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Human Biomedical Research

Embryos and Stem Cells

Human Biological Materials

International Frameworks

Policies	Guidelines	Other readings
-	ISSCR Guidelines for Stem Cell Research and Clinical Translation 2021	The ISSCR Forms Embryo Models Working Group 2024 Hyun et al. (2020) Toward Guidelines for Research on Human Embryo Models Formed from Stem Cells

Europe

Policies	Guidelines	Other readings
Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application 2024 Regulation (EU) 2021/695 Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination	Report on Human Embryonic Stem Cell Research 2003	European Commission: European Group on Ethics in Science and New Technologies (EGE) Isasi et al. (2022) Mending the Gaps: Ethically Sensitive Cells and The Evolution of European Stem Cell Policy Statement by the Commission on Ethics or Stem Cell Research under Regulation (EU) 2021/695 Final Report Summary - EU-HPSCREG (European human Pluripotent Stem Cell Registry)

Singapore

Policies	Guidelines	Other readings
Human Cloning and Other Prohibited Practices Act 2004 Human Biomedical Research Act 2015 Human Biomedical Research (Restricted Research) Regulations 2017	Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning 2002 Donation of Human Eggs for Research 2008 Human-Animal Combinations in Stem Cell Research 2010 Ethics Guidelines for Human Biomedical Research (2021 Revised Edition)	Lim and Ho (2003) The Ethical Position of Singapore on Embryonic Stem Cell Research

South Korea

Policies	Guidelines	Other readings
Bioethics and Safety Act No. 16371 (2019) Enforcement Decree of the Bioethics and Safety Act No. 30141 (2019) Enforcement Rule of Bioethics and Safety Act No. 733 (2020)	-	Kurihara (2012) Revision of Bioethics and Safety Act

United Kingdom

Policies	Guidelines	Other readings
Human Fertilisation and Embryology Act 1990 Human Fertilisation and Embryology Act 2008 The Human Fertilisation and Embryology (Amendment) Regulations 2024	HFEA Code of Practice 9th Edition 2023	Explanatory Memorandum to The Human Fertilisation and Embryology (Amendment) Regulations 2024

United States

Policies	Guidelines	Other readings
Executive Order 13505-Removing Barriers to Responsible Scientific Research Involving Human Stem Cells 2009 42 U.S.C. 289g-1 Research on Transplantation of Fetal Tissue 2018	NIH Guidelines for Human Stem Cell Research 2009	FAQs on NIH Guidelines for Human Stem Cell Research NIH Human Embryonic Stem Cell Registry Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research 2010

International Frameworks

Policies	Guidelines	Other readings
Infectious Substances Shipping Regulations (ISSR)	ISBER Best Practices for Repositories Fifth Edition (2023) CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016)	ISBER Biobank Assessment Tool (BAT)

Europe

Policies	Guidelines	Other readings
Convention on Human Rights and Biomedicine (ETS No. 164) Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application 2024	Additional Protocol to the Convention on Human Rights and Biomedicine, relating to Biomedical Research (CETS No. 195)	Recommendation Rec(2016)6 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin

Singapore

Policies	Guidelines	Other readings
Medical (Therapy, Education and Research) Act 1972 Human Biomedical Research Act 2015 Human Biomedical Research (Tissue Banking) Regulations 2019	Guide to the Prohibition Against Commercial Trading of Human Tissue Guidance on the Requirement of Appropriate Consent for the Conduct of Human Biomedical Research and Handling of Human Tissue Ethics Guidelines for Human Biomedical Research (2021 Revised Edition)	Frequently Asked Questions on Human Biomedical Research Act HBRA SAE Infographics

South Korea

Policies	Guidelines	Other readings
Bioethics and Safety Act No. 16371 (2019) Enforcement Decree of the Bioethics and Safety Act No. 30141 (2019) Enforcement Rule of Bioethics and Safety Act No. 733 (2020)	-	Kurihara (2012) Revision of Bioethics and Safety Act

United Kingdom

Policies	Guidelines	Other readings
Human Tissue Act 2004 The Human Tissue (Quality and Safety for Human Application) Regulations 2007	Code of Practice A Guiding Principles and the Fundamental Principle of Consent Code of Practice E Research	Explanatory Memoradum for The Human Tissue (Quality and Safety for Human Application) Regulations 2007

United States

Policies	Guidelines	Other readings
45 CFR Part 46 Protection of Human Subjects, Subparts A (the Common Rule), B, C, D, and E (2018) United States Code, Title 42, Chapter 6A – Public Health Service	OHRP Human Research Protections Guidance (Various)	AATB Guidance on Training and Competency

Think Tank
Health Regulation Projects
Asia Pacific (APAC) Network of Healthcare Regulators
Human Biomedical Research