Explanation & Elaboration

7. Ethical issues

• Describes ethical aspects of implementing and studying the improvement, such as privacy concerns, protection of participants' physical well-being, and potential author conflicts of interest, and how ethical concerns were addressed

Example

1. "Residents [of the nursing home] who were not expected to live more than 30 days from the date of enrollment (as judged by their attending physician and nurse),those residents with a history of anaphylactic or serious allergic reaction to fluoroquinolones, or those residents with advance directives precluding transfer to hospital were excluded. The research protocol was approved by St Joseph's Healthcare Hamilton Research Ethics Review Board. All participants or their designated surrogate decision makers gave informed consent." [23]  
   
   "Study nurses made routine visits to the nursing home to assess resident eligibility, discuss the trial obtain informed consent, and enrolled residents." [23]
2. "[T]he purpose of our improvement project was to improve the consistency and reliability of the caesarean delivery process and to achieve emergency caesarean delivery response times of less than 30 minutes." [24]

Elaboration

A quality improvement publication should reflect and affirm that ethical standards have been addressed in the planning and implementation of the study. As efforts to enhance the quality of health care grow, there is a need to ensure that ethical practices are reflected in these efforts. The ethical principles of autonomy (do not deprive freedom), beneficence (act to benefit the patient, avoiding self-interest), non-maleficence (do not harm), justice (fairness and equitable care), and do your duty (adhering to one's professional and organizational responsibilities) form a foundation for the delivery of health care. Those same principles should underpin the planning, implementation, and publishing of quality improvements activities.

Some of the specifically noted ethical standards for quality improvement activities are derived from the above principles and include the following: social or scientific value from the QI activity (responsible application of limited resources); scientifically valid methodology (avoiding inappropriate harm to subjects and waste of resources); fair participant selection to achieve an equitable distribution of burdens and benefits (justice); favorable risk-benefit, limiting risks and maximizing benefits (non-maleficence, avoiding harm); respect for participants by respecting privacy and confidentially (respect for individual autonomy); informed consent when minimal-risk quality improvement activities is part of patient's treatment (respect for autonomy); and, independent review of the ethical conduct and accountability of the quality improvement (professional, organizational, and public accountability). [25]   Another ethical standard related to professional responsibility and organizational accountability is avoiding any real or perceived conflicts of interest. These ethical standards form the foundation for ensuring the ethical quality of QI. 

Example (a) above is from a formal, planned QI research study designed to produce generalizable results. The reader has a clear understanding that the study addressed ethical standards because the protection of the participants was noted in both the research design and consent process. The other ethics guidelines were addressed as part of the independent review process. Because this example meets the generally accepted interpretation of a research project as reflected in the Common Rule as a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge," [26] the quality improvement activity must adhere to these requirements. The article indicates that the QI protocol was reviewed and approved by the St Joseph's Healthcare Hamilton Research Ethics Review Board. This statement verifies that the protocol received independent review, suggesting that its protocol was appropriately designed to address a scientifically and socially important question, used a fair participant selection process, obtained adequate informed consent process, and involved a suitable risk-benefit ratio. 

The authors in example (a) provided further detail on the ethical conduct of the project by stating that study nurses discussed the trial and sought informed consent to enroll eligible patients who met the inclusion criteria. Those nursing home "residents who were not expected to live more than 30 days...or those residents with advance directives precluding transfer to hospital were excluded" from the study. [23]  The reported findings indicate that some nursing homes chose not to participate in the study. The authors also report that "consent could not be obtained from next of kin" from a total of 89 nursing residents or their surrogate and 5 refused to consent to the study. [23]  The refusal to participate in the research study by some patients or their surrogates suggests the scope of the shared decision process - fostering an ethically grounded valid consent and refusal process. 

In QI, ethical standards must also be addressed in the planning and implementation of the activity because improvement activities carry the potential for risk to patients or misuse of organizational resources. In order to foster adherence to ethical guidelines, health care organizations should ensure that "ethical oversight of QI... becomes part of an enhanced accountability system for professional responsibility and the supervision and management of clinical care." (p.688) [25]  An example of non-research quality improvement providing "systematic, data-guided activities designed to bring about immediate improvements in the health care delivery in particular setting" [25] is found in example (b). [24]  The article describes a carefully planned and implemented process to improve the consistency and reliability of the caesarean delivery process in a small rural hospital; however, the publication does not explicitly indicate whether an independent review occurred, including the ethical conduct of the effort. It would be reasonable to expect that the QI project coordinators (authors) indicate that previously noted [25] QI ethical guidelines were addressed in the planning and implementation of the project. This is not meant to suggest that an institutional review board (IRB) review is necessary for such non-research QI activity; however, authors should indicate that the QI activities they are reporting adhered to appropriate ethical guidelines in their publications. 

The ethical concerns regarding potential conflict of interest in QI efforts were significantly different in the two publications. In example (a) which is a QI research publication, [23] the authors provide detailed disclosure information regarding the authors' contribution to the publication, financial disclosures, funding support, role of sponsors, and acknowledgments. The extensive disclosure at the end of article is likely to be the journal's requirement, and it provides the necessary transparency regarding any potential conflict of interest to be considered by the reader. Example (b) [24] provides only a brief acknowledgement that does not fully address the real, potential, or lack of conflict of interest. Because QI activities often seek to improve delivery practices, outcomes, effectiveness, and efficiency of health care services at a particular facility, QI investigators may encounter potential conflicting between obligations to individual patients and the general care provided by the facility or organization. Therefore, QI publications should include disclosure of conflict of interest information. 

The central issue in these examples is not whether the publication is a research project or not, rather that the reader is assured that ethical standards have been addressed in the planning and implementation of the QI activity. Transparency regarding the adherence to ethical standards is a vital aspect of the preparation of the manuscript and the journal's decision to publish - reinforcing the point that ethics is an essential element of quality and of quality improvement activities.  [27]

References

23. Loeb M, Carusone S, Goeree R. Effect of a clinical pathway to reduce hospitalizations in nursing home residents with pneumonia. JAMA. 2007;295(21):2303-2310.

24. Mooney SE, Ogrinc G, Steadman W. Improving emergency caesarean delivery response times at a rural community hospital. Quality & safety in health care. 2007;16(1):60-66.

25. Lynn J, Baily M, Bottrell M. The ethics of using quality improvement methods in health care. Annals of Internal Medicine. 2007;146(9):666-673.

26. Protection of Human Subjects 2000.

27. Nelson W, Gardent P. The linkage between ethics and quality. Healthcare Exe. 2008;in press.

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