Research ethics committees: Differences and moral judgement

Bioethics

Volumn 18, Issue 5, 2004, Pages 408-427

  Edwards, Sarah J L ^a   Ashcroft, Richard ^b   Kirchin, Simon ^c  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b IMPERIAL COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY OF KENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; JURISPRUDENCE; JUSTICE; MEDICAL RESEARCH; MORALITY; ORGANIZATION; RESEARCH ETHICS; REVIEW;

EID: 4544343304     PISSN: 02699702     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2004.00407.x     Document Type: Review

References (40)

1. nd General Assembly. Edinburgh.
2. Department of Health, UK. 2001. The Role of RECs, Governance Arrangements for NHS Research Ethics Committees. Section 2. Department of Health. Research Governance Framework for Health and Social Care. Available at: http://www.doh.gov.uk/research
3. World Health Organisation. 2000. Operational Guidelines for Ethics Committees that Review Biomedical Research. Available at: http://www.who.int/ tdr/publications/publications/ethics.htm
4. J.D. Moreno. 1995. Deciding Together. Bioethics and Moral Consensus. Oxford. Oxford University Press. T. Smith. 1999. Ethics in Medical Research: A Handbook of Good Practice. Cambridge. Cambridge University Press: 5.
5. J.D. Moreno. 1995. Deciding Together. Bioethics and Moral Consensus. Oxford. Oxford University Press. T. Smith. 1999. Ethics in Medical Research: A Handbook of Good Practice. Cambridge. Cambridge University Press: 5.
6. 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. Available at: http://europa.eu.int/ This piece of legislation was influenced by international guidelines adopted by the US, European and Japanese Pharmaceutical Industry associations and regulatory authorities. International Conference on Harmonisation of Good Clinical Practice. 1997. General Considerations for Clinical Trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997. Tripartite Guideline. Available at: http://www.ifpma.org/ich1.html
7. 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. Available at: http://europa.eu.int/ This piece of legislation was influenced by international guidelines adopted by the US, European and Japanese Pharmaceutical Industry associations and regulatory authorities. International Conference on Harmonisation of Good Clinical Practice. 1997. General Considerations for Clinical Trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997. Tripartite Guideline. Available at: http://www.ifpma.org/ich1.html
8. 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. Available at: http://europa.eu.int/ This piece of legislation was influenced by international guidelines adopted by the US, European and Japanese Pharmaceutical Industry associations and regulatory authorities. International Conference on Harmonisation of Good Clinical Practice. 1997. General Considerations for Clinical Trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997. Tripartite Guideline. Available at: http://www.ifpma.org/ich1.html
9. European Forum for Good Clinical Practice. 1997. Guidelines and Recommendations for European Ethics Committees. Available at: http://www.efgcp.org/
10. Department of Health. UK. 1997. Local Research Ethics Committees HSG (91) 5, and Ethics Committee Review of Multi-centre Research Establishment of Multi-centre Research Ethics Committees HSG (97) 23. Department of Health. Stationery Office.
11. I b i d.
12. S.J.L. Edwards, T. Stone & T. Swift. Differences in the Judgements of Research Ethics Committees: An Empirical Review. In preparation.
13. M. Clarke & I. Chalmers. Meta-Analyses, Multivariate Analyses, and Coping with the Play of Chance. Lancet 1998; 351: 1062-1063.
14. I b i d.
15. M. Warnock. A National Ethics Committee: To Meet the Growing Public Demand for Candour. BMJ 1988; 297: 1626-1627.
16. P.G. Stone & C.F. Blogg. Local Research Ethics Committees. National Research Ethics Committee is Needed. BMJ 1997; 315: 60-61.
17. There are now published guidelines that move in this direction. However, these guidelines concern only the establishment of the audit process rather than describing what would be evaluated, e.g. consistency, the worth of the judgements reached etc. European Forum of Good Clinical Practice. European Guidelines for Auditing Ethics Committees. Work in Progress. Available at: http://www.efgcp.org/index.asp
18. Ibid. Section 4.10.
19. Section 7.3 of the new governance arrangements states that standard operating procedures shall be compatible with European and UK law.
20. I b i d.
21. Smith, op. cit. note 4, pp. 36-37.
22. I. Kant. 1997. Groundwork of Metaphysics of Morals. Introduction by C.M. Korsgaard. M. Gregor, ed. Cambridge. Cambridge University Press.
23. T. Hill. 2000. Respect, Pluralism and Justice. Oxford. Oxford University Press: Chapter 3.
24. J. Rawls. 1971. A Theory of Justice. Cambridge, MA. Harvard University Press.
25. I b i d.
26. Department of Health and Human Services. January 1983. Non-Local IRB Review. Memorandum. US Food and Drug Administration: 1-2.
27. Ibid. Section 2. Emphasis added.
28. R.E. Ashcroft, D.W. Chadwick, S.R.L. Clark, R.H.T Edwards, L. Frith, & J.L. Hutton. Implications of Socio-Cultural Contexts for the Ethics of Clinical Trials. Health Technology Assessment 1997; 1: 9.
29. W. Kymlicka. 1989. Liberalism, Community, and Culture. Oxford. Clarendon Press.
30. For more detailed discussion see: Ruth Chang, ed. 1997. Incommensurability, Incomparability, and Practical Reason. Cambridge, MA. Harvard University Press.
31. Rawls, op. cit. note 21.
32. Paul M. McNeill. 1993. The Ethics and Politics of Human Experimentation. Cambridge, NY. Cambridge University Press.
33. Moreno, op. cit. note 4, pp. 55-72.
34. J. Habermas. 1992. Moral Consciousness and Communicative Action. Cambridge. Polity Press.
35. N. Daniels. Accountability for Reasonableness. BMJ 2000; 321: 1300-1301.
36. T. Hill. 2000. Respect, Pluralism and Justice. Oxford. Oxford University Press: 82.
37. R.E. Ashcroft. Research Governance: Between Regulation, Morality and Ethics. New Review of Bioethics 2004; 1: 41-58.
38. T.L. Beauchamp & J.F. Childress. 1994. Principles of Biomedical Ethics. Fourth edition. Oxford. Oxford University Press: 92-99. T.H. Engelhart Jr. 1976. Introduction. In Science, Ethics, and Medicine. Tristram H. Engelhart Jr. & Daniel Callahan, eds. Hastings-on-Hudson, NY. Hastings Center.
39. T.L. Beauchamp & J.F. Childress. 1994. Principles of Biomedical Ethics. Fourth edition. Oxford. Oxford University Press: 92-99. T.H. Engelhart Jr. 1976. Introduction. In Science, Ethics, and Medicine. Tristram H. Engelhart Jr. & Daniel Callahan, eds. Hastings-on-Hudson, NY. Hastings Center.
40. European Forum of Good Clinical Practice, op. cit. note 14.