The protection of patients’ rights in clinical trials
- Marek Czarkowski MD
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The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting.
- World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects http://www.wma.net/e/policy/b3.htm.
- Operational Guidelines for Ethics Committees That Review Biomedical Research. (2000) World Health Organization Geneva.
- Guidelines and Recommendations for European Ethics Committees. (1997) European Forum for Good Clinical Practice. Revised Edition EFGCP.
- April 30, 2004 Order of the Minister of Finance concerning the mandatory civil liability insurance of researchers and sponsors. (2004) Legislation Journal of the Republic of Poland 101: Pos. 1034
- May 18, 2005 Order of the Minister of Finance amending the regulation concerning the mandatory civil liability insurance of researchers and sponsors. (2005) Legislation Journal of the Republic of Poland 101: Pos. 845
- Directive 2001/20/EC of the European Parliament and of the Council 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 on medicinal products for human use (2001) Official Journal of the European Communities 44: 34–44.
- March 13, 2004 Proclamation by the Speaker of the Sejm (Polish Lower House of Parliament) announcing the passing of a uniform Pharmaceutical Act. (2004) Legislation Journal of the Republic of Poland 53: Pos. 533.
- April 7, 2005 Order of the Minister of Health concerning the nature and extent of inspection of clinical trials. (2005) Legislation Journal of the Republic of Poland 69: pos. 623.
- The protection of patients’ rights in clinical trials
Science and Engineering Ethics
Volume 12, Issue 1 , pp 131-138
- Cover Date
- Print ISSN
- Online ISSN
- Kluwer Academic Publishers
- Additional Links
- protection of patients’ rights
- clinical trials
- ethic committees
- Author Affiliations
- 1. Department of Internal Medicine and Endocrinology, Medical University of Warsaw, ul. Banacha 1A, 02-097, Warsaw, Poland