International variation in ethics committee requirements: comparisons across five Westernised nations
Tóm tắt
Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.
Tài liệu tham khảo
Beauchamp T, Childress J: Principles of biomedical ethics. New York: Oxford University Press,. 1994
National Advisory Committee on Health and Disability Services Ethics. National Standard for Ethics Committees. Wellington;. 1996
Smith R: BMJ's preliminary response to the need for ethics committee approval. BMJ. 2000, 320: 322-323. 10.1136/bmj.320.7230.322.
University of Auckland Human Subjects Ethics Committee. Revised Guidelines for Applicants. Auckland: University of Auckland;. 1999
Paul C: Health researchers' views of ethics committee functioning in New Zealand. NZMJ. 2000, 113: 210-4.
Redshaw ME, Harris A, Baum JD: Research ethics committee audit: differences between committees. J Med Ethics. 1996, 22: 78-82.
Dal-Re R, Espada J, Ortega R: Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. J Med Ethics. 1999, 25: 268-73.
Alberti KG: Local research ethics committees. BMJ. 1995, 311: 639-40.
Ahmed AH, Nicholson KG: Delays and diversity in the practice of local research ethics committees. J Med Ethics. 1996, 22: 263-6.
Harries UJ, Fentem PH, Tuxworth W, Hoinville GW: Local research ethics committees. Widely differing responses to a national survey protocol. J R Coll Physicians Lond. 1994, 28: 150-4.
Hotopf M, Wessely S, Noah N: Are ethical committees reliable?. J R Soc Med. 1995, 88: 31-3.
Stone PG, Blogg CF: Local research ethics committees. National research ethics committee is needed. BMJ. 1997, 315: 60-1.
Koski G: Risks, benefits, and conflicts of interest in human research: ethical evolution in the changing world of science. Journal of Law, Medicine & Ethics. 2000, 28: 330-1.
Weijer C: The ethical analysis of risk. Journal of Law, Medicine & Ethics. 2000, 28: 344-61.
Levine R: Ethics and regulation of clinical research. New Haven: Yale University Press,. 1988, 2
King NM: Defining and describing benefit appropriately in clinical trials. Journal of Law, Medicine & Ethics. 2000, 28: 332-43.
Chalmers D, Pettit P: Towards a consensual culture in the ethical review of research. Australian Health Ethics Committee. Med J Aust. 1998, 168: 79-82.
Wolpe P: The Triumph of Autonomy in American Medical Ethics. In: Bioethics and Society: Sociological Investigations of the Enterprise of Bioethics. Edited by: DeVries R, Subedi H. 1998, New York: Prentice-Hall, 38-59.
Childress J: The place of autonomy in bioethics. Hastings Center Report. 1990, 20: 12-17.
Gross ML: Autonomy and paternalism in communitarian society. Patient rights in Israel. Hastings Center Report. 1999, 29: 13-20.
Savulescu J, Chalmers I, Blunt J: Does setting good practice standards for research ethics committees increase their legal liability?. BMJ. 1997, 314: 1833-
Goodman NW, MacGowan A: Are research ethics committees behaving unethically? If committees were sued who would be liable?. BMJ. 1997, 314: 676-7.
Harvey I, Chadwick R: Compensation for harm: the implications for medical research. Soc Sci Med. 1992, 34: 1399-404. 10.1016/0277-9536(92)90148-J.
Wilson A, Grimshaw G, Baker R, Thompson J: Differentiating between audit and research: postal survey of health authorities' views. BMJ. 1999, 319: 1235-
Graham IFM: Audit and research: greater clarity needed. BMJ. 1999, 319: 1321-
Choo V: Thin line between research and audit. Lancet. 1998, 352: 337-8.
Goodyear-Smith F, Arroll B: Audit or research?. NZMJ. 2001, 114: 500-502.
The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6939/3/2/prepub