Ethics committees and achievement of good clinical practice

Therapie

Volumn 51, Issue 4, 1996, Pages 369-372

  Glasa, J ^a   Holoman J ^a   Klepanec, J ^a   Soltes L ^a  

^a University Hospital in Bratislava   (Slovakia)

Author keywords

Biomedical research; Clinical trials of new medicines; Ethics committees; Good clinical practice; Informed consent

Indexed keywords

CONFERENCE PAPER; DECISION MAKING; DRUG RESEARCH; ETHICS; GOOD CLINICAL PRACTICE; PRIORITY JOURNAL; STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; DECISION MAKING; ETHICS COMMITTEES; HUMANS; INFORMED CONSENT; PHYSICIAN'S PRACTICE PATTERNS; RESEARCH; SLOVAKIA; SOCIAL RESPONSIBILITY;

EID: 0029782586     PISSN: 00405957     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (34)

1. Summary Report. Towards an International Ethic for Research with Human Beings: Proceedings of the International Summit Conference on Bioethics, April 5-10, 1987, Ottawa, Canada, pp. 60-66. Ottawa, Ontario: Medical Research Council of Canada (1988). Cited from: Reich W.T. (Ed.): Encyclopedia of Bioethics, 2nd Edition, New York, Macmillan: vol. I.-V., 1995: 2790-2794.
2. Summary Report. Towards an International Ethic for Research with Human Beings: Proceedings of the International Summit Conference on Bioethics, April 5-10, 1987, Ottawa, Canada, pp. 60-66. Ottawa, Ontario: Medical Research Council of Canada (1988). Cited from: Reich W.T. (Ed.): Encyclopedia of Bioethics, 2nd Edition, New York, Macmillan: vol. I.-V., 1995: 2790-2794.
3. Recommendation No. R (90) 3 of the Committee of Ministers to Member States Concerning Medical Research on Human Beings. Council of Europe (1990).
4. Rothman DJ. Research human: historical aspects. In: Reich WT (ed.), Simon & Schuster, Encyclopedia of bioethics, 2nd Edition. New York: Macmillan, Vol. I.-V., 1995: 2248-2258.
5. Anonymous. All the world's a stage for ethical dilemmas. Bull Med Ethics 1995; 109: 3-7.
6. Glasa J (Ed.). Contemporary Problems of Medical Ethics in Central Europe. Bratislava (Slovakia), Chads: 1992; 128.
7. Haderka J. Why cooperation in medical ethics in Central European area is advisable and how to acheive it. In: Glasa J(Ed.). Contemporary. 1992; 31-37.
8. Szawarski Z. Research ethics in eastern Europe. Bull Med Eth 1992; 82: 13-18.
9. Maximilian C. Dilemmas of medicine in the transition period (Romania). Int J Bioethics 1995; 6: 36.
10. Dzúrik R, Fedelešová V. GCP in Central and East European Countries. In: Holomán J, Glasa J, Bechtel PR, Tiribelli C (Eds.). Liver and Drugs '94, Progress in Hepato-Pharmacology, 1, 1995; 64-66.
11. Holomán J. Good clinical practice and hepatology. In: Holomán J, Glasa J, Bechtel PR, Tiribelli C (Eds.): Liver and drugs '94, Progress in Hepato-Pharmacology, 1, 1995; 62-63.
12. Glasa J. Present controversies and future perspectives of bioethics: A Central European's View. In: D'Agostino F. (Ed.). Bioethics in confrontation. Proceedings of the Conference 'Bioetiche a confronta', Rome, October 20, 1995, Comitato Nazionale per la Bioetica, Rome, 1996 (in press).
13. CPMP Working Party on Efficacy of Medicinal Products, Commission of the European Community: Good Clinical Practice for Trials on Medicinal Products in the European Community, Note for Guidance, III/3976/88-EN, Brussels, 1991, 36 pages.
14. Spilker B. 27. Informed Consent and Ethics Committee/Institutional Review Board Processes. In: Spilker B (Ed.). Guide to Clinical Trials. New York: Raven Press, 1991: 202-218.
15. Spilker B. 33. Ethical consideration isues. In: Spilker B (Ed.): Guide to clinical trials. New York: Raven Press, 1991: 245-257.
16. Glasa J. Ethical considerations in GCP. In: Holomán J, Glasa J, Bechtel PR, Tiribelli C (Eds.). Liver and Drugs '94, Progress in Hepato-Pharmacology (Bratislava), 1, 1995; 67-73.
17. Informed consent refers to the voluntary confirmation of a subject's willigness to participate in a particular trial, and the documentation thereof. It should only be sought after information has been given about the trial including an explanation of its objectives, potential benefits and risks and inconveniences, and of subject's rights and responsibilities in accordance with the current revision of the Helsinki Declaration of the World Medical Association (17) (according to (18)).
18. Helsinki Declaration, cited from (18), p. 47-50.
19. Bankowski Z (Ed.). International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS & WHO, Geneva, August 1992, 8-52.
20. Levine RJ. Informed consent. In: Levine RJ. Ethics and Regulation of Clinical Research. Baltimore, Munich: Urban & Schwarzenberg, 1981: 69-115.
21. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979). OPRR Reports. Washington, DC, US. Government Printing Office (1988), 201-778/803/19. Cited from: Reich WT (Ed.): Encyclopedia of Bioethics, 2nd Edition. New York: Macmillan, Vol. I-V, 1995: 2767-2773.
22. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979). OPRR Reports. Washington, DC, US. Government Printing Office (1988), 201-778/803/19. Cited from: Reich WT (Ed.): Encyclopedia of Bioethics, 2nd Edition. New York: Macmillan, Vol. I-V, 1995: 2767-2773.
23. DHHS Regulations for the Protection of Human Subjects (45 CFR 46), June 18, 1991. OPRR Reports. Washington, DC, US Government Printing Office (1992), 0-307-551. Cited from: Reich WT (Ed.): Encyclopedia of Bioethics, 2nd Edition. New York: Macmillan, Vol. I-V, 1995: 2773-2790.
24. DHHS Regulations for the Protection of Human Subjects (45 CFR 46), June 18, 1991. OPRR Reports. Washington, DC, US Government Printing Office (1992), 0-307-551. Cited from: Reich WT (Ed.): Encyclopedia of Bioethics, 2nd Edition. New York: Macmillan, Vol. I-V, 1995: 2773-2790.
25. Glasa J. Správna vedecká prax a problém poctivého prístupu k vedeckej práci (Good scientific practice and the problem of a honest attitude to the scientific work). Biochem Clin Bohemoslov 1992; 21: 323-331.
26. Levine RJ. Research ethics committees. In: Reich WT (Ed.), Simon & Schuster. Encyclopedia of Bioethics, 2nd Edition. New York: Macmillan, Vol. I-V, 1995: 2266-2270.
27. Protection of persons undergoing biomedical research. Law No. 88-1138 of Dec. 20, 1988 (Journal officiel' dated Dec. 22, 1988) as amended by Law No. 90-86 of Jan. 23, 1990 ('Journal officiel' dated Jan. 25, 1990), Acts of Parliament, Vol. I., Code of Public Health, Book IIa, Paris, France.
28. Glasa J. Medical ethics and bioethics in the Slovak Republic (1990-1992). Int J Bioethics 1993; 4: 228-230.
29. Guidelines on Establishment and Work of Ethics Committees within the Department of Health of the Slovak Republic, Ministry of Health, Bratislava, June 1992, Medical Ethics and Bioethics (Bratislava), 1(2), 1994; 5-6, 11.
30. Robbins G. Ethics Committees. Lancet, 1995; i: 653.
31. Saunders J. LREC problems: a member's perspective. Bull Med Ethics 1995; 112: 5-17.
32. Doyal L. Towards a standard application form for LRECs. Bull Med Ethics 1994; 101: 15-28.
33. Scott G, Goode K. Reporting the outcome of ethics review. Bull Med Ethics 1995; 110: 16-17.
34. Niederland TR. Úlohy klinickych biochemikov v rámci práce etickch komisií pre biomedicínsky vyskum (Role of clinical biochemists in the work of ethics committees for biomedical research). Biochem Clin Bohemoslov 1992; 21: 229-235.