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 
Institute of Laboratory Animal Resources
Commission on Life Sciences National Research Council - Guide for the Care and Use of Laboratory Animals - 1996
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 de la loi sur la protection des animaux
Rapport explicatif de l'avant-projet - September 2001 - (23 pages)
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 
European Commission Directorate - General XII Science, Research and Development- Biotechnology R&D in Europe - 1996 - (37 pages) http://europa.eu.int/comm/research/biotech/national.pdf 
European Commission, Directorate - General XII Science, Research Development - Coordination of Structural Biology in Europe, National EC and Industry Joint Efforts - (156 pages) http://europa.eu.int/comm/research/biotech/structur.pdf 
European Parliament: Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine - Report on the ethical, legal, economic and social implications of human genetics - November 8, 2001 - http://www.europarl.eu.int/comparl/tempcom/genetics/rapfin/rapfin_en.doc 
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