Human Research Standards in Europe by Country

General

Key Organizations

• European Commission — Research & Innovation
• Council of Europe — Bioethics Unit
• Uppsala University — CODEX Rules & Guidelines for Research

Relevant Standards

• European Group on Ethics (EGE) — Opinions & Statements
• EU Research & Innovation — Law and Regulations
• Horizon 2020 — Ethics Self‑Assessment Guide (2015)
• Oviedo Convention on Human Rights and Biomedicine & Protocols
• Council of Europe — Bioethics Recommendations
• Council of Europe — Bioethics Guides
• Guide for Research Ethics Committee Members

Drugs, Biologics, and Devices

Key Organizations

• European Commission — Public Health (Pharmaceuticals)
• European Medicines Agency (EMA)

Relevant Standards

• EU Legal Framework — Medicinal Products
• EU Clinical Trials — Regulations, Directives, Guidance
• EudraLex — Body of EU Pharmaceutical Law
• Pharma Strategy — Reform of EU Pharmaceutical Legislation (2023)
• EU Medical Devices — New Regulations
• EU Medical Devices — Directives
• EMA — Research & Development
• EMA — Clinical Trials in Human Medicines
• ICH E6(R1) — Good Clinical Practice (1997)
• ICH E6(R2) — Good Clinical Practice (2016)
• Data Quality Framework for EU Medicines Regulation (2023)

Clinical Trial Registries

Key Organizations

• EU Clinical Trials Register / CTIS

Relevant Standards

• EU CTR — Guidance & Q&As
• EU CTR — FAQs

Research Injury

Relevant Standards

• EU Public Health — Pharmaceuticals
• Clinical Trials Directive 2001/20/EC
• Clinical Trials Regulation (EU) No 536/2014
• Oviedo Convention (Article 24 — Research Injury)

Privacy/Data Protection

Key Organizations

• European Data Protection Board (EDPB)
• European Medicines Agency (EMA)
• Council of Europe — Data Protection & Cybercrime

Relevant Standards

• General Data Protection Regulation (GDPR) — Regulation (EU) 2016/679
• EDPB — Guidelines, Recommendations, Best Practices
• EDPB Opinion 3/2019 — CTR / GDPR Interplay
• EU Data Governance Act — Regulation (EU) 2022/868
• EMA Policy — Publication of Clinical Data
• Convention 108 (1981) — Automatic Processing of Personal Data
• Convention 108+ (2018) — Amending Protocol
• Recommendation R(97)5 — Protection of Medical Data
• Recommendation CM/Rec(2019)2 — Health‑related Data

Human Biological Materials

Key Organizations

• European Group on Ethics (EGE)
• EU — Blood, Tissues, Cells & Organs
• Council of Europe — Bioethics Unit

Relevant Standards

• EU BTC&O — Key Documents
• Directive 2004/23/EC — Human Tissues/Cells Quality & Safety
• ATMP — GCP Guidelines
• Oviedo Convention — Articles 21–22
• Additional Protocol — Transplantation of Organs/Tissues (ETS 186)
• Recommendation Rec(2016)6 — Research on Biological Materials

Genetic Research

Key Organizations

• EMA
• Council of Europe — Bioethics Unit

Relevant Standards

• Regulation (EC) No 1394/2007 — Advanced Therapy Medicinal Products
• Additional Protocol — Genetic Testing for Health Purposes (CETS 203)
• Recommendation R(92)3 — Genetic Testing/Screening
• Recommendation CM/Rec(2006)4 — Biological Materials in Research
• Recommendation CM/Rec(2016)8 — Health Data for Insurance (incl. Genetic Tests)

Embryos, Stem Cells, and Cloning

Key Organizations

• EGE
• Council of Europe — Bioethics Unit

Relevant Standards

• European Commission statements on hESC research (2003, 2006, 2013)
• EGE Opinion No. 22 — Ethics Review of hESC FP7 Projects
• Additional Protocol — Prohibition of Cloning Human Beings (ETS 168)
• Council of Europe — Statement on Genome Editing (2015)

Drugs, Biologics, and Devices

Key Organizations

• Scientific Center of Drug and Medical Technologies Expertise (SCDMTE)
• Ministry of Health — Ethics Committee
• National Center for AIDS Prevention — Ethical Committee

Relevant Standards

• Law on Medical Aid & Maintenance of the Population (1996), Article 21
• Procedure for Clinical Trials of New Medications (Government Resolution, 2002)
• Law on Prevention of Disease Caused by HIV (2012)
• Declaration of Helsinki (2013)

General

Key Organizations

• Ministry of Health
• Forum of Austrian Ethics Committees
• Bioethics Commission

Relevant Standards

• University Act (2002; last amended 2024)
• Hospitals Act
• Regulation on Leading Ethics Committees (2004)

Drugs, Biologics, and Devices

Key Organizations

• Austrian Agency for Health & Food Safety (AGES)
• Federal Office for Safety in Health Care (BASG)

Relevant Standards — Drugs

• Austrian Drug Law
• BASG — Clinical Trials (guidance & forms)

Relevant Standards — Devices

• Medical Devices Act (2021)
• BASG — Medical Devices (clinical investigation)

Research Injury

Relevant Standards

• Austrian Drug Law, Article 32

Privacy/Data Protection

Key Organizations

• Austrian Data Protection Authority

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Data Protection Act No. 165/1999

Human Biological Materials

Relevant Standards

• Law on Safety of Blood
• Law on Quality & Safety of Human Tissue and Cells
• Regulation on Tissue Banks

Genetic Research

Relevant Standards

• Gene Technology Act

Embryos, Stem Cells, and Cloning

Relevant Standards

• Reproductive Medicine Act

General

Key Organizations

• Ministry of Health (MOH)
• National Bioethics Committee
• Center for Examinations and Tests in Health Service

Relevant Standards

• Constitution — Article 25
• Law on Health Care System (2010)
• Ordinance No. 274 — Establishing the National Bioethics Committee (2006)
• Decree No. 55 — Ethics Committees (2008)
• Code of Medical Ethics (1999)
• Guidelines for Ethics Committees SOP (No. 55‑0004, 2000)

Drugs, Biologics, and Devices

Relevant Standards — Drugs

• Law on Drugs (2009), Articles 15–16
• Law on Health Care System — Article 40
• Ordinance No. 254 — Clinical Drug Trials & GCP (1999)
• Ordinance No. 161 — Accreditation & Attestation for trials (1999)
• Decree No. 55 — Ethics Committees (2008)
• Decree No. 50 — Certain Aspects of Clinical Drug Trials (2009)
• Instruction No. 55‑0504 — Accreditation/Attestation (2004)

Relevant Standards — Devices

• Law on Health Care System — Article 40
• Ordinance No. 161 — Accreditation & Attestation (1999)
• Decree No. 216 — Clinical Trials of Medical Devices (2008)
• Instruction No. 55‑0504 — Accreditation/Attestation (2004)

Clinical Trial Registries

Key Organizations

• Center for Examinations and Tests in Health Service

Research Injury

Key Organizations

• Center for Examinations and Tests in Health Service
• Local Ethics Committees
• Insurance companies

Privacy/Data Protection

Key Organizations

• Ministry of Health
• National Bioethics Committee
• Center for Examinations and Tests in Health Service

Relevant Standards

• Constitution — Article 28
• Law on Health Care System — Article 46

Human Biological Materials

Key Organizations

• Ministry of Health (MOH)
• National Bioethics Committee
• State Service of Forensic Medicine (SSFM)
• Center for Examinations and Tests in Health Service

Relevant Standards

• Law on Health Care System — Articles 40 & 46
• Ordinance No. 111 — National Pathology Service (1993)
• Ordinance No. 38‑c — Rules for Morphological Examinations (1999)

General

Key Organizations

• Federal Agency for Medicines and Health Products (FAMHP)
• Belgian Advisory Committee on Bioethics (BACB)

Relevant Standards

• Law Relating to Experimentation on Humans (2004)
• Royal Decree (4 Apr 2014) — Measures re Ethics Committee
• Royal Decree (30 Jun 2004; mod. 18 May 2006) — Measures for Carrying Out the Law
• BACB — Opinions

Drugs, Biologics, and Devices

Key Organizations

• FAMHP — Drugs: Clinical Trials
• FAMHP — Devices
• Clinical Trial College

Relevant Standards

• Law Relating to Experimentation on Humans (2004)
• Royal Decrees on Ethics Committees & Clinical Trials
• BACB Opinion No. 58 — Financing Expensive Medication

Research Injury

Relevant Standards

• Law Relating to Experimentation on Humans, Chapter XVII (Responsibility & Insurance), Article 29

Privacy/Data Protection

Key Organizations

• Belgian Data Protection Authority

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Act of 30 July 2018 — Protection of Natural Persons re Processing of Personal Data

Human Biological Materials

Key Organizations

• FAMHP
• Superior Health Council (CSS)

Relevant Standards

• Law on Use of Human Biological Materials (19 Dec 2008) & Royal Decrees

Embryos, Stem Cells, and Cloning

Key Organizations

• Federal Commission — Research on Embryos in Vitro

Relevant Standards

• Act on Research on Embryos in Vitro (2003)
• Law on Medically Assisted Reproduction & Destination of Supernumerary Embryos/Gametes (2007)
• Royal Decree — Criteria for “Reproductive Medicine” Care Programs (1999)

General

Key Organizations (FBiH)

• Medicines & Medical Devices Agency of Bosnia and Herzegovina
• Ministry of Health (Federation of Bosnia and Herzegovina)

Relevant Standards

• Oviedo Convention
• Additional Protocol concerning Biomedical Research
• Law on Health Protection (Republika Srpska, 2015)
• Law on Health Protection (FBiH), No. 46/10
• Agency — Documents

Drugs, Biologics, and Devices

Key Organizations (FBiH)

• Ministry of Health (FBiH)
• Medicines & Medical Devices Agency

Relevant Standards (RS)

• Medicinal Products & Medical Devices Act (Law No. 58/08)
• Ordinance — Clinical Trials on Medical Products/Devices (2010)
• Regulation on Medical Devices (2010)

Clinical Trial Registries

Key Organizations

• Agency — Clinical Trials

Research Injury

Relevant Standards (FBiH)

• Oviedo Convention — Article 24
• Medicinal Products & Medical Devices Act — Articles 52 & 116
• Law on Health Insurance (FBiH), Official Gazette No. 46/10
• Ordinance — Clinical Trials of IMP & Medical Devices (4/10)

Relevant Standards (RS)

• Medicinal Products & Medical Devices Act — Articles 52 & 116
• Law on Health Insurance (Republika Srpska), Official Gazette No. 106/09
• Ordinance — Clinical Trials of IMP & Medical Devices (4/10)

Social‑Behavioral Research

Key Organizations

• Institute for Public Health FBiH
• Institute for Public Health of Republika Srpska

Privacy/Data Protection

Relevant Standards

• Law on Protection of Personal Data (2005)
• Amendments (2011)
• Compilation of Domestic & International Data Protection Regulations

Human Biological Materials

Relevant Standards (FBiH)

• Oviedo Convention — Articles 21–22
• Law on Blood & Blood Components

Embryos, Stem Cells, and Cloning

Relevant Standards (FBiH)

• Additional Protocol — Prohibition of Cloning Human Beings
• Law on Transplantation of Organs & Tissues (OG No. 75/09)
• Law on Blood & Blood Products (OG No. 09/10)

Relevant Standards (RS)

• Law on Transplantation of Organs (2010)
• Law on Transplantation of Human Tissues and Cells (2010)

General

Key Organizations

• https://www.mh.government.bg/en/

Relevant Standards

• Constitution of the Republic of Bulgaria, Amendment SG. 18/25, Article 29 (2015)
• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Oviedo Convention, Additional Protocol concerning Biomedical Research (CETS No. 195)
• Law Ratifying the Additional Protocol on Biomedical Research (2006)
• Medicinal Products in Human Medicine Act (2017)
   
• Healthcare Act, Articles 197-206 (2018)

International Compilation of Human Research Standards

• List of Laws

General

Key Organizations

• Central Ethics Committee
• Ministry of Health
• Agency for Medicinal Products & Medical Devices (HALMED)

Relevant Standards

• Oviedo Convention
• Patient Protection Act (2008), Article 20

Drugs, Biologics, and Devices

Relevant Standards — Drugs

• Medicinal Product Act (2013)
• Rule Book — Amendments (2014)
• Ordinance — Clinical Trials & GCP (2015)

Relevant Standards — Devices

• Medical Devices Act (2013)
• Regulation (EU) 2017/745 — Medical Devices
• Regulation (EU) 536/2014 — Clinical Trials

Clinical Trial Registries

Relevant Standards

• Ministry of Health — Various
• HALMED — Industry Front Page

Research Injury

Key Organizations

• HALMED
• Ministry of Health
• Croatian Health Insurance Fund

Relevant Standards

• Oviedo Convention — Article 24
• Law on Mandatory Health Insurance (2013)
• Ordinance on Clinical Trials & GCP (Articles 11, 16 etc.) (2015)

Privacy/Data Protection

Key Organizations

• Personal Data Protection Agency (AZOP)

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Implementation Act of GDPR (NN 42/18)

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22
• Law on Blood and Blood Products (2006)
• Law on Implementation of Human Tissues & Cells (2012)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning
• Medical Fertilization Act — Article 32 (2012)

General

Relevant Standards

• Oviedo Convention
• Safeguarding & Protection of Patients’ Rights Law (2004)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health — Pharmaceutical Services
• National Bioethics Committee

Relevant Standards

• Law for Good Clinical Practice (2004)

Research Injury

Key Organizations

• Ministry of Health

Relevant Standards

• Oviedo Convention — Article 24
• Legislation Concerning Medicinal Products (Human Use) — GCP No. 452/2004, Article 11(8)

Privacy/Data Protection

Key Organizations

• Commissioner’s Office for the Protection of Personal Data

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Law 125(I)/2018 — Protection of Natural Persons re Processing of Personal Data

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning Human Beings

General

Key Organizations

• Ministry of Health — Central Ethics Committee

Relevant Standards

• Oviedo Convention
• Act No. 130/2002 — Research & Development Support (as amended)
• Act No. 372/2011 — Healthcare Services (as amended)
• Act No. 373/2011 — Specific Healthcare Services (as amended)

Drugs, Biologics, and Devices

Key Organizations

• State Institute for Drug Control (SÚKL)

Relevant Standards — Drugs

• Act No. 378/2007 — Pharmaceuticals (as amended)
• Regulation (EU) 536/2014 — Clinical Trials
• Decree No. 226/2008 — Good Clinical Practices
• SÚKL — Clinical Trials Guidelines

Relevant Standards — Devices

• Act No. 375/2022 Coll. — Medical Devices / IVDs
• SÚKL — Medical Devices

Clinical Trial Registries

Relevant Standards

• EU Clinical Trials Register

Research Injury

Relevant Standards

• Oviedo Convention — Article 24
• Civil Code — Law No. 89/2012 Coll.

Privacy/Data Protection

Key Organizations

• Office for Personal Data Protection

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Act No. 110/2019 Coll. — Personal Data Processing

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22

Genetic Research

Relevant Standards

• Additional Protocol — Genetic Testing for Health Purposes

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Education, Youth and Sport
• Bioethical Commission — R&D Council

Relevant Standards

• Additional Protocol — Prohibition of Cloning Human Beings
• Act No. 227/2006 Sb. — Research on Human Embryonic Stem Cells (as amended)

General

Key Organizations

• National Scientific Ethics Committee (NVK) & Scientific Medical Ethics Committees (VMK)
• Danish Research Ethics Committees

Relevant Standards

• Oviedo Convention
• Act No. 1338 (2020) — Research Ethics Review of Health/Health Data Research Projects
• Executive Order No. 825 (2020) — Obligation to Notify
• Danish Research Ethics — Guidelines

Drugs, Biologics, and Devices

Key Organizations

• Danish Medicines Agency

Relevant Standards

• Act No. 1252 (2018) — Clinical Trials on Medicinal Products
• Act No. 1853 (2020) — Review of Clinical Trials on Medical Devices
• Executive Order No. 295 (2004) — Clinical Trials of Medicinal Products on Humans
• Guidelines — Authorisation of Clinical Trials in Humans

Clinical Trial Registries

Relevant Standards

• Act No. 1338 (2020) — Notification/Registration obligations
• Overview of Mandatory Reporting

Research Injury

Key Organizations

• Patient Compensation Association

Relevant Standards

• Oviedo Convention — Article 24
• Act No. 995 (2018) — Right to Complain & Receive Compensation (Health Service)

Privacy/Data Protection

Key Organizations

• Danish Data Protection Agency (DPA)

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Data Protection Act (2018; amended 2024)
• Health Act No. 903 — Chapter 9

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22
• Health Act No. 903
• Guidelines on Use of Biological Material (2017)

Genetic Research

Relevant Standards

• Act No. 1338 (2020)
• Executive Order No. 825 (2020)
• Executive Order No. 965 (2021) — Reporting Significant Findings
• Guidance on Genomics & Sensitive Bioinformatics Data (2020)

Embryos, Stem Cells, and Cloning

Key Organizations

• Danish Council of Ethics

Relevant Standards

• Act No. 440 — Danish Council of Ethics (2004)
• Executive Order No. 902 — Medically Assisted Reproduction (2019)

General

Key Organizations

• Estonian Council on Bioethics

Relevant Standards

• Oviedo Convention
• Constitution — Paragraph 18
• Code of Ethics of Estonian Scientists

Drugs, Biologics, and Devices

Key Organizations

• State Agency of Medicines
• Minister of Social Affairs
• Estonian Health Board

Relevant Standards

• Medicinal Products Act — Chapter 5
• Rules of Procedure — Medical Ethics Committee for Clinical Trials (2005)
• Regulation No. 23 — Conducting Clinical Trials of Medicinal Products (2005)
• Medical Devices Act (2004)

Research Injury

Key Organizations

• Minister of Social Affairs
• Estonian Health Insurance Fund

Relevant Standards

• Oviedo Convention — Article 24
• Medicinal Products Act — Section 90
• Regulation No. 23 — Clinical Trials of Medicinal Products

Privacy/Data Protection

Key Organizations

• Estonian Data Protection Inspectorate

Relevant Standards

• GDPR — Regulation (EU) 2016/679
• Personal Data Protection Act (2018)

Genetic Research

Relevant Standards

• Human Genes Research Act (RT I 2000, 104, 685)

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22
• Additional Protocol — Transplantation of Organs/Tissues (ETS 186)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning (Estonian; 2002)
• Additional Protocol — Prohibition of Cloning Human Beings
• Artificial Insemination & Embryo Protection Act (RT I 1997, 51, 824)

General

Key Organizations

• Ministry of Social Affairs and Health
• National Committee on Medical Research Ethics (TUKIJA)
• Finnish Advisory Board on Research Integrity (TENK)
• Finnish Institute for Health and Welfare (THL)
• Findata
• Finnish Medicines Agency (Fimea)

Relevant Standards

• Oviedo Convention
• Decree of National Research Ethics Council No. 1347/1991
• Decree on Medical Research Nos. 986/1999, 313/2004, 65/2016
• Decrees on TUKIJA (2010 & 2018)
• TUKIJA — Legislation
• Data Protection Act 1050/2018
• Criminal Code of Finland
• Act on Secondary Use of Health & Social Data (552/2019)
• Responsible Conduct of Research Guidelines (TENK)

Drugs, Biologics, and Devices

Key Organizations

• Fimea
• MSAH
• TUKIJA
• National Supervisory Authority for Welfare & Health (Valvira)

Relevant Standards — Drugs

• TUKIJA — Legislation
• Medicines Act 395/1987
• Decree No. 1347/1991
• Decrees 986/1999, 313/2004, 65/2016
• Decrees on TUKIJA (820/2010, 788/2018)

Relevant Standards — Devices

• TUKIJA — Legislation
• Act on Specific Medical Devices (629/2010)

Clinical Trial Registries

Key Organizations

• Fimea — Clinical Drug Trials

Research Injury

Key Organizations

• Patient Insurance Centre
• Pharmaceutical Injuries Insurance

Relevant Standards

• Oviedo Convention — Article 24
• Patient Injuries Act 948/2019

Social‑Behavioral Research

Key Organizations

• TENK

Relevant Standards

• Ethical Principles for Research with Human Participants (2019)
• Act on Secondary Use of Health & Social Data

Privacy/Data Protection

Key Organizations

• Findata
• Office of the Data Protection Ombudsman

Relevant Standards

• GDPR
• Data Protection Act 1050/2018

Human Biological Materials

Relevant Standards

• Oviedo Convention Articles 21–22
• Additional Protocol — Transplantation of Organs & Tissues
• Act on Medical Use of Human Organs, Tissues & Cells (101/2001)
• Law on Biobanks (688/2012)

Genetic Research

Key Organizations

• TUKIJA
• Board for Gene Technology

Relevant Standards

• Gene Technology Act (377/1995; last amended 39/2023)

Embryos, Stem Cells, and Cloning

Key Organizations

• Valvira
• TUKIJA
• TENK
• ETENE

Relevant Standards

• Additional Protocol — Prohibition of Cloning Human Beings
• Medical Research Act 488/1999
• Act on Assisted Fertility Treatments 1237/2006
• Criminal Code — Chapter 22, Section 4 (Cloning forbidden)

General

Key Organizations

• Ministry of Social Affairs & Health
• National Consultative Bioethics Committee (CCNE)
• CNIL — National Commission for Information & Liberties

Relevant Standards

• Oviedo Convention
• Law No. 2012‑300 — Research Involving Human Persons
• Law No. 2011‑814 — Bioethics
• Public Health Code R1121‑1+

Drugs, Biologics, and Devices

Key Organizations

• ANSM — National Agency for Medicines & Health Products Safety

Relevant Standards

• Medications for Human Use — Public Health Code Articles 5111‑1+
• Decision on Good Clinical Practices

Privacy/Data Protection

Key Organizations

• CNIL

Relevant Standards

• GDPR
• French Data Protection Act (Act 78‑17; updated 2018)
• Decree 2019‑536 — Application of Data Protection Act

Human Biological Materials

Relevant Standards

• Donation & Use of Human Body Elements (Public Health Code L1211‑1+)
• Decree No. 2017‑1549 — Conservation & Preparation of Human Body Elements

Genetic Research

Relevant Standards

• Civil Code Articles 16‑10 to 16‑13
• Public Health Code R1131‑1+

Embryos, Stem Cells, and Cloning

Relevant Standards

• Law No. 2013‑715
• Decree 2015‑155 — Research on Embryos

"

General

Key Organizations

• Bioethics & Health Law Studies Society

Relevant Standards

• Oviedo Convention
• Additional Protocol concerning Biomedical Research
• Law on Health Care — Chapter XIX
• Law on Medicines & Pharmaceutical Activities

Drugs, Biologics, and Devices

Relevant Standards

• Regulation No. 176 — Approval of Clinical Trials (2005)
• Order adopting ICH E6 GCP & Declaration of Helsinki

Clinical Trial Registries

Relevant Standards

• No public registry

Research Injury

Relevant Standards

• Oviedo Convention Article 24

Social‑Behavioral Research

Key Organizations

• Social & Psychological Agency

Relevant Standards

• EPSY — Various
• Personal Data Protection Inspector — Various

Privacy/Data Protection

Key Organizations

• Personal Data Protection Inspector

Relevant Standards

• Law on Data Protection (2018)

Human Biological Materials

Relevant Standards

• Oviedo Convention Articles 21–22
• Additional Protocol — Transplantation (ETS 186)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning
• Law on Health Care — Article 142

"

General

Key Organizations

• German Medical Association (BÄK)
• ZEKO — Central Ethics Committee
• Working Party of Research Ethics Committees
• German Ethics Council
• Federal Ministry of Health

Relevant Standards

• Professional Code for Physicians — Article 15
• DFG — Guidelines for Safeguarding Good Research Practice (2022)

Drugs, Biologics, and Devices

Key Organizations

• BfArM — Federal Institute for Drugs & Medical Devices
• Paul‑Ehrlich‑Institute (PEI)

Relevant Standards

• Medicinal Products Act (AMG)
• Medical Device Law Implementation Act

Clinical Trial Registries

Key Organizations

• German Clinical Trials Register (DRKS)

Research Injury

Relevant Standards

• AMG Section 40(3)
• Medical Device Law Implementation Act Section 26

Privacy/Data Protection

Key Organizations

• Federal Commissioner for Data Protection

Relevant Standards

• GDPR
• Federal Data Protection Act (BDSG)

Human Biological Materials

Relevant Standards

• Act on Quality & Safety of Human Tissue & Cells
• Transfusion Law
• Transplantation Law

Genetic Research

Relevant Standards

• Embryo Protection Act
• Genetic Engineering Act

Embryos, Stem Cells, and Cloning

Relevant Standards

• Stem Cell Act
• Regulation on Central Ethics Committee for Stem Cell Research

"

General

Key Organizations

• National Bioethics Commission (NBC)

Relevant Standards

• Oviedo Convention
• Research Ethics for Biological Sciences (2008)
• Guide for Research Ethics Committees (2008)

Drugs, Biologics, and Devices

Key Organizations

• National Organization for Medicines (NOM)

Relevant Standards

• Act 2619/1998 — Biomedicine Convention
• Act 3418/2005 — Code on Medical Ethics
• Ministerial Decisions on harmonization with EU Directives 2001/20/EC & 2005/28/EC

Research Injury

Relevant Standards

• Act 3418/2005 — Code on Medical Ethics

Privacy/Data Protection

Key Organizations

• Hellenic Data Protection Authority

Relevant Standards

• Greek Constitution — Art. 9.1
• Act 2472/1997 — Protection of Personal Data
• GDPR

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22

Genetic Research

Relevant Standards

• Greek Constitution Article 5.5
• Act 2619/1998 — Human Rights & Biomedicine
• NBC Recommendation — Biobanks

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning
• Civil Code (Act 3089/2002) — Medically Assisted Reproduction

"

General

Key Organizations

• Ministry of Human Capacities
• Medical Research Council — Research Ethics Committees
• National Center for Public Health and Pharmacy

Relevant Standards

• Oviedo Convention
• Fundamental Law of Hungary (Articles II–III)
• Act CLIV of 1997 — Health Care
• Act VI of 2002 — Promulgation of the Oviedo Convention
• Act LXXXI of 2006 — Additional Protocol

Drugs, Biologics, and Devices

Relevant Standards — Drugs

• Act XCV of 2005 — Medicinal Products for Human Use
• Decree 35/2005 — Clinical Trials & GCP

Relevant Standards — Devices

• Act CLIV of 1997 — Health Care Section 159
• Decree 4/2009 — Medical Devices

Clinical Trial Registries

Relevant Standards

• Hungarian Register of Clinical Trials

Research Injury

Relevant Standards

• Oviedo Convention Article 24

Privacy/Data Protection

Relevant Standards

• GDPR
• Act CXII of 2011 — Informational Self‑Determination & Freedom of Information

Human Biological Materials

Relevant Standards

• Act XLVII of 1997 — Handling of Medical & Related Data

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning

"

General

Key Organizations

• Ministry of Health
• National Bioethics Committee (NBC)

Relevant Standards

• Act on Scientific Research in the Health Sector No. 44/2014
• Oviedo Convention

Drugs, Biologics, and Devices

Key Organizations

• Icelandic Medicines Agency

Relevant Standards

• Medicinal Products Act No. 100/2020
• Regulation on Clinical Trials No. 443/2004

Research Injury

Relevant Standards

• Act on Patient Insurance No. 111/2000

Privacy/Data Protection

Key Organizations

• Data Protection Authority

Relevant Standards

• GDPR
• Act No. 90/2018 — Data Protection

Human Biological Materials

Relevant Standards

• Biobanks Act No. 110/2000 (amended 2015)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning

"

General

Key Organizations

• Department of Health

Relevant Standards

• Operational Procedures for Research Ethics Committees (2004)
• HSE National Consent Policy

Drugs, Biologics, and Devices

Relevant Standards

• European Communities Clinical Trials Regulations (2004)

Research Injury

Relevant Standards

• Regulations 2004 — Section 13(6)(k)

Privacy/Data Protection

Key Organizations

• Data Protection Commissioner (DPC)

Relevant Standards

• GDPR
• Data Protection Act 2018

Human Biological Materials

Relevant Standards

• Human Biological Material Recommendations (2005)

Genetic Research

Relevant Standards

• Guidelines for Pharmacogenetic Research (2006)

"

General

Key Organizations

• National Bioethics Committee (CNB)

Relevant Standards

• CNB — Opinions & Documents

Drugs, Biologics, and Devices

Key Organizations

• Italian Medicines Agency (AIFA)
• National Observatory on Clinical Trials (OsSC)

Relevant Standards

• AIFA — Clinical Trial Legislation
• Legislative Decree 211/2003 — Good Clinical Practice
• Legislative Decree 200/2007 — GCP/Manufacturing Requirements

Research Injury

Relevant Standards

• Ministerial Decree 14 July 2009 — Insurance Requirements for Clinical Trials

Social‑Behavioral Research

Relevant Standards

• Register of Observational Studies (RSO)

Privacy/Data Protection

Key Organizations

• Italian Data Protection Authority

Relevant Standards

• GDPR
• Italian Personal Data Protection Code (Leg. Decree 196/2003)

Genetic Research

Key Organizations

• Istituto Superiore di Sanità (ISS)
• Italian Society of Human Genetics (SIGU)

Relevant Standards

• ISS Guidelines — Gene Somatic Therapy Trials

Embryos, Stem Cells, and Cloning

Relevant Standards

• Law 40/2004 — Medically Assisted Reproduction (Article 13)

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General

Key Organizations

• Central Medical Ethics Committee

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Statutes of Central Medical Ethics Committees (1998)

Drugs, Biologics, and Devices

Key Organizations

• State Agency of Medicines
• Central Medical Ethics Committee

Relevant Standards — Drugs

• Law on Pharmacy — Section 26
• Cabinet Regulation No. 289 — Clinical trial procedures & GCP

Relevant Standards — Devices

• Medical Treatment Law — Section 34
• Cabinet Regulation No. 891 — Device clinical trials

Clinical Trial Registries

Key Organizations

• State Agency of Medicines

Research Injury

Relevant Standards

• Oviedo Convention — Article 24
• Cabinet Regulation No. 289 — indemnity sections
• Cabinet Regulation No. 891 — device trial injury provisions

Privacy/Data Protection

Key Organizations

• Data State Inspectorate

Relevant Standards

• EU GDPR (2016/679)
• Personal Data Processing Law (2014)
• Law on the Rights of Patients — Section 10
• Cabinet Regulation No. 446 — Use of patient data in research

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22
• Law on Protection of the Body of Deceased Persons & use of tissues/organs (2008)
• Cabinet Regulation No. 1176 — Use of human tissues & cells (2013)

Genetic Research

Key Organizations

• Ministry of Health
• Data State Inspectorate
• Central Medical Ethics Committee

Relevant Standards

• Human Genome Research Law (2005)
• Law on the National DNA Database (2006)
• Procedures for Genetic Research (2004)

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Health
• Central Medical Ethics Committee

Relevant Standards

• Additional Protocol — Prohibition of Cloning Human Beings (ETS No. 168)
• Sexual and Reproductive Health Law — Sections 15–20
• Cabinet Regulation No. 1176 — Use of human tissues & cells

General

Key Organizations

• Ministry of Health (MOH)
• Lithuanian Bioethics Committee (LBEC)

Relevant Standards

• Oviedo Convention (ETS No. 164)
• Law on Ethics of Biomedical Research (2019; with amendments)
• V‑405 — Biomedical research records & information (2010)
• Government Decree No. 1458 — State fees (2017)
• V‑15 — Compensation for research participation expenses (2018)
• V‑28 — Consent content requirements (2018)
• V‑1483 — List of minimally detrimental interventions (2018)
• V‑235/A1‑83 — Minors’ participation (2018)
• V‑28 (2011) — Research on medical documents
• V‑7 — Protocol/sample forms (2017)
• V‑24 — Submission to LBEC for CT approvals (2016)
• LBEC — Updated ICF guidelines (2023)

Drugs, Biologics, and Devices

Key Organizations

• State Medicines Control Agency (SMCA)
• Lithuanian Bioethics Committee
• State Health Care Accreditation Agency (SHCA)

Relevant Standards — Drugs

• Law on Ethics of Biomedical Research
• Law on Pharmacy — consolidated
• Decree No. 320 — Rules of Good Clinical Practice (2006)
• Correction of GCP terminology (2006)
• V‑6 — Sample forms for CT opinion request (2016)
• Decree No. 435 — Clinical trial approvals & conduct (2017)

Relevant Standards — Devices

• V‑2 — Approvals to conduct biomedical research (2017)
• EU MDR 2017/745
• EU CTR 2014/536 (effective 2022)
• LBEC — Permits for device clinical investigations

Clinical Trial Registries

Key Organizations

• Ministry of Health

Relevant Standards

• Law on Ethics of Biomedical Research
• Decree No. 745 — Compulsory civil liability insurance (2016)

Research Injury

Relevant Standards

• Oviedo Convention — Article 24

Social-Behavioral Research

Key Organizations

• State Data Protection Inspectorate

Relevant Standards

• EU GDPR
• Law on Legal Protection of Personal Data

Privacy/Data Protection

Key Organizations

• Ministry of Health
• LBEC

Relevant Standards

• EU GDPR
• Law on the Re‑Use of Health Data
• LBEC — Personal data protection resources

Human Biological Materials

Relevant Standards

• Oviedo Convention — Articles 21–22

Genetic Research

Key Organizations

• Ministry of Health

Relevant Standards

• Additional Protocol — Prohibition of Cloning (ETS 168)
• Law on Ethics of Biomedical Research
• V‑660 — Transit of embryonic/fetal tissues & stem cell lines (2007)
• V‑659 — Import of cord/placenta stem cells & genetic research samples (2017)

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Health

Relevant Standards

• Additional Protocol — Prohibition of Cloning (ETS 168)
• Approval of samples of cord/placenta stem cells for research

General

Key Organizations

• National Ethics Consultative Commission (CNE)
• Ministry of Health
• National Research Ethics Committee (CNER)

Relevant Standards

• CNE — Opinions & notices (various)
• 2014 Government Regulation establishing CNE
• CNER — Statutes, international & national legal framework
• CNER — Guidance & activity reports

Privacy/Data Protection

Key Organizations

• National Data Protection Commission (CNPD)

Relevant Standards

• EU GDPR
• Act of 1 Aug 2018 — CNPD organisation & GDPR framework

Human Biological Materials

Relevant Standards

• Law of 1 Aug 2007 — Human tissues/cells for human application

Genetic Research

Key Organizations

• National Research Ethics Committee (CNER)

Relevant Standards

• CNER — Statutes & legal framework (various)
• CNER — Guidance & reports

General

Key Organizations

• Bioethics Committee

Relevant Standards

• Bioethics Committee — Opinions (various)

Drugs, Biologics, and Devices

Key Organizations

• Medicines Authority
• MCCAA — Technical Regulations Division

Relevant Standards — Drugs

• Medicines Act (2003)
• Clinical Trials Regulations (2004)
• GCP & manufacturing/import authorization (2006)
• Guidance Notes on Good Clinical Practice (2018)

Relevant Standards — Devices

• Product Safety Act (2001)
• In Vitro Diagnostic Medical Devices Regulations (2003)
• Medical Devices Regulations (2010)
• Active Implantable Medical Devices Regulations (2010)

Privacy/Data Protection

Key Organizations

• Office of the Information and Data Protection Commissioner

Relevant Standards

• EU GDPR
• Data Protection Act (2018)
• EU GDPR (canonical link)

General

Key Organizations

• Ministry of Health — National Committee for Ethical Expertise of Clinical Trials

Relevant Standards

• Oviedo Convention (ETS No. 164)
• Additional Protocol concerning Biomedical Research (CETS No. 195)
• Law No. 1409 (1997) — Medicines, Arts. 11–12
• Law No. 263 (2005) — Patients’ rights & responsibilities

Drugs, Biologics, and Devices

Key Organizations

• Medicines and Medical Devices Agency

Relevant Standards

• Law No. 1409 (1997) — Medicines
• Law No. 263 (2005) — Patients’ rights
• Government Decision No. 5/18.01.2016 — National Committee for Ethical Examination of Clinical Trial

Research Injury

Relevant Standards

• Oviedo Convention — Article 24

Privacy/Data Protection

Key Organizations

• National Center for Personal Data Protection (NCPDP)

Relevant Standards

• Convention 108 (1981) & Protocol (2018) — automatic processing of personal data
• Law No. 982 (2000) — Access to Information
• Law No. 133 (2011) — Protection of Personal Data
• EU GDPR (reference)
• Gov. Decision No. 1123 (2010) — Personal data security requirements
• NCPDP — national data protection legislation

Human Biological Materials

Key Organizations

• Transplant Agency

Relevant Standards

• Oviedo Convention — Articles 21–22
• Additional Protocol — Transplantation of organs & tissues (ETS 186)
• Law No. 42‑XVI (2008) — Transplantation of organs, tissues & cells

Genetic Research

Relevant Standards

• Additional Protocol — Genetic testing for health purposes (CETS 203)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Additional Protocol — Prohibition of Cloning (ETS 168)
• Regulation No. 902 (2000) — Licensing research in genetics & microbiology

General

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Oviedo Convention, Additional Protocol concerning Biomedical Research (CETS No. 195)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health of Montenegro
• Institute for Medicines and Medical Devices

Relevant Standards

• Various, Legislations
• Various, Good Practice Guidelines
• Forms, Medicines
• Forms, Devices
• Various, Instructions

Research Injury

Key Organizations

• Institute for Medicines and Medical Devices

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Law on Medicines, Various Legislations
• Law on Medical Devices, Various Legislations

Privacy/Data Protection

Key Organizations

• National Security Agency
• Ministry of Health of Montenegro

Relevant Standards

• Law on the Protection of Personal Data (Official Gazette of Montenegro No. 79/08, 70/09, 44/12)
• Ministry of Health, Law on Data Collection in the Field of Health Care (2009)

Human Biological Materials

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)

Genetic Research

Key Organizations

• Ministry of Health of Montenegro

Relevant Standards

• Oviedo Convention, Additional Protocol Concerning Genetic Testing for Health Purposes (CETS No. 203)
• Law on the Protection of Genetic Data (Official Gazette of Montenegro No. 25/2010)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)

General

Key Organizations

• Central Committee for Research Involving Human Subjects (CCMO)

Relevant Standards

• Population Screening Act (1996)
• Medical Research Involving Human Subjects Act (1998)
• CCMO, Legal Framework for Medical Scientific Research, Various Standards
• Various, Laws
• Various, Decrees and Ministerial Regulations
• Various, CCMO Directives
• Various, Codes of Conduct

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health, Welfare, and Sport (VWS)
• Central Committee for Research Involving Human Subjects (CCMO)
• Medicines Evaluation Board (MEB)

Relevant Standards

• VWS, Medicines Act (2007)
• VWS, Medicines Act Decree (2007)
• VWS, Medicines Act Regulation (2007)
• CCMO, Clinical Trials with Medicinal Products (CTR), Various Standards
• CCMO, Clinical Trials with Medical Devices (MDR), Various Standards
• CCMO Memorandum, Definition of Medical Research

Clinical Trial Registries

Key Organizations

• Netherlands Trial Register
• CCMO Register

Research Injury

Key Organizations

• Ministry of Health, Welfare and Sport
• Central Committee for Research Involving Human Subjects (CCMO)

Relevant Standards

• Medical Research Involving Human Subjects Act, Article 7 (1998)
• CCMO, Decree of 2014 on Compulsory Insurance

Social-Behavioral Research

Key Organizations

• National Ethics Council for Social and Behavioural Sciences
• Central Committee for Research Involving Human Subjects (CCMO)

Relevant Standards

• Netherlands Code of Conduct for Research (2018)
• CCMO, Memorandum Behavioural Research

Privacy/Data Protection

Key Organizations

• Dutch Data Protection Authority

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Law for the Protection of Personal Information (2000)

Human Biological Materials

Relevant Standards

• Civil Code, Article 467 (1994)
• Human Tissue and Medical Research: Code of Conduct for responsible use (2011)

Genetic Research

Key Organizations

• Dutch Health Care Inspectorate (IGZ)

Relevant Standards

• Medical Research Involving Human Subjects Act (1998)
• Guidelines for Researchers and Sponsors with Regard to the Assessment by Official Bodies of Clinical Research Involving Gene Therapeutics in the Netherlands (2012)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Fetal Tissue Act (2001) (Dutch)
• Embryos Act (2002)

Drugs, Biologics, and Devices

Key Organizations

• Drug and Devices Register
• Drug Agency

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Drug and Devices Register, Various Laws
• Drug and Devices Register, Medicines, Various Regulations
• Drug and Devices Register, Medical Devices, Various Regulations
• Health Care Law (Official Gazette No. 43/2012) and Laws Amending and Supplementing the Law, Article 275

Research Injury

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24

Social-Behavioral Research

Key Organizations

• Center for public health, Department for Social Medicine

Privacy/Data Protection

Key Organizations

• Directorate for Personal Data Protection

Relevant Standards

• Law on Ratification on Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2005)
• Law on Ratification on Additional Protocol to the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (2008)
• Law on Personal Data Protection, Consolidated (2016)
• Amendments (2021)
• Regulations on Protection of Personal Data
• Rule book for the Manner of Performing Inspection Supervision
• Rulebook on transfer of personal data

Human Biological Materials

Key Organizations

• Health Insurance Fund of Republic of Macedonia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
• Law on Ratification of the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, With Additional Protocols (2009)
• Health Care Law (Official Gazette No. 43/2012) and Amendments (2012–2016)
• Law on Taking and Transplanting of the Human Body for Treatment (Official Gazette No. 47/2011) and Amendments (2011–2016)
• Regulation on Criteria Relating to Space, Personnel and Equipment for Organ and Tissue Collection, Transfer, Exchange and Storage (2012)

Genetic Research

Key Organizations

• Ministry of Health of Republic of Macedonia

Relevant Standards

• Law on Patient Rights Protections, Article 21: Action on Human Genome (2012)

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Health of Republic of Macedonia

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)

General

Key Organizations

• Norwegian Directorate of Health
• National Committee for Medical and Health Research Ethics (NEM)
• Regional Committees for Medical and Health Research Ethics (REK)
• National Committee for Research Ethics in Science and Technology (NENT)

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Oviedo Convention, Additional Protocol concerning Biomedical Research (CETS No. 195)
• Law regarding Ethics and Integrity in Research (2006)
• Act on Health Care Research (2008)
• Organization of Health Research
• Population-Based Health Survey
• Right of Children Between 12-16 Years to Consent to Participate in Health Research
• Guidelines for Research on Persons with Impaired Informed Consent Capacity (2005)
• Payment for Research Participants in Medical and Health Research (2009)
• Guidelines for Ethical and Scientific Evaluation of Qualitative Research Projects in Medical and Health Research (2009)
• Guidelines for Research, Various
• NENT, Research Ethics Guidelines for Science and Technology (2016)

Drugs, Biologics, and Devices

Key Organizations

• Norwegian Medical Products Agency (NOMA)

Relevant Standards

Drugs

• The Medicines Act
• Act on Health Care Research
• Regulation Relating to Clinical Trials on Medicinal Products for Human Use (2009)
• Regulations Amending the Regulations Relating to Medicinal Products (The Medicines Regulations) (2023)
• Clinical trials – Regulation EU No 536/2014

Devices

• Act of 12 January 1995 No. 6 Relating to Medical Devices
• Act on Health Care Research (2009)
• Regulations on Medical Devices, No. 1690 (2005)
• Various

Research Injury

Key Organizations

• Norwegian System of Patient Injury Compensation

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Act on Patient Injury Compensation (2001)
• Act on Product Liability, Chapter 3

Social-Behavioral Research

Key Organizations

• National Committee for Research Ethics in the Social Sciences and the Humanities (NESH)
• National Committee for Research Ethics on Human Remains (NCEHR)

Relevant Standards

• Research Ethics Act (2017)
• Act of Cultural Heritage (1978)

General

Key Organizations

• Minister of Health (MOH)
• Bioethics Appeals Commission
• Center of Bioethics of the Supreme Medical Council (NIL)
• Association for Good Clinical Practice in Poland (GCPpl)

Relevant Standards

• Constitution of Poland, Article 39 (1997)
• Medical Profession Act, Articles 21–29 (1996)
• Code of Medical Ethics, Chapter II (2003)
• GCPpl legal acts and ethical standards

Drugs, Biologics, and Devices

Key Organizations

• Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Relevant Standards

• Legal acts and regulations for medicinal products, medical devices, and biocidal products are available via URPL

Clinical Trial Registries

Key Organizations

• Central Register of Clinical Trials
• Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Research Injury

Key Organizations

• Minister of Development Funds and Regional Policy
• Minister of Finance

Relevant Standards

• Order of Minister of Finance (2005) on mandatory civil liability insurance for researchers and sponsors conducting clinical research

Privacy/Data Protection

Key Organizations

• Personal Data Protection Office

Relevant Standards

• General Data Protection Regulation (GDPR) Regulation (EU) 2016/679
• Act on the Protection of Personal Data (2018)

Human Biological Materials

Relevant Standards

• Act on the Public Blood Service (2021)
• Act Regarding Sampling, Storage, and Transplanting of Cells, Tissues, and Organs (2017)

Genetic Research

Key Organizations

• Ministry of Health
• Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Relevant Standards

• Regulations of Minister of Health (2015) on quality standards for medical diagnostic and microbiological labs
• Act of 27 July 2001 on laboratory diagnosis

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Health
• Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Relevant Standards

• Act on Medical and Dental Professions (1996)
• Regulation on documentation for reproductive cells and embryos (2015)
• Act on collection, storage, and transplantation of cells, tissues, and organs (2005)
• Regulation on export/import of germ cells and embryos (2015)

General

Key Organizations

• National Council of Ethics for the Life Sciences (CNECV)

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Additional Protocol concerning Biomedical Research (CETS No. 195)
• CNECV Opinions

Drugs, Biologics, and Devices

Key Organizations

• National Authority for Medicines and Health Products (INFARMED)
• National Ethics Committee for Clinical Research (CEIC)
• National Registries of Clinical Trials (CRNEC)

Relevant Standards

• Compiled Pharmaceutical Legislation, Title V, Health Products, Chapter II, Medical Devices
• CEIC Clinical Trials Regulations
• CRNEC National Legislation

Clinical Trial Registries

Key Organizations

• CRNEC Clinical Trials Registry

Relevant Standards

• National Legislation Governing the Registry

Research Injury

Relevant Standards

• Oviedo Convention, Article 24

Privacy/Data Protection

Key Organizations

• National Data Protection Commission (CNPD)

Relevant Standards

• General Data Protection Regulation (GDPR) Regulation (EU) 2016/679
• Constitution of Portugal, Article 35 (1997)
• Act No. 58/2019 on Personal Data Protection

Human Biological Materials

Relevant Standards

• Oviedo Convention, Articles 21–22
• Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)

Genetic Research

Relevant Standards

• Additional Protocol Concerning Genetic Testing for Health Purposes (CETS No. 203)
• Law 12/2005 on Genetic and Health Information

Embryos, Stem Cells, and Cloning

Key Organizations

• National Council of Ethics for the Life Sciences (CNECV)

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Portuguese Law on Assisted Reproductive Technologies (2006), Articles 7 and 9
• CNECV Opinions 15/1995, 47/2005, 48/2006

General

Key Organizations

• Ministry of Health (MOH)

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Ordinance on Scientific Research and Technological Development, No. 57/16.08.2002 (2002)

Drugs, Biologics, and Devices

Key Organizations

• National Agency for Medicines and Medical Devices
• National Bioethics Committee for Medicines and Medical Devices

Relevant Standards

• Order 904/25July 2006 on Approval of Rules Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use ‒ Transposition of 2001/20/EC Directive, and various legislation for CTs
• Clinical Trials, Legislation, Various
• Regulation (EU) No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use (2014)

Clinical Trial Registries

Key Organizations

• National Agency for Medicines and Medical Devices, Clinical Studies platform

Research Injury

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24

Social-Behavioral ResearchKey Organizations

• The Romanian Academic Society of Behavioral Sciences

Privacy/Data Protection

Key Organizations

• National Supervisory Authority for Personal Data Processing

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Law No. 667/2001 On the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data

Human Biological Materials

Key Organizations

• Ministry of Health (MOH)

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
• Law No. 95/2006 Regarding the Reform in Health Field. Title VI. Performing of Sampling and Transplant of Organs, Tissues and Human Origin Cells with Therapeutic Purpose
• ORDER no. 1,527 of December 16, 2014, On the Methodological Norms for the Application of Title VI "Carrying out the Collection and Transplantation of Organs, Tissues and Cells of Human Origin for Therapeutic Purposes"
• ORDER no. 855 of July 26, 2017, For the Approval of Therapeutic Protocols for the Removal of Organs, Tissues and Cells of Human Origin from Living and/or Deceased Donors
• Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on Standards of Quality and Safety of Human Organs Intended for Transplantation

Genetic Research

Key Organizations

• Regional Centers of Medical Genetics (CRGM)

Relevant Standards

• ORDER no. 1.358 of November 13, 2014 on the establishment of the medical genetics network

Embryos, Stem Cells, and Cloning

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Law No. 301 from 2004 Penal Code – Chapter IV – Crimes and Felonies Regarding Genetic Manipulation

NOTE: For a database of Russian legislation, see: https://cis-legislation.com/index.fwx

General

Key Organizations

• Ministry of Healthcare of the Russian Federation (MOH)
• Federal Service on Surveillance in Healthcare (Roszdravnadzor)
• Russian Committee for Bioethics

Relevant Standards

• Constitution of the Russian Federation, Article 21 (1993)
• Federal Law #FZ 323 “On Foundations of Protection of Citizen’s Health in the Russian Federation” (2011)
• Federal Law #FZ55 “On Introduction of Changes in FZ “On Foundations of Protection of Citizens’ Health in the Russian Federation” with Regard to Questions of Organization of Medical Aid Administered in the Course of Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation” (2015)
• Ministry of Health Order 433n (July 10, 2015) “On Adoption of the Regulations on Organization of Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment and Rehabilitation (Including Order of Patients’ Assignment for Administering Such Medical Help), Standard Form of Protocol for Clinical Approbation of the Methods of Prevention, Diagnostics, Treatment, and Rehabilitation”
• Ministry of Health Order 435h “On Ethics Committee of the Ministry of Health of the Russian Federation” (July 10, 2015)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Healthcare of the Russian Federation (MOH)
• Association of Clinical Trials Organizations
• Federal Agency for Technical Regulation and Metrology (Rosstandart)

Relevant Standards

• Federal Law No. 61FZ “On Circulation of Medicines” (2011)
• Ministry of Health Order on Procedure for Suspension of Use of Medicine for Medical Application, No. 758n (2010)
• MOH, “On Assertion of Order of Organization and Carrying out of Ethical Review…” (Russian)
• Ministry of Health Order No. 774n (August 31, 2010) “On Council of Ethics” (Russian)
• Ministry of Health Order of April 1, 2016, No. 200н "On Approval of the Rules of Good Clinical Practice”
• GOST, Good Clinical Practice. GOST-R 52379-2005 (September 27, 2005)
• Government Decree No. 673 of September 3, 2010 “Approval of Rules for Import and Export of Biological Materials Obtained in Clinical Trials of a Medicinal Product for Medical Use Into and From the Russian Federation”

Research Injury

Relevant Standards

• Federal Law No. 61FZ “On Circulation of Medicines” (2011), Art. 38-44

Privacy/Data Protection

Relevant Standards

• Federal Law of the Russian Federation on Information, Information Technologies, and Protection of Information (2006)
• Federal Law of the Russian Federation No. 152-FZ on Personal Data (2006)

Genetic Research

Key Organizations

• Interdepartmental Commission on Genetic-Engineering Activity

Relevant Standards

• Federal Law of July 5, 1996, N OF 8'-FZ “About the State Control in the Area of Genetic-Engineering Activity”
• Order of the Ministry of Education and Science of the Russian Federation #154: “Statute of the Inter-Departmental Commission on Genetic-Engineering Activity” (2005)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Federal Law #30-FZ “On Introduction of Change in Art. 1 of the Federal Law “On Temporary Ban on Human Cloning” (2010)

General

Key Organizations

• San Marino Bioethics Committee (Italian)

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Guidelines for the Processing of Personal Data in the Context of Clinical Trials of Medicinal Products, Genetic/Genomic Analyses and Biobanks

Research Injury

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24

Human Biological Materials

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22

General

Key Organizations

• Ministry of Health (MOH)
• Medicines and Medical Devices Agency of Serbia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Medicines and Medical Devices Agency of Serbia, Laws

Drugs, Biologics, and Devices

Key Organizations

• Medicines and Medical Devices Agency of Serbia

Relevant Standards

• Medicines and Medical Devices Agency of Serbia, Various Laws
• Law on Medicines and Medical Devices (2010)
• Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices, Official Gazette of RS, 64/2011, 91/2013, 60/2016, and 9/2018

Clinical Trial Registries

Key Organizations

• Medicines and Medical Devices Agency of Serbia, Search Approved Clinical Trials

Research Injury

Key Organizations

• Medicines and Medical Devices Agency of Serbia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Law on Medicines and Medical Devices, Article 72
• Law on Patients' Rights, Article 25 Official Gazette of RS, 45/2013 and 25/2019

Privacy/Data Protection

Key Organizations

• Commissioner for Information of Public Importance and Personal Data Protection

Relevant Standards

• Law on the Protection of Personal Data, Official Gazette 87/2018

Genetic Research

Relevant Standards

• Law on the Prevention and Diagnosis of Genetically Conditioned Diseases, Genetically Caused Anomalies and Rare Diseases, Official Gazette 8/2015

Human Biological Materials

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22

Embryos, Stem Cells, and Cloning

Relevant Standards

• Law on Organ Transplantation, Official Gazette No. 57/2018
• Law on Human Cells and Tissues, Official Gazette No. 57/2018

General

Key Organizations

• Ministry of Health (Slovak)
• Institute of Medical Ethics and Bioethics

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Oviedo Convention, Additional Protocol concerning Biomedical Research (CETS No. 195)
• Additional Protocol on Biomedical Research (2005)
• Act No. 576/2004 Coll on Health Care, As Amended by Acts No. 350/2005, 282/2006, 662/2007, 345/2009 Coll.

Drugs, Biologics, and Devices

Key Organizations

• State Institute for Drug Control

Relevant Standards

• Act No. 140/1998 Coll. on Drugs and Medical Devices, as amended by Acts No. 9/2004 and 542/2006, 489/2008, and 402/2009 Coll.
• Ministerial Regulation No. 239/2004 Coll. on Requirements for Clinical Trials and Good Clinical Practice, as Amended by Ministerial Regulation No. 148/2009 Coll.

Research Injury

Relevant Standards

• Law 277/1994 on Health Care, Section 44
• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24

Privacy/Data Protection

Key Organizations

• Office for Personal Data Protection

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Act No. 428/2002 Coll. on Protection of Personal Data, as amended by Act No. 90/2005 Coll.
• Act no. 18/2018 On Personal Data Protection and Amending and Supplementing Certain Acts (2018)

Human Biological Materials

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Act No. 576/2004 Coll. on Health Care, Sections 35-39, and 26.10.a.
• Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b).
• Governmental Regulation No. 20/2007 Coll. on Tissue and Cell Collection

Embryos, Stem Cells, and Cloning

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Act No. 576/2004 Coll. on Health Care, Sections 35-39, and 26.10.a
• Act No. 489/2008 Coll. on Drugs and Medical Devices, Section 18 (29b)
• Governmental Regulation No. 20/2007 Coll. on Tissue and Cell Collection

General

Key Organizations

• Ministry of Health of the Republic of Slovenia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Oviedo Convention, Additional Protocol concerning Biomedical Research (CETS No. 195)
• Health Services Act
• Decree Ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (2005)
• Patient Rights Act, Official Gazette No. 15/2008 55/2017
• Mental Health Act, Official Gazette Nos. 77/2008 and 46/2015
• Code of Medical Ethics (2016)

Drugs, Biologics, and Devices

Key Organizations

• Republic of Slovenia National Medical Ethics Committee (NMEC)
• Ministry of Health of the Republic of Slovenia
• Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Relevant Standards

• Ministry of Health, Various Legislation (scroll down to “Medicines and medical devices”)
• Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014
• Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012
• JAZMP, General Information about Medical Devices, Various Legislation

Research Injury

Key Organizations

• Ministry of Health of the Republic of Slovenia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Decree ratifying the Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research
• Rules on Clinical Testing of Medicinal Products, Official Gazette, No. 54/2006 and 17/2014
• Rules on Medical Devices, Official Gazette Nos. 37/2010 and 66/2012

Privacy/Data Protection

Key Organizations

• Information Commissioner of the Republic of Slovenia

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Personal Data Protection Act No. 94/2007

Human Biological Materials

Key Organizations

• Institute for transplantation of Organs and Tissues of the Republic of Slovenia

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
• Institute for transplantation of Organs and Tissues of the Republic of Slovenia, Various Laws and Regulations

Genetic Research

Relevant Standards

• Oviedo Convention, Additional Protocol Concerning Genetic Testing for Health Purposes (CETS No. 203)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Infertility Treatment and Procedures of Biomedically-Assisted Procreation Act, Official Gazette No. 70/2000, Section 9 (Slovenian)

NOTE: Many of the 17 Spanish autonomous regions have their own laws and regulations on human subject protections.

General

Key Organizations

• Spanish Bioethics Committee

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Spanish Bioethics Committee, Various State and Autonomous Legislation

Drugs, Biologics, and Devices

Key Organizations

• Spanish Agency of Medicines and Medical Devices (AEMPS)

Relevant Standards

• AEMPS, Various Standards for Clinical Trials with Medicines for Human Use
• AEMPS, Various Standards for Clinical Trials with Medical Devices

Research Injury

Key Organizations

• Spanish Agency of Medicines and Medical Devices

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Law 14/2007 on Biomedical Research, Article 18
• Regulation No. 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, Repealing Directive 2001/20/EC
• Royal Decree 1090/2015 Regulating Clinical Trials with Medicinal Products, Ethics Committees for Investigation with Medicinal Products and the Spanish Clinical Studies Registry

Privacy/Data Protection

Key Organizations

• Spanish Data Protection Authority
• Spanish Agency of Medicines and Medical Devices (AEMPS)

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Law 14/2007 on Biomedical Research, Title I, Article 5
• Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guaranteeing Digital Rights
• Royal Decree 1720/2007 Approving Organic Law 15/1999 for the Protection of Personal Data (2008)
• AEMPS, Revised Instructions for Updating the Section “Protection of Personal Data in the Subject Information Sheet (HIP /CI) Regarding the Regulation (EU) No. 2016/679 General Data Protection (2018)

Human Biological Materials

Key Organizations

• Ministry of Science Innovation and Research

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
• Law 14/2007 of July 3 on Biomedical Research, Title I, Article 11; Title III, Article 37; Title V
• Royal Decree 1716/2011 on Biobanks
• Royal Decree 9/2014 on Quality and Security Rules Regarding Donating, Gathering, Evaluation, Processing, Storage, Preservation, and Distribution of Human Cells and Tissues and Rules Regarding Coordination and Functioning of their Use in Human Beings

Genetic Research

Relevant Standards

• Law 14/2007 of July 3 on Biomedical Research, Title I, Articles 6-9; Title V

Embryos, Stem Cells, and Cloning

Key Organizations

• National Biobank Network
• National Bank of Cell Lines

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Law 14/2006 on Methods of Assisted Human Reproduction, Chapters IV and V
• Law 14/2007 of July 3 on Biomedical Research, Title III
• Royal Decree 1527/2010 By Which the Guarantees Commission for the Donation and Use of Human Cells and Tissues and Registration Research Projects is Regulated

For an overview of human subject protections in Sweden, see CODEX: Rules and Guidelines for Research

General

Key Organizations

• Swedish Ethical Review Authority
• Ethics Review Appeal Board
• Swedish Research Council
• National Board of Health and Welfare (Socialstyrelsen)

Relevant Standards

• Act on the Ethical Review of Research Involving Humans (2003:460)
• Ordinance Concerning the Ethical Vetting of Research Involving Humans (2003:615)
• Statute with Instructions for the Swedish Ethical Review Authority (2018:1879)
• Statute with Instructions for the Ethics Review Appeals Board (2007:1068)
• Good Research Practice (2017)

Drugs, Biologics, and Devices

Key Organizations

• Medical Products Agency

Relevant Standards 

Drugs

• Pharmaceuticals Act (2015:315)
• MPA, Various Laws and Regulations (searchable database)
• MPA, Regulations on Clinical Drug Trials in Humans (2011:19)

Devices

• Swedish Medical Devices Act (1993:584)
• Medical Devices Ordinance (1993:876)
• Swedish Implementation of Directive 93/42/EEC (2003:11)
• The National Board of Health and Welfare's regulations on the use of medical devices in health care (2021:52)

Social-Behavioral Research

Key Organizations

• Swedish Research Council

Relevant Standards

• Good Research Practice: Observational Studies Conducted Through Participating, Observing, and Recording (2017) (currently being updated. New report expected in 2024)
• Research Review 2023, Humanities and social sciences

Privacy/Data Protection

Key Organizations

• Swedish Authority for Privacy Protection

Relevant Standards

• General Data Protection Regulation (GDPR), Regulation (EU) 2016/679
• Patient Data Act (2008:355)
• Publicity and Privacy Act (2009:400)
• Act on Certain Health Research Registers (2013:794)
• Act Complement to the GDPR (2018:218)
• Public Access to Information and Secrecy Ordinance (2009:641)
• General Data Protection Regulation (2018)
• Transmission to Third Countries (2018)

Human Biological Materials

Key Organizations

• Health and Social Care Inspectorate (IVO)
• Biobank Sweden

Relevant Standards

• Biobanks in Medical Care Act (2002:297)
• Regulation on Biobanks in Health Care, etc. (2002:746)
• The National Board of Health and Welfare's regulations on amendments to the regulations and general guidelines (SOSFS 2009: 32) on the use of tissues and cells in health care and clinical research, etc. (2018:52) (updated 2021)

Genetic Research

Key Organizations

• Medical Products Agency
• The Swedish Gene Technology Advisory Board (SGTAB)

Relevant Standards

• Act on Genetic Integrity (2006:351)
• Drug Administration Regulations and Guidelines (2004:10) on the Intentional Release of Clinical Trials of Medicinal Products Containing or Consisting of Genetically Modified Organisms

Embryos, Stem Cells, and Cloning

Relevant Standards

• Legal Regulation of Stem Cell Research (2002:119)
• Regulations and Guidelines for the Use of Tissues and Cells in Healthcare and Clinical Research - SOSFS (2009:32)

General

Key Organizations

• Federal Office of Public Health (FOPH)
• Federal Office of Public Health, Portal for Human Research (FOPH)
• National Advisory Commission on Biomedical Ethics (NEK-CNE)
• Swiss Association of Research Ethics Committees
• Swiss Academy of Medical Sciences (SAMW)

Relevant Standards

• SAMW, Medical-Ethical Guidelines, Various
• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164)
• Federal Constitution of the Swiss Confederation, RS 101, Article 118b (1999)
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30 (2011) (current as of September, 2023)
• Ordinance on Clinical Trials in Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301 (2013)
• Ordinance on Organizational Aspects of the Human Research Act (HRA Organisational Ordinance, OrgO-HRA), RS 810.308 (2013)
• Swiss Clinical Trial Organization, Guidelines for Good Operational Practice (GGOP) (2017)

Drugs, Biologics, and Devices

Key Organizations

• Swiss Agency for Therapeutic Products (Swissmedic)

Relevant Standards

• Clinical Trials, Various Applicable Laws
• Clinical trials on medicinal products, Various Applicable laws and guidelines (Swiss Legislation and International Guidelines)
• Regulation of Medical Devices, Legal Framework

Clinical Trial Registries

Key Organizations

• Swiss National Clinical Trials Portal

Relevant Standards

• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 56, 64, 65, and 67 (2011) (current as of September, 2023)

Research Injury

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 24
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 19-20 (2011) (current as of September, 2023)
• Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance HRO), RS 810.301, Articles 8, 12, 13, and 15, and Annexes 1-2 (2013)
• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance CLinO), RS 810.305, Articles 7, 10-13, 25, and 71, and Annexes 2-3 (2013)

Privacy/Data Protection

NOTE: Most Swiss cantons have enacted laws regarding data collection in the public sector that are similar to the Federal Act on Data Protection.

Key Organizations

• Federal Data Protection and Information Commissioner (FDPIC)

Relevant Standards

• Federal Act on Data Protection (FADP), RS 235.1 (1992)
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2, 3, 8, 16-18, 31-35, 41-45, 47, 49, 58-60, and 63 (2011)
• Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 5 - 8, 10, 15, 21, 24-34, 37-39, 41, and 44-45, and Annex 2 (2013)
• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305 Articles 5, 7, 9, 12, 16-18, and 25, and Annexes 2-3 (2013)

Human Biological Materials

Relevant Standards

• Oviedo Convention on Human Rights and Biomedicine (ETS No. 164), Articles 21-22
• Oviedo Convention, Additional Protocol Concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186)
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 2, 3, 17, 18, 31, 32 - 35, 41-43, 45, 47, 49, and 63 (2011)
• Ordinance on Human Genetic Testing, RS 810.122.1 (2007)
• Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301 Articles 5 - 8, 10, 15, 21, 24-30, 33-34, 37 - 39, 41, 44-45 and Annex 2) (2013)
• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305, Articles 7, 9, 12, 16 - 18 and Annex 2 (2013)

Genetic Research

Relevant Standards

• Federal Constitution of the Swiss Confederation of 18 April 1999, RS 101, Article 119 (1999)
• Federal Act on Human Genetic Testing (HGTA), RS 810.12 (2004)
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30, Articles 3, 32-35, 42, and 49 (2011)
• Ordinance on Human Genetic Testing, RS 810.122.1 (French) (2007)
• Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 28–32 (2013)
• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305 Articles 22 and 35, and Annexes 3 and 4 (2013)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Oviedo Convention, Additional Protocol on the Prohibition of Cloning Human Beings (ETS No. 168)
• Federal Act on Research Involving Human Beings (Human Research Act, HRA), RS 810.30 Articles 2, 25 - 27, 39, 40, 44, and 62 (2011)
• Federal Act on Research Involving Embryonic Stem Cells (Stem Cell Research Act, StRA), RS 810.31 (2003)
• Ordinance on Research involving Embryonic Stem Cells (Stem Cell Research Ordinance, SCRO), RS 810.311 (2005)
• Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), RS 810.301, Articles 44–46, and Annex 2 (2013)
• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, CLinO), RS 810.305, Articles 49, 53, 55, and 56, and Annexes 3 and 4 (2013)
• Research Involving Human Embryos and Fetuses, Opinion No. 11 (2006)
• Pre-Implantation Genetic Diagnosis II, Opinion No. 14 (2007)

MARTIAL LAW IN UKRAINE: Since February 24, 2022, Ukraine has been under martial law due to an attack by the Russian Federation. For information about the work of the Ministry of Health during martial law, as well as news and advice for citizens, doctors, and clarifications for business entities working in the field of health care, visit: https://moz.gov.ua/en/military-stateNOTE: For a database of Ukrainian legislation, see: https://cis-legislation.com/index.fwx

General

Key Organizations

• Ministry of Health of Ukraine
• Ukrainian Institute on Public Health Policy (UIPHP)

Relevant Standards

• To search all documents in the Ukraine Legislation database visit
• Constitution of Ukraine, Article 28 (1996)
• Civil Code of Ukraine, Article 281 (2003)
• Criminal Code of Ukraine 2001, Article 141,142 and 321 (2010)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health of Ukraine State Expert Center

Relevant Standards

• Law of Ukraine About Medicines, No.22 (1996)
• Preclinical studies, Various Applicable Laws
• Clinical Trials, Various Applicable Laws, Various
• Various Unofficial Legislation in English
• Medicines and Studies, Various Guidelines

Privacy/Data Protection

Key Organizations

• Ukrainian Parliament Commissioner for Human Rights

Relevant Standards

• The Law of Ukraine on Personal Data Protection (2010)

Human Biological Materials

Key Organizations

• Association of Cryobanks of Cord Blood and Other Human Tissues and Cells

Relevant Standards

• Laws, Decrees, and Regulations, Various

Embryos, Stem Cells, and Cloning

Key Organizations

• Ukrainian Ministry of Health

Relevant Standards

• Act on the Banning of Human Reproductive Cloning (2004)

NOTE: For an overview of clinical research regulations in the United Kingdom, see the ClinRegs reportNOTE: Unless otherwise noted, all laws, regulations, and guidelines listed for England also apply to the entire United Kingdom

General

Key Organizations

• Health Research Authority (HRA)
• Department of Health and Social Care (DHSC)
• Medical Research Council (MRC)
• National Institute for Health Research (NIHR)
• UK Research Integrity Office (UKRIO)
• Integrated Research Application System (IRAS)

Relevant Standards

• HRA, Various Policies, Standards, and Legislation Applicable to Research and Clinical Trials
• HRA, Governance Arrangements for Research Ethics Committees
• HRA, Policies, Standards & Legislation, Prison Research
• HRA, Policies, Standards & Legislation, Research Involving Children
• HRA, Policies, Standards & Legislation, Public Health Emergency Research
• HRA, Policies, Standards & Legislation, Research in Emergency Settings
• HRA, Guidance for Health and Social Care Researchers at the End of the Transition Period
• DHSC, Mental Capacity Act (2005) (England and Wales only)
• DHSC, Health and Social Care Act (2012)
• DHSC, Care Act (2014)
• DHSC, Ionising Radiation (Medical Exposure) Regulations (2017)
• MRC, Good Research Practice, Various Policies and Guidance
• NHS, Participant Information Quality Standards (2023)
• NHS, Participant Information Design and Review Principles (2023)
• ABPI, Clinical Trials Best Practice Guide: Helping to Improve Clinical Trial Set-Up Processed in the UK (2024)

Scotland

Key Organizations

• NHS Scotland, Chief Scientist Office (CSO)
• NHS Research Scotland

Relevant Standards

• Adults with Incapacity (Scotland) Act 2000, Section 51
• Adults with Incapacity (Ethics Committee) (Scotland) Amendment Regulations (2002)
• CSO, Research Governance Framework for Health and Community Care (2006)

Wales

Key Organizations

• Health and Care Research Wales

Relevant Standards

• Health and Care Research Wales, Support and guidance for researchers

Northern Ireland

Key Organizations

• Department of Health, Social Services and Public Safety
• Office for Research Ethics Committees Northern Ireland

Relevant Standards

• Office for Research Ethics Committees Northern Ireland, Guidance for Applicants

Drugs, Biologics, and DevicesKey Organizations

• Medicines and Healthcare Products Regulatory Agency (MHRA)
• Administration of Radioactive Substances Advisory Committee (ARSAC) (UK)
• Department of Environment, Food & Rural affairs (DEFRA)
• Health and Safety Executive (HSE)
• Association of the British Pharmaceutical Industry (ABPI)
• Association of British HealthTech Industries (ABHI)
• Health Research Authority (HRA)
• Medical Device Coordination Group (MDCG)

Relevant Standards

• HRA, Policies, Standards & Legislation, Clinical Trials of Investigational Medicinal Products (CTIMPs), Various Currently Applicable Legislation and resources
• HRA, Policies, Standards & Legislation, Phase 1 Clinical Trials
• MDCG, MDCG Endorsed Documents and Other Guidance, Various
• The Medical Devices Regulations (2002)

Drugs

• Medicines Act (1968)
• Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument, No. 1031 (2004)
• Medicines for Human Use (Clinical Trials) Amendment Regulations No. 1928 (2006)
• Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and Adults with Incapacity (Scotland) Act 2000 to Facilitate Clinical Research in Emergency Settings No. 2984 (2006)
• Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations, No. 941 (2008)
• Genetically Modified Organisms (Deliberate Release) Regulations, No. 2443 (2002)
• Genetically Modified Organisms (Contained Use) Regulations, No. 1663 (2014) (England, Scotland and Wales)
• Genetically Modified Organisms (Contained Use) Regulations, No. 339 (Northern Ireland) (2015)
• ABPI, Guidelines for Phase I Clinical Trials (2018)
• National Institute for Health Research, Clinical Trials Toolkit

Devices

• Medical Devices Regulations, No. 618 (2002)
• Medical Devices (Amendment) Regulations, No. 2936 (2008)
• Various Regulatory Guidance for Medical Devices
• Notify MHRA About a Clinical Investigation for a Medical Device, Guidance
• HRA, Medical Devices and Software Applications

Clinical Trial Registries

Key Organizations

• International Standard Randomized Controlled Trial Number (ISRCTN)
• Health Research Authority (HRA)

Relevant Standards

• ISRCTN, FAQs
• HRA, Transparency: Researchers’ Responsibilities

Research Injury

Key Organizations

• Medicines and Healthcare Products Regulatory Agency (MHRA)
• Department of Health (DH)
• Association of the British Pharmaceutical Industry (ABPI)

Relevant Standards

• MHRA, Medicines for Human Use (Clinical Trials) Regulations, Statutory Instrument, No. 1031, Regulation 15(5)(i)(j)(k) and Schedule 3 Part 1, Paragraphs 1(g) and 3(c) (2004)
• DH, NHS Indemnity Arrangements for Clinical Negligence Claims in the NHS
• ABPI, Insurance and Compensation in the Event of Injury in Phase I Clinical Trials (2012)
• ABPI, Clinical Trial Compensation Guidelines (2014)

Social-Behavioral Research

Key Organizations

• Economic and Social Research Council (ESRC)
• UK Research Integrity Office
• Health Research Authority (HRA)

Relevant Standards

• ESRC, Framework for Research Ethics (2015)
• Good Practice in Research: Internet-Mediated Research (2016)
• HRA, Policies, Standards & Legislation, Social Care Research

Privacy/Data Protection

NOTE: Due to the United Kingdom’s departure from the European Union (EU), there are notable differences in the UK regarding scope and protections of the General Data Protection Regulation (GDPR).United Kingdom

Key Organizations

• Information Commissioner’s Office (ICO)
• Confidentiality Advisory Group (CAG)

Relevant Standards

• Data Protection Act (2018)
• ICO, The UK GDPR
• ICO, UK GDPR guidance and resources
• ICO, International Transfers (2018)
• HRA, Data Protection and Information Governance, Currently Applicable Legislation
• HRA, GDPR Guidance
• HRA, Consent in Research (2018)
• HRA, Research Tissue Banks and Research Databases
• HRA, Research Data and Tissue Resources
• HRA, Confidential Patient Information, Section 251
• MRC, Using Information About People in Health Research (2017)
• Health Service (Control of Patient Information) Regulations, No. 1438 (2002)

Human Biological Materials

United Kingdom

Key Organizations

• Human Tissue Authority (HTA)
• Health Research Authority (HRA)

Relevant Standards

• The Human Tissue Act (2004) (Applies to England, Wales, and Northern Ireland. Section 45 also applies in Scotland)
• Regulation 2006 No. 1260, The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) (Applies to England, Wales, and Northern Ireland)
• Regulation 2006 No. 1659, The Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) (Different provisions apply to England, Wales, Northern Ireland, and/or Scotland)
• HTA, Guidance for Professionals
• MRC, Human Tissue and Biological Samples for Use in Research (2019)
• HRA, Use of Human Tissue in Research
• HRA, Research Tissue Banks and Research Databases
• HRA, Research Data and Tissue Resources

Scotland

Key Organizations

• Healthcare Improvement Scotland

Relevant Standards

• Human Tissue (Scotland) Act 2006

Genetic ResearchKey Organizations

• Public Health Genetics Foundation
• Gene Therapy Advisory Committee
• Genomics England

Embryos, Stem Cells, and CloningKey Organizations

• Human Fertilisation and Embryology Authority (HFEA)
• Human Tissue Authority (HTA)

Relevant Standards

• Human Fertilisation and Embryology Act (1990)
• Human Fertilisation and Embryology Act (2008)
• Human Fertilisation and Embryology Regulation, Guidance
• HFEA, Code of Practice 9th Edition (2018)