Research ethics committees deserve support
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《英国医生杂志》
1 South West Multicentre Research Ethics Committee, Lescaze Offices, Dartington TQ9 6JE jialexander@macunlimited.net
I agree with Wade that audit and certain kinds of research have similarities in purpose, structure, and ethics and that audit is not reviewed within the same strict ethical guidelines.1 However, this does not indicate that "research and audit cannot be distinguished." The definitions and differences have been published.2 3 Audit and research surveys raise similar issues regarding validity, confidentiality, inconvenience, and the revelation of unacceptable practice, but the potential ethical problems are less than for, say, trials of medicines. Both audit and surveys merit a thorough but possibly truncated review.
Who should decide?
Wade says that the decision of an ethics committee should not be accepted without question because the decisions of committees may vary. A research ethics committee is formed of medical, paramedical, and lay representatives, including pharmacists and statisticians, men and women. It considers the conflicting ethical interests of, say, the goal of the research, the risks and potential benefits, the autonomy of participants, and the duty of care owed to participants. Different committees may weight these factors differently, but provided that consideration is thorough, the review is valid. Unfavourable opinions are not given for minor reasons. Committee members who have a vested interest are excluded. This cannot be said of the researcher and not always of a third party. A journal editor, for example, has an interest in publishing controversial or newsworthy articles that will be quoted.
Placing ethical responsibility with journals is dangerous. If journals consider the moral aspects by obtaining their own review or asking the author to discuss the ethical dilemmas within the paper instead of accepting the opinion of an ethics committee, unethical actions may have already taken place by the time of publication. Unacceptable risks may have been taken, autonomy compromised, or participants recruited with inadequate or biased information.
Investigators cannot be relied on
Informed consent receives scant mention except that it should be proportionate—that is, the investigator should decide how much the participant should be told. This view has led to scandals and eroded trust.4 Participants being given inadequate or misleading information is the most frequent cause of concern to research ethics committees. Guidance, based on law and ethics, for providing information is published with the research ethics application form, but few investigators meet the standard. Information leaflets should be understood by all for whom they are intended. The imposition of conditions and interventions greater than those presumed from the information causes rancour.5 Physical risk is not the only determinant. The undisclosed retention of superfluous biopsy tissue, or organs from dead people, which holds no risk for the owner, has been shown to be unacceptable to the public.
If investigators are to take more responsibility for the ethical concerns of research and audit, they will need to be trained in the same way as research ethics committees. They can avail themselves of training by serving on these committees. The trusts, or their patients, stand to gain from research. They should encourage attendance.
Competing interests: JA has reviewed nearly 4000 research proposals.
References
Wade DT. Ethics, audit, and research: all shades of grey. BMJ 2005;330: 468-71.
National Institute for Clinical Excellence. Clinical audit. www.nice.org.uk/page.aspx?o=may2004content.ourguidance.otherniceguidance.clinaudit (accessed 27 Jan 2005).
United Bristol Healthcare NHS Trust Clinical Audit. How to tell the difference between audit and research. Bristol: UBHT, 2000.
Laurence J. Parents were misled over hospital trials that killed premature babies. Independent 2000 May 8.
Stone TJ. Rationality, informed consent and patient decision making for clinical trials. . Bristol: University of Bristol, 2004.(John Alexander, chair1)
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Who should decide?
Wade says that the decision of an ethics committee should not be accepted without question because the decisions of committees may vary. A research ethics committee is formed of medical, paramedical, and lay representatives, including pharmacists and statisticians, men and women. It considers the conflicting ethical interests of, say, the goal of the research, the risks and potential benefits, the autonomy of participants, and the duty of care owed to participants. Different committees may weight these factors differently, but provided that consideration is thorough, the review is valid. Unfavourable opinions are not given for minor reasons. Committee members who have a vested interest are excluded. This cannot be said of the researcher and not always of a third party. A journal editor, for example, has an interest in publishing controversial or newsworthy articles that will be quoted.
Placing ethical responsibility with journals is dangerous. If journals consider the moral aspects by obtaining their own review or asking the author to discuss the ethical dilemmas within the paper instead of accepting the opinion of an ethics committee, unethical actions may have already taken place by the time of publication. Unacceptable risks may have been taken, autonomy compromised, or participants recruited with inadequate or biased information.
Investigators cannot be relied on
Informed consent receives scant mention except that it should be proportionate—that is, the investigator should decide how much the participant should be told. This view has led to scandals and eroded trust.4 Participants being given inadequate or misleading information is the most frequent cause of concern to research ethics committees. Guidance, based on law and ethics, for providing information is published with the research ethics application form, but few investigators meet the standard. Information leaflets should be understood by all for whom they are intended. The imposition of conditions and interventions greater than those presumed from the information causes rancour.5 Physical risk is not the only determinant. The undisclosed retention of superfluous biopsy tissue, or organs from dead people, which holds no risk for the owner, has been shown to be unacceptable to the public.
If investigators are to take more responsibility for the ethical concerns of research and audit, they will need to be trained in the same way as research ethics committees. They can avail themselves of training by serving on these committees. The trusts, or their patients, stand to gain from research. They should encourage attendance.
Competing interests: JA has reviewed nearly 4000 research proposals.
References
Wade DT. Ethics, audit, and research: all shades of grey. BMJ 2005;330: 468-71.
National Institute for Clinical Excellence. Clinical audit. www.nice.org.uk/page.aspx?o=may2004content.ourguidance.otherniceguidance.clinaudit (accessed 27 Jan 2005).
United Bristol Healthcare NHS Trust Clinical Audit. How to tell the difference between audit and research. Bristol: UBHT, 2000.
Laurence J. Parents were misled over hospital trials that killed premature babies. Independent 2000 May 8.
Stone TJ. Rationality, informed consent and patient decision making for clinical trials. . Bristol: University of Bristol, 2004.(John Alexander, chair1)