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2020 International Compilation of Human Research Standards

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2020 International Compilation of Human Research Standards International Compilation of Human Research Standards 2020 Edition Compiled By: Office for Human Research Protections U.S. Department of Health and Human Services PURPOSE The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as “standards”) that govern human subject protections in 133 countries, as well as standards from a number of international and regional organizations. First published in 2005, the Compilation is intended for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research protections around the world. Content experts from around the world, listed at the end of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. Two new countries are featured in the 2020 Edition: Nicaragua and Paraguay. ORGANIZATION The Table of Contents is on pages 3-4. For each country, the standards are categorized by row as: 1. General, i.e., applicable to most or all types of human subjects research 2. Drugs, Biologics, and Devices 3. Clinical Trial Registries 4. Research Injury 5. Social-Behavioral Research (also see Description and Analysis of Social-Behavioral Research Standards: https://www.hhs.gov/ohrp/international/social- behavioral-research-standards/index.html) 6. Privacy/Data Protection (also see Privacy International reports: https://www.privacyinternational.org/reports) 7. Human Biological Materials 8. Genetic (also see the HumGen International database: http://www.humgen.umontreal.ca/int/) 9. Embryos, Stem Cells, and Cloning These nine categories often overlap, so it may be necessary to review the other standards to obtain an accurate understanding of the country’s requirements. The information is then organized into four columns: 1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research. 2. Legislation – encompasses statutes, statutory instruments, and legislative decrees, as well as any pertinent constitutional provisions. 3. Regulations – refer to instruments that are created and issued in the name of governmental administrative bodies. 4. Guidelines – pertain to non-binding instruments. 1 The year of the document’s most recent version (or date of initial approval, if never amended) is indicated in parenthesis when that information is available, unless the date is part of the document’s title, e.g., Law No. 46/2018. HOW TO ACCESS A DOCUMENT Documents can be accessed in four possible ways: 1. Link to the web address (URL). 2. Search for a document at the website of the agency listed in the Key Organizations column. 3. Perform an Internet search on the document title. 4. Request a local research ethics committee to provide the document. In many cases the documents are available in English. When the URL links to a non-English website or document, an online language translator usually can render an English version. TOPICS NOT COVERED In order to focus its scope, the International Compilation of Human Research Standards does not include standards from the state, provincial, or local levels. Nor does the Compilation cover: 1. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects standards, but do not direct the content of those regulations. 2. Laws, regulations, or guidelines that are disease-specific or focus on research integrity, clinical bioethics, product liability, clinical trial inspection procedures, intellectual property, good manufacturing practice, bioequivalence testing, or informed consent in clinical practice. 3. Ethics codes of academic, medical, or other professional organizations – see the Ethics Codes Collection: http://ethics.iit.edu/ecodes/about 4. Working papers, drafts, commentaries, or discussion papers. NEW STANDARDS, UPDATES, AND BROKEN LINKS To request inclusion of a new standard in the Compilation or to report updates or broken links, contact [email protected] . DISCLAIMER Although this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to human subject protections. While in-country persons have been requested to review listings to assure their accuracy and completeness, researchers and other individuals should check with local authorities and/or research ethics committees before commencing research activities. 2 TABLE OF CONTENTS Romania .............................................................. 89 Saudi Arabia ..................................................... 155 Russia .................................................................. 90 Sudan ................................................................ 155 San Marino .......................................................... 92 Tunisia .............................................................. 156 INTERNATIONAL ..................................................... 5 Serbia .................................................................. 92 Turkey ............................................................... 156 Slovakia .............................................................. 94 United Arab Emirates ....................................... 158 Slovenia .............................................................. 94 NORTH AMERICA .................................................. 10 LATIN AMERICA AND THE CARIBBEAN ................ 159 Spain ................................................................... 98 Canada ................................................................ 10 Sweden .............................................................. 101 Regionwide ....................................................... 159 United States ....................................................... 12 Switzerland ....................................................... 103 Argentina .......................................................... 159 EUROPE ................................................................ 21 Ukraine.............................................................. 107 Barbados ........................................................... 161 United Kingdom ............................................... 109 Bermuda ............................................................ 161 Regionwide ......................................................... 21 Bolivia ............................................................... 161 ASIA/PACIFIC ..................................................... 116 Armenia .............................................................. 27 Brazil ................................................................. 162 Austria ................................................................. 27 Australia ............................................................ 116 Chile .................................................................. 167 Belarus ................................................................ 29 Bangladesh ........................................................ 119 Colombia ........................................................... 169 Belgium ............................................................... 31 China, People’s Republic of.............................. 119 Costa Rica ......................................................... 172 Bosnia and Herzegovina ..................................... 33 India .................................................................. 123 Cuba .................................................................. 173 Bulgaria ............................................................... 36 Indonesia ........................................................... 126 Dominica ........................................................... 173 Croatia ................................................................. 39 Japan ................................................................. 126 Dominican Republic ......................................... 173 Cyprus ................................................................. 41 Kazakhstan ........................................................ 129 Ecuador ............................................................. 173 Czech Republic ................................................... 42 Korea ................................................................. 130 El Salvador ........................................................ 175 Denmark.............................................................. 43 Kyrgyzstan ........................................................ 133 Grenada ............................................................. 176 Estonia ................................................................ 44 Malaysia ............................................................ 134 Guyana .............................................................. 176 Finland ................................................................ 46 Myanmar ........................................................... 137 Guatemala ......................................................... 176 France ................................................................
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