Introduction | US | EU | CH | International | Clinical Registers | Companies | Medical Journals | Other sources
Introduction
This page contains information regarding public disclosure of information, particularly ongoing clinical trials and trial results. Disclosure occurs mainly through publications in medical journals, public registers and freedom of information requests.
Other issues covered on this webpage include public access to journal articles and whistleblowing.
United States
Statutes | Regulation | FDA | Court decisions | State attorneys | GAO | Self regulation
Statutes
- FDA Revitalization Act of 2007 - Food and Drug Administration Amendments Act of 2007 - section 801
- Freedom of Information Act (FOIA)
- Federal Advisory Committee Act (FACA), 5 U.S.C. App.2
- Government in the Sunshine Act, 5 U.S.C. 552b
- 42 U.S.C. 282 §j and § k
- FDA, Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov
- Section 506B of the FDCA amended by the Modernization Act (Pub.L. 105-115) - 21 U.S.C. 356b (Reports of postmarketing studies)
- 5 U.S.C. §552
- Whistleblower Protection Act of 1989, Public Law No. 101-12, 5 U.S.C. 1211 (and Public Law 103-424 in 1994 & NoFEAR Act of 2002, Public Law 107-174)
- Sarbanes-Oxley Act of 2002 (SOX), Public Law No 107-204, section 806, 18 U.S.C. 1514A
Regulations
- 21 C.F.R. Part 20
- 21 C.F.R.§ 312 & 314
- 21 C.F.R.§ 360aaa
- 45 C.F.R. Part 5
- 29 C.F.R. 1980 (SOX)
- 5 C.F.R. 1201, 1209 (Whistleblowing)
Congress
- Lobbying Disclosure Act of 1995
- Lobbying Disclosure Act Guidance
- Senate, Office of Public Records Lobby Filing Disclosure Program
Proposed Bills
- The Enhancing Drug Safety and Innovation Act of 2006
- S. 470 and H.R. 3196, the Fair Access to Clinical Trials Act of 2005 or the FACT Act
- OLPA on the FACT Bill
- Grassley Co-Sponsors Clinical Trial Registry Legislation (February 28, 2005)
FDA
- FDA web page: What's new for advisory committees - new documents posted
- FDA, News, FDA Publishes Guidance on Communication of Drug Safety Information (March 2, 2007)
- FDA Guidance, Drug Safety Information, FDA's Communication to the Public (March 2007)
- Food and Drug Modernization Act of 1997 (FDAMA), Section 113
- Best Pharmaceuticals for Children Act of 2002
- Report on the performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies, 72 FR p.5069 (Feb.2, 2007)
- A Milestone for ClinicalTrials.gov Web Site (October 2003)
- FDAMA Section 113: Analysis of Cancer Trials Submitted May - July, 2005 (June 2006)
- FDAMA Section 113: Status Report on Implementation (August 2005)
- Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (March 2002)
- Procedures for Completing and Processing the Form "Annual Report Review: Postmarketing Study Commitment Summary", MAPP 6004.2 (March 16, 2005)
- Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies, 69 FR p.121623
- Draft Guidance, Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (April 2001)
- Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Delay of Effective Date, 66 FR 10815 (February 20, 2001)
- Final rule, 65 FR 64608 (Oct.30, 2000) [no link]
- Proposed rule, 64 FR 67207 (Dec.1, 1999) [no link]
Court decisions
FOIA Court decisions
- Judicial Watch v. U.S. FDA, (Lexis 73067) (D.D.C., Oct. 2, 2007)
- Physicians Committee for Responsible Medicine v. NIH, 2004 U.S. Dist. LEXIS 12464 (D.D.C. 2004)
- Public Citizen Health Research Group v. NIH, 209 F.Supp. 2d 37 (D.D.C. 2002)
- Heeney v. FDA, 7 Fed. Appx. 770 (9th Cir. 2001)
- R&D Labs, Inc. v. FDA, 2000 U.S. Dist. LEXIS 20209 (D.D.C. 2000)
- Public Citizen Health Research Group v. FDA, 2000 U.S. Dist. LEXIS 4108 (D.D.C. 2000)
- Public Citizen Health Research Group v. FDA, 185 F.3d 898 (D.C.Cir. 1999)
- Serono Labs Inc. v. Shalala, 35 F.Supp. 2d 1 (D.D.C. 1999)
- Public Citizen Health Research Group v. FDA, 997 F.Supp. 56 (D.D.C. 1998)
- Public Citizen Health Research Group v. FDA, 964 F.Supp. 413 (D.D.C. 1997)
- Citizens Commission on Human Rights v. FDA, 45 F.3d 1325, p.1329 (9th Cir. 1995)
- Bowen v. FDA, 925 F.2d 1225 (9th Cir. 1991)
- Teich v. FDA, 751 F.Supp. 243 (D.D.C. 1990)
- Anderson v. HHS, 907 F.2d 936 (10th Cir. 1990)
- Genentech, Inc. v. Bowen, 1987 U.S. Dist. LEXIS 16914 (D.D.C. 1987)
- Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C.Cir. 1983)
- Public Citizen Health Research Group v. HHS, 668 F.2d 537 (D.C.Cir. 1981)
- St-Paul's Institute v. U.S. , 506 F.Supp. 822 (N.D.Geo. 1980)
- Johnson v. HHS, 462 F.Supp. 336 (D.D.C. 1978)
- Washington Research Project, Inc. v. HHS, 504 F.2d 238 (D.C.Cir. 1974)
Whistleblowing
- Portes v. Wyeth, (Lexis 60824), (S.D.N.Y. Aug.20, 2007), citing Fraser v. Fiduciary Trust, 417 F. Supp.2d 310 (S.D.N.Y. 2006); Collins v. Beazer Homes,334 F.Supp.2d 1365 (N.D.Ga. 2004)
- Rockwell International Corp. v. U.S. (James Stone), 549 U.S. __ (2007)
- Garcetti v. Ceballos - Majority Opinion - Souter Dissenting Opinion - Stevens Dissenting Opinion - Breyer Dissenting Opinion - transcript of re-argument in March 2006 - transcript of argument in October 2005 - Respondent’s Brief on the Merits (7/22/05)
State Attorneys
- GSK Paxil case
- Forrest case
GAO
- Whistleblower Protection, VA Did Little Until Recently to Inform Employees About their Rights (GAO-GGD-00-70) (April 2000)
- Whistleblower Protection, Determining Whether Reprisal Occurred Remains Difficult (GAO/GGD-93-3) (October 1992)
- Whistleblower Protection, Survey of Federal Employees on Misconduct and Protection From Reprisal (GAO/GGD-92-120FS) (July 1992)
Self Regulations
European Union
Statutes | Court decisions | EMEA | Commission | Other EU | UK | France | Germany | Self-regulation
Statutes
Court decisions (not necessarily related to the biomedical field)
- C-64/05 - IFAW International Tierschutz-Fonds, Sweden (December 17, 2007)
- T-264/04 - WWF European Policy Programme v/ Council (April 25, 2007)
- T-110/03 - Jose Maria Sison v. Council (April 26, 2005)
- T-2/03 - Verein für Konsumenteninformation v. Commission (April 13, 2005)
- T-84/03 - Turco v. Council (November 23, 2004)
- C-353/01 - Mattila v. Conseil (January 22, 2004)
- T-211/99 - Kuijer v. Council (February 7, 2002)
- C-353/99 - Conseil v. Hautala, (December 6, 2001)
- T-111/00 - British American Tobacco v. Commission (October 10, 2001)
- T-20/99 - Denkavit v. Commission (December 13, 2000)
- T-188/98 - Kuijer v. Conseil (April 6, 2000)
- T-92/98 - Interporc v. Commission, (December 7, 1999)
- T-309/97 - Bavarian Lager Co. v. Commission, (October 14, 1999)
- T-14/98 - Hautala (July 19, 1999)
- T-188/97 - Rothmans (July 19, 1999)
- T-124/96 - Interporc (February 6, 1998)
- T-105/95 - WWF v. Commission (March 5, 1997)
- T-194/94 - Carvel v. Conseil (October 19, 1995)
EMEA
Key Web pages
General documents
- Work instructions, Coordination of requests in relation to Access to Documents (August 2007)
- Work instructions, Redaction of Documents in relation to Access to Documents (August 2007)
- Draft Principles to Be Applied for the Deletion of Commercially Confidential Information for the Disclosure of EMEA Documents (EMEA/45422/2006) (11 July 2006)
- Section 7 of the Guideline on Procedures for Re-examination of CHMP Opinions (EMEA/CHMP/50745/2005) (26 June 2006)
- Reflection paper, Publication of Withdrawals (EMEA/239350/2005) (5 October 2006)
- Overview of comments received on reflection papier on publication of withdrawals (5 October 2006)
- Section 6 of Q&A on Notification to the EMEA of actual Marketing and Cessation of Placing on the Market for Centrally Authorised Medicinal Products (EMEA/180078/2005) (23 February 2006)
- EPAR summaries for the public: A further step for the provision of better information about medicines (February 2, 2006)
- Rules for the implementation of the Regulation 1049/2001 on access to EMEA documents (EMEA/MB/203359/2006) (8 June 2006)
- New EMEA transparency policy measures (October 31, 2003)
- EMEA Response to ISDB Assessment of 9 EPARs (18 December 1998)
- Report on withdrawn centralised applications 1995-1998
Specific documents
- Marketing Authorisation Withdrawals and Suspensions
- Marketing Authorisation Applications Withdrawals
- Q&A on the withdrawal of the marketing application for: Lumiracoxib (2007) - Vitragan (2007) - Draxxin (2007) - Arxxant (2007) - Synordia (2006) - Orathecin (2006) - Glivec change (2006) - NovoSeven change (2006) - DepoCyte variation (2006) - Scintimun (2006) - Reetane (2006) - And EMEA access page
- Press release on the withdrawal of application for:
Gastromotal (2007) -
Garenoxacin (2007) -
Cerepro (2007) -
Retisert (2007) -
Iplex (2007) -
Synordia (2007) -
Arxxant (2007) -
Voraxaze (2007) -
Vitragan (2007) -
Riquent (2006) -
Scintimun (2006) -DepoCyte
extension (2006) -Orathecin
(2006) -
Opatanol extension (2006) -
NovoNorm change (2006) -
Ximelagatran (2006) -
And EMEA
access page
Commission
- Consultation Page on the European Transparency Initiative
- Green Paper on European Transparency Initiative (COM(2006) 194 final) (May 2006)
- Communication from the Commission, Towards a reinforced culture of consultation and dialogue - General principles and minimum standards for consultation of interested parties by the Commission (COM(2002) 704 final) (2002)
- Proposing the Launch of a European Transparency Initiative
Other EU documents
- Article 29 Data Protection Working Party, Opinion 1/2006 on the application of EU data protection rules to internal whistleblowing schemes in the fields of accounting, internal accounting controls, auditing matters, fight against bribery, banking and financial crime (00195/06/EN) (2006).
- Decision of the Court of Auditors No 12-2005 of 10 March 2005 regarding public access to Court of Auditors documents (2005/C 96/01)
United Kingdom
- Public Interest Disclosure Act 1998
- DTI, Disclosures in the public interest: Protections for workers who 'blow the whistle' - Guidance
- James Gobert & Maurice Punch, Whistleblowers, the Public Interest, and the Public Interest Disclosure Act 1998, 63 Modern Law Review p.25–54 (2000)
France
- Loi CADA No 78-753 du 17 juillet 1978, Code de santé publique article 5323-4
- Christine Noiville & Marie-Angèle Hermitte, Quelques pistes pour un statut juridique du chercheur lanceur d’alerte, 14 Natures Sciences Sociétés p.269-277 (2006)
- Dominique Chouchan, Protéger les lanceurs d'alerte (17 février 2004)
- Marie-Angèle Hermitte et al., La protection du lanceur d'alerte en droit français, Santé publique et droit du travail (4 septembre 2005)
Germany
- Dieter Deiseroth, Whistleblowing: Zivilcourage am Arbeitsplatz, (2003)
- Matthias Schmidt, 'Whistle Blowing' Regulation and Accounting Standards Enforcement in Germany and Europe - An Economic Perspective, 25 International Review of Law and Economics p.143–168 (2005)
Self-regulation
Switzerland
Lois et ordonnances | | Jurisprudence | Conseil fédéral | Parlement | Swissmedic | OFSP | FNS | CFB
Lois et ordonnances
- Loi fédérale sur le principe de la transparence dans l'administration (LTrans) (RS 152.3) & son Ordonnance (OTrans) (RS 152.31)
- Code des obligations - Droit du travail: articles 321a et 336 - Droit du mandat: articles 397 et 398
- Code pénal: articles 303, 305bis, 305ter et 322ter et suivants (corruption)
- Loi fédérale sur le blanchiment d'argent (RSS 955.0)
- DFJP, Pour une administration publique plus transparente, Projet de loi fédérale sur la transparence de l’administration et rapport explicatif (Avril 2000)
- Genève, LIPAD, Loi sur l'information aux publics et sur l'accès des données (A 2 08)
- Genève, Loi du 7avril 2006 sur la santé (K 1 03), en particulier ses article 62 et 63
Jurisprudence
CEDH concernant la Suisse
- Hertel v. Switzerland decision (59/1997/843/1049)(25 August 1998) - Arrêt de la CEDH, affaire Hertel c / Suisse, VPB 62.119, (25 août 1998)
- Décision de la CEDH déclarant irrecevable la requête n° 53440/99, Hertel c / Suisse, GAAC 66.121 (17 janvier 2002)
- Arrêt de la CEDH dans l'affaire Monnat c. Suisse (n° 73604/01) (21 septembre 2006) - Extrait de l'arrêt rendu par la CEDH le 21 septembre 2006, affaire Monnat c / Suisse, req. n° 73604/01, JAAC 70.117
Federal
- Arrêt 4C.312/2006 du 13 décembre 2006 (employment law)
- Arrêt 4C.23/2006 du 4 mai 2006
- ATF 127 III 310, arrêt du 30 mars 2001 (employment law)
Genève (LIPAD, y compris sans relation avec le secteur biomédical)
- Arrêt du Tribunal administratif du 2 mai 2006 ATA/231/2006
- Arrêt du Tribunal administratif du 29 novembre 2005 ATA/807/2005
- Arrêt du Tribunal administratif du 20 septembre 2005 ATA/621/2005
- Arrêt du Tribunal administratif du 22 mars 2005 ATA/162/2005
- Arrêt du Tribunal administratif du 28 septembre 2004 ATA/752/2004
- Arrêt du Tribunal administratif du 6 avril 2004 ATA/297/2004
- Arrêt du Tribunal administratif du 26 août 2003 ATA/634/2003
- Arrêt du Tribunal administratif du 29 avril 2003 ATA/244/2003
- Arrêt du Tribunal administratif du 25 mars 2003 ATA/166/2003
- Arrêt du Tribunal administratif du 21 janvier 2003 ATA/48/2003
Conseil fédéral (et départements)
- CDC, Press release, Les Contrôles des finances mettent en garde contre un perfectionnisme exagéré et renforce la prévention de la corruption (8 septembre 2006)
- Office fédéral de la justice, Commentaire de l'Ordonnance relative à la loi fédérale sur le principe de la transparence.(24 mai 2006)
- Rapport sur la prévention de la corruption, p.10 (99.3388) (16 juin 2003)
- Message du Conseil fédéral relatif à la loi fédérale sur la transparence de l’administration du 12 février 2003 (03.013), FF 2003 p.1807
- Office fédéral de la justice, Synthèse des résultats de la procédure de consultation relative à la loi fédérale sur la transparence de l'administration (mars 2001)
- Avant-projet de loi fédérale sur la transparence de l'administration (2000)
- Rapport explicatif "Pour une administration plus transparente) (2000)
- Organe parlementaire de contrôle de l'administration, L'éthique dans le Service public, rapport à l'intention de la Commission de gestion du Conseil national (30 octobre 1998)
Parlement
Motions Gysin Remo et Dick Marty
- Débat au Conseil national sur la motion Gysin Remo (22 juin 2007)
- Communiqué de presse, Protection des dénonciateurs en cas de corruption, Une commission du National a accepté de retoucher son projet (24 novembre 2006)
- Rapport de la Commission du Conseil national sur la motion Remo Gysin (23 novembre 2006)
- Rapport de la Commission des affaires juridiques du 21 février 2006 approuvant la motion Gysin (03.3212) - Dénonciateurs de corruption
- Débats au Conseil national au sujet de la motion Gysin du 13 juin 2005 (03.3212)
- Débats au Conseil des Etats sur la motion Marty du 2 octobre 2003 (03.3344)
- Motion de Gysin Remo, Protection juridique pour les personnes qui découvrent des cas de corruption (03.3212) du 7 mai 2003 et réponse du Conseil fédéral du 10 septembre 2003
- Motion de Dick Marty, mesures de protection des 'whistleblowers' (03.3344) et prise de position du Conseil fédéral du 10 septembre 2003
Autres
- Débat au Conseil national sur l'initiative parlementaire Roger Nordman (06.406) (26 septembre 2007)
- Débat au Conseil national sur l'initiative parlementaire de Louis Shelbert (06.462) sur la "Divulgation des liens d'intérêts financiers"
- Rapport de la Commission des institutions politiques sur l'initative de Louis Shelbert (06.462) sur la "Divulgation des liens d'intérêts financiers" (29 mars 2007)
- Débat au Conseil des Etats du 18 décembre 2006 (05.3785) - Transparence des journalistes
- Initiative parlementaire de Louis Shelbert (06.462) sur la "Divulgation des liens d'intérêts financiers" (2 octobre 2006)
- Rapport de la Commission des institutions politiques sur l'initiative parlementaire de Roger Nordman "Transparence du financement des partis politiques, des lobbies, des campagnes électorales et des campagnes de votation"(15 septembre 2006)
- Rapport de la Commission des institutions politiques du 28 août 2006 sur la motion de Jürg Stahl (05.3785) - Transparence des journalistes
- Débat au Conseil national du 9 mai 2006 sur la motion de Jürg Stahl (05.3785) - Transparence des journalistes
- Page de Jürg Stahl sur le site du Parlement
- Initiative parlementaire de Roger Nordman du 20 mars 2006 sur la "Transparence du financement des partis politiques, des lobbies, des campagnes électorales et des campagnes de votation"
- Motion de Jürg Stahl sur la transparence sur les intérêts représentés par les journalistes accrédités au Palais fédéral (05.3785) et prise de position du Conseil fédéral du 17 mars 2006
- Débats du Conseil national sur la convention pénale et le protocole additionnel du Conseil de l'Europe sur la corruption du 6 octobre 2005 (04.072)
- Motion de Vreni Hubmann "Pour plus de transparence" (05.3136 ) et Avis du Conseil fédéral du 11 mai 2005
- Débat du 6 octobre 2004 au Conseil des Etats sur la loi fédérale sur la transparence (03.013)
- Débat du 20 septembre 2004 au Conseil National sur la loi fédérale sur la transparence (03.013)
- Débat du 9 décembre 2003 au Conseil des Etats sur la loi fédérale sur la transparence (03.013)
- Interpellation de Remo Gysin sur la lutte contre la corruption en Suisse (02.3763) et réponse du Conseil fédéral du 26 février 2003
Swissmedic
- Rapport Swissmedic 2006, p.49
- Rapport Swissmedic 2005, p.54-55
- Rapport Swissmedic 2004, p.53-55
- Rapport Swissmedic 2003, p.50-51
- Rapport Swissmedic 2002, p.42 et 43
- Swissmedic, Commentaires sur la Loi fédérale sur le principe de la transparence dans l’administration et Renseignements
- Formulaire d'accès
OFSP Federal Office for Public Health
FNS
- Bernhard Schaaf, L'ère de la transparence, FNSinfo n° 10 (juin 2006)
- Andreas Dick, Libre accès: la recherche comme bien public, FNSinfo n°9 p.8(mars 2006)
- Dieter Imboden, Libre accès: jusqu'à quel point les bases de données scientifiques doivent-elles être rendues publiques? FNSinfo n°9 p.3 (mars 2006)
- Pour un libre accès, FNSinfo n° 8 (mars 2006)
- Communiqué de presse, La communauté académique suisse s'engage pour le libre accès aux résultats scientifiques (7 février 2006)
- Déclaration de Berlin sur le libre accès à la connaissance en sciences exactes, sciences de la vie, sciences humaines et sociales
Universities
- Déclaration de Berlin sur le libre accès à la connaissance en sciences exactes, sciences de la vie, sciences humaines et sociales
- ZORA (Zurich Open Repository and Archive) - open and worldwide access to the research and scholarly output of the University of Zurich
- InfoSciences - EPFL - Le portail d'information scientifique
CFB (Swiss federal banking commission)
- CFB (Commission fédérale des banques), entrée en vigueur de la circulaire CFB sur la surveillance et le contrôle interne (4 octobre 2006) ("il a été renoncé à la procédure de dénonciation d'éventuelles irrégularités au sein de l'établissement ("whistleblowing") car le Parlement en débat actuellement")
- CFB, Circulaire "Surveillance et contrôle interne" du 27 septembre 2006 - sans protection du whistleblower !
- CFB, article 3.4. du Projet de Circulaire "Surveillance et contrôle internes" - et lettre d'accompagnement (4 mai 2005)
SECO (State Secretariat for Economic Affairs)
- Mark Pieth, Bekämpfung der transnationalen Korruption: Das OECD-Instrument (2005)
- Prévenir la corruption - conseils aux entreprises suisses actives à l'étranger (23 septembre 2003)
- Prévenir la corruption - conseils aux entreprises - feuille d'information (septembre 2003)
- Feuille d’information : corruption et lutte contre la corruption (septembre 2003)
- Brochure - prévenir la corruption
CFF (Swiss Federal Audit Office)
- Rapport annuel 2006, p.50-51
- Mise en place d'un système de contrôle interne (2003)
- Annexe A: Check-list de questions permettant d’évaluer son environnement de contrôle
- Michel Huissoud & Eleonore Roquette, Prévention de la corruption au sein de l'administration fédérale
- Michel Huissoud, Fraude et corruption : les auditeurs s’intéressent aux dénonciateurs
Ombudsman Zurich
- Korruptionsmeldestelle / "Whistleblowing"
- Korruptionsmeldestelle - Information
- Tätigkeitsbericht 2006 - Article by Adrian von Kaenel
Conseil de la presse
- Déclaration des devoirs et des droits du journaliste, en particulier aux articles 9 et 10
- Directives relatives à la déclaration, en particulier aux pojnts 9 et 10
- Vade-mecum du journaliste: 8.1. Indépendance à l'égard des acteurs économiques
- Vade-mecum du journaliste: 8.2. Indépendance à l'égard des annonceurs et des sponsors
- Vade-mecum du journaliste: 8.3. Indépendance à l'égard des autorités et des politiciens
- Vade-mecum du journaliste: 8.4. Engagement politique des journalistes
- Prise de position du Conseil suisse de la presse du 2 février 2001, No 8/2001: Indépendance du journaliste (FSJ/SLJ c. Jeannet)
-
Prise de position du Conseil suisse de la presse du 31 mars 2000, No 11/2000:Journalisme et charge publique (Association des médecins de canton de Genève c. „Le Temps“)
Various sources
- Gabriela Nagel-Jungo & Andreas Haeringer, Whistleblowing und Korruptionsbekämpfung, Seminararbeit (2007)
- Daniel Jositsch, Korruptionsbekämpfung bedeuted Schutz von Whistleblower
- Ernst & Young, Press release, Employees call for better safeguards for 'whistleblowers' (June 2007)
- Olivier Dunant, Whistleblowing et gouvernement d’entreprise, Ernst & Young Legal News (2006)
- Corruption hotline rings company alarm bells, NZZonline, Swissinfo (March 27, 2006)
- Bureau fédéral de la consommation, Proposition d’introduire une protection pour le « sonneur d’alarme » (Whistleblower) (22 février 2006)
- Transparency International (Suisse), Stellungnahme, Vernehmlassung EBK-Rundschreiben „Interne Überwachung und Kontrolle“
- Transparency International (Suisse), Whistleblowing
- Alexandre Bläuer, Étude sur la criminalité économique et sur la corruption dans l’Administration fédérale: création d’une cellule de protection des whistleblowers au sein du Contrôle fédéral des finances, Executive Summary (2003)
- Martin Studer & Jan Birgerson, «Whistleblowing»: la responsabilité du comité d’audit, Ernst & Young (2004)
International
WHO | | ICJME | IFPMA | UN | OECD | Council of Europe | Others
WHO
- WHO, International Clinical Trials Registry Platform
- WHO, list of 20 items to be submitted (2006)
- WHO; Glossary
- WHO, International Clinical Trials Registry Platform, FAQ
- WHO, International Clinical Trials Registry Platform, PPT presentation
- WHO, Press release, Clinical trial registry initiative: a correction (February 1, 2006)
- WHO, International Clinical Trials Registry Platform, Formal Consultation on Disclosure Timing (April, 26 2006)
- WHO, Press release, The World Health Organization announces new standards for registration of all human medical research (May 19, 2006)
- WHO, International Clinical Trials Registry Platform, Newsletter (July 2006)
Comments on WHO process
ICJME
- Is This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal Editors (June 9, 2005)
- Clinical Trial Registration — A Statement From the International Committee of Medical Journal Editors, (September 15, 2004)
IFPMA
- New IFPMA Clinical Trials Portal Upgrade allows Patients and Physicians to Search Faster, More Precisely and in Five Languages (March 22, 2006)
- IFPMA Improves Biomedical Data Transparency with Launch of First Worldwide Clinical Trials Portal (September 21, 2005)
- Patients and Physicians to Gain Easy Access to Clinical Trials Information via New IFPMA Search Portal (May 16, 2005)
- Global Industry Position On Disclosure of Information About Clinical Trials (January 6, 2005)
United Nationa
- Articles 8.4, 10, 12 and 33 of the United Nations Convention against Corruption
- Tool 33 of the UN Anti-corruption toolkit
OECD
- Point c. iv) of the 1997 Revised Recommendation of the Council on Combating Bribery in International Business Transactions
- Suisse: Phase 2, Rapport sur l'application de la Convention sur la lutte contre la corruption d'agents publics étrangers dans les transactions commerciales internationales (2004)
- Guidelines for Multinational enterprises (2000)
- OECD Principles of Corporate Governance (2004)
Council of Europe
- Article 9 of the Civil Law Convention on Corruption, Strasbourg, (4 November 1999)
- Civil Law Convention on Corruption, Explanatory Report, (ETS No. 174)
Others
- Ottawa Statement
- HON Code of Conduct (HONcode) for medical and health Web sites
- Good publication practice for pharmaceutical companies (Elizabeth Wager , Elizabeth A. Field and Leni Grossman), 19(3) Current Medical Research and Opinion p. 149–154 (2003) & Web site on GPP
- Council of Science Editors. Conflicts of interest and the peer review process
- World Association of Medical Editors. WAME recommendations on publication ethics policies for medical journals
- Déclaration de Berlin sur le libre accès à la connaissance en sciences exactes, sciences de la vie, sciences humaines et sociales
- Bethesda Statement on Open Access Publishing (June 2003)
- Budapest Open Access Initiative (14 février 2002)
Clinical Registers
- www.clinicaltrials.gov (National Library of Medicine)
- www.clinicalstudyresults.org/ (PhRMA)
- http://clinicaltrials-dev.ifpma.org/ (IFPMA)
- ISRCTN Register
- Australian Clinical Trials Registry
- Nederlands Trial Register
- UMIN Clinical Trials Registry
Companies
Pfizer
- Pfizer's Commitment to the Disclosure of Clinical Trial Information
- Policy on Public Disclosure of Clinical Trial Results
- Pfizer's Commitment to Conducting Ethical Clinical Trials
- Policy on Global Clinical Trial Standards
- Policy on Compensation to Investigators in Clinical Trials
- Policy on Compensation to Human Research Subjects
- Policy on Compassionate Use of Unapproved Pfizer Drugs
GSK
- BMJ, Liza Gibson, GSK to publish clinical trials after US lawsuit, 328 p.1513 (June 26, 2004)
- BMJ, Owen Dyer, GSK faces US lawsuit over concealment of trial results, 328 p.1395 (June 12, 2004)
- BMJ, David Spurgeon, GlaxoSmithKline staff told not to publicise ineffectiveness of its drug (February 21, 2004)
- GSK Clinical Trial Register
- GSK Policy on Disclosure of Clinical Trial Information
Eli Lilly
Roche
Medical Journals
2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | pre-2000
2008
- JAMA, C. DeAngelis & P. Fontanarosa, Impugning the Integrity of Medical Science, 299 p.1833 (2008)
- JAMA, J. Ross et al., Guest authorship and Ghostwriting in Publications Related to Rofecoxib, 299 p.1800 (2008)
- JAMA, Phil B. Fontanarosa & Catherine DeAngelis, Publication of Clinical Trials in JAMA, Information for authors, 299 p.95-96 (2008)
- NEJM, R. Schwartz et al., Full Disclosure and the Funding of Biomedical Research, 358 p.1850 (2008)
- NEJM, E. Turner et al., Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, 358 p.252 (2008)
2007
- BMJ, News, Caroline White, Surgery outcomes are to be made public - but a five year wait is likely, 335 p.416 (2007)
- BMJ, News, Caroline White, WHO database to include drug trials in China and India, 335 p.226 (2007)
- Chest, Deborah A. Zarin & Alla Keselman, Registering a Clinical Trial in ClinicalTrials.gov, 131 p.909 (2007)
- JAMA, Deborah A. Zarin et al., Issues in the Registration of Clinical Trials, 297 p.2112 (2007)
- NEJM, Jeffrey M. Drazen et al., Open Clinical Trials, 357 p.1756 (2007)
- NEJM, Clinical Trial Registration - Looking Back and Moving Ahead, 356 p.26 (2007)
- NEJM, Jeffrey M. Drazen & Deborah A. Zarin, Salvation by Registration, 356 p.184 (2007)
- PLOS, Catriona J. MacCallum, When Is Open Access Not Open Access? 5 p.e285 (2007)
2006
- BMJ, Fiona Godlee, An international standard for disclosure of clinical trial information, 332 p.1107 (2006)
- JAMA, Daniel K. Benjamin et al., Peer-reviewed publication of clinical trials completed for pediatric exclusivity, 296(10) p.1266 (2006)
- JAMA, P.M. Ridker, Incomplete financial disclosure for study of funding and outcomes in major cardiovascular trials , 295 p. 2725-2726 (2006)
- Lancet, Frank W Rockhold & Ronald L Krall, Trial summaries on results databases and journal publication, 367 p.1635 (2006)
- Lancet, Richard Horton, Trial registers: protecting patients, advancing trust, 367 p.1633 (2006)
- Lancet, Sim I, Chan et al., Clinical trial registration: transparency is the watchword. 367 p.1631-3 (2006)
- NEJM, DA Zarin et al., Trial registration at ClinicalTrials.gov between May and October 2005, 353 p. 2779 (2006)
- NEJM, Martin Frank, Access to the Scientific Literature - A Difficult Balance, 354(15) p.1552 (2006)
- Nature, Meredith Wadman, Industry anger over stringent trial disclosure requirements, 5 Nature Reviews p.527 (2006)
- Nature, Meredith Wadman, Verdict on clinical trials registries? Good, but must do better, 5 p. 175 (2006)
- PLOS, Elizabeth Wager, Publishing Clinical Trial Results: The Future Beckons, 1(6) e31 (2006)
- PLOS, The Impact of Open Access upon Public Health, 3(5) PLOS Medicine p.e252 (2006)
- PLOS Biology, Gunther Eysenbach, Citation Advantage of Open Access Articles, 4(5) p. e157 (2006)
- PLOS Biology, Catriona J. MacCallum and Hemai Parthasarathy, Open Access Increases Citation Rate, 4(5) p.e176 (2006)
- PLOS, Richard Smith & Ian Roberts, Patient Safety Requires a New Way to Publish Clinical Trials, PLOS Clinical Trials p.1 (2006)
- Prescrire, Agence française des produits de santé: accès à l'information : Jour J + 75 2006 ; 26 (269) Revue Prescrire p.103. (2006)
- Iain Chalmers, From optimism to disillusion about commitment to transparency in the medico-industrial complex, 99 J R Soc Med p. 337-341(2006)
2005
- BMJ, Kamran Abbasi & Fiona Godlee, Next step in clinical registration, 330 p.1222 (2005)
- BMJ, Jonathan D Wren, Open access and openly accessible: a study of scientific publications shared via the internet, 330 p.1128 (2005)
- BMJ, UK and US groups announce new initiatives on open access publishing, 330 p.1104 (2005)
- BMJ, Peter Suber, Open access, impact, and demand, Why some authors self archive their articles, 330 p.1097 (2005)
- BMJ, Karmela Krleza-Jeric et al., Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1), 330 p.956-958 (2005)
- BMJ, Jesse A. Berlin, Why industry should register and disclose results of clinical studies—Perspective of a recovering academic. 330 p.959 (2005)
- BMJ, Jeffrey K Aronson, Commentary: Open access publishing: too much oxygen? 330 p.759 (2005)
- BMJ, Sara Schroter et al., Perceptions of open access publishing: interviews with journal authors, 330 p.756 (2005)
- BMJ, Krall R, Rockhold F, More on compulsory registration of clinical trials: GSK has created useful register, 330 p.479 (2005)
- BMJ, Zosia Kmietowicz, US health agency scales down plans for free, online research results, 330 p.165 (2005)
- BMJ, Susan Mayor, Drug companies agree to make clinical trial results public, 330 p.109 (2005)
- BMJ, Kamran Abbasi, Trial results: the next battle, 330 (2005)
- JAMA, Fontanarosa et al., Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. 294 p.110-111 (2005)
- Lancet, WHO facilitates international collaboration in setting standards for clinical trial registration, The Lancet ( May 24, 2005)
- Nature, Setting new standards, 4 Nature reviews p.859 (2005)
- NEJM, Haug et al., Registries and Registration of Clinical Trials, 353 p.2811-2812 (2005)
- NEJM, Drazen & Wood, Trial Registration Report Card, 353 p. 2809-2811 (2005)
- NEJM, Deborah A. Zarin Trial Registration at ClinicalTrials.gov between May and October 2005, 353 p. 2779-2787 (2005)
- NEJM, Is This Clinical Trial Fully Registered? - A Statement from the International Committee of Medical Journal Editors, 352(23) p.2436 (2005)
- NEJM, Robert Steinbrook, Public Access to NIH-Funded Research, 352(17) p.1739 (2005)
- PLOS, Karmela KrleŽa-Jerić, Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group, 2 e378 (2005)
- PLOS, Ida Sim & Don E. Detmer, Beyond Trial Registration: A Global Trial Bank for Clinical Trial Reporting, 2(11) e 365 (2005)
- Eugene H Rubin, The Complexities of Individual Financial Conflicts of Interest, 30 Neuropsychopharmacology p.1-6 (2005)
2004
- BMJ, Giselle Jones &Kamran Abbasi, Trial protocols at the BMJ, 329 p. 1360 (2004)
- BMJ, Bob Roehr, Law is introduced in US Congress to give access to details of clinical trials, 329 p.996 (2004)
- BMJ, Kamran Abbasi, Compulsory registration of clinical trials, 329 p.637-638 (2004)
- BMJ, Owen Dyer, GlaxoSmithKline to set up comprehensive online clinical trials register, 329 p.590 (2004)
- BMJ, Andrew Herxheimer, Open access to industry's clinically relevant data, 329 p.64 (2004)
- BMJ, Liza Gibson, GSK to publish clinical trials after US lawsuit, 328 p.1513 (2004)
- BMJ, Owen Dyer, GSK faces US lawsuit over concealment of trial results, 328 p.1395 (2004)
- CMAJ, Mohit Bhandari et al., Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. 170 p. 477 (2004)
- CMAJ, Joel Lexchin & Barbara Mintzes, Transparency in drug regulation: Mirage or Oasis?, 171(11) p.1363 (2004)
- CMAJ, David Moher & Alan Bernstein, Registering CIHR-funded randomized controlled trials: A global public good, 171 p.750–775 (2004)
- JAMA, Drummond Rennie,Trial Registration, A Great Idea Switches From Ignored to Irresistible, 292(11) p.1359 (2004)
- Lancet, How, where, and when should trial data be reported, 364 p.1730 (2004)
- Lancet, Helen Frankish, Publishing wars, 364 The Lancet p.1391 (2004)
- Lancet, Evans et al., Registering clinical trials: an essential role for WHO, 363 (2004)
- Lancet, Is GSK guilty of fraud? 363 The Lancet p.1919 (2004)
- MJA, Thomas A Faunce & Stephen N C Bolsin, Three Australian whistleblowing sagas: lessons for internal and external regulation, 181 p.44 (2004)
- Nature Biotechnology, Tom Jacobs, The best companies bare all, 22(11) p.1363 (2004)
- Nature, Simon Frantz, Calls for full disclosure of clinical trials, 3 p.635 (2004)
- NEJM, Robert Steinbrook, Registration of Clinical Trials - Voluntary or Mandatory? 351(18) p.1820 (2004)
- NEJM, J. Drazen & G. Curfman, Responses by the authors, Public Access to Biomedical Research, 351 NEJM 2879 (2004)
- NEJM, Jeffrey M. Drazen & Gregory D. Curfman, Public Access to Biomedical Research, 351(13) p.1343 (2004)
- NEJM, Robert Steinbrook, Public Registration of Clinical Trials, 351(4) p.315 (July 22, 2004)
- PLOS, Erick H. Turner, A Taxpayer-Funded Clinical Trials Registry and Results Database, 1(3) e60 (2004)
- PLOS, Editorial, From Registration to Publication, 1(2) e 46 (2004)
- Chalmers I. In the dark. Drug companies should be forced to publish all the results of clinical trials. How else can we know the truth about their products. 19 New Scientist (March 6, 2004)
2003
- BMJ, Hans Melander et al., Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. 326 BMJ p.1171 (2003)
- BMJ, J. Lexchin et al., Pharmaceutical industry sponsorship and research outcome and quality: systematic review, 326 p. 1167 (2003)
- E. Wager et al., Good Publication Practice for pharmaceutical companies, 19 Curr Med Res Opinion, p. 149 (2003)
- JAMA, Kay Dickersin & Drummond Rennie, Registering clinical trials, 290(4) p.516-523 (2003)
- JAMA, Monika Krzyzanowska et al., Factors Associated With Failure to Publish Large Randomized Trials Presented at an Oncology Meeting, 290 p.495-501 (2003)
2002
- BMJ, Samena Chaudhry et al., Does declaration of competing interests affect readers' perceptions? A randomised trial, 325 (2002)
- BMJ, Eric Manheimer & Diana Anderson, Survey of public information about ongoing clinical trials funded by industry: evaluation of completeness and accessibility, 325 p.528-531 (2002)
- BMJ, Alison Tonks, A clinical trials register for Europe, 325 p.1314-1315 (2002)
- JAMA, Carin Olson et al., Publication bias in editorial decision making, 287 p.2825-2828 (2002)
2001
- Revue Prescrire, Some Drug Agencies Are More Open than Others (May 2001)
- JAMA, DeAngelis et al., Reporting financial conflicts of interest and relationships between investigators and research sponsors, 286 p.89-91 (2001)
- S. Krimsky & L.S. Rothenberg. Conflict of interest policies in science and medical journals: editorial practices and author disclosures,7 Sci Eng Ethics p.205-218 (2001)
2000
- Annals, Alexa T. McCray, Better access to information about clinical trials, 133 p.609-614 (2000)
- BMJ, Fred Charatan, US launches new clinical trials database, 320 p.668 (2000)
- T. Gibbs & E. Wager, Realities of trial registration: the Glaxo Wellcome experience. 14 Int J Pharmaceut Med p.203 (2000)
- Alexa T. McCray & Nicholas C. Ide, Design and Implementation of a National Clinical Trials Registry, 7(3) J Am Med Inform Assoc.p.313–323 (2000)
Pre-2000
- BMJ, Jacqui Wise CSM takes small step towards openness, 319 p.939 (1999)
- BMJ, News, Clare Dyer, UK introduces far reaching law to protect whistleblowers, 319 p.7 (1999)
- BMJ, Ian Roberts, An amnesty for unpublished trials, 317 p.763-764 (1998)
- BMJ,Richard Smith & Ian Roberts, An amnesty for unpublished trials, Editorial, 315 p.622 (1997)
- BMJ, Richard Horton & Richard Smith, The time to register randomized trials, 319 p.865 (1999)
- JAMA, John Ioannidis, Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials, 279 p.281-286 (1998)
- JAMA, Rennie D, Flanagin A, Glass RM. Conflicts of interest in the publication of science. 266 p.266-267 (1991)
- JAMA, Ian Chalmers, Under-reporting research is scientific misconduct. 263 JAMA p.1405 (1990)
- RJ Simes, Publication bias: the case for an international registry of clinical trials, 4 Journal of Clinical Oncology p.1529-1541(1986)
- Lancet, Horton R, Smith R. Time to register randomized trials, 354 p.1138 (1999)
- Lancet, Easterbrook & Berlin JA. Publication bias in clinical research, 337 p.867-872 (1991)
- Science, Gary Taubes, A plan to register unpublished studies, 277 p.1754 (1997)
- Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986;4: 1529-41(1986)
- Meinert CL. Toward prospective registration of clinical trials. Control Clin Trials 1988;9: 1-5 (1988)
Other sources
2007
2006
2005
2004
- Jeannette Campbell, Dare I blow the whistle? Is adequate protection given to SA employees in terms of the Protected Disclosures Act 26 of 2000? (10 September 2004)
- Brian Martin & Will Rifkin, The Dynamics of Employee Dissent: Whistleblowers and Organizational Jiu-Jitsu, 4 Public Organization Review p.221 (2004)
2003
2002
2001
2000
Pre-2000
- Tom Devine (GAP) Courage Without Martyrdom, The Whistleblower's - Survival Guide - Part 1 - Part 2 - Part - Part 4
Websites
- BioMed Central - Institutional open access guides and resources
- International Society of Drug Bulletins (ISDB) - Newsletters
- Brian Martin's website "Suppression of dissent"
- GAP - Government Accountability Project
- Corporate Crime Reporter
- For lawyers: Freivogel on Conflicts - A guide to conflicts of interest for lawyers