ethical review and ethical behaviour
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《英国医生杂志》
1 Hull York Medical School, Department of Philosophy, University of Hull, Hull HU6 7RX, 2 Centre for Professional Ethics, Keele University, Keele ST5 5NA
Correspondence to: J McMillan john.mcmillan@hyms.ac.uk
Wade's main concern is that the distinction between audit and research is arbitrary and often means that attention is not paid to what is really ethically important in many aspects of medicine.1 We agree that the distinction between audit and research is difficult to sustain. He is right to insist that the features specific to proposed research or audit are what determine it's ethical importance and whether it should be scrutinised. Whether a proposal is audit or research does not and cannot affect its ethical importance.
That said, the intuitive distinction between audit and research often tracks the burdens and risks that Wade points to. So, by and large, audit involves gentler burdens and risks than (clinical) research. Although this is not always the case, audit and studies that do not require ethical scrutiny are likely to roughly correspond. (Confidentiality and consent are likely to remain important in audit-type studies.)
Part of Wade's response to the problems with the distinction between audit and research will place even greater onus on researchers to recognise ethical concerns. But if researchers were always of good character, the distinction between audit and research would not matter—part of their good character would include the recognition that this was so. The distinction has come to matter precisely because some lead investigators either cannot recognise and appreciate ethically important features or because they are unwilling to do so.
Does ethical review ensure ethical behaviour?
In one way it seems odd to question the success of ethical review in ensuring that studies are conducted ethically. However, although we think that ethical review is important, it can encourage the view that ethics is simply a matter of gaining approval from a research ethics committee. Given that ethical approval is a major hurdle for researchers, it would be surprising if many of them didn't consider approval as the beginning and end of their obligation to consider ethics. So, ethical review itself might be accused of encouraging a bureaucratic approach to ethics. It might not be the best way to ensure that people are moral, especially given that Wade suggests that ethics is concerned with the moral character of individuals, as shown by their actions.
This view of ethics is one that we find plausible, but it's one that requires more than ethical review. The moral character of individuals requires a particular kind of sensitivity to the ethically relevant aspects of research, audit, or clinical practice. This sensitivity is primarily obtained by reflection on, and education about, the content and structure of ethics. The practical upshot of this, in line with Wade's recommendations, is that the focus of ethical training should be as much on lead researchers as on ethics committees.
Competing interests: MS and the Centre for Professional Ethics provide training for research ethics committees
References
Wade D. Ethics, audit, and research: all shades of grey. BMJ 2005;330: 468-71.(John McMillan, senior lecturer in medica)
Correspondence to: J McMillan john.mcmillan@hyms.ac.uk
Wade's main concern is that the distinction between audit and research is arbitrary and often means that attention is not paid to what is really ethically important in many aspects of medicine.1 We agree that the distinction between audit and research is difficult to sustain. He is right to insist that the features specific to proposed research or audit are what determine it's ethical importance and whether it should be scrutinised. Whether a proposal is audit or research does not and cannot affect its ethical importance.
That said, the intuitive distinction between audit and research often tracks the burdens and risks that Wade points to. So, by and large, audit involves gentler burdens and risks than (clinical) research. Although this is not always the case, audit and studies that do not require ethical scrutiny are likely to roughly correspond. (Confidentiality and consent are likely to remain important in audit-type studies.)
Part of Wade's response to the problems with the distinction between audit and research will place even greater onus on researchers to recognise ethical concerns. But if researchers were always of good character, the distinction between audit and research would not matter—part of their good character would include the recognition that this was so. The distinction has come to matter precisely because some lead investigators either cannot recognise and appreciate ethically important features or because they are unwilling to do so.
Does ethical review ensure ethical behaviour?
In one way it seems odd to question the success of ethical review in ensuring that studies are conducted ethically. However, although we think that ethical review is important, it can encourage the view that ethics is simply a matter of gaining approval from a research ethics committee. Given that ethical approval is a major hurdle for researchers, it would be surprising if many of them didn't consider approval as the beginning and end of their obligation to consider ethics. So, ethical review itself might be accused of encouraging a bureaucratic approach to ethics. It might not be the best way to ensure that people are moral, especially given that Wade suggests that ethics is concerned with the moral character of individuals, as shown by their actions.
This view of ethics is one that we find plausible, but it's one that requires more than ethical review. The moral character of individuals requires a particular kind of sensitivity to the ethically relevant aspects of research, audit, or clinical practice. This sensitivity is primarily obtained by reflection on, and education about, the content and structure of ethics. The practical upshot of this, in line with Wade's recommendations, is that the focus of ethical training should be as much on lead researchers as on ethics committees.
Competing interests: MS and the Centre for Professional Ethics provide training for research ethics committees
References
Wade D. Ethics, audit, and research: all shades of grey. BMJ 2005;330: 468-71.(John McMillan, senior lecturer in medica)