Ethics and evaluating infection control

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Infection control, especially of healthcare associated infections, presents major challenges to not only the costs and effectiveness of healthcare in Australia; but also the management of hospitals and health care institutions; the professional responsibilities of health care professions; and the welfare of patients.

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The challenge is the subject of national guidelines and standards issued by the National Health and Medical Research Council (NHMRC) and collected by the Australian Commission on Safety and Quality in Health Care. There is no lack of practical advice on preventing infection from guidelines to standard signage to online instruction modules and toolkits.
The ethical basis for such programs and guidelines merits consideration. Insofar as the guidelines set out conduct to be followed by healthcare professionals, the ethical basis sits squarely on the conventional ground of non-maleficence and the prevention of harm to patients. A similar basis could be found in the protection of healthcare professionals from harm that adhering to the guidelines will achieve. This is an understandable expression of the individual focus that has dominated the modern development of medical ethics with its focus on the dyadic relationships between patients and healthcare professionals. In this focus, the importance of acting for the benefit of individual patients, respecting their autonomy by providing information that will inform their decisions about treatment and care and minimising harm are now familiar to modern healthcare professionals. Fulfilment of these obligations is central to establishing the trust of healthcare professionals by patients that it is essential to the effective functioning of a healthcare system.
Those same professionals will also be familiar with the well-defined situations in which those ethical responsibilities to individual patients give way to responsibilities to prevent predictable harm to others in the community. There is now clear legal authority, for example, to notify public health authorities in relation to certain infectious diseases and to include in those notifications identifying information of patients who present that risk. The statutory base of these exceptions is a clear expression of public acceptance that, in those circumstances, those community interests are more important than ethical obligations to individual patients.
Infection control is an example of the recognition of both ethical obligations. It is important because it addresses the risk to treatment of individual patients but also because it addresses the risk of infection to others in the immediate community of a hospital or a wider community beyond. Fulfilling responsibilities to achieve infection control is also important in building trust communities need to have in their healthcare institutions.
These two ethical frames come into sharp relief in studies or assessments of the effectiveness of infection control measure and procedures. A clear example was the Keystone study that involved an assessment of the impact of recommended interventions to prevent catheter related bloodstream infections in a large number of intensive care units in Michigan [1]. Towards the end of the study, a complaint was made to the Federal research ethics agency (Office for Human Research Protections) that the study should have had institutional review board ethics approval but did not.
The agency agreed that review had been necessary but that it was ethically justifiable not to require the consent of health professionals whose conduct was being studied.
The details of that story depend heavily on statutory definitions in United States regulations. However, evaluations of the effectiveness of infection control measures do raise a tension between, on the one hand, the conventional individualistic ethical principles of human research ethics and, on the other, the ethical foundations of infection control and possibly even the emerging ethics of the practice of public health.
As research projects, these evaluations would normally involve carefully assessing the value and validity of the proposed assessment, the risks and benefits to participants, whether health professionals or patients establishing appropriate procedures to seek the voluntary consent of those participants based on information about their involvement.
On the other hand, the community importance of identifying effective infection control measures may have more ethical weight and may justify at least waiving the requirement for the conventional voluntary and informed consent to participation, if not the need for formal ethical review and approval by a human research ethics committee.
Alternatively, these evaluations and assessments could be regarded as quality improvement or even as public health surveillance, emphasising the wider community and public health ethical values and follow established institutional approval processes for these activities.
The Keystone experience is salutary and suggests that at institutional, regional or even national levels in Australia, it would be prudent to provide guidance to infection control practitioners and institutions on the ethical considerations that need to inform the conduct of the evaluation of infection control measures.
Colin Thomson
BA, LLB, LLM (Sydney)
www.ehealthinfo.gov.au
Colin Thomson, BA, LLM (Sydney) is Professor of Law at the University of Wollongong and Academic Leader for Health Law and Ethics in the Graduate School of Medicine. He also works as a consultant.
He was a member of the Medical Research Ethics Committee (1988-91) of the National Health and Medical Research Council and, from 1998-2002 a member, and from 2006- 2009, chair of the Australian Health Ethics Committee. As a consultant, he has advised NHMRC, FaHCSIA, Health Departments of NSW, Qld and Vic and several universities. He is a Senior Consultant with Australasian Human Research Ethics Consultancy Services (www.ahrecs.com).
Colin has provided training to human research ethics committees, chairs the CSIRO Social Science HREC and is a member of HRECs at Department of Health and Ageing and University of Wollongong/ Illawarra Shoalhaven LHD.
He is a joint author of Good Medical Practice: professionalism, ethics and law, 2010, Cambridge University Press.