LETTER OF APPROVAL INDEPENDENT ETHICS COMMITTEE

Transcription

1 Bijlage C METC - SOP LETTER OF APPROVAL INDEPENDENT ETHICS COMMITTEE Study : PRA-code : Study Centre : Pharmaceutical Research Associates International Stationsweg GP ZUIDLAREN The Netherlands Sponsor : Sponsor-code : CCMO-code : NL The Independent Ethics Committee (Medisch Ethische ToetsingsCommissie) of the Foundation Evaluation of Ethics in Biomedical Research (Stichting Beoordeling Ethiek Biomedisch Onderzoek), Assen, The Netherlands, is constituted according to the Dutch national act on medical-scientific research in human beings [Wet Medisch- wetenschappelijk Onderzoek met mensen (WMO)], the Regulations of the U.S. Food and Drug Administration as laid down in the Code of Federal Regulations, 21 CFR, Part 56 (Institutional Review Board), and the ICH Harmonised Tripartite Guideline E6 on Good Clinical Practice (ICH-GCP). In accordance with the WMO the Committee has been accredited by the Central Committee on Research Involving Human Subjects [Centrale Commissie Mensgebonden Onderzoek (CCMO)] and by the Dutch Association of Ethics Committees [Nederlandse Vereniging van Medisch-Ethische Toetsingscommisses (NVMETC)]. The members of the Committee have taken into consideration the contents of the above-mentioned Regulations and the Declaration of Helsinki (1964), as lately amended by the 52 nd General Assembly, of the World Medical Association (Edinburgh, 2000) and the EU Clinical Trial Directive 2001/20/EC. The Committee has reviewed the information as indicated in Appendix I from ethical, legal and medical points of view and considers the protocol adequate for the aims to be investigated. All activities of the Committee were performed in accordance with the METC-SOP, version - 5, dated 28 August 2008.

2 PRA code: In the opinion of the Committee all human subjects have been adequately informed and sufficient safeguards for the protection of rights and welfare of the human subjects, participating in this investigation, have been assured by the Protocol and the participating investigators. Revised Protocols or Amendments that are implemented after the date of the approval must be subjected to the additional approval of the Committee. The Committee must be kept informed about the progress of the study and must be immediately informed (within 24 hours) about serious adverse events (including those indicated in Article 10, sub 1, of the medical Research in Human Subjects Act [also known by its Dutch abbreviation WMO] and about suspected unexpected serious adverse events. The Committee should also be informed about the beginning and the (premature) termination of the study. The Committee must be provided with a detailed report on the study, within one year after completion of the study. The Committee is of the opinion that all conditions mentioned in article 3 of the WMO have been met. The approval has a limited period of validity of one year after the date of signing as far as the start of the study is concerned. In case of a multi centre trial, approval is only granted for the parts to be carried out at centres that have provided a statement of local feasibility (see Appendix I). With the above considerations the undersigned declare that the Committee gives her approval to perform the investigations in accordance with the above-mentioned Protocol. We would like to point out that, based on section 7:1 of the Dutch national act on public administration (Algemene wet bestuursrecht, Awb), the party whose interest is directly involved in this decision can file a notice of objection, within six weeks after the day upon which the decision was made public, with the Stichting Beoordeling Ethiek Biomedisch Onderzoek. Such a notice of objection should be addressed to The Secretary of Stichting BEBO, P.O. Box 1004, 9400 BA Assen. Finally the party concerned can lodge an appeal with the Court of Justice against a decision that concerns scientific research with medicinal products within six weeks after the day upon which the decision was made public. Assen, Chairman, Secretary, M.F. Korver. Ph.D., M.D. J.P. van Dijk, Ph.D., M.D., LL.M. J.N. Jedema, Pharm. D. Mrs. Y.E. van Dijk, L.L.M.

3 LETTER OF APPROVAL APPENDIX I The Independent Ethics Committee (Medisch Ethische ToetsingsCommissie) of the 'Stichting Beoordeling Ethiek Biomedisch Onderzoek', Assen, The Netherlands, reviewed in the meeting of the information on the study with PRA-code, entitled: The following documents and revised versions, provided by the applicant, have been submitted to the Independent Ethics Committee on and on. CCMO-registration number: NL, ABR-Form version EudraCT number:, EudraCT Application Form, dated Clinical Study Protocol and Appendices, dated PRA Study Synopsis, dated Information Leaflet for the volunteers (Dutch version), dated Informed Consent including Statement of Willingness (English and Dutch version), dated Certificates of Insurance of - WMO subject insurance for PRA with, HDI-Gerling Industrie Versicherung AG Policy number: Liability insurance for PRA with, HDI-Gerling Verzekeringen NV Policy number: Medical malpractice insurance for PRA with Bloemers & Partners Ltd, Policy number: 441/L Curricula Vitae of - the Medical Investigator: - the Independent Physician: J.T.M. van Leeuwen, M.D. Statement of Local Feasibility, dated Comment on Sample Size Calculation, dated Medical Information, consisting of: - Investigators Drug Brochure on, dated - Investigational Medicinal Product Dossier on, dated

4 LETTER OF APPROVAL APPENDIX II PRA code: Members of the INDEPENDENT ETHICS COMMITTEE voting on the protocol entitled: M.F. Korver, Ph.D., M.D., chairman S.J.A. Bolman, Pharm. D. Mrs. E.A.G. Bouma, M.Sc., R.N. Mrs. A.A. Broekema, Ph.D., M.D. J.P. van Dijk, Ph.D., M.D., LL.M., secretary W.M.T. Janssen, Ph.D., M.D. Mrs. W.M. Noordhoek Eekhof Mrs. A.N. Raat, M.Sc. D.R.A. Uges, Ph.D., Pharm. D. Retired Director Medical Affairs Wilhelmina Hospital, Assen Specialist in Internal Medicine, n.p. Havelte Hospital Pharmacist, n.p. Staphorst Staff Nurse Management Team Department of Surgery Specialist in Anaesthesiology Assistant Professor of Social Medicine Assistant Professor of Health Law Faculty of Medical Sciences Specialist in Internal Medicine / Nephrologist Martini Hospital, Groningen Lay member, with special responsibilities to protect the interests of the volunteers, Blokzijl Medical Ethicist Co-ordinator Medical Education and Staff member Medical Assessment Faculty of Medical Sciences Professor of Clinical and Forensic Toxicology Hospital Pharmacist / Clinical Pharmacologist Head of Laboratory of Drug Analysis Department of Pharmacy R. Venekamp, M.D. Senior Staff member Realisation Teaching Hospitals Mrs. E.M. ten Vergert, Ph.D. Sociologist, Methodologist

5 Associate Professor of Health Science Head, Office for Medical Technology Assessment

6 LETTER OF APPROVAL PRA code: APPENDIX II Members of the INDEPENDENT ETHICS COMMITTEE voting on the protocol entitled: J.N. Jedema, Pharm. D., chairman G.L. Bartels, Ph.D., M.D. Mrs. H.J.M. Berg-Pilaar Mrs. D.S. Bosscher, M.A., R.N. J.R.B.J. Brouwers, Ph.D., Pharm. D. Mrs. Y.E. van Dijk, L.L.M., secretary Hospital Pharmacist Director Outpatient Clinic Licensed Expert on Radioactivity Wilhelmina Hospital, Assen Cardiologist Martini Hospital, Groningen Lay member, with special responsibilities to protect the interests of the volunteers, Assen Nurse Practitioner Specialist in Lung Transplantation Professor of Pharmacotherapy Hospital Pharmacist / Clinical Pharmacologist Department of Pharmacy Legal Policy Advisor Zorggroep Noorderbreedte Leeuwarden- Heerenveen K. Hoogenberg, Ph.D., M.D. Specialist in Internal Medicine / Endocrinologist Martini Hospital, Groningen Mrs. E.L.M. Maeckelberghe, Ph.D. N.J.G.M. Veeger, M.Sc. L.J.G. Veehof, Ph.D., M.D. Assistant Professor of Ethics Ethicist, Faculty of Medical Sciences Senior Staff member, Expertise Centre of Ethics in Care Clinical Epidemiologist / Methodologist Thorax Center General Practitioner, Groningen Assistant Professor in General Practice

7 Faculty of Medical Sciences