Clinical trials
| Title | Link |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects - Revised draft, January 2002 | http://www.cioms.ch/frame_guidelines_january_2002.htm |
| 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/ |
| 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 |
| 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 |
| 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 |
| 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/ |
| 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 |
| 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 |
| 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 |
| 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 - 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/$file/SmallN6pager.pdf |
| Advisory Committee on Human Radiation Experiments - Final Report | http://tis.eh.doe.gov/ohre/roadmap/achre/report.html |
| Swissmedic - Checkliste documents pour essais cliniques de thérapie génique/ OGM | http://www.swissmedic.ch/files/pdf/B3.1.83_Checkliste_documents_essais_cliniques_th%E9rapie_g%E9nique_OGM.doc http://www.swissmedic.ch/files/pdf/B3.1.82_Requ%EAte_autorisation_essais_cliniques_th%E9rapie_g%E9nique_OGM.dot |
| Beth Cunningham , Gary Gaffield, Andrea Halpern, Jerome Rackoff - Starting an Institutional Review Board at a PUI - (12 pages) | http://www.facstaff.bucknell.edu/cunningm/%5Cpromotion%5CIRB.article.CURQFinal.pdf |
| WHO - Operational Guidelines for Ethics Committees That Review Biomedical Research - 2000 - (39 pages) | http://www.who.int/tdr/publications/publications/pdf/ethics.pdf |
| Glenn McGee, Joshua P. Spanogle, Arthur L. Caplan, David A. Asch- A National Study of Ethics Committees | http://bioethics.net/ethicsstudy/AJOB_ethics.pdf http://bioethics.net/ethicsstudy/CQHE_ethics.pdf |
| Governance arrangements for NHS Research Ethics Committees - July 2001 - (35 pages) | http://www.doh.gov.uk/research/documents/gafrec.pdf |
| South West Local Research Ethics Committees Common Application Form Guidance Notes - August 2001 - (19 pages) | http://www.doh.gov.uk/research/swro/rd/ethics/ethforms/ethguid.pdf |
| Australian commonwealth Department of Health and Aged Care - Human Research Ethics Committees and the Therapeutic Goods Legislation - June 2001 - (66 pages) | http://www.health.gov.au/tga/docs/pdf/unapproved/hrec.pdf |
| New Zealand Ministry of Health - Operational Standard for Ethics Committees - March 2002 - (145 pages) | http://www.moh.govt.nz/moh.nsf/c7ad5e032528c34c4c2566690076db9b/ffc06a2c2009deeecc256b9400787b61/$FILE/OperationalStandard_final.pdf |
| 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 |
| Solomon R Benatar, Peter A Singer - A new look at international research ethics - (3 pages) | http://www.md.ucl.ac.be/ebim/research.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 |
| FDA - Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999 - | http://www.fda.gov/cder/reports/race_ethnicity/race_ethnicity_report.htm |
| GAO - NIH Clinical Trials: Various Factors Affect Patient Participation, October 1999 | http://www.gao.gov/archive/1999/he99182.pdf |
| GAO - ·Women's Health: NIH Has Increased Its Efforts to Include Women in Research, May 2000, | http://www.gao.gov/archive/2000/he00096.pdf |
| The Committee For the Protection of Human Subjects - homepage - University of California at Berkeley | http://cphs.berkeley.edu:7006/ |
| U.S. Code of Federal Regulations CFR - Title 45 - Public Welfare - Part 46 - Protection of human subjects | http://www.brown.edu/Administration/Research_Administration/OPRR/46index.html |
| Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research - April 18, 1979 | http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm |
| Harvard Forms - Human Subjects Committee | http://www.hsph.harvard.edu/hsc/forms.html |
| Stuart L. Nightingale - Challenges in Human Subject Protection - 50 Food and Drug Law Journal 493-501 (1995) - (9 pages) | http://www.fdli.org/pubs/Journal%20Online/50_4/art3.pdf |
| The Antiretroviral Pregnancy Registry - home page - "intended to provide an early signal of any major teratogenic effect associated with a prenatal exposure to the products monitored through the Registry" | http://www.apregistry.com/ |
Last updated: July 7, 2002