Research Ethics Committees - Documents
European and International Documents concerning Research Ethics Committees
- European Parliament Clinical Trials Directive 2001/20/EC [EC]
- European Commission Good Clinical Practice Directive 2005/28/EC [EC]
- World Medical Association Declaration of Helsinki
- Universal Declaration on the Human Genome and Human Rights
- Convention on Human Rights and Biomedicine, CoE
- Additional Protocul to the Convention on Human Rights and Biomedicine, concerning biomedical research 2005, CoE
- World Health Organisation Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
- ICH-GCP: Guidelines for Good Clinical Practice, EMEA, E6
- Nuremberg Code of 1947
Clinical Trials Directive Guidance
- Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use as required by Article 8 of Directive 2001/20/EC revision 1 - EC
- Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial as required by Article 9 (8) of Directive 2001/20/EC revision 1
Useful European/International Reports
- 'European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations' EuroSOCAP is coordinated by Professor Roy McClelland, Queen's University Belfast, published online July 2005.
- 'International Compilation of Human Subject Research Protections' coordinated by E. Bartlett, International Activities Program, Office for Human Research Protection, Washington US, published online June 2005.
- 'Provision of Support for Producing a European Directory of Local Ethics Committees (LECs)' by M. Fuchs, M. Heyer, N. Fischer and R. Avulyte, EC contract no SAS5-CT-2002-30047, published online Jan 2005.
- 'Ethical Review of Biomedical Research in Europe: Suggestions for best national practices' by Povl Riis, Steering Committee on Bioethics (CDBI) Working Party on Biomedical Research, 22 June 1998. The D.E.B.R.A Project.
- National Bioethics Committees
- Steering Committee on Bioethics (CDBI) Council of Europe
- European Group on Ethics in Science and New Technulogies (EGE)
- EGE Opinion No 17 - Ethical aspects of clinical research in developing countries
- Originpharm.com - Overview of the EC Directive on Clinical Trials
- European Agency for the Evaluation of Medicinal Products (EMEA)
- EMEA Report 2001 on Ethical Considerations in Clinical Trials
- The European Conference of National Ethics Committees (COMETH)
- European Commission Pharmacos click on 'F2' for pharmaceutical news
- European Forum on Good Clinical Practice