance (2017)
p.000006:
p.000006: Access: http://www.who.int/ethics/publications/en/ Declaration of Helsinki (2013):
p.000006: https://www.wma.net/policies-post/wma- declaration-of-helsinki-ethical-principles-for-
p.000006: medical-research-involving-human-subjects/
p.000006:
p.000006: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (2016):
p.000006: https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4_2016_1109.pdf
p.000006: 1. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2005):
p.000006: http://whqlibdoc.who.int/publications/2005/92 4159392X_eng.pdf
p.000006: 2. Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
p.000006:
p.000006: IMDRF:
p.000006: Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects-
p.000006:
p.000006: Country Key Organizations Legislation
p.000006: Regulations Guidelines
p.000006:
p.000006: Drugs, Biologics, and Devices
p.000006: Good Clinical Practice” (2015): http://www.imdrf.org/docs/imdrf/final/proced ural/imdrf-proc-150326-statement-
p.000006: iso141552011.pdf
p.000006:
p.000006: Archived Documents from the Global Harmonization Task Force (GHTF), replaced by the IMDRF in 2012:
p.000006: 1. Clinical Evaluation (2007)
p.000006: 2. Clinical Evidence – Key Definitions and Concepts (2007)
p.000006: 3. Post-Market Clinical Follow-Up Studies (2010)
p.000006: 4. Clinical Investigations (2010)
p.000006: 5. Reportable Events During Pre-Market Clinical Investigations (2012)
p.000006: 6. Clinical Evidence for IVD Medical Devices (2012)
p.000006: 7. Scientific Validity Determination and Performance Evaluation (2012)
p.000006: 8. Clinical Performance Studies for IVD Medical Devices (2012)
p.000006:
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p.000006: Research Injury
p.000006:
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p.000006: International Standards Organization:
p.000006: http://www.iso.org/iso/home.html
p.000006:
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p.000006: World Health Organization – International Clinical Trials Registry Platform: http://www.who.int/ictrp/en/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000006:
p.000006: International Committee of Medical Journal Editors: http://www.icmje.org/
p.000006:
p.000006: World Medical Association:
p.000006: http://www.wma.net/e/
p.000006:
p.000007: 7
p.000007: Access: http://www.imdrf.org/ghtf/ghtf- archived-docs.asp
p.000007: Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice. Standard Number 14155:2011:
p.000007: http://www.iso.org/iso/iso_catalogue/catalogu e_ics/catalogue_detail_ics.htm?csnumber=455 57
p.000007: Resolution WHA 58.34 (2005): http://www.wpro.who.int/health_research/poli cy_documents/ministerial_summit_on_health_
p.000007: research_may2005.pdf?ua=1
p.000007: Declaration of Helsinki, Article 35 (2013):
p.000007: http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000007: Clinical Trial Registration: http://icmje.org/recommendations/browse/pub lishing-and-editorial-issues/clinical-trial-
p.000007: registration.html
p.000007: Declaration of Helsinki, Paragraph 15 (2013):
p.000007: http://www.wma.net/en/30publications/10poli
p.000007:
p.000007: Country Key Organizations Legislation
p.000007: Regulations Guidelines
p.000007: cies/b3/index.html
p.000007:
p.000007: Research Injury
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p.000007: Social- Behavioral Research
p.000007: Privacy/Data Protection
p.000007:
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p.000007: Human Biological Materials
p.000007: International Conference on Harmonization (ICH): http://www.ich.org/
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p.000007: Council for International Organizations of Medical Sciences: http://www.cioms.ch/
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p.000007: UNESCO: http://www.unesco.org/
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p.000007: http://www.wma.net/e/index.htm
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p.000007: World Health Organization:
p.000007: http://www.who.int/en/
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p.000007: World Medical Association
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p.000007: International Air Transport Association:
p.000007: http://www.iata.org/
p.000007: International Society for Biological and Environmental Repositories:
p.000007: http://www.isber.org
p.000008: 8
p.000008: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice , Section 5.8 (2016):
p.000008: https://www.ich.org/fileadmin/Public_Web_Si te/ICH_Products/Guidelines/Efficacy/E6/E6_ R2 Step_4.pdf
p.000008: International Ethical Guidelines for Health-related Research Involving Humans (2016), Guideline 14:
p.000008: https://cioms.ch/shop/product/international- ethical-guidelines-for-health-related-research- involving-humans/
p.000008: Code of Conduct and Ethical Guidelines for Social Science Research: http://www.unesco.org/new/fileadmin/MULTI
p.000008: MEDIA/HQ/SHS/pdf/Soc_Sci_Code.pdf
p.000008: 1. Declaration of Helsinki, Paragraph 24 (2013): http://www.wma.net/en/30publications/10poli cies/b3/index.html
p.000008: 2. Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: 1. Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997):
p.000008: www.who.int/csr/emc97_3.pdf
p.000008: 2. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research
p.000008: (2003): http://www.who.int/reproductivehealth/topics/ ethics/human_tissue_use.pdf
p.000008: Declaration of Taipei (2016): https://www.wma.net/policies-post/wma- declaration-of-taipei-on-ethical-
p.000008: considerations-regarding-health-databases- and-biobanks/
p.000008: Infectious Substances and Diagnostic Specimens Shipping Guidelines (2005)
p.000008: 1. ISBER Best Practices: Recommendations for Repositories (2018)
p.000008:
p.000008: Country Key Organizations Legislation
p.000008: Regulations Guidelines
p.000008:
p.000008: Human Biological Materials
p.000008:
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p.000008: Genetic Research
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p.000008: Embryos, Stem Cells, and Cloning
p.000008:
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p.000008: Human Genome Organization:
p.000008: http://www.hugo-international.org/
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p.000026: Ethical Committee of the National Center for AIDS Prevention: http://www.armaids.am/main/index.php?l ng=1
p.000026:
p.000026: 1. Ministry of Health:
p.000026: http://www.bmg.gv.at
p.000026: 2. Forum of Austrian Ethics Committees: http://www.ethikkommissionen.at
p.000026: 3. Bioethics Commission:
p.000026: 1. Law of the Republic of Armenia of May 4, 1996: About Medical Aid, The Maintenance of the Population, Article 21:
p.000026: http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=71619
p.000026: 2. Resolution of the Government of Armenia of January 24, 2002: Procedure for Clinical Trials of New Medications in
p.000026: Armenia: http://www.arlis.am/DocumentView
p.000026: .aspx?docID=9154
p.000026: RA Law on Prevention of Disease Caused by HIV (2012): http://www.arlis.am/DocumentView
p.000026: .aspx?DocID=78616
p.000026:
p.000026: 1. University Act (2011):
p.000026: http://www.ris.bka.gv.at/Dokumente
p.000026: /Erv/ERV_2002_1_120/ERV_2002
p.000026: _1_120.pdf
p.000026: 2. Hospitals Act (2014):
p.000026: http://www.ris.bka.gv.at/GeltendeFa
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p.000027: Regulation on Leading Ethics Committees (2004): http://www.ris.bka.gv.at/GeltendeFas sung.wxe?Abfrage=Bundesnormen&
p.000027: Gesetzesnummer=20003352&ShowP rintPreview=True
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p.000027: Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2013)
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p.000027: Bioethics Commission:
p.000027: 1. Codification of Legislation on Medical Research (2011)
p.000027: 2. Research on Persons without the Capacity to Consent (2013)
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p.000027: Regulations Guidelines
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p.000027: Note: The Austrian states also have privacy/data protection laws
p.000027: http://www.bundeskanzleramt.at/site/3575
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p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
p.000027: 3. Austrian Federal Office for Safety in Health Care: http://www.basg.gv.at/en/basg-austrian-
p.000027: federal-office-for-safety-in-health-care/ Devices
p.000027: 1. Ministry of Health:
p.000027: http://www.bmg.gv.at
p.000027: 2. Austrian Agency for Health and Food Safety: http://www.ages.at/ages/en/ages-austrian-
p.000027: agency-for-health-and-food-safety/
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p.000049: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
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p.000049: http://rama.moh.gov.ge/
p.000049: 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001)
p.000049: 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195
p.000049: (2010)
p.000049: 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
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p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
p.000050: http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf
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p.000050: Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996)
p.000050: including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf
p.000050:
p.000050: Country Key Organizations Legislation
p.000050: Regulations Guidelines
p.000050: Research Injury Convention on Human Rights
p.000050: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000050: 164 (2001)
p.000050:
p.000050: Privacy/Data Protection
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p.000050: Embryos, Stem Cells, and Cloning
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p.000050: General
p.000050: Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home
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p.000050: association/
p.000050: 2. Central Ethics Committee of the German Medical Association (ZEKO):
p.000050: http://www.zentrale-ethikkommission.de/
p.000050: 3. Permanent Working Party of Research Ethics Committees in Germany:
p.000050: http://www.ak-med-ethik-komm.de/
p.000050: 4. German Ethics Council:
p.000050: https://www.ethikrat.org/en/
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p.000020: 1. European Group on Ethics in Science and New Technologies (EGE): https://ec.europa.eu/research/ege/index.cf m
p.000020: 2. Directorate-General for Research and Innovation: http://ec.europa.eu/research/participants/d
p.000020: ocs/h2020-funding-guide/cross-cutting- issues/ethics_en.htm
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p.000020: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000020: 2. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, CETS No. 195
p.000020: (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG
p.000020:
p.000020: 1. Directive 2001/20/EC on the Approximation of the Laws, Regulations and Administrative Provisions of the Member
p.000020: States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products
p.000020: for Human Use: http://ec.europa.eu/health/files/eudra lex/vol- 1/dir_2001_20/dir_2001_20_en.pdf
p.000020: 2. Directive 2005/28/EC Laying
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p.000021: EGE:
p.000021: 1. Ethical Aspects of Clinical Research in Developing Countries (2003): http://ec.europa.eu/bepa/european-group-
p.000021: ethics/docs/avis17_en.pdf
p.000021: 2. Horizon 2020: How to Complete your Ethics Self –Assessment (2015): http://ec.europa.eu/research/participants/portal/
p.000021: doc/call/h2020/h2020-msca-if-2015/1645175- h2020_-_guidance_ethics_self_assess_en.pdf
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p.000022: Human Use, Repealing Directive 2001/20/EC:
p.000022: ne/2012/04/WC500125437.pdf
p.000022: 3. Guideline for Good Clinical Practice E6(R2) (2016): http://www.ema.europa.eu/docs/en_GB/docum
p.000022: ent_library/Scientific_guideline/2009/09/WC5 00002874.pdf
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p.000022: Various: http://ec.europa.eu/consumers/sectors/medical- devices/documents/guidelines/index_en.htm
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p.000023: http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2014_536/reg_2014_536_en. pdf
p.000023: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (1997):
p.000023: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000023: 2. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Article 13,
p.000023: 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
p.000023: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural
p.000023: Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive
p.000023: 95/46/EC (General Data Protection Regulation):
p.000023: http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX
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p.000023: 1. Guidelines on consent under Regulation 2016/679, WP259 rev.01: http://ec.europa.eu/newsroom/article29/item-
p.000023: detail.cfm?item_id=623051
p.000023: 2. Transfers of Personal Data to Third Countries: Applying Articles 25 and 26 of the EU Data Protection Directive
p.000023: (1998): Consent (2018): http://ec.europa.eu/justice/article- 29/documentation/opinion-
p.000023: recommendation/files/1998/wp12_en.pdf
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p.000024: European Medicines Agency (EMA):
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p.000024: Data Protection and Cybercrime Division: http://www.coe.int/t/dghl/standardsetting/ dataprotection/default_EN.asp
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p.000024: European Group on Ethics in Science and New Technologies: http://ec.europa.eu//research/ege/index.cf m
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p.000024: Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1981):
p.000024: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=10 8&CL=ENG
p.000024:
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p.000024: Directive 2004/23/EC on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing,
p.000024: Preservation, Storage, and Distribution of Human Tissues and Cells: http://eur- lex.europa.eu/LexUriServ/LexUriSe
p.000024: rv.do?uri=CELEX:32004L0023:EN
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p.000024: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22, ETS No. 164 (1997):
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p.000025: 1. European Medicines Agency policy on publication of clinical data for medicinal products for human use
p.000025: https://www.ema.europa.eu/documents/other/e uropean-medicines-agency-policy-publication-
p.000025: clinical-data-medicinal-products-human- use_en.pdf
p.000025: 2. Questions and Answers on the European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products
p.000025: for Human Use (2015): http://www.ema.europa.eu/docs/en_GB/docum ent_library/Report/2014/10/WC500174378.pdf
p.000025: 3. External Guidance on the Implementation of the European Medicines Agency Policy on the Publication of Clinical Data
p.000025: for Medicinal Products for Human Use (2016): https://www.ema.europa.eu/documents/regulat
p.000025: ory-procedural-guideline/external-guidance- implementation-european-medicines-agency-
p.000025: policy-publication-clinical-data_en-1.pdf
p.000025: 1. Recommendation No. R (97) 5 on the Protection of Medical Data (1997): https://wcd.coe.int/ViewDoc.jsp?id=571075&S
p.000025: ite=CM&BackColorInternet=C3C3C3&BackC olorIntranet=EDB021&BackColorLogged=F5 D383
p.000025: 2. Article 29 Working Party Documentation: http://ec.europa.eu/justice/data- protection/article-29/index_en.htm
p.000025: Guidelines on Good Clinical Practice Specific to Advanced Therapy Medicinal Products:
p.000025: https://ec.europa.eu/health/sites/health/files/file s/eudralex/vol-10/atmp_guidelines_en.pdf
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p.000025: Recommendation Rec (2016) 6 of the Committee of Ministers to Member States on Research on Biological Materials of Human
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p.000025: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000025: Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation
p.000025: (EC) No. 726/2004: http://ec.europa.eu/health/files/eudra lex/vol- 1/reg_2007_1394/reg_2007_1394_e n.pdf
p.000025: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14, ETS No. 164 (1997):
p.000025: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000025: 2. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, CETS No. 195
p.000025: (2005): http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=19 5&CM=1&DF=10/24/2007&CL=E NG
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p.000025: 1. Statements by the Commission Re: Article 6 (2006): http://www.uv.es/operuv/docs_7pm/ FP7ECStatementsComm_Ethical.pd
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p.000025: 2. Statement of the Commission Related to Research Activities Involving Human Embryonic Stem Cells (2013):
p.000025: http://eur- lex.europa.eu/LexUriServ/LexUriSe
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p.000026: http://wcd.coe.int/ViewDoc.jsp?id=612007&Si te=CM&BackColorInternet=9999CC&BackCo
p.000026: lorIntranet=FFBB55&BackColorLogged=FFA C75
p.000026: 2. Recommendation Rec (2006)4 of the Committee of Ministers to Members States on Research on Biological Materials of
p.000026: Human Origin (2016): https://search.coe.int/cm/Pages/result_details.as px?ObjectId=090000168064e8ff
p.000026: 3. Recommendation Rec(2016)8 of the Committee of Ministers to Member States on the Processing of Personal Health-
p.000026: Related Data for Insurance Purposes, Including Data Resulting from Genetic Tests (2016):
p.000026: https://search.coe.int/cm/Pages/result_details.as px?ObjectId=09000016806b2c5f
p.000026: 1. Commission Staff Working Paper Report on Human Embryonic Stem Cell Research (2003):
p.000026: https://ec.europa.eu/research/press/2003/pdf/se c2003-441report_en.pdf
p.000026: 2. Opinion No. 22 - The Ethics Review of hESC FP7 Research Projects (2007):
p.000026: http://bookshop.europa.eu/ga/recommendations
p.000026: -on-the-ethical-review-of-hesc-fp7-research- projects-pbKAAJ07022/downloads/KA-AJ-07- 022-EN-
p.000026: C/KAAJ07022ENC_002.pdf;pgid=y8dIS7GU
p.000026:
p.000026: Country Key Organizations Legislation
p.000026: Regulations Guidelines
p.000026:
p.000026: Embryos, Stem Cells, and Cloning
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Armenia
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Council of Europe, Bioethics Unit:
p.000026: http://www.coe.int/bioethics
p.000026: rv.do?uri=OJ:C:2013:373:0012:001 5:EN:PDF
p.000026:
p.000026:
p.000026: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 18, ETS No. 164 (1997):
p.000026: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000026: 2. Additional Protocol on Prohibition of Human Cloning, ETS No. 168 (1998): http://conventions.coe.int/Treaty/Comm
p.000026: un/QueVoulezVous.asp?NT=168&CM= 7&DF=9/15/2008&CL=ENG
p.000026: WMdSR0EAlMEUUsWb0000dz-
p.000026: kvfzb;sid=Iexx3tq0IOFxyokBvtfvebiRJj93DZf XP54=?FileName=KAAJ07022ENC_002.pdf
p.000026: &SKU=KAAJ07022ENC_PDF&CatalogueNu mber=KA-AJ-07-022-EN-C
p.000026: Statement on Genome Editing Technologies by the Committee on Bioethics (2015): https://rm.coe.int/168049034a
p.000026: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS
p.000026: Countries,” Chapter 3, Section 1:
p.000026: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000026: Note: All websites and documents are in Armenian.
p.000026:
p.000026: Drugs, Biologics, and Devices
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Human Biological Materials
p.000026:
p.000026:
p.000026: Austria
p.000026: General
p.000026: 1. Drug and Medical Technology Agency: http://www.pharm.am/
p.000026: 2. Ethics Committee of the Ministry of Health
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: Ethical Committee of the National Center for AIDS Prevention: http://www.armaids.am/main/index.php?l ng=1
p.000026:
p.000026: 1. Ministry of Health:
p.000026: http://www.bmg.gv.at
p.000026: 2. Forum of Austrian Ethics Committees: http://www.ethikkommissionen.at
p.000026: 3. Bioethics Commission:
...
p.000032: concertation/commission-federale- embryons
p.000032: 3. Law on Medically Assisted Reproduction and the Destination of Supernumerary Embryos and Gametes (2007):
p.000032: https://www.afmps.be/fr/humain/pro duits_de_sante/materiel_corporel_h umain/banques_de_materiel_corpor
p.000032: el_humain/legislation/apres_le_01_ 12_2009
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Royal Decree Fixing the Criteria for the Program Applicable to the Care Programs ‘Reproductive Medicine’ (15 February
p.000032: 1999): https://organesdeconcertation.sante.be lgique.be/fr/organe-d'avis-et-de- concertation/commission-federale-
p.000032: embryons
p.000032: CSS:
p.000032: Various: https://www.health.belgium.be/en/superior- health- council?f%5B0%5D=field_shc_doc%3A1145 BACB:
p.000032: 1. Opinion No. 10: Reproductive Human Cloning (1999)
p.000032: 2. Opinion No. 18: Research on Human Embryos in Vitro (2002)
p.000032: 3. Opinion No. 33: Somatic and Germinal Line Gene Modification (2005)
p.000032: 4. Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012)
p.000032:
p.000032: Access: http://www.health.belgium.be/en/belgian- advisory-committee-bioethics
p.000032: Bosnia and Herzegovina
p.000032: Note: All websites and documents are in Bosnian.
p.000032: General 1. Convention on
p.000032: Human Rights
p.000032: and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (2007):
p.000032: 2. Additional Protocol Concerning Biomedical Research, CETS No. 195 (2007)
p.000032: 3. Law on Health Protection, MoH Republic of Srpska (2015): http://www.vladars.net/sr-SP-
p.000032: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20zdravstven
p.000032:
p.000033: 33
p.000033:
p.000033: Country Key Organizations Legislation
p.000033: Regulations Guidelines
p.000033:
p.000033: General
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Drugs, Biologics, and Devices
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Federation of Bosnia and Herzegovina
p.000033: 1. Ministry of Health:
p.000033: http://www.fmoh.gov.ba/
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
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p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: Republic of Srpska
p.000033: 1. Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000033: ges/Splash.aspx
p.000033: 2. Medicines and Medical Devices Agency of Bosnia and Herzegovina: http://www.almbih.gov.ba/
p.000033: oj%20zastiti%20sa%20izmjenama
p.000033: %20106-99%20%2044-15.pdf
p.000033: 4. Law on Health Protection, MoH Federation of Bosnia and Herzegovina, No 46/10:
p.000033: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- zdravstvenoj-zastiti
p.000033:
...
p.000035:
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p.000035:
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p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Bulgaria
p.000035: General
p.000035: Ministry of Health: http://www.fmoh.gov.ba/
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Republic of Srpska
p.000035: Ministry of Health and Social Welfare (Bosnian): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/OMin/Pa
p.000035: ges/Splash.aspx
p.000035:
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p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Ministry of Healthcare:
p.000035: http://www.mh.government.bg/
p.000035: 1. Law on Transplantation of Organs and Tissues, Official Gazette of Bosnia and Herzegovina No. 75/09:
p.000035: http://www.fmoh.gov.ba/index.php/ zakoni-i-strategije/zakoni/zakon-o- transplantaciji-organa-i-tkiva-u- svrhu-lijecenja
p.000035: 2. Law on Blood and Blood Products, Official Gazette of Bosnia and Herzegovina No. 09/10:
p.000035: http://www.fbihvlada.gov.ba/bosans ki/zakoni/2010/zakoni/8bos.htm
p.000035:
p.000035: 1. Law on Transplantation of Organs (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Doc
p.000035: uments/Zakon%20o%20transplanta ciji%20ljudskih%20organa.pdf
p.000035: 2. Law on Transplantation of Human Tissues and Cells (2010): http://www.vladars.net/sr-SP-
p.000035: Cyrl/Vlada/Ministarstva/MZSZ/Doc uments/Zakon%20o%20transplanta ciji%20ljudskih%20tkiva%20i%20c elija.pdf
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 1. Constitution of the Republic of Bulgaria, Amendment SG. 18/25, Article 29 (2015): http://www.parliament.bg/bg/const
p.000035: 2. Oviedo Convention on Human Rights and Biomedicine (2003)
p.000035: 3. Law Ratifying the Additional Protocol on Biomedical Research (2006): https://www.mh.government.bg/me
p.000035: dia/filer_public/c6/12/c612c85a-
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p.000036:
p.000036:
p.000036:
p.000036: Rulebook about Testing Procedure for Donor of Transplant Organs in Terms of Diseases Which can be Transmitted by
p.000036: Transplantation (2010): http://www.vladars.net/sr-SP- Cyrl/Vlada/Ministarstva/MZSZ/Documents/%d
p.000036: 0%9f%d1%80%d0%b0%d0%b2%d0%b8%d0
p.000036: %bb%d0%bd%d0%b8%d0%ba_%d0%be_%d 0%ba%d1%80%d0%b8%d1%82%d0%b5%d1
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p.000036: b8%d0%bc%d0%b0_%d0%b7%d0%b0_%d1
p.000036: %82%d0%b5%d1%81%d1%82%d0%b8%d1
p.000036: %80%d0%b0%d1%9a%d0%b5_%d0%b4%d0
p.000036: %b0%d0%b2%d0%b0%d0%bb%d0%b0%d1
p.000036: %86%d0%b0_%d1%99%d1%83%d0%b4%d1
p.000036: %81%d0%ba%d0%b8%d1%85_%d0%be%d1
p.000036: %80%d0%b3%d0%b0%d0%bd%d0%b0_64_1 0.pdf
p.000036:
p.000036: Country Key Organizations Legislation
p.000036: Regulations Guidelines
p.000036:
p.000036: General
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Drugs, Biologics, and Devices
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
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p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Research Injury
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: Drugs
p.000036: 1. Ministry of Healthcare (MOH):
p.000036: http://www.mh.government.bg/
...
p.000037: 2. Research (2018): https://www.cpdp.bg/en/index.php?p=element &aid=1162
p.000037: 3. Consent (2018): https://www.cpdp.bg/en/index.php?p=element &aid=1162
p.000037:
p.000038: 38
p.000038:
p.000038: Country Key Organizations Legislation
p.000038: Regulations Guidelines Croatia
p.000038: Note: All websites and documents are in Croatian.
p.000038:
p.000038: General
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: Drugs, Biologics, and Devices
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: Research Injury
p.000038: Central Ethics Committee: http://www.halmed.hr/en/O-HALMED- u/Sredisnje-eticko-povjerenstvo-SEP/
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: Drugs
p.000038: 1. Ministry of Health:
p.000038: https://zdravlje.gov.hr/
p.000038: 2. Agency for Medicinal Products and Medical Devices: http://www.halmed.hr/
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038: Devices
p.000038: 1. Ministry of Health:
p.000038: https://zdravlje.gov.hr/
p.000038: 2. Agency for Medicinal Products and Medical Devices: http://www.halmed.hr/
p.000038: 1. Agency for Medicinal Products and Medical Devices of Croatia: http://www.halmed.hr/
p.000038: 2. Ministry of Health:
p.000038: https://zdravlje.gov.hr/
p.000038: 3. Croatian Health Insurance Fund:
p.000038: http://www.hzzo.hr/en/
p.000038: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (1997):
p.000038: http://conventions.coe.int/Treaty/Co mmun/QueVoulezVous.asp?NT=16 4&CM=7&DF=9/15/2008&CL=EN G
p.000038: 2. Patient Protection Act, Article 20 (2008): http://www.zakon.hr/z/255/Zakon- o-za%C5%A1titi-prava-pacijenata
p.000038:
p.000038: 1. Medicinal Product Act (2013):
p.000038: http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1522.html
p.000038: 2. Rule Book on Amendments to Medicinal Product Act (2014): http://narodne- novine.nn.hr/clanci/sluzbeni/2014_0
p.000038: 7_90_1809.html
p.000038:
p.000038:
p.000038:
p.000038: Medical Devices Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1521.html
p.000038:
p.000038: 1. Law on Mandatory Health Insurance (2013): http://www.hzzo.hr/wp- content/uploads/2013/10/ZOZO_PR
p.000038: OCISCENI_TEKSTv2.pdf?6d8ad4
p.000038: 2. Medicinal Product Act (2013): http://narodne- novine.nn.hr/clanci/sluzbeni/2013_0 6_76_1522.html
p.000038: 3. Rule Book on Amendments to Medicinal Product Act (2014): http://narodne- novine.nn.hr/clanci/sluzbeni/2014_0
p.000039: 39
p.000039:
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p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: 1. Ordinance on Clinical Trials and Good Clinical Practice (2015): http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03
p.000039: _25_534.html
p.000039: 2. Ordinance on Amendments to the Ordinance on Clinical Trials and Good Clinical Practice (2015):
p.000039: https://narodne- novine.nn.hr/clanci/sluzbeni/2014_07
p.000039: _90_1809.html
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: Ordnance on Clinical Trials and Good Clinical Practice, Articles 11 and 16, Act 5.8., 6.8. and
p.000039: 8.2.5 (2015):
p.000039: http://narodne- novine.nn.hr/clanci/sluzbeni/2015_03
p.000039: _25_534.html
p.000039:
...
p.000040:
p.000040: Embryos, Stem Cells, and Cloning
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Cyprus
p.000040: General
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Drugs, Biologics, and Devices
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Research Injury
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Privacy/Data Protection
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
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p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: 1. Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/Moh/phs/phs.nsf/
p.000040: dmlindex_en/dmlindex_en?opendocument
p.000040: 2. Ministry of Health, National Bioethics Committee: http://www.bioethics.gov.cy/moh/cnbc/cn
p.000040: bc.nsf/index_en/index_en?OpenDocumen t
p.000040: Ministry of Health, Pharmaceutical Services: http://www.moh.gov.cy/moh/moh.nsf/ind ex_en/index_en?OpenDocument
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000040: Commissioner's Office for the Protection of Personal Data: http://www.dataprotection.gov.cy/dataprot
p.000040: ection/dataprotection.nsf/index_en/index_ en?opendocument
p.000040: 2. Medical Fertilization Act, Article 32: (2012): http://www.hzzo- net.hr/dload/zakoni/20_01.pdf
p.000040: 3. Law on the Implementation of Human Tissues and Cells (2012): http://narodne- novine.nn.hr/clanci/sluzbeni/2012_1
p.000040: 2_144_3070.html
p.000040:
p.000040: 1. Law No. 31 (III)/2001:
p.000040: Oviedo Convention on Human Rights and Biomedicine
p.000040: 2. The Safeguarding and Protection of Patients’ Rights Law (2004): http://www.bioethics.gov.cy/Moh/c
p.000040: nbc/cnbc.nsf/All/745717D26F0685 82C2257CCA003B350F/$file/Patie nts%20Rights%20Law- English%20translation.pdf
p.000040: Law for Good Clinical Practice (2004):
p.000040: http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C
p.000040: F%84%CE%BF%CF%85%202004.
p.000040: pdf?OpenElement
p.000040:
p.000040: Legislation Concerning Medicinal Products of Human Use (Good Clinical Practice) No. 452/2004 Article 11 (8):
p.000040: http://www.moh.gov.cy/Moh/phs/ph s.nsf/All/9C064264122B82BEC225 72FA003433A5/$file/%CE%9A.% CE%94.%CE%A0.%20452%20%C
p.000040: F%84%CE%BF%CF%85%202004.
p.000040: pdf?OpenElement
p.000040: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000040: 2. Protection of Natural Persons Against the Processing of Personal Data and the Free
p.000041: 41
p.000041:
p.000041: Country Key Organizations Legislation
p.000041: Regulations Guidelines
p.000041:
p.000041: Privacy/Data Protection
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Embryos, Stem Cells, and Cloning
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Czech Republic
p.000041: General
p.000041:
p.000041:
p.000041:
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p.000041: Drugs, Biologics, and Devices
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p.000041:
p.000041: Ministry of Health, Central Ethics Committee: http://www.mzcr.cz
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041:
p.000041: Drugs
p.000041: 1. Ministry of Health (MOH):
p.000041: http://www.mzcr.cz
p.000041: 2. State Institute for Drug Control (SUKL): http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Devices
p.000041: State Institute for Drug Control (SUKL):
p.000041: http://www.sukl.cz/index.php?lchan=1&lr ed=1
p.000041: Circulation of such Data Act of 2018 (Law 125 (I)):
p.000041: http://www.dataprotection.gov.cy/d ataprotection/dataprotection.nsf/all/ DE97F6F59835A03AC22582DD00
p.000041: 3D895E/$file/%CE%9D%CF%8C
p.000041: %CE%BC%CE%BF%CF%82%201
p.000041: 25(%CE%99)_2018.pdf?openeleme nt
p.000041: Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000041: the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (2002)
p.000041:
p.000041: 1. Oviedo Convention on Human Rights and Biomedicine (2001)
p.000041: 2. Act No. 130/2002 Collection on Research and Development Support, as Amended (2018)
p.000041: 3. Act No. 372/2011 on Healthcare Services, As Amended (2019)
p.000041: 4. Act. No. 373/2011 on Specific Healthcare Services, As Amended (2018)
p.000041:
p.000041: Act No. 378/2007 Collection on Pharmaceuticals, As Amended (2019)
p.000041:
p.000041:
p.000041:
p.000041: 1. Act No 268/2014 Coll., on Medical Devices and on Amendment to Act. 634/2004 Coll., on Administrative Fees, As
p.000041: Amended (2017)
p.000041: 2. Decree No 62/2015 Coll. Implementing Certain Provisions of the Act on
p.000042: 42
p.000042:
p.000042:
p.000042:
p.000042:
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p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: MOH:
p.000042: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical- devices?highlightWords=501%2F200 0
p.000042:
p.000042:
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p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: SUKL:
p.000042: Various:
p.000042: http://www.sukl.cz/medicinal-products- clinical-trials-guidelines-1
p.000042:
p.000042:
p.000042:
p.000042: Various:
p.000042: http://www.sukl.cz/medical-devices-guidelines
p.000042:
p.000042: Country Key Organizations Legislation
p.000042: Regulations Guidelines
p.000042: Medical Devices
p.000042: Research Injury 1. Convention on Human
p.000042: Rights
p.000042: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000042: 164 (2001)
p.000042: 2. Law No. 89/2012 Coll. Civil Code: http://www.czechlegislation.com/en
p.000042: /89-2012-sb
p.000042:
p.000042: Privacy/Data Protection
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Embryos, Stem Cells, and Cloning
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Denmark
p.000042: General
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Drugs, Biologics, and Devices
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Research Injury
p.000042: Office for Personal Data Protection:
p.000042: https://www.uoou.cz/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: 1. Ministry of Education, Youth, and Sport: http://www.msmt.cz/index.php?lchan=1& lred=1
p.000042: 2. Research and Development Council, Bioethical Commission: http://www.vyzkum.cz/FrontClanek.aspx? idsekce=15908
p.000042:
p.000042: National Committee on Health Research Ethics (NVK): http://www.nvk.dk/english
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Danish Medicines Agency:
p.000042: https://laegemiddelstyrelsen.dk/en/
p.000042:
p.000042:
p.000042:
p.000042:
p.000042: Patient Compensation Association:
p.000042: http://pebl.dk/en.aspx
p.000042: 1. Act No. 110/2019 Coll., On Personal Data Processing: https://www.uoou.cz/en/assets/File.
p.000042: ashx?id_org=200156&id_dokument y=1837
p.000042: 2. General Data Protection Regulation (2018): https://gdpr-info.eu/
...
p.000043:
p.000043:
p.000043:
p.000043: Danish Council of Ethics:
p.000043: http://www.etiskraad.dk/english
p.000043:
p.000043:
p.000043:
p.000043:
p.000043: Estonian Council on Bioethics:
p.000043: http://www.eetikakeskus.ut.ee/en
p.000043: 0cc47a6a52de- 8126763cf8cbd825&u=https://www
p.000043: .retsinformation.dk/forms/R0710.as px?id=202098
p.000043: 2. Act No. 1022 on the Right to Complain and Receive Compensation within the Health Service (2017):
p.000043: https://www.retsinformation.dk/For ms/R0710.aspx?id=192623
p.000043: 1. Act No. 429 on Processing of Personal Data (2007): https://www.datatilsynet.dk/med ia/6894/danish-data-protection-
p.000043: act.pdf
p.000043: 2. General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000043: 1. Act No. 1083 on Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For
p.000043: ms/R0710.aspx?id=192671
p.000043: 2. Data Protection Act 2018: https://www.datatilsynet.dk/media/6 894/danish-data-protection-act.pdf Act No. 1083 on
p.000043: Research Ethics Review of Health Research Projects (2017): https://www.retsinformation.dk/For ms/R0710.aspx?id=192671
p.000043:
p.000043: 2013 version (English): http://www.nvk.dk/english/act-on- research
p.000043: Act No. 440 on Danish Council of Ethics (2004): https://www.retsinformation.dk/for ms/r0710.aspx?id=9909
p.000043:
p.000043:
p.000043: 1. Oviedo Convention on Human Rights and Biomedicine (2002)
p.000043: 2. Constitution of the Republic
p.000044: 44
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Executive Order No. 903 on Health Law, Chapter 9 (2019): https://www.retsinformation.dk/Form
p.000044: s/R0710.aspx?id=210110#id56770de c-1ec6-44de-9fb0-8fabec8f4a62
p.000044:
p.000044:
p.000044:
p.000044: Health Law (2019): https://www.retsinformation.dk/Form s/R0710.aspx?id=210110
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Executive Order No. 902 on Medically Assisted Procreation (2019):
p.000044: https://www.retsinformation.dk/Form s/R0710.aspx?id=210080
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Guidelines on the Use of Biological Material in Health Research Projects (2017):
p.000044: http://www.nvk.dk/emner/biobanker/vejledning
p.000044: -om-bio-mat
p.000044:
p.000044:
p.000044:
p.000044: Guidelines on Health Research Projects Involving Genome Research (2018): http://www.nvk.dk/emner/genomer/vejledning-
p.000044: om-genomer
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044:
p.000044: Code of Ethics of Estonian Scientists: http://www.akadeemia.ee/_repository/File/AL USDOKUD/Code-ethics.pdf
p.000044:
p.000044: Country Key Organizations Legislation
p.000044: Regulations Guidelines
p.000044:
p.000044: General
p.000044:
...
p.000047:
p.000047: France
p.000047: General
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Drugs, Biologics, and Devices
p.000047: 2. Board for Gene Technology:
p.000047: http://www.geenitekniikanlautakunta.fi/en
p.000047:
p.000047:
p.000047:
p.000047: 1. National Supervisory Authority for Welfare and Health: http://www.valvira.fi/web/en
p.000047: 2. National Committee on Medical Research Ethics (TUKIJA) http://www.tukija.fi/en
p.000047: 3. Finnish Advisory Board on Research Integrity (TENK): http://www.tenk.fi/en/
p.000047: 4. National Advisory Board on Social Welfare and Health Care Ethics (ETENE): http://www.etene.fi/en
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 1. Ministry of Social affairs and Health: http://www.sante.gouv.fr/
p.000047: 2. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr/en
p.000047: 3. National Commission for Information and Freedoms (CNIL): https://www.cnil.fr/en/home
p.000047: 1. National Consultative Bioethics Committee for Health and Life Sciences (CCNE): http://www.ccne- ethique.fr
p.000047: 2. National Health Products Safety Agency (ANSM): http://ansm.sante.fr/
p.000047: http://www.finlex.fi/en/laki/kaannok set/1999/en19990488
p.000047: 2. Gene Technology Act No. 377/1995: https://www.finlex.fi/fi/laki/ajantasa
p.000047: /1995/19950377
p.000047: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000047: Cloning (2002)
p.000047: 2. Medical Research Act No. 488/1999 (amended 295/2004, 749/2010, and 143/2015): http://www.finlex.fi/en/laki/kaannok
p.000047: set/1999/en19990488
p.000047: 3. Act on Assisted Fertility Treatments No. 1237/2006: http://www.finlex.fi/fi/laki/ajantasa/ 2006/20061237
p.000047: 4. Criminal Code of Finland (39/1889), Chapter 22, Section 4: Cloning of a Human is Forbidden:
p.000047: https://www.finlex.fi/en/laki/kaanno kset/1889/en18890039.pdf
p.000047:
p.000047:
p.000047: 1. Law No. 2012-300 of 5
...
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Ethical Issues in Connection with the Development of Foetal Genetic Testing on Maternal Blood (2013)
p.000049: 2. Ethical Reflection on Developments in Genetic Testing in Connection with Very High Throughput Human DNA Sequencing
p.000049: (2016)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: 1. Commercialization of Human Stem Cells and Other Cell Lines (2006)
p.000049: 2. Opinion on the Ethical Reflection Concerning Research on Human Embryonic Cells and on Human Embryos in Vitro (2010)
p.000049:
p.000049: Access:
p.000049: http://www.ccne- ethique.fr/en/type_publication/avis
p.000049: For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS
p.000049: Countries,” Chapter 3, Section 4:
p.000049: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000049:
p.000049: General
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: Drugs, Biologics, and Devices
p.000049: Bioethics and Health Law Studies Society: http://www.patientsrights.ge/index.php?pa ge=385&lang=geo
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049:
p.000049: State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs:
p.000049: http://rama.moh.gov.ge/
p.000049: 1. Oviedo Convention on Human Rights and Biomedicine ETS No.164 (2001)
p.000049: 2. Additional Protocol to the Convention’s on Human Rights and Biomedicine, concerning Biomedical Research, ETS No. 195
p.000049: (2010)
p.000049: 3. Law on Health Care, Chapter XIX (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000049: Law on Medicines and Pharmaceutical Activities No. 659 and 1586 (2015):
p.000049: https://matsne.gov.ge/en/document/ view/29836?impose=translateEn
p.000049:
p.000050: 50
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Regulation about the Rules and Conditions of Issuing of the Approval of Clinical Trials Approved #176 (2005):
p.000050: http://rama.moh.gov.ge/res/docs/2016 0809105943176.pdf
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Order of Health Minister about Implementation of “ICH: E6 Good Clinical Practice: Consolidated Guidance” (1996)
p.000050: including WMA: Declaration of Helsinki (2013): http://rama.moh.gov.ge/res/docs/9539N233.pdf
p.000050:
p.000050: Country Key Organizations Legislation
p.000050: Regulations Guidelines
p.000050: Research Injury Convention on Human Rights
p.000050: and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000050: 164 (2001)
p.000050:
p.000050: Privacy/Data Protection
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Embryos, Stem Cells, and Cloning
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: Germany
p.000050: General
p.000050: Office of the Personal Data Protection Inspector: https://personaldata.ge/en/home
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050: 1. German Medical Association (BÄK): http://www.bundesaerztekammer.de/weite re-sprachen/english/german-medical-
p.000050: association/
p.000050: 2. Central Ethics Committee of the German Medical Association (ZEKO):
p.000050: http://www.zentrale-ethikkommission.de/
p.000050: 3. Permanent Working Party of Research Ethics Committees in Germany:
p.000050: http://www.ak-med-ethik-komm.de/
p.000050: 4. German Ethics Council:
p.000050: https://www.ethikrat.org/en/
p.000050: 5. Federal Ministry of Health (BMG): http://www.bundesgesundheitsministeriu m.de/en/en.html
p.000050: 6. German Research Foundation (DFG), Permanent Senate Commission on Key Questions in Clinical Research (SCCR):
p.000050: http://www.dfg.de/en/dfg_profile/statutor y_bodies/senate/clinical_research/index.ht
p.000050: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000050: 2. Law on Data Protection (2018): https://matsne.gov.ge/en/document/ view/1561437?publication=15
p.000050: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Additional Protocol on Prohibition of Human
p.000050: Cloning ETS No. 168 (2001)
p.000050: 2. Law on Health Care, Article 142 (2017): https://matsne.gov.ge/en/document/ view/29980?publication=37
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
p.000050:
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p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: BÄK:
p.000051: (Model) Professional Code for Physicians in Germany, Article 15 (2018): http://www.bundesaerztekammer.de/fileadmin/
p.000051: user_upload/downloads/pdf- Ordner/MBO/MBO-AE_EN_2018.pdf
p.000051:
p.000051: Country Key Organizations Legislation
p.000051: Regulations Guidelines
p.000051: ml
p.000051:
p.000051: Drugs, Biologics, and Devices
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Clinical Trials Registry
p.000051:
p.000051: Research Injury
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: Privacy/Data Protection
p.000051:
p.000051: Note: The 16 German states also have data protection
p.000051: Drugs
p.000051: 1. Federal Institute for Drugs and Medical Devices (BfArM): http://www.bfarm.de/EN/Home/home_no de.html
...
p.000057:
p.000057: Embryos, Stem Cells, and Cloning
p.000057: Hungary
p.000057: Note: All webpages and documents are in Hungarian.
p.000057: Reproduction
p.000057: Access: http://www.bioethics.gr/index.php/gnomes
p.000057:
p.000057: General
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
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p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs, Biologics, and Devices
p.000057: 1. Ministry of Human Capacities (EMMI): http://www.kormany.hu/hu/emberi- eroforrasok-miniszteriuma
p.000057: 2. Medical Research Council, Research Ethics Committees (KFEB, TUKEB, HRB): https://ett.aeek.hu/en/secretariat/
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: Drugs
p.000057: 1. National Institute of Pharmacy and Nutrition: http://www.ogyei.gov.hu
p.000057: 2. Medical Research Council, Ethics Clinical Pharmacology Ethics Committee (KFEB): https://ett.aeek.hu/kfeb/
p.000057: 1. Fundamental Law of Hungary, Updated with the Fifth Amendment (2016), Articles II- III:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=140968.322953
p.000057: 2. Act CLIV of 1997 on Health Care, Chapters VIII and IX: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=30903.339193
p.000057: 3. Act VI. of 2002 on the Promulgation of the Oviedo Convention on Human Rights and Biomedicine:
p.000057: http://njt.hu/cgi_bin/njt_doc.cgi?doc id=64201.264663
p.000057: 4. Act LXXXI of 2006 on the Promulgation of the Additional Protocol to the Convention on Human Rights and Biomedicine,
p.000057: Concerning Biomedical Research
p.000057: 5. Act C of 2012 on the Criminal Code, Chapter XVI Medical Procedures and Criminal Offenses Against the Order of
p.000057: Research, Sections 168-175
p.000057:
p.000057: Clinical Trials:
p.000057: Act XCV of 2005 on Medicinal Products for Human Use, Section 3: http://net.jogtar.hu/jr/gen/getdoc.cgi
p.000057: ?docid=a0500095.tv&dbnum=62
p.000057:
p.000057: Non-Interventional Trials: Act CLIV of 1997 on Health Care, Chapter VIII, Section 164/A:
p.000057: http://net.jogtar.hu/jr/gen/hjegy_doc
p.000058: 58
p.000058: 1. Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings:
p.000058: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0200023.EUM&celpara= #xcelparam
p.000058: 2. Decree 35/2005 (VIII.26.) of
p.000058: the Minister of Health on the Clinical Trials of Investigational Medicinal Products for Human Use and on the
p.000058: Application of Good Clinical Practice: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0500035.EUM
p.000058: 3. Decree No. 235/2009 (X.20.)
p.000058: from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical
p.000058: Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices:
p.000058: http://net.jogtar.hu/jr/gen/hjegy_doc.c gi?docid=A0900235.KOR&celpara= #xcelparam
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Clinical Trials:
...
p.000060: =99800018.EUM&celpara=#xcelparam
p.000060:
p.000060: NBC:
p.000060: 1. Vulnerable Groups Including Children: http://www.vsn.is/en/content/vulnerable- groups-including-children
p.000060:
p.000060: Country Key Organizations Legislation
p.000060: Regulations Guidelines
p.000060:
p.000060: General
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs, Biologics, and Devices
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
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p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Research Injury
p.000060: (NBC):
p.000060: http://www.vsn.is/en
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Drugs
p.000060: 1. Icelandic Medicines Agency (MCA):
p.000060: http://www.ima.is/
p.000060: 2. National Bioethics Committee (NBC):
p.000060: www.visindasidanefnd.is
p.000060:
p.000060:
p.000060: Devices
p.000060: Ministry of Health: https://www.government.is/ministries/min istry-of-health/
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Icelandic Health Insurance Agency (MCA):
p.000060: http://www.sjukra.is/english
p.000060: media/media/acrobat- enskar_sidur/Health-Sector- Research-Act-No-44-2014.pdf
p.000060: 3. Oviedo Convention on Human Rights and Biomedicine (2004)
p.000060:
p.000060:
p.000060:
p.000060:
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p.000060: Medicinal Products Act No. 93/1994 (2013):
p.000060: http://eng.velferdarraduneyti.is/acts- of-Parliament/nr/20128
p.000060:
p.000060:
p.000060:
p.000060:
p.000060:
p.000060: Act on Medical Devices No 16/2001 (2011):
p.000060: https://www.government.is/media/v elferdarraduneyti- media/media/acrobat- enskar_sidur/Medicinal-Products-
p.000060: Act-NoMedicinal-Products-Act-No- 93-1994-as-amended.pdf
p.000060:
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p.000061:
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p.000061:
p.000061: MCA:
p.000061: Regulation on Clinical Trials of Medicinal Products in Humans No. 443/2004 (2010):
p.000061: http://eng.velferdarraduneyti.is/media
p.000061: /acrobat-enskar_sidur/Medicinal- Products-Act-NoMedicinal-Products- Act-No-93-1994-as-amended.pdf
p.000061:
p.000061: 1. Regulation on Medical Devices No. 934/2010 (2010): http://eng.velferdarraduneyti.is/media
p.000061: /acrobat-enskar_sidur/16012012_Act- on-Medical-Devices-No-16-2001-as- amended.pdf
p.000061: 2. Regulation on Active Implantable Medical Devices No. 320/2011: http://www.stjornartidindi.is/Advert.a
p.000061: spx?ID=c50d676c-4651-46c2-83b5- ad946f3deeaa
p.000061: 3. Regulation on In Vitro Diagnostic Medical Devices No. 936/2011: http://stjornartidindi.is/Advert.asp
p.000061: x?ID=f20b3e4e-ab25-44d3-8e32- e5f42a7b02f0
...
p.000066: 2. Law on the Development and Use of the National DNA Database (2006): https://likumi.lv/ta/en/en/id/90819-
p.000066: law-on-development-and-use-of- the-national-dna-database
p.000066: Sexual and Reproductive Health Law, Sections 15-20 (2004): https://likumi.lv/ta/en/en/id/58982-
p.000066: sexual-and-reproductive-health-law
p.000066: Procedures for the Clinical Trial of Medical Devices Intended for Human Use, Sections 42.7 and 62.5 (2010):
p.000066: https://likumi.lv/ta/en/en/id/218764- procedures-for-the-clinical-trial-of- medical-devices-intended-for-human- use
p.000066: Cabinet Regulation No. 446: Procedures for Using Patient Data in a Specific Research Study (2015):
p.000066: https://likumi.lv/ta/en/en/id/275747- procedures-for-using-the-patient- data-in-a-specific-research
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Cabinet Regulation No. 1176 (2013) Procedures for Use of Human Tissues and Cells:
p.000066: http://likumi.lv/ta/id/261810-cilveka- audu-un-sunu-izmantosanas-kartiba
p.000066:
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p.000066:
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p.000066: Regulation of the Cabinet of Ministers: “Procedures for Genetic Research” (2004): http://likumi.lv/doc.php?id=92330
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Cabinet Regulation No. 1176 (2013) Procedures for Use of Human Tissues and Cells:
p.000066: http://likumi.lv/ta/id/261810-cilveka- audu-un-sunu-izmantosanas-kartiba
p.000066: Note: All websites and documents are in Lithuanian.
p.000067: 67
p.000067:
p.000067: Country Key Organizations Legislation
p.000067: Regulations Guidelines
p.000067:
p.000067: General
p.000067: Ministry of Health (MOH):
p.000067: http://www.sam.lt/go.php/lit/IMG
p.000067: 1. Oviedo Convention on Human Rights and Biomedicine (2002): http://conventions.coe.int/treaty/en/t
p.000067: reaties/html/164.htm
p.000067: 2. Law on Ethics of Biomedical Research (2019): https://www.e- tar.lt/portal/lt/legalAct/TAR.234B15 954C2F/wKarWpLPIL
p.000067: 3. Changes of Law on Ethics of Biomedical Research No. 536/2014 (2017):
p.000067: https://www.e- tar.lt/portal/lt/legalAct/43db5e50d0 5f11e7910a89ac20768b0f
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p.000068: Information on Biomedical Research (2010): https://e- seimas.lrs.lt/portal/legalAct/lt/TAD/T AIS.372121
p.000068: 2. Government of the Republic of Lithuania: Decree No. 1458 on State Fees (2017):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/TAR.E3A145 C8DD49/adJtSaHbRM
p.000068: 3. V-15, Decree on the Procedure for Calculating and Paying Compensation for the Expenses Incurred Due to Participation
p.000068: in Biomedical Research and the Time Spent (2018):
p.000068: https://www.e- tar.lt/portal/lt/legalAct/2a0242a0b5fe 11e5a6588fb85a3cc84b/ILdhwknYP P
p.000068: 4.V-28, Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research
...
p.000076:
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p.000076: Office of the Information and Data Protection Commissioner: http://idpc.gov.mt/index.aspx
p.000076: Use) Regulations, 2004: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=11285&l=1
p.000076:
p.000076: 1. Product Safety Act, 2001: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8893&l=1
p.000076: 2. Subsidiary Legislation, 427.16, In Vitro Diagnostic Medical Devices Regulations, 2003
p.000076: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10756&l=1
p.000076: 3. Subsidiary Legislation, 427.44, Medical Devices Regulations, 2010: http://justiceservices.gov.mt/Downl
p.000076: oadDocument.aspx?app=lom&itemi d=10781&l=1
p.000076: 4. Subsidiary Legislation, 427.10, Active Implantable Medical Devices Regulations, 2010:
p.000076: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=10753&l=1
p.000076: 1. Data Protection Act, 2002: http://justiceservices.gov.mt/Downl oadDocument.aspx?app=lom&itemi d=8906&l=1
p.000076: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000076: For an overview of human subject protections in Moldova, see “Ethical Review of Biomedical Research in the CIS
p.000076: Countries,” Chapter 3, Section 7:
p.000076: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000076: Note: All websites and documents are in Moldovian.
p.000076:
p.000076: General
p.000076: Ministry of Health, National Committee for Ethical Expertise of Clinical Trials:
p.000076: http://ms.gov.md/?q=comitetul-national- etica
p.000076: Oviedo Convention on Human Rights and Biomedicine (2002)
p.000076:
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p.000077:
p.000077: Country Key Organizations Legislation
p.000077: Regulations Guidelines
p.000077:
p.000077: Drugs, Biologics, and Devices
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Research Injury
p.000077:
p.000077:
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p.000077:
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p.000077: Privacy/Data Protection
p.000077: 1. Ministry of Health , National Committee for Ethical Expertise of Clinical Trials:
p.000077: http://ms.gov.md/?q=comitetul-national- etica
p.000077: 2. Medicines and Medical Devices Agency:
p.000077: http://www.amed.md/
p.000077:
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p.000077:
p.000077:
p.000077:
p.000077:
p.000077: Ministry of Health
p.000077: (MOH): http://www.ms.gov.md/
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
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p.000077: National Center for Personal Data Protection of the Republic of Moldova: http://www.datepersonale.md/en/start/
p.000077: 1. Law No. 1409 Dated 17.12.1997 on Medicines, Articles 11 and 12: http://lex.justice.md/index.php?actio
p.000077: n=view&view=doc&lang=1&id=31 1586
p.000077: 2. Law No. 263 Dated 27.10.2005 on Patients’ Rights and Responsibilities. Articles 9, 10, 11, 12, 13, and 14:
p.000077: http://lex.justice.md/index.php?actio n=view&view=doc&lang=1&id=31 3060
p.000077:
...
p.000081:
p.000082: 82
p.000082:
p.000082: Country Key Organizations Legislation
p.000082: Regulations Guidelines
p.000082:
p.000082: Embryos, Stem Cells, and Cloning
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: Norway
p.000082: General
p.000082: Central Committee for Research Involving Human Subjects (CCMO): http://www.ccmo.nl/en/
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: National Committee for Medical and Health Research Ethics (NEM): https://www.etikkom.no/en/our-
p.000082: work/about-us/the-national-committee- for-medical-and-health-research-ethics- nem/
p.000082:
p.000082:
p.000082:
p.000082:
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p.000082:
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p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: National Committee for Research Ethics in the Social Sciences and the Humanities (NESH): https://www.etikkom.no/en/our-
p.000082: work/about-us/the-national-committee- for-research-ethics-in-the-social-sciences- and-the-humanities-nesh/
p.000082:
p.000082:
p.000082:
p.000082:
p.000082: National Committee for Research Ethics in Science and Technology (NENT):
p.000082: https://www.etikkom.no/en/our-
p.000082: 1. Foetal Tissue Act (2001) (Dutch): http://wetten.overheid.nl/BWBR001 2983/
p.000082: 2. Embryos Act (2002): http://www.ccmo.nl/attachments/file s/embryos-act.pdf
p.000082:
p.000082: 1. Oviedo Convention on Human Rights and Biomedicine (2006)
p.000082: 2. Law regarding Ethics and Integrity in Research (2006): http://www.ub.uio.no/ujur/ulovdata/ lov-20060630-056-eng.pdf
p.000082: 3. Act on Health Care Research (2008): http://www.lovdata.no/cgi-
p.000082: wift/wiftldles?doc=/usr/www/lovdat a/all/nl-20080620- 044.html&emne=helseforskningslov
p.000082: *&&
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p.000083: 1. Organization of Health Research: https://lovdata.no/dokument/SF/forsk rift/2009-07-01-955
p.000083: 2. Population-Based Health Survey: https://lovdata.no/dokument/SF/forsk rift/2018-04-27-645
p.000083: 3. Right of Children Between 12- 16 Years to Consent to Participate in Health Research:
p.000083: https://lovdata.no/dokument/SF/forsk rift/2017-06-28-1000
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. Guidelines for Research on Persons with Impaired Informed Consent Capacity (2005)
p.000083: 2. Payment for Research Participants in Medical and Health Research (2009)
p.000083: 3. Guidelines for Research Ethical and Scientific Evaluation of Qualitative Research Projects in Medical and Health
...
p.000083: work/about-us/the-national-committee- for-research-ethics-on-human-remains/ Drugs
p.000083: Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: Devices
p.000083: Norwegian Medicines Agency: http://www.legemiddelverket.no/English/ Sider/default.aspx
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: Norwegian System of Patient Injury Compensation: https://www.npe.no/en/information- compensation-claimants/drug-
p.000083: injury/clinical-trials/
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1. National Committee for Research Ethics in the Social Sciences and the Humanities (NESH)
p.000083: 2. National Committee for Research Ethics on Human Remains (NCEHR):
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 1.Medicines Act:
p.000083: https://lovdata.no/dokument/NL/lov
p.000083: /1992-12-04-
p.000083: 132?q=lov%20om%20legemidler 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov
p.000083: /2008-06-20-
p.000083: 44?q=helseforskningsloven
p.000083:
p.000083: Act of 12 January 1995 No. 6 Relating to Medical Devices (1995):
p.000083: http://lovdata.no/dokument/NL/lov/ 1995-01-12-
p.000083: 6?q=lov+om+medisinsk+utstyr 2.Act on Health Care Research: https://lovdata.no/dokument/NL/lov
p.000083: /2008-06-20-
p.000083: 44?q=helseforskningsloven
p.000083: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (2007)
p.000083: 2. Act on Patient Injury Compensation (2001): https://lovdata.no/dokument/NL/ lov/2001-06-15-53
p.000083: 3. Act on Product Liability, Chapter 3: https://lovdata.no/dokument/NL/lov
p.000083: /1988-12-23-
p.000083: 104?q=produktansvarsloven Research Ethics Act (2017): https://lovdata.no/dokument/NL/lov
p.000083: /2017-04-28-23?q=forskningsetikk
p.000083: 2. Act of Cultural Heritage (1978):
p.000084: 84
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
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p.000084:
p.000084:
p.000084: Regulation Relating to Clinical Trials on Medicinal Products for Human Use (2009):
p.000084: http://lovdata.no/dokument/SF/forskri ft/2009-10-30-
p.000084: 1321?q=forskrift+om+kliniske+utpr
p.000084: %C3%B8vning
p.000084:
p.000084:
p.000084: Regulation of December 15th 2005 No. 1690 Relating to
p.000084: Medical Devices (2005): http://lovdata.no/dokument/SF/forskri ft/2005-12-15-
p.000084: 1690?q=forskrift+medisinsk+utstyr
p.000084:
p.000084:
p.000084: Guidelines for Research Ethics on Human Remains:
p.000084: https://www.etikkom.no/en/ethical-guidelines- for-research/guidelines-for-research--ethics-on- human-remains/
p.000084:
p.000084: Guidelines for the Regulations Concerning Clinical Trials of Human Drugs (1999):
p.000084: http://www.legemiddelverket.no/Godkjenning_ og_regelverk/Klinisk- utproving/Regelverk%20og%20veiledninger/D
p.000084: ocuments/Veiledning%20-
p.000084: %20revidert%20versjon%202.2%2006.11.201 2.pdf
p.000084:
p.000084: Various: https://legemiddelverket.no/english/medical- devices/regulatory-information-regarding- medical-devices
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
...
p.000087: Regulations Guidelines
p.000087:
p.000087: Human Biological Materials
p.000087:
p.000087:
p.000087:
p.000087: Portugal
p.000087: General
p.000087:
p.000087: Drugs, Biologics, and Devices
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Research Injury
p.000087:
p.000087:
p.000087: Privacy/Data Protection
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: National Council of Ethics for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/
p.000087: Drugs
p.000087: 1. National Institute of Pharmacy and Medicines: http://www.infarmed.pt/portal/page/portal/ INFARMED/ENGLISH
p.000087: 2. Ethics Commission for Clinical Research (CEIC): http://www.infarmed.pt/portal/page/portal/
p.000087: INFARMED/MEDICAMENTOS_USO_H UMANO/CEIC
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Devices
p.000087: National Institute of Pharmacy and Medicines: http://www.infarmed.pt/portal/page/portal/ INFARMED/DISPOSITIVOS_MEDICOS
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: National Data Protection Commission:
p.000087: http://www.cnpd.pt/english/index_en.htm
p.000087: 2. July 1, 2005 Act Regarding Sampling, Storage, and Transplanting of Cells, Tissues, and Organs:
p.000087: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20170001000
p.000087:
p.000087:
p.000087: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000087:
p.000087:
p.000087: 1. Approval of the Applicable Legal Standards for the Conduct of Clinical Trials of Medicines for Human Use, Law No.
p.000087: 46/2004
p.000087: 2. Approval of the Composition, Operations, and Financing of the Ethics Commission for Clinical Research, Decree No.
p.000087: 57/2005: http://www.infarmed.pt/portal/page/ portal/INFARMED/LEGISLACAO/ LEGISLACAO_FARMACEUTICA
p.000087: _COMPILADA/TITULO_III/TITU
p.000087: LO_III_CAPITULO_I/portaria_57- 2005.pdf
p.000087:
p.000087: Various: http://www.infarmed.pt/portal/page/ portal/INFARMED/LEGISLACAO/ LEGISLACAO_FARMACEUTICA
p.000087: _COMPILADA/TITULO_V/TITU LO_V_CAPITULO_II
p.000087: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000087: 164 (2001)
p.000087: 1. Constitution, Article 35 (1997)
p.000087: 2. Act on the Protection of Personal Data, No. 67/98 (1998): http://www.cnpd.pt/english/bin/legis lation/Law6798EN.HTM
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Decree-Law No. 102/2007 of April 2
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Various:
p.000087: http://www.cnecv.gov.pt/cnecv/en/opinions/
p.000087:
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087: Various: http://www.infarmed.pt/portal/page/portal/INF ARMED/DISPOSITIVOS_MEDICOS/NOTAS
p.000087: _INFORMATIVAS
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
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p.000088:
p.000088: Country Key Organizations Legislation
p.000088: Regulations Guidelines
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088: Genetic Research
p.000088:
p.000088: Embryos, Stem Cells, and Cloning
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Romania
p.000088: General
p.000088:
p.000088:
p.000088: Drugs, Biologics, and Devices
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
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p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Research Injury
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Privacy/Data Protection
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health: http://www.portugal.gov.pt/en/the- ministries/ministry-of-health.aspx National Council of Ethics
p.000088: for the Life Sciences: http://www.cnecv.gov.pt/cnecv/en/
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088:
p.000088:
p.000088: 1. Ministry of Health (MOH):
p.000088: http://www.ms.ro/
p.000088: 2. National Agency for Medicines and Medical Devices: https://www.anm.ro/en/
p.000088: 3. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: 1. National Agency for Medicines and Medical Devices: http://www.anm.ro/anmdm/en/index.html
p.000088: 2. National Bioethics Committee for Medicines and Medical Devices: http://www.bioetica-medicala.ro/ National
p.000088: Supervisory Authority for Personal Data Processing:
p.000088: 3. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj Law 12/2005
p.000088:
p.000088: 1. Oviedo Convention on Human Rights and Biomedicine, Additional Protocol on Prohibition of Human Cloning (2001)
p.000088: 2. Portuguese Law on Assisted Reproductive Technologies, Articles 7 and 9 (2006)
p.000088:
p.000088:
p.000088:
p.000088:
p.000088: Oviedo Convention on Human Rights and Biomedicine (2001)
p.000088:
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p.000088:
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p.000088:
p.000088:
p.000088: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000088: 164 (2001)
p.000088:
p.000088: 1. Law No. 667/2001 On the Protection of Individuals with
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p.000089:
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p.000089:
p.000089:
p.000089: Ordinance No. 57/16.08.2002 (2002):
p.000089: http://www.research.ro/ro/articol/10 21/despre-ancs-legislatie
p.000089: MOH:
p.000089: Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of
p.000089: Clinical Trials on Medicinal Products for Human Use -- Transposition of 2001/20/EC Directive
p.000089:
p.000089: Access:
p.000089: https://www.anm.ro/en/medicamente
p.000089: -de-uz-uman/legislatie/legi- ordonante-si-hotarari-de-guvern/
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: 1. Opinion 15/CNECV/95 on Embryo Research (1995)
p.000089: 2. Opinion 47/CNECV/2005 on Stem Cell Research (2005): http://www.cnecv.gov.pt/NR/rdonlyres/F13B34 FD-F9F7-4C9D-96DC-
p.000089: 419999D9B693/0/47CNECV2005.pdf
p.000089: 3. Opinion 48/CNECV/2006 on Human Cloning (2006): http://www.cnecv.gov.pt/NR/rdonlyres/770EA3 90-9326-4FF9-B28D-
p.000089: D70A7E9AD961/0/p048_en.pdf
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: MOH:
p.000089: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
p.000089:
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p.000091:
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p.000091: San Marino
p.000091: General
p.000091:
p.000091:
p.000091: Research Injury
p.000091:
p.000091:
p.000091: Serbia
p.000091: Drugs, Biologics, and Devices
p.000091:
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p.000091: Interdepartmental Commission on Genetic-Engineering Activity
p.000091:
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p.000091:
p.000091:
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p.000091:
p.000091:
p.000091: San Marino Bioethics Committee (Italian): http://www.sanita.sm/on- line/home/comitato-bioetica/comitato-
p.000091: sammarinese-di-bioetica.html
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: 1. Ministry of Health (MOH):
p.000091: http://www.zdravlje.gov.rs/
p.000091: 2. Serbian Drug Agency
p.000091: http://www.alims.gov.rs/eng/
p.000091: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000091: .docx
p.000091: 1. Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information
p.000091: (2006): http://www.consultant.ru/document/ cons_doc_LAW_165971/
p.000091: 2. Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006): http://base.garant.ru/12148567/ Federal
p.000091: Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic- Engineering Activity:”
p.000091: http://base.garant.ru/10135402/
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010):
p.000091: http://base.garant.ru/184467/
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine (1998)
p.000091:
p.000091: Oviedo Convention on Human Rights and Biomedicine, Article 24, ETS No. 164 (1998)
p.000091:
p.000091: Law on Medicines and Medical Devices, Official Gazette of RS No. 30/2010, 107/2012, 113/2017, and 105/2017:
p.000091: https://www.paragraf.rs/propisi_do wnload/zakon_o_lekovima_i_medic inskim_sredstvima.pdf
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p.000092:
p.000092:
p.000092:
p.000092:
p.000092: Order of the Ministry of Education and Science of the Russian Federation #154: “Statute of the Inter- Departmental
p.000092: Commission on Genetic-Engineering Activity” (2005):
p.000092: http://www.zakonprost.ru/content/ba se/part/438157
p.000092:
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p.000092:
p.000092:
p.000092:
p.000092: MOH:
p.000092: Regulation on Content of Requests and Documents for Approval of Clinical Trials and Procedures for Conducting Clinical
p.000092: Trials, Official Gazette of RS, 64/2011, 91/2013,
p.000092:
p.000092: Country Key Organizations Legislation
p.000092: Regulations Guidelines
p.000092:
p.000092: Drugs, Biologics, and Devices
p.000092: Research Injury
p.000092:
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p.000092:
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p.000092:
p.000092:
p.000092:
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p.000092: Privacy/Data Protection
p.000092:
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p.000092:
p.000092: Genetics
p.000092:
p.000092:
p.000092:
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p.000092:
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p.000092:
p.000092:
p.000092: Embryos, Stem Cells, and Cloning
p.000092:
p.000092:
p.000092:
...
p.000093: 018/03/Pravilnik-o-klinickim- ispitivanjima-preciscen-tekst.pdf
p.000093: 2. Law on Patients' Rights, Article 25 Official Gazette of RS, 45/2013 and 25/2019:
p.000093: https://www.paragraf.rs/propisi/zako n_o_pravima_pacijenata.html
p.000093:
p.000093: Country Key Organizations Legislation
p.000093: Regulations Guidelines
p.000093:
p.000093: Embryos, Stem Cells, and Cloning Slovakia General
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Drugs, Biologics, and Devices
p.000093:
p.000093:
p.000093:
p.000093: Research Injury
p.000093:
p.000093: Privacy/Data Protection
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Human Biological Materials
p.000093:
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p.000093: Embryos, Stem Cells, and Cloning
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093: Slovenia
p.000093:
p.000093:
p.000093:
p.000093: 1. Ministry of Health (Slovak):
p.000093: http://www.health.gov.sk/
p.000093: 2. Institute of Medical Ethics and Bioethics:
p.000093: http://www.bioethics.sk/
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: State Institute for Drug Control:
p.000093: http://www.sukl.sk/en
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Office for Personal Data Protection:
p.000093: https://dataprotection.gov.sk/uoou/en
p.000093: wnload/zakon-o-ljudskim-celijama- i-tkivima.pdf
p.000093:
p.000093: 1. Oviedo Convention on Human Rights and Biomedicine (1998)
p.000093: 2. Additional Protocol on Biomedical Research (2005)
p.000093: 3. Act No. 576/2004 Coll on Health Care, As Amended by Acts No. 350/2005, 282/2006, 662/2007, 345/2009 Coll.
p.000093: 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
p.000093: Coll.
p.000093:
p.000093: Law 277/1994 on Health Care, Section 44
p.000093: 1. Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll.
p.000093: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000093: 1. Act No. 576/2004 Coll. on Health Care, Sections 35-39.
p.000093: 2. Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b).
p.000093: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000093: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000093: 2. Act No. 576/2004 Coll. on Health Care, Section 26.10.a.
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Ministerial Regulation No. 239/2004 Coll. on Requirements for Clinical Trials and Good Clinical Practice, as Amended by
p.000093: Ministerial Regulation No.
p.000093: 148/2009 Coll.
p.000093:
p.000093:
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p.000093: Governmental Regulation No. 20/2007 Coll. on Tissue and Cell Collection
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p.000095:
p.000095: Privacy/Data Protection
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: Human Biological Materials
p.000095: 1. Ministry of Health of the Republic of Slovenia:
p.000095: http://www.mz.gov.si/
p.000095: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000095: 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000095:
p.000095:
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p.000095:
p.000095:
p.000095: Information Commissioner of the Republic of Slovenia: http://www.ip-rs.si/
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: 1. Ministry of Health of the Republic of Slovenia:
p.000095: http://www.mz.gov.si/
p.000095: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000095: 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000095: 4. Institute for transplantation of Organs and Tissues of the Republic of Slovenia:
p.000095: http://www.slovenija- transplant.si/index.php?id=predstavitev&L
p.000095: =2
p.000095: 1. Medicinal Products Act, Official Gazette No. 17/2014: http://www.uradni- list.si/1/objava.jsp?sop=2014-01- 0539
p.000095: 2. Medical devices Act Official Gazette No. 98/2009 http://www.pisrs.si/Pis.web/pregled Predpisa?id=ZAKO5503
p.000095: 3. Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No. 164 (1999)
p.000095: 4. Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005) Decree
p.000095: ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research:
p.000095: http://pisrs.si/Pis.web/pregledPredpi sa?id=URED3728
p.000095: 1. Personal Data Protection Act No. 94/2007: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO3906
p.000095: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000095: 1. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Transplantation of Organs and
p.000095: Tissues of Human Origin (2006)
p.000095: 2. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No.
p.000095: 61/2007: http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297
p.000095: 3. Rules on Donation and Procurement of Human Tissues
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p.000096: 1. Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014:
p.000096: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV6611
p.000096: 2. Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012: http://www.pisrs.si/Pis.web/pregledP
p.000096: redpisa?id=PRAV9508
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p.000096:
p.000096: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000096: 2. On Interventions into the Human Corpse Which are Not Part of the Routine Autopsy and on Handling with Biologic
p.000096: Material of Human Origin (2004):
p.000096: http://bswww.mf.uni- lj.si/pls/bs/BS_full_rec?lang=SLO&c_docid=1 05859
p.000096:
p.000096: Country Key Organizations Legislation
p.000096: Regulations Guidelines
p.000096:
p.000096: Human Biological Materials
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: Genetic
p.000096:
p.000096:
p.000096:
p.000096: Embryos, Stem Cells, and Cloning
p.000096: 5. Institute Service of Slovenia for Transfusion Medicine: http://www.ztm.si/en/
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096:
p.000096: Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000096:
p.000096:
p.000096: 1. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000096: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000096: and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014
p.000096: 4. Act Regulating the Collection and Transplantation of Human Body Parts for the Purposes of Medical Treatment,
p.000096: Official Gazette No. 56/2015: http://www.uradni- list.si/1/objava.jsp?sop=2015-01- 2357
p.000096: Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes
p.000096: (2009)
p.000096: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000096: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000096: 2. Infertility Treatment and Procedures of Biomedically- Assisted Procreation Act, Official Gazette No. 70/2000,
p.000096: Section 9 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2000-01- 3307
p.000096: 3. Act on Quality and Safety of Human Tissues and Cells, for the Purposes for Medical Treatment, Official Gazette No.
p.000096: 61/2007 (Slovenian): http://www.uradni- list.si/1/objava.jsp?sop=2007-01- 3297
p.000096: 4. Rules on Donation and Procurement of Human Tissues and Cells, Official Gazette Nos. 70/2008, 67/2014, and 79/2014
p.000096:
p.000096:
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p.000097:
p.000097: Country Key Organizations Legislation
p.000097: Regulations Guidelines Spain
p.000097: Note: Many of the 17 Spanish autonomous regions have their own laws and regulations on human subject protections.
p.000097:
p.000097: General
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097: Drugs, Biologics, and Devices
p.000097: 1. Spanish Bioethics Committee: http://www.comitedebioetica.es/?lang=en_ US
p.000097: 2. Coordinating Center for Ethical Committees on Clinical Research (Spanish): http://www.msc.es/profesionales/farmacia/
p.000097: ceic/home.htm
p.000097: 3. Institute of Health Carlos III, Ministry of Science and Innovation http://www.isciii.es/htdocs/en/index.jsp
p.000097:
p.000097: Drugs
p.000097: Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es/en/investigacion Clinica/medicamentos/home.htm
p.000097: 1. Oviedo Convention on Human Rights and Biomedicine (1999): http://www.coe.int/t/dg3/healthbioet
p.000097: hic/texts_and_documents/ETS164S panish.pdf
p.000097: 2. Law 14/2007 on Biomedical Research: http://www.catedraderechoygenoma humano.es/images/novedades/Spani
p.000097: shLawonBiomedicalResearchEnglis h.pdf
p.000097:
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p.000098:
p.000098: 1. Order SCO/362/2008 that Modifies Order SCO/256/2007: http://www.aemps.gob.es/legislacion
p.000098: /espana/investigacionClinica/docs/rc l_2008_410.pdf
p.000098: 2. Order SAS/3470/2009 on Drugs Post Authorization Research: http://www.aemps.gob.es/legislacion
p.000098: /espana/medicamentosUsoHumano/d ocs/farmacovigilancia/rcl_2009_257 7.pdf
p.000098: 3. Royal Decree 1015/2009: Drug Availability for Special Purposes: http://www.boe.es/boe/dias/2009/07/
p.000098: 20/pdfs/BOE-A-2009-12002.pdf
p.000098: 4. Royal Decree 577/2013 Regulating Pharmacovigilance in Human Use Medicines: http://www.boe.es/diario_boe/txt.ph
p.000098: p?id=BOE-A-2013-8191
p.000098: 5. Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with
p.000098: Medicinal Products and the Spanish Clinical Studies Registry: http://noticias.juridicas.com/base_da
p.000098: tos/Admin/565124-rd-1090-2015-
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p.000155:
p.000155: Country Key Organizations Legislation
p.000155: Regulations Guidelines
p.000155:
p.000155: General
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: Drugs, Biologics, and Devices
p.000155:
p.000155:
p.000155: Human Biological Materials
p.000155:
p.000155:
p.000155: Genetic Research
p.000155:
p.000155: Tunisia
p.000155: Drugs, Biologics, and Devices
p.000155:
p.000155:
p.000155: Turkey
p.000155: General
p.000155:
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p.000155:
p.000155:
p.000155: National Medicines and Poisons Board: http://www.nmpb.gov.sd/en/
p.000155:
p.000155:
p.000155: 1. Federal Ministry of Health:
p.000155: http://www.fmoh.gov.sd/
p.000155: 2. National Council on Biosafety
p.000155:
p.000155: University of Khartoum, Institute of Endemic Diseases: http://iend.uofk.edu/index.php?lang=en
p.000155:
p.000155: Ministry of Public Health, Institut Pasteur: www.pasteur.tn
p.000155:
p.000155:
p.000155:
p.000155: Ministry of Health (Turkish):
p.000155: http://www.saglik.gov.tr/
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p.000155:
p.000155:
p.000155:
p.000155: Act on Pharmaceuticals and Poisons (2009) (Arabic): http://www.nmpb.gov.sd/index.php/ 2015-08-05-11-05-
p.000155: 04/regulations/113-laws2009
p.000155: 1. Human Organs and Tissues Transplant Legislation, Chapter 2, Articles 3 and 4 (1978)
p.000155: Act on Biosafety (2010)
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: 1. Turkish Constitution, Article 17
p.000155: 2. Health Services Basic Law No. 3359 (1987)
p.000155: 3. Oviedo Convention on Human Rights and Biomedicine (2004)
p.000155: 4. Update on the Law of the Support of Research and Development Activities (2016). Official Gazette (Turkish):
p.000155: http://www.resmigazete.gov.tr/eskil er/2016/02/20160226-1.pdf
p.000155:
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p.000155:
p.000155:
p.000155: Conditions of Contract and Specifications Related to Medical or Scientific Experimentation of Medicines Intended for
p.000155: Humans
p.000155:
p.000155: 1. Regulation on Medical Deontology, Article 11 (1960)
p.000155: 2. Bylaw on Patient Rights No. 23420 (1998)
p.000155: 2. Accreditation Guidelines for Research Ethics Committees In Sudan (2017):
p.000155: http://snrec.sd/wp- content/uploads/2017/05/Accredition- guidelines.pdf
p.000155: 3. Operation Guidelines, Functions, and Procedures (2016)
p.000155: 4. NHREC protocol application form http://snrec.sd/wp- content/uploads/2017/05/NHREC- PROTOCOL-APPLICATION-FORM.pdf
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: Guidelines for Genetics Research on Sudanese Subjects (2005)
p.000155:
p.000155:
p.000155: Disposals and Director’s Principles Related to Good Practices in Clinical Trials
p.000155:
p.000155:
p.000156: 156
p.000156:
p.000156: Country Key Organizations Legislation
p.000156: Regulations Guidelines
p.000156:
p.000156: Drugs, Biologics, and Devices
p.000156:
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p.000156:
p.000156:
p.000156: Research Injury
p.000156: Drugs
p.000156: 1. Turkey Pharmaceuticals and Medical Devices Agency (Turkish) (TITCK):
p.000156: http://www.titck.gov.tr
p.000156: 2. Clinical Research Association (CRA): www.klinikarastirmalar.org
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p.000156:
p.000156:
p.000156: Devices
p.000156: Turkey Pharmaceuticals and Medical Devices Agency (TITCK): http://www.titck.gov.tr
p.000156:
p.000156: Turkey Pharmaceuticals and Medical Devices Agency (TITCK): http://www.titck.gov.tr
p.000156:
p.000156: Turkish Penal Law, Article 90 (2005)
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p.000156:
p.000156: Convention on Human Rights and Biomedicine (Convention of Oviedo), Article 24, ETS No.
p.000157: 157
p.000157:
p.000157: 1. Fundamental Law #3359 on Health Services, Supplemental Article 10 (2011):
p.000157: 2. Regulation on Clinical Trials with Drugs and Biological Products (2015): An Update of 2014 Clinical Trials
p.000157: Regulation: http://www.klinikarastirmalar.org/Det ail/1992/ilac-ve-biyolojik-urunlerin- klinik-arastirmalari-hakkinda-
p.000157: yonetmelikte-degisiklik-yapilmasina- dair-yonetmelik-2015
p.000157: 3. Regulation on Efficacy, Safety, and Clinical Trials of Cosmetic Products (2015):
p.000157: http://www.klinikarastirmalar.org.tr/d oc/file_346.pdf
p.000157: 4. Update on the Regulation of the Management and Inspection of the Support of Research and Development Activities
p.000157: (2016). Official Gazette: http://www.resmigazete.gov.tr/eskiler
p.000157: /2016/08/20160810-7.htm
p.000157: 5. Bylaw on Clinical Research of Traditional and Complementary Medicine (2019): http://www.klinikarastirmalar.org/Det
p.000157: ail/2631/geleneksel-ve-tamamlayici- tip-uygulamalarinin-klinik- arastirmalari-hakkinda-yonetmelik- 2019
p.000157: 7. Guideline on Phase 1 Clinical Research Centers (2019) https://titck.gov.tr/storage/Archive/20
p.000157: 19/legislation/ad316d19-8b9e-420c- 86db-3946c56add1d.pdf
p.000157:
p.000157: Regulation on Research on Medical Devices (2014): http://www.klinikarastirmalar.org.tr/d oc/file_318.pdf
p.000157:
p.000157: CRA:
p.000157: 1. GCP Guideline (2015): http://www.klinikarastirmalar.org.tr/doku man.php?id=374
p.000157: 2. Guideline on the Audit of Pharmacovigilance: https://titck.gov.tr/storage/Archive/2019/l
p.000157: egislation/05ef1188-6756-4165-b0d5- bb0a28bbebb3.pdf
p.000157: 3. Various: http://www.klinikarastirmalar.org.tr/en/do cuments.php?dok_cat=0
p.000157:
p.000157:
p.000157:
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p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: Guidance on Insuring Volunteers in a Clinical Trial (2011)
p.000157:
p.000157: Country Key Organizations Legislation
p.000157: Regulations Guidelines
p.000157:
p.000157: Research Injury Human Biological Materials
p.000157:
p.000157:
p.000157:
p.000157: Genetic Research
p.000157:
p.000157:
p.000157: Embryos, Stem Cells, and Cloning
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157: United Arab Emirates
p.000157: 164 (2004)
p.000157: 1. Law on Procurement, Preservation, Grafting, and Transplantation of Organs and Tissues, No. 2238 (1979)
p.000157: 2. Law on Blood and Blood Products, No. 2857 (1983)
p.000157:
p.000157: Regulation on Blood and Blood Products, No. 7314 (1983)
p.000157:
p.000157:
p.000157:
p.000157: Regulation on Centers for Diagnosis and Genetic Diseases, No. 23368 (1998)
p.000157: 1. Regulation on Centers for Medically Assisted Procreation, No. 19551 (1987)
p.000157: 2. Regulation on Organ and Tissue Transplantation Services (2005)
p.000157: 3. Regulation on Cordon Blood Banks (2005)
p.000157:
p.000157: 1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 21-22 (1999)
p.000157: 2. Good Clinical Practice Guidelines for Advanced Therapy Medicinal Products (2011)
p.000157: Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 12-14 (1999)
p.000157: 1. Circular on Research of Embryonic Stem Cells (2005)
p.000157: 2. Guideline on Clinical Research of Non- Embryonic Stem Cells (2006)
p.000157:
p.000157: General
p.000157: Health Authority - Abu Dhabi:
p.000157: http://www.haad.ae/haad/
p.000157: Standard Operating Procedures for Research Ethics Committees (2012): http://www.haad.ae/HAAD/LinkClick.aspx?fil
p.000157: eticket=UL7o8f5mukc%3D&tabid=820
p.000157:
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p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000158: 158
p.000158:
p.000158: Country Key Organizations Legislation
p.000158: Regulations Guidelines
p.000158:
p.000158: LATIN AMERICA and the CARIBBEAN
p.000158: Regionwide
p.000158: General Caribbean Public Health Agency: http://carpha.org/What-We-Do/Research-
p.000158: Training-and-Policy-Development
p.000158:
p.000158: Drugs, Biologics, and Devices
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158:
p.000158: Argentina
p.000158: Drugs
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158:
p.000158: Devices
p.000158: Pan American Health Organization:
p.000158: http://www.paho.org/
p.000158:
p.000158: Good Clinical Practices: Document for the Americas (2005): http://www.paho.org/english/ad/ths/ev/GCP- Eng-doct.pdf
p.000158:
p.000158: A Model Regulatory Program for Medical Devices: An International Guide (2001):
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000107: http://zakon4.rada.gov.ua/laws/sho w/123/96-%D0%B2%D1%80
p.000107: 1. Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2010)
p.000107: 2. On Protection of Personal Data Act, 01.06.2010 with changes from 19.10.2017: http://zakon3.rada.gov.ua/laws/sho
p.000107: w/2297-17
p.000107: 1. Cabinet Ministry of Ukraine Act No. 286 on 02.03.2016 License Conditions on Providing Activities of Banks of Cord
p.000107: Blood and Other Human Tissues and Cells: http://zakon2.rada.gov.ua/laws/sho w/286-2016-%D0%BF
p.000107: 2. Ministry of Health Act
p.000107: 20.04.12 No. 276 On Approving the List of Human Tissues and Cells, Allowing the Use of Banks of Cord Blood and Other
p.000107: Human Tissues and Cells: http://zakon3.rada.gov.ua/laws/sho w/z1124-12
p.000107: v0095282-09
p.000107: 2. Ministry of Health Act 14.12.2009 N 944 on Approval of the Clinical Trial and Expertise of Clinical Trials:
p.000107: http://zakon4.rada.gov.ua/laws/show
p.000107: /z0053-10
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107:
p.000107: Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of
p.000107: Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007) with Changes from 23.09.2009
p.000107: No. 690:
p.000107: http://zakon1.rada.gov.ua/laws/show
p.000107: /z1206-07
p.000107: 3. Methodological Aspects of Central EC Activity of Ukrainian Ministry of Health (2007)
p.000107: 4. Ethical Aspects of Placebo Controlled Clinical Trials in Patients with MS (2008)
p.000107: 5. Optimization of Local Ethics Committee Activities (2009)
p.000107:
p.000107: Ministry of Health:
p.000107: Guidelines for Pre-Clinical and Clinical Trials: http://www.dec.gov.ua/index.php/ekspertiza-
p.000107: materialiv-doklinichnikh-ta-klinichnikh- viprobuvan/metodichni-rekomendatsiji- shchodo-provedennya-doklinichnikh-ta-
p.000107: klinichnikh-viprobuvan
p.000107:
p.000108: 108
p.000108:
p.000108: Country Key Organizations Legislation
p.000108: Regulations Guidelines
p.000108:
p.000108: Embryos, Stem Cells, and Cloning
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108:
p.000108: United Kingdom
p.000108: 1. National Academy of Sciences Bioethics Committee: http://biomed.nas.gov.ua/index- en/bioethics-committee
p.000108: 2. Ukrainian Ministry of Health:
p.000108: http://www.moz.gov.ua/en/
p.000108: 1. Act on the Banning
p.000108: of Human Reproductive Clonin g (2004):
p.000108: http://zakon0.rada.gov.ua/laws/sho w/2231-15
p.000108: 2. Act on the Transplantation on Human Using Anatomic Materials (2019): http://zakon.rada.gov.ua/laws/show/ 2427-19
p.000108: 1. Ukrainian Ministry of Health Order No. 630 Regarding Approval of the Procedure for the Conduct of Clinical Trials of
p.000108: Tissue and Cell Transplants and Expert Evaluation of Materials of Clinical Trials (2007):
p.000108: http://zakon1.rada.gov.ua/laws/show
p.000108: /z1206-07
p.000108: 2. Ukrainian Ministry of Health Order No. 787 on Approval of the Use of Reproductive Technologies in Ukraine
p.000108: 09.09.2013: http://zakon4.rada.gov.ua/laws/show
p.000108: /z1697-13
...
p.000163: Regulations Guidelines
p.000163:
p.000163: Drugs, Biologics, and Devices
p.000163:
p.000163:
p.000163:
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p.000163:
p.000163: Clinical Trials Registry
p.000163: Research Injury
p.000163:
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p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163: Devices
p.000163: Brazilian Health Surveillance Agency (ANVISA):
p.000163: http://portal.anvisa.gov.br/english
p.000163:
p.000163:
p.000163:
p.000163:
p.000163:
p.000163: Brazilian Clinical Trials Registry:
p.000163: http://www.ensaiosclinicos.gov.br/
p.000163:
p.000163: 1. Brazilian Health Surveillance Agency: http://portal.anvisa.gov.br/english
p.000163:
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p.000163:
p.000163:
p.000163:
p.000163: ANVISA:
p.000163: Law Nº 6360/76:
p.000163: http://www.planalto.gov.br/ccivil_0
p.000164: 164
p.000164:
p.000164: CFM:
p.000164: 1. Resolution CFM Nº 1.885, 2008 – about placebo: http://www.portalmedico.org.br/resol ucoes/cfm/2008/1885_2008.htm
p.000164:
p.000164: ANVISA:
p.000164: 1. Resolution ANVISA 09/15 - Regulations for Clinical Trials with Drugs: https://clinregs.niaid.nih.gov/docume
p.000164: nts/brazil/ResolutionNo9-English.pdf
p.000164: 2. Resolution RDC No. 9, 20 February 2015 Regarding Regulation for Realization of Clinical Trials of Medication in
p.000164: Brazil: https://clinregs.niaid.nih.gov/docume nts/brazil/ResolutionNo9-English.pdf
p.000164: 3. Resolution RDC No. 260, 21 December 2018: Regulation for Conducting Clinical Trials with Investigational Advanced
p.000164: Therapy Product in Brazil, and Makes Other Arrangements: http://portal.anvisa.gov.br/documents/
p.000164: 10181/2718376/RDC_260_2018_.pdf
p.000164: /dd889184-bd4a-40ea-ae1c- b93155b20ea1
p.000164:
p.000164: Resolution ANVISA 10/15 - Regulations for Clinical Trials with Medical Devices: http://pesquisa.in.gov.br/imprensa/jsp
p.000164: /visualiza/index.jsp?data=03/03/2015 &jornal=1&pagina=73&totalArquivo s=140
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: CNS/CONEP:
p.000164: 1. Standards Survey of New Drugs, Medicines, Vaccines, and
p.000164: and Cancellations on DDCM (2018): http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+Para+Submiss%C3%A3o+de+
p.000164: Modifica%C3%A7%C3%B5es%2C+Emendas
p.000164: %2C+Suspens%C3%B5es+e+Cancelamentos+
p.000164: -
p.000164: +4%C2%AA+edi%C3%A7%C3%A3o/85672f
p.000164: fa-db76-4869-b286-ff59bc3fcf60
p.000164:
p.000164:
p.000164:
p.000164:
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p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: ANVISA:
p.000164: Manual for Submission of Modifications, Amendments, Suspensions, and Cancellations on DICD (2015):
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(return to top)
p.000008: 3. Statement on Gene Therapy Research (2001): http://www.hugo- international.org/img/gene_2001.pdf
p.000008: 4. Statement on Human Genomic Databases (2002): http://www.hugo- international.org/img/genomic_2002.pdf
p.000008: 1. Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998-1999 (1997):
p.000008: http://unesdoc.unesco.org/images/0011/00110 2/110220e.pdf#page=47
p.000008: 2. International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences
p.000008: (2003): http://unesdoc.unesco.org/images/0013/00133 1/133171e.pdf#page=45
p.000008: Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006): http://www.isscr.org/docs/default-source/hesc-
p.000008: guidelines/isscrhescguidelines2006.pdf
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Country Key Organizations Legislation
p.000009: Regulations Guidelines
p.000009:
p.000009:
p.000009: NORTH AMERICA
p.000009: Canada
p.000009: Note: Several Canadian provinces and territories also have human subject research standards.
p.000009: General 1. Interagency Advisory Panel on Research Ethics (PRE):
p.000009: http://www.pre.ethics.gc.ca/eng/index
p.000009: 2. National Defence and the Canadian Armed Forces: http://www.forces.gc.ca/en/index.page
p.000009: 3. Correctional Service of Canada:
p.000009: http://www.csc-scc.gc.ca/index-eng.shtml
p.000009:
p.000009:
p.000009:
p.000009: PRE:
p.000009: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2018):
p.000009: http://www.pre.ethics.gc.ca/eng/document s/tcps2-2018-en-interactive-final.pdf
p.000009:
p.000009: National Defence and the Canadian Armed Forces:
p.000009: Research Involving Human Subjects (1998): http://www.forces.gc.ca/en/about- policies-standards-defence-admin-orders-
p.000009: directives-5000/5061-0.page
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs, Biologics, and Devices
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Drugs
p.000009: 1. Health Canada, Therapeutic Products Directorate: http://www.hc- sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
p.000009: dgpsa/tpd-dpt/index-eng.php
p.000009: 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 1. Regulations Amending the Food and Drug Regulations (1024
p.000009: – Clinical Trials) (2001): http://www.hc-sc.gc.ca/dhp- mps/alt_formats/hpfb- dgpsa/pdf/compli-conform/1024- eng.pdf
p.000009: Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2017): http://www.csc-
p.000009: scc.gc.ca/acts-and-regulations/009-cd-en.shtml
p.000009:
p.000009: Health Canada:
p.000009: Good Clinical Practice: Integrated Addendum to E6(R1)
p.000009: ICH Topic E6(R2) (2017)
p.000009: https://www.canada.ca/content/dam/hc- sc/migration/hc-sc/dhp- mps/alt_formats/pdf/prodpharma/applic-
p.000009: demande/guide-ld/ich/efficac/e6r2-step4- eng.pdf
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Devices
p.000009: Health Canada, Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md- im/index-eng.php
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Medical Devices Regulations (SOR/98-282) (1998): http://laws- lois.justice.gc.ca/eng/regulations/sor-
p.000009: 98-282/FullText.html
p.000010: 10
p.000010: PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 11: Clinical Trials
p.000010: (2018):
p.000010: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000010: Country Key Organizations Legislation
p.000010: Regulations Guidelines
p.000010:
p.000010: Clinical Trials Registry
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Research Injury
p.000010:
p.000010:
p.000010:
p.000010: Social-Behavioral Research
p.000010:
p.000010:
p.000010: Privacy/Data Protection
p.000010:
p.000010: Note: Each of the Canadian provinces and territories also has enacted privacy legislation.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Human Biological Materials
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Genetic Research
p.000010: 1. Health Canada Clinical Trial Database: http://www.hc-sc.gc.ca/dhp- mps/prodpharma/databasdonclin/index- eng.php
p.000010: 2. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index Interagency Advisory
p.000010: Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000010:
p.000010:
p.000010: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000010:
p.000010:
p.000010: 1. Office of the Privacy Commissioner of Canada (OPC): https://www.priv.gc.ca/en
...
p.000010: 3. Canadian Institutes of Health Research (CIHR): http://www.cihr- irsc.gc.ca/e/193.html
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 1. Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000010: 2. Canadian Biotechnology Advisory Committee (CBAC): http://www.hc- sc.gc.ca/sr-sr/biotech/role/strateg-eng.php
p.000010: 3. Health Canada, Biologics and
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 1. Privacy Act, Sections 7-8 (1983): http://laws- lois.justice.gc.ca/PDF/P-21.pdf
p.000010: 2. Personal Information Protection and Electronic Documents Act, Articles 5 and 7 (2001): http://laws-
p.000010: lois.justice.gc.ca/PDF/P-8.6.pdf
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: OPC:
p.000010: SOR/2001-6, SOR/2001-7, and
p.000010: SOR/2001-8 (September 29,
p.000010: 2014)
p.000010: PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Chapter 11.D. (2018):
p.000010: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Article 3.2(j) (2018):
p.000010: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010: Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans. Qualitative Research (Chapter 10) (2018):
p.000010: http://www.pre.ethics.gc.ca/eng/policy- politique/initiatives/tcps2-eptc2/Default/ PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 5: Privacy and
p.000010: Confidentiality (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000010: CIHR:
p.000010: CIHR Best Practices for Protecting Privacy in Health Research (2005): http://www.cihr-
p.000010: irsc.gc.ca/e/documents/et_pbp_nov05_sept200 5_e.pdf
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12: Human Biological
p.000010: Materials Including Materials Related to Human Reproduction (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp
p.000010: s2-2018-en-interactive-final.pdf
p.000010: PRE:
p.000010: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 13: Human Genetic
p.000010: Research (2018): http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000010:
p.000011: 11
p.000011:
p.000011: Country Key Organizations Legislation
p.000011: Regulations Guidelines
p.000011:
p.000011: Genetic Research
p.000011:
p.000011:
p.000011: Embryos, Stem Cells, and Cloning
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: United States
p.000011: Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch- dirgen/hpfb-dgpsa/bgtd-dpbtg/index- eng.php
p.000011: Interagency Advisory Panel on Research Ethics (PRE): http://www.pre.ethics.gc.ca/eng/index
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction Act (2004): http://laws- lois.justice.gc.ca/eng/acts/A-13.4/
p.000011:
p.000011:
p.000011:
p.000011: Assisted Human Reproduction (Section 8 Consent) Regulations (2007): http://laws- lois.justice.gc.ca/eng/regulations/SO
p.000011: R-2007-137/index.html
p.000011:
p.000011:
p.000011:
p.000011: PRE:
p.000011: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 12, Sections E and F
p.000011: (2018):
p.000011: http://www.pre.ethics.gc.ca/eng/documents/tcp s2-2018-en-interactive-final.pdf
p.000011: All of the following departments and agencies subscribe to subpart A, often referred to as the Common Rule (last
p.000011: updated in 2018), and codified in the relevant section of the Code of Federal Regulations:
p.000011: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Some departments and agencies subscribe to additional
p.000011: subparts, such as:
p.000011: • Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
p.000011: • Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
p.000011: Subjects (1978)
p.000011: • Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
p.000011: • Subpart E: Institutional Review Board Registration Requirements (2009)
p.000011:
p.000011: General
p.000011: Agency for International Development: www.usaid.gov/
p.000011:
p.000011:
p.000011: Central Intelligence Agency: https://www.cia.gov/index.html Consumer Product Safety
p.000011: Commission: www.cpsc.gov/
p.000011: Department of Agriculture:
p.000011: www.usda.gov/wps/portal/usdahome/
p.000011:
...
Orphaned Trigger Words
p.000062:
p.000062:
p.000062:
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p.000062:
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p.000062:
p.000062:
p.000062: 1. Data Protection Act (1988), as Amended (2003): http://www.irishstatutebook.ie/2003
p.000062: /en/act/pub/0006/index.html
p.000062: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000062: 3. Data Protection Act 2018: https://www.oireachtas.ie/en/bills/bi ll/2018/10/
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p.000063:
p.000063:
p.000063: European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004):
p.000063: http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html
p.000063:
p.000063: European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, Section 13(6)(k) and
p.000063: Schedule 1, Part 2, Paragraph 4 (S.I. No. 190
p.000063: of 2004):
p.000063: http://www.irishstatutebook.ie/eli/200 4/si/190/made/en/html
p.000063: Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018: http://www.hrb.ie/funding/gdpr-
p.000063: guidance-for-researchers/gdpr-and- health-research/health-research- regulations-2018/
p.000063:
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p.000063:
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p.000063:
p.000063:
p.000063:
p.000063: OSS:
p.000063: Ministerial Decree of 12 May 2006: Terms of Reference for the Establishment and the Functioning of Ethics Committees
p.000063: Consent Policy, Part 3: http://www.hse.ie/eng/about/Who/qualityandpa tientsafety/National_Consent_Policy/ Various:
p.000063: https://www.hpra.ie/homepage/site- tools/search?query=clinical%20trials
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: DPC:
p.000063: 1. 12 Steps to Being Prepared (2018):
p.000063: http://gdprandyou.ie/organisations/
p.000063: 2. Transfers Abroad (2018): https://www.dataprotection.ie/docs/Transfers- Abroad/y/37.htm
p.000063:
p.000063: HRB:
p.000063: Health Research Regulations 2018 FAQ: http://www.hrb.ie/funding/gdpr-guidance-for- researchers/general-gdpr-faq/
p.000063: Human Biological Material: Recommendations for Collection, Use, and Storage in Research (2005):
p.000063: http://health.gov.ie/wp- content/uploads/2014/07/Human_Biological_ Material1.pdf
p.000063: Guidelines for Pharmacogenetic Research (2006):
p.000063: http://lenus.ie/hse/bitstream/10147/96983/1/Ph armacogenetic06.pdf
p.000063:
p.000063: CNB:
p.000063: Various: http://www.governo.it/bioetica/eng/opinions.ht ml
p.000063:
p.000063: Country Key Organizations Legislation
p.000063: Regulations Guidelines
p.000063:
p.000063: General
p.000063: Drugs, Biologics,
p.000063: and Devices
p.000063: http://oss-sper-clin.agenziafarmaco.it/
p.000063: Drugs
p.000063: 1. National Monitoring Center for Clinical Trials: http://www.agenziafarmaco.com/en/conte
p.000063: nt/national-monitoring-centre-clinical- trials
p.000063: 2. Italian Medicines Agency:
p.000063: http://www.agenziafarmaco.it/
p.000063: 3. Ministry of Health (MOH):
p.000063: http://www.ministerosalute.it
p.000063:
p.000063:
p.000063: 1. Decree of the President of the Republic: Regulations to Simplify the Procedures and to Verify and Check New Systems
...
p.000070: Exporting Therefrom (2017): https://www.e- tar.lt/portal/lt/legalAct/TAR.E2473B1 958CA/gEtbNSRzzc
p.000070:
p.000070: Note: All websites and documents are available in French.
p.000070: General National Ethics Commission:
p.000070: http://www.cne.lu
p.000070:
p.000070: Various: http://www.cne.public.lu/fr/publications/a vis.html
p.000070:
p.000070: Drugs, Biologics, and Devices
p.000070: 1. Ministry of Health:
p.000070: http://www.ms.public.lu and
p.000070: Hospitals Act of 1998 (2010):
p.000070: http://legilux.public.lu/eli/etat/leg/lo
p.000071: 71
p.000071: Grand-Ducal Decree of May 30, 2005 on the Conduct of Clinical
p.000071: CNER:
p.000071: 1. Guidance Regarding Elements to
p.000071:
p.000071: Country Key Organizations Legislation
p.000071: Regulations Guidelines
p.000071:
p.000071: Drugs, Biologics, and Devices
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Privacy/Data Protection
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: Genetic Research
p.000071:
p.000071:
p.000071:
p.000071: Macedonia
p.000071: http://www.sante.lu
p.000071: 2. National Research Ethics Committee (CNER): http://www.cner.lu
p.000071: 3. Division of Pharmacy and Medicines of the Ministry of Health: http://www.sante.public.lu/fr/politique-
p.000071: sante/ministere-sante/direction-sante/div- pharmacie-medicaments/index.html National Data Protection Commission:
p.000071: http://www.cnpd.public.lu/fr/index.html
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: National Research Ethics Committee (CNER):
p.000071: http://www.cner.lu
p.000071: i/2018/03/08/a222/jo
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: 1. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural
p.000071: Persons with Regard to the
p.000071: Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data
p.000071: Protection Regulation): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000071: 2. Act of 1 August 2018 on the Organisation of the National Data Protection Commission, Articles 63-65:
p.000071: https://cnpd.public.lu/dam- assets/fr/legislation/droit-lux/Act- of-1-August-2018-on-the-
p.000071: organisation-of-the-National-Data- Protection-Commission-and-the- general-data-protection- framework.pdf
p.000071: Trials on Medicinal Products for Human Use: http://www.legilux.public.lu/leg/a/arc hives/2005/0084/2005A15161.html
p.000071: Include in the Participant Information Sheet and Informed Consent Form
p.000071: 2. Secondary Use of Samples Collected in the Framework of a Research Project
p.000071: 3. Incidental Findings
p.000071:
...
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/844338380?t:ac=1/2
p.000073: 2. Rulebook on the Manner of Reporting Adverse Effects During the Use of Medical Devices, Types of Reactions they
p.000073: Cause, the Actions of Health Workers and Suppliers, As Well as the Manner of Organizing the System of Monitoring
p.000073: Adverse Effects and Reactions to Medical Devices (Official Gazette No.100/2016) (Document No.8):
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments/1/2
p.000073: Rulebook on the Manner and the Procedure for Clinical Trials on Medicinal Products and Documentation Contents (2009):
p.000073: https://lekovi.zdravstvo.gov.mk/docu ments.documentcomponent:download file/817325622?t:ac=1/1 Regulations on Protection
p.000073: of Personal Data: http://www.dzlp.mk/mk/podzakonski
p.000073: _akti
p.000074: 74
p.000074:
p.000074: Country Key Organizations Legislation
p.000074: Regulations Guidelines
p.000074:
p.000074: Privacy/Data Protection
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074: Human Biological Materials
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074: 1. Ministry of Health of the Republic of Macedonia:
p.000074: http://moh.gov.mk/
p.000074: 2. Health Insurance Fund of Republic of Macedonia: http://www.fzo.org.mk
p.000074: Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2008):
p.000074: http://www.dzlp.mk/sites/default/fil es/pdf/Dopolnitelen_protokol_Konv encija_108.pdf
p.000074: 3. Law on Personal Data Protection, Consolidated (2016): http://www.dzlp.mk/sites/default/fil
p.000074: es/u4/ZZLP_konsolidiran_tekst_201 6.pdf
p.000074: 1. Law on Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard
p.000074: to the Application of Biology and Medicine, With Additional Protocol on the Prohibition of Cloning Human Beings and
p.000074: Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (2009):
p.000074: http://www.pravo.org.mk/document Detail.php?id=5543
p.000074: 2. Law on Health Protection: (Official Gazette No. 43/2012) and Laws Amending and Supplementing the Law (2012- 2016):
p.000074: http://zdravstvo.gov.mk/zakon-za- zdravstvenata-zashtita/
p.000074: 3. Law on Taking and Transplanting of Human Body Organs (Official Gazette No. 47/2011) and Laws Amending and
p.000074: Supplementing the Law (2011-2016): http://zdravstvo.gov.mk/zakon-za- zemanje-i-presaduvanje-na-delovi-
p.000074: na-chovechkoto-telo-zaradi- lekuvanje/
p.000074: 4. Sub-Law Acts : http://www.fzo.org.mk/default.asp?I temID=6541AC10FFC3C5498F088
p.000075: 75
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Regulations for Transplantation of Tissues and Organs (13 regulations): http://www.fzo.org.mk/default.asp?It
p.000075: emID=6541AC10FFC3C5498F0887 C57131D996
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: Regulation on Criteria Relating to Space, Personnel and Equipment for Collection, Transplantation and Exchange of
p.000075: Organs and Tissues, the Necessary Space, Equipment and Staff Required to be Provided by the Health Institution for the
p.000075: Collection, Transfer, Exchange and Storage of Organs and Tissues from Human Body for Treatment Purposes (2012):
p.000075: http://zdravstvo.gov.mk/wp- content/uploads/2012/12/za_pobliskite_kriteriu mi_vo_odnos_na_prostorot_kadarot_i_opremat
...
p.000078:
p.000078:
p.000078:
p.000078: Montenegro Drugs, Biologics, and Devices
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health (MOH):
p.000078: http://www.ms.gov.md/
p.000078: 2. Transplant Agency
p.000078: http://lex.justice.md/md/334622
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health (MOH):
p.000078: http://www.ms.gov.md/
p.000078: 2. National Commission on Biological Security: http://lex.justice.md/index.php?action=vie w&view=doc&lang=1&id=303353
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 1. Ministry of Health of Montenegro: http://www.mzd.gov.me/en/ministry?alph abet=lat
p.000078: 2. Agency for Medicines and Medical Devices: https://www.calims.me/Portal/faces/glavn a?_adf.ctrl-state=rsbe35pln_83
p.000078: 4. Law No.133 Dated 08.07.2011 on the Protection of Personal Data: http://lex.justice.md/index.php?actio
p.000078: n=view&view=doc&lang=1&id=34 0495
p.000078: 5. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000078: 6. LP143 Din 19.07.18, MO309-
p.000078: 320/17.08.18 Article 482
p.000078: 1. Law No. 42 Dated 06.03.2008
p.000078: on Transplantation of Organs, Tissues and Human Cells: http://lex.justice.md/index.php?actio
p.000078: n=view&view=doc&lang=1&id=32 7709
p.000078: 2. LP79 Din 24.05.18, MO195-
p.000078: 209/15.06.18 Article 338
p.000078:
p.000078: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being, on the
p.000078: Prohibition of Cloning Human Beings (2002)
p.000078: 2. Law No. 42 Dated 06.03.2008
p.000078: on Transplantation of Organs, Tissues and Human Cells: http://lex.justice.md/index.php?actio
p.000078: n=view&view=doc&lang=1&id=32 7709
p.000078: 3. LP79 Din 24.05.18, MO195-
p.000078: 209/15.06.18 Article 338
p.000078:
p.000078: 1. Law on Medicines (“Official Gazette of Montenegro”, No. 56/2011 and 06/13): https://www.calims.me/Portal/faces/
p.000078: servlet1?putanja=CG_Zakon_o_ljek ovima.pdf&_afrWindowMode=0&_ afrLoop=3654755254077715&_adf. ctrl-state=13nzchbscd_171
p.000078: 2. Law on Medical Devices (“Official Gazette of
p.000078:
p.000079: 79
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: MOH:
p.000079: Order No.648/12.08.2016
p.000079: Concerning the Regulation of Authorizing the Conduct of Clinical Trials in Republic of Moldova:
p.000079: http://amed.md/sites/default/files/Leg islatie/Ordine%20ale%20MS/Ordinul
p.000079: %20MS%20nr.%20648.pdf
p.000079:
p.000079:
p.000079:
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p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Rulebook on More Detailed Conditions and Documentation Required for Approval and Conduct of Clinical Trials of
p.000079: Medicines for Human Use (2013):
p.000079: https://www.calims.me/Portal/faces/ser vlet1?_afrLoop=26656243505641585&
p.000079: _afrWindowMode=0&putanja=Ruleboo k%2520on%2520Clinial%2520trials.pd f&_adf.ctrl-state=wdqo8wvwo_214
p.000079:
p.000079: Country Key Organizations Legislation
p.000079: Regulations Guidelines
p.000079:
p.000079: Drugs, Biologics, and Devices
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: Research Injury
p.000079:
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...
p.000085: ?id=WDU19990470480
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: Decree of the Minister of Health on Clinical Trials on Minors (2004):
p.000085: http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20041041108
p.000085: science-and-technology/
p.000085:
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p.000085:
p.000085:
p.000085:
p.000085:
p.000085: NIL:
p.000085: Code of Medical Ethics, Chapter II (2003):
p.000085: http://www.nil.org.pl/dokumenty/kodeks-etyki- lekarskiej
p.000085:
p.000086: 86
p.000086:
p.000086: Country Key Organizations Legislation
p.000086: Regulations Guidelines
p.000086:
p.000086: Drugs, Biologics, and Devices
p.000086: Devices
p.000086: Ministry of Health, Office for Registration of Therapeutic, Medical, and Biocidal Products:
p.000086: http://www.urpl.gov.pl/en/medical- devices
p.000086:
p.000086: Act on Medical Devices: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000175
p.000086:
p.000086: 1. Regulation of the Minister of Health on Detailed Conditions to be Met for Clinical Evaluation of Medical Devices or
p.000086: Active Implantable Medical Devices (2011): http://prawo.sejm.gov.pl/isap.nsf/Doc Details.xsp?id=WDU20110630331
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: Research Injury
p.000086:
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p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: Privacy/Data Protection
p.000086:
p.000086:
p.000086:
p.000086: Human Biological Materials
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
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p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: Personal Data Protection Office:
p.000086: https://uodo.gov.pl/en
p.000086:
p.000086:
p.000086:
p.000086: Pharmaceutical Law, Chapter 36b:
p.000086: http://prawo.sejm.gov.pl/isap.nsf/Do cDetails.xsp?id=WDU20190000499
p.000086:
p.000086:
p.000086:
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p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086:
p.000086: 1. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000086: 2. Act on the Protection of Personal Data (2018): https://uodo.gov.pl/pl/131/262
p.000086: 1. Act of 22 August 1997 on the Public Blood Service: http://prawo.sejm.gov.pl/isap.nsf/Do
p.000086: cDetails.xsp?id=WDU20190001222
p.000086: Various: http://www.urpl.gov.pl/pl/wyroby- medyczne/akty-prawne/przepisy-rp
p.000086: 1. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors
p.000086: (2004): http://isap.sejm.gov.pl/DetailsServlet
p.000086: ?id=WDU20041011034
p.000086: 2. Order of the Minister of Finance Amending the Regulation Concerning the Mandatory Civil Liability Insurance of
p.000086: Researchers and Sponsors (2005): http://isap.sejm.gov.pl/DetailsServlet
p.000086: ?id=WDU20051010845
p.000086: 3. Order of the Minister of Finance Concerning the Mandatory Civil Liability Insurance of Researchers and Sponsors in
p.000086: Clinical Trials of Medicinal Products (2010): http://isap.sejm.gov.pl/DetailsServlet
p.000086: ?id=WDU20101941290
p.000086:
p.000087: 87
p.000087:
p.000087: Country Key Organizations Legislation
p.000087: Regulations Guidelines
p.000087:
p.000087: Human Biological Materials
p.000087:
p.000087:
p.000087:
p.000087: Portugal
p.000087: General
p.000087:
p.000087: Drugs, Biologics, and Devices
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
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p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087: Research Injury
p.000087:
p.000087:
p.000087: Privacy/Data Protection
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
p.000087:
...
p.000089: 0008_ro.htm
p.000089: http://www.dataprotection.ro/?page=Regulame ntul_nr_679_2016
p.000089: For an overview of human subject protections in Russia, see
p.000089: http://www.unesco.org/new/fileadmin/MULTIMEDIA/FIELD/Moscow/pdf/ethical_review_cis_book_kubar_english.pdf
p.000089:
p.000089: General
p.000089: 1. Ministry of Healthcare of the Russian Federation (MOH): http://www.rosminzdrav.ru
p.000089: 2. Federal Service on Surveillance in Healthcare (Roszdravnadzor): http://www.roszdravnadzor.ru/
p.000089: 3. Russian Committee for Bioethics:
p.000089: http://www.bioethics.ru/eng/
p.000089: 1. Constitution of the Russian Federation, Article 21 (1993): http://www.constitution.ru/en/10003 000-03.htm
p.000089: 2. Federal Law #FZ 323 “On Foundations of Protection of Citizen’s Health in the Russian Federation” (2011):
p.000090: 90
p.000090: MOH:
p.000090: 1. Ministry of Health Order 433n (July 10, 2015) “On Adoption of the Regulations on Organization of Clinical
p.000090: Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation (Including Order of Patients’
p.000090: Assignment for Administering Such Medical Help),
p.000090:
p.000090: Country Key Organizations Legislation
p.000090: Regulations Guidelines
p.000090:
p.000090: General
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: Drugs, Biologics, and Devices
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: 1. Council of Ethics of the Ministry of Healthcare of the Russian Federation (MOH): http://www.grls.rosminzdrav.ru/
p.000090: 2. Association of Clinical Trials Organizations: http://acto-russia.org/en/
p.000090: 3. Federal Agency for Technical Regulation and Metrology (GOST): http://www.gost.ru/wps/portal/pages.en.M ain
p.000090: http://acto- russia.org/en/index.php?option=co m_content&task=view&id=105
p.000090: 3. Federal Law #FZ55 “On Introduction of Changes in FZ “On Foundations of Protection of Citizens’ Health in the Russian
p.000090: Federation” with Regard to Questions of Organization of Medical Aid Administered in the Course of Clinical Approbation
p.000090: of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation” (2015): http://www.consultant.ru/document/
p.000090: cons_doc_LAW_176159
p.000090: Federal Law #61FZ “On Circulation of Medicines” (2011):
p.000090: http://acto- russia.org/files/zakon_ob_obr_ls_en
p.000090: .docx
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: MOH:
p.000090: 1. Ministry of Health Order No. 753n (August 26, 2010)
p.000090: “On Assertion of Order of Organization and Carrying out of Ethical Review…” (Russian): http://base.garant.ru/12178437/
p.000090: 2. Ministry of Health Order No. 774n (August 31, 2010) “On Council of Ethics” (Russian):
p.000090: http://www.rg.ru/2013/02/22/etika- dok.html
p.000090: 3. Ministry of Health Order of April 1, 2016 No. 200н "On Approval of the Rules of Good Clinical Practice:”
p.000090: http://acto- russia.org/files/prikaz_200n.docx
p.000090: Standard Form of Protocol for Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment, and
p.000090: Rehabilitation”: http://base.consultant.ru/cons/cgi/online.cgi?req
p.000090: =doc;base=LAW;n=183847
p.000090: 2. Ministry of Health Order 435h “On Ethics Committee of the Ministry of Health of the Russian Federation” (July 10,
p.000090: 2015): http://base.consultant.ru/cons/cgi/online.cgi?req
p.000090: =doc;base=LAW;n=183677
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090: Research Injury
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
p.000090:
...
p.000093:
p.000093: Law 277/1994 on Health Care, Section 44
p.000093: 1. Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll.
p.000093: 2. EU General Data Protection Regulation (2016): https://eur- lex.europa.eu/eli/reg/2016/679/oj
p.000093: 1. Act No. 576/2004 Coll. on Health Care, Sections 35-39.
p.000093: 2. Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b).
p.000093: 1. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard
p.000093: to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (1998)
p.000093: 2. Act No. 576/2004 Coll. on Health Care, Section 26.10.a.
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Ministerial Regulation No. 239/2004 Coll. on Requirements for Clinical Trials and Good Clinical Practice, as Amended by
p.000093: Ministerial Regulation No.
p.000093: 148/2009 Coll.
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Governmental Regulation No. 20/2007 Coll. on Tissue and Cell Collection
p.000093:
p.000093:
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: GDPR Regulation (2018): https://dataprotection.gov.sk/uoou/sk/main- content/nariadenie-gdpr
p.000093: Note: All websites and documents are in Slovenian.
p.000093: General Republic of Slovenia National 1. Health Services Act
p.000093: Code of Medical Ethics (2016): 94
p.000093:
p.000093: Country Key Organizations Legislation
p.000093: Regulations Guidelines
p.000093:
p.000093: General
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Drugs, Biologics, and Devices
p.000093: Medical Ethics Committee (NMEC):
p.000093: http://www.kme-nmec.si/
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Drugs
p.000093: 1. Ministry of Health of the Republic of Slovenia
p.000093: http://www.mz.gov.si/
p.000093: 2. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000093: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: Devices
p.000093: 1. Ministry of Health of the Republic of Slovenia:
p.000093: http://www.mz.gov.si/
p.000093: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000093: 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000093: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO214
p.000093: 2. Decree Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical
p.000093: Research (2005): http://pisrs.si/Pis.web/pregledPredpi sa?id=URED3728
p.000093: 3. Patient Rights Act, Official Gazette No. 15/2008 55/2017: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO4281 and
p.000093: https://www.uradni-list.si/glasilo-uradni- list-rs/vsebina/2017-01-2526?sop=2017- 01-2526
p.000093: 4. Mental Health Act, Official Gazette Nos. 77/2008 and 46/2015: http://pisrs.si/Pis.web/pregledPredpi sa?id=ZAKO2157
p.000093:
p.000093: 1. Medicinal Products Act, Official Gazette No. 17/2014: http://www.uradni- list.si/1/objava.jsp?sop=2014-01- 0539
p.000093: 2. EU Clinical Trials Regulation No. 536/2014: http://eur- lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CEL
p.000093: EX:32014R0536&from=EN
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: 1. Medical Devices Act, Official Gazette No. 98/2009: http://www.pisrs.si/Pis.web/pregled Predpisa?id=ZAKO5503
p.000093:
p.000093:
p.000093:
p.000093:
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p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093:
p.000093: 1. Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014:
p.000093: http://www.pisrs.si/Pis.web/pregledP redpisa?id=PRAV6611
p.000093: 2. Rules on the Composition, Duties, Responsibilities, and Working Methods of the Commission for Medical Ethics,
p.000093: Official Gazette No. 21/2018: http://pisrs.si/Pis.web/pregledPre dpisa?id=PRAV13345
p.000093:
p.000093: Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012: http://www.pisrs.si/Pis.web/pregledP
p.000093: redpisa?id=PRAV9508
p.000093: https://www.zdravniskazbornica.si/docs/default
p.000093: -source/zbornicni-akti/kodeks- 2016.pdf?sfvrsn=2
p.000093:
p.000095: 95
p.000095:
p.000095: Country Key Organizations Legislation
p.000095: Regulations Guidelines
p.000095:
p.000095: Research Injury
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: Privacy/Data Protection
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: Human Biological Materials
p.000095: 1. Ministry of Health of the Republic of Slovenia:
p.000095: http://www.mz.gov.si/
p.000095: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
p.000095: 3. Republic of Slovenia National Medical Ethics Committee (NMEC): http://www.kme-nmec.si/
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: Information Commissioner of the Republic of Slovenia: http://www.ip-rs.si/
p.000095:
p.000095:
p.000095:
p.000095:
p.000095: 1. Ministry of Health of the Republic of Slovenia:
p.000095: http://www.mz.gov.si/
p.000095: 2. Agency for Medicinal Products and Medical Devices (JAZMP): http://www.jazmp.si/
...
p.000104: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html
p.000104: 3. Ordinance of 20 September 2013 on Organisational Aspects of the Human Research Act (HRA Organisational Ordinance,
p.000104: OrgO-HRA), RS 810.308, Articles 6-7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html
p.000104:
p.000104: 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance
p.000104: HRO), RS 810.301, Article 7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html
p.000104: 2. Ordinance of 20 September 2013
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
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p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Swissmedic Guide to the Regulation of Medical Devices: https://www.swissmedic.ch/medizinprodukte/0
p.000104: 0287/index.html?lang=en
p.000104:
p.000104: Country Key Organizations Legislation
p.000104: Regulations Guidelines
p.000104:
p.000104: Drugs, Biologics, and Devices
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Clinical Trials Registry
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Research Injury
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Privacy/Data Protection
p.000104:
p.000104: Note: Most Swiss cantons have enacted laws
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Swiss National Clinical Trials Portal: http://kofam.ch/en/swiss-clinical-trials- portal/
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: 1. Swiss Agency for Therapeutic Products (Swissmedic): http://www.swissmedic.ch/index.html?lan g=en
p.000104: 2. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000104: =en
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Federal Data Protection and Information Commissioner (FDPIC): http://www.edoeb.admin.ch/index.html?la ng=en
p.000104: 2011on Research involving Human Beings, (Human Research Act, HRA), RS. 810.30:
p.000104: https://www.admin.ch/opc/en/classif ied- compilation/20061313/index.html
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: Federal Act on Research Involving Human Beings, Articles 56, 64, 65, and 67
p.000104: (2014):
p.000104: https://www.admin.ch/opc/en/classif ied- compilation/20061313/index.html Federal Act of 30 September 2011 on Research
p.000104: Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 19-20: http://www.admin.ch/opc/en/classifi ed-
p.000104: compilation/20061313/index.html
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104:
p.000104: 1. Federal Act of 19 June 1992 on Data Protection (FADP), RS 235.1: http://www.admin.ch/opc/en/classifi ed-
p.000104: compilation/19920153/index.html
p.000104: 2. Federal Act of 30 September
p.000105: 105
p.000105: on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), RS 810.305 articles 20, 32,
p.000105: 37, 42-45 and Annexes 1, 3 and 4: https://www.admin.ch/opc/en/classif ied- compilation/20121176/index.html
p.000105: 3. Ordinance of 20 September 2013 on Organisation Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-
p.000105: HRA), RS 810.308, Articles 6-7: https://www.admin.ch/opc/en/classif ied- compilation/20121179/index.html
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance
p.000105: HRO), RS 810.301, Articles 8, 12, 13, and 15, and Annexes 1-2: https://www.admin.ch/opc/en/classif ied-
p.000105: compilation/20121179/index.html
p.000105: 2. Ordinance of 20 September 2013 on Clinical Trials in Human Research (Clinical Trials Ordinance ClinO), RS 810.305,
p.000105: Articles 7, 10-13, 25, and 71, and Annexes 2-3: https://www.admin.ch/opc/en/classif ied-
p.000105: compilation/20121176/index.html
p.000105: 1. Ordinance of 20 September 2013 on Human Research with the Exception of Clinical Trials (Human Research Ordinance,
p.000105: HRO), RS 810.301, Articles 5 - 8, 10, 15, 21, 24-34, 37-39, 41,
p.000105:
p.000105: Country Key Organizations Legislation
p.000105: Regulations Guidelines
p.000105:
p.000105: regarding data collection in the public sector that are similar to the Federal Act on Data Protection.
p.000105:
p.000105:
p.000105:
p.000105:
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p.000105: Human Biological Materials
p.000105:
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p.000105:
p.000105:
p.000105: Genetic Research
p.000105:
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p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: 1. Federal Office of Public Health (FOPH): http://www.bag.admin.ch/index.html?lang
p.000105: =en
p.000105: 2. Swiss Academy of Medical Sciences (SAMS): http://www.samw.ch/en/News/News.html
p.000105:
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p.000105:
p.000105:
p.000105: Federal Office of Public Health (FOPH):
p.000105: http://www.bag.admin.ch/index.html?lang
p.000105: =en
p.000105: 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2, 3, 8, 16-18,
p.000105: 31-35, 41-45, 47, 49, 58-60, and
p.000105: 63:
p.000105: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000105:
p.000105:
p.000105:
p.000105: Federal Act of 30 September 2011 on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2,
p.000105: 3, 17, 18, 31,
p.000105: 32 - 35, 41-43, 45, 47, 49, and
p.000105: 63:
p.000105: http://www.admin.ch/opc/en/classifi ed- compilation/20061313/index.html
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: 1. Federal Constitution of the Swiss Confederation of 18 April 1999, RS 101, Article 119:
p.000105: http://www.admin.ch/opc/en/classifi ed- compilation/19995395/index.html
...
p.000125: 2. Pharmaceuticals and Medical Devices Agency: http://www.pmda.go.jp/english/index.htm l
p.000125: Indonesian Health Act No. 23/1992 Section on Health Research, Article 69
p.000125:
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p.000125:
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p.000125:
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000125:
p.000125: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000125: gov.go.jp/htmldata/S35/S35HO145. html
p.000125: 2. Clinical Trials Act (2017):
p.000125: https://www.mhlw.go.jp/file/06-
p.000126: 126
p.000126: 1. Regulation No. 39/1995 on Health Research and Development
p.000126: 2. Presidential Decree No. 100/1993: Research by Foreigners
p.000126: 1. Ministry of Health Decree No. 56/2000: Guidelines on Clinical Trials of Traditional Drugs
p.000126: 2. Guidelines on Good Clinical Practice (2001)
p.000126: National Guidelines on Use of Stored Biological Materials (2005)
p.000126:
p.000126:
p.000126:
p.000126:
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p.000126:
p.000126: MHLW:
p.000126: Ministerial Ordinance on Good Clinical Practice for Drugs (2016):
p.000126: http://elaws.e- gov.go.jp/search/elawsSearch/elaws_ search/lsg0500/detail?lawId=409M50 000100028&openerCode=1
p.000126:
p.000126:
p.000126:
p.000126: MHLW:
p.000126: Ministerial Ordinance on Good Clinical Practice for Medical Devices (2016):
p.000126: http://law.e- gov.go.jp/htmldata/H17/H17F190010 00036.html
p.000126: National Guidelines on Ethics in Health Research (2003)
p.000126:
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p.000126: MEXT and MHLW:
p.000126: Ethics Guidelines for Medical and Health Research Involving Human Subjects (2017):
p.000126: https://www.lifescience.mext.go.jp/files/pdf/n2 181_01.pdf
p.000126:
p.000126: Country Key Organizations Legislation
p.000126: Regulations Guidelines
p.000126:
p.000126: Drugs, Biologics, and Devices
p.000126: Clinical Trials Registry
p.000126:
p.000126:
p.000126:
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p.000126: Privacy/Data Protection
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p.000126: Research Injury
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p.000126:
p.000126:
p.000126:
p.000126: Human Biological Materials
p.000126:
p.000126:
p.000126:
p.000126: 1. Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index
p.000126: .html
p.000126: 2. National Institute of Public Health: https://www.niph.go.jp/index_en.html
p.000126: 3. Japan Registry of Clinical Trials: https://jrct.niph.go.jp/
p.000126: 1. Personal Information Protection Commission: http://www.ppc.go.jp/en/
p.000126: 2. Office of Healthcare Policy of the Cabinet Secretariat: http://www.kantei.go.jp/jp/singi/kenkouir you/en/
p.000126:
p.000126:
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p.000126:
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p.000126: Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000126:
p.000126:
p.000126:
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p.000126:
p.000126:
p.000126: Ministry of Health, Labor, and Welfare (MHLW): http://www.mhlw.go.jp/english/index.htm l
p.000126: Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000126:
p.000126: Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000126:
p.000126:
p.000126:
p.000126:
p.000126:
p.000126: 1. Amended Act on the Protection of Personal Information (2017): https://www.ppc.go.jp/files/pdf/Act
p.000126: _on_the_Protection_of_Personal_In formation.pdf
p.000126: 2. Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field (2017):
p.000126: http://www.kantei.go.jp/jp/singi/ken kouiryou/jisedai_kiban/pdf/170310_ shiryou3.pdf
p.000126:
p.000126:
p.000126:
p.000126:
p.000126: 1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (2016): http://law.e-
p.000126: gov.go.jp/htmldata/S35/S35HO145. html
p.000126: 2. Clinical Trials Act (2017): https://www.mhlw.go.jp/file/06- Seisakujouhou-10800000- Iseikyoku/0000213334.pdf
p.000126:
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p.000127: 2009 version (English): https://www.pmda.go.jp/files/000153 732.pdf
p.000127:
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p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: 1. Amendment to the Cabinet Order to Enforce the Act on the Protection of Personal Information (2016):
p.000127: https://www.ppc.go.jp/files/pdf/Cabin et_Order.pdf
p.000127: 2. Enforcement Rules for the Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/PPC_
p.000127: rules.pdf
p.000127: 3. Regulation for Enforcement of the Clinical Trials Act, Article 20 (2018): https://www.mhlw.go.jp/file/06-
p.000127: Seisakujouhou-10800000- Iseikyoku/0000195391.pdf
p.000127: 1. Ministerial Ordinance on Good Clinical Practice for Drugs, Article 14 (2016):
p.000127: http://law.e- gov.go.jp/htmldata/H09/H09F036010 00028.html
p.000127: 2. Ministerial Ordinance on Good Clinical Practice for Medical Devices, Article 14 and 23 (2016): http://law.e-
p.000127: gov.go.jp/htmldata/H17/H17F190010 00036.html
p.000127:
p.000127:
p.000127: NIPH Clinical Trials Search: http://rctportal.niph.go.jp/en/
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: Guidelines for Act on the Protection of Personal Information (2016): https://www.ppc.go.jp/files/pdf/guidelines01.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines02.p df https://www.ppc.go.jp/files/pdf/guidelines03.p df
p.000127: https://www.ppc.go.jp/files/pdf/guidelines04.p df
p.000127:
p.000127:
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p.000127:
p.000127:
p.000127:
p.000127: Ethics Guidelines for Medical and Health Research Involving Human Subjects, Chapter 2, No. 5, 1-(3) and No. 6, 2-(2)
p.000127: (2017):
p.000127: http://www.lifescience.mext.go.jp/files/pdf/n1859_01
p.000127: .pdf
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: On Research and Development Utilizing Human Tissues Removed by Surgery and Other Procedures (1998) (Japanese):
p.000127: https://www.mhlw.go.jp/www1/shingi/s9812/s 1216-2_10.html
p.000127:
p.000127: Country Key Organizations Legislation
p.000127: Regulations Guidelines
p.000127:
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p.000159: Research: http://servicios.infoleg.gob.ar/infolegInternet/a nexos/185000-189999/187206/norma.htm
p.000159:
p.000159: Country Key Organizations Legislation
p.000159: Regulations Guidelines
p.000159:
p.000159: Drugs, Biologics, and Devices
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p.000159: Clinical Trial Registries
p.000159:
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p.000159: Privacy/Data Protection
p.000159:
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p.000159:
p.000159:
p.000159:
p.000159: Devices
p.000159: National Administration of Drugs, Foods, and Medical Devices (ANMAT):
p.000159: https://www.argentina.gob.ar/anmat
p.000159:
p.000159:
p.000159:
p.000159: National Registry of Health Research: https://www.argentina.gob.ar/salud/registr oinvestigaciones
p.000159:
p.000159:
p.000159:
p.000159: National Directorate for the Protection of Personal Data: https://www.argentina.gob.ar/aaip/datospe rsonales
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p.000159:
p.000159:
p.000159: 1. Personal Data Protection Act No. 25.326 (2000): http://www.protecciondedatos.com. ar/law25326.htm
p.000159: 2. Decree 1558/2001. Regulation of the Personal Data Protection Act: http://servicios.infoleg.gob.ar/infole
p.000159: gInternet/anexos/70000- 74999/70368/norma.htm
p.000159: 4. Provision ANMAT 4008/2017: Substitution of Article 2° of Provision ANMAT N° 6677/10:
p.000159: http://www.anmat.gov.ar/boletin_an mat/Abril_2017/Dispo_4008-17.pdf
p.000159: 5. Provision ANMAT 4009/2017: Health Care Institutions: Requirements and Conditions of Authorization for Conducting
p.000159: Phase I and/or Bioequivalence Clinical Pharmacology Studies: http://www.anmat.gov.ar/boletin_an
p.000159: mat/Abril_2017/Dispo_4009-17.pdf 6. Provision 10017-E/2017 ANMAT: Promoting Cooperation Between ANMAT and
p.000159: Jurisdictional Health
p.000159: Authorities for the Evaluation and Oversight of Clinical Research Sites and Investigators:
p.000159: http://servicios.infoleg.gob.ar/infolegI nternet/verNorma.do?id=279820
p.000159:
p.000159: Provision ANMAT No. 969/97 on the Regulation of Good Clinical Practice with Medical Devices (1997):
p.000159: http://www.anmat.gov.ar/webanmat/ Legislacion/Medicamentos/Disp_969
p.000159: -97_actualizada.pdf
p.000159: Resolution 1480/2011 Approving a Guide for Human Subjects Research: http://servicios.infoleg.gob.ar/infolegI
p.000159: nternet/anexos/185000- 189999/187206/norma.htm
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p.000159: FAQs: https://sisa.msal.gov.ar/sisa/#Renis
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p.000160: Country Key Organizations Legislation
p.000160: Regulations Guidelines
p.000160:
p.000160: Human Biological Materials
p.000160:
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p.000162: http://conselho.saude.gov.br/resoluco es/2007/Reso370.doc
p.000162: 7. Resolution CNS No. 446/2011on Composition of the National Commission on Research Ethics:
p.000162: http://conselho.saude.gov.br/images/c
p.000162: CNS/CONEP:
p.000162: 1. Operating Normative 001/2013 Organization and Operation of CEP/CONEP System:
p.000162: http://conselho.saude.gov.br/images/comissoes/ conep/documentos/NORMAS- RESOLUCOES/Norma_Operacional_n_001-
p.000162: 2013_Procedimento_Submisso_de_Projeto.pdf
p.000162: 2. Various:
p.000162: http://plataformabrasil.saude.gov.br/login.jsf
p.000162:
p.000162: Country Key Organizations Legislation
p.000162: Regulations Guidelines
p.000162:
p.000162: General
p.000162:
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p.000162: Drugs, Biologics, and Devices
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p.000162:
p.000162: Drugs and Biologics
p.000162: 1. National Health Council (CNS):
p.000162: http://www.conselho.saude.gov.br/
p.000162: 2. Brazilian Health Surveillance Agency (ANVISA): http://portal.anvisa.gov.br/english
p.000162: 3. Federal Council of Medicine (CFM):
p.000162: http://portal.cfm.org.br/
p.000162: 4. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
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p.000162:
p.000162:
p.000162: Law Nº 9782/99 Defining the National Health Surveillance System: http://www.planalto.gov.br/ccivil_0 3/leis/L9782.htm
p.000162:
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p.000163: 163
p.000163: omissoes/conep/documentos/NORM AS-
p.000163: RESOLUCOES/Resoluo_n_446_-
p.000163: _2011_-
p.000163: Sobre_composio_da_CONEP.pdf
p.000163: 8. Resolution CNS No. 466/2012 on Guidelines and Rules for Research Involving humans Subjects:
p.000163: http://conselho.saude.gov.br/resoluco es/2012/466_english.pdf
p.000163: 9. Resolution CNS Nº 506/2016 Accreditation of CEP: http://conselho.saude.gov.br/resoluco es/2016/Reso_506.pdf
p.000163: 10. Resolution CNS No 563/2017 on Research Participant's Right in Ultra-rare Diseases:
p.000163: http://conselho.saude.gov.br/images/c omissoes/conep/documentos/NORM AS- RESOLUCOES/Resoluo_n_563_-
p.000163: _2017_-
p.000163: _Regulamenta_direito_participante_d e_pesquisa_com_doenas_ultrarraras.p df
p.000163: 11. Resolution CNS No 580/2018 on Research of Strategic Interest for the Unified Health System (SUS):
p.000163: http://conselho.saude.gov.br/resoluco es/2018/Reso580.pdf
p.000163:
p.000163: CNS:
p.000163: 1. Resolution CNS No. 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines,
p.000163: Vaccines, and Diagnostic Tests: http://conselho.saude.gov.br/resoluco es/1997/Res251_en.pdf
...
p.000164: /visualiza/index.jsp?data=03/03/2015 &jornal=1&pagina=73&totalArquivo s=140
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p.000164: CNS/CONEP:
p.000164: 1. Standards Survey of New Drugs, Medicines, Vaccines, and
p.000164: and Cancellations on DDCM (2018): http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+Para+Submiss%C3%A3o+de+
p.000164: Modifica%C3%A7%C3%B5es%2C+Emendas
p.000164: %2C+Suspens%C3%B5es+e+Cancelamentos+
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p.000164: ANVISA:
p.000164: Manual for Submission of Modifications, Amendments, Suspensions, and Cancellations on DICD (2015):
p.000164: http://portal.anvisa.gov.br/documents/33912/27 85629/Manual+Para+Submiss%C3%A3o+de+ Modifica%C3%A7%C3%B5es%2C+Emendas
p.000164: %2C+Suspens%C3%B5es+e+Cancelamentos/ 431fa7ef-24e6-4b14-80b9-ce68bccc24d8 FAQs:
p.000164: http://www.ensaiosclinicos.gov.br/assistance/fa q/
p.000164: CNS/CONEP:
p.000164: Orientation of Adverse Event Reporting in Clinical Trials (008/2011):
p.000164:
p.000164: Country Key Organizations Legislation
p.000164: Regulations Guidelines
p.000164:
p.000164: Research Injury
p.000164:
p.000164:
p.000164:
p.000164:
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p.000164:
p.000164:
p.000164:
p.000164:
p.000164: Social-Behavioral Research
p.000164:
p.000164: Privacy/Data Protection
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: Human Biological Materials
p.000164: 2. National Health Council (CNS):
p.000164: http://www.conselho.saude.gov.br/
p.000164: 3. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000164:
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p.000164:
p.000164:
p.000164: National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000164: 1. National Health Council (CNS): http://www.conselho.saude.gov.br/
p.000164: 2. National Commission on Research Ethics (CONEP): http://conselho.saude.gov.br/comissoes- cns/conep
p.000164: 3. Federal Council of Medicine (CFM): http://portal.cfm.org.br
p.000164:
p.000164:
p.000164:
p.000164:
p.000164: 1. National Health Council (CNS):
p.000164: http://www.conselho.saude.gov.br/
p.000164: 2. National Commission on Research Ethics (CONEP):
p.000164: 3/leis/l6360.htm
p.000164:
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p.000164:
p.000164:
p.000164: General Data Protection Law (2018):
p.000164: http://www.planalto.gov.br/ccivil_0 3/_Ato2015-
p.000164: 2018/2018/Lei/L13709.htm
p.000164:
p.000164:
p.000164:
p.000164:
p.000164:
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p.000164:
p.000164:
p.000164: Ordinance No. 2.201/11: Establishing the National Guidelines for Biobanks of Human Biological Material for
p.000165: 165
p.000165: Diagnostic Tests Involving Human Beings - Resolution CNS No. 251/97:
p.000165: http://conselho.saude.gov.br/resoluco es/1997/Res251_en.pdf
p.000165: 2. Resolution CNS No. 346/2005 on Multicenter Research: http://conselho.saude.gov.br/resoluco es/2005/Res346_en.pdf
p.000165: 3. Resolution MS/CNS No. 466/2012 - Guidelines and Rules for Research Involving Human Subjects:
p.000165: http://conselho.saude.gov.br/resoluco es/2012/466_english.pdf
p.000165:
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p.000165:
p.000165: Resolution No. 510 of April 7,
p.000165: 2016:
p.000165: http://conselho.saude.gov.br/resoluco es/2016/Reso510.pdf CNS/CONEP:
p.000165: Circular Letter No. 039/2011 - Use of Medical Record Data for Research Purposes: http://conselho.saude.gov.br/images/c
p.000165: omissoes/conep/documentos/CARTA S/CartaCircular039.pdf
p.000165:
p.000165: CFM:
p.000165: Resolution CFM Nº 1.821, 23
p.000165: November 2007: http://www.portalmedico.org.br/resol ucoes/cfm/2007/1821_2007.htm CONEP:
p.000165: 1. Resolution CNS No. 441 of 12 May 2011: Storage of Human Biological Material or Use of
p.000165: http://conselho.saude.gov.br/images/comissoes/ conep/documentos/CARTAS/Carta_Circular_0 08.pdf
p.000165:
p.000165: ANVISA:
p.000165: 1. Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Drugs (2016):
p.000165: http://portal.anvisa.gov.br/documents/33836/24 92465/Manual+para+Notifica%C3%A7%C3%
p.000165: A3o+de+Eventos+Adversos+e+Monitorament o+de+Seguran%C3%A7a+em+Ensaios+Cl%C 3%ADnicos+-
...
p.000172: Various: http://www.cecmed.cu/ensayos- clinicos/autorizos
p.000172:
p.000172:
p.000172:
p.000172:
p.000172: Guidelines for the Conduct of Research on Human Subjects (2005)
p.000172:
p.000172:
p.000172: Dominican Republic
p.000172: General National Council on Health Bioethics:
p.000172: http://conabios.gob.do/
p.000172:
p.000172: National Health Law 42-01, Chapter VI: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf
p.000172:
p.000172: Regulation for Evaluation Request for a Clinical Investigation Project: http://conabios.gob.do/index.php/regl amentos
p.000172:
p.000172: Biological Materials
p.000172:
p.000172:
p.000172: Ecuador
p.000172: Note: All websites and documents are in Spanish.
p.000172: National Health Law 42-01, Book Five: https://www.dol.gov/ilab/submissio ns/pdf/20100408-10.pdf
p.000172:
p.000172: General
p.000172: Ministry of Public Health :
p.000172: http://www.salud.gob.ec/
p.000172: 1. Constitution of the Republic: http://www.asambleanacional.gob.e c/sites/default/files/documents/old/c
p.000172: onstitucion_de_bolsillo.pdf
p.000172: 2. Organic Health Law of 22 December 2006, Articles 207- 208 (2018)
p.000172: 3. Code on Childhood and Adolescence. Law 100 Official Register 737 of January 3, 2003 (2019)
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
p.000172:
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p.000173: 1. Regulation on Research, Ministerial Agreement No. 0066, Public Registry No. 292 (March 11, 2008):
p.000173: https://www.controlsanitario.gob.ec/ wp- content/uploads/downloads/2017/01/ A.M.-66-REGLAMENTO-DE- PROYECTOS-EN-
p.000173: INVESTIGACION-DE-SALUD.pdf
p.000173: 2. Regulation for the Approval of Ethics Committees (2014): https://www.salud.gob.ec/aprobac ion-de-comites-de-etica/
p.000173: 4. Regulation on Health Research Ethics Committees (2014): https://www.controlsanitario.gob.ec/ wp-
p.000173: content/uploads/downloads/2016/12/ A-4889-Reglamento-para-la- aprobaci%C3%B3n-y-seguimiento-
p.000173: 1. National Policy on Scientific Research. Ministerial Agreement 209, Public Registry No. 87 of August 23, 2005
p.000173: 2. Approval of Ethics Committees: https://www.salud.gob.ec/aprobacion-de- comites-de-etica/
p.000173: 3. Approval of Health Research: https://www.salud.gob.ec/autorizacion-de- investigaciones-en-salud/
p.000173:
p.000173: Country Key Organizations Legislation
p.000173: Regulations Guidelines
p.000173: de-CEISH-y-CEAS-L.pdf
p.000173:
p.000173: Drugs, Biologics, and Devices
p.000173:
p.000173:
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p.000173:
p.000173:
p.000173: Privacy/Data Protection
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: Biological Materials
p.000173: 1. Ministry of Public Health:
p.000173: http://www.salud.gob.ec/
p.000173: 2. National Health Agency for Regulation, Control, and Oversight: http://www.controlsanitario.gob.ec/ensayo s-clinicos/
p.000173:
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p.000173:
p.000173: Ministry of Public Health:
p.000173: http://www.salud.gob.ec/
p.000173:
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: National Institute on Donation and Transplantation of Organs, Tissues, and Cells:
p.000173: http://www.donaciontrasplante.gob.ec/ind ot/
p.000173:
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p.000173:
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: Constitution of the Republic of Ecuador 2008 (Article: 92): http://www.asambleanacional.gob.e
p.000173: c/sites/default/files/documents/old/c onstitucion_de_bolsillo.pdf
p.000173:
p.000173:
p.000173: 1. Organic Health Law of December 22, 2006, Articles 81- 86 (2018)
p.000173: 2. Organic Law on the Donation and Transplantation of Organs, Tissues, and Cells (2017)
p.000173:
p.000173:
p.000173:
p.000173:
p.000174: 174
p.000174: 1. Regulation for the Approval, Development, Oversight, and Control of Clinical Trials (2017):
p.000174: http://www.controlsanitario.gob.e c/wp- content/uploads/downloads/2017/ 08/Normativa-Ensayos- Cli%CC%81nicos-Registro-
p.000174: Oficial.pdf
...
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Law 1119/97 Regarding Health Products and Other Products, Article 30: https://www.mspbs.gov.py/depende
p.000179: ncias/dnvs/adjunto/1d0e83- LEYN11191997DEPRODUCTOSP ARALASALUDYOTROS.pdf
p.000179: Statute and Operating Procedures (2017) (Spanish): https://www.mspbs.gov.py/dependen cias/cnbioetica/adjunto/a03ba4-
p.000179: CEIINS.VersionFinal.pdf
p.000179: For an overview of clinical research regulations in Peru, see the ClinRegs report:
p.000179: http://clinregs.niaid.nih.gov/single_country.php?c_id=170
p.000179:
p.000179: General
p.000179:
p.000179:
p.000179: Drugs, Biologics, and Devices
p.000179: National Institute of Health:
p.000179: http://www.ins.gob.pe/
p.000179:
p.000179:
p.000179: 1. National Institute of Health (INS) General Office on Research and Technology Transfer (OGITT):
p.000179: http://www.ins.gob.pe/
p.000179: 2. National Directorate of Drugs and Medical Devices (MINSA): www.digemid.minsa.gob.pe
p.000179: General Health Law No. 26842, Article 28 (1997): https://www.gob.pe/institucion/mins a/normas-legales/256661-26842
p.000179:
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p.000180:
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p.000180:
p.000180: INS:
p.000180: Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials (2017):
p.000180: https://www.gob.pe/institucion/minsa
p.000180: /normas-legales/189280-021-2017-sa
p.000180: 2. Errata - Supreme Decree No. 021-2017-SA – Clinical Trials Regulation (2017): https://busquedas.elperuano.pe/norma
p.000180:
p.000180:
p.000180:
p.000180: OGITT:
p.000180: Procedures Manual for Clinical Trials (2017)
p.000180:
p.000180: Country Key Organizations Legislation
p.000180: Regulations Guidelines
p.000180:
p.000180: Privacy/Data Protection
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180: Clinical Trials Registry
p.000180:
p.000180:
p.000180: Research Injury
p.000180:
p.000180:
p.000180:
p.000180: Privacy/Data Protection
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
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p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180: Saint Lucia Drugs, Biologics, and Devices
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180: Peruvian Registry of Clinical Trials: http://www.ensayosclinicos- repec.ins.gob.pe/en/about-repec/clinical-
p.000180: trial-search
p.000180:
p.000180: National Institute of Health:
p.000180: http://www.ins.gob.pe/
p.000180:
p.000180:
p.000180:
p.000180: National Directorate of Drugs and Medical Devices: www.digemid.minsa.gob.pe
p.000180:
p.000180:
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p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180: 1. Law 29733 for the Protection of Personal Information (2011): http://www.minjus.gob.pe/legislacio n/
p.000180: 2. Law for Electronic Medical Charts (2013): http://elperuanolegal.blogspot.com/ 2013/05/ley-30024-ley-que-crea-el-
p.000180: registro.html
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180:
p.000180: Clinical Trials Act (2016): http://slugovprintery.com/template/f iles/document_for_sale/laws/3742/
p.000180: Act%2010%20of%202016.pdf
p.000180: slegales/-fe-de-errata-ds-n-021-2017- sa-1542992-1/
p.000180:
p.000180: MINSA:
p.000180: Ministerial Resolution N° 655- 2019/MINSA (2019):
p.000180: https://www.gob.pe/institucion/minsa
p.000180: /normas-legales/286523-655-2019- minsa
p.000180: Supreme Decree No. 021-2017- SA. Regulation of Clinical Trials, Articles 102-103 (2017):
p.000180: https://www.gob.pe/institucion/minsa
p.000180: /normas-legales/189280-021-2017-sa Regulation on Clinical Trials in Peru: Articles 27-29:
p.000180: http://www.ins.gob.pe/portal/jerarqui a/2/990/reglamento-de-ensayos- clinicos/jer.990
p.000180: 1. Supreme Decree No. 003- 2013-JUS, Regulation of Law No. 29733 for the protection of personal information (2013):
p.000180: https://www.minjus.gob.pe/wp- content/uploads/2013/04/DS-3-2013- JUS.REGLAMENTO.LPDP_.pdf
p.000180: 2. Supreme Decree No. 009-2017- SA, Regulation of Law No. 30024 for Electronic Medical Charts (2017):
p.000180: https://busquedas.elperuano.pe/norma slegales/aprueban-el-reglamento-de- la-ley-n-30024-ley-que-crea-el-r-
p.000180: decreto-supremo-n-009-2017-sa- 1500555-3/
p.000180:
p.000180: Trinidad and Tobago
p.000180: 1. Ministry of Health
p.000180: http://www.health.gov.tt/
p.000180: 2. University of the West Indies (UWI), St. Augustine: https://sta.uwi.edu/research/ethics.asp
p.000180:
p.000180:
p.000180:
p.000180:
...
p.000181: (FONACIT): www.fonacit.gov.ve/
p.000181: 2. Venezuelan Institute of Scientific Research, Bioethics Commission
p.000181:
p.000181: Constitution, Article 46 (3): http://www.venezuelaemb.or.kr/eng lish/ConstitutionoftheBolivarianingl es.pdf
p.000181:
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000182: Resolution No. 48 (1998):
p.000182: http://www.ivic.gob.ve/bioetica/?mod
p.000182: =bioeticahome.php
p.000182:
p.000182: FONACIT:
p.000182: Code on Bioethics and Biosecurity (2002)
p.000182:
p.000182: IVIC:
p.000182: 1. Annex 1: General Ethical Issues in Research Involving Living Persons:
p.000182:
p.000182: Country Key Organizations Legislation
p.000182: Regulations Guidelines
p.000182:
p.000182: General
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182: Drugs, Biologics, and Devices
p.000182:
p.000182: Genetic Research
p.000182: (IVIC):
p.000182: http://www.ivic.gob.ve/bioetica/?mod=ho me.php
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182: National Institute of Hygiene “Rafael Rangel”: http://www.inhrr.gob.ve/
p.000182:
p.000182: Venezuelan Institute of Scientific Research, Bioethics Commission: http://www.ivic.gob.ve/bioetica/?mod=ho me.php
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182:
p.000182: Medicines Act, Title III, Chapter II:
p.000182: http://www.ginecoweb.com/PDF/Le y-del-Ejercicio-de-la-Medicina.pdf
p.000182: http://www.ivic.gob.ve/bioetica/?mod=Anexo. php
p.000182: 2. Annex 2: Necessity of Establishing a Clear and Precise Study Protocol Before Starting Research:
p.000182: http://www.ivic.gob.ve/bioetica/?mod=Anexo. php
p.000182: 3. Informed Consent: http://www.ivic.gob.ve/bioetica/?mod=manual. php
p.000182:
p.000182:
p.000182:
p.000182:
p.000182: 1. Contract for Accessing Genetic Resources (2003): http://www.ivic.gob.ve/bioetica/contrato.pdf
p.000182: 2. Revised Outline of the International Declaration of Human Genetic Data (2003):
p.000182: http://www.ivic.gob.ve/bioetica/chapter3.pdf
p.000182:
p.000182:
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p.000183:
p.000183: Country Key Organizations Legislation
p.000183: Regulations Guidelines
p.000183:
p.000183: AFRICA
p.000183: Regionwide
p.000183:
p.000183: Clinical Trials Registry
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: Algeria
p.000183: Drugs, Biologics, and Devices
p.000183:
p.000183:
p.000183:
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p.000183:
p.000183:
p.000183:
p.000183: Benin
p.000183: General
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: Botswana
p.000183: General
p.000183: Pan African Clinical Trials Registry:
p.000183: http://www.pactr.org/
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: Directorate of Pharmacy and Medicine: http://www.ands.dz/
p.000183:
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p.000183:
p.000183: Ministry of Health, Research and Development Committee: http://www.moh.gov.bw/
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
...
p.000184: 732/25889598/1422112465653/ch5
p.000184: 9-
p.000184: 02%2BANTHROPOLOGICAL%2
p.000184: BRESEARCH.pdf%3Ftoken%3DT SMJNydkWHdUJ7iPvvm7Qkzk4u U%253D+&cd=1&hl=en&ct=clnk &gl=us
p.000184: Drugs and Related Substances Regulations (1993)
p.000184: 1. SADC Guidelines for Regulating Clinical Trials in Human Subjects (2006)
p.000184: 2. Guideline for Regulating the Conduct of Clinical Trials Using Medicines in Human Participants (2012):
p.000184: http://www.moh.gov.bw/Publications/drug_reg ulation/CLINICAL%20TRIAL%20GUIDELIN ES%20botswana%20v4-060312.pdf
p.000184:
p.000184: Note: All websites and documents are in French.
p.000184: General Ethics Committee for Health Research
p.000184:
p.000184:
p.000184: Drugs, Biologics, and Devices
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000184: Cameroon
p.000184:
p.000184: Joint Order 2004-147 / MS / MESSE of 11 May 2004 on the Organization and Functioning of the Ethics Committee for Health
p.000184: Research in Burkina Faso
p.000184: Order No. 2010-292/MS /CAB of 1 October 2010 on the Conditions for Granting Authorizations for Clinical Trials:
p.000184: http://elearning.trree.org/pluginfile.ph p/34806/mod_folder/content/0/19_Ar rete_autorisations_essais_cliniques.p
p.000184: df?forcedownload=1
p.000184: For an overview of human subject protections in Cameroon, see:
p.000184: http://elearning.trree.org/mod/nationalsupplement/view.php?id=227
p.000184:
p.000184: General
p.000184: Cameroon Bioethics Initiative:
p.000184: www.cambin.org
p.000184: Ministerial Order No. 079/A/MSP/DS of MINSANTE (1987):
p.000184: http://elearning.trree.org/pluginfile.ph p/34735/mod_folder/content/0/cm- arrete-079-MSP- CreationComiteEthique-
p.000184: 1987.pdf?forcedownload=1
p.000184: Operational Guidelines for Ethics Committees in Charge of the Evaluation of Biomedical Research
p.000184:
p.000185: 185
p.000185:
p.000185: Country Key Organizations Legislation
p.000185: Regulations Guidelines Congo, Democratic Republic of
p.000185:
p.000185: General
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Drugs, Biologics, and Devices Côte-d'Ivoire
p.000185: Decree-Law Framework on Public Health, Title VII: Regarding the National Medical Ethics Committee, Biomedical Research,
p.000185: Transplantation of Organs and Tissues, Genetic Treatment, and Cloning: https://www.mindbank.info/item/25 43
p.000185: 1. Proposal for Ministerial Order No. 1250 Establishing the National Advisory Committee on Ethics Health (2004):
p.000185: https://healthresearchweb.org/?action=downloa d&file=DRCPOlicy.pdf
p.000185: 2. Guidelines for the Ethical Evaluation of Research Involving Human Subjects in the Democratic Republic of Congo
p.000185: (2011) (Fench): https://clinregs.niaid.nih.gov/sites/default/files/ documents/DRC/G-EthicalEval.pdf
p.000185: For an overview of human subject protections in Côte-d'Ivoire, see: http://elearning.trree.org/course/view.php?id=19
p.000185: Note: All websites and documents are in French.
p.000185:
p.000185: Drugs, Biologics, and Devices
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: Ethiopia
p.000185: General
p.000185:
p.000185:
p.000185:
p.000185: Drugs and Devices
p.000185:
p.000185:
p.000185: Human Biological Materials
p.000185:
p.000185:
p.000185: Gambia
p.000185: Genetic Research
p.000185: National Committee on Ethics and Research
p.000185:
p.000185:
p.000185:
...
p.000187: 2. Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011): http://clinregs.niaid.nih.gov/documen
p.000187: ts/liberia/G-LIBR-NHSREC.pdf
p.000187: Operational Guidelines of the National Research Ethics Board (2019):
p.000187: https://clinregs.niaid.nih.gov/sites/default/files/ documents/liberia/G-NREB-revised.pdf
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187:
p.000187: Guideline for Application to
p.000187: Conduct Clinical Trials in Liberia (2014):
p.000187: https://clinregs.niaid.nih.gov/documents/liberia
p.000187: /G-LibClinTrial.pdf
p.000187:
p.000187:
p.000187:
p.000188: 188
p.000188:
p.000188: Country Key Organizations Legislation
p.000188: Regulations Guidelines Malawi
p.000188: For an overview of the clinical research regulations in Malawi, see the ClinRegs report:
p.000188: http://clinregs.niaid.nih.gov/single_country.php?c_id=129
p.000188:
p.000188: General
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188: Drugs, Biologics, and Devices
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188: Social-Behavioral Research
p.000188: 1. National Commission for Science and Technology (NCST): http://www.ncst.mw/
p.000188: 2. National Health Sciences Research Committee (NHSRC): http://www.ncst.mw/national-health-
p.000188: science-research-committee-nhsrc/
p.000188: 3. College of Medicine Research and Ethics Committee (COMREC): http://www.medcol.mw/
p.000188: 4. Ministry of Health:
p.000188: www.malawi.gov.mw
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188: Pharmacy, Medicines, and Poisons Board of Malawi
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188: National Committee on Research in the Social Sciences and Humanities
p.000188: 1. Presidential Decree on 30th March 1974
p.000188: 2. Malawi Government Gazette, June 11, 1976, General Notice No. 398
p.000188: 3. Constitution of Malawi, Article 19(5) (1994)
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188: 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=
p.000188: 1&cad=rja&uact=8&ved=0CB0QFj AAahUKEwi3qf2P2vLIAhUEqh4K HfyNBvw&url=http%3A%2F%2F www.malawilii.org%2Ffiles%2Fm
p.000188: w%2Flegislation%2Fconsolidated- act%2F35%3A01%2Fpharmacy_me dicines_poisons_act_pdf_19885.pdf &usg=AFQjCNFJR-
p.000188: Y4F7y3eoC6DV0H7Jr77s5Msg
p.000188: 2. Section 42(1) of PMPB Act, 2003 Supplement
p.000188:
p.000188:
p.000189: 189
p.000189: NCST:
p.000189: 1. The Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi (2011)
p.000189: 2. Policy Requirements, Procedures and Guidelines for the Conduct and Review of Research (2012)
p.000189: 3. National Policy Measures and Requirements for the Improvement of Health Research Co-ordination in Malawi (2012)
p.000189: 4. National Policy Requirements and Guidance for the Provision of Insurance Cover for Research Participants in Clinical
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 45XcfrX46 | common rule |
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| accessXtoXinformation | Access to information |
| age | Age |
| armedXforces | Soldier |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| cadavers | Cadavers |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| commonXrule | common rule |
| crime | Illegal Activity |
| criminal | criminal |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| family | Motherhood/Family |
| fetuses | Fetus/Neonate |
| foia | Access to information |
| freedomXofXinformation | Access to information |
| geneticXheritage | genetic heritage |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| impaired | Cognitive Impairment |
| incapacity | Incapacitated |
| indigenous | Indigenous |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| minor | Youth/Minors |
| nation | stateless persons |
| neonates | Fetus/Neonate |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| political | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| socialXwelfare | Access to Social Goods |
| stemXcells | stem cells |
| tri-council | tri-council policy statement |
| union | Trade Union Membership |
| usage | Drug Usage |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| 45XcfrX46 | ['commonXrule'] |
| HIV | ['hiv/aids'] |
| access | ['socialXwelfare'] |
| accessXtoXinformation | ['foia', 'freedomXofXinformation'] |
| child | ['children'] |
| children | ['child'] |
| commonXrule | ['45XcfrX46'] |
| drug | ['usage'] |
| education | ['educational'] |
| educational | ['education'] |
| fetuses | ['neonates'] |
| foia | ['accessXtoXinformation', 'freedomXofXinformation'] |
| freedomXofXinformation | ['accessXtoXinformation', 'foia'] |
| hiv/aids | ['HIV'] |
| home | ['property'] |
| liberty | ['restricted'] |
| minor | ['youth'] |
| neonates | ['fetuses'] |
| opinion | ['philosophy'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| political | ['party'] |
| property | ['home'] |
| restricted | ['liberty'] |
| socialXwelfare | ['access'] |
| usage | ['drug'] |
| youth | ['minor'] |
Trigger Words
capacity
consent
cultural
developing
ethics
justice
protect
protection
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input