Ethics is about questioning morality, what is right and what is wrong (Gensler, 2011).We can divide the questions surrounding these morality issues into 2 categories; metaethics, which considers the nature and methodology of moral judgements, and normative ethics, which questions the chosen principles that people chose to live by (Gensler, 2011).For example, “What is good?” , “What does good mean?” and “How do we know something is good?” are all questions considered under the metaethics branch of ethics (Gensler, 2011).Questioning how we ought to apply those metaethics to everyday life in order to maximise benefit for all is a feature of normative ethics. “What are the basic virtues and rights?”, “What would make a just society?” are questions that cover this characteristic (Gensler, 2011).
Quality improvementin healthcare is a cyclical process employed to improve a process or a system (U.S. Department of Health and Human, 2011). While this process is efficient in improving patient care outcomes, it can come under fire when considered from an ethics point of view (Jennings, 2007).Groups such as the World Health Organisation have outlined specific guidelines regarding the ethical treatment of human beings involved in research, including their right to information, right to choice and causing them no harm (WHO, 2000).Ethical issues arise in QI because attempts to improve the quality of care for some patients may sometimes inadvertently cause harm, or may benefit some at the expense of others, or may waste scarce health care resources. Ethical issues also arise because some activities aimed at improvement have been interpreted as a form of medical research in which patients are used as subjects (Baily, Bottrell, Lynn & Jennings, 2006). If this interpretation is correct, QI would be subject to the same complex review and regulatory requirements that have been set up to govern biomedical and other types of human-subjects research. But is this type of regulation necessary, given what QI involves (Jennings, Baily, Bottrell & Lynn, 2007)?
Clinical research is governed by this set of ethical principles.____________________________________The growing amount of research into the ethics of quality improvement is suggesting that these principles be applied to all quality improvement projects as well.Image retrieved from http://www.thehastingscenter.org/uploadedImages/Publications/Briefing_Book/clinicaltrials_requirements.gif
The overall goal of a QI effort is to improve the experience and care that the patient receives, by reducing harm and waste, in terms of wasting ideas, money, clinician time, and patient time. Both clinicians and patients have an ethical responsibility to participate in QI activities that adhere to specified ethical requirements (Barclay, 2007). The current environment surrounding the ethical management of quality improvement is resulting in quality improvement projects being delayed or made impossible by the process of review adopted to limit risks to human subjects of research (Barclay, 2007). Given that the goal of QI in health care is so focused on bettering the patient experience, can this type of regulation be considered really necessary? Is it the most effective and reasonable way to regulate QI to ensure that it is carried out in an ethical fashion? These questions are important conceptually and practically. Thus far, however, relatively few attempts have been made to address QI from an ethical perspective, and the interface between research and quality improvement has not been adequately explored or defined (Barclay, 2007).
The research that has been carried out in the field of quality improvement and its relation to ethics has concluded that recommendations should be followed when quality improvement projects are implemented.Image taken from Clipart.
The line between QI activities and non-QI activities are not always clear. This may be aided by the employment of the ‘Common Rule’ of research:Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (National Center for Ethics in Health Care, 2006).
Licensing standards, accreditation requirements, and statutory and case law ConfidentialityBest interests of the patient
Ensure that increasing patient protection does not impede quality improvement efforts (National Center for Ethics in Health Care, 2006).
A nominated person must be clearly responsible for the correct ethical conduct during a QI project, to make sure that ethical standards are followed and upheld. This recommendation ensures that the judgement of ethical dilemmas stays constant and there is no opportunity for bias (National Center for Ethics in Health Care, 2006).
It is unacceptable to impose any burden on patients unless a project can reasonably be expected to be valuable. QI projects should be well designed and the measures they use should be reliable and valid. To increase the likelihood of benefit, QI projects should be conducted by well-supervised personnel with adequate training or access to consultative advice (National Center for Ethics in Health Care, 2006).
Fairness is a central principle of the ethical conduct of research (National Center for Ethics in Health Care, 2006).
Different institutions have different ethical considerations.
Basically, it is a responsibility of hcw’s to participate in QI to continually improve care, while at the same time protecting the rights and best interest of the patient. The ethical dilemma exists in where to draw the line between protection and the need for improvement.
When an outcome of a process or system does not meet the necessary or desired quality.To identify areas/processes that are causing deficit to a final outcome.To test and implement positive change. To monitor progress of outcomes.
Reduce harm and Ethical QI projets Is it justified andGoal of QI ? waste implications delayed/cancelled neceiessary?
Health care organizations should recognize that QI cannot always be meaningfully differentiated from other activities that occur in the clinical arena, notably treatment and research
Health care organizations should ensure that the rights and interests of patients involved in all health care activities – including QI – are adequately protected.
Health care organizations should take care that efforts designed to protect patients do not unnecessarily encumber the QI process.
Health care organizations should clearly define the locus of responsibility for the ethical conduct of QI.
Health care organizations should proactively promote the ethical conduct of QI.
QI activities should produce benefits that outweigh their potential burdens or risks.
QI activities should respect each patient’s right to self-determination.
QI activities should preserve patients’ privacy and confidentiality.
QI activities should be fairly distributed across patient groups.
Health care organizations should develop specific policies and procedures that fit their unique circumstances and needs
Baily, M., Bottrell, M., Lynn, J., & Jennings, B. (2006). The ethics of using QI methods to improve health care quality and safety. Garrison, NY: The Hasting’s Center. Barclay, L. (2007). Guidelines issued for ethics of quality improvement. Annals of internal medicine, 146, 666-673. Gensler, H. (2011). Ethics. New York, NY: Routledge. Jennings, B., Baily, M., Bottrell, M., & Lynn, J. (Eds.). (2007). Health care quality improvement: Ethical and regulatory issues. Garrison, NY: The Hastings Center. National Centre for Ethics in Health Care. (2006). Recommendations for the ethical conduct of quality improvement. Retrieved from http://www.ethics.va.gov/docs/necrpts/NEC_Report_20020501_Ethical_Conduct_ of_Quality_Improvement.pdf U.S. Department of Health & Human. (2011). Report to congress: National strategy for quality improvement in health care. Ontario: Queens Printer. World Health Organization. (2000). Operational guidelines for ethics committees that review biomedical research. Geneva, Switzerland: Author. World Health Organization. (2012). Ethics. Retrieved from http://www.who.int/topics/ethics/en/