INTRODUCTION

Quality improvement (QI) is described by the Agency for Healthcare Research and Quality as the process to test, understand, and revise processes constantly to improve the way care is delivered to patients.1 A high-reliability healthcare organization (HRO) is one that participates in QI and clinical audits as part of standard work. To achieve this, real and potential threats to reliability are solved quickly through both cognitive and behavioral standards used every time.2 Patient outcomes including reduction in patient harm, empowering patient decision-making, and improving health equity and delivery of services are enhanced through ongoing QI initiatives. Quality improvement has often been described as existing in a zone between clinical practice and health research. There is confusion of what constitutes the foundations of QI and what is required in terms of ethical oversight and by whom. There is limited international collaboration to achieve consensus on what ethical oversight or frameworks should apply to QI initiatives. A systematic qualitative review exploring the ethical issues in a learning healthcare system revealed the following3:

* Designing activities-ensuring that they do not appear to be research that may in turn result in an initiative that lacks buy-in from key stakeholders

* Ethical oversight of activities-conflict between oversight regulations and learning healthcare, confusion of what part requires ethical oversight

* Conducting oversight-when and how the participants should be notified

* Implementing learning-changing practices after QI activity, issues of transparency

The systematic review highlighted the issue that many QI initiatives do not fit into "research" or "practice," which then poses an issue as it conflicts with the regulatory system that HROs must adhere to.3

AN INTERNATIONAL PERSPECTIVE

An analysis of international practice regarding QI activities resulted in several countries being compared and explored.4 The authors of the article conducted an in-depth review at guidance on ethical review, consent, vulnerable groups, and personal health data. The countries reviewed were Ireland, England, Australia, New Zealand, Canada, United States, and the European Union (EU). A summary of their results is as follows:

Ethical Frameworks

England, Australia, New Zealand, United States, and Canada are countries that have in common an office that has oversight and responsibility for national ethical standards in health research. Ireland was identified as not having a national regulatory body for research. In the United States, there is no requirement for QI activities to undergo review by an institutional review board (IRB) if the activity is aimed at measuring and reporting provider performance for clinical, practical, or administrative uses. The national regulatory body for research in the United States is the Office for Human Research Protections.5 When comparing all the countries, 3 of them, England, Canada, and the United States, stated that QI activities are outside the scope of existing research frameworks.

Two countries including Australia and New Zealand provide ethical guidance on QI activities. In Australia, there is an ethical guidance document that is specific for QI activities, and in New Zealand, there is an integrated "National Ethical Standards for Health and Disability Research and Quality Improvement" framework that all projects including QI activities must adhere to. Canada, England, the EU, and Ireland do not routinely address the ethical considerations around QI and clinical audits. The United States has recently updated its Federal Policy for the Protection of Human Subjects otherwise known as the "Common Rule" to address QI activities in the frequently asked questions section.4 It is called the Common Rule as it has been adopted by several federal departments and agencies.

Minimal Risk

A common rule by all 6 countries was related to QI activity that presented minimal risk. All stated that it did not require ethical review by an IRB or designated committee.4 However there was no consensus in the literature of what the definition of minimal risk was. In Australia and New Zealand to overcome this lack of general definition a list of criteria is used to determine if a risk higher than minimal exists.6,7 In comparison in the United States if the QI activity represents a systematic investigation that will contribute to generalizable knowledge it is required to undergo an ethics review.8 There exists considerable variation across the countries in terms of oversight when an ethical review is required.

Consent

There is a lot of variation across the countries on requirements for consent by the participant. New Zealand is the only country that has a standard for consent in relation to QI activities that are higher than minimal risk.6 In comparison Australia, New Zealand, United States and Canada allow an ethics committee to wave requirements for consent if certain criteria are met and there is minimal risk to the participants.

Vulnerable Groups

Two countries, Australia and New Zealand had guidelines that considered QI activities involving vulnerable groups as research needing a full review by an IRB.6,7 The other countries did not have specific guidelines, and none of the countries addressed minimal risk QI activities that included vulnerable groups.

Personal Health Data

Quality improvement activities are considered by most countries to be part of standard work and best practice to improve the care of patients and improve processes. Technology, electronic medical records, and artificial intelligence present issues for research and QI. The EU has introduced the General Data Protection Regulation legislation-with the aim to harmonize data privacy laws across Europe.9 Under this legislation, data protection is a right for all EU citizens, and any use of personal data is strictly reviewed. Each country in the EU interprets the legislation individually.9 England has developed an ethical infrastructure allowing the public an avenue to exclude their healthcare information from anything not directly related to their care.10 Ireland adheres to the Health Research Regulations 2018 Act, which requires all researchers accessing healthcare information to obtain consent from all data subjects.11 In the United States, when specific criteria are met, secondary use of data without explicit consent is allowed.

CONCLUSION

Exploring the literature around QI, clinical audits, research, and ethical considerations present more questions than answers. The literature reveals divergent views on which QI should go through a full ethical review and which should be treated within a framework that focuses on learning in healthcare.12,13 There is no international consensus and common definitions, which has implications for harmonization of data across countries and for comparing outcomes. The lack of national QI ethics frameworks and best practice guideline is concerning as it presents a "conflict between regulatory systems designed for research and the flexibility required by learning healthcare systems that depend on QI."4 From the publication just summarized, it would appear that New Zealand has an approach that could be replicated by other countries.

IMPLICATIONS FOR THE CLINICAL NURSE SPECIALIST

The approach to how QI is reviewed has implications for the clinical nurse specialist (CNS). Quality improvement activities are a large part of the CNS function as well as postgraduate degrees. The doctor of nursing practice, which many CNSs and others are undertaking, often involves QI projects. It is important that the doctor of nursing practice student follow all the regulatory requirements within the institution while conducting any QI project, including permission to publish the outcome of the project. Each HRO will have its own policies and IRB requirements that must be adhered to, ensuring that protection of patient data and privacy is maintained.

References