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Most discussions about the ethics of healthcare research focus on the possible harm that could be done to participants. Sometimes such deliberations will highlight tensions between the clinical duty of care to protect the life and health of individual patients to the highest standard and the need to engage in the research that makes improvements in health care possible. Because of the potential risks, patients should not be involved in research unless they have given their informed consent. Equally, they should not be asked to participate unless the project itself has been passed through a process of independent review and its risks assessed. The moral principles for such reviews are summarised in the Declaration of Helsinki. This states, among other things, that consent is only valid if it is based on detailed and appropriate information, that risks should always be proportional to potential benefit, that confidentiality should be protected, and that the interests of individuals should never be compromised solely in order to further the interests of the public.
The ethical review of healthcare research is carried out by research ethics committees (RECs) designed to implement the Helsinki principles. Few now seriously question the moral importance of this work and its centrality for sustaining the trust of research participants. While there may be criticisms of the effectiveness and efficiency of RECs, these are usually arguments for their improvement rather than against their very existence. Some healthcare professionals will always be uncomfortable with any review process that may question the moral quality of their practice. However, such discomfort is a small price to pay for achieving the more important goal of respecting human rights and reinforcing the willingness of all the relevant parties to participate in research to improve health care.
However, research is not the only activity necessary for achieving medical progress. While this work contributes to the creation of new knowledge and skills, strategies for carrying out audit and quality improvement (AQI) are also essential if these innovations are to be delivered to patients in the most appropriate ways. AQI can take a variety of forms from regular reviews of the clinical results of individual practitioners to ongoing assessments of the successes and failures of particular delivery systems and the development of strategies for their improvement. Just as it is unethical to engage in research on humans that cannot achieve its stated goals, it is also immoral to squander the potential of good research through the use of ineffective or hazardous methods to deliver it.
As the well referenced paper in this issue by Joanne Lynne demonstrates, AQI may also pose problems of its own within the terms of the Helsinki principles.1 For example, the confidentiality of medical records, patients, or staff may be breached and the wording of questionnaires may distress relatives or staff. Although these and other risks may not be as great as those associated with more conventional forms of medical research, they do need serious consideration. We need to ask whether the same moral principles applied to research proposals should be used to review proposals for AQI. A good deal of confusion surrounds this issue, along with that of how to distinguish between research and AQI.2 Certainly, if already over-stretched RECs also had to review AQI projects, they would have even less time for looking at research proposals that could potentially pose more serious hazards. Moreover the time and energy required would involve a risk of stifling new AQI initiatives.3 Yet as long as AQI strategies continue to pose at least some of the same ethical problems as research, Lynn rightly argues that a way must be found of striking the right moral balance between respect for the rights of participants and the duty to protect them and anyone else who might be potentially harmed. This will require careful assessment of different types of AQI and their risk potential.
Many proposals for AQI are so ethically benign that full REC evaluation would be absurd. An example would be a limited review of medical records with strict methods in place for the protection of confidentiality and no intent to make any further contact with patients. But even here, patients should be given explicit information about the ongoing process of quality review and why it is in the interests of everyone involved. Through a policy of opt out linked to an effective information campaign, they should have the option not to participate in such a review (although refusals are unlikely to happen if the information provided is clear). It is increasingly accepted that some element of choice should always be present when patients or staff are used to facilitate any form of healthcare inquiry. There are a variety of feasible and practical ways of achieving this as regards AQI.
Where full REC review is deemed inappropriate for an AQI project, some form of ethical review may still be appropriate. Of course, this often occurs informally during the process of project design. For example, most AQI practitioners will take care to minimise the potential distress of their questionnaires and to properly protect the privacy of those who complete them. However, review of this kind should be formalised to ensure the independence of the process.4 There is no reason to assume that this would be institutionally burdensome if it was properly organised. Were it to be so, academic journals that refuse to publish AQI results without REC approval would look silly. Until it is, they may have a point.
One very important reason for ensuring the independent review of AQI as well as research is that the line between them can sometimes become blurred. For example, as Lynn observes, although some studies may be designed only to investigate particular examples of healthcare delivery they may still propose controls and the randomisation of the population under investigation. Such proposals should be sent to a REC.5 Any form of selective intervention within health care can lead to distress and a breakdown of trust, even when there is little or no chance of other forms of harm.6 It is therefore of great importance that high standards of moral assessment—especially those concerning consent and confidentiality—are seen to be applied before studies of this kind are allowed to proceed.
Of course, requiring appropriate ethical review of all AQI initiatives’ methods may result in some of this work not taking place. The same point applies to the requirement that all healthcare research is reviewed by RECs. If this means that the rights and dignity of those who receive and deliver health care are protected—and that the moral quality of health care is preserved–it is a price worth paying.
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