Academy of Medical SciencesA New Pathway for the Regulation and Governance of Health ResearchLondonAcademy of Sciences 2011
Addicott, D.C.‘Regulating Research on the Terminally Ill: A Proposal for Heightened Safeguards’ 1999 15 Journal of Contemporary Health Law and Policy479
Agriculture and Environment Biotechnology Commission (AEBC)Crops on Trial – A Report by the AEBCLondonAEBC 2001
Ahmed, A.S.‘The Last Twist of the Knife: Encouraging the Regulation of Innovative Surgical Procedures’ 2005 105 Columbia Law Review1529
Allspaw, K.M.‘Engaging the Public in the Regulation of Xenotransplantation: Would the Canadian Model of Public Consultation Be Effective in the US?’ 2004 13 Public Understanding of Science417
American Fertility Society‘Ethical Considerations of the New Reproductive Technologies’ 1986 46 Fertility and Sterility1S
American Medical Association (AMA), Council on Ethical and Judicial AffairsOpinions of the Council on Ethical and Judicial Affairs: Gene Therapy and Surrogate MothersChicago, ILAMA 1988
American Medical Association (AMA) 1998 www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion207.shtml
American Medical Association (AMA) 2000 www.ama-assn.org/ama1/pub/upload/mm/code-medical-ethics/2169a.pdf
American Medical Association (AMA) 2001 www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion80315.shtml
American Medical Association (AMA) 2001 www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2169.shtml
Anderson, W.F.Fletcher, J.C.‘Gene Therapy in Humans: When Is It Ethical to Begin?’ 1980 303 New England Journal of Medicine1293
Andorno, R.‘The Precautionary Principle: A New Legal Standard for a Technological Age’ 2004 1 Journal of International Biotechnology Law11
Angell, E.Sutton, A.J.Windridge, K.Dixon-Woods, M.‘Consistency in Decision Making by Research Ethics Committees: A Controlled Comparison’ 2006 32 Journal of Medical Ethics662
Annas, G.J. 1985 15
Annas, G.J.‘The Changing Landscape of Human Experimentation: Nuremberg, Helsinki and Beyond’ 1992 2 Health Matrix119
2009
1998
Appelbaum, P.S.Roth, L.H.Lidz, C.W.‘The Therapeutic Misconception: Informed Consent in Psychiatric Research’ 1982 5 International Journal of Law and Psychiatry319
Arthur, C 1995
Bach, F.H.Fishman, J.A.Daniels, N.Proimos, J.Anderson, B.Carpenter, C.B.Forrow, L.Robson, S.C.Fineberg, H.V.‘Uncertainty in Xenotransplantation: Individual Benefit versus Collective Risk’ 1998 4 Nature Medicine141
Bach, F.H.Ivinson, A.J.Weeramantry, C.‘Ethical and Legal Issues in Technology: Xenotransplantation’ 2001 27 American Journal of Law and Medicine283
Bailey, L.L.Nehlsen-Cannarella, S.L.Concepcion, W.Jolley, J.B.‘Baboon-to-Human Cardiac Xenotransplantation in a Neonate’ 1985 254 Journal of the American Medical Association3321
Baldan, N.Rigotti, P.Calabrese, F.Cadrobbi, R.Dedja, A.Iacopetti, I.Boldrin, M.Seveso, M.Dall'Olmo, L.Frison, L.De Benedictis, G.Bernardini, D.Thiene, G.Cozzi, E.Ancona, E.‘Ureteral Stenosis in HDAF Pig-to-Primate Renal Xenotransplantation: A Phenomenon Related to Immunological Events?’ 2004 4 American Journal of Transplantation475
Barnard, C.N.‘A Human Cardiac Transplant: An Interim Report of a Successful Operation Performed at the Groote Schuur Hospital, Cape Town’ 1967 41 South African Medical Journal1271
Bateman, D.Hilton, D.Love, S.Zeidler, M.Beck, J.Collinge, J.‘Sporadic Creutzfeldt–Jakob Disease in a 18-year-old in the UK’ 1995 346 The Lancet1155
Beauchamp, T.L.Childress, J.FPrinciples of Biomedical EthicsNew York, NYOxford University Press 2009
Beck, URisk Society: Towards A New ModernityLondonSage 1992
Beddard, S.Lyons, DThe Science and Ethics of XenotransplantationSheffieldUncaged Campaigns 1997
Bennett, P.‘Understanding Responses to Risk: Some Basic Findings’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 3
Bennett, P.Coles, D.McDonald, A.‘Risk Communication as a Decision ProcessBennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 207
Berg, P.Baltimore, D.Brenner, S.Roblin, R.O.Singer, M.F.‘Summary Statement of the Asilomar Conference on Recombinant DNA Molecules’ 1975 72 Proceedings of the National Academy of Science1981
Better Regulation Commission (BRC)Risk, Responsibility and Regulation – Whose Risk Is It Anyway?LondonBRC 2006
Better Regulation Task Force (BRTF)Scientific Research: Innovation with ControlsLondonBRTF 2003
Beyleveld, D.Brownsword, R.Human Dignity in Bioethics and BiolawOxford University Press 2001
Beyleveld, D.Finnegan, T.Pattinson, S.D‘The Regulation of Hybrids and Chimeras in the UK’Taupitz, J.Weschka, M.Chimbrids: Chimeras and Hybrids in Comparative European and International Research: Scientific, Ethical, Philosophical and Legal AspectsBerlinSpringer 2009 645
Biggs, HHealthcare Research Ethics and Law: Regulation, Review and ResponsibilityLondonRoutledge-Cavendish 2010
Bier, V.M.‘On the State of the Art: Risk Communication to the Public’ 2001 71 Reliability Engineering and System Safety139
Birmingham, K.‘WHO Hosts Web Discussion on Xenotransplantation Policy’ 1999 5 Nature Medicine595
Birmingham, K.‘Skepticism Surrounds Diabetes Xenograft Experiment’ 2002 8 Nature Medicine1047
Blaese, R.M.Culver, K.W.Miller, A.D.Carter, C.S.Fleisher, T.Clerici, M.Shearer, G.Chang, L.Chiang, Y.Tolstoshev, P.Greenblatt, J.J.Rosenberg, S.A.Klein, H.Berger, M.Mullen, C.A.Ramsey, W.J.Muul, L.Morgan, R.A.Anderson, W.F.‘T Lymphocyte-Directed Gene Therapy for ADA Deficiency SCID: Initial Trial Results after 4 Years’ 1995 270 Science475
Bloom, E.T.‘Xenotransplantation: Regulatory Challenges’ 2001 12 Current Opinion in Biotechnology312
Blumgart, H.L.‘The Medical Framework for Viewing the Problem of Human Experimentation’ 1969 98 Daedalus248
Boisson de Chazournes, L.‘New Technologies, the Precautionary Principle, and Public Participation’Murphy, T.New Technology and Human RightsOxford University Press 2009 161
Boseley, S 2008
Bosk, C.L.‘Obtaining Voluntary Consent for Research in Desperately Ill Patients’ 2002 40 Medical CareV
Bramstedt, K.A.‘Arguments for the Ethical Permissibility of Transgenic Xenografting’ 2000 7 Gene Therapy633
Brazier, M.‘Patient Autonomy and Consent to Treatment: The Role of the Law?’ 1987 7 Legal Studies169
Brazier, M.‘Do No Harm – Do Patients Have Responsibilities Too?’ 2006 65 Cambridge Law Journal397
Brazier, M.Cave, EMedicine, Patients and the LawLondonLexisNexis Butterworths 2007
Brazier, M.Harris, J.‘Public Health and Private Lives’ 1996 4 Medical Law Review171
Breitsameter, C.‘Medical Decision-Making and Communication of Risks: an Ethical Perspective’ 2010 36 Journal of Medical Ethics349
British Medical Association (BMA) Working Group on In Vitro Fertilization‘Interim Report on Human In Vitro Fertilization and Embryo Replacement and Transfer’ 1983 286 British Medical Journal1594
British Medical Association (BMA) Working Group on In Vitro FertilizationThe Medical Profession and Human Rights: Handbook for a Changing AgendaLondonZed Books 2001
British Medical Association (BMA) Working Group on In Vitro FertilizationReport of the Consent Working Party: Incorporating Consent ToolkitLondonBMA 2001
British Medical Association (BMA) Working Group on In Vitro FertilizationConsent Tool KitLondonBMA 2009
Britton, T.C.Al-Sarraj, S.Shaw, C.Campbell, T.Collinge, J.‘Sporadic Creutzfeldt–Jakob Disease in a 16-year-old in the UK’ 1995 346 The Lancet1155
Bronitt, S. 1994
Brownsword, R‘What the World Needs Now: Techno-Regulation, Human Rights and Human Dignity’Brownsword, R.Global Governance and the Quest for JusticeOxfordHart 2004 203
Brownsword, R.‘Biotechnology and Rights: Where Are We Coming from and Where Are We Going?’King, M.Murray, A.Human Rights in the Digital AgeLondonGlass House Press 2005 219
Bubela, T.Nisbet, M.C.Borchelt, R.Brunger, F.Critchley, C.Einsiedel, E.Geller, G.Gupta, A.Hampel, J.Hyde-Lay, R.Jandciu, E.W.Jones, A.A.Kolopack, P.Lane, S.Lougheed, T.Nerlich, B.Ogbogu, U.O'Riordan, K.Ouellette, C.Spear, M.Strauss, S.Thavaratnam, T.Willemse, L.Caulfield, T.‘Science Communication Reconsidered’ 2009 27 Nature Biotechnology514
Butler, D.‘Last Chance to Stop and Think on Risks of Xenotransplants’ 1998 391 Nature320
Cabezuelo, J.B.Ramirez, P.Chavez, R.Majado, M.Munitiz, V.Muñoz, A.Hernandez, Q.Palenciano, C.G.Pino-Chávez, G.Loba, M.Yélamos, J.Vizcaino, A.S.Cayuela, M.Segura, B.Marin, F.Rubio, A.Fuente, T.Gago, M.R.Rios, A.Montoya, M.Esteban, A.Bueno, F.S.Robles, R.Cozzi, E.White, D.J.G.Parrilla, P.‘Assessment of Renal Function During the Postoperative Period Following Liver Xenotransplantation From Transgenic Pig to Baboon’ 2002 34 Transplantation Proceedings321
Cabinet OfficeOffice of Science and TechnologyThe Advisory and Regulatory Framework for Biotechnology: Report from the Government's ReviewLondonCabinet Office 1999
Calman, K.C.‘Cancer: Science and Society and the Communication of Risk’ 1996 313 British Medical Journal799
Campbell, A.V‘Dependency: The Foundational Value in Medical Ethics’Fulford, K.W.M.Gillett, G.Soskice, J.M.Medicine and Moral ReasoningNew York, NYCambridge University Press 1994 184
Campbell, D. 2010
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada 2010 www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf
Canadian Public Health Association (CPHA)Animal-to-Human Transplantation: Should Canada Proceed? A Public Consultation on XenotransplantationOntarioCPHA 2001
Caplan, A.‘Is It Sound Public Policy to Let the Terminally Ill Access Experimental Medical Innovations?’ 2007 7 American Journal of Bioethics1
Caplan, A.L.‘Ethical Issues Raised by Research Involving Xenografts’ 1985 254 Journal of the American Medical Association3339
Catholic Bishops’ Joint Committee on Bioethical IssuesGenetic Intervention on Human Subjects: The Report of a Working Party of the Catholic Bishops’ Joint Committee on Bioethical IssuesLondonCatholic Bishops’ Joint Committee 1996
Catholic Health Association of the United StatesResearch Group on Ethical Issues in Early Human Development and GeneticsHuman Genetics: Ethical Issues in Genetic Testing, Counseling, and TherapySt Louis, MOCatholic Health Association of the United States 1990
Caulfield, T.A.Robertson, G.B.‘Xenotransplantation: Consent, Public Health and Charter Issues’ 2001 5 Medical Law International81
Center for Law and the Public's Health at Georgetown and Johns Hopkins Universities 2001 www2a.cdc.gov/phlp/docs/msehpa2.pdf
Center for Technology Assessment, Federal Office of Public Health, Swiss National Science Foundation 2001
Chahal, M.‘Off-Trial Access to Experimental Cancer Agents for the Terminally Ill: Balancing the Needs of Individuals and Society’ 2010 36 Journal of Medical Ethics367
Chapman, L.‘Speculation, Stringent Reasoning, and Science’ 1999 77 Bulletin of the World Health Organization68
Chapman, L.E.Bloom, E.T.‘Clinical Xenotransplantation’ 2001 285 Journal of the American Medical Association2304
Chari, R.S.Collins, B.H.Magee, J.C.DiMaio, J.M.Kirk, A.D.Harland, R.C.McCann, R.L.Platt, J.L.Meyers, W.C.‘Brief Report: Treatment of Hepatic Failure with Ex Vivo Pig-Liver Perfusion Followed by Liver Transplantation’ 1994 331 New England Journal of Medicine234
Childress, J.F.Bernheim, R.G.‘Beyond the Liberal and Communitarian Impasse: A Framework and Vision for Public Health’ 2003 55 Florida Law Review1191
Childress, J.F.Faden, R.R.Gaare, R.D.Gostin, L.O.Kahn, J.Bonnie, R.J.Kass, N.E.Mastroianni, A.C.Moreno, J.D.Nieburg, P.‘Public Health Ethics: Mapping the Terrain’ 2002 30 Journal of Law, Medicine and Ethics170
Chwang, E.‘A Puzzle about Consent in Research and in Practice’ 2010 27 Journal of Applied Philosophy258
Cichutek, K.Krämer, I.‘Gene Therapy in Germany and in Europe: Regulatory Issues’ 1997 2 Quality Assurance Journal141
Clark, M.A.‘This Little Piggy Went to Market: The Xenotransplantation and Xenozoonose Debate’ 1999 27 Journal of Law, Medicine and Ethics137
Code of Health and Disability Services Consumers’ Rightswww.hdc.org.nz/media/24833/brochure-code-white.pdf
Coggon, J.‘Public Health, Responsibility and English Law: Are There Such Things as No Smoke Without Ire or Needless Clean Needles?’ 2009 17 Medical Law Review127
Coggon, J.‘Harmful Rights-Doing? The Perceived Problem of Liberal Paradigms and Public Health’ 2008 34 Journal of Medical Ethics798
Cohen-Haguenauer, O.‘Overview of Regulation of Gene Therapy in Europe: A Current Statement Including Reference to US Regulation’ 1995 6 Human Gene Therapy773
Cohen-Haguenauer, O.Rosenthal, F.Gänsbacher, B.Bolhuis, R.Dorsch-Häsler, K.Eshhar, Z.Gahrton, G.Hokland, P.Melani, C.Rankin, E.Thielemans, K.Vile, R.Zwierzina, H.Cichutek, K.for the Euregenethy Network‘Opinion Paper on the Current Status of the Regulation of Gene Therapy in Europe’ 2002 13 Human Gene Therapy2085
Coker, R.Martin, R.‘Introduction: The Importance of Law for Public Health Policy and Practice’ 2006 120 Public Health2
Coker, R.J.Mounier-Jack, S.Martin, R.‘Public Health Law and Tuberculosis Control in Europe’ 2007 121 Public Health266
Coles, D.‘The Identification and Management of Risk: Opening Up the Process’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 195
Collinge, J.Sidle, K.C.L.Meads, J.Ironside, J.Hill, A.F.‘Molecular Analysis of Prion Strain Variation and the Aetiology of “New Variant” CJD’ 1996 383 Nature685
Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé (CCNE) 1984 www.ccne-ethique.fr/docs/en/avis003.pdf
Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé (CCNE) 1986 www.ccne-ethique.fr/docs/en/avis008.pdf
Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé (CCNE) 1990 www.ccne-ethique.fr/docs/en/avis022.pdf
Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé (CCNE) 1993 www.ccne-ethique.fr/docs/en/avis036.pdf
Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé (CCNE) 1999 www.ccne-ethique.fr/docs/en/avis061.pdf
Commission of the European Communities 2000
Committee to Consider Social, Ethical and Legal Issues Arising from In Vitro FertilizationReport on the Disposition of Embryos Produced by In Vitro FertilizationMelbourneParliament of the State of Victoria 1984
Committee for Human Medicinal Products 2007
1985
Committee for Proprietary Medicinal Products (CPMP) 2001
Committee for Proprietary Medicinal Products (CPMP) 2003
Committee on Xenograft Transplantation: Ethical Issues and Public Policy, Division of Health Sciences Policy, Division of Health Care Services, Institute of MedicineXenotransplantation – Science, Ethics and Public PolicyWashington, DCNational Academy Press 1996
Connolly, K. 2010
Connolly, K. 2010
Cook, P.S.‘What Constitutes Adequate Public Consultation? Xenotransplantation Proceeds in Australia’ 2011 8 Bioethical Inquiry67
Cook-Deegan, , R.M.‘Human Gene Therapy and Congress’ 1990 1 Human Gene Therapy163
Cooper, D.K.C.‘Global Consultation on Regulatory Requirements for Xenotransplantation in Clinical Trials, Conference held in Changsha, China, 19–21 November 2008’ 2009 16 Xenotransplantation58
Cooper, D.K.C.Ezzelarab, M.Hara, H.Ayares, D.‘Recent Advances in Pig-to-Human Organ and Cell Transplantation’ 2008 8 Expert Opinion in Biological Therapeutics1
Cooper, D.K.C.Gollackner, B.Sachs, D.H.‘Will the Pig Solve the Transplantation Backlog?’ 2002 53 Annual Review of Medicine133
Cooper, D.K.C.Keogh, A.M.Brink, J.Corris, P.A.Klepetko, W.Pierson, R.N.Schmoeckel, M.Shirakura, R.Warner Stevenson, L.‘Report of the Xenotransplantation Advisory Committee of the International Society for Heart and Lung Transplantation: The Present Status of Xenotransplantation and Its Potential Role in the Treatment of End-Stage Cardiac and Pulmonary Diseases’ 2000 19 Journal of Heart and Lung Transplantation1125
Cooper, D.K.C.Lanza, R.P.Xeno – The Promise of Transplanting Animal Organs into HumansOxford University Press 2000
Coote, A.Franklin, J.‘Negotiating Risks to Public Health – Models for Participation’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 183
Corrigan, O.‘Empty Ethics: The Problem with Informed Consent’ 2003 25 Sociology of Health and Illness768
Council of Europe Working Party on Xenotransplantation 2000
Council of Europe, Recommendation Rec 2003
Council of Europe 2003 www.coe.int/t/dg3/healthbioethic/activities/06_xenotransplantation_en/XENO(2003)1_SAR.pdf
Council for International Organizations of Medical Sciences (CIOMS)The Declaration of Inuyama, adopted by the XXIVth Round Table Conference of CIOMS on Genetics, Ethics and Human Values: Human Genome Mapping, Genetic Screening and Gene TherapyTokyo 1990
CIOMS and World Health Organization (WHO)International Ethical Guidelines for Biomedical Research Involving Human SubjectsGenevaCIOMS 2002
Council for Responsible Genetics‘Position Paper on Human Germ Line Manipulation Presented by Council for Responsible Genetics, Human Genetics Committee Fall, 1992’ 1993 4 Human Gene Therapy35
Cozzi, E.Tallacchini, M.Flanagan, E.B.Pierson, R.N.Sykes, M.Vanderpool, H.Y.‘The International Xenotransplantation Association Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes – Chapter 1: Key Ethical Requirements and Progress Toward the Definition of an International Regulatory Framework’ 2009 16 Xenotransplantation203
Cranor, C.F.‘Learning from the Law to Address Uncertainty in the Precautionary Principle’ 2001 7 Science and Engineering Ethics313
Curtis, P 2007
Cyranoski, D.‘Stem-Cell Therapy Faces More Scrutiny in China’ 2009 459 Nature146
Daar, A.S.‘Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics’ 1997 21 World Journal of Surgery975
Daar, A.S.‘Xenotransplantation – Science, Risk and International Regulatory Efforts’Caulfield, T.A.William-Jones, B.The Commercialization of Genetic Research – Ethical, Legal and Policy IssuesNew York, NYKluwer Academic 1999 129
Daar, A.S. 2000 www.bmj.com/content/320/7238/868/reply#bmj_el_7566
Dawson, A.Garrard, E.‘In Defence of Moral Imperialism: Four Equal and Universal Prima Facie Principles’ 2006 32 Journal of Medical Ethics200
Dawson, A.Verweij, M.Ethics, Prevention and Public HealthOxford University Press 2007
Department for EnvironmentFood and Rural Affairs (DEFRA), Scottish Executive Environment and Rural Affairs Department, Welsh Assembly Government, Department of the Environment in Northern IrelandThe GM Dialogue: Government ResponseLondonDEFRA 2004
Department for EnvironmentThe GM Public Debate: Lessons Learned from the ProcessLondonDEFRA 2004
Department of Health (DH)Report of the Committee on the Ethics of Gene Therapy CmLondonHMSO 1992
Department of Health (DH)Animal Tissue into HumansLondonDH 1996
Department of Health (DH)Communicating About Risks to Public Health: Pointers to Good PracticeLondonDH 1997
Department of Health (DH) 1998
Department of Health (DH)Learning from Bristol: The Report of the Public Inquiry into Children's Heart Surgery at the Bristol Royal Infirmary 1984–1995LondonStationery Office 2001
Department of Health (DH)Reconfiguring the Department of Health's Arm's Length BodiesLondonDH 2004
Department of Health (DH)Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics CommitteesLondonDH 2005
Department of Health (DH)Research Governance Framework for Health and Social CareLondonDH 2005
Department of Health (DH) 2006 www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063074.pdf
Department of Health (DH)Reference Guide to Consent for Examination or TreatmentLondonDH 2009
Department of Health (DH)Liberating the NHS: Report of the Arm's Length Bodies ReviewLondonDH 2010
Department of Health and Social SecurityReport of the Committee of Inquiry into Human Fertilisation and EmbryologyLondonHMSO 1984
Department of Trade and Industry (DTI)GM Nation? The Findings of the Public DebateLondonDTI 2003
Di Nicuolo, G.D'Alessandro, A.Andria, B.Scuderi, V.Scognamiglio, M.Tammaro, A.Mancini, A.Cozzolino, S.Di Florio, E.Bracco, A.Calise, F.Chamuleau, R.A.F.M.‘Long-Term Absence of Porcine Endogenous Infection in Chronically Immunosuppressed Patients after Treatment with the Porcine Cell-Based Academic Medical Center Bioartificial Liver’ 2010 17 Xenotransplantation431
Dickson, D.‘Pig Heart Transplant “Breakthrough” Stirs Debate over Timing of Trials’ 1995 377 Nature185
Dieckhoff, B.Petersen, B.Kues, W.A.Kurth, R.Niemann, H.Denner, J.‘Knockdown of Porcine Endogenous Retroviruses (PERV) Expression by PERV-Specific shRNA in Transgenic Pigs’ 2008 15 Xenotransplantation36
Director-General's Notice, Pharmaceutical Affairs Bureau, Ministry for Health and WelfareGuidance for Quality and Safety Assurance in Drugs for Gene TherapyTokyoMinistry for Health and Welfare 1995
Dobson, J.M.Dark, J.HThe Physiology of XenotransplantationLondonDH 2002
Doern, G.B. 2003
Dossetor, J.B.‘Innovative Treatment Versus Clinical Research: An Ethics Issue in Transplantation’ 1990 22 Transplantation Proceedings966
Doyal, L.‘Informed Consent: Moral Necessity or Illusion?’ 2001 10 Quality in Health Carei29
Dratwa, J.‘Taking Risks with the Precautionary Principle: Food (and the Environment) for Thought at the European Commission’ 2002 4 Journal of Environmental Policy and Planning197
Dunbar-Jacob, J.Mortimer-Stephens, M.K.‘Treatment Adherence in Chronic Disease’ 2001 54 Journal of Clinical EpidemiologyS57
Dutch Consumer and Biotechnology FoundationXenotransplantation: Is and Should It Be Possible? Final Report in Respect of the Public Debate on XenotransplantationThe HagueDutch Consumer and Biotechnology Foundation 2001
Dutton, D.BWorse than the Disease: Pitfalls of Medical ProgressNew York, NYCambridge University Press 1988
Edwards, A.Elwyn, G.‘Understanding Risk and Lessons for Clinical Risk Communication about Treatment Preferences’ 2001 10 Quality in Health Carei9
Edwards, R.G.Bavister, B.D.Steptoe, P.C.‘Early Stages of Fertilization of Human Oocytes Matured ’ 1969 221 Nature632
Edwards, R.G.Sharpe, D.J.‘Social Values and Research in Human Embryology’ 1971 231 Nature87
Edwards, R.G.Steptoe, P.C.Purdy, J.M.‘Fertilization and Cleavage of Preovulator Human Oocytes’ 1970 227 Nature1307
Einsiedel, E.F.‘Assessing a Controversial Medical Technology: Canadian Public Consultations on Xenotransplantation’ 2002 11 Public Understanding of Science315
Einsiedel, E.F.Ross, H.‘Animal Spare Parts? A Canadian Public Consultation on Xenotransplantation’ 2002 8 Science and Engineering Ethics579
Elliott, R.B.Escobar, L.Garkavenko, O.Croxson, M.C.Schroeder, B.A.McGregor, M.Ferguson, G.Beckman, N.Ferguson, S.‘No Evidence of Infection with Porcine Endogenous Retrovirus in Recipients of Encapsulated Porcine Islet Xenografts’ 2000 9 Cell Transplantation895
Elliott, R.B.Escobar, L.Tan, P.L.J.Muzina, M.Zwain, S.Buchanan, C.‘Live Encapsulated Porcine Islets from A Type 1 Diabetic Patient 9.5 Years after Xenotransplantation’ 2007 14 Xenotransplantation157
Enquête Commission‘An Extract from Prospects and Risks of Gene Technology: The Report of the Enquête Commission to the Bundestag of the Federal Republic of Germany’ 1988 2 Bioethics254
Ethics Advisory Board, Department of Health, Education and Welfare 1979 http://bioethics.georgetown.edu/pcbe/reports/past_commissions/HEW_IVF_report.pdf
Ethics Committee of the Transplantation Society‘Human Xenotransplantation – Position Paper’ 1993 1 Transplantation Society Bulletin8
Ethics Committee of the Transplantation Society‘The Transplantation Society and Xenotransplantation (Draft Guidelines)’ 1997 6 Transplantation Society Bulletin11
European Agency for the Evaluation of Medicinal Products (EMEA) 1994 www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC195763449.pdf
European Agency for the Evaluation of Medicinal Products (EMEA)Committee for Proprietary Medicinal Products Safety Working Party and Biotechnology Working PartySafety Studies for Gene Therapy Products – Annex to Note for Guidance on Gene Therapy Quality Aspects in the Production of Vectors and Genetically Modified Somatic CellsLondonEMEA 1998
European Agency for the Evaluation of Medicinal Products (EMEA) 2000
European Commission, Health and Consumer Protection Directorate-General 2001
European Medical Research Councils (EMRC)‘Recommendations on Human In Vitro Fertilization and Embryo Transfer’ 1983 322 The Lancet1187
European Medical Research Councils (EMRC)‘Gene Therapy in Man: Recommendations of European Medical Research Councils’ 1988 2 The Lancet1271
Expert Scientific Group on Phase One Clinical TrialsFinal ReportLondonStationery Office 2006
Family Law CouncilCreating Children: A Uniform Approach to the Law and Practice of Reproductive Technology in AustraliaCanberraAustralian Government Publishing Service 1985
Fano, A‘If Pigs Could Fly, They Would: The Problems with Xenotransplantation’Tokar, B.Redesigning Life? The Worldwide Challenge to Genetic EngineeringLondonZed Books 2001 182
Faulder, CWhose Body Is It? The Troubling Issue of Informed ConsentLondonVirago Press 1985
Feinberg, JThe Moral Limits of the Criminal Law: Harm to Others Volume OneNew York, NYOxford University Press 1984
Feintuck, M.‘Precautionary Maybe, But What's the Principle? The Precautionary Principle, the Regulation of Risk, and the Public Domain’ 2005 32 Journal of Law and Society371
Ferguson, P.R.‘Patients’ Perceptions of Information Provided in Clinical Trials’ 2002 28 Journal of Medical Ethics45
Ferguson, P.R.‘Human “Guinea Pigs”: Why Patients Participate in Clinical Trials’McLean, S.A.M.First Do No Harm – Law, Ethics and HealthcareAldershotAshgate 2006 165
Fidler, D.PInternational Law and Infectious DiseasesOxfordClarendon Press 1999
Fidler, D.P.‘Constitutional Outlines of Public Health's “New World Order”’ 2004 77 Temple Law Review247
Fiebig, U.Stephan, O.Kurth, R.Denner, J.‘Neutralizing Antibodies against Conserved Domains of p15E of Porcine Endogenous Retroviruses: Basis for a Vaccine for Xenotransplantation?’ 2003 307 Virology406
Fischbacher-Smith, D.Calman, K.‘A Precautionary Tale: The Role of the Precautionary Principle in Policy-Making for Public Health’Bennett, P.Calman, K.Curtis, S.Fischbacher-Smith, D.Risk Communication and Public HealthOxford University Press 2010 202
Fisher, ERisk Regulation and Administrative ConstitutionalismOxfordHart 2007
Fisher, E.Harding, R‘The Precautionary Principle: Towards a Deliberative, Transdisciplinary Problem-Solving Process’Harding, R.Fisher, E.Perspectives on the Precautionary PrincipleNew South WalesFederation Press 1999 292
Fishman, J‘Infection and Xenotransplantation: Developing Strategies to Minimize Risk’Fishman, J.Sachs, D.Shaikh, R.Xenotransplantation: Scientific Frontiers and Public PolicyNew York, NYNew York Academy of Sciences 1998 52
Fishman, J.A.‘SARS, Xenotransplantation and Bioterrorism: Preventing the Next Epidemic’ 2003 3 American Journal of Transplantation909
Fishman, J.Sachs, D.Shaikh, R.Xenotransplantation: Scientific Frontiers and Public PolicyNew York, NYNew York Academy of Sciences 1998
Fisk, D.‘Perception of Risk – Is the Public Probably Right?’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 133
Fleck, L.M.‘Can We Trust “Democratic Deliberation”?’ 2007 37 Hastings Center Report22
Fletcher, J.C.‘Moral Problems and Ethical Issues in Prospective Human Gene Therapy’ 1983 69 Virginia Law Review515
Florencio, P.S.Ramanathan, E.D.‘Are Xenotransplantation Safeguards Legally Viable?’ 2001 16 Berkeley Technology Law Journal937
Florencio, P.S.Ramanathan, E.D.‘Legal Enforcement of Xenotransplantation Public Health Safeguards’ 2004 32 Journal of Law, Medicine and Ethics117
Foster, C.The Ethics of Medical Research on HumansCambridge University Press 2001
Fovargue, S.‘Consenting to Bio-Risk: Xenotransplantation and the Law’ 2005 25 Legal Studies404
Fovargue, S.‘“Oh Pick Me, Pick Me”: Selecting Participants for Xenotransplant Clinical Trials’ 2007 15 Medical Law Review176
Fovargue, S.Miola, J.‘One Step Forward, Two Steps Back?: The GMC, the Common Law and “Informed” Consent’ 2010 36 Journal of Medical Ethics494
Fovargue, S.Ost, S.‘When Should Precaution Prevail? Interests in (Public) Health and the Risk of Harm: The Xenotransplantation Example’ 2010 18 Medical Law Review302
Fowler, G.Juengst, E.T.Zimmerman, B.Z.‘Germ-Line Gene Therapy and the Clinical Ethics of Medical Genetics’ 1989 10 Theoretical Medicine151
Fox, M‘Research Bodies: Feminist Perspectives on Clinical Research’Sheldon, S.Thomson, M.Feminist Perspectives on Health Care LawLondonCavendish 1998 115
Fox, M.‘Clinical Research and Patients: The Legal Perspective’Tingle, J.Cribb, A.Nursing Law and EthicsOxfordBlackwell 2002 252
Fox, R.C.Swazey, J.PThe Courage to Fail – A Social View of Organ Transplants and DialysisNew Brunswick, NJTransaction 2002
Frewer, L.J.‘Public Risk Perceptions and Risk Communication’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 20
Frewer, L.Salter, B.‘Public Attitudes, Scientific Advice and the Politics of Regulatory Policy: The Case of BSE’ 2002 29 Science and Public Policy137
Friedmann, T.‘A Brief History of Gene Therapy’ 1992 2 Nature Genetics93
Furger, F.Fukuyama, F.‘A Proposal for Modernizing the Regulation of Human Biotechnologies’ 2007 37 Hastings Center Report16
Garrafa, V.Solbakk, J.H.Vidal, S.Lorenzo, C.‘Between the Needy and the Greedy: The Quest for A Just and Fair Ethics of Clinical Research’ 2010 36 Journal of Medical Ethics500
Gavaghan, CDefending the Genetic Supermarket: The Law and Ethics of Selecting the Next GenerationOxfordRoutledge-Cavendish 2007
GM Science Review PanelGM Science Review: First ReportLondonDTI 2003
GM Science Review PanelGM Science Review: Second ReportLondonDTI 2004
Gene Therapy Advisory Committee (GTAC)Guidance on Making Proposals to Conduct Gene Therapy Research on Human SubjectsLondonDH 1994
Gene Therapy Advisory Committee (GTAC)First Annual Report November 1993–December 1994LondonDH 1995
Gene Therapy Advisory Committee (GTAC)Seventh Annual Report January 2000–December 2000LondonDH 2001
Gene Therapy Advisory Committee (GTAC)Guidance on the Content of a Proposal and Participant Information SheetsLondonDH 2009
General Medical Council (GMC)Consent: Patients and Doctors Making Decisions TogetherLondonGMC 2008
General Medical Council (GMC)ConfidentialityLondonGMC 2009
General Medical Council (GMC)Consent to ResearchLondonGMC 2010
General Medical Council (GMC)Good Practice in ResearchLondonGMC 2010
Giddens, A.‘Risk and Responsibility’ 1999 62 Modern Law Review1
Gjørv, I.L.‘Political Considerations of Controversial Medical Issues: Xenotransplantation and Society. A Presentation of the Work of the Norwegian National Working Group on Xenotransplantation’ 2004 45 Acta Veterinaria ScandinavicaS53
Glanz, K.Yang, H.‘Communicating About Risk of Infectious Diseases’ 1996 275 Journal of the American Medical Association253
Glass, K.C.Lemmens, T‘Conflict of Interest and Commercialization of Biomedical Research: What Is the Role of Research Ethics Review’Caulfield, T.A.Williams-Jones, B.The Commercialization of Genetic Research: Ethical, Legal and Policy IssuesNew York, NYKluwer Academic Press 1999 79
Glover, JEthics of New Reproductive Technologies: The Glover Report to the European Commission – Studies in Biomedical PolicyDeKalb, ILNorthern Illinois Press 1989
Gold, E.R.Adams, W.A.Reconciling Private Benefit and Public Risk in Biotechnology: Xenotransplantation as a Case Study in Consent’ 2002 10 Health Law Journal31
Gostin, L.OPublic Health Law: Power, Duty, RestraintBerkeley, CAUniversity of California Press 2008
Gostin, L.O.Bayer, R.Fairchild, A.L.‘Ethical and Legal Challenges Posed by Severe Acute Respiratory Syndrome: Implications for the Control of Severe Infectious Disease Threats’ 2003 290 Journal of the American Medical Association3229
Green, E.Short, S.D.Duarte-Davidson, R.Levy, L.S.‘Public and Professional Perceptions of Environmental and Health Risks’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 51
Grieβler, E.Littig, B.Hüsing, B.Zimmer, R.Santos, D.Munoz, E.Ponce, G.Gronke, H.Dordoni, PFinal Report – Increasing Public Involvement in Debates on Ethical Questions of XenotransplantationViennaInstitute for Advanced Studies 2004
Griffin, G.Muir, DInfection Risks in XenotransplantationLondonDH 2001
Griffiths, S.Lau, J.‘The Influence of SARS on Perceptions of Risk and Reality’ 2009 31 Journal of Public Health466
Groth, C.G.‘Editorial – Looking Back, Heading Forward’ 2008 15 Xenotransplantation1
Groth, C.G.Korsgren, O.Tibell, A.Tollemar, J.Möller, E.Bolinder, J.Östman, J.Reinholt, F.P.Hellerström, C.Andersson, A.‘Transplantation of Porcine Fetal Pancreas to Diabetic Patients’ 1994 344 The Lancet1402
Gruskin, S.‘Is There a Government in the Cockpit: A Passenger's Perspective or Global Public Health: The Role of Human Rights’ 2004 22 Temple Law Review313
Guest, S.‘Compensation for Subjects of Medical Research: The Moral Rights of Patients and the Power of Research Ethics Committees’ 1997 23 Journal of Medical Ethics181
Gunning, J.English, V.Human In Vitro Fertilisation – A Case Study in the Regulation of Medical InnovationAldershotDartmouth 1993
Guttmacher, S.‘HIV Infection: Individual Rights v. Disease Control’ 1990 17 Journal of Law and Society66
Haller, J.D.Cerruti, M.M.‘Heart Transplantation in Man: Compilation of Cases – January 1 1964 to October 23 1968 1968 22 American Journal of Cardiology840
Halliday, S.‘A Comparative Approach to the Regulation of Human Embryonic Stem Cell Research in Europe’ 2004 12 Medical Law Review40
Halliday, S.Steinberg, D.L.‘The Regulated Gene: New Legal Dilemmas’ 2004 12 Medical Law Review2
Halpern, S.ALesser Harms: The Morality of Risk in Medical ResearchChicago, ILUniversity of Chicago Press 2006
Hanson, M.J. 1995
Hansson, M.O.‘Balancing the Quality of Consent’ 1998 24 Journal of Medical Ethics182
Hansson, S.O.‘Philosophical Perspectives on Risk’ 2004 8 Techné10
Harcourt, B.E.‘The Collapse of the Harm Principle’ 1999 90 Journal of Criminal Law and Criminology109
Hardy, J.D.Chavez, C.M.‘The First Heart Transplant in Man – Developmental Animal Investigations with Analysis of the 1964 Case in the Light of Current Clinical Experience’ 1968 22 American Journal of Cardiology772
Hardy, J.D.Chavez, C.M.Kurrus, F.D.Neely, W.A.Eraslan, S.Turner, M.D.Fabian, L.W.Labecki, T.D.‘Heart Transplantation in Man’ 1964 188 Journal of the American Medical Association1132
Harrington, J.A.‘Deciding Best Interests: Medical Progress, Clinical Judgment and the “Good Family”’ 2003 3 Web Journal of Current Legal Issues
Harris, A.Martin, R.‘The Exercise of Public Health Powers In An Era Of Human Rights: The Particular Problems of Tuberculosis’ 2004 118 Public Health313
Harris, J.‘Research on Human Subjects, Exploitation, and Global Principles of Ethics’Freeman, M.Lewis, A.D.E.Law and Medicine: Current Legal IssuesOxford University Press 2000 379
Hastillo, A.Hess, M.L.‘Heart Xenografting: A Route Not Yet to Trod’ 1993 12 Journal of Heart and Lung Transplantation3
Hattenstone, S 2001
Häyry, M.Takala, T.‘Genetic Information, Rights and Autonomy’ 2001 22 Theoretical Medicine403
Health Canada, TPPReport of the National Forum on Xenotransplantation: Clinical, Ethical, and Regulatory Issues November 6–8, 1997OttawaHealth Canada 1998
Health Canada, TPPProposed Canadian Standard for XenotransplantationOttawaHealth Canada 1999
Health Canada, TPP 1999 www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/xeno_survey-enquete-eng.pdf
Health Canada, TPP 2000 www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/awsreport-rapportvif-eng.pdf
Health Canada, TPP 2001
Health Canada, TPP 2004 www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/anim_tiss-eng.php
Health Canada, TPP 2009 www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/com/eacx-ccerx/index-eng.php
Health Canada, Science and Research 2006 www.hc-sc.gc.ca/sr-sr/biotech/about-apropos/xeno-eng.php
Health Council of the NetherlandsArtificial ProcreationThe HagueHealth Council of the Netherlands 1986
Health Council of the NetherlandsHeredity: Science and Society – On the Possibilities and Limits of Genetic Testing and Gene TherapyThe HagueHealth Council of the Netherlands 1989
Health Council of the Netherlands, Committee on Gene TherapyGene TherapyRijswijkHealth Council of the Netherlands 1997
Health Council of the Netherlands, Committee on Gene TherapyCommittee on XenotransplantationXenotransplantationRijswijkHealth Council of the Netherlands 1998
Health Protection Agency (HPA)The Human Animal Infections and Risk Surveillance (HAIRS) Group, First Report 2004–2007LondonHPA 2008
Health Research Council (HRC) 2002 www.hrc.govt.nz/assets/pdfs/publications/Ethics%20Guidelines%20July%202006.pdf
HRC Gene Technology Advisory Committee 2007 www.hrc.govt.nz/assets/pdfs/publications/Guidelines%20for%20Preparation%20of%20Applications%20Involving%20Clinical%20Trials%20of%20Xenotransplantation%20in%;20NZ.pdf
HRC Gene Technology Advisory Committee 2008 www.hrc.govt.nz/assets/pdfs/publications/GTACProcess%20and%20Guidelines%202008%20_2_.pdf
Herring, J.Medical Law and EthicsOxford University Press 2010
Herring, J.Criminal Law: Text, Cases and MaterialsOxford University Press 2010
Hewlett, S.‘Consent to Clinical Research – Adequately Voluntary or Substantially Influenced?’ 1996 22 Journal of Medical Ethics232
Heyvaert, V.‘Globalizing Regulation: Reaching Beyond the Borders of Chemical Safety’ 2009 36 Journal of Law and Society110
Hilbrands, L.B.Hoitsma, A.J.Koene, R.A.P.‘Medication Compliance After Renal Transplantation’ 1995 60 Transplantation914
Hill, A. 2007
Holder, J.Elworthy, S.‘The BSE Crisis: A Study of the Precautionary Principle and the Politics of Science in Law’Reece, H.Law and Science: Current Legal IssuesOxford University Press 1998 129
Holland, J.A.‘The “Catch-22” of Xenotransplantation: Compelling Compliance with Long-Term Surveillance’ 2007 7 Houston Journal of Health Law and Policy151
House of Commons Science and Technology Committee 2004
House of Commons Science and Technology CommitteeScientific Advice, Risk and Evidence Based Policy MakingLondonStationery Office 2006
House of Lords Select Committee on Science and TechnologyScience and SocietyLondonHouse of Lords 2000
House of Lords Select Committee on Intergovernmental Organisations 2008
HSC 2003
Hughes, J.‘Xenografting: Ethical Issues’ 1998 24 Journal of Medical Ethics18
Hughes, V.‘When Patients March In’ 2010 28 Nature Biotechnology1145
Human Gene Therapy SubcommitteeNIH Recombinant DNA Advisory Committee, ‘Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human Subjects’ 1986 11 Recombinant DNA Research119
Hyder, N. 2011 www.bionews.org.uk
Ibrahim, Z.Ezzelarab, M.Kormos, R.Cooper, D.K.C.‘Which Patients First? Planning the First Clinical Trial of Xenotransplantation: A Case for Cardiac Bridging’ 2005 12 Xenotransplantation168
Incorvati, G.‘Xenotransplantation and Public Responsibility’ 2003 10 European Journal of Health Law295
Institute of Medicine (IOM)Xenotransplantation: Science, Ethics and Public PolicyWashington, DCNational Academy Press 1996
International Advisory Board of the III World Congress on In Vitro Fertilisation and Embryo Transfer‘Helsinki Statement on Human In Vitro Fertilization’ 1985 442 Annals of New York Academy of Sciences571
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 www.ich.org/LOB/media/MEDIA482.pdf
Isasi, R.M.Knoppers, B.M.‘Mind the Gap: Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 Countries’ 2006 13 European Journal of Health Law9
Jackson, E.‘The Donation of Eggs for Research and the Rise of Neopaternalism’Freeman, M.Law and Bioethics: Current Legal Issues 2008Oxford University Press 2008 286
Jackson, E.Medical Law: Text, Cases and MaterialsOxford University Press 2010
Jackson, R.Barbagallo, F.Haste, H.‘Strengths of Public Dialogue on Science-Related Issues’ 2005 8 Critical Review of International Social and Political Philosophy349
Jacobs, L.A.‘Rights and Quarantine During the SARS Global Health Crisis: Differentiated Legal Consciousness in Hong Kong, Shanghai, and Toronto’ 2007 41 Law and Society Review511
Jamieson, D.‘The Precautionary Principle and Electric and Magnetic Fields’ 2001 91 American Journal of Public Health1355
Jasanoff, S.‘Civilization and Madness: The Great BSE Scare of 1996’ 1997 6 Public Understanding of Science221
Jayaraman, K.S.‘Pig Heart Transplant Surgeon Held in Jail’ 1997 385 Nature378
Johnson, L‘Particular Issues of Public Health: Infectious Disease’Martin, R.Johnson, L.Law and the Public Dimension of HealthLondonCavendish 2001 243
Johnson, M.H.‘The Art of Regulation and the Regulation of ART: The Impact of Regulation on Research and Clinical Practice’ 2002 9 Journal of Law and Medicine399
Johnson, M.H.‘Regulating the Science and Therapeutic Application of Human Embryo Research: Managing the Tension Between Biomedical Creativity and Public Concern’Spence, J.R.du Bois-Pedain, A.Freedom and Responsibility in Reproductive ChoiceOxfordHart 2006 91
Jones, K.E.Patel, N.G.Levy, M.A.Storeygard, A.Balk, D.Gittleman, J.L.Daszak, P.‘Global Trends in Emerging Infectious Diseases’ 2008 451 Nature990
Jones, MMedical NegligenceLondonSweet & Maxwell 2008
Jones, M.A.‘Informed Consent and other Fairy Stories’ 1999 7 Medical Law Review103
Kass, LToward a More Natural Science – Biology and Human AffairsNew York, NYFree Press 1985
Kass, N.E.Sugarman, J.Faden, R.Schoh-Spana, M.‘Trust – The Fragile Foundation of Contemporary Biomedical Research’ 1996 26 Hastings Center Report25
Katz, J.‘Human Experimentation and Human Rights’ 1993 38 Saint Louis University Law Journal7
Keeney, R.L.von Winterfeldt, D.‘Appraising the Precautionary Principle – A Decision Analysis Perspective’ 2001 4 Journal of Risk Research191
Kennedy, I.Treat Me Right – Essays in Medical Law and EthicsOxford University Press 1988
Kennedy, I.Grubb, AMedical LawLondonButterworths 2000
Kent, G.‘Shared Understandings for Informed Consent: The Relevance of Psychological Research on the Provision of Information’ 1996 43 Social Science and Medicine1517
King, N.‘Experimental Treatment: Oxymoron or Aspiration?’ 1995 25 Hastings Center Report6
King, N.‘Defining and Describing Benefit Appropriately in Clinical Trials’ 2000 28 Journal of Law, Medicine and Ethics332
Knoppers, B.M.‘Reflections: The Challenge of Biotechnology and Public Policy’ 2000 45 McGill Law Journal559
Kong, W.M.‘The Regulation of Gene Therapy Research in Competent Adult Patients, Today and Tomorrow: Implications of EU Directive 2001/20/EC’ 2004 12 Medical Law Review164
Kong, W.M.‘Legitimate Requests and Indecent Proposals: Matters of Justice in the Ethical Assessment of Phase I Trials Involving Competent Patients’ 2005 31 Journal of Medical Ethics205
Kriebel, D.Tickner, J.‘Reenergizing Public Health Through Precaution’ 2001 91 American Journal of Public Health1351
Kumar, P.D.‘Xenotransplantation in the New Millennium: Moratorium or Cautious Experimentation?’ 2000 4 Perspectives in Biology and Medicine562
Laing, J.‘Incompetent Patients, Experimental Treatment and the “ Test” – v. ; v. ’ 2003 11 Medical Law Review237
Langford, I.H.Marris, C.O'Riordan, T.‘Public Reactions to Risk: Social Structures, Images of Science, and The Role of Trust’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 33
Langley, G.D'silva, J. 1998 www.ciwf.org.uk/includes/documents/cm_docs/2008/a/animal_organs_in_humans_1998.pdf
Law CommissionConsent in the Criminal Law Consultation PaperLondonHMSO 1995
Law Reform Commission of CanadaBiomedical Experimentation Involving Human Subjects, Working PaperOttawaLaw Reform Commission of Canada 1989
Le, Bas-BernardetBlancho, S., G.‘Current Cellular Immunological Hurdles in Pig-to Primate Xenotransplantation’ 2009 21 Transplant Immunology60
Le Tissier, P.Stoye, J.P.Takeuchi, Y.Patience, C.Weiss, R.A.‘Two Sets of Human-Tropic Pig Retrovirus’ 1997 389 Nature681
Lee, R.G.Morgan, DHuman Fertilisation and Embryology – Regulating the Reproductive RevolutionOxfordBlackstone 2001
Lenoir, N.‘Biotechnology, Bioethics and Law: Europe's 21st Century Challenge’ 2006 69 Modern Law Review1
Levine, R.J.‘The Impact of HIV Infection on Society's Perception of Clinical Trials’ 1994 4 Kennedy Institute of Ethics Journal93
Levy, G.A.Ghanekar, A.Mendicino, M.Phillips, M.J.Grant, D.R.‘The Present Status of Xenotransplantation’ 2001 33 Transplantation Proceedings3050
Little, G.‘BSE and the Regulation of Risk’ 2001 64 Modern Law Review730
Lloyd, A.J.‘The Extent of Patients’ Understanding of the Risk of Treatments’ 2001 10 Quality in Health Carei14
Louz, D.Bergmans, H.E.Loos, B.P.Hoeben, R.C.‘Reappraisal of Biosafety Risks Posed by PERVs in Xenotransplantation’ 2008 18 Reviews in Medical Virology53
Lupton, D.‘Risk as Moral Danger: The Social and Political Functions of Risk Discourse in Public Health’ 1993 23 International Journal of Health Services425
Macintosh, K.LIllegal Beings: Human Clones and the LawNew York, NYCambridge University Press 2005
Mackenzie, C.Stoljar, N.Relational Autonomy: Feminist Perspectives on Autonomy, Agency and the Social SelfNew York, NYOxford University Press 2000
Maclean, A.‘Giving the Reasonable Patient a Voice: Information Disclosure and the Relevance of Empirical Evidence’ 2005 7 Medical Law International1
Malhotra, P.Malu, S.Kanpur, S. 2009 http://emedicine.medscape.com/article/432209-overview
Manson, N.O'Neill, O.Rethinking Informed Consent in BioethicsCambridge University Press 2007
Marchant, G.E.Sylvester, D.J.Abbott, K.W.‘What Does the History of Technology Teach Us About Nano Oversight?’ 2009 37 Journal of Law, Medicine and Ethics724
Marteau, T.Drake, H.Bobrow, M.‘Counselling Following Diagnosis of a Fetal Abnormality: The Differing Approaches of Obstetricians, Clinical Geneticists, and Genetic Nurses’ 1994 31 Journal of Medical Genetics864
Martin, R.‘The Exercise of Public Health Powers in Cases of Infectious Disease: Human Rights Implications: v. European Court of Human Rights: [2005] ECHR 56529/00’ 2006 14 Medical Law Review132
Martin, R.‘The Role of Law in Public Health’Dawson, A.The Philosophy of Public HealthSurreyAshgate 2009 11
Mason, J.K‘Organ Donation and Transplantation’Dyer, C.Doctors, Patients and the LawOxfordBlackwell 1992 120
Mason, J.K.Laurie, G.T.Mason & McCall Smith's Law and Medical EthicsOxford University Press 2011
Mattiuzzo, G.Scobie, L.Takeuchi, Y.‘Strategies to Enhance the Safety Profile of Xenotransplantation: Minimizing the Risk of Viral Zoonoses’ 2008 13 Current Opinion in Organ Transplantation184
Maxwell, R.J.‘The British Government's Handling of Risk: Some Reflections on the BSE/CJD Crisis’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 95
McGregor, C.G.A.Byrne, G.W.Vlasin, M.Walkjer, R.C.Tazelaar, H.D.Davies, W.R.Chandrasekaran, K.Oehler, E.A.Boilson, B.A.Wiseman, B.S.Logan, J.S.‘Preclinical Orthotopic Cardiac Xenotransplantation’ 2009 28 XenotransplantationS224
McKee, M.Coker, R.‘Trust, Terrorism and Public Health’ 2009 31 Journal of Public Health462
McKendrick, EContract LawBasingstokePalgrave MacMillan 2009
McKendrick, E.Contract Law – Text, Cases and MaterialsOxford University Press 2010
McLean, S.‘Gene Therapy – Cure or Challenge?’Freeman, M.Lewis, A.Law and Medicine: Current Legal IssuesOxford University Press 2000 205
McLean, S.Williamson, L.‘The Demise of UKXIRA and the Regulation of Solid-Organ Xenotransplantation in the UK’ 2007 33 Journal of Medical Ethics373
McLean, S.Williamson, L.‘Xenotransplantation: A Pig in a Poke?’ 2004 57 Current Legal Problems443
McLean, S.Williamson, L.Xenotransplantation: Law and EthicsAldershotAshgate 2005
Medical Research Council (MRC)‘Statement on Research Related to Human Fertilization and Embryology’ 1982 285 British Medical Journal1480
Medical Research Council (MRC)MRC Guidelines for Good Clinical Practice in Clinical TrialsLondonMRC 1998
Medical Research Council of CanadaGuidelines for Research on Somatic Cell Gene Therapy in HumansOttawaMinister of Supply and Services 1990
Medical Research Modernization Committee 1997 www.crt-online.org/mrmc.html
Medicines and Healthcare products Regulatory Agency (MHRA)A Guide to What Is a Medicinal ProductLondonMHRA 2007
Michael, M.Brown, N.‘The Meat of the Matter: Grasping and Judging Xenotransplantation’ 2004 13 Public Understanding of Science379
Michael, M.Brown, N.‘Scientific Citizenships: Self-Representations of Xenotransplantation's Public’ 2005 14 Science as Culture39
Michelson, E.S‘Individual Freedom or Collective Welfare? An Analysis of Quarantine as a Response To Global Infectious Disease’Selgelid, M.J.Battin, M.P.Smith, C.B.Ethics and Infectious DiseasesOxfordWiley-Blackwell 2006 53
Michie, C.‘Xenotransplantation: Endogenous Pig Retroviruses and the Precautionary Principle’ 2001 7 Trends in Molecular Medicine62
Mill, J.S.On Liberty and Other EssaysOxford University Press 2008
Millard, A.-L.Mueller, N.J.‘Critical Issues Related to Porcine Xenograft Exposure to Human Viruses: Lessons from Allotransplantation’ 2010 15 Current Opinion in Organ Transplantation230
Miller, D.Macintyre, S.‘Risk Communication: The Relationships between the Media, Public Beliefs, and Policy-Making’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 229
Miola, J.‘On the Materiality of Risk – Paper Tigers and Panaceas’ 2009 17 Medical Law Review76
Ministry for Agriculture, Food and Fisheries (MAFF), Department of Health (DH)Report of the Working Party on Bovine Spongiform EncephalopathyLondonMAFF/DH 1989
Ministry for Agriculture, Food and Fisheries (MAFF), Department of Health (DH)Consultative Committee on Research into Spongiform Encephalopathies, Interim ReportLondonMAFF 1990
Ministry of Health (MH)Operational Standard for Ethics CommitteesWellingtonMH 2006
Ministry of Health, Labour and Welfare (MHLW)Guidelines on Issues of Infectious Diseases in Public Health Associated with Clinical Trials of XenotransplantationTokyoMHLW 2001
Ministry of Health and Social AffairsSwedish Act Concerning the Use of Gene Technology on Human Beings and Experiments with Fertilised OvaStockholmThe Ministry 1991
Mohiuddin, M.M.‘Clinical Transplantation of Organs: Why Aren't We There Yet?’ 2007 75 PLoS Medicine0429
Montgomery, J.Health Care LawOxford University Press 2002
Montgomery, J.‘Medicalising Crime? Criminalising Health?’Erin, C.Ost, S.The Criminal Justice System and Health CareOxford University Press 2007 257
Moran, C. 2008
Moran, N.‘Pig-to-Human Heart Transplant Slated to Begin in 1996’ 1995 1 Nature Medicine987
Morgan, DIssues in Medical Law and EthicsLondonCavendish 2001
Moses, L.B.‘Recurring Dilemmas: The Law's Race to Keep up with Technological Change’ 2007 2 Journal of Law, Technology and Policy239
Muir, D.A.Griffin, GInfection Risks in XenotransplantationLondonDH 2001
Mullen, C.Hughes, D.Vincent-Jones, P.‘The Democratic Potential of Public Participation: Healthcare Governance in England’ 2011 20 Social and Legal Studies21
Murphy-Lawless, J.‘The Impact of BSE and FMD on Ethics and Democratic Process’ 2004 17 Journal of Agricultural and Environmental Ethics385
National Bioethics Committee 1991 www.palazzochigi.it/bioetica/eng/opinions.html
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1975 http://bioethics.georgetown.edu/pcbe/reports/past_commissions/research_fetus.pdf
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979 http://ohsr.od.nih.gov/guidelines/belmont.html
National Council of ChurchesPanel on Bioethical ConcernsGenetic Engineering: Social and Ethical ConsequencesNew York, NYPilgrim Press 1984
National Expert Panel on New and Emerging Infections (NEPNEI)First Annual Report (November 2003–December 2004)LondonNEPNEI 2006
National Expert Panel on New and Emerging Infections (NEPNEI)Combined Report 2006–2007LondonDH 2008
National Expert Panel on New and Emerging Infections (NEPNEI) 2008 www.nhc.health.govt.nz/moh.nsf/pagescm/7547/$File/nhc-living-cell-technologies-report-oct082.pdf
National Health and Medical Research Council (NHMRC)‘Ethics in Medical Research’Report of the NHMRC Working Party on Ethics in Medical ResearchCanberraAustralian Government Publishing Service 1982
National Health and Medical Research Council (NHMRC)Ethics in Medical Research Involving the Human Fetus and Human Fetal TissueCanberraAustralian Government Publishing Service 1983
National Health and Medical Research Council (NHMRC)Ethical Aspects of Research on Human Gene Therapy: Report to the NHMRC by the Medical Ethics Committee of NHMRCCanberraAustralian Government Publishing Service 1987
National Health and Medical Research Council (NHMRC)Human Gene Therapy and Related Procedures: An Information Paper to Assist in the Consideration of Ethical Aspects of Human Gene TherapyCanberraAustralian Government Publishing Service 1995
National Health and Medical Research Council (NHMRC)Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related TherapiesCanberraNHMRC 1999
National Health and Medical Research Council (NHMRC) 2009 www.nhmrc.gov.au/_files_nhmrc/file/about/committeess/expert/gtrap/nhmrc_xeno_discussion_paper_website.pdf
National Health and Medical Research Council (NHMRC) 2002 www.nhmrc.gov.au/_files_nhmrc/file/about/committeess/expert/gtrap/xeno.pdf
National Health and Medical Research Council (NHMRC) 2009 www.nhmrc.gov.au/media/noticeboard/notice09/091210-xenotransplantation.htm
National Health and Medical Research Council (NHMRC) 2010 www.nhmrc.gov.au/health_ethics/health/xeno.htm
National Health and Medical Research Council (NHMRC) 2010 www.nhmrc.gov.au/health_ethics/health/xeno.htm
National Health and Medical Research Council (NHMRC)Australian Research Council, Australian Vice-Chancellor's CommitteeNational Statement on Ethical Conduct in Human ResearchCanberraAustralian Government 2007
National Health and Medical Research Council (NHMRC)www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e55.pdf
National Health and Medical Research Council (NHMRC) 2003 www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e54.pdf
National Health and Medical Research Council (NHMRC)Animal-to-Human Transplantation (Xenotransplantation): Final Report and Advice to the National Health and Medical Research CouncilCanberraNHMRC 2004
National Health and Medical Research Council (NHMRC)Guidelines for Clinical Animal-to-Human Transplantation (Xenotransplantation) Research DRAFT for NHMRC ConsiderationCanberraNHMRC 2004
NHS Blood and Transplant 2010 www.uktransplant.org.uk/ukt/statistics/transplant_activity_report/transplant_activity_report.jsp
National Institute for Health and Clinical Excellence (NICE)www.nice.org.uk/aboutnice/whatwedo/about_interventional_procedures/about_interventional_procedures.jsp
NICEConsent – Procedures for which the Benefits and Risks are UncertainLondonNICE 2003
NICE 2004 www.nice.org.uk/media/8BD/2B/Legal_context_nice_guidance.pdf
National Research Ethics Service (NRES)Information Sheets & Consent Forms: Guidance for Researchers and ReviewersLondonNRES 2009
Nelson, R.M.Merz, J.F.‘Voluntariness of Consent for Research: An Empirical and Conceptual Review’ 2002 40 Medical CareV
Nichols, E.KHuman Gene TherapyCambridgeHarvard University Press 1988
Nowak, R.‘Xenotransplants Set to Resume’ 1994 266 Science1148
Nuffield Council on BioethicsAnimal-to-Human Transplants – The Ethics of XenotransplantationLondonNuffield Council on Bioethics 1996
Nuffield Council on BioethicsGenetically Modified Crops: The Ethical and Social IssuesLondonNuffield Council on Bioethics 1999
Nuffield Council on BioethicsPublic Health: Ethical IssuesLondonNuffield Council on Bioethics 2007
O'Brien, M.‘Have Lessons Been Learned from the UK Bovine Spongiform Encephalopathy (BSE) Epidemic?’ 2000 29 International Journal of Epidemiology730
O'Neill, O.Autonomy and Trust in BioethicsCambridge University Press 2002
O'Riordan, T.Jordan, A.‘The Precautionary Principle in Contemporary Environmental Politics’ 1995 4 Environmental Values191
Obasogie, O. 2010 www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4034&blogid=140
Office of Science and Technology‘Proposal for a Coordinated Framework for Regulation of Biotechnology’ 1984 49 Federal Register50856
Oliver, I.Lewis, D.‘Public Trust is Necessary to Protect the Population from Threats to Public Health’ 2009 31 Journal of Public Health468
Ontario Law Reform CommissionReport on Human Artificial Reproduction and Related MattersOntarioMinistry of the Attorney-General 1985
Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission 1994 http://ec.europa.eu/european_group_ethics/docs/opinion4_en.pdf
Organisation for Economic Co-operation and Development (OECD)www.oecd.org/document/29/0,3343,en_2649_34537_1887773_1_1_1_1,00.html
Organisation for Economic Co-operation and Development (OECD)www.oecd.org/document/62/0,3343,en_2649_34537_1887806_1_1_1_1,00.html
Organisation for Economic Co-operation and Development (OECD)www.oecd.org/document/36/0,3343,en_2649_34537_2352420_1_1_1_1,00.html
Organisation for Economic Co-operation and Development (OECD)Working PapersAdvances in Transplantation Biotechnology and Animal to Human Organ Transplants (Xenotransplantation) Safety, Economic and Ethical AspectsParisOECD 1996
Organisation for Economic Co-operation and Development (OECD)Xenotransplantation: International Policy IssuesParisOECD 1999
Organisation for Economic Co-operation and Development (OECD) 2001
Orme, N.M.Fletcher, J.G.Siddiki, H.A.Scott Harmsen, W.O'Byrne, M.M.Port, J.D.Tremaine, W.J.Pitot, H.C.McFarland, E.G.Robinson, M.E.Koenig, B.A.King, B.F.Wolf, S.M.‘Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden’ 2010 170 Archives of Internal Medicine1525
Ormerod, D.C.Gunn, M.J.‘Criminal Liability for the Transmission of HIV’ 1996 1 Web Journal of Current Legal Issues
Paradis, K.Langford, G.Long, Z.Heneine, W.Sandstrom, P.Switzer, W.M.Chapman, L.E.Lockey, C.Onions, D.the XEN 111 Study GroupOtto, E.‘Search for Cross Species Transmission of Porcine Endogenous Retrovirus in Patients Treated with Living Pig Tissue’ 1999 285 Science1236
Parliamentary Assembly, Council of Europe 2010
Patience, C.Scobie, L.Quinn, G.‘Porcine Endogenous Retrovirus – Advances, Issues and Solutions’ 2002 9 Xenotransplantation373
Patience, C.Takeuchi, Y.Weiss, R.A.‘Infection of Human Cells by Endogenous Retrovirus of Pigs’ 1997 3 Nature Medicine282
Pattinson, S.Medical Law and EthicsLondonSweet & Maxwell 2009
Pennisi, E.‘FDA Panel OKs Baboon Marrow Transplant’ 1995 269 Science293
Perico, N.Benigni, A.Remuzzi, G.‘Xenotransplantation in the 21st Century’ 2002 20 Blood Purification45
Persak, N.Criminalising Harmful Conduct: The Harm Principle, Its Limits and Continental CounterpartsNew York, NYSpringer-Verlag 2007
Persson, A.‘Research Ethics and the Development of Medical Biotechnology’ 2006 13 Xenotransplantation511
Peters, P.G.How Safe is Safe Enough? Obligations to the Children of Reproductive TechnologyNew York, NYOxford University Press 2004
Lord, Phillips‘Lessons from the BSE inquiry’ 2001 17 FST Journal3
Lord, PhillipsBridgeman, J.Ferguson-Smith, M.The BSE Inquiry: Report: Evidence and Supporting Papers of the Inquiry into the Emergence and Identification of Bovine Spongiform Encephalopathy (BSE) and variant Creutzfeldt–Jakob Disease (CJD) and the Action Taken in Response to it up to 20 March 1996LondonStationery Office 2000
Picciotto, S.‘Introduction: Reconceptualizing Regulation in the Era of Globalization’ 2002 29 Journal of Law and Society1
Pidgeon, N.Henwood, K.Maguire, B.‘Public Health Communication and The Social Amplification of Risks: Present Knowledge and Future Prospects’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 65
Pidgeon, N.Kasperson, R.Slovic, P.The Social Amplification of RiskCambridge University Press 2003
Pierson, R.N.Dorling, A.Rees, M.A.Seebach, J.D.Fishman, J.A.Hering, B.H.Cooper, D.K.C.‘Current Status of Xenotransplantation and Prospects for Clinical Application’ 2009 16 Xenotransplantation263
Pierson, R.N.White, D.J.G.Wallwork, J.‘Ethical Considerations in Clinical Cardiac Xenografting – Letter’ 1993 12 Journal of Heart and Lung Transplantation876
Plomer, A.‘Beyond the HFE Act? The Regulation of Stem Cell Research in the UK’ 2002 10 Medical Law Review132
Pontifical Academy for Life 2001 www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20010926_xenotrapianti_en.html
Powell, D.Leiss, WMad Cows and Mother's Milk: The Perils of Poor Risk CommunicationQuebecMcGill-Queen's University Press 1997
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral ResearchMaking Health Care Decisions: The Ethical and Legal Implications of Informed Consent in the Patient–Practitioner Relationship, Volume One: ReportWashington, DCPresident's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 1982
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural ResearchSplicing Life: The Social and Ethical Issues of Genetic Engineering with Human BeingsWashington, DCPresident's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 1982
Price, D.Legal and Ethical Aspects of Organ TransplantationCambridge University Press 2000
Price, D.‘Remodelling the Regulation of Postmodern Innovation in Medicine’ 2005 1 International Journal of Law in Context121
Rainsbury, J.M.‘Biotechnology on the RAC – FDA/NIH Regulation of Human Gene Therapy’ 2000 55 Food and Drug Law Journal575
Ramsoondar, J.Vaught, T.Ball, S.Mendicio, M.Monahan, J.Jobst, P.Vance, A.Duncan, J.Wells, K.Ayares, D.‘Production of Transgenic Pigs that Express Porcine Endogenous Retrovirus Small Interfering RNAs’ 2009 16 Xenotransplantation164
Ravelingien, A.‘Xenotransplantation and the Harm Principle: Factoring Out Foreseen Risk’ 2007 16 Journal of Evolution and Technology127
Ravelingien, A.Mortier, F.Kerremans, I.Braeckman, J.‘Proceeding with Clinical Trials of Animal to Human Organ Transplantation: A Way out of the Dilemma’ 2004 30 Journal of Medical Ethics92
Reemtsma, K.McCracken, B.H.Schlegel, J.U.Pearl, M.A.Pearce, C.W.DeWitt, C.W.Smith, P.E.Hewitt, R.L.Flinner, R.L.Creech, O.‘Renal Heterotransplantation in Man’ 1964 160 Annals of Surgery384
1984
Resnik, D.B.‘Is the Precautionary Principle Unscientific?’ 2003 34 Studies in History and Philosophy of Biological and Biomedical Sciences329
Richards, E.P.Rathbun, K.C.‘The Role of the Police Power in 21st Century Public Health’ 1999 26 Sexually Transmitted Disease350
Roberts, L.‘Human Gene Therapy Test’ 1988 241 Science419
Roberts, L. 1996
Rothstein, M.A.‘Are Traditional Public Health Strategies Consistent With Contemporary American Values?’ 2004 77 Temple Law Review175
Royal College of Obstetricians and Gynaecologists (RCOG)Report of the RCOG Ethics Committee On In Vitro Fertilization and Embryo Replacement or TransferLondonRCOG 1983
Royal College of Physicians (RCP)Guidelines on the Practice of Ethics Committees in Medical Research with Human ParticipantsLondonRCP 2007
Royal Commission 2002 www.mfe.govt.nz/publications/organisms/royal-commission-gm/
Royal Commission on New Reproductive TechnologiesProceed with Care: Final Report of the Royal Commission on New Reproductive TechnologiesOttawaMinistry of Supply and Services 1993
2001
Rule, S 1990
Sandin, P.Peterson, M.Hansson, S.O.Rudén, C.Juthe, A.‘Five Charges Against the Precautionary Principle’ 2002 5 Journal of Risk Research287
Schumacher, F.Small is BeautifulLondonVintage 1973
Science and Technology Policy Research Unit, Environment and Science Research Unit, Policy Studies Institute 2004 www.deliberative-mapping.org/papers/f-briefing-5.pdf
Scobie, L.Takeuchi, Y.‘Porcine Endogenous Retrovirus and Other Viruses in Xenotransplantation’ 2009 14 Current Opinion in Organ Transplantation175
Scott, S.Freeman, R.‘Prevention as a Problem of Modernity: The Example of HIV and AIDS’Gabe, J.Medicine, Health and Risk: Sociological ApproachesOxfordBlackwell 1995 151
Sgroi, A.Bühler, L.H.Morel, P.Sykes, M.Noel, L.‘International Human Xenotransplantation Inventory’ 2010 90 Transplantation597
Sharkey, K.Savulescu, J.Aranda, S.Schofield, P.‘Clinician Gate-Keeping in Clinical Research Is Not Ethically Defensible: An Analysis’ 2010 36 Journal of Medical Ethics363
Sherr, L.‘Counselling and HIV Testing: Ethical Dilemmas’Bennett, R.Erin, C.A.HIV and AIDS; Testing, Screening and ConfidentialityOxford University Press 1999 39
Shimizu, A.Hisashi, Y.Kuwaki, K.Tseng, Y.-L.Dor, F.J.M.F.Houser, S.L.Robson, S.C.Schuurman, H.-J.Cooper, D.K.C.Sachs, D.H.Yamada, K.Colvin, R.B.‘Thrombotic Microangiopathy Associated with Humoral Rejection of Cardiac Xenografts from Alpha 1,3-Galactosyltransferase Gene-Knockout Pigs in Baboons’ 2008 172 American Journal of Pathology1471
Shimm, D.S.Spece, R.G.‘An Introduction to Conflicts of Interest in Clinical Research’Spece, R.G.Shimm, D.S.Buchanan, A.E.Conflicts of Interest in Clinical Practice and ResearchOxford University Press 1996 361
Siegrist, M.‘The Influence of Trust and Perceptions of Risks and Benefits on the Acceptance of Gene Technology’ 2000 20 Risk Analysis195
Slovic, P.‘Perception of Risk’ 1987 236 Science280
Smith, C.B.Battin, M.P.Jacobsen, J.A.Francis, L.P.Botkin, J.R.Aslund, E.P.Domek, G.J.Hawkins, B.‘Are There Characteristics of Infectious Diseases that Raise Special Ethical Issues?’ 2004 4 Developing World Bioethics1
Smith, J.A.Michie, S.Allanson, A.Elwy, R.‘Certainty and Uncertainty in Genetic Counselling: A Qualitative Case Study’ 2000 15 Psychology and Health1
Smith, K.J.M.‘Sexual Etiquette, Public Interest and the Criminal Law’ 1991 42 Northern Ireland Legal Quarterly309
Smith, R.‘All Changed, Changed Utterly’ 1998 316 British Medical Journal1917
Smith, S.L.‘Xenotransplantation Action Plan: US Food and Drug Administration Approach to the Regulation of Xenotransplantation’ 2000 1 Medscape Transplantation
Snowdon, C.Elbourne, D.Garcia, J.‘Declining Enrolment in a Clinical Trial and Injurious Misconceptions: Is there a Flipside to the Therapeutic Misconception?’ 2007 2 Clinical Ethics193
Snyder, L.Leffler, C.‘Position Paper – Ethics Manual Fifth Edition’ 2005 142 Annals of Internal Medicine560
Sola, C.de.‘Current Developments on Xenotransplantation in the Council of Europe’Fishman, J.Sachs, D.Shaikh, R.Xenotransplantation: Scientific Frontiers and Public PolicyNew York, NYNew York Academy of Sciences 1998 211
Sommerville, M.A.‘Searching for Ethics in a Secular Society’Ethics of Science and Technology, Explorations of the Frontiers of Science and EthicsParisUNESCO 2006
Somsen, H.‘Cloning Trojan Horses: Precautionary Regulation of Reproductive Technologies’Brownsword, R.Yeung, K.Regulating Technologies: Legal Futures, Regulatory Frames and Technological FixesOxfordHart 2008 221
Soule, E.‘Assessing the Precautionary Principle’ 2000 14 Public Affairs Quarterly309
Specke, V.Rubant, S.Denner, J.‘Productive Infection of Human Primary Cells and Cell Lines with Porcine Endogenous Retroviruses’ 2001 285 Virology177
Spillman, M.A.Sade, R.M.‘Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required’ 2007 35 Journal of Law, Medicine and Ethics265
Standing Committee of European Doctors 1985 http://cpme.dyndns.org:591/adopted/cp%201985_93.pdf
Starzl, T.E.Fung, J.Tzakis, A.Todo, S.Demetris, A.J.Marino, I.R.Doyle, H.Zeevi, A.Warty, V.Michaels, M.Kusne, S.Rudert, W.A.Trucco, M.‘Baboon-to-Human Liver Transplantation’ 1993 341 The Lancet65
Statement of Position of the SAMS (Swiss Academy of Medical Sciences)‘Medical–Ethical Principles of Xenotransplantation’ 2001 131 Swiss Medical Weekly388
Steele, K.‘The Precautionary Principle: A New Approach to Public Decision-Making’ 2006 5 Law, Probability and Risk19
Steering Committee on Bioethics (CDBI), European Health Committee (CDSP)Explanatory Report to Recommendation Rec(2003)10 of the Committee of Ministers to member states on xenotransplantationCDBI/INF 2003
Stirling, A.On Science and Precaution in the Management of Technological Risk, Volume I A Synthesis of Case StudiesSevilleEuropean Commission Institute for Prospective Technological Studies 1999
Strategy UnitField Work: Weighing Up the Costs and Benefits of GM CropsLondonCabinet Office 2003
Strategy Unit, Cabinet OfficeRisk: Improving Government's Capability to Handle Risk and Uncertainty: Full Report – A Source DocumentLondonCabinet Office 2002
Sunstein, C.R.Laws of Fear: Beyond the Precautionary PrincipleCambridge University Press 2005
Swedish Committee on XenotransplantationFrom One Species to Another – Transplantation from Animals to Humans: Summary and Statutory ProposalsStockholmSwedish Committee on Xenotransplantation 1999
Swiss Science Council 1998 www.ta-swiss.ch/incms_files/filebrowser/1998_TA30A_KF_xenotransplantation_e.pdf
Sykes, M.‘2007 IXA Presidential Address: Progress Toward an Ideal Source Animal: Opportunities and Challenges in a Changing World’ 2008 15 Xenotransplantation7
Sykes, M.d'Apice, A.Sandrin, M.‘Position Paper of the Ethics Committee of the International Xenotransplantation Association’ 2003 10 Xenotransplantation194
Sykes, M.Sandrin, M.Cozzi, E.‘International Cooperation on Xenotransplantation’ 2004 10 Nature Medicine119
Tallacchini, M.‘Community and Public Participation in the Risk Assessment of Experimental Clinical Trials’ 2007 14 Xenotransplantation356
Taylor, I.E.‘Political Risk Culture: Not Just A Communication Failure’Bennett, P.Calman, K.Risk Communication and Public HealthOxford University Press 2001 152
ten Have, H‘UNESCO and Ethics of Science and Technology’ in Ethics of Science and Technology, Explorations of the Frontiers of Science and EthicsParisUNESCO 2006
Templeton, S.-K 2008
Thornton, H.‘Clinical Trials – A Brave New Partnership?’ 1994 20 Journal of Medical Ethics19
Toi te, TaiaoBioethics CouncilThe Cultural, Spiritual and Ethical Aspects of Xenotransplantation: Animal-to-Human Transplantation – Final ReportWellingtonNew Zealand 2005
Toi te, TaiaoBioethics CouncilThe Cultural, Spiritual and Ethical Aspects of Xenotransplantation: Animal-to-Human Transplantation – A Discussion DocumentWellingtonNew Zealand 2005
Tomlinson, T.‘The Physician's Influence on Patients’ Choices’ 1986 7 Theoretical Medicine and Bioethics105
Townsend, M 2003
Transplantation Society of Australia and New Zealand 1998
Trent, R.J.A.‘Oversight and Monitoring of Clinical Research with Gene Therapy in Australia’ 2005 182 Medical Journal of Australia441
Ullman, E.‘Tissue and Organ Transplantation’ 1914 60 Annals of Surgery195
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Guidance on Making Proposals to Conduct Xenotransplantation on Human SubjectsLondonDH 1998
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Draft Guidance Notes on Biosecurity Considerations in Relation to XenotransplantationLondonDH 1999
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Draft Report of the Infection Surveillance Steering Group of the UKXIRALondonDH 1999
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Second Annual Report September 1998-August 1999LondonDH 2000
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Third Annual Report September 1999-November 2000LondonDH 2001
United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA)Fifth Annual Report January 2002-September 2003LondonDH 2004
UNAIDSCriminal Law, Public Health and HIV Transmission: A Policy Options PaperGenevaUNAIDS 2002
United Nations Educational, Scientific and Cultural Organization (UNESCO) 1998 www.eubios.info/UNESCO/ibc1994.pdf
UNESCO, World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) 2005 http://unesdoc.unesco.org/images/0013/001395/139578e.pdf
US Congress, Office of Technology Assessment (OTA)Human Gene Therapy – A Background PaperWashington, DCOTA 1984
US Congress, Office of Technology Assessment (OTA)New Developments in Biotechnology, Volume 2: Background Paper: Public Perceptions of BiotechnologyWashington, DCOTA 1987
US Department of Health, Education and Welfare (DHEW)‘Protection of Human Subjects, Policies and Procedures’ 1973 38 Federal Register31738
US Department of Health, Education and Welfare (DHEW)‘Protection of Human Subjects: Fetuses, Pregnant Women and In Vitro Fertilization’ 1975 40 Federal Register33526
US Department of Health, Education and Welfare (DHEW)NIH, ‘Recombinant DNA Research: Guidelines’ 1976 41 Federal Register27902
US DHHS, Public Health Service‘Draft Public Health Service (PHS) Guideline on Infectious Disease Issues in Xenotransplantation’ 1996 61 Federal Register49920
US DHHS, Public Health Service 1999 www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/ucm092866.pdf
US DHHS, Public Health Service 2000 http://archive.hhs.gov/news/press/2000pres/20000307A.html
US DHHS, Food and Drug Administration (FDA)‘Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products’ 1993 58 Federal Register53248
US DHHS, Food and Drug Administration (FDA) 2001 www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/UCM092858.pdf
US DHHS, Food and Drug Administration (FDA)Center for Biologics Evaluation and Research (CBER) 1998 www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm081670.pdf
US DHHS, Food and Drug Administration (FDA)Center for Biologics Evaluation and Research (CBER) 2002 www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080375.pdf
US DHHS, Food and Drug Administration (FDA)Center for Biologics Evaluation and Research (CBER) 2003 www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/ucm092707.pdf
US DHHS, National Institutes of Health (NIH)‘Notice of Establishment’ 1999 64 Federal Register46697
US DHHS, Office of Biotechnology Activities (OBA)‘Recombinant DNA Research: Actions Under the NIH Guidelines’ 2001 66 Federal Register57970
US DHHS, Secretary's Advisory Committee on Xenotransplantation (SACX) 2004 www.scribd.com/doc/1111353/National-Institutes-of-Health-IC-draft-030905
US DHHS, Secretary's Advisory Committee on Xenotransplantation (SACX) 2004 www.nelsonerlick.com/PDF/NIH%20Report%20on%20State%20of%20Xenotransplantation%202005.pdf
US House of RepresentativesHearings on Human Genetic Engineering Before the Subcommittee on Investigations and Oversight of the Committee on Science and TechnologyWashington, DCGovernment Printing Office 1982
van Zwanenberg, P.Millstone, E.BSE: Risk, Science, and GovernanceOxford University Press 2005
von Hirsch, A.‘Extending the Harm Principle: “Remote” Harms and Fair Imputation’Simester, A.P.Smith, A.T.H.Harm and CulpabilityOxfordClarendon Press 1996 259
Valdés-González, R.A.Dorantes, L.M.Nayely Garibay, G.Bracho-Blanchet, E.Mendez, A.J.Dávila-Pérez, R.Elliott, R.B.Terán, L.White, D.J.G.‘Xenotransplantation of Porcine Neonatal Islets of Langerhans and Sertoli Cells: A 4-Year Study’ 2005 153 European Journal of Endocrinology419
Vanderpool, H.Y.‘Critical Ethical Issues in Clinical Trials with Xenotransplants’ 1998 351 The Lancet1347
Vanderpool, H.Y.‘Informed Consent in Clinical Research’ 2007 14 Xenotransplantation353
Vanderpool, H.Y.‘The International Xenotransplantation Association Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet products in Type 1 Diabetes – Chapter 7: Informed Consent and Xenotransplantation Clinical Trials’ 2009 16 Xenotransplantation255
Waring, D.R.Lemmens, T.‘Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform’Law Commission of CanadaLaw and RiskVancouverUBC Press 2005
Lord, WarnerHansard, HL 2006 www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61212-wms0001.htm
Watson, J.D.‘Moving Toward the Clonal Man’ 1971 227 Atlantic Monthly50
Weeramantry, C.G.Xenotransplantation: The Ethical and Legal ConcernsSri LankaWeeramantry International Centre for Peace Education and Research 2007
Weinberg, A.M.‘Science and Trans-science’ 1972 10 Minerva209
Weiss, R.A.‘Xenografts and Retroviruses’ 1999 285 Science1221
Welin, S.‘Starting Clinical Trials of Xenotransplantation – Reflections on the Ethics of the Early Phase’ 2006 26 Journal of Medical Ethics231
Welin, S.Sandrin, M.S.‘Some Ethical Problems in Xenotransplantation: Introductory Remarks at Ethics Workshop’ 2006 13 Xenotransplantation500
Wellcome TrustWhat Do People Think About Gene Therapy?LondonWellcome Trust 2005
Wellcome TrustInformation and Attitudes: Consulting the Public About Biomedical ScienceLondonWellcome Trust 2005
Welsh, I.Evans, R.‘Xenotransplantation, Risk, Regulation and Surveillance: Social and Technological Dimensions of Change’ 1999 18 New Genetics and Society197
Wendler, D.Grady, C.‘What Should Research Participants Understand to Understand that They Are Participants in Research?’ 2008 22 Bioethics203
Wertz, D.C.‘Embryo and Stem Cell Research in the United States: History and Politics’ 2002 9 Gene Therapy674
Wheatley, S. 2001
Williamson, L.Fox, M.McLean, S.‘The Regulation of Xenotransplantation in the United Kingdom After UKXIRA: Legal and Ethical Issues’ 2007 34 Journal of Law and Society441
Wilsdon, J.Willis, R.See-Through Science: Why Public Engagement Needs to Move UpstreamLondonDemos 2004
Wilsdon, J.Wynne, B.Stilgoe, J.The Public Value of Science: Or How to Ensure that Science Really MattersLondonDemos 2005
Wilson, C.A.‘Porcine Endogenous Retroviruses and Xenotransplantation’ 2008 65 Cellular and Molecular Life Sciences3399
Winston, R 2008
Working Group on XenotransplantationXenotransplantation: Medical Use of Live Cells, Tissues and Organs from AnimalsOsloMinistry of Health 2001 18
Working Party of Council for Science and SocietyHuman Procreation: Ethical Aspects of the New TechniquesOxford University Press 1984
World Council of Churches, Subunit on Church and SocietyManipulating Life: Ethical Issues in Genetic EngineeringGenevathe Council 1982
World Council of Churches, Subunit on Church and SocietyBiotechnology: Its Challenges to the Churches and the WorldGenevathe Council 1989
World Health Association (WHA) 2004
World Health Organization (WHO) 1998 http://whqlibdoc.who.int/hq/1998/WHO_EMC_ZOO_98.1.pdf
World Health Organization (WHO) 1998 www.who.int/emc-documents/zoonoses/whoemczoo982c.html
World Health Organization (WHO) 2000 www.who.int/docstore/peh-emf/publications/facts_press/EMF-Precaution.htm
World Health Organization (WHO)Operational Guidelines for Ethics Committees that Review Biomedical ResearchGenevaWHO 2000
World Health Organization (WHO)Ethics, Access and Safety in Tissue and Organ Transplantation: Issues of Global Concern – Madrid, Spain, 6–9 October 2003 – ReportMadridWHO 2003
World Health Organization (WHO)International Health Regulations (2005)GenevaWHO 2008
World Health Organization (WHO)Statement from the Xenotransplantation Advisory Consultation, Xenotransplantation: Hopes and ConcernsGeneva 2005
World Medical Association (WMA)Declaration of Helsinki, Recommendations Guiding Physicians in Biomedical Research in Biomedical Research Involving Human SubjectsHelsinki, Finland 1964
World Medical Association (WMA)WMA Statement on Genetic Counseling and Genetic EngineeringWorld Medical Assembly MadridSpain 1987
World Medical Association (WMA)World Medical Association Statement on Human Organ Donation and Transplantation 2000 WMA General Assembly, PilanesbergSouth Africa
World Medical Association (WMA)Declaration of Helsinki, Ethical Principles for Medical Research Involving Human SubjectsWMAHelsinki, Finland 2008
