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Volumn 27, Issue 2, 2004, Pages 154-165

Research Ethics Committees: Can They Contribute to the Improvement of Clinical Research in Europe

Author keywords

Bioethics; Ethics committees clinical; Ethics committees research; Scientific misconduct; Therapeutic human experimentation

Indexed keywords

CLINICAL PROTOCOL; CLINICAL RESEARCH; EUROPE; INFORMED CONSENT; PUBLICATION; REPRODUCIBILITY; RESEARCH ETHICS; REVIEW;

EID: 1642326714     PISSN: 01489917     EISSN: None     Source Type: Journal    
DOI: 10.1097/00004479-200404000-00012     Document Type: Review
Times cited : (10)

References (43)
  • 1
    • 0034728855 scopus 로고    scopus 로고
    • Multicentre research ethics committees: Has the cure been worse than the disease?
    • Alberti, K. G. M. M. (2000). Multicentre research ethics committees: Has the cure been worse than the disease? British Medical Journal, 320, 1157-1158.
    • (2000) British Medical Journal , vol.320 , pp. 1157-1158
    • Alberti, K.G.M.M.1
  • 2
    • 0034682384 scopus 로고    scopus 로고
    • Is academic medicine for sale?
    • Angell, M. (2000). Is academic medicine for sale? New England Journal of Medicine, 342(20), 1516-1518.
    • (2000) New England Journal of Medicine , vol.342 , Issue.20 , pp. 1516-1518
    • Angell, M.1
  • 3
    • 0037460781 scopus 로고    scopus 로고
    • Under-reporting of clinical trials is unethical
    • Antes, G., Chalmers, I. (2003). Under-reporting of clinical trials is unethical. Lancet, 361, 978.
    • (2003) Lancet , vol.361 , pp. 978
    • Antes, G.1    Chalmers, I.2
  • 4
    • 0035954091 scopus 로고    scopus 로고
    • Ethics behind closed doors. Do research ethics committees need secrecy?
    • Ashcroft, R., & Pfeffer, N. (2001). Ethics behind closed doors. Do research ethics committees need secrecy? British Medical Journal, 322, 1294-1296.
    • (2001) British Medical Journal , vol.322 , pp. 1294-1296
    • Ashcroft, R.1    Pfeffer, N.2
  • 5
    • 0029558308 scopus 로고
    • The relationships between methodological quality and conclusions in review of spinal manipulation
    • Assendelft, W. J. J., Koes, B. W., Knipschild, P. G., & Bouter, L. M. (1995). The relationships between methodological quality and conclusions in review of spinal manipulation. JAMA, 274, 1942-1948.
    • (1995) JAMA , vol.274 , pp. 1942-1948
    • Assendelft, W.J.J.1    Koes, B.W.2    Knipschild, P.G.3    Bouter, L.M.4
  • 6
    • 0032477565 scopus 로고    scopus 로고
    • Meeting the challenges facing research ethics committees: Some practical suggestions
    • Blunt, J., Savulescu, J., & Watson, A. J. M. (1998). Meeting the challenges facing research ethics committees: some practical suggestions. British Medical Journal, 316, 58-61.
    • (1998) British Medical Journal , vol.316 , pp. 58-61
    • Blunt, J.1    Savulescu, J.2    Watson, A.J.M.3
  • 7
    • 85025552136 scopus 로고    scopus 로고
    • Aspirin vs clopidogrel: The wrong question?
    • Born, G. V., & Collins, R. (1997). Aspirin vs clopidogrel: The wrong question? Lancet, 349, 806-807.
    • (1997) Lancet , vol.349 , pp. 806-807
    • Born, G.V.1    Collins, R.2
  • 8
    • 0042527710 scopus 로고    scopus 로고
    • Characteristics of medical schools faculty members serving in Institutional Review Boards (IRBs): Results of a national survey
    • Campbell, E. G., Weissman, J. S., Clarridge, B., Yucel, R., Causino, N., Blumenthal, D., et al. (2003). Characteristics of medical schools faculty members serving in Institutional Review Boards (IRBs): Results of a national survey. Academic Medicine, 78(8), 831-836.
    • (2003) Academic Medicine , vol.78 , Issue.8 , pp. 831-836
    • Campbell, E.G.1    Weissman, J.S.2    Clarridge, B.3    Yucel, R.4    Causino, N.5    Blumenthal, D.6
  • 9
    • 0036792615 scopus 로고    scopus 로고
    • New governance arrangements for research ethics committees: Is facilitating research achieved at the costs of participants interests?
    • Cave, E., & Holm, S. (2002). New governance arrangements for research ethics committees: Is facilitating research achieved at the costs of participants interests? Journal of Medical Ethics, 28, 318-321.
    • (2002) Journal of Medical Ethics , vol.28 , pp. 318-321
    • Cave, E.1    Holm, S.2
  • 10
    • 84948750458 scopus 로고    scopus 로고
    • Using systematic reviews and registers of ongoing trials for scientific and ethical trial design, monitoring, and reporting
    • M. Egger, G. D. Smith, D. G. Altman (Eds.), London: BMJ Books
    • Chalmers, I. (2001). Using systematic reviews and registers of ongoing trials for scientific and ethical trial design, monitoring, and reporting. In M. Egger, G. D. Smith, D. G. Altman (Eds.), Systematic reviews in health care: Meta analysis in context (pp. 429-443). London: BMJ Books.
    • (2001) Systematic Reviews in Health Care: Meta Analysis in Context , pp. 429-443
    • Chalmers, I.1
  • 11
    • 0032982208 scopus 로고    scopus 로고
    • Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical protocols on medicines
    • Dal Re, R., Espada, J., & Ortega, R. (1999). Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical protocols on medicines. Journal of Medical Ethics, 25, 268-273.
    • (1999) Journal of Medical Ethics , vol.25 , pp. 268-273
    • Dal Re, R.1    Espada, J.2    Ortega, R.3
  • 13
    • 85039567100 scopus 로고    scopus 로고
    • Linee Guida di Riferimento per la Istituzione dei Comitati Etici
    • Decreto Ministeriale. Linee Guida di Riferimento per la Istituzione dei Comitati Etici. 2003. Gazzetta Ufficiale n. 122 del 28 maggio 1998. Retrived September 20, 2003, from http://oss-sper-clin.sanita.it/normativa/DM18& lowbar;03_1998.pdf.
    • (2003) Gazzetta Ufficiale n. 122 del 28 Maggio 1998
  • 14
    • 0038455700 scopus 로고    scopus 로고
    • Registering clinical trials
    • Dickersin, K., & Rennie, D. (2003). Registering clinical trials. JAMA, 290, 516-523.
    • (2003) JAMA , vol.290 , pp. 516-523
    • Dickersin, K.1    Rennie, D.2
  • 15
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel, E., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283, 2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.1    Wendler, D.2    Grady, C.3
  • 16
    • 0003177157 scopus 로고    scopus 로고
    • European Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001. On the approximation of law, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal product for human use
    • 1.5.2001
    • European Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001. On the approximation of law, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal product for human use. Official Journal of the European Communities L121, 1.5.2001, (pp. 34-41).
    • Official Journal of the European Communities , vol.L121 , pp. 34-41
  • 18
    • 0038777088 scopus 로고    scopus 로고
    • How can research ethics committees protect patients better?
    • Garattini, S., Bertelè, V., Li & Bassi, L. (2003). How can research ethics committees protect patients better? British Medical Journal, 326, 1199-1201.
    • (2003) British Medical Journal , vol.326 , pp. 1199-1201
    • Garattini, S.1    Bertelè, V.2    Li3    Bassi, L.4
  • 19
  • 20
    • 0026485449 scopus 로고
    • Unethical placebo assignment in clinical trials of thrombolysis
    • Geraci, E. (1992). Unethical placebo assignment in clinical trials of thrombolysis. Journal of American College of Cardiology, 20(5), 1302-1303.
    • (1992) Journal of American College of Cardiology , vol.20 , Issue.5 , pp. 1302-1303
    • Geraci, E.1
  • 21
    • 0035922432 scopus 로고    scopus 로고
    • Withholding proven treatment in clinical research
    • Huston, P., & Peterson, P. (2001). Withholding proven treatment in clinical research. New England Journal of Medicine, 345(12), 912-914.
    • (2001) New England Journal of Medicine , vol.345 , Issue.12 , pp. 912-914
    • Huston, P.1    Peterson, P.2
  • 22
    • 21744451562 scopus 로고    scopus 로고
    • (October), Verona, Italy
    • Italian Cochrane Centre. (2002, October) VIII Annual meeting: The role of research ethics committees. Verona, Italy. Retrieved September 18, 2003 from http://www.cochrane.it/main.asp?pag = convegnoco-mitati&menu=arc.
    • (2002) VIII Annual Meeting: The Role of Research Ethics Committees
  • 23
    • 0034025634 scopus 로고    scopus 로고
    • Reasons for accepting or declining to participate in randomised clinical trials for cancer therapy
    • Jenkins, V., & Fallowfield, L. (2000). Reasons for accepting or declining to participate in randomised clinical trials for cancer therapy. British Journal of Cancer, 82, 1783-1788.
    • (2000) British Journal of Cancer , vol.82 , pp. 1783-1788
    • Jenkins, V.1    Fallowfield, L.2
  • 24
    • 1642342196 scopus 로고    scopus 로고
    • Failure to publish results of epidemiologic studies is unethical
    • Kravitz, D. A. (2000). Failure to publish results of epidemiologic studies is unethical. Epidemiology, 283, 2701-2711.
    • (2000) Epidemiology , vol.283 , pp. 2701-2711
    • Kravitz, D.A.1
  • 25
    • 0042431931 scopus 로고    scopus 로고
    • Shattuck Lecture. Clinical research to clinical practice: Lost in translation?
    • Lenfant, C. (2003). Shattuck Lecture. Clinical research to clinical practice: Lost in translation? New England Journal of Medicine, 349(9), 868-874.
    • (2003) New England Journal of Medicine , vol.349 , Issue.9 , pp. 868-874
    • Lenfant, C.1
  • 26
    • 0030767808 scopus 로고    scopus 로고
    • Unethical trials of intervention to reduce perinatal transmission of the human immunodeficiency virus in developing countries
    • Lurie, P., & Wolfe, S. (1997). Unethical trials of intervention to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine, 337, 853-856.
    • (1997) New England Journal of Medicine , vol.337 , pp. 853-856
    • Lurie, P.1    Wolfe, S.2
  • 27
    • 0037014856 scopus 로고    scopus 로고
    • Research ethics committees and public dissemination of clinical trials results
    • Mann, H. (2002). Research ethics committees and public dissemination of clinical trials results. Lancet, 360, 406-408.
    • (2002) Lancet , vol.360 , pp. 406-408
    • Mann, H.1
  • 28
    • 0037927884 scopus 로고    scopus 로고
    • Role of research ethics committees in follow up and publication of results
    • Martini, N., Tomino, C., & Liberati, A. (2003). Role of research ethics committees in follow up and publication of results. Lancet, 361, 2246.
    • (2003) Lancet , vol.361 , pp. 2246
    • Martini, N.1    Tomino, C.2    Liberati, A.3
  • 30
    • 26544462207 scopus 로고    scopus 로고
    • Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (responsabile Carlo Tomino)
    • Giugno
    • Ministero della Salute. (2003). Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (responsabile Carlo Tomino). Bollettino no. 2, Giugno 2003. Bollettino di Informazione sui Farmaci (BIF) (inserto Speciale) Anno X n. 3-4. Retrieved September 27, 2003, from http://oss-sper-clin.sanita.it/dati_ pubblicazioni.htm.
    • (2003) Bollettino no. 2
  • 31
    • 85039568345 scopus 로고    scopus 로고
    • Anno X n. 3-4
    • Ministero della Salute. (2003). Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (responsabile Carlo Tomino). Bollettino no. 2, Giugno 2003. Bollettino di Informazione sui Farmaci (BIF) (inserto Speciale) Anno X n. 3-4. Retrieved September 27, 2003, from http://oss-sper-clin.sanita.it/dati_ pubblicazioni.htm.
    • (2003) Bollettino di Informazione sui Farmaci (BIF) (Inserto Speciale)
  • 32
    • 0024332944 scopus 로고
    • Quality evolution and clinical implication of randomised controlled trials in the treatment of lung cancer. A lost opportunity for metanalysis
    • Nicolucci, A., Grilli, R., Alexanian, A. A., Apolone, G., Torri, V., & Liberati, A. (1989). Quality evolution and clinical implication of randomised controlled trials in the treatment of lung cancer. A lost opportunity for metanalysis. JAMA, 262, 2101-2107.
    • (1989) JAMA , vol.262 , pp. 2101-2107
    • Nicolucci, A.1    Grilli, R.2    Alexanian, A.A.3    Apolone, G.4    Torri, V.5    Liberati, A.6
  • 33
    • 0035936261 scopus 로고    scopus 로고
    • A practical guide to informed consent to treatment
    • Oxman, A., Chalmers, I., & Sackett, D. L. (2001). A practical guide to informed consent to treatment. British Medical Journal, 323, 1464-1466.
    • (2001) British Medical Journal , vol.323 , pp. 1464-1466
    • Oxman, A.1    Chalmers, I.2    Sackett, D.L.3
  • 34
    • 85039576547 scopus 로고
    • Is proper methodology associated with the use of clinically relevant end point? The case of randomised control trials on medical treatment of open angle glaucoma (Document no. 100)
    • Novermber 11
    • Rossetti, L., Marchetti, I., Orzalesi, N., Scorpiglione, N., & Liberati, A. (1993, Novermber 11) Is proper methodology associated with the use of clinically relevant end point? The case of randomised control trials on medical treatment of open angle glaucoma (Document no. 100). Online Journal of Current Clinical Trials.
    • (1993) Online Journal of Current Clinical Trials
    • Rossetti, L.1    Marchetti, I.2    Orzalesi, N.3    Scorpiglione, N.4    Liberati, A.5
  • 35
  • 36
    • 0036964057 scopus 로고    scopus 로고
    • Clinical epidemiology: What, who and whither
    • Sackett, D. (2002). Clinical epidemiology: What, who and whither. Journal of Clinical Epidemiology, 55(12), 1161-1166.
    • (2002) Journal of Clinical Epidemiology , vol.55 , Issue.12 , pp. 1161-1166
    • Sackett, D.1
  • 37
    • 1642386187 scopus 로고
    • Why was treatment of cytomegalovirus retinitis randomised?
    • Salit, I. E. (1992). Why was treatment of cytomegalovirus retinitis randomised? Annals of Internal Medicine, 116(7), 104-105.
    • (1992) Annals of Internal Medicine , vol.116 , Issue.7 , pp. 104-105
    • Salit, I.E.1
  • 38
    • 0029848062 scopus 로고    scopus 로고
    • Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability
    • Savulescu, J., Chalmers, I., & Blunt, J. (1996). Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. British Medical Journal, 313, 1390-1393.
    • (1996) British Medical Journal , vol.313 , pp. 1390-1393
    • Savulescu, J.1    Chalmers, I.2    Blunt, J.3
  • 39
    • 0027534577 scopus 로고
    • Sulfasalazine revisited: A meta-analysis of 5 Aminosalycitic acid in the treatment of ulcerative colitis
    • Sutherland, L. R., May, G. R., & Shaffer, E. A. (1993). Sulfasalazine revisited: A meta-analysis of 5 Aminosalycitic acid in the treatment of ulcerative colitis. Annals of Internal Medicine, 118, 540-549.
    • (1993) Annals of Internal Medicine , vol.118 , pp. 540-549
    • Sutherland, L.R.1    May, G.R.2    Shaffer, E.A.3
  • 41
    • 0030803133 scopus 로고    scopus 로고
    • Ethical complexities of conducting research in developing countries
    • Varmus, H., & Satcher, D. (1997). Ethical complexities of conducting research in developing countries. New England Journal of Medicine, 337, 847-849.
    • (1997) New England Journal of Medicine , vol.337 , pp. 847-849
    • Varmus, H.1    Satcher, D.2
  • 42
    • 0038167780 scopus 로고    scopus 로고
    • Who's afraid of the European Clinical Trials Directive?
    • Who's afraid of the European Clinical Trials Directive? [Editorial]. (2003). Lancet, 361, 2167.
    • (2003) Lancet , vol.361 , pp. 2167


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