Laws and Policies
Links to policies related to embryonic stem (ES) cell research in the US and worldwide as well as published guidelines for human ES cell research.
Public Health Council Overturns Restrictive Stem Cell Regulations October, 2007. The Massachusetts Public Health Council amended the 2005 regulations to ease restrictions on human stem cell research.
Enhancing Regenerative Medicine in the Commonwealth . This law, passed in 2005, placed limitations on human ES cell research in Massachusetts.
Legislation by State
State Embryonic and Fetal Research Laws Comprehensive summary of state policies produced by the National Conference of State Legislatures.
Documents Detailing State Legislation, Rules and Policies Compiled by the Interstate Alliance for Stem Cell Research.
US Federal Policy Links to Executive Orders regarding stem cell research and NIH guidelines.
U.S. Federal Stem Cell Legislation Sourcewatch article on stem cell legislation efforts of the 110th Congress (2007-2008)
Congressional Legislation NIH links to U.S. House and Senate bills related to stem cell research for the past four years.
International hESC Policies
World Human ES Cell Policies . This is an interactive map that provides information on human ES cell policies throughout the world. Colored maps indicate if countries or states have permissive legislation, place restrictions on or prohibit human ES cell research. The site also contains excerpts from countries with written policy statements. The site was created by the Hinxton Group, an international consortium of human ES cell researchers, ethicists and policy experts.
StemGen Searchable Laws and Policy Database This is a comprehensive database of international, regional, and national laws and policies concerning stem cell research. The database can be searched by title, organization, key word, jurisdiction, year of publication (1985-2011) and language (English or French).
StemGen Literature Database StemGen’s literature database provides a selective review of peer reviewed articles, book chapters, and monographs concerning the social, ethical and legal aspects of stem cell research. The database includes contemporary literature, published since 2000.
Guidelines for Human ES Cell Research
National Institutes of Health Guidelines for Human Stem Cell Research Published in 2009, these guidelines establish policy and procedures under which the NIH will fund ES cell research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.
The International Stem Cell Banking Initiative (ISCBI) In 2009 ISCBI adopted the Consensus Guidance for Banking and Supply of Human Embryonic Stem Cell Lines for Research Purposes in order to establish the best practices in banking for the supply of high quality human stem cells for research. ISCBI was established by the International Stem Cell Forum with the objective of creating a global network of stem cell banks to facilitate the best practices in stem cell research and clinical cell delivery.
2005 National Academy of Sciences Guidelines for Human Embryonic Stem Cell Research A comprehensive description of the current ethical standards and guidelines for the derivation and use of human ES cells in the United States. Available for purchase, free download or read online (225 pages).
2007 Amendments to the NAS Guidelines for Human Embryonic Stem Cell Research This amendment contains updated information from the NAS Human Embryonic Stem Cell Research Advisory Committee.
2008 Amendments to the NAS Guidelines for Human Embryonic Stem Cell Research Among the issues addressed in these amendments are the applicability of the guidelines to non-embryonic pluripotent stem cells.
ISSCR Guidelines for Human Embryonic Stem Cell Research . Developed by the International Society for Stem Cell Research , these principles were written by scientific, ethical and legal experts from 14 countries in order to foster international collaborations.
Human Genome Organization (HUGO) In 2004, the Ethics Committee released its Statement on Stem Cells which encourages respect for differing personal and religious beliefs on the status of the human embryo.
European Commission The European Group on Ethics in Science and New Technologies published Opinion No. 15 Ethical Aspects of Human Stem Cell Research and Use in 2000, which clarifies the powers of European institutions with respect to ethical considerations and research funding.
Guidelines for Human Stem Cell-Based Therapies
International Society for Stem Cell Research (ISSCR) Guidelines for the Clinical Translation of Stem Cells was released in 2008 which recommended that unproven treatments using stem cells or their derivatives should not, as a rule, be administered to patients outside of an established clinical trial. These guidelines can be read in French, German, Japanese and Spanish.
A Closer Look at Stem Cell Treatments was launched by ISSCR in 2010 to provide patients with resources to help make thoughtful and informed decisions about potential treatments.
European Union In 2007, regulations were introduced to promote harmonization with regards to the authorization and supervision of cell therapy products and other “advanced therapy medicinal products”. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004).