2020 International Compilation of Human Research …

1 1 International Compilation of Human Research Standards 2020 Edition Compiled By: Office for Human Research Protections Department of Health and Human Services PURPOSE The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations , and guidelines (collectively referred to as standards ) that govern Human subject protections in 133 countries, as well as standards from a number of International and regional organizations. First published in 2005 , the Compilation is intended for use by researchers, IRBs/ Research Ethics Committees, sponsors, and others who are involved in Human subjects Research protections around the world.

2 Content experts from around the world, listed at the end of the Compilation , provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. Two new countries are featured in the 2020 Edition: Nicaragua and Paraguay. ORGANIZATION The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as: 1. General, , applicable to most or all types of Human subjects Research 2. Drugs, Biologics, and Devices 3. Clinical Trial Registries 4.

3 Research Injury 5. Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards: ) 6. Privacy/Data Protection (also see Privacy International reports: ) 7. Human Biological Materials 8. Genetic (also see the HumGen International database: ) 9. Embryos, Stem Cells, and Cloning These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate understanding of the country s requirements. The information is then organized into four columns: 1.

4 Key Organizations include those groups that issue regulations or guidelines, or serve in a national oversight role for Human subjects Research . 2. Legislation encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent constitutional provisions. 3. regulations refer to instruments that are created and issued in the name of governmental administrative bodies. 4. Guidelines pertain to non-binding instruments. 2 The year of the document s most recent version (or date of initial approval, if never amended) is indicated in parenthesis when that information is available, unless the date is part of the document s title, , Law No.

5 46/2018. HOW TO ACCESS A DOCUMENT Documents can be accessed in four possible ways: 1. Link to the web address (URL). 2. Search for a document at the website of the agency listed in the Key Organizations column. 3. Perform an Internet search on the document title. 4. Request a local Research ethics committee to provide the document. In many cases the documents are available in English. When the URL links to a non-English website or document, an online language translator usually can render an English version. TOPICS NOT COVERED In order to focus its scope, the International Compilation of Human Research Standards does not include standards from the state, provincial, or local levels.

6 Nor does the Compilation cover: 1. Enabling legislation, , laws that authorize an agency to promulgate Human subjects standards, but do not direct the content of those regulations . 2. Laws, regulations , or guidelines that are disease-specific or focus on Research integrity, clinical bioethics, product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice, bioequivalence testing, or informed consent in clinical practice. 3. Ethics codes of academic, medical, or other professional organizations see the Ethics Codes Collection: 4.

7 Working papers, drafts, commentaries, or discussion papers. NEW STANDARDS, UPDATES, AND BROKEN LINKS To request inclusion of a new standard in the Compilation or to report updates or broken links, contact . DISCLAIMER Although this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations , or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations , and guidelines relating to Human subject protections.

8 While in-country persons have been requested to review listings to assure their accuracy and completeness, researchers and other individuals should check with local authorities and/or Research ethics committees before commencing Research activities. 3 TABLE OF CONTENTS International .. 5 NORTH AMERICA .. 10 Canada .. 10 United States .. 12 EUROPE .. 21 Regionwide .. 21 Armenia .. 27 Austria .. 27 Belarus .. 29 Belgium .. 31 Bosnia and Herzegovina .. 33 Bulgaria .. 36 Croatia .. 39 Cyprus .. 41 Czech Republic.

9 42 43 Estonia .. 44 Finland .. 46 France .. 48 50 51 Greece .. 55 Hungary .. 58 Iceland .. 60 Ireland .. 62 Italy .. 63 Latvia .. 65 Lithuania .. 67 Luxembourg .. 71 Macedonia .. 72 Malta .. 76 Moldova .. 77 Montenegro .. 79 Netherlands .. 81 83 Poland .. 86 Portugal .. 88 Romania .. 89 Russia .. 90 San Marino .. 92 Serbia .. 92 Slovakia .. 94 Slovenia .. 94 Spain .. 98 Sweden .. 101 Switzerland .. 103 107 United Kingdom .. 109 ASIA/PACIFIC .. 116 Australia .. 116 Bangladesh .. 119 China, People s Republic 119 India.

10 123 Indonesia .. 126 Japan .. 126 Kazakhstan .. 129 Korea .. 130 Kyrgyzstan .. 133 Malaysia .. 134 Myanmar .. 137 Nepal .. 137 New Zealand .. 138 Pakistan .. 140 Philippines .. 141 Singapore .. 144 Sri Lanka .. 146 Taiwan .. 147 Tajikistan .. 149 Thailand .. 149 Uzbekistan .. 150 Vietnam .. 150 MIDDLE EAST/NORTH AFRICA .. 152 Egypt .. 152 Iran .. 152 Israel .. 152 Jordan .. 153 Kuwait .. 154 Qatar .. 154 Saudi Arabia .. 155 Sudan .. 155 Tunisia .. 156 Turkey .. 156 United Arab Emirates .. 158 LATIN AMERICA AND THE CARIBBEAN.