All Research
| Title | Link |
|---|---|
| OECD - Conference on New Biotechnology Food and Crops, Science, Safety and Society - Bangkok, Thailand, July 10-12, 2001.- (29 pages) | http://www1.oecd.org/bangkok/bangkokfinalreport.PDF |
| OECD - Report of the OECD workshop on the toxicological and nutritional testing of novel foods -Meeting of the Ad Hoc Expert Group on Food Safety - (48 pages) | http://www1.oecd.org/ehs/ehsmono/aussoidrEN.pdf |
| OECD - Safety Assessments of new foods - results of an OECD Survey of Serum Banks for Allergenicity testing, and use of databases - Internal co-ordination group for biotechnology - February 1997 - (34 pages) | http://www1.oecd.org/ehs/ehsmono/surveydrEN.pdf |
| The New England Journal of Medicine - registration for full text of Original and Special Articles six months after publication and to receive the Table of Contents by e-mail. | https://secure.mms.org/custserv/single_signin.asp?productcode=toc |
| E-Mail Alert Service - "JAMA and Archives Journals offer free tables of contents from JAMA, the Archives Journals, and news listings from American Medical News via e-mail" | http://www.ama-assn.org/public/journals/tocalert.htm |
| The Scientist - "Registration is required to view our online articles. Registration is FREE" | http://www.the-scientist.com/register.htm |
| Annals of Internal Medicine - "Sign up below and we will e-mail you the Table of Contents for each issue on the day of publication" | http://www.annals.org/shared/ealert_regtoc.html |
| The Economics of TB Drug Development - Global Alliance for TB Drug Development - October 2001 - (168 pages) | http://www.tballiance.org/3_per.cfm?rm=economics&sub=per |
| U.S. Department of Health and Human Services - Pediatric Advisory Subommittee Ethical Issues Day 1 - November 15, 1999 - (291 pages) | http://www.medicigroup.com/resources/Resources-Ethics%20&%20Patient%20Recruitment.pdf |
| Marie Abbet - Cobayes Humains - L'insoutenable légèreté de nos autorités - l'Hebdo - 3 juin 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_22/cobaye_22.html |
| Béatrice Schaad - Cobayes Humains - La Suisse importe des cobayes humains - l'Hebdo - 12 mai 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_20/dossier_intro_20.html |
| Marie Abbet - Cobayes Humains - La chimie bâloise paiera-t-elle le prix de la honte? - L'Hebdo - 1er juillet 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_26/cobayes_26.html |
| J.C. Dumon, M. Sneyers et W. Moens - Report: First Gene Therapy Related Death - Belgian Biosafety Council - 2000 - (20 pages) | http://biosafety.ihe.be/GT/regulatory/RapportEN27_06_2001.pdf |
| Gene Therapy Advisory Committee - Health Departments of the United Kingdom - 1999 - (58 pages) | http://www.doh.gov.uk/genetics/gtac6.pdf |
| IHGT -Insitute for Human Gene Therapy - University of Pennsylvania - More information on OTC Deficiency and the Clinical Trial | http://www.uphs.upenn.edu/ihgt/otcinfo.html |
| Association of American Medical Colleges - Protecting Subjects, Preserving Trust, Promoting Progress– Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research - December 2001 - (25 pages) | http://www.aamc.org/members/coitf/firstreport.pdf |
| Report of Independent Panel Reviewing the University of Pennsylvania's Institute for Human Gene Therapy | http://www.upenn.edu/almanac/v46/n34/IHGT-review.html |
| Action by the University of Pennsylvania in Response to the "Report of the Independent Panel Reviewing the Institute for Human Gene Therapy" | http://www.upenn.edu/almanac/v46/n34/OR-IHGT-actions.html |
| FDA - Warning Letter of March 3, 2000 to the University of Pennsylvania in relation with the death of Jesse Gelsinger during a clinical trial | http://www.fda.gov/foi/warning_letters/m3435n.pdf |
| University of Pennsylvania - ORA web site home page - regulatory affairs | http://www.upenn.edu/regulatoryaffairs/ |
| Institute of Medicine - Small Clinical Trials: issues and challenges - 2001 | http://books.nap.edu/books/0309073332/html/R1.html#pagetop |
| Uniform Requirements for Manuscripts Submitted to Biomedical Journals - Updated May 1999 | http://www.acponline.org/journals/annals/01jan97/unifreqr.htm |
| Biotechnology, Ethics and Government: Report to the Interdepartmental Working Group on Ethics - Winter 1998 - (125 pages) | http://strategis.ic.gc.ca/pics/bh/bioteche.pdf |
| DeAngelis CD. Conflict of interest and the public trust. JAMA. 2000;284:2237-2238 | http://jama.ama-assn.org/issues/v284n17/fpdf/jed00080.pdf |
| Conseil national - Motion CSEC-CN (00.455). Autorisation du diagnostic préimplantatoire lors de risque grave - March 20, 2002 | http://www.parlament.ch/ab/frameset/f/n/4612/55916/f_n_4612_55916_55939.htm |
| WHO - Lignes Directrices Opérationnelles pour les Comités d’Ethique chargés de l’évaluation de la Recherche Biomédicale - 2000 - (19 pages) | http://www.who.int/tdr/publications/publications/pdf/ethicsfr.pdf |
| H. Peter Steeves - “Start a Line and Get Me a Consent Waiver, STAT!” Autonomy, Community Consultation, and Informed Consent in Emergency Research - (54 pages) | http://www.ars-rhetorica.net/Queen/VolumeSpecialIssue/Articles/Steeves.pdf |
| Lausanne University - Règlement de la Commission Permanente d'Ethique de la Recherche Clinique - (6 pages) | http://www.unil.ch/cercfm/docs/Regl_cercfm_2000.pdf |
| Lausanne University - Recommandations pour la rédaction d'un protocole de recherche soumis à la Commission d'Ethique de la Recherche clinique de la Faculté de Médecine | http://www.unil.ch/cercfm/recommandations.html |
| Lausanne University - Exemple de formulaire de consentement éclairé (consentement écrit) | http://www.unil.ch/cercfm/formulaire.html |
| Lausanne University - Demande d’évaluation de l’essai clinique: | http://www.unil.ch/cercfm/docs/SoumissionLS.dot.pdf |
| Critique internationale des essais suisses de prescription d’héroïne Rapport de la Commission externe d’experts de l’OMS Prises de position de l’Organe international de contrôle des stupéfiants (OICS) - (53 pages) | http://www.aegd.ch/pdf/kritik_franz.PDF |
| Analysis of the Scientific Value of the Evaluation Heroin Distribution in Switzerland - (48 pages) | http://www.aegd.ch/pdf/kritik_engl.PDF |
| Swiss Ethics Committee on Non-human Gene Technology Avis relatif au projet de loi fédérale sur la transplantation d'organes, de tissus et de cellules (loi sur la transplantation, LTx) mis en consultation - (11 pages) | http://www.buwal.ch/stobobio/ekah/pdf/280200f.pdf |
| Académie Suisse des Sciences Médicales Directives pour la recherche expérimentale sur l’être humain - (16 pages) | http://www.samw.ch/content/Richtlinien/f_Forschungsunters.pdf |
| Helsinki Declaration - World Medical Association - Ethical Principles for Medical Research Involving Human Subjects - last amendment 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 - (5 pages) | http://www.wma.net/e/policy/17c.pdf |
| Title 21--Food and Drugs Chapter I - - Part 50--Protection of Human Subjects | http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html |
| Title 21--Food and Drugs Chapter I-- Part 56--Institutional Review Boards | http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html |
| The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research - April 18, 1979 | http://ohsr.od.nih.gov/mpa/belmont.php3 |
| US - Title 45 CFR Part 46 - Protection Of Human Subjects | http://ohsr.od.nih.gov/mpa/45cfr46.php3 |
| Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health | http://ohsr.od.nih.gov/guidelines.php3 |
| IRB Protocol Review Standards - Minimal regulatory requirements for IRB review, discussion and documentation in the meeting minutes | http://ohsr.od.nih.gov/info/checklist_IRB_protocol.html |
| IRB - OHSR Information Sheets | http://ohsr.od.nih.gov/info/ |
| Swissmedic - Formulaire de base pour la soumission d'un projet de recherche biomédicale | http://www.swissmedic.ch/files/pdf/f_FormEKAntrag.doc |
| Swissmedic - Formulaire d'avis de la Commission d'éthique de la recherche | http://www.swissmedic.ch/files/pdf/f_FormEKBeschluss.doc |
| Swissmedic - Formulaire de notification pour les essais cliniques de médicaments | http://www.swissmedic.ch/files/pdf/B3.1.121_Formulair_de_notification_pour_les_essais_cliniques_de_m%E9dicaments.dot |
| Swissmedic - list of ethics committee | http://www.swissmedic.ch/files/pdf/Liste_Ethikkommissionen-f.pdf |
| OClin - Federal Ordinance on clinical trials | http://www.admin.ch/ch/f/rs/8/812.214.2.fr.pdf |
| Geneva University - Conclusions et mesures du rectorat faisant suite à la dénonciation sur l’existence de liens entre l’industrie du tabac et l’Université de Genève - November 6, 2001 | http://www.prevention.ch/ryrapuni061101.htm |
| ASSM - Commission centrale d’éthique Rapport annuel 2000 | http://www.samw.ch/content/Kommissionen/fk_ZEK.htm#Rapport annuel |
| Préposé fédéral à la protection des données - Guide relatif au traitement de données personnelles dans le domaine médical - (53 pages) | http://www.edsb.ch/f/doku/leitfaeden/medizin.pdf |
| Conseil de l'Europe Comité des Ministres Recommandation No R(90)3 du Comité des Ministres aux Etats membres sur la recherche médicale sur l'être humain adoptée par le Comité des Ministres le 6 février 1990 | http://www.inserm.fr/ethique/Ethique.nsf/397fe8563d75f39bc12563f60028ec43/325e8f4b601fa154c125675400383408?OpenDocument |
| COMITE
DIRECTEUR POUR LA BIOETHIQUE (CDBI) - Développement dans le domaine de
la bioéthique dans les Etats membres, dans les autres Etats et dans les organisations internationales - Strasbourg, le 26 Octobre 2001 - (83 pages) |
http://www.legal.coe.int/bioethics/pdf/CDBI-INF(2001)6F.pdf |
| The Danish Council of Ehtics - Genetic investigation of Healthy Subjects - Report on Presymptomatic Gene Diagnosis | http://www.etiskraad.dk/publikationer/genetic/ren.htm |
| HGC and the Human Fertilisation Embryology Authority (HFEA) - Outcome of the Public Consultation on Preimplantation Genetic Diagnosis - (33 pages) | http://www.hgc.gov.uk/business_publications_pgdoutcome.pdf |
| Human Genetics Commission - First Annual Report- (58 pages) | http://www.hgc.gov.uk/business_publications_annualreport_first.pdf |
| CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects - Revised draft, January 2002 | http://www.cioms.ch/frame_guidelines_january_2002.htm |
| CIOMS - The Declaration of Inuyama - Human Genome Mapping, Genetic Screening and Gene Therapy | http://www.cioms.ch/frame_1990_texts_of_guidelines.htm |
| CIOMS - International Guiding Principles for Biomedical Research Involving Animals (1985) | http://www.cioms.ch/frame_1985_texts_of_guidelines.htm |
| Global Forum for Health Research - home page - "to help correct the 10/90 gap by focusing research efforts on diseases representing the heaviest burden on the world's health " | http://www.globalforumhealth.org/pages/index.asp |
| Global Forum for Health Research - Monitoring Financial Flows for Health Research (publication of 5 chapters) | http://www.globalforumhealth.org/FilesUpld/20.pdf |
| Global Forum for Health Research - The 10/90 Report on Health Research 2000 - (publication of 7 chapters) | http://www.globalforumhealth.org/non_compliant_pages/report00/00intro.pdf |
| ICSU - International Council for Science - home page - "a non-governmental organization, founded in 1931 to bring together natural scientists in international scientific endeavour | http://www.icsu.org/ |
| EFGCP - International Guidelines on Bioethics Informal Listing of Selected International Codes, Declarations, Guidelines, etc. on Medical Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health - 3rd Edition - (18 pages) | http://www.efgcp.org/webdocs/international.pdf |
| EFGCP - Optional Guideline for Good Clinical Practice Compliance and Quality Systems Auditing In conformity with the Note for Guidance on GCP CPMP/ICH/135/95 (ICH GCP) | http://www.efgcp.org/webdocs/engage.pdf |
| EFGCP - Guidelines and Recommendations for European Ethics Committees - (18 pages) | http://www.efgcp.org/webdocs/efgcprecommendation.pdf |
| EFGCP - Audit Working Party The handling of Case Report Form (CRF) at an investigational site | http://www.efgcp.org/webdocs/handling_of_CRF.pdf |
| EFGCP - Audit Working Party Protocol Compliance - (6 pages) | http://www.efgcp.org/webdocs/protocol_compliance.pdf |
| EFGCP - Records Management and Archiving Working Party Guidelines for Retention of Clinical Trial Records at Investigator Study Sites - / pages) | http://www.efgcp.org/webdocs/guidelines_for_retention.pdf |
| EU - Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.efgcp.org/webdocs/guidelines_for_retention.pdf |
| SIDCDER - home page - "an independent international cooperative project designed to facilitate the development of the ethical review of biomedical research" | http://www.sidcer.net/ |
| Academy for Health Services Research and Health Policy - home page " provides a professional home and technical assistance resource for researchers and policy professionals" | http://www.academyhealth.org |
| Andreas Pyka and Paolo Saviotti - Innovation Networks in the Biotechnology-Based Sectors - July 2001 - (35 pages) | http://www.wiwi.uni-augsburg.de/vwl/institut/paper/205.pdf |
| Federal Department of Justice - Explications relatives à l'ordonnance sur la Commission nationale d'éthique dans le domaine de la médecine humaine - (4 pages) | http://www.ofj.admin.ch/themen/fortpflmed/vnvo-ber-vnek-f.pdf |
| Loi fédérale sur la protection des données (LPD) du 19 juin 1992 -RS 235.1 - (16 pages) | http://www.admin.ch/ch/f/rs/2/235.1.fr.pdf |
| Proposed changes to the Federal Law on Data Protection (LPD) - (19 pages) | http://www.ofj.admin.ch/themen/datenschutz/bg-revision-f.pdf |
| Avant-projet et rapport explicatif relatif à la révision de la loi fédérale sur la protection des données; Protocole additionnel à la Convention pour la protection des personnes à l'égard du traitement automatisé des données à caractère personnel | http://www.ofj.admin.ch/themen/datenschutz/vn-ber-f.pdf |
| United Kingdom - Advice to Research Ethics Committees - Points to consider in ethical review of medical research involving genetic testing - October 1998 - (13 pages) | http://www.doh.gov.uk/pub/docs/doh/recrev3.pdf |
| American Academy of Pediatrics - Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations (RE9503) | http://www.aap.org/policy/00655.html |
| FDA - Guidance for Industry - Content and format of investigational new drug applications (inds) for phase 1 studies of drugs, including wellcharacterized, therapeutic, biotechnology-derived products - (18 pages) | http://www.fda.gov/cder/guidance/phase1.pdf |
| ICH - Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials - May 2001 - (37 pages) | http://www.fda.gov/cder/guidance/4155fnl.pdf |
| FDA
- Guidance for Industry Acceptance of Foreign Clinical Studies -March 2001 - (4 pages) |
http://www.fda.gov/cder/guidance/fstud.pdf |
| FDA - Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators- IRB Operations and Clinical Investigation Requirements - 1998 Update | http://www.fda.gov/oc/ohrt/irbs/default.htm |
| EMEA - EMEA/17424/01 Position Statement on the Use of Placebo in Clinical Trials with regard to the Revised Declaration of Helsinki - June 2001 | http://www.emea.eu.int/pdfs/human/press/pos/1742401en.pdf |
| EMEA - CPMP/EWP/462/95 Note for Guidance on Clinical Investigation of Medicinal Products in Children (CPMP adopted March 97) - (12 pages) | http://www.emea.eu.int/pdfs/human/ewp/046295en.pdf |
| FDA - Compliance Program Guidance Manual For FDA Staff - Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators | http://www.fda.gov/ora/compliance_ref/bimo/7348_811/default.htm |
| FDA - Compliance Program 7348.810 - Bioresearch Monitoring Sponsors, Contract Research Organizations and Monitors - Date of Issuance: February 21, 2001 - Guidance for FDA Staff | http://www.fda.gov/ora/compliance_ref/bimo/7348_810/default.htm |
| FDA - Good Laboratory Practice - GLP Final Rule - (81 pages) | http://www.fda.gov/ora/compliance_ref/bimo/GLP/78fr-glpfinalrule.pdf |
| WHO - WHO Technical Report Series, No. 850, 1995, Annex 3 - Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - (35 pages) | http://www.who.int/medicines/library/par/ggcp/GCPGuidePharmatrials.pdf |
| WHO - General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine - (80 pages) | http://www.who.int/medicines/library/trm/who-edm-trm-2000-1/who-edm-trm-2000-1.pdf |
| Centre for Evidence-Based Medicine - home page | http://cebm.jr2.ox.ac.uk/ |
| NIH - Public Health Service Policy relating to Distribution of Unique Research Result Resources produced with PHS Funding - NIH Guide , Volume 25, Number 23, July 12, 1996 | http://grants1.nih.gov/grants/guide/notice-files/not96-184.html |
| NIH -Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice | http://ott.od.nih.gov/NewPages/RTguide_final.html#guide |
| NIH - Implementation Issues for Human Embryonic Stem Cell Research - Frequently Asked Questions | http://grants1.nih.gov/grants/stem_cell_faqs_topic.htm |
| NIH - Human Embryonic Stem cell registry | http://escr.nih.gov/ |
| NIH - Notice of criteria for federal funding of research on existing human embryonic stem cells and establishment of NIH human embryonic stem cell registry | http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html |
| Stanford University - Sample Consent Form for informed consent to participate in a clinical trial (9 pages) | http://humansubjects.stanford.edu/medical/SUSampCons.html |
| Résultats de la procédure de consultation sur la Convention internationale sur les droits de l'homme et la biomédecine - 6 pages) | http://www.ofj.admin.ch/themen/bioeth/ve-ber-f.pdf |
| Rapport en vue de la procédure de consultation sur la Convention internationale sur la biomédecine - Septembre 1998 - (42 pages) | http://www.ofj.admin.ch/themen/bioeth/vn-ber-f.pdf |
| Swiss Expert Committee for Biosafety (EFBS/CFSB) - English home page - "the permanent federal advisory Committee on questions relating to the protection of people and the environment in the areas of gene- and biotechnology" | http://www.buwal.ch/stobobio/cfsb/e/index.htm |
| Arrêté fribourgeois du 12 septembre 1995 concernant les essais cliniques sur l’être humain | http://www.fr.ch/v_ofl_bdlf/en_vigueur/fra/8212022v0001.doc |
| FDA - Use of Placebo controls in developing countries - (13 pages) | http://www.citizen.org/documents/1558attachment.pdf |
| Harvard Bioethics discussion group - Program on Ethical Issues in International Health Research at the Harvard School of Public Health - E-mail list | http://www.hsph.harvard.edu/bioethics/ |
| Ethics committee of the Tessin Canton | http://www.ti.ch/DOS/DSP/SezS/ComEC/ |
| AgBioWord.org - Mexican Maize Resource Library | http://www.agbioworld.org/biotech_info/articles/mexmaizeresource.html |
| Food Fist - Home page - "a member-supported, nonprofit 'peoples' think tank and education-for-action center [that] highlights root causes and value-based solutions to hunger and poverty" | http://www.foodfirst.org/ |
| Nuffield Council on Bioethics - Discussion Paper: The ethics of clinical research in developing countries - November 2001 - (36 pages) | http://www.nuffieldbioethics.org/filelibrary/pdf/clinicaldiscuss1.pdf |
| Nuffield Council on Bioethics - Genetic Screening Ethical Issues - December 1993 - (130 pages) | http://www.nuffieldbioethics.org/filelibrary/pdf/genetic_screening.pdf |
| Nuffield Council on Bioethics - Stem Cell Therapy: the ethical issues a discussion paper - November 2001 - (20 pages) | http://www.nuffieldbioethics.org/filelibrary/doc/stem_cell_therapy2.doc |
| Nuffield Council on Bioethics - Animal-to-Human Transplants the ethics of xenotransplantation - March 1996 - (168 pages) | http://www.nuffieldbioethics.org/filelibrary/pdf/xenotransplantation.pdf |
| Nuffield Council on Bioethics - Report: Human Tissue: Ethical and Legal Issues.Published: April 1995 - (182 pages) | http://www.nuffieldbioethics.org/filelibrary/pdf/human_tissue.pdf |
| Institute of Medicine - The Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector (1995) | http://books.nap.edu/books/0309052440/html/1.html |
| Center Watch - "a wealth of information related to clinical trials, such as a listing of more than 41,000 industry- and government-sponsored clinical trials as well as new drug therapies recently approved by the FDA" | http://www.centerwatch.com/index.html |
| Current Clinical Trials - "searchable, international database of ongoing randomised controlled trials in all areas of healthcare" | http://www.controlled-trials.com/ |
| Database of Abstracts of Reviews of Effectiveness (DARE) - at the University of York | http://agatha.york.ac.uk/darehp.htm |
| NHS Economic Evaluation Database (NHS EED) - at the University of York | http://agatha.york.ac.uk/nhsdhp.htm |
| AUTM - Association of University Technology Managers, Inc.- Licensing Survey: FY 1999 Survey Summary | http://www.autm.net/surveys/99/survey99A.pdf |
| Institute of Medicine Rational Therapeutics for Infants and Children - Workshop Summary | http://search.nap.edu/html/rational_therapeutics/ |
| Jean Lang and Susan C. Wood - Development of Orphan Vaccines: An Industry Perspective - (8 pages) | http://www.cdc.gov/ncidod/eid/vol5no6/pdf/lang.pdf |
| Dimitris K. Agrafiotis,Victor S. Lobanov and F. Raymond Salemme - Combinatorial Informatics in the Post-Genomics Era - Nature - (10 pages) | http://www.nature.com/cgi-taf/DynaPage.taf?file=/nrd/journal/v1/n5/full/nrd791_fs.html&filetype=pdf |
| Nature Reviews - access to certain articles in full text | http://www.nature.com/reviews/featuredarticles/ |
| PhRMA - Discoverers Award 2002 - (42 pages) | http://www.phrma.org/publications/2002-03-21.372.pdf |
| PhRMA - Biomedicine Promises For Health - ((23 pages) | http://www.phrma.org/publications/publications/brochure/biomed/biomed.pdf |
| Weissmann. Stem Cells -- Scientific, Medical, and Political Issues - New England Journal of Medicines - May 6, 2002 (4 pages) | http://content.nejm.org/cgi/reprint/NEJMsb020693v1.pdf |
| Evers - European Perspectives on Therapeutic Cloning - May 6, 2002 - New England Journal of Medicine - (4 pages) | http://content.nejm.org/cgi/reprint/NEJMsb020527v1.pdf |
| George J. Annas - Cloning and the U.S. Congress - New England Journal of Medicine - May 6, 2002 - (4 pages) | http://content.nejm.org/cgi/reprint/NEJMlim020762v1.pdf |
| NIH - NIH Policy for Data and Safety Monitoring - June 10, 1998 | http://grants1.nih.gov/grants/guide/notice-files/not98-084.html |
| FDA - Guidance Financial Disclosure by Clinical Investigators | http://www.fda.gov/oc/guidance/financialdis.html |
| NIH - Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials - June 11, 1999 | http://grants1.nih.gov/grants/guide/notice-files/not99-107.html |
| HHS - Institutional Review Board (IRB) Registration | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/irbs.htm |
| HHS - Informed Consent Checklist / Tips | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm |
| Ethical and Legal Aspects of Human Subjects Research on the Internet - 1999 - (20 pages) | http://www.aaas.org/spp/dspp/sfrl/projects/intres/report.pdf |
| OHRP - Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/regirbt.htm |
| Penn University - Confidential Financial Disclosure Statement | http://www.upenn.edu/researchservices/pdfs/findisc.pdf |
| Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf |
| The 10/90 Report on Health Research 2001-2002 - Health research and global security - April 2002 | http://www.globalforumhealth.org/FilesUpld/24.pdf http://www.globalforumhealth.org/FilesUpld/25.pdf http://www.globalforumhealth.org/FilesUpld/27.pdf |
| Dina Mirpuri - Ethical and Management Considerations of Conducting International Clinical Trials in Developing Countries - Boston University School of Public Health - (25 pages) | http://dcc2.bumc.bu.edu/richardl/IH820/Resource_materials/Dina-CRO-Dev_countries-051102.doc |
| ECRI - Should I Enter a Clinical Trial ? (132 pages) | http://www.ecri.org/documents/prg/survey/prg.pdf |
| FDA - Inspection report of Abbott Laboratories (3 pages) | http://www.citizen.org/documents/1619appendix.pdf |
| Institute of Medicine - Exploring the Biological Contributions to Human Health: Does Sex Matter? - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/DoesSexMatter8pager/$file/DoesSexMatter8pager.pdf |
| Institute of Medicine - Exploring the Map of Clinical Research for the Coming Decade: Symposium Summary, Clinical Roundtable, December 2000 - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/CRR8pager3/$file/CRR8pager3.pdf |
| Institute of Medicine - Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (April 17, 2001) - Summary - (6 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/IRB-6Pager/$file/IRB-6Pager.PDF |
| Institute of Medicine - Public Confidence and Involvement in Clinical Research: Symposium Summary, Clinical Roundtable, September 2000 - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/CRR8pager2/$file/CRR8pager2.pdf |
| Institute of Medicine -Small Clinical Trials: Issues and Challenges (April 10, 2001) - Summary (6 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/SmallN6pager/$file/SmallN6pager.pdf |
| Institute of Medicine - Stem Cells and the Future of Regenerative Medicine (September 11, 2001) - 71 pages | http://books.nap.edu/html/stem_cells/report.pdf |
| Institutional Animal Care and Use Committee Guidebook - 2002 - (230 pages) | http://grants1.nih.gov/grants/olaw/GuideBook.pdf |
| Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity - August 2001 - (370 pages) | http://iccvam.niehs.nih.gov/methods/invidocs/finalall.pdf |
| Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity - August 2001 - (100 pages) | http://iccvam.niehs.nih.gov/methods/invidocs/guidance/iv_guide.pdf |
| Current Bibliographies in Medicine 93-1 -Laboratory Animal Welfare | http://www.nlm.nih.gov/pubs/cbm/labanim.html |
| Advisory Committee on Human Radiation Experiments - Final Report | http://tis.eh.doe.gov/ohre/roadmap/achre/report.html |
| Annual Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) December 19, 2001 - (21 pages) | http://iccvam.niehs.nih.gov/about/annrpt/annrpt01.doc |
| Public Health Service Policy on Humane Care and Use of Laboratory Animals - (24 pages) | http://grants1.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf |
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http://www.nap.edu/readingroom/books/labrats/ |
| Published Articles Office of Laboratory Animal Welfare | http://grants1.nih.gov/grants/olaw/references/publishedarticles.htm |
| Animal Welfare Act and Regulations | http://www.nal.usda.gov/awic/legislat/usdaleg1.htm |
| Loi fédérale relative à la recherche sur les embryons surnuméraires et sur les cellules souches embryonnaires (Loi relative à la recherche sur les embryons, LRE) Rapport explicatif sur le projet de loi - Mai 2002 - (86 pages) | http://www.bag.admin.ch/embryonen/bundesgesetz/f/erl_efg.pdf |
| Draft - Loi fédérale Projet relative à la recherche sur les embryons surnuméraires et sur les cellules souches embryonnaires | http://www.bag.admin.ch/embryonen/bundesgesetz/f/entw_efg.pdf |
| The National Institute for Health Care Management Research and Educational Foundation - Changing Patterns of Pharmaceutical Innovation - May 2002 - (24 pages) | http://www.nihcm.org/innovations.pdf |
| United States Senate Joint Economic Committee, The Benefits of Medical Research and the Role of the NIH, May 2000 - (64 pages) | http://rxpolicy.com/studies/nih-randd-jec.pdf |
| Swissmedic - Checkliste documents pour essais cliniques de thérapie génique/ OGM | http://www.swissmedic.ch/files/pdf/B3.1.83_Checkliste_documents_essais_cliniques_th%E9rapie_g%E9nique_OGM.doc http://www.swissmedic.ch/files/pdf/B3.1.82_Requ%EAte_autorisation_essais_cliniques_th%E9rapie_g%E9nique_OGM.dot |
| Swiss Ethics Committee on Non-human Gene Technology - Avis relatif à la concrétisation de la notion de dignité de la créature dans le cadre du projet de révision de la loi sur la protection des animaux - (11 pages) | http://www.buwal.ch/stobobio/ekah/pdf/171199f.pdf http://www.buwal.ch/stobobio/ekah/pdf/tier_f.pdf |
| Swiss Ethics Committee on Non-human Gene Technology - Avis relatif à l’article 120, alinéa 2, de la version française de la constitution fédérale -.(2 pages) | http://www.buwal.ch/stobobio/ekah/pdf/0300f.pdf |
| Classeur "Protection des animaux - expériences sur animaux et méthodes de substitution" | http://www.bvet.admin.ch/tierschutz/f/berichte_publikationen/tierversuche/1_index.html |
| Réorientation du droit suisse sur la protection des animaux Rapport du groupe de travail à l’intention de l’Office vétérinaire fédéral du 12 août 1998 | http://www.bvet.admin.ch/tierschutz/f/berichte_publikationen/tierschutzpolitik/98-10-01-bericht.html |
| Swiss Federal Act on Animal Protection of March 9, 1978 (State as per July 1, 1995) | http://www.bvet.admin.ch/tierschutz/e/gesetzgebung/tschg_tschv_version_2001.pdf |
| Federal Veterinary Office - Form A and Form B for experiments on animals | http://www.bvet.admin.ch/tierschutz/d/vollzugshilfen/tv-formulare/formular_a_e.pdf http://www.bvet.admin.ch/tierschutz/e/vollzugshilfen/tv-formulare/c_form_engl.pdf |
| 3 Warning Letters on Good Laboratory Practices | http://www.fda.gov/foi/warning_letters/g1990d.pdf http://www.fda.gov/foi/warning_letters/g1864d.pdf http://www.fda.gov/foi/warning_letters/g2044d.pdf |
| Rapport du 18 mai 1999 de la Commission des affaires juridiques du Conseil national Avis du Conseil fédéral du 20 septembre 1999 | http://www.ofj.admin.ch/themen/tiere/stellungnahme-br-f.pdf |
| Révision
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http://www.bvet.admin.ch/info-service/f/vernehmlassungen/010921tschg_erl.pdf |
| Débat parlementaire sur l'initiative relative au statut de l'animal | http://www.parlament.ch/ab/frameset/d/s/4604/17669/d_s_4604_17669_17799.htm http://www.parlament.ch/ab/frameset/d/s/4612/49803/d_s_4612_49803_50511.htm?DisplayTextOid=50512 http://www.parlament.ch/ab/data/d/s/4612/49803/d_s_4612_49803_50511.htm |
| Rapport de la Commission des affaires juridiques (CAJ) du 18 mai 2000 sur l'initiative "Les animaux dans l'orde juridique suisse" (CAJ-CE) | http://www.parlament.ch/afs/data/f/bericht/1999/f_bericht_s_k25_0_19990467_01.htm#a2 |
| Génie génétique et Législation | http://www.catholink.ch/vaud/dossier/gene/gen1.html |
| Message du Conseil fédéral concernant les initiatives populaires fédérales «pour un meilleur statut juridique des animaux (Initiative pour les animaux)» et «Les animaux ne sont pas des choses!» du 25 avril 2001 - (19 pages) | http://www.admin.ch/ch/f/ff/2001/2390.pdf |
| Council Directive - of 24 November 1986 - 86/609/EEC - on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes | http://europa.eu.int/comm/food/fs/aw/aw_legislation/scientific/86-609-eec_en.pdf |
| Council Directive of 7June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (88/320/EEC) | http://europa.eu.int/eur-lex/en/consleg/pdf/1988/en_1988L0320_do_001.pdf |
| OTA - Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues OTA-BP-H-163 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9524/9524.PDF |
| OTA - The Effectiveness of Research and Experimentation Tax Credits - 1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9558/9558.PDF |
| OTA - Federal Technology Transfer and the Human Genome Project - OTA-BP-EHR-162 - 1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9526/9526.PDF |
| OTA - Impacts of Antibiotic-Resistant Bacteria OTA-H-629 -1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9503/9503.PDF |
| OTA - Researching Health Risks - OTA-BBS-570 - 1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9352/9352.PDF |
| OTA - Biomedical Ethics in U.S. Public Policy OTA-BP-BBS-105 -1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9312/9312.PDF |
| OTA - Review of a Protocol for a Study of Reproductive Health Outcomes Among Women Vietnam Veterans - December 1991 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1991/9135/9135.PDF |
| Beth Cunningham , Gary Gaffield, Andrea Halpern, Jerome Rackoff - Starting an Institutional Review Board at a PUI - (12 pages) | http://www.facstaff.bucknell.edu/cunningm/%5Cpromotion%5CIRB.article.CURQFinal.pdf |
| AAU - Task Force on Research Accountability - Report and Recommendations - Report on Individual and Institutional Financial Conflict of Interest - October 2001 - (22 pages) | http://www.aau.edu/research/COI.01.pdf |
| Charles A. Goldman, T. Williams with David M. Adamson, Kathy Rosenblatt - Paying for University Research Facilities and Administration | http://www.rand.org/publications/MR/MR1135.1/MR1135.1.pdf/MR1135.1.chap1.pdf http://www.rand.org/publications/MR/MR1135.1/MR1135.1.pdf/MR1135.1.chap2.pdf http://www.rand.org/publications/MR/MR1135.1/MR1135.1.pdf/MR1135.1.chap3.pdf |
| AAU - Task Force on Research Accountability - Report on University Protections of Human Beings Who Are the Subjects of Research - June 2000 - (12 pages) | http://www.aau.edu/reports/HumSubRpt06.28.00.pdf |
| GAO Report on Research Universities' Administration of the Bayh-Dole Act - May 7, 1998 - (7 pages) | http://www.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=gao&docid=f:rc98126.txt.pdf |
| Stem Cell Research: A Target Article Collection - (28 pages) | http://muse.jhu.edu/demo/ajb/2.1green.pdf |
| WHO - Operational Guidelines for Ethics Committees That Review Biomedical Research - 2000 - (39 pages) | http://www.who.int/tdr/publications/publications/pdf/ethics.pdf |
| Glenn McGee, Joshua P. Spanogle, Arthur L. Caplan, David A. Asch- A National Study of Ethics Committees | http://bioethics.net/ethicsstudy/AJOB_ethics.pdf http://bioethics.net/ethicsstudy/CQHE_ethics.pdf |
| Governance arrangements for NHS Research Ethics Committees - July 2001 - (35 pages) | http://www.doh.gov.uk/research/documents/gafrec.pdf |
| South West Local Research Ethics Committees Common Application Form Guidance Notes - August 2001 - (19 pages) | http://www.doh.gov.uk/research/swro/rd/ethics/ethforms/ethguid.pdf |
| Australian commonwealth Department of Health and Aged Care - Human Research Ethics Committees and the Therapeutic Goods Legislation - June 2001 - (66 pages) | http://www.health.gov.au/tga/docs/pdf/unapproved/hrec.pdf |
| New Zealand Ministry of Health - Operational Standard for Ethics Committees - March 2002 - (145 pages) | http://www.moh.govt.nz/moh.nsf/c7ad5e032528c34c4c2566690076db9b/ffc06a2c2009deeecc256b9400787b61/$FILE/OperationalStandard_final.pdf |
| New Zealand - Guide on Codes of Ethical Conduct - May 2002 (28 pages) | http://202.78.129.207/biosecurity/animal-welfare/naeac/papers/naeaccec.pdf |
| Peter A Singer, Edmund D Pellegrino and Mark Siegler - Debate Clinical ethics revisited - BMC Medical Ethics (2001) 2:1- (8 pages) | http://www.biomedcentral.com/content/pdf/1472-6939-2-1.pdf |
| Thomas O. Stair et al., - Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial - (6 pages) | http://healthcare.partners.org/marc/articles/StairAEM.pdf |
| Judy E. Stern and Deni Elliott- The Ethics of Scientific Research A Guidebook for course development - (75 pages) | http://www.dartmouth.edu/artsci/ethics-inst/Stern_Elliott.pdf |
| Solomon R Benatar, Peter A Singer - A new look at international research ethics - (3 pages) | http://www.md.ucl.ac.be/ebim/research.pdf |
| Lois Snyder and Daniel P. Sulmasy - Physician-Assisted Suicide - (8 pages) | http://www.annals.org/issues/v135n3/pdf/200108070-00015.pdf |
| Lori B. Andrews - Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health and Fundamental Rights Models - Wust - (65 pages) | http://law.wustl.edu/WULQ/79-1/791-221.pdf |
| Ethics, Genetic Technologies, and Social Responsibility in the Twenty-first Century - (40 pages) | http://bancroft.berkeley.edu/ROHO/bioethics.pdf |
| Iain Chalmers - Current Controlled Trials: an opportunity to help improve the quality of clinical research - (6 pages) | http://cvm.controlled-trials.com/content/pdf/cvm-1-1-003.pdf |
| Solomon R Benatar et al. - Clinical ethics revisited: responses - BMC Medical Ethics (2001) 2:2 Debate - April 2001 - (10 pages) | http://www.biomedcentral.com/content/pdf/1472-6939-2-2.pdf |
| Proceedings of the 5th European Conference of National Ethics Committees (COMETH) 4-5 September 2000, - Strasbourg - (81 pages) | http://www.legal.coe.int/bioethics/gb/pdf/5e_conference.pdf |
| Ordonnance du 2 février 2000 sur les Bonnes pratiques de laboratoire (OBPL) | http://www.admin.ch/ch/f/rs/8/813.016.5.fr.pdf |
| Loi fédérale du 18 décembre 1998 sur la procréation médicalement assistée (LPMA) | http://www.admin.ch/ch/f/rs/8/814.90.fr.pdf |
| Ordonnance du 4 décembre 2000 sur la procréation médicalement assistée (OPMA) | http://www.admin.ch/ch/f/rs/8/814.902.2.fr.pdf |
| Ordonnance du 4 décembre 2000 sur la Commission nationale d'éthique dans le domaine de la médecine humaine (OCNE) | http://www.admin.ch/ch/f/rs/8/814.903.fr.pdf |
| Generics - home page - "consultancy, IP exploitation, and technology investment" | http://www.generics.co.uk |
| RCT - Research Corporation Technologies - home page - "an independent technology management company that provides value-adding commercialization services to academia and industry" | http://www.rctech.com/ |
| International Business Incubator - home page - "designed to be a first home for international companies expanding to the US for the first time" | http://www.ibi-sv.org/ |
| National Business Incubation Association - home page - "provides thousands of professionals with the information, education, advocacy and networking resources to bring excellence to the process of assisting early-stage companies" | http://www.nbia.org/ |
| GeneBio - home page - "providing quality databases, software tools and services to the Life Science industry particularly in the field of proteomics" | http://www.genebio.com |
| GeneProt - home page - "goal is to become the leader in the discovery, identification and characterization of proteins and their functions for major disabling or life threatening diseases" | http://www.geneprot.com |
| John H. Krystal - Naltrexone in the Treatment of Alcohol Dependence - New England Journla of Medicine - Volume 345:1734-1739 December 13, 2001 Number 24 - abstract | http://content.nejm.org/cgi/content/short/345/24/1734?query=TOC |
| Committee on Transgenic Nomenclature, Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council, Standardized Nomenclature for Transgenic Animals, ILAR News Vol 34(4) -- 1992 | http://www4.nas.edu/cls/ijhome.nsf/44bf87db309563 |
| Integrity in Science, Non profit organizations with ties to the industry, a CSPI Project | http://www.cspinet.org/integrity/corp_funding.htm |
| Kate Schiel, the war on cancer is a fraud, Disinformation, May 13, 2001 | http://www.disinfo.com/pages/dossier/id336/pg1/ |
| Holly Stewart, Vivienne Murray, Premarin The Hidden Costs, Earth Save Canada | http://www.earthsave.bc.ca/materials/articles/art |
| ISREC - Swiss Institute for Experimental Cancer Research - home page - "Founded in Lausanne in 1964, subsidized by the Swiss Confederation, Non-profit organization" | http://www.isrec.ch/en_frameset_gen.html |
| Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials | http://europa.eu.int/eur-lex/en/lif/dat/2001/en_3 |
| Washington Post, The Body Hunters, | http://www.washingtonpost.com/wp-dyn/world/issues/bodyhunters/ |
| Decision of the Swiss Federal Office for Justice, dated November 17, 1995, regarding the status of embryos | http://www.vpb.admin.ch/franz/doc/60/60.67.html |
| Swiss Centre for Technology Assessment - RESEARCH ON HUMAN SUBJECTS: UK DEBATE - September 2001 - (4 pages) | http://www.ta-swiss.ch/www-support/news/Materials_news_temp/human_research.pdf |
| Demande pour l'évaluation d'un projet de recherche biomédicale, élaboré sous la direction de l’Académie suisse des sciences médicales (ASSM/SAMW) en accord avec les commissions d’éthique, les cantons, l’OICM et l’OFSP. | http://www.samw.ch/content/Formulare/f_FormEKAntrag.doc |
| Robert A. Book, Public Research Funding and Private Innovation: The Case of the Pharmaceutical Industry, December 2000 - (72 pages) | http://home.uchicago.edu/~rabook/Book_PharmInnov.pdf |
| Maureen McKelvey* and Luigi Orsenigo - Pharmaceuticals as a Sectoral Innovation System - November 2001 - (74 pages) | http://www.cespri.uni-bocconi.it/essy/mckelors.PDF |
| Nicola Lacetera and Luigi Orsenigo - Political regimes, technological regimes and innovation in the evolution of the pharmaceutical industry in the USA and in Europe - CEPRIS - March 2001 - (rough draft) - (59 pages) | http://www.unisi.it/ricerca/prog/epris/abstract/pdf/Lacetera-Orsenigo-Baltimore2.PDF |
| CESPRI - Centre for Research on Innovation and Internationalisation - home page | http://www.cespri.uni-bocconi.it/ |
| ERPIS - home page - "The main objective of EPRIS is to develop a comprehensive analysis of the structure and evolution of the European Pharmaceutical Regulation and Innovation Systems" | http://www.unisi.it/ricerca/prog/epris/index.htm |
| CenterWatch - home page - "We provide information services used by patients, pharmaceutical, biotechnology and medical device companies, CROs and research centers involved in clinical research around the world" | http://www.centerwatch.com |
| Commission d’experts du secret professionnel en matière de recherche médicale, Autorisation particulière de lever le secret professionnel à des fins de recherche dans les domaines de la médecine et de la santé publique, May 18, 2001, FF2001 5576-5583 | http://www.admin.ch/ch/f/ff/2001/5576.pdf |
| Corey A. Salsberg - Resurrecting the Woolly Mammoth: Science, Law, Ethics, Politics, and Religion - 2000 STAN. TECH. L. REV. 1 - Stanford University - | http://stlr.stanford.edu/STLR/Articles/00_STLR_1/index.htm |
| Jennifer Kulynych- Intent to Deceive: Mental State and Scienter in the New Uniform Federal Definition of Scientific Misconduct - 1998 STAN. TECH. L. REV. 2 - Stanford University | http://stlr.stanford.edu/STLR/Articles/98_STLR_2/index.htm |
| Interpharma, Des recherches et des médicaments pour le bien de votre santé | http://www.interpharma.ch/themen/medi/archiv/pdf/vom-f.pdf |
| The European Group on Ethics in Science and new Technologies - - Adoption of an Opinion on Ethical Aspects of Stem Cell Research and Use- January 2001 - (230 pages) | http://www.europa.eu.int/comm/european_group_ethics/docs/dp15.pdf |
| The European Group on Ethics in Science and New Technologies to the European Commission - General Report on its activities 1998-2000 - (163 pages) | http://www.europa.eu.int/comm/european_group_ethics/docs/rap_en.pdf |
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| Council of Europe - Recommendation 934 (1982) on genetic engineering | http://stars.coe.fr/ta/ta82/erec934.htm |
| Council of Europe - Recommendation 1046 (1986) on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and c |