Ethical Considerations of Quality Improvement and Human Subjects Research: Is There a Slippery Slope?

Introduction

The art and science of bariatric nursing has rapidly evolved over the past decade with bariatric nursing research, literature, education, and certification becoming a reality. However, bariatric nurses must be prepared to address some of the ethical dilemmas that emerge with the joys and excitement of growth. Respect for personal autonomy is an important ethical ideal, particularly in the United States. The American Constitution is grounded on principles of respect for personal autonomy, thus ideals of autonomy have become an integral part of American culture. In healthcare, the concept of consent has emerged from respect for personal autonomy. In both human subjects research (HSR) and quality improvement (QI), the mandates for consent occasionally pose questions. ¹

Both QI measures and HSR have contributed to the improvement of bariatric patient care and organizational health. Yet, bariatric nurses report that the distinctions between QI measures and HSR are often difficult to appreciate. Further, there are growing pressures to share results from both activities—QI and HSR—not only from a publication point of view, but also for use in organizational planning and marketing. Publication, whether poster, manuscript, or oral presentations, serves as a common method to communicate learning experiences among professionals, further driving best practice ideals. Yet, ethical considerations must maintain presence in such activities. Strategies to differentiate between the two categories of investigation are described herein, along with an ethical and practical approach to the same.

Defining Terms

Some experts believe that if QI is a form of HSR, it should fall under the existing regulations and oversight framework for the latter activity. Others think that QI is not research and therefore does not require the kind of oversight required for HSR. Defining terminology is the first step in clarity. Both The Centers for Medicare and Medicaid Services and The Office for Human Research Protections offer such guidance. For instance, The Centers for Medicare and Medicaid Services (CMS) defines QI as an assessment, conducted by or for an organization, of a patient care problem for the purpose of improving patient care through peer analysis, intervention, resolution of the problem, and follow-up. CMS further describes QI as a set of related activities designed to achieve measurable improvement in processes and outcomes of patient care. Improvements are achieved through interventions that target healthcare providers, practitioners, plans, and/or beneficiaries.^2,3

On the other hand, The Office for Human Research Protections, which is a national U.S. organization, provides leadership and oversight in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). To that end, The Office for Human Research Protections explains that the federal government defines HSR as a systematic investigation, designed to develop or contribute to generalizable knowledge about human disease and healthcare.^4,5

Ethical Considerations

Consent emerges from the basic bioethical principles of autonomy, beneficence, non-maleficence, and justice, but primarily respect for personal autonomy. Consent has historical roots in professional and international declarations such as the Hippocratic Oath and the Declaration of Helsinki, as well as legal considerations. In the United States and many other Western nations, autonomy is an important bioethical ideal and legal mandate. It is regarded as a personal liberty, wherein an individual chooses his or her own plan and possesses the freedom to act upon that plan. In the broadest sense, autonomy is that of being one's own person, without restriction either by another person's action or one's own psychological or physical limitations. Institutions and professionals who respect a patient's autonomy recognize the individual's unconditional worth and capacity to determine one's own destiny.

Over the past century, consent has become increasingly important to investigational activities. For example, prior to 1906 when the Pure Food and Drug Act was passed, there were no regulations regarding ethical considerations of HSR. ⁶ Further in this development was the Nuremburg trial, which charged 23 physicians and administrators with willingly conducting medical experiments on thousands of concentration-camp prisoners without their consent. In 1948, the Nuremberg Code was established, outlining that the voluntary consent of the human subject is absolutely essential in research activities, making it clear that subjects should give consent and that the benefits of research must outweigh the risks. ⁷

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was to identify basic ethical principles that underlie the conduct of biomedical and behavioral research that involved human subjects. In addition, the Commission developed guidelines to assure that research was conducted accordingly. Since 1974, a number of groups have continued to seek methods to protect patients from harm in the face of investigational activities, including the U.S. Department of Health and Human Services. On July 22, 2011, this agency announced that the federal government is further investigating methods for enhancing current regulations, which have been in place since 1991. These revisions will look at ways to better oversee HSR.^8–12

Regardless, a central ethical concern is whether the study includes identifiable patient data. Even when data are expressed numerically and there are no unique patient identifiers, professional organizations often request that authors submit protocols for Institutional Review Board (IRB) oversight. This oversight may be approved for either expedited or exempt status. In so doing, institutions signal to the external community that there was IRB recognition and that the project upheld ethical standards. When a hospital project is exempt from full IRB review, it does not mean that interaction with the IRB did not occur; rather, it simply means that the authors of the QI publication sought IRB approval with specifically designated exempt status.

The Practical Issues

From a practical perspective, one of the issues that concerns stakeholders and creates confusion is that QI and HSR seemingly share many characteristics. Experts vary about the degree to which QI should or should not be included under the umbrella of HSR. ¹³ For instance, both efforts ask clinically relevant questions, access patient data, download data from medical record databases (both clinical and billing), utilize statistical models, and have as their goal improving therapeutic, cost, or satisfaction outcomes. ¹⁴

But clearly, these activities are different, with the central factor being the potential risk to individual patients. Therein lies the consent imperative. In the face of potential harm, a well-crafted and meaningful consent document is necessary. This consent document describes for the human subject (patient) the foreseeable or unforeseeable risks and benefits associated with study participation. The patients are given a choice about whether they would like to participate.

In some cases, a project will be exempt from the organization's IRB. ¹⁵ For example, QI projects are designed to bring about improvements and sustain these improvements in healthcare institutions. Professional organizations suggest to investigators that the QI versus HSR question is addressed at the very outset of the project, not at the time a publication is submitted. Knowing how to place the project correctly within these two categories serves to ensure patient protection processes are in place, and therefore streamline the ability to share outcomes. The degree to which oversight is rendered is one practical distinction between QI and HSR.

Experts argue QI is a necessary, mandated, integral activity to a bariatric service line, but HSR is not. Authors explain that in QI projects, patients may not be exposed to more than minimal risk, so IRB may not either be necessary, or the project may be deemed exempt from the same oversight as HSR. ¹⁶

Implications for Bariatric Nurses

As bariatric nursing continues to evolve, a number of QI opportunities are created. Organizational stakeholders now recognize the clinical, humanistic, and cost concerns associated with bariatric patient care. For example, the obese are especially at risk for these events when hospitalized.^17,18 In the United States, nearly 70% of adults are overweight, although, to date, outcome studies pertaining to hospitalized obese patients are few. However, the need to understand better exists.

For example, managing immobility-related adverse outcomes and size is essential to improving care. Specific positive outcome measures might include decreased pressure ulcers, fewer falls, or improved mobilization. Further, when immobility exists, patients of all ages are at risk for immobility-related adverse outcomes, many of which are non-reimbursable, as indicated by the Centers for Medicare and Medicaid Services.^19,20 Hazards of immobility that affect all hospitalized patients may include ventilator associated pneumonia (VAP), atelectasis, delayed extubation, peristaltic impairment, wound infections, depression, social isolation, embolic conditions, urinary tract infection, extended or repeated lengths of stay, and avoidable or unavoidable pressure ulcers. ²¹ The inability to reposition patients adequately is a significant concern, especially among obese, disabled, critical care, trauma, neurologic, or orthopedic patients. ²²

QI processes offer a practical framework for outcome opportunities. QI findings may guide stakeholders to a more clinically relevant, fiscally sound approach to bariatric nursing practices. Several relevant QI questions, which impact bariatric nursing and the intersection of other science, might include, but are not limited to:

Occasionally, QI findings can be so compelling that the information ought to be shared. The concern for bariatric nurses who have completed a well-structured QI project and seek to publish results is showing how oversight was accomplished. When QI was an intervention and the proposed publication contains patient data, confidentiality and consent becomes imperative. An IRB review may thus be suggested to ensure that patient safety was upheld, consent was obtained, and HIPAA compliance was ensured in the QI activity.

Summary

In the future, QI and HSR will likely continue to drive patient and organizational care decisions pertaining to relevant and meaningful bariatric nursing. Specialized bariatric training, resources (clinical experts), and tools (equipment) are the essence of meaningful intervention and successful outcomes. ²³ The challenge in caring for complex and costly populations continues to pose clinical, humanistic, and cost concerns. Therefore, it makes sense that bariatric nurses and fiscal experts consider QI projects that examine the impact of bariatric nursing to patient outcomes (clinical and economic). Regardless, clinical and institutional experts, researchers, government policymakers, and facility stakeholders agree patient protection is at the heart of both QI and HSR efforts. Bariatric nurses and their institutions have an obligation to recognize their responsibility in ethical oversight of both QI and HSR.^24,25