EuropaBio: European Association for Bio Industries
Scientists Center for Animal Welfare (SCAW)
The Foundation for Biomedical Research (FBR)
The Institute for In Vitro Sciences (IIVS)
International society for stem cell research
The Massachusetts Society for Medical Research (MSMR)
The Universities Federation for Animal Welfare (UFAW)
Canadian Council on Animal Care: The national peer review agency responsible for setting and maintaining standards for the care and use of animals used in research, teaching and testing throughout Canada.
Health Canada, Therapeutic Products Directorate
- Good Clinical Practice Consolidated Guidelines (1997)
- Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials) (2004)
Canadian Public Health Association: Public Consultation on Xenotransplantation
Public perceptions of transgenic animals and the implications for public policy are examined in this data review conducted by E. F. Einsiedel, Communications Studies Programme at the University of Calgary, Alberta, Canada. The data reviewed originated from surveys conducted in the U.S, Canada and within Europe examining public acceptance of a variety of applications.
Partners In Research (PIR) is 'a national Canadian charity established in 1988 to educate the lay public -particularly young people- about the history, importance, accomplishments and promise of health research in all its aspects'.
Xenotransplantation Acion Plan: FDA approach to the regulation of xenotransplantation. A description of the Xenotransplantation Action Plan of the U.S Food and Drug Administration produced by the Centre for Biologics Evaluation and Research (CBER)
Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (Device coverage - Section 360) (2004)
Public Health Service Act, 42 USC Section 262 (1944)
Good Clinical Practice in FDA-Regulated Clinical Trials
Other
Guidance for Industry. Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans. (US FDA, Center for Biologics Evaluation and Research. Final Guidance, April 2003)
(US) Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation. January 2001 (FDA)
Secretary's Advisory Committee on Xenotransplantation (SACX): Chartered by US Department of Health and Human Services)
Report on the State of the Science in Xenotransplantation (US Department of Health and Human Services, Secretary's Advisory Committee on Xenotransplantation. Draft September 2004.): Executive Summary
Website in Spain relating to the animal welfare
National Centre for the Replacement, Refinement and Reduction of Animals in Research
Netherlands Centre for Alternatives to Animal Use (NCA)
The Australian Health Ethics Committee (AHEC) The National Health Medical Research Council was created in 1992 to provide funding and advice for medical research. The site includes links to related NHMRC publications, including guidelines, codes of practice, policy statements, legislation and regulations, fact sheets, and links to related web publication from other Australian and international organizations. A separate list of all NHMRC publications, current and rescinded, is included and all NHMRC media releases back to 1996 are available in full.
A MORI (largest independently-owned market research company in the United Kingdom) survey commissioned by the Coalition for Medical Progress to ask British people what they thought about the use of animals in medical research. This follows on from a study conducted by MORI for the MRC in 1999 - Animals in Medicine and Science.
UK Biotechnology Regulatory Atlas. This Atlas is aimed mainly at biotechnologists, providing information on the legal and regulatory framework that encompasses biotechnology.
UK Xenotransplantation Interim Regulatory Authority (UKXIRA) is an advisory body to the Secretaries of State for Health, Northern Ireland, Scotland and Wales providing guidance on the regulation of xenotransplantation.
(Report on the implications of cloning on the welfare of livestock) The Farm Animal Welfare Council (FAWC) is an independent advisory body established by the U.K. Government in 1979.
Research Defense Society (RDS), founded in 1908 by Dr Stephen Paget FRCS, is the UK organization representing medical researchers in the public debate about the use of animals in medical research and testing. RDS provides information about the needs for animal research, the controls under which this research is carried out, and the benefits to medicine which have resulted. The Society also assists Government and animal welfare groups to promote best practice in laboratory animal welfare and help develop non-animal techniques.
Society for Accountability in Animal Studies in Biomedical Research & Education (SABRE) was formed in 2002 by a group of scientists, researchers, and patients concerned about the absence of systematic scientific evidence supporting the use of animal as models of human disease. The mission is to raise awareness of the need to evaluate animal research in order to determine its contribution to human medicine.
This resource (jointly produced by Australian and New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) and the Animal Welfare Science and Bioethics Centre at Massey University) provides information about the use of animals in science, i.e. animal use in research, teaching and testing. Sections (containing links to sub-topics and a glossary)
Huntingdon Life Sciences (HLS) is a product development company renowned for using animals in its research. This page of their website confronts the ethical issues raised by animal testing while presenting their viewpoint that animal testing is invaluable in medical research.
Institute for Laboratory Animals (ILAR), founded in 1952, functions within the mission of the National Academies. ILAR is instrumental in developing guidelines and disseminating information on the scientific, technological and ethical use of animals in research, testing and education.
The Johns Hopkins University Center for Alternatives to Animal Testing (CAAT) follows the three Rs of Reduction, Refinement and Replacement. The site contains information on the Center, including current mission statement, aims, achievements and awards, and a list of advisory board members, staff and sponsors.
International Council for Laboratory Animal Science (ICLAS) An organization dedicated to advancing human and animal health by promoting the ethical care and use of laboratory animals in research worldwide.
European Parliament. Science and Technology Options Assessment (STOA) STOA Workshop on "Assessing Animal Welfare: a New Approach"
STOA: a resource for Committees of the European Parliament
The European Parliament defines its position on these issues through reports prepared by its Committees. If Committees decide that it would be helpful to their policy making role to seek out expert, independent assessments of the various scientific or technological options in the policy sectors concerned, then they have STOA at their disposal: The Parliament’s own Scientific and Technological Options Assessment unit.
STOA organized a workshop with the objective of presenting the main results of the STOA project "Impact of Animal Welfare" commissioned by STOA (Science and Technology Options Assessment), European Parliament and carried out by the European Technology Assessment Group (ETAG)
The workshop was focused on the (im)possibilities of introducing a European system of on-farm monitoring of animal welfare using animal-based indicators. Is such a system techonologically and economically feasible? Will it accommodate public concerns?
What could be the related policy issues?
The workshop was held on 28 January 2009 in Brussels
Some of the questions observed in the workshop were, for instance, the following ones:
- Animal welfare as pressing and ongoing public concern
- Current welfare assessment not satisfying: external parameters only tell part of the story
- Scientific research provides a more direct method to assess animal welfare: animal based approach
- Key question: what are the (im)possibilities of introducing an animal based welfare monitoring system in the EU?
The European commission (DG SANCO and DG TRADE) together with the royal society for the prevention of cruelty to animals (RSPCA), eurogroup for animals, compassion in world farming and world society for the protection of animals (WSPA)
All these organizations organized an International Forum on Global Aspects of Farm Animal Welfare on 22-23 April 2008 and a Conference on Global Trade and Farm Animal Welfare on 20-21 January 2009.The aim of the events is to bring together different constituents from all continents, who will present and discuss positive experiences of inclusion of animal welfare in the trade environment.
Through exchange and sharing of concrete case studies, the Forum and Conference should prepare the ground for and facilitate the adoption of similar policies worldwide. Workshop "Animal Welfare in Europe: achievements and future prospects"
An international workshop on animal welfare, organised by the Commission, the Finnish Presidency, the Council of Europe and the World Organisation for Animal Health (OIE), took place in Strasbourg on 23 and 24 November 2006, with the aim of bringing the gap between animal welfare legislation and its practical application.
Senior government and veterinary representatives from 50 countries in the European region took part in the workshop, which was hosted by the Council of Europe in Strasbourg, in cooperation with the European Union and the OIE. They had the opportunity to exchange best practice solutions and discuss ways to overcome social, legal, and economic obstacles that hinder the effective implementation of animal welfare guidelines throughout Europe.
The workshop also allowed the CoE, EU and OIE to consider how their existing activities could complement each other, with a view to maximizing the efforts being made to improve animal welfare in Europe.
At the end of the workshop, the Council of Europe (CoE), the European Union (EU) and the World Organisation for Animal Health (OIE) adopted a joint declaration entitled "Animal Welfare in Europe: achievements and future prospects". In the Declaration, the Council of Europe, the OIE and the European Union commit to providing mutual support and cooperating on all aspects of animal welfare, from the elaboration of legislation, to the training of veterinary professionals and para-professionals, to raising public awareness of the societal value of animal welfare.
The important link between animal welfare and the need for adequate scientific and veterinary expertise is stressed in the document. Furthermore, the Declaration commits to efficiently assisting countries to comply with, develop or enforce animal welfare laws, standards and guidelines at a national level.
World Health Organization
Interim Clinical Islet Recommendations
Recent publications and key regulatory documents related to xenotransplantation:
WHO - Xenotransplantation Advisory Consultation Report (Geneva - April 2005) Informed Consent In Clinical Research Involving Xenotransplantation (June 2004) WHA57.18 - 57th World Health Assembly (May 2004) Guidance for Industry - Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (April 2003) PHS Guideline on Infectious Disease Issues in Xenotransplantation (January 2001) Position Paper of the Ethics Committee of IXA (December 2002)
In response to a recent request, the IXA Council and TTS executive committee have unanimously endorsed Interim Recommendations for Preclinical Data to support Clinical Islet Xenotransplantation. The IXA, in concert with The Transplantation Society, will work closely with WHO and national regulatory bodies during 2008 to help craft consensus guidelines for design and conduct of clinical xenotransplantation trials.
There is a document that presents an evaluation of the risks involved and offers ideas on how to minimize them. By addressing the concepts presented in this document, interested parties should be able start developing appropriate guidelines for preventing or managing the infectious disease risks associated with this technology.
First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, China, 19-21 November 2008.
Organization for economic co-operation and development
Xenotransplantation: International Policy Issues. Washington, DC: Organization for Economic Co-operation and Development (OECD), 1999.
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