Ethics is a pause to wonder, to question, to step back, to notice. (Moules, 2006, p. 7.)

In 2006, researchers at Johns Hopkins University published results of a program designed to prevent specific types of hospital infections in intensive care units. The program involved a simple, five-step checklist to remind physicians that before implementing specific procedures, such as inserting central lines into patients, they should carry out routine precautions, for example washing their hands and wearing a sterile gown and gloves. After three months of using the checklist, the rate of bloodstream infections from the central lines was decreased by two-thirds. Researchers estimated that in the 18-month period following implementation of the checklist, the program saved more than 1,500 lives and nearly $200,000,000 (Gawande, 2007).

In spite of these amazing results, the Office for Human Research Protections (OHRP) in Michigan, where the checklist program had been implemented by Johns Hopkins University researchers, halted the program. Further, Johns Hopkins was required to discontinue its plans to extend the program to hospitals in New Jersey and Rhode Island. Why was this decision made? The Office for Human Research Protections ruled that federal monitoring and written informed consent from patients should be required for the study in the same way that these would be required for the research (Gawande, 2007).

This scenario raises interesting, ironic, and difficult ethical questions for healthcare professionals. With increasing evidence of unnecessary surgery, inappropriate use of medications, inadequate preventive measures, avoidable exacerbations of chronic conditions, and other errors and waste, initiatives to improve quality of care have become a major force in shaping healthcare. These diverse initiatives share a common goal of generating knowledge that will guide improvements in healthcare (Casarett, Karlawish, & Sugarman, 2000). Some of the most effective approaches have evolved from methods pioneered in manufacturing: pursuing high quality by systematically implementing changes, and monitoring the effects of those changes to guide ongoing improvement. This general approach has come to be called “quality improvement” (Johnson, Vermeulen, & Smith, 2006).

Previously, organizational efforts that focused on quality improvement of healthcare had been exempt from scientific research regulations (Gawande, 2007). Increasingly, however, organizational efforts are focusing on more scientific approaches to studying enhancement of quality in healthcare. How will future decisions be made to ensure that vital quality improvement initiatives are implemented within appropriate guidelines focused on patient safety?

Ethical issues arise in quality improvement because attempts to improve care for some patients may inadvertently cause harm or may benefit some at the expense of others; these ethical concerns mirror those in which patients are used as subjects in medical research (Casarett, Karlawish, & Sugarman, 2000). Gawande (2007) notes that although the decision of Michigan’s Office for Human Research Protections in response to the quality improvement checklist initiative was questionable and even dangerous, there was a certain logic to it: A checklist is an alteration in medical care similar to an experimental drug. It is unethical to use an experimental drug in people without federal monitoring and explicit written permission from each patient. Therefore, the ruling stated, it is unethical to do the same with a checklist. In fact, the agency concluded that a checklist may require even more stringent oversight because collecting data might bring risk to not only patients, but also healthcare providers, whose failure to follow basic infection-prevention procedures might be exposed.

Thus, the increasingly scientific approaches to quality improvement measures are obscuring a clear difference between quality improvement activities and research activities. Both ask clinically important questions and have improvement of patient care as a goal. Both approaches may download information from hospital or billing databases, apply complex statistical analyses to those data, and retrieve patient information directly from the bedside (Morris & Dracup, 2007). Key federal agencies have disagreed about the boundaries between research and quality improvement. This lack of consensus has important implications for patients, as well as researchers, quality improvement practitioners, healthcare organizations, funding agencies, policymakers, and Institutional Review Board (IRB) members.

Since the appearance of the Health Insurance Portability and Accountability Act (HIPAA), the clinical research environment has become more complex in terms of regulatory oversight and the overlap between quality improvement and research has come under increasing scrutiny (Morris & Dracup, 2007). If a quality improvement initiative is judged to be “research,” federal regulations require a variety of procedures to be followed for protection of the human subjects involved. If quality improvement activities are implemented under research regulations, this may precipitate substantial delays, costs, and conflicts.

Pausing to wonder, to question, to step back, to notice

On February 15, 2008, the National Office for Human Research Protections (OHRP) concluded its review of the Johns Hopkins checklist project and determined that “Michigan hospitals can continue implementing a checklist to reduce the rate of catheter-related infections in intensive care unit settings (ICUs) without falling under regulations governing human subjects research” (OHRP, 2008a). Although it was determined that the media frenzy triggered by the project involved some factual misperceptions and misunderstanding of governing regulations (IRB Forum, 2008), the ethical questions raised by the controversy are important. A variety of criteria have been suggested for helping to differentiate between quality improvement and research and for ensuring that the rights and interests of those who participate in quality improvement initiatives are protected.

One framework proposes two criteria to determine whether a quality improvement initiative should be reviewed as research. These two proposed criteria for reviewing a study as research are that: (a) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (b) additional risks or burdens are imposed to make the results generalizable (Casarett, Karlawish, & Sugarman, 2000). Another framework was put forward by The Hastings Center, which convened stakeholders from a variety of disciplines to address ethical requirements for quality improvement (Hastings Center, 2006). This group defined quality improvement as a systematic, data-guided process that is an intrinsic part of normal healthcare operations and designed to bring about immediate improvements in healthcare delivery. The group formulated a framework that would use key characteristics of a project and its context to categorize it as quality improvement, research, or both, with the potential of a customized institutional review board process for the overlap category (Hastings Center, 2006).

The United States Department of Health and Human Services is reviewing guidelines for evidence-based, quality improvement activities, such as the Johns Hopkins project, to determine whether any changes are needed to encourage such work while safeguarding the rights and welfare of human subjects (OHRP, 2008a). OHRP has implemented guidelines for helping institutions to evaluate and strengthen the quality of their human research protection programs for both quality assurance/improvement and human subjects research (OHRP, 2008b). Objectives and an overview of the OHRP Quality Improvement Program are contained in a 2002 document (OHRP, 2002). This document provides guidelines to help institutions identify strengths and areas for improvement; clarify regulatory requirements; provide detailed review of IRB written procedures; identify "best practices;" explore ways to improve the quality, efficiency, and effectiveness of IRB administration; and foster partnerships and collaborations among institutions.

Ethical oversight of the systematic collection and analysis of patient data for any purpose is the responsibility of nurses and other healthcare professionals. The newly revised Code of Ethics for Nurses provides important insights into the increasing complexity of ethical issues (Fowler, 2008). Interpretive Statement 3.3 of the Code, Protection of Participants in Research, notes “the complexity of options that occur when research is combined with care” (Fowler, 2008, p. 29). As reflected by the six articles focused on the January 31, 2008 OJIN topic, First Genetics, Now Genomics: What Do Nurses Need to Know?, as well as many previous articles in OJIN that address critical issues in healthcare, we need to pause to consider how the stellar breakthroughs in scientific medicine and the increasing complexity of healthcare will affect ethical decision making.

The two models of deontological ethics and consequential ethics, focusing on a rule-governed procedure of decision making, have been dominant for a long time (Dinkins, 2006; Slosar, 2006). Rules that “fit” in a less complex healthcare environment, however, may no longer be applicable; an important element of being a moral practitioner is to thoughtfully and deliberately examine the “rules.”  Within bioethics, the principles of the good and the right often conflict with one another in situations where “morally perplexing healthcare decisions must be made” (Slosar, 2006, p.142). The goal of medicine is to ensure the best possible outcome for each patient, but healthcare providers address this goal within a maze of diverse value perspectives, professional codes of ethics, institution-specific policies, and state and federal regulations.

New ethical perspectives may be found, not only by looking into the future, but by reflecting back on ancient ethical ideas (Dinkins, 2006; Slosar, 2006). Socrates believed that all searches for the good must take place through dialogue, in a respectful exchange of ideas. Dialogue among quality assurance experts, researchers, oversight specialists, and institutional representatives, as well as the public, can help to focus attention on the increasing complexity of ethical decision making in today’s healthcare environment.

It is only recently that ethical decision making has focused on the healthcare organizations themselves. Creating ethical spaces for dialogue within an organization is essential in order to provide opportunities for reflection and discussion about protection of all within the healthcare community and to ensure safe and improved patient care. It is evident that healthcare organizations will see increasing complexity and struggle with new ethical questions. Rather than retreating to long-held rules and regulations, it may be time to question, to step back, to notice -- ethics is a pause to wonder.

Jeanne Merkle Sorrell, PhD, RN, FAAN
E-mail: Jsorrell@gmu.edu

Jeanne Merkle Sorrell is Professor in the School of Nursing, College of Health and Human Services at George Mason University. She earned a BSN from the University of Michigan, a MSN from the University of Wisconsin, and a PhD from George Mason University. Her scholarly interests focus on philosophical inquiry, writing across the curriculum, qualitative research, and ethical considerations for patients with chronic illness. Her current research uses interpretive phenomenology to explore ethical concerns in the lived experience of patients and caregivers with Alzheimer's Disease. Findings from the research are presented in a video, Quality Lives: Ethics in the Care of Persons with Alzheimer's, and a play, Six Characters in Search of an Answer, both of which received Sigma Theta Tau International Media Awards.